A blockchain is a public ledger, yet the proceeds of crypto fraud still disappear every day. Using the AdBlast pyramid scheme, which according to press reports harmed up to 90,000 people and caused losses of around USD 32 million, we trace how investor money is moved from a “private wallet” to cash withdrawn at an ATM. We then look at the criminal, fiscal and regulatory tools available in Poland as of November 2026, a moment when MiCA’s transitional period has expired but Poland still has no national crypto-asset supervisor, and at what this means for victims seeking to recover their funds.

AdBlast: an advertising portal that was a pyramid

AdBlast presented itself as an innovative social and advertising portal based on a “revenue-share” model. In reality it was a pyramid scheme built on the Ponzi principle. The Polish competition and consumer protection authority (UOKiK) found as early as 2020 that it was a pyramid, banned the operator, Nevada-registered Alternet LLC, from continuing the practice and ordered refunds to customers (TVN24).

Users had to buy advertising packages, typically worth USD 10 to 50, and watch a set number of ads each day to earn a promised return of up to 120%. The money paid out did not come from advertisers but from new participants recruited through a highly organised multi-level marketing structure. The ads themselves were of poor quality and mostly promoted related projects or the platform’s own ecosystem, such as the Alterdice crypto exchange.

According to press reports from August 2026, up to 90,000 people may have been affected and losses reach around USD 32 million. The investigation, first conducted in Wrocław, was taken over by the National Prosecutor’s Office, which in April 2026 disclosed how the proceeds were moved: converted into crypto-assets, cashed out and withdrawn at ATMs or via BLIK. That route is the subject of the next sections.

How the money disappears: placement and layering

Schemes of this kind follow the classic three-stage laundering model, adapted to blockchain technology:

1. Placement: the victim’s money enters a wallet controlled by the organisers.
2. Layering: one-time addresses, peel chains, mixers and cross-chain swaps break the link between source and destination.
3. Integration: the “cleaned” assets return to centralised exchanges, are converted into fiat currency and withdrawn as cash or invested in real assets.

The illusion of a private wallet

The deposit is the only moment at which the investor’s verified identity, for example from buying crypto through a bank account, touches the criminal infrastructure. It is rather like showing ID at a casino cash desk before buying the first chips. When the user requests a deposit, the platform generates a unique public address for that single operation and presents it as the user’s “private wallet”. In fact it is a technical drop box whose private keys are held by the organisers, who can move the funds at any time without the supposed owner’s knowledge.

One-time addresses and dispersal

The concealment strategy rests on hierarchical deterministic wallets (standards such as BIP32 and BIP44), which generate a virtually unlimited number of linked addresses from a single master key. Once an address has received funds, it is abandoned, like a disposable cup. The aim is to avoid concentrating capital in one account that exchange monitoring systems would easily flag. Thousands of small deposits look statistically insignificant and clutter transaction graphs, making it hard to show that seemingly unrelated wallets belong to one organised structure.

Peel chains

As soon as a one-time address is funded, the system moves the money on to reduce the risk of a freeze. In a peel chain, part of the balance is sent to the next intermediary wallet and the “change” goes to a newly generated address, much like receiving change from a banknote, except that every piece of change lands in a fresh, unused box. Random time delays and varying transaction fees break behavioural patterns, forcing investigators to test a large number of dead-end paths.

Mixing, CoinJoin and cross-chain hops

Mixing services pool criminal funds with other users’ assets in a shared liquidity pool, then pay out different units. Tracing a specific coin becomes like trying to retrieve a glass of water poured into a full swimming pool. CoinJoin achieves a similar effect: many users sign one combined transaction, so an outside observer sees hundreds of inputs and outputs but cannot link a sender to a recipient. Swapping assets between blockchains adds a further layer, the digital equivalent of changing cars during a getaway.

These techniques remain difficult to unpick, but they are no longer a safe harbour. Mixer operators and developers have faced criminal prosecution in several jurisdictions, and from 10 July 2027 the EU Anti-Money Laundering Regulation (AMLR) will prohibit crypto-asset service providers from maintaining anonymous accounts or accounts that allow transactions to be anonymised, including through privacy coins.

Back into the real economy: integration

Exchanges, money mules and synthetic identities

Laundered assets must eventually return to platforms connected to the banking system, so they are moved to wallets on centralised exchanges. To get past know-your-customer (KYC) checks, organisers use money mules (in Polish slang, słupy), often recruited from socially excluded groups. They also use synthetic profiles built from stolen data and, increasingly, deepfake-based manipulation of biometric checks. To avoid losing everything to a single exchange’s freeze, deposits are spread across many smaller accounts, preferably in jurisdictions with lighter supervision.

Conversion to fiat and a paper trail of “trading profits”

The assets are then sold for fiat currency. Smaller amounts go through ordinary spot markets, where the sales blend in with normal investor activity. Large volumes are handled over the counter (OTC) by private brokers or in peer-to-peer (P2P) trades settled directly between two parties outside the public order book, which avoids moving the price and bypasses intermediaries’ internal limits. The key legal objective at this stage is documentation: when a bank or tax authority asks about the source of wealth, the organisers produce exchange statements presenting the money as legitimate profit from years of trading.

Smurfing and cash-out

Once in fiat, the funds enter the banking system. The main technique for avoiding financial intelligence scrutiny is smurfing: splitting large transfers into dozens of smaller ones below reporting thresholds. The pieces are sent to a network of accounts held by shell companies or front persons, often abroad, which slows international investigations. Transfer titles are varied to mimic everyday commercial and private payments.

The cycle ends when the money is materialised and the digital trail is cut. Couriers withdraw cash with linked payment cards at ATMs across the country or, in jurisdictions with looser rules, at bank counters. In the AdBlast case, prosecutors also point to withdrawals via BLIK. The cash is then integrated into the legitimate economy through real estate and luxury vehicles. At that point, linking it to the original one-time wallets becomes very difficult, and so does confiscation for the benefit of victims.

Criminal and fiscal liability in Poland

Organisers and helpers

Under Polish law, running a platform such as AdBlast exposes its creators to several overlapping offences:

Money mules should not assume they are mere bystanders. Depending on what they knew, they may be charged as accessories or as direct perpetrators of money laundering.

Tax offences

Crypto fraudsters rarely meet their tax obligations, which opens the door to charges under the Fiscal Penal Code. Art. 54 § 1 penalises a taxpayer who evades taxation by failing to disclose the subject or basis of taxation. Art. 55 § 1 targets those who conceal the scale of their business by acting under a false name or using another person’s data, which is exactly how mule networks operate. In parallel, tax authorities may assess income from undisclosed sources, which can reach assets the criminal case has not yet secured.

The regulatory framework: strong on paper, incomplete in Poland

Exchanges as obligated institutions under the AML Act

Centralised exchanges and other virtual asset service providers are obligated institutions under the Polish Act of 1 March 2018 on Counteracting Money Laundering and Terrorist Financing (the AML Act). Under Art. 34 they must apply customer due diligence, including identifying the customer (KYC) and verifying identity against reliable documents. Failure to do so exposes them to administrative sanctions under Arts. 147 and 150, which can reach millions of euros and, in serious cases, removal from the register or withdrawal of authorisation. Directive (EU) 2018/1673 on combating money laundering by criminal law (often called AMLD6) harmonises the definition of laundering offences across the EU, making it easier to prosecute cases spanning several Member States.

MiCA and the Travel Rule

At EU level, two regulations are designed to close the gaps exploited by fraudsters:

• MiCA (Regulation (EU) 2023/1114). Art. 59 requires an authorisation to provide crypto-asset services. Since 1 July 2026, when the last transitional period expired, providing such services in the EU without a MiCA licence breaches EU law.
• TFR (Regulation (EU) 2023/1113). Since 30 December 2024 the “Travel Rule” has required every crypto-asset transfer to carry information on the originator (Art. 14) and the beneficiary, and the beneficiary’s provider must check it and act on missing data (Art. 16). Anonymous transfers between regulated providers are therefore no longer lawful, and transfers involving self-hosted wallets attract additional verification.

The AMLR (Regulation (EU) 2024/1624), applying from 10 July 2027, and the new EU Anti-Money Laundering Authority (AMLA) will tighten the regime further, including the ban on anonymous crypto accounts mentioned above.

The Polish gap

Poland is a notable exception in implementation. The Sejm has passed the Crypto-Asset Market Act three times, and the President has vetoed it three times, most recently on 11 June 2026; the attempt to override that veto failed on 4 September 2026 (Prawo.pl). As a result, Poland has still not designated a competent authority under MiCA. The KNF cannot grant CASP licences, and no domestic MiCA sanctions regime exists (PAP). Providers serving Polish customers must rely on licences issued in other Member States. In September 2026 the President filed his own draft in the Sejm, based on the vetoed text, and the government announced a fourth, stricter version of its bill; at the time of writing, neither has been enacted (Interia).

For victims this matters in practice. MiCA itself applies directly, but without a national supervisor there is no Polish authority to which a complaint about a CASP can be addressed and no domestic enforcement of MiCA’s conduct rules. The AML Act, criminal law and cross-border cooperation therefore remain the main levers.

Tracing, evidence and recovery

Investigative tools

Despite its apparent anonymity, a blockchain is a public and immutable record, and that works in investigators’ favour. Blockchain analytics software such as Chainalysis clusters addresses, follows peel chains and identifies the points at which funds are split for smurfing or reach a regulated exchange. Investigators also reverse-engineer the fraudulent platforms themselves, analysing website source code to uncover links to servers and databases. Because these schemes operate globally, cooperation through Europol, Interpol and the network of financial intelligence units is essential. The Polish FIU (GIIF) can exchange information with foreign counterparts and, under the AML Act, can request a block on an account or the suspension of a transaction for up to 96 hours, which the prosecutor can then extend by securing the assets in criminal proceedings.

Sources of evidence

Successful cases rest on a combination of digital evidence:

• Server logs of the platform, recording IP addresses and connection times, which help locate the perpetrators physically.
• On-chain transaction history, showing the path the victims’ money took.
• Exchange KYC data: identity document scans, verification selfies and linked bank accounts. Under Art. 49 of the AML Act, obligated institutions must keep this data for five years, so it remains available long after a pyramid collapses.
• Travel Rule data collected under the TFR, which now accompanies transfers between regulated providers.

What victims can do

Speed is decisive, because each hour gives the organisers time to move funds further along the chain. Victims and their advisers should:

1. Preserve evidence at once: transaction hashes, deposit addresses, screenshots of the platform and all communications.
2. Commission blockchain tracing early, ideally from licensed crypto investigators whose reports can be used in court.
3. Notify the exchanges where funds have landed and file a criminal complaint, asking the prosecutor to secure assets (Art. 291 of the Code of Criminal Procedure).
4. Join the criminal proceedings as an injured party and seek a compensation order (Art. 46 of the Criminal Code), while considering parallel civil claims, including against intermediaries.
5. Where assets have left Poland, pursue disclosure and freezing orders abroad and plan for the recognition and enforcement of Polish judgments in the relevant jurisdictions.

Conclusion

The AdBlast case shows that crypto laundering is sophisticated but not untraceable. Every stage, from the fake “private wallet” to the ATM withdrawal, leaves data somewhere: on-chain, in exchange KYC files, in server logs or in bank records. The EU has built a dense framework of MiCA, the TFR and, from 2027, the AMLR. Poland’s failure to designate a MiCA supervisor leaves a gap, so for now victims must rely on criminal law, the AML Act and fast, coordinated cross-border action. In crypto fraud, the chances of recovery fall with every day of delay.

Sources

TVN24: Piramida finansowa AdBlast? Poszkodowanych mogło być nawet 90 tys. osób (24 August 2026)

Prawo.pl: Ustawa o rynku krypto. Sejm zdecydował ws. prezydenckiego weta (4 September 2026)

Prawo.pl: Prezydent wnosi nowy projekt o kryptoaktywach (8 September 2026)

PAP: Świat od lat reguluje rynek krypto. Polska nadal bez ustawy (15 May 2026)

Interia: Rząd się nie poddaje. Będzie czwarta wersja projektu ustawy o kryptoaktywach

Cointelegraph: EU to ban anonymous crypto accounts and privacy tokens by 2027

Artykuł Following the Money Through the Blockchain: Crypto Ponzi Schemes, Laundering Techniques and Legal Remedies in Poland pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

After three years of negotiations, the reform of EU pharmaceutical legislation is one step away from completion. A new regulation and a new directive will replace the current Community code and the EMA Regulation, reshaping data and market protection periods, the rules for orphan medicines, the Bolar exemption and supply obligations. Originator and generic companies alike will need to revisit their strategies, and Poland faces a thorough overhaul of its Pharmaceutical Law.

From political agreement to adoption

The EU Pharma Package is the broadest revision of EU pharmaceutical legislation since 2004. It aims to boost innovation and competitiveness, secure the supply of medicines and prevent shortages. The European Commission tabled its proposal in April 2023, the European Parliament adopted its position in April 2024 and the Council of the European Union adopted its mandate on 4 June 2025, under the Polish Presidency, which had made the package one of its priorities. The Council and the Parliament reached a political agreement on 11 December 2025, and on 28 September 2026 the Council formally adopted its first-reading position. To complete the procedure, the Parliament must still approve that position at second reading (a plenary vote has been signalled for autumn 2026), after which the acts will be published in the Official Journal of the EU.

The package consists of two acts:

• a regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (EMA); it amends Regulations (EC) No 1394/2007 (advanced therapy medicinal products) and (EU) No 536/2014 (clinical trials) and repeals Regulations (EC) No 726/2004 (Union procedures and the EMA), (EC) No 141/2000 (orphan medicinal products) and (EC) No 1901/2006 (paediatric medicinal products);
• a directive on the Union code relating to medicinal products for human use, repealing Directive 2001/83/EC (the current code) and Directive 2009/35/EC (colouring matters that may be added to medicinal products).

Data and market protection: the 8+1(+1)(+1) model

Companies placing a new medicine on the market will keep an eight-year period of regulatory data protection. During this period, other applicants may not rely on the pre-clinical and clinical data submitted for the original marketing authorisation. It is followed by a period of market protection, during which generics and biosimilars may be authorised but not yet placed on the market. Baseline market protection is cut from two years to one.

The lost year can be regained. An additional year of market protection is available where the medicine addresses an unmet medical need, or where it contains a new active substance and one of the following scenarios applies:

• comparative clinical trials were conducted and the marketing authorisation application was filed first in the EU, or no later than 90 days after the first filing outside the EU;
• comparative clinical trials were conducted, together with clinical trials in more than one Member State;
• where comparative trials are not possible or appropriate, clinical trials were conducted in more than one Member State and the application was filed first in the EU, or within 90 days of the first filing outside the EU.

A further year of market protection may be granted (once) for a new therapeutic indication bringing a significant clinical benefit. The overall protection period is, as a rule, capped at 11 years; the only exception is the use of the exclusivity voucher described below, which can take it to 12 years.

Orphan medicinal products

Orphan medicines treat rare diseases, and developing them is often not commercially viable. The standard period of orphan market exclusivity is reduced from 10 to 9 years, but breakthrough orphan medicinal products will benefit from 11 years. A product qualifies as breakthrough where it targets a condition for which no treatment is authorised in the EU and delivers a clinically relevant reduction in morbidity or mortality. Exclusivity will be tied to the product rather than to individual indications; a further 12 months may be obtained for a new indication in a different orphan condition approved at least two years before exclusivity expires. Applications for similar products may be filed during the last two years of exclusivity, so that they can enter the market as soon as it ends.

A faster authorisation procedure

The EMA assessment will be shortened from 210 to 180 days, and the Commission decision should follow within 46 days instead of 67. The EMA structure will be streamlined from five scientific committees to two, the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), with broader representation of patients and healthcare professionals. Marketing authorisations will by default be valid for an unlimited period, reducing the burden of renewals.

A broader Bolar exemption

The Bolar exemption allows generic and biosimilar manufacturers to carry out preparatory steps while the reference product is still protected by patents and regulatory exclusivities, without infringing those rights. The package extends it beyond studies, clinical trials and marketing authorisation applications to pricing and reimbursement procedures and participation in tenders. The aim is to allow equivalent products to launch on day one after intellectual property rights expire.

A transferable exclusivity voucher for priority antimicrobials

To tackle antimicrobial resistance, the package introduces a transferable exclusivity voucher for companies that develop a priority antimicrobial targeting multidrug-resistant organisms. The voucher grants an additional 12 months of regulatory data protection either to that antimicrobial or to another centrally authorised product, including one held by a different company. It is subject to limits:

• it is valid for five years and may be transferred only once;
• it may be used only in the fifth or sixth year of the data protection period of the product to which it is applied;
• it cannot be used for a product whose annual gross sales in the EU exceeded EUR 490 million in any of its first four years after authorisation (the so-called blockbuster clause);
• the scheme will run for 15 years or until five vouchers have been granted, whichever comes first.

Applicants for antimicrobials will also have to submit an antimicrobial stewardship plan.

Availability of medicines and shortages

A key aim of the reform is better monitoring and prevention of shortages. Marketing authorisation holders will have to report shortage risks earlier, maintain shortage prevention plans and respond to critical shortages. A Union list of critical medicines will be established and their availability closely monitored. Member States will also be able to require a holder to place a medicine on their market and supply it in quantities sufficient to meet patient needs, subject to exceptions for circumstances outside the holder’s control.

Environmental protection

The requirements for the environmental risk assessment (ERA) submitted with a marketing authorisation application, and for the related risk mitigation measures, are strengthened. A specific methodology is foreseen to assess the risk that the manufacture of antimicrobials selects for resistance in the environment.

Timeline

Both acts will enter into force on the twentieth day after their publication in the Official Journal of the EU. The regulation will generally apply 24 months after entry into force (with exceptions for certain provisions), and Member States will have 24 months to transpose the directive. Under the transitional provisions, reference products for which a marketing authorisation application is filed before that date will keep the current protection periods (8+2+1).

Under Article 288 TFEU, a regulation is binding in its entirety and directly applicable in all Member States. It needs no transposition, but national law must still be adapted, including by repealing conflicting or duplicating provisions, designating competent authorities and laying down penalties. A directive, by contrast, is binding as to the result to be achieved, leaves the choice of form and methods to the Member States, and must be transposed into national law.

What the package means for Poland

The Polish Pharmaceutical Law Act of 6 September 2001 largely implements Directive 2001/83/EC and refers directly to its definitions, requirements and procedures, as well as to the regulations being repealed. Their repeal will require a thorough amendment of the Act, or a new statute, within two years of the package entering into force. As a significant producer of generic medicines, Poland stands to benefit from the broader Bolar exemption, including the ability to take part in tenders, file applications and conduct studies before protection expires. The shorter EMA procedure should speed up access to innovative therapies, and the new supply obligations should strengthen the security of medicine supply. Both originator and generic companies should already be reviewing their product portfolios and protection strategies against the new rules.

Artykuł The EU Pharma Package – the most far-reaching reform of EU pharmaceutical law in two decades pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

What the Overdeck divorce teaches Polish advisers of wealthy international families

The divorce of Two Sigma co-founder John Overdeck, fought without a prenuptial agreement over a fortune estimated at around USD 8 billion, shows how quickly a private dispute can become a risk for a business, its partners and its investors. This study uses the case as a starting point to compare the New Jersey prenuptial agreement with the Polish marital property agreement (intercyza) and sets out what Polish law permits, what it prohibits and what should be negotiated when advising wealthy international families.

1. Case study: the Overdeck family

An article published by The Wall Street Journal on 31 August 2026 under the title A Hedge-Fund Titan’s Divorce Is Putting Wall Street’s Staggering Wealth on Public View describes the high-profile divorce of John Overdeck, co-founder of the Two Sigma fund, and his wife Laura. The couple’s wealth is estimated at around USD 8 billion, and Forbes lists John Overdeck among the 400 richest people in the world[1]. The Overdeck case illustrates well the risks and problems that arise when spouses with substantial and complex assets do not enter into a prenuptial agreement.

1.1. How the lack of a prenuptial agreement widened the dispute

A useful comparison is the 2015 divorce of Ken Griffin and Anne Dias, also mentioned in the article. In that case a valid prenuptial agreement considerably simplified the process and both parties ultimately accepted its terms (Anne Dias received USD 22.5 million, a further USD 1 million for each year of marriage and co-ownership of a penthouse in Chicago). In the Overdeck case, the absence of a prenuptial agreement has led to widely diverging expectations as to the division of assets: John Overdeck has offered his wife a settlement of USD 723 million, while Laura claims 35% of her husband’s interest in Two Sigma, which her lawyers value at USD 6.2 billion.

This raises the further problem of valuing John’s actual interest in Two Sigma, which according to his lawyers is worth considerably less, namely USD 4.9 billion. Laura’s attempts to have Two Sigma’s financial data made public have not succeeded, and the public is excluded from the courtroom each time the matter is discussed, which further complicates and delays the proceedings.

The complex structure of the assets, with no prenuptial agreement in place, has also led Laura to bring separate proceedings against lawyers from Seward & Kissel, the firm that handled the couple’s estate planning. She accuses them of conspiring with her husband, as early as 2005, to give him unilateral control over the couple’s trusts and family foundation. The dispute has therefore spread across several sets of proceedings, with higher costs and a timetable extended by many months.

1.2. Assets, corporate rights and economic interests at stake

The article mentions a joint bank account into which Overdeck paid hundreds of millions of dollars during the marriage (and from which Laura withdrew USD 75 million on the eve of filing for divorce). The marital assets also include a property in New Jersey of 6,000 square feet (John has offered to sell his share in the property to his wife for USD 6 million).

By far the most valuable item in dispute is the privately held interest in Two Sigma. Laura values it at USD 6.2 billion and claims 35% of it, that is around USD 2.17 billion. John’s lawyers value it at USD 4.9 billion and offer, instead of a share in the interest, a one-off payment of USD 723 million. A further item is the division of the gains attributable to John’s premarital assets and of his earnings and share in Two Sigma’s investment profits during the marriage, which he values at USD 685 million.

The settlement also covers a charitable foundation with assets of USD 900 million and a number of trusts, including a trust intended to secure the future of later generations of the family (a generation-skipping trust). Finally, the divorce touches on corporate rights in Two Sigma: if Laura succeeded, her stake would change the balance of power in the firm’s governance and aggravate the existing tensions between the co-founders, John Overdeck and David Siegel.

1.3. Why an interest in a private hedge fund is harder to value

The value of bank accounts, listed securities or real estate is easy to verify, so these assets can be divided or bought out at a specific price. An interest in a private hedge fund such as Two Sigma is different: as the article points out, its value rests largely on paper gains and there is no market price for the stake. Valuation depends on a variety of complex methodologies, which in the Overdeck divorce has produced a difference of USD 1.3 billion between the two sides’ estimates. In addition, the lack of transparency of the firm’s financial data makes it impossible to test the competing valuations thoroughly.

1.4. Formal ownership, corporate rights, control and economic value

The formal position at Two Sigma is as follows: John Overdeck and David Siegel remain the principal owners and co-chairmen. Because of the conflict between them, they changed the firm’s management and control structure, stepping down as co-CEOs in favour of a two-person management committee, which Overdeck himself later joined. This fragile compromise between the founders could be further destabilised if Laura acquired any influence over the firm.

These four notions need to be kept apart. Economic participation means a right to share in the firm’s profits. It does not necessarily carry any right to manage the firm, although it may be used as an argument for obtaining a degree of decision-making power. Conversely, formal title and control may sit with a person other than the one who ultimately receives the economic benefit.

1.5. Acquisition date, source of funding and growth in value during the marriage

These factors are central to the division of assets in the case. Two Sigma was founded in 2001 and John Overdeck married Laura in 2002, so he acquired his interest before the marriage. New Jersey applies the principle of equitable distribution to property acquired during the marriage (N.J.S.A. 2A:34-23(h) and 2A:34-23.1). In broad terms, wealth attributable to a spouse’s efforts during the marriage is subject to division, whereas premarital property and its passive growth driven by market forces remain the separate property of the spouse concerned. John therefore argues that a substantial part of the fortune derives from passive growth and is not divisible on divorce. How the assets placed in the trusts and in the family foundation should be treated is a separate question, which depends on when and with what funds those structures were financed.

1.6. Trusts, foundations, holding entities and transfers between structures

In her separate lawsuit, Laura accuses lawyers from Seward & Kissel of handing John unilateral control over the couple’s trusts and family foundation in the course of estate planning. John denies these allegations. The underlying problem remains, however: once assets are moved into such entities, control over them is no longer obvious and does not necessarily rest with the owner.

Transfers between wealth structures also make it harder to establish the true value of the estate and who actually bears a cost or receives a benefit. Individual structures may carry liabilities, as with the generation-skipping trust that bought an interest in Two Sigma with money borrowed from John. In other situations such liabilities may be hidden or difficult to prove, while having a real effect on the value of the estate.

1.7. How marital conflict affects the business

A divorce at this level of wealth has a real impact on the way a business is run. Laura is claiming 35% of her husband’s interest in Two Sigma, and a stake of that size would undoubtedly unsettle a governance arrangement that is already fragile. Relations between Overdeck and Siegel have been strained for years, to the point that the firm had to disclose the situation to investors as a material risk and change its management structure. If Laura’s claim to a share of the interest were upheld, the current balance of power in the firm could collapse altogether.

Divorce proceedings also force the disclosure of financial data, including sensitive data about the firm. Laura’s lawyers sought to have that data made public, which the court has so far blocked. Laura herself was barred from testifying and from calling witnesses after secretly obtaining her husband’s confidential emails and committing other violations.

From the investors’ perspective, the risks generated by a divorce that seemingly has nothing to do with them, such as a leak of financial data and other confidential information, are considerable. Despite the firm’s assurances that it is not involved in the divorce, a scenario in which some investors withdraw their capital, reducing the value of the whole business, becomes very likely.

1.8. What could have been agreed in advance

• A full schedule of assets and liabilities drawn up before the agreement, identifying the property held by each party before the wedding. This would have made it clearer which assets were brought into the marital estate and which remained separate property.
• Rules for classifying the growth in value of the business, distinguishing passive growth from growth resulting from a spouse’s personal efforts. A clear classification of gains would have prevented doubts as to whom they belong.
• Rules for shares, options, deferred bonuses, carried interest and other incentive schemes. Agreeing their treatment in advance would have avoided later doubts as to whether such receipts are separate or marital property.
• A valuation methodology, a valuation date and a procedure for appointing an independent valuer. The valuations of John’s interest prepared for the two sides differ by more than a billion dollars. Each side is protecting its own position, so neither is aiming at an objective figure but at the most favourable divorce terms. An agreed independent valuer, method and date would have removed much of this discrepancy.
• Rules for valuing illiquid assets, including discounts for lack of marketability or control and potential tax liabilities.
• Rules for dividends, redemptions, buy-outs and proceeds from a sale of the business.
• Disclosure duties concerning trusts and other structures and restrictions on transfers between related entities. Such arrangements would have ensured transparency and avoided accusations of conspiring to obtain unilateral control over assets forming part of the estate.
• Protection of the business’s confidential information. Strict clauses restricting the use of confidential information about the firm might have deterred Laura from obtaining it and creating a risk for investors. This would also have worked in her favour, since she would not have lost the right to testify and to call witnesses.
• A cash settlement option that does not involve transferring corporate rights to the other spouse.
• Coordination of the agreement with the partnership agreement, the company’s constitutional documents, the fund documentation and the succession plan. The spouses’ property arrangements should be compatible with the nature of such a profitable business so that it remains stable even in the event of divorce.

It should be borne in mind that there is no single federal law of marital agreements in the United States: the Overdeck case is governed by the law of the State of New Jersey, and the rules on marital agreements differ from state to state. For that reason, and because of numerous significant differences, the American prenuptial agreement should not be equated with the Polish marital property agreement.

2. The US prenup and the Polish marital property agreement compared

Marital agreements in the United States are a matter for state legislatures. In New Jersey, where the Overdeck divorce is pending, premarital agreements are governed by the Uniform Premarital and Pre-Civil Union Agreement Act (N.J.S.A. 37:2-31 to 37:2-41), adopted in that state in 1988 and amended in 2013[2]. In Poland, the marital property agreement is regulated mainly by the Family and Guardianship Code of 1964 (Kodeks rodzinny i opiekuńczy, KRO), supplemented by the Civil Code (Kodeks cywilny, KC) and the Private International Law Act of 2011 (Prawo prywatne międzynarodowe, PPM).

2.1. Key differences at a glance

2.2. Problems a well-prepared agreement could have avoided

• Large discrepancies in the valuation of the divisible estate (for example John’s interest in Two Sigma).
• Disputes over the line between wealth resulting from John’s work and wealth resulting from market movements.
• The risk to Two Sigma’s stability arising from Laura’s claim to 35% of her husband’s interest instead of a predetermined sum.

2.3. Issues likely to remain contentious even with an agreement

• Attempts to challenge the validity of the prenuptial agreement.
• Collateral claims against advisers and third parties, brought to maximise the chances of success in the main proceedings.
• Matters concerning children: a prenuptial agreement does not cover them, so custody and child support may still be disputed on divorce.

2.4. Practical takeaways for a Polish lawyer advising a wealthy international family

• The marital property agreement should be synchronised with company articles, shareholders’ agreements and the succession plan.
• Wealth planning must take account of the rules of private international law.
• The documentation should set out in advance the methodologies for valuing illiquid assets.
• It is worth including a clause providing for renegotiation of the agreement (in common law jurisdictions this is typically done by a post-nuptial agreement, that is a new agreement made during the marriage; in Poland by amending the agreement in notarial form under Art. 47 § 2 KRO).

3. The legal nature of the Polish intercyza

3.1. A closed catalogue of regimes

The marital property agreement is regulated in Art. 47 KRO. The provision defines the subject matter of the agreement, namely a choice among the four contractual regimes provided for by statute: extended community of property, limited community of property, separation of property, or separation of property with equalisation of accrued gains. Spouses cannot create a new regime not provided for in the statute. Nor may contractual provisions infringe the fundamental principles of family law, such as the equality of spouses. That would be contrary to the principles of social coexistence, which under Art. 58 §§ 2 and 3 KC renders the agreement invalid in whole or in part[3]. A Polish intercyza cannot exclude or restrict marital rights and duties, nor can it regulate matters concerning children, succession or maintenance.

Marital property regimes in Polish law

The nature of the Polish intercyza must also be seen against the principle of freedom of contract (Art. 353¹ KC). Although concluding the agreement is an expression of the spouses’ autonomy, they are not free to shape their property relations entirely as they wish. They must choose one of the statutory regimes and may regulate their property relations only within its framework.

3.2. Mandatory rules

When drafting an intercyza, attention must be paid to mandatory provisions (ius cogens). Failure to observe them, or an attempt to modify them, renders the agreement invalid in whole or in part:

• The agreement must be concluded in the form of a notarial deed (Art. 47 § 1 KRO).
• An agreement extending the community cannot extend it to the items listed in Art. 49 § 1 KRO.
• A spouse may rely on the agreement against third parties only if its conclusion and type were known to them (Art. 47¹ KRO).
• The provisions on equal rights and duties in marriage, mutual assistance, fidelity and cooperation for the good of the family (Art. 23 KRO), and on contributing to the needs of the family according to one’s abilities (Art. 27 KRO), are mandatory.
• Maintenance obligations lie outside the permitted content of the agreement, which is confined to the property regime (Art. 47 § 1 KRO). The statutory duties of maintenance towards children (Art. 133 KRO) and between spouses (Arts. 27 and 60 KRO) cannot be excluded in advance by an intercyza.
• Clauses contrary to statute or to the principles of social coexistence, or intended to circumvent the law, are invalid and may render the whole agreement invalid (Art. 58 KC).

3.3. Permitted additional provisions

Within the chosen regime, the spouses may add further provisions that are:

• organisational, for example rules on bearing the costs of maintaining the family or on managing joint bank accounts;
• settlement-related, for example how to account for outlays made on an asset forming part of a spouse’s personal property (Art. 45 § 1 KRO), or how accrued gains are to be equalised when a marriage under the equalisation regime ends;
• procedural, for example how expenses are to be documented in order to facilitate later settlements, or an arbitration clause for any future dispute.

Such provisions are permitted as long as they do not create a new property regime and are not contrary to the law.

3.4. The intercyza and related legal instruments

The marital property agreement must be clearly distinguished from other legal acts of a similar nature:

• Agreement on the division of joint property. This agreement divides the joint property once the community has ceased, for example after separation of property has been established during the marriage (where no intercyza was signed before the wedding). The provisions on the division of an inherited estate apply accordingly (Art. 46 KRO), so a notarial deed is required if the joint property includes real estate (Art. 1037 § 2 KC); the same form should be used where it includes a cooperative ownership right to premises. In other cases no special form is required, although written form is advisable for evidentiary purposes. An agreement establishing separation of property does not in itself divide the existing joint property, so a separate division (by agreement or by the court) is needed.
• Sale, gift or transfer of a specific asset. Transferring ownership between the spouses’ personal estates is a separate legal act requiring a separate agreement, again in the appropriate form (for example a notarial deed for real estate).
• Agreement on the financing of joint investments. A separate civil-law contract setting out each spouse’s contribution, share and return. It does not change the property regime.
• Shareholders’ or partnership agreement. Not mandatory for spouses running a business together, but advisable in order to regulate, among other things, the division of profits between the spouses (depending on the property regime), shareholdings, distributions and the resolution of disagreements.
• Will. Joint wills are not permitted in Polish law (Art. 942 KC). Where the spouses were in a community of property, it ceases by operation of law on the death of a spouse; as a rule one half of the joint property remains with the surviving spouse and the other half passes by succession. Under separation of property this issue does not arise and the whole of the deceased spouse’s personal property passes by succession.
• Choice-of-law agreement. In an international marriage, under Art. 52(1) PPM the spouses may submit their property relations to the national law of either of them or to the law of the state in which either of them is domiciled or habitually resident.

3.5. Growing popularity of marital property agreements

Recent years have seen growing interest in regulating property relations by way of a marital property agreement, at the same time as the number of marriages has fallen to its lowest level since the Second World War[4].

Marriages and marital property agreements concluded in Poland in 2025

Source: Rzeczpospolita

4. Types of contractual property regimes

4.1. Extended community of property

The legal basis for the extended community is Art. 47 § 1 KRO, which allows spouses both to extend and to limit the statutory community by a marital property agreement. Under Art. 48 KRO, the provisions on the statutory community apply accordingly to a community established by agreement, except for the matters modified or excluded by the agreement. The modification concerns Arts. 31 § 2, 33 and 34 KRO, whereas Arts. 34¹-40, 45 and 46 KRO continue to apply unchanged. Where the agreement brings into the community items that under the statutory community would belong to the personal estates, Art. 41 KRO applies, subject to Art. 50 KRO[5].

Art. 49 § 1 KRO lists what cannot be brought into the joint property. Regardless of the spouses’ arrangements, items such as property acquired by a spouse through inheritance, legacy or gift, and non-transferable rights that can be vested in one person only, remain in that spouse’s personal property. Under Art. 49 § 2 KRO, in case of doubt, items serving exclusively the personal needs of one spouse are deemed not to have been brought into the community.

Characteristically for this regime, the items acquired before the wedding that are identified in the agreement enter the joint property, while items acquired after the wedding are treated in accordance with the provisions on the statutory community, subject to the modifications and extensions set out in the agreement. Management of the joint property follows the statutory community rules, that is Arts. 36-40 KRO.

Income from work, business activity or investments typically forms part of the joint property under Art. 31 § 2(1) and (2) KRO: remuneration for work and income from other gainful activity of each spouse, as well as income from the joint property and from each spouse’s personal property. The components of the joint property may be extended further, within the limits of Art. 49 § 1 KRO.

Where the joint property has been extended, creditors may seek satisfaction from it if the obligation was incurred with the consent of the other spouse (Art. 41 § 1 KRO). A creditor may therefore reach an item contributed by the other spouse that would not have formed part of the joint property under the statutory community. If the claim arose before the community was extended, a creditor whose debtor is only one of the spouses may also seek satisfaction from the items that would have belonged to the debtor’s personal property had the community not been extended (Art. 50 KRO).

The regime has clear advantages. It considerably simplifies the management of family wealth, since the split into joint and personal estates often complicates day-to-day family finances. It also makes it possible to even out unequal contributions to the joint property by bringing in personal assets.

Its disadvantages must not be overlooked, particularly when advising a wealthy international couple. Extending the joint property means losing sole control over items that previously formed part of personal property. It may expose a spouse to the other spouse’s debts and the resulting costs. Division of property on divorce also becomes more difficult, which is why this regime should generally be advised against for particularly wealthy couples.

4.2. Limited community of property

Unlike the other three contractual regimes, the limited community has no dedicated set of provisions. Its legal basis is again Art. 47 § 1 KRO, which allows the spouses to exclude from the joint property items that would enter it under the statutory community, or to confine the joint property to a closed catalogue of items. The provisions on the statutory community again apply accordingly. The agreement may not, however, infringe mandatory provisions, for example by excluding the duty to contribute to the needs of the family (Art. 27 KRO), nor be contrary to statute or to the principles of social coexistence, as this would render the agreement invalid in whole or in part (Art. 58 KC).

Items acquired before the marriage belong to each spouse’s personal property in accordance with Art. 33(1) KRO. Items acquired after the limited community is established enter the joint property as under the statutory community, with the exception of the categories of items specified in the agreement.

The joint property is managed under the statutory community rules, while each spouse independently manages the items excluded from the community as part of his or her personal property. Depending on the spouses’ arrangements, income from work, investments or business activity may be excluded from the joint property and form part of personal property.

An agreement limiting the statutory community is effective against creditors who were aware of it (Art. 47¹ KRO). If a creditor was not aware of it, the agreement does not operate against that creditor, for whom the spouses remain in the regime in force before its conclusion.

The advantage of this regime is that a potentially risky business activity or investment can be carved out in order to protect the joint property. It carries, however, a risk of economic inequality where highly profitable items are excluded, and a risk of liability for the other spouse’s debts where creditors were unaware of the agreement. The regime may be attractive to couples in which one spouse runs a business and makes investments but still wishes to retain a degree of community with the other.

4.3. Separation of property

Separation of property is likewise provided for in Art. 47 § 1 KRO and regulated in more detail in Arts. 51-51¹ KRO. Under this regime, each spouse retains the property acquired before the agreement and the property acquired later. If the agreement is concluded before the wedding, no joint property arises at all, and each spouse manages his or her property independently (Art. 51¹ KRO). Beyond establishing the separation itself, the agreement leaves little room for regulating other matters.

Property acquired after the wedding enters the personal property of the spouse who acquired it. An item purchased together does not create a marital community: the spouses become co-owners in fractional shares within the meaning of the Civil Code and are subject to its rules (Arts. 195-221 KC). There is one important exception, in Art. 30 § 1 KRO: spouses are jointly and severally liable for obligations incurred by either of them to meet the ordinary needs of the family, and neither the property regime nor any arrangement between the spouses affects this[6].

Each spouse is fully independent in managing his or her property, as Art. 51¹ KRO expressly provides. Income from work, investments and business activity likewise goes exclusively to the personal property of the spouse who earned it, and each spouse answers for his or her obligations with his or her own personal property.

The advantages of this regime are full protection of one’s property against the other spouse’s debts, a much simpler division of property on divorce and complete freedom of management. The risk lies with the lower-earning spouse, since there is no mechanism for evening out the difference: on the death of the other spouse or on divorce, that person may find himself or herself in a difficult financial position. Separation of property is a good solution for entrepreneurs, for spouses with different levels of wealth and for people entering a subsequent marriage who wish to protect the interests of their children.

4.4. Separation of property with equalisation of accrued gains

This regime is provided for in Art. 47 § 1 KRO and regulated in Arts. 51²-51⁵ KRO. Under Art. 51² KRO, the provisions on separation of property apply accordingly, subject to the further rules on accrued gains and their equalisation. While the agreement is in force, the regime does not differ from ordinary separation of property: property acquired by a spouse before and after the wedding remains personal property and is managed by that spouse. The exception in Art. 30 § 1 KRO continues to apply. The special rules come into play when the regime ends, for example on divorce.

Accrued gains (dorobek) are defined as the increase in the value of a spouse’s property after the marital property agreement was concluded (Art. 51³ § 1 KRO). The spouses may define in the agreement which items are disregarded in calculating accrued gains, or rely on the default rules in Art. 51³ § 2 KRO. Under those rules, the calculation disregards property acquired before the agreement and the items listed in Art. 33(2), (5)-(7) and (9) KRO (including property acquired by inheritance, legacy or gift), as well as items acquired in exchange for them. The following are added: the value of gifts made by a spouse (other than gifts to the spouses’ common descendants and small customary gifts to other persons), services rendered personally by one spouse for the benefit of the other spouse’s property, and outlays and expenses made on one spouse’s property from the property of the other. Accrued gains are calculated according to the state of the property at the time the separation of property ends and according to prices at the time of settlement (Art. 51³ § 3 KRO).

After the separation of property ends, the spouse whose accrued gains are smaller may demand equalisation by payment or by transfer of a right (Art. 51⁴ § 1 KRO). For important reasons, either spouse may demand a reduction of the equalisation obligation, and if the parties cannot agree on the manner or amount of equalisation, the court decides (Art. 51⁴ §§ 2 and 3 KRO). On the death of a spouse, equalisation takes place between that spouse’s heirs and the surviving spouse. The heirs may demand a reduction of the equalisation obligation only if the deceased had brought an action for annulment of the marriage or for divorce, or had applied for separation (Art. 51⁵ §§ 1 and 2 KRO).

The advantages largely mirror those of ordinary separation of property (protection against the other spouse’s debts, freedom of management), combined with protection for the financially weaker spouse and flexibility as to how accrued gains are accounted for. On the other hand, settlements on divorce are considerably more complex and contentious, valuation becomes an issue, and the amount of the former spouse’s claim is hard to predict. The regime is recommended for couples in which one spouse runs a business and wishes to limit the other’s interference in that property, while preserving an element of fairness on divorce, for instance where one spouse gives up a career to look after the home and the children.

4.5. Which regime for which client?

Owner of a family business. Separation of property with equalisation of accrued gains should be considered. The business (whether founded before or after the wedding) and the income from it will be personal property. Full separation, however, could prove unfair on divorce to a spouse who supported the firm or took care of the home. Separation with equalisation appears to be the best compromise: the business stays outside any division of property, while the other spouse’s contribution to family life is recognised. In addition, the flexibility in defining accrued gains, including the possibility of excluding the value of the business from the calculation, leaves considerable room for shaping the terms of any equalisation.

Founder of a technology company. Here full separation of property is recommended. A company founded during the marriage under the statutory community forms part of the joint property and would be subject to division on divorce. Full separation ensures the stability of the business in the event of divorce, which investors particularly value; this cannot be guaranteed under the statutory community, or under separation with equalisation if shares in the company had to be transferred. The technology sector also carries risk, so the agreement protects the other spouse against potential liability for the founder’s debts.

Private equity or venture capital investor. Full separation of property is again the best choice, for reasons of stability, protection of the other spouse’s property, no need for spousal consent to investments and ease of settlement on divorce. Assets such as carried interest or interests in funds and portfolio companies are difficult to value, and valuing them on divorce can be costly and contentious. Alternatively, separation with equalisation may be considered, but with a precisely defined method of calculating accrued gains in order to keep the investments as stable as possible.

Owner of a real estate portfolio. The recommendation depends on how the properties were acquired. Properties acquired before the wedding are personal property even under the statutory community (Art. 33(1) KRO). Separation with equalisation would nevertheless be beneficial: it removes the need for spousal consent to the transactions listed in Art. 37 KRO, which greatly facilitates dealing in and managing real estate, while the equalisation mechanism takes account of the growth in value of the properties and ensures a fair outcome on divorce.

Spouse receiving a large inheritance. An inheritance is personal property whether or not a marital property agreement has been concluded (Art. 33(2) KRO). The income generated by inherited property is different: it enters the joint property under Art. 31 § 2(2) KRO. To keep both the inheritance and the income from it as sole property, the spouses should establish separation of property, or a limited community excluding that income from the joint property.

Spouse limiting a professional career to raise children. The most favourable regime is the statutory community or an extended community. If the estates need to be separated, separation with equalisation of accrued gains is strongly recommended. Full separation offers no protection on divorce, despite what is often a very substantial contribution to the functioning of the family and the upbringing of the children.

Person engaged in a high-risk activity. Separation of property (full or with equalisation) should be considered. Both variants separate the spouses’ estates; the difference between them appears only when the regime ends. It must be remembered, however, that the agreement is not effective against persons who did not know of it, so creditors should be informed (Art. 47¹ KRO). If a creditor does not know that separation of property has been established, the regime that applied before the agreement, for example the statutory community, governs relations with that creditor.

International family connected with Poland, with assets in several countries. Such a family falls within the scope of the Private International Law Act of 2011. Under Art. 52(1) PPM the spouses may choose the law governing their property relations: the national law of either of them, or the law of the state in which either of them is domiciled or habitually resident. A couple choosing Polish law is subject to the KRO. In that situation, separation of property (full or with equalisation) is recommended. Independent management of personal property, clarity of ownership, protection against the other spouse’s debts and (under full separation) ease of division on divorce are among the advantages of this regime where parts of the estates are located abroad.

5. Form, procedure and documents

5.1. Notarial form and timing

A marital property agreement must be concluded in the form of a notarial deed, as Art. 47 § 1 KRO expressly requires, whichever regime the spouses choose. Failure to observe the notarial form always renders the agreement invalid (Art. 73 § 2 KC). An agreement concluded, for example, in ordinary written form is invalid and the existing regime (for example the statutory community) continues to apply. Such an agreement cannot be validated after the event; the only solution is to conclude a new agreement in the required notarial form.

The agreement may be concluded both before the wedding and during the marriage. It may also be amended or terminated at any time, each time in notarial form (Art. 47 KRO). An agreement concluded before the wedding in the required form is valid but produces no effects until the marriage is concluded. If the agreement is terminated during the marriage, the statutory community arises by default, unless the spouses decide to establish another regime (Art. 47 § 2 KRO).

5.2. Acting through an attorney

A marital property agreement may be concluded in person or through an attorney, since the law does not require the spouses to act personally (Art. 95 § 1 KC). Concluding such an agreement clearly exceeds ordinary management, so a power of attorney for that specific legal act is required (Art. 98 KC). As to form, under Art. 99 KC the power of attorney must be granted in the same special form as is required for the validity of the act itself, that is a notarial deed. Failure to observe that form when granting the power of attorney again renders any agreement signed on its basis invalid.

5.3. Capacity of the parties

Full legal capacity is required to conclude a marital property agreement, which as a rule means having reached the age of 18. One situation deserves attention: marriage by a woman who has reached the age of 16. The guardianship court may permit it for important reasons (for example pregnancy) where the marriage will be in the interest of the new family (Art. 10 § 1 KRO). Before the marriage, however, she remains a person with limited legal capacity (Art. 15 KC), so the validity of a marital property agreement depends on the consent of her statutory representative (Art. 17 KC). She attains majority by marrying and does not lose it even if the marriage is annulled, so she may subsequently conclude and terminate marital property agreements on her own.

A fully incapacitated person cannot conclude a marital property agreement, because such a person has no legal capacity (Art. 12 KC) and any agreement concluded would be invalid (Art. 14 § 1 KC). Nor can such a person marry at all (Art. 11 § 1 KRO). The position of a partially incapacitated person is different. Despite limited legal capacity, such a person may marry[7], although in the case of mental illness or intellectual disability the court’s permission is required (Art. 12 § 1 KRO). A marital property agreement may be concluded, but requires the consent of the curator (Arts. 16 § 2 and 17 KC). It should also be noted that if a spouse is incapacitated during the marriage, separation of property arises by operation of law (Art. 53 § 1 KRO).

5.4. Defects of consent

A further question is the effect of defects of consent on the validity of the agreement. An agreement concluded in a state excluding conscious or free decision-making (Art. 82 KC), or concluded as a sham (Art. 83 § 1 KC), is absolutely void[8].

A material error as to the content of the agreement (Art. 84 KC) makes the agreement voidable: it remains valid and effective until the mistaken party submits to the other party a written declaration avoiding the legal effects of the declaration of intent made under the influence of error. The spouse has one year from discovering the error to do so (Art. 88 § 2 KC). An agreement concluded under an error fraudulently induced by the other spouse is likewise voidable, but in that case the error need not be material or relate to the content of the agreement (Art. 86 § 1 KC). The rules on avoidance are the same as for error (Art. 88 §§ 1 and 2 KC).

Threat also makes the agreement voidable (Art. 87 KC). The declaration avoiding the effects of the agreement is again made to the other party in writing (Art. 88 § 1 KC), within one year from the moment the state of fear ceased (Art. 88 § 2 KC). Not every form of pressure exerted on a spouse will meet all the elements of a threat, namely unlawfulness, seriousness and the creation of a state of fear. If, however, the pressure had a material influence on the conclusion of the agreement, this may be assessed as contrary to the principles of social coexistence, which would render the agreement absolutely void (Art. 58 § 2 KC).

5.5. No retroactive effect and entry into force

An agreement establishing separation of property (full or with equalisation) has no retroactive effect. A clause providing that the agreement applies “from the beginning of the marriage” would therefore be invalid: the estates are separated from the conclusion of the agreement, and the joint property accumulated until then continues to exist until it is divided. An agreement extending the community does not operate retroactively either, but it may cover assets the spouses already hold: items that by default belong to personal property can be brought into the joint property. Similarly, the community may be limited in respect of items that form part of the joint property at the time the agreement is concluded.

The moment from which the new regime applies depends on when the agreement is concluded and on its terms. If it is concluded before the marriage, the regime applies from the conclusion of the marriage (for example, if separation of property was agreed, no community arises at all). If it is concluded during the marriage, as a rule it applies from the signing of the notarial deed, unless the agreement specifies a later date (Art. 116 § 1 KC). The same applies to an amendment of an existing agreement. Termination of a marital property agreement takes effect on signing the notarial deed to that effect, and the regime reverts by default to the statutory community, unless the spouses have chosen another regime.

5.6. Documents to obtain from foreign clients

It is advisable to obtain from prospective foreign clients documents concerning:

• Identity – a valid passport or identity card (for EU/EEA/Swiss citizens); a residence card, a certificate of registration of residence of an EU citizen or a visa may serve as supporting documents.
• Citizenship or multiple citizenships – passports evidencing all citizenships and the client’s written declaration of the citizenships held. This may be needed to determine the state with which the client is most closely connected, and thus which law applies as his or her national law under Art. 2(2) PPM. If one of the citizenships is Polish, Polish law applies as the national law (Art. 2(1) PPM).
• Domicile and habitual residence – a certificate of registered address or its foreign equivalent; a lease or title deed together with utility bills; a bank statement.
• Tax residence – a certificate of tax residence issued by the competent tax authority.
• Conclusion and validity of the marriage – a copy of the marriage certificate, where necessary with a sworn translation and an apostille or legalisation.
• Previous marriages and divorces – copies of marriage certificates and divorce judgments with confirmation that they are final.
• Previous property agreements – copies of earlier Polish marital property agreements or their foreign equivalents (for example a prenuptial or postnuptial agreement) with a sworn translation.
• Foreign judgments – for example divorce judgments, decisions on the division of joint property, succession decisions and decisions on parental responsibility, with a sworn translation.
• Powers of attorney – a power of attorney in the form of a notarial deed; if drawn up abroad, with an apostille or legalisation and a sworn translation.
• Assets and liabilities – extracts from land and mortgage registers and their foreign equivalents, extracts from the National Court Register concerning businesses held, bank statements, investment portfolio statements, insurance policies, credit and loan agreements, and documentation of liabilities and any debts.

5.7. Apostille and sworn translation

An apostille is a certificate confirming the official character of a document that is to be used abroad in a state party to the Hague Convention of 1961 Abolishing the Requirement of Legalisation for Foreign Public Documents, to which Poland is a party. If the document is to be used in a state that is not a party to the Convention, traditional legalisation is required[9].

A sworn (certified) translation is one made by a sworn translator entered on the list of sworn translators kept by the Ministry of Justice. The profession is regulated by the Act of 25 November 2004 on the Profession of Sworn Translator; a translation certified with the translator’s seal is accepted by authorities and courts. It is required for translations of, among other things, contracts, notarial deeds and court documents. Under Art. 2 § 3 of the Notaries Act (Prawo o notariacie), notarial acts are performed in Polish; at a party’s request, however, the notary may additionally perform the act in a foreign language, relying either on his or her own command of that language, demonstrated in the manner required of sworn translators, or on the assistance of a sworn translator. Furthermore, under Art. 87 § 1(1) of the same Act, if a person taking part in the act does not know the language in which the deed is drawn up, the notary should translate the deed or other document personally or with the assistance of a translator.

5.8. Securing evidence of informed and voluntary consent

How, in practice, can one secure evidence that a foreign client knew the content of the agreement, understood its effects and concluded it freely?

• Provide the client with the draft deed in his or her language in a way that allows the content to be properly reviewed.
• Include in the deed the party’s statement that he or she has read the translation and understands the content and effect of the marital property agreement.
• Recommend that the foreign client take independent legal advice before signing (not mandatory in Poland, but standard practice in common law jurisdictions).
• Document the preparatory meetings with the client (notes, correspondence) in order to demonstrate an informed decision.
• Where there are doubts as to the client’s mental health and awareness of his or her actions, consider a medical consultation and a medical certificate confirming that the client is fit to perform the act.

6. Essential terms and scope of negotiation

6.1. Essential and optional elements of the deed

Under Art. 92 § 3 of the Notaries Act, where a notarial deed concerns a legal act it should contain the content essential to that act, as well as any other statements needed in the circumstances. It is therefore necessary to distinguish the essential elements (essentialia negotii), without which the act is defective, from additional elements (accidentalia negotii), which do not affect the validity or effectiveness of the agreement itself:

• Identification of the parties – essential, required by Art. 92 § 1(4) of the Notaries Act. Without it, it would not be known who is making the declaration of intent and establishing the contractual regime.
• Reference to the existing marriage or the planned marriage – essential; it determines the moment the agreement takes effect.
• Unambiguous choice of regime – essential. The regime chosen should be specified precisely, preferably using the terminology of the KRO, to avoid any uncertainty.
• Moment of entry into force – optional. If the parties do not regulate it, the agreement takes effect on signing the deed or (for an agreement concluded before the marriage) on the conclusion of the marriage. As noted above, the effective date cannot be backdated; it can only be postponed.
• Relationship to earlier agreements – essential in practice. It must be clear whether a marital property agreement already exists and whether the new deed amends it or terminates it entirely (Art. 47 § 2 KRO). Where an agreement is terminated, it must also be clear whether the statutory community arises or the spouses establish another regime.
• Description of the limitation or extension of the community – essential. When either of these regimes is established, the deed must state clearly what exactly is excluded from or brought into the joint property (within the limits of Art. 49 § 1 KRO in the case of an extension), to avoid uncertainty as to the composition of the joint and personal estates. This is crucial for settlements in the event of divorce.
• Rules for equalising accrued gains – optional. Where the equalisation regime is chosen (which must be stated clearly in the agreement), the spouses may, but need not, set their own rules for calculating accrued gains. Failing such arrangements, Art. 51³ § 2 KRO provides the default method, specifying what is disregarded and what is added. Both the manner and the amount of equalisation may also be agreed, and failing agreement the court decides (Art. 51⁴ § 3 KRO)[10].
• Schedules listing assets – optional. The absence of a schedule of assets does not affect the validity of the agreement. A schedule may, however, be important evidence on divorce, making it easier to establish the state of the estates at the time of the agreement and helping to avoid disputes.
• Consequences of omitting a particular asset – optional; the omission does not affect the validity of the agreement. Under full separation it is of little significance. Where accrued gains fall to be equalised, however, it becomes harder to prove that the asset formed part of personal property when the agreement was signed and is therefore not a gain accrued afterwards. Under an agreement extending or limiting the community, an item not identified as included or excluded is governed by the general rules: property acquired before the marriage remains personal property, and property acquired afterwards enters the joint property.
• Periodic review mechanism – optional. There is no statutory duty to review the agreement, nor any prohibition on including such clauses (for example allowing the parties to check every few years whether the terms remain appropriate). The review itself is not subject to formal requirements, but any amendment of the terms or change of regime requires a notarial deed.

6.2. Key negotiation points

Once the essential and optional elements have been identified, it is worth considering which issues will matter most in negotiations:

• The opening estate of each party – useful under any regime, but particularly important under separation with equalisation, in order to distinguish accrued gains precisely from assets held before the intercyza. The method and date of valuation (self-declaration or an independent valuer) should be negotiated.
• Growth in value of premarital property – under a community regime: whether the growth of personal property is to enter the joint property or be kept outside it; under separation with equalisation: whether it counts towards accrued gains or is disregarded on divorce.
• Passive growth versus growth resulting from the work of one or both spouses – as the statute draws no such distinction, it is for the spouses to decide whether growth generated by an investment portfolio is to be included in the joint property or accrued gains or kept outside them; the same applies to growth resulting from a spouse’s work.
• Income from work – under the statutory community, including an extended community, it forms part of the joint property by default (Art. 31 § 2(1) KRO); under separation with equalisation it generally increases accrued gains. Negotiations may concern whether it is counted at all, as well as organisational arrangements for the use of earnings.
• Business income – whether the business and its income fall within the joint property or accrued gains, or are excluded.
• Dividends, interest and rental income – these are civil fruits (Arts. 53 § 2 and 54 KC), which under the statutory community enter the joint property even if they derive from personal property; under separation with equalisation they increase the spouse’s accrued gains. The parties may consider limiting the inclusion of certain fruits in the joint property or in accrued gains.
• Shares – whether they, and the income from them, are excluded from accrued gains or from the joint property.
• Incentive schemes, options, RSUs, carried interest and other deferred benefits – the agreement should state at what moment such rights are treated as acquired (grant, vesting or payment) and whether they count towards the joint property or accrued gains.
• Intellectual property rights – copyright, patents and trade marks may be of great value, so the right itself should be distinguished from the income from its exploitation, and the parties should agree whether each enters the joint property or accrued gains or is excluded.
• Income and benefits received abroad – the method of valuation and the currency used for the purposes of equalisation should be agreed.
• Future inheritances and gifts – under the statute, the joint property cannot be extended to items acquired by a spouse by inheritance, legacy or gift (Art. 49 § 1(1) KRO), and under separation with equalisation they are disregarded by virtue of Art. 51³ § 2 KRO. This does not apply, however, to the income they may generate (for example from an inherited property), so that question should be regulated.
• Joint financial investments in unequal proportions – under separation of property, joint investments are treated as co-ownership under Art. 195 KC. Each party’s share in the investment (for example 30% and 70%) should be stated clearly, so that on divorce the proceeds of sale are divided in those proportions.
• Outlays from one spouse’s property on the property of the other – if this is not regulated and the equalisation regime is chosen, such outlays are added when calculating accrued gains (Art. 51³ § 2(3) KRO). They should be carefully documented to avoid disputes on divorce.
• Costs of maintaining the family – the duty under Art. 27 KRO is mandatory and cannot be excluded by agreement; the agreement may, however, specify how and in what proportions it is to be performed.
• Economic consequences of a career break by one spouse – relevant mainly for couples under separation with equalisation.
• Debts, guarantees, sureties and contingent liabilities – in order to protect the joint property, the agreement may state that debts, guarantees, sureties and contingent liabilities connected with business activity burden the personal property of the spouse concerned, or that they are left out of account in calculating accrued gains.
• Sale of the business, entry of an investor or an IPO – whether the proceeds of a sale of the business enter the personal property of one spouse (Art. 33(10) KRO, where the business itself was personal property) or the joint property is extended to cover them. Investors may require a specific, stable shareholder structure, which could be upset by a divorce in a marriage under a community regime and a transfer of part of the shares to the former spouse. For that reason, separation of property, or a limitation of the joint property excluding the business, is recommended.
• Relocation to another country – absent a choice of law, the spouses’ personal and property relations are governed by their common national law and, failing that, by the law of the state in which both are domiciled or, failing that, habitually resident (Art. 51(1) and (2) PPM). For spouses of different nationalities, a move may therefore change the applicable law. It is advisable to choose the governing law directly in the marital property agreement, so that relocations do not undermine the legal stability of the estate.

7. Additional clauses

7.1. Clauses worth including

When drafting the clauses that shape the regime, attention should also be paid to additional provisions that do not create a new regime. Some belong in the deed itself, some in a schedule to the main agreement, and some in an entirely separate agreement.

• Disclosure of assets and liabilities – the deed should state that the parties have truthfully disclosed their personal property in detail in an information schedule attached to the deed. Polish law imposes no duty to disclose assets when signing a marital property agreement, but such a schedule is worth preparing for evidentiary purposes in the event of divorce.
• Statements on the completeness of the information provided – these should form part of the notarial deed.
• Independent legal advice – Polish law does not require consultation with an independent lawyer before signing. It is nevertheless worth including a statement that each party had the opportunity to consult a legal adviser or chose not to, in order to counter potential allegations of defects of consent.
• Confirmation of sufficient time to review the document – the deed should record the dates on which the draft agreement and, where applicable, its translation were delivered, together with a statement that the time was sufficient; acknowledgements of receipt or email correspondence may be added to the information schedule.
• Language clause – the deed should record the participation of a sworn translator or translation by the notary personally (Art. 2 § 3 of the Notaries Act); the translation should be attached as a schedule.
• Confidentiality – this should be the subject of a separate agreement, with sanctions for breach, and the deed should refer to the fact that such an agreement has been concluded. Importantly, confidentiality cannot extend to the existence of the marital property agreement and its type, since the agreement could then never be relied on against third parties under Art. 47¹ KRO.
• Cost-sharing – the deed should refer to the existence of the arrangement, with the details in a schedule: whether the costs of meeting the family’s needs are shared equally or in proportion to earnings, and how the various categories of costs are allocated, including rent, utilities and day-to-day living expenses.
• Cooperation in updating foreign registers – a separate provision obliging the parties to cooperate in this respect.
• Periodic review – the deed should mention that the agreement is to be reviewed at specified intervals, with the review procedure set out in a schedule, while making clear that any amendment or termination of the agreement requires a separate notarial deed.
• Severability – to be included in the deed as a reinforcement of the rule in Art. 58 § 3 KC, which upholds the remaining provisions not affected by invalidity.
• Documentation of outlays – an obligation to keep records (invoices, transfer confirmations) of outlays made from one estate on the other, so that they can be accounted for when the regime ends.
• Joint accounts and joint investments – rules on contributions to and withdrawals from joint accounts and on each spouse’s share in jointly held investments.
• Dispute resolution mechanisms – the deed may provide for a tiered procedure: negotiation, mediation and, finally, a court or arbitration. This requires a mediation agreement or an arbitration clause.
• Choice of court – under Art. 41 of the Code of Civil Procedure (Kodeks postępowania cywilnego, KPC), an action arising from the marital relationship must be brought before the court in whose district the spouses last had their common residence, provided that one of them still has his or her domicile or habitual residence there; this is exclusive venue, which the parties cannot change by agreement[11]. The division of joint property is in turn dealt with in non-contentious proceedings, which have their own venue rules. A choice-of-court clause under Art. 46 KPC (a written agreement submitting an existing or future dispute to a chosen court of first instance) can therefore operate only within those limits and should be drafted narrowly, for clearly defined property claims between the spouses.

7.2. Clauses that are impermissible, risky or potentially ineffective

It is equally worth listing examples of clauses that would be impermissible, risky or potentially ineffective:

• a waiver of future maintenance;
• a determination in advance of fault for the breakdown of the marriage;
• penalties for infidelity or for filing for divorce;
• provisions on custody of children or contact with them;
• provisions limiting child maintenance;
• an automatic transfer of real estate without the required form;
• a waiver of succession rights in an improper form;
• attempts to exclude liability towards creditors;
• clauses contrary to the principles of social coexistence or public policy.

Importantly, because of the differences between legal systems, some clauses that are permissible in English or American prenuptial agreements may prove entirely unacceptable in a Polish marital property agreement.

8. Conclusions

The Overdeck case shows very clearly how destructive it can be for such a wealthy couple to leave property matters unregulated in the event of divorce, not only for the divorcing parties but also for the business and for third parties. Advising wealthy international families should therefore rest on a confident command of private international law and of Polish family, civil and procedural law. Depending on the regime, this means regulating precisely the extension or limitation of the joint property, or defining what counts as a spouse’s accrued gains, while respecting mandatory rules (ius cogens) and aligning the agreement with the needs of the business, so that the parties’ interests are protected as fully as possible.

Bibliography

1. Bugajski B., Domański M., Gołębiowski K. [in:] Prawo rodzinne i opiekuńcze. System Prawa Prywatnego. Tom 11, ed. J. Haberko, 1st ed., 2025.
2. Pietrzykowski K. [in:] Kodeks rodzinny i opiekuńczy. Komentarz, ed. K. Pietrzykowski, 9th ed., 2025.
3. Rudkowska-Ząbczyk E. [in:] Kodeks postępowania cywilnego. Komentarz, eds. E. Marszałkowska-Krześ, I. Gil, 40th ed., 2026.
4. Sobolewski P. [in:] Kodeks cywilny. Komentarz, ed. W. Borysiak, 35th ed., 2026.
5. Li J., Gottfried M., Rudegeair P., A Hedge-Fund Titan’s Divorce Is Putting Wall Street’s Staggering Wealth on Public View, The Wall Street Journal, 31 August 2026, https://www.wsj.com/personal-finance/a-hedge-fund-titans-divorce-is-putting-wall-streets-staggering-wealth-on-public-view-6c419f4c.
6. Ministry of Foreign Affairs of the Republic of Poland, Apostille i legalizacja dokumentów, https://www.gov.pl/web/dyplomacja/apostille-legalizacja-dokumentow [accessed: 28 September 2026].
7. New Jersey State Library, Uniform Premarital and Pre-Civil Union Agreement Act (legislative materials), https://dspace.njstatelib.org/server/api/core/bitstreams/505213d0-5ea7-46c7-bc31-8f92a08b9ff7/content [accessed: 28 September 2026].
8. Forbes, Profile: John Overdeck, https://www.forbes.com/profile/john-overdeck/ [accessed: 28 September 2026].
9. Szymczyk-Przewoźna J., Najmniej małżeństw i najwięcej intercyz w historii. Niedługo będzie ich 100 tys. rocznie, Rzeczpospolita, https://www.rp.pl/w-sadzie-i-w-urzedzie/art45153471-najmniej-malzenstw-i-najwiecej-intercyz-w-historii-niedlugo-bedzie-ich-100-tys-rocznie [accessed: 29 September 2026].

[1] Forbes, Profile: John Overdeck, https://www.forbes.com/profile/john-overdeck/ [accessed: 28 September 2026].

[2] https://dspace.njstatelib.org/server/api/core/bitstreams/505213d0-5ea7-46c7-bc31-8f92a08b9ff7/content

[3] K. Pietrzykowski [in:] K. Pietrzykowski (ed.), Kodeks rodzinny i opiekuńczy. Komentarz, 9th ed., 2025, Art. 47.

[4] J. Szymczyk-Przewoźna, Najmniej małżeństw i najwięcej intercyz w historii. Niedługo będzie ich 100 tys. rocznie, https://www.rp.pl/w-sadzie-i-w-urzedzie/art45153471-najmniej-malzenstw-i-najwiecej-intercyz-w-historii-niedlugo-bedzie-ich-100-tys-rocznie

[5] K. Pietrzykowski [in:] K. Pietrzykowski (ed.), Kodeks rodzinny i opiekuńczy. Komentarz, 9th ed., 2025, Art. 48.

[6] Judgment of the Court of Appeal in Gdańsk of 31 January 2022, I ACa 943/21, LEX no. 3581589.

[7] Judgment of the Supreme Court of 7 April 1967, I CR 559/66, LEX no. 6135.

[8] P. Sobolewski [in:] W. Borysiak (ed.), Kodeks cywilny. Komentarz, 35th ed., 2026, Arts. 82 and 83.

[9] https://www.gov.pl/web/dyplomacja/apostille-legalizacja-dokumentow

[10] B. Bugajski, M. Domański, K. Gołębiowski [in:] J. Haberko (ed.), Prawo rodzinne i opiekuńcze. System Prawa Prywatnego. Tom 11, 1st ed., 2025, Art. 51⁴ of the Family and Guardianship Code (editorial extract).

[11] E. Rudkowska-Ząbczyk [in:] E. Marszałkowska-Krześ, I. Gil (eds.), Kodeks postępowania cywilnego. Komentarz, 40th ed., 2026, Art. 41.

Artykuł Cross-Border Marital Property Agreements pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

We are proud to announce that KG Legal Kiełtyka Gładkowski has been named a winner in the inaugural European Legal Awards 2026, hosted by EU Business News. The firm received the title Most Trusted Cross-Border Law Firm 2026 – Poland.

About the award

The European Legal Awards are a recognition programme of EU Business News, a publication of AI Global Media. The programme honours law firms and legal professionals who demonstrate excellence, adaptability and a commitment to delivering outstanding legal services across Europe in an increasingly demanding regulatory and business environment. According to the organiser, winners are selected through independent, merit-based research.

Why this recognition matters to us

Cross-border work has been at the core of our practice since the firm was founded. From our offices in Kraków, Warsaw and New York, a team of more than 35 lawyers advises clients from Europe, the United States, Asia and the Middle East for whom Poland is an investment market, a forum for a dispute, or a jurisdiction where rights need to be effectively enforced.

In practice, this includes:

• cross-border litigation and arbitration, including recognition and enforcement of foreign judgments and arbitral awards in Poland,
• international asset tracing and recovery, supported by OSINT specialists and licensed cryptocurrency investigators,
• regulatory advice for the life sciences and healthcare sector, data privacy and EU regulatory matters,
• corporate, M&A and intellectual property work with an international element,
• international family law and private client matters.

The category in which we were recognised is about trust. In cross-border matters trust carries particular weight: a client hands over a case in a legal system they often do not know, in a foreign language and at a distance. This is why we focus on clear communication, a candid assessment of risk and realistic timelines rather than promises.

“We see this award above all as a thank you to our clients and partner law firms around the world who entrust us with their Polish matters. Trust is built over years, one case at a time, and it remains our most important measure of quality,” says Małgorzata Kiełtyka, co-founding partner of KG Legal.”.

The EU Business News award joins the firm’s existing recognitions, including continuous presence in the Legal 500 EMEA ranking since 2019 and the Legal 500 CEE Awards 2025 title of Healthcare and Life Sciences Lawyer of the Year.

We would like to thank our clients, our international partners and the entire KG Legal team. This recognition is shared.

Read more:

• Winner profile at EU Business News
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Artykuł KG Legal Kiełtyka Gładkowski named Most Trusted Cross-Border Law Firm 2026 – Poland in the European Legal Awardsdd pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Poland’s Ministry of Health wants to place medicines with different active substances in a single reimbursement limit group where they work in a similar way, and to reward hospitals for choosing the cheapest therapy available. The change is meant to bring prices down and free up funds for innovative treatment, but clinicians warn that cost equivalence is not the same as clinical equivalence. We examine how the proposed baskets of equivalent therapeutic technologies could affect physicians’ autonomy, patients’ rights and competition in the pharmaceutical market, and what safeguards the legislation should contain.
KG LEGAL KIELTYKA GLADKOWSKI supports international pharmaceutical, biotechnology and healthcare businesses operating in Poland. For legal assistance with pharmaceutical regulation, reimbursement and market access, contact our team at office@kg-legal.pl.

Introduction

The aims of the reform

Optimising the spending of the National Health Fund (NFZ), keeping the total reimbursement budget stable and stimulating price competition: according to its official explanatory memorandum, these are the aims of the draft amendment to the Polish Reimbursement Act, adopted by the Council of Ministers in October 2026. The draft reforms the rules on public funding of pharmacotherapy and medical devices, introducing new instruments such as baskets of equivalent therapeutic technologies and price corridors. Although it is intended to protect the economic interests of the system and improve healthcare in Poland, its content has provoked lively debate from the outset. To assess the real value of the planned changes, it is worth starting with the legal framework they are meant to replace.

The previous model: individual decisions and unanimity of manufacturers

Until recently, the description of a drug programme was an annex to the individual administrative decision issued to a specific manufacturer. As a result, any change to the programme – adding a new medicine, modifying patient eligibility criteria or updating the required diagnostics – required the unanimous consent of all manufacturers holding reimbursement decisions within that programme. Limit groups also played an important role; in practice they generally comprised medicines containing the same active substance, although the Act already allows, to a limited extent, medicines with different international non-proprietary names to be grouped together. In the Ministry of Health’s view, this model fostered blocked competition and monopolisation, since the objection of a single manufacturer could halt the introduction of a new therapy and thus hinder the timely adjustment of drug programmes to current clinical guidelines and patient needs.

What has already changed and what is still to come

The first step was an amendment that entered into force on 1 July 2026. Its priority was to move away from the former annexes to decisions and to introduce Article 16a, which removes drug programme descriptions from the decisions issued to individual companies. This was, however, only one of the changes announced in the draft. Its central proposal remains a new way of grouping medicines, namely baskets of equivalent therapeutic technologies: placing medicines with different active substances in a common limit group where they show a similar therapeutic effect and a similar mechanism of action. In addition to organisational benefits for healthcare providers, the change is meant to generate savings, on the assumption that putting alternative medicines in a single basket and financially rewarding hospitals for choosing the cheapest of them will drive prices down and reduce public expenditure.

I. How are the baskets of equivalent therapeutic technologies meant to work?

Criteria for inclusion in a basket

To assess whether this solution will actually achieve its stated aims, we first need to look at its mechanisms and assumptions. Under Article 15a(2) of the draft, the basic criteria for placing medicines in a common limit group are the same or similar indications or intended uses for which they are reimbursed, and similar efficacy. A basket may include a medicine with the same international non-proprietary name (i.e. meeting the criterion of an identical active substance, which is the primary criterion under the current Reimbursement Act) or a medicine with a similar therapeutic effect and a similar mechanism of action. The baskets are to apply primarily to medicinal products and foods for special medical purposes used in drug programmes. They cover advanced innovative medicines, biologics and biosimilars used in specialised hospital therapies, including oncology (including chemotherapy), haematology, rheumatology and dermatology.

The procedure for setting a drug programme description

The description of the drug programme within which a basket operates goes through several stages set out in Article 16a, in force since 1 July 2026:

1.    the Minister of Health prepares a draft description after consulting the relevant national or regional consultant and, where justified, the relevant medical society;

2.    the draft is sent to the President of the Agency for Health Technology Assessment and Tariff System (AOTMiT) for an opinion and, once the opinion is received, forwarded to the applicant;

3.    the applicant is required to submit its opinion within no more than 7 days; that opinion is, however, not binding on the Minister.

These rules, already in force, show how the role of expert opinions in shaping drug programmes has changed: they are now the substantive basis for creating and updating programmes. The requirement of unanimity among pharmaceutical companies has been replaced by a mandatory consultation of the national or regional consultant in the relevant field of medicine and a mandatory opinion from the President of AOTMiT. This obligation applies, however, to the creation of a description; when it is later amended, the Minister may, but need not, seek these opinions. In addition, where a change to the programme description alters the target population, the President of AOTMiT calls on the applicant to supplement its health technology assessment (HTA), i.e. the analysis comparing the technology with the existing standard of care (Article 35(2a)). Consulting a medical society, by contrast, remains optional. The programme description prepared in this way is annexed to the Minister of Health’s notice on the list of reimbursed medicines, foods for special medical purposes and medical devices, published in the Minister’s official journal.

The doubts: what exactly does “equivalence” mean?

Although the direction of the draft seems positive at first glance, several issues may prove problematic in implementation. The first point of contention is the scope of the baskets, i.e. the criteria for their “equivalence”. The draft uses only general phrases such as “similar therapeutic effect” and “similar mechanism of action”, without any verifiable quantitative criteria. This has raised concerns among clinicians, who point out that the absence of an exhaustive list of clinical indicators may give the regulator broad discretion. This creates a real risk of equating economic equivalence with clinical equivalence. In the view of experts in the specialties covered by the programmes, grouping therapies deemed equivalent in a single basket will significantly complicate physicians’ everyday practice. In the current wording of the proposed provisions, the healthcare sector therefore sees above all an economic motive.

II. Financial incentives for hospitals to use the cheapest therapies

These concerns appear justified, especially as the proposed basket model is closely linked to the way the NFZ settles payments for healthcare services. The system is to rely on an existing instrument, correction coefficients, which are currently used to adjust the valuation of services, for example for holding quality accreditation, meeting certain staffing standards or delivering comprehensive care programmes. The drafters give this tool a new purpose: rewarding hospitals for choosing the medicine that sets the limit base within a given basket. A hospital that, within a basket, treats a patient with the drug technology with the lowest average cost per day of therapy, or with the product selected in a tender as the most price-competitive, is to receive a more favourable correction coefficient. In practice, the mechanism therefore encourages hospitals to be guided by the lowest unit price.

Formally, all products included in a given basket remain on the reimbursement list, as follows from Article 37 of the Reimbursement Act. The problem is therefore not a narrower range of available medicines, but a possible restriction of physicians’ freedom of decision and autonomy. This risk is particularly real given the chronic underfunding of hospitals, where management decisions may be driven by the need to stabilise finances and tilt towards the cheapest medicine in the hospital’s public tender.

III. Cost equivalence versus clinical equivalence

Same line of treatment does not mean interchangeable

The key question in assessing equivalence baskets is whether the same line of treatment and the same indication are enough to consider medicines equivalent. Medical experts and national consultants answer this firmly in the negative: belonging to the same line of therapy does not mean that medicines are clinically interchangeable. They may have different chemical structures and differ in, among other things, toxicity profile, metabolism or route of administration. The basket mechanism therefore cannot be equated with safe generic or biosimilar substitution. Whereas generics and biosimilars involve demonstrated bioequivalence (or, for biosimilars, demonstrated biosimilarity) of the same active substance, distinct therapeutic technologies show only comparable efficacy in averaged populations. What does this mean in practice?

The different characteristics of products are particularly significant in fields where treatment efficacy relies on molecularly targeted therapies, such as oncology and haematology. The cheapest medicine in a basket may be less precisely targeted at a specific genetic mutation than a more expensive one that does not set the limit base. More generally, adverse reactions must also be considered, as their frequency and severity may differ between medicines in the same basket. The negative consequences of selecting a product in this way may be especially severe for frail patients.

A patient is not a population average

The burden of choosing a one-size-fits-all, economically advantageous solution therefore grows with the degree to which a patient’s needs are individual. Previous therapies often affect the immune system and the body’s response to subsequent treatment, so the sequence of therapies is crucial. Widespread use of a single medicine also carries a risk of interactions in patients with comorbidities, which may sometimes absolutely rule out the use of a given product. Moreover, choosing a suboptimal medicine at an early stage may make it impossible to use the most effective therapy in a later line. All of this shows the possible consequences of a simplified assessment of equivalence and underlines the importance of personalised medicine, which should not give way to a hospital’s economic pressures.

The methodology of the studies on which medicines are authorised, and subsequently reimbursed, is based on population statistics. Similar average efficacy across a study sample cannot be equated with efficacy in an individual patient. Analysis of a patient’s individual biological profile cannot be reduced to simplifications introduced to make product selection easier; it should take individual predispositions into account so as to minimise the risk of ineffective treatment or, worse, serious complications.

IV. Physician autonomy and responsibility for the choice of therapy

Due diligence versus economic pressure

Taking the patient’s individual situation into account, as part of acting in accordance with current medical knowledge, is a statutory duty of physicians under the Act on the Professions of Physician and Dentist and, at the same time, a deontological duty under the Code of Medical Ethics (KEL). Since physicians must practise in accordance with current medical knowledge, using the methods and means available and with due diligence, they should not use the cheapest medicine in a basket if it does not comply with current clinical guidelines for the particular disease subtype. Imposing such a product for cost-saving reasons would be contrary to the standards set by Article 4 of the Act on the Professions of Physician and Dentist, the Code of Medical Ethics and Article 6 of the Act on Patient Rights and the Patient Ombudsman. These provisions guarantee physicians freedom to choose the methods they consider most effective. Rewarding hospitals for using the tender-winning medicine may, however, lead to a situation in which physicians’ formal autonomy is in practice curtailed by market mechanisms and economic considerations.

Who bears the consequences?

An independent public healthcare institution (SPZOZ) covers its operating costs from its own revenue and must cover any net loss itself. If debt ratios are at risk of being exceeded, hospital management may be forced to issue internal instructions and design tender procedures so that only the cheapest medicines in a given basket are used, placing administrative pressure on physicians. If, as a result, a patient suffers serious adverse reactions where current medical knowledge called for a different product, the physician may face professional liability before a medical court and criminal liability and, depending on the legal basis on which they provide services, civil liability. The healthcare provider is also liable for damage resulting from the provision of services or the unlawful failure to provide them: for physicians employed under an employment contract, it is generally the provider that is liable to the patient (Article 430 of the Civil Code in conjunction with Article 120 of the Labour Code), while for physicians engaged under civil-law contracts it is jointly and severally liable with the physician (Article 27(7) of the Act on Medical Activity). Such an event may also constitute a culpable infringement of the patient’s right to services consistent with current medical knowledge, giving rise to a claim for compensation for non-pecuniary harm under Article 4 of the Act on Patient Rights.

How can physicians protect themselves?

To avoid breaching the law, a physician may, and sometimes should, depart from the economically preferred technology. In doing so, the physician must give the patient accessible information about the proposed treatment methods, their risks and expected benefits, which includes the reasons for choosing a specific therapy. Choosing a personalised therapy that departs from the hospital’s economic standard should be documented in detail in the medical record, together with the substantive medical justification.

V. Patients’ rights and the principle of individualised treatment

Informed consent requires full information

Polish law thus imposes specific duties on physicians towards patients. Besides treatment consistent with current medical knowledge and tailored to the specific condition, i.e. personalised treatment, patients have the right to information about their health, diagnosis and possible treatment options, including the alternatives available within the basket. From this perspective, patients should also know whether the choice of a particular medicine results from its clinical profile or from the facility’s organisational and financial constraints. This information is not an empty formality but a condition of informed consent. A patient may consent to, or refuse, specific healthcare services only after receiving the full information specified in Article 9 of the Act on Patient Rights. If a patient consents without having received this information in an accessible and comprehensible form, the consent is defective and the medical intervention is, as a rule, unlawful.

The risk of unequal access to therapy

The legal position of patients in Poland is grounded both in statute and in Article 68 of the Constitution, which guarantees the right to health protection and equal access to publicly funded healthcare services. In practice, however, these principles face obstacles. Besides the risk of a hidden barrier to access resulting from the drive to balance the budget, there is a risk that the level of care will vary between patients. Equivalence baskets, combined with rewarding hospitals for choosing the medicine that won a local tender, may lead to fragmentation of treatment. Imagine that hospital A in one region selects medicine X in its tender, while hospital B in a neighbouring region selects medicine Y. Two patients with identical biological and clinical profiles may then receive different medicines simply because one was admitted to hospital A and the other to hospital B. Making geography and the outcome of a tender the deciding factor in treatment could raise serious doubts as to compliance with the constitutional principle of equal access to healthcare services (Article 68(2) of the Constitution).

VI. Could the mechanism restrict competition in the pharmaceutical market?

Market concentration around the tender winner

From the Ministry of Health’s perspective, creating common limit groups for medicines with similar therapeutic effects is meant to break down artificial monopolies and introduce price competition between manufacturers. Introducing baskets may, however, also have a less desirable effect: strong pressure to choose the most economically advantageous product. Medicines will formally remain on the reimbursement list, but a large share of orders will go to the winner of the hospital tender. This would mean market concentration around the medicine setting the limit base, even though the basket also includes other, more expensive options.

Unit price is not the whole cost of therapy

It is also worth looking more closely at the economics of the solution. The most financially advantageous options in tender procedures and in setting the limit base are determined using a fairly narrow criterion: the official selling price or the price per dose unit. Relying solely on this indicator can be misleading, as it ignores additional costs related, for example, to the pharmaceutical form and route of administration and, in some cases, to medicines that mitigate adverse reactions or the need to switch therapy when the first product does not deliver the expected results.

Risk-sharing discounts as the benchmark for further cuts

Existing risk-sharing schemes (RSS) also take on a new significance. The draft provides that the mandatory 25% price reduction after protection expires is to be calculated from the effective price, i.e. the price net of the confidential RSS discount. Whereas the idea behind these instruments was to separate the official selling price from the actual cost to the budget, once the proposed changes take effect the discount would become a fixed benchmark for further cuts. Paradoxically, those who stand to lose most are the companies that have so far been the most flexible in price negotiations.

Across the system as a whole, the cumulative price pressure – mandatory 25% reductions after protection expires and price corridor requirements – may lead some manufacturers to withdraw from the reimbursement list because it is no longer profitable. The draft’s option of extending the settlement period for outcome-based RSS to as long as 10 years does not solve the problem. Given the costs of manufacturing, transport and certification, selling a medicine in Poland may become loss-making for a manufacturer, and to limit losses manufacturers may stop offering large RSS discounts when launching new therapies, knowing that a discount granted today will be used in a few years as the basis for a forced, drastic price cut. A solution meant to increase price competition may thus restrict competition in another area and even jeopardise the continuity of supply of medicines to patients.

VII. Potential benefits – the drafters’ arguments

Price pressure and cost-effectiveness

How do the drafters justify the proposed changes in the face of clinicians’ objections? The Ministry of Health’s arguments include several important elements: aligning the legal framework with market realities, creating mechanisms for flexible management of the total reimbursement budget (CBR) and improving cost-effectiveness. Flexible design of limit groups is meant to exert price pressure, bring prices closer to market levels and strengthen hospitals’ negotiating position when purchasing medicines at prices close to the limit base. Inclusion in a common limit group, and indirectly the level of funding, would no longer be determined by the active substance alone but by a broader clinical profile, so that large price disparities would gradually even out. The amendment therefore aims to reduce the costs of inpatient care on many levels.

Where are the savings meant to go?

According to the Ministry of Health, the savings are to fund new, innovative therapies: technologically advanced medicines whose use places a significant burden on the budget over the longer term. These include in particular targeted therapies in oncology and haematology, advanced therapy medicinal products (ATMPs) and highly innovative drug technologies (TLWI). Clinical experts and representatives of the pharmaceutical industry stress, however, that translating these savings into genuinely better access to treatment will require additional safeguards, so that legitimate aims are not reduced to a mere battle over price.

VIII. What safeguards should the legislation contain?

Precise equivalence criteria

A safe implementation of the new rules therefore requires solutions that reconcile rationalised spending with a guarantee of personalised medical care. First and foremost, precise criteria for creating baskets should be considered, so that baskets are not based on a general similarity of indications and on regulatory discretion. Membership of a common limit group should be determined by demonstrated clinical equivalence, not merely by belonging to the same line of treatment. A comprehensive health technology assessment (HTA) covering the molecular profile of the disease, mechanism of action, metabolism, route of administration, toxicity profile and sequencing of therapies would be an effective preventive measure.

Expert involvement and ongoing monitoring

Since such an assessment requires specialist medical knowledge, it seems natural that specialists from the relevant fields of medicine must take part in it. The rules in force since 1 July 2026 require the national or regional consultant to be consulted when a drug programme description is created, but not when it is amended. Given the risks arising from an improperly conducted procedure, it would be justified to extend this obligation to amendments and to make consultation with medical societies and patient organisations mandatory as well. Beyond precise rules on determining the composition of baskets, there must also be oversight of how they operate and monitoring of the efficacy and safety of therapies, with the possibility of modifying a basket. The legislation should require AOTMiT to carry out periodic reviews of existing limit groups for hidden costs of hospitalisation, treatment of complications and rates of treatment discontinuation, based on reliable NFZ registry data. It should also provide for an appeal procedure against drug programme descriptions published in the Minister of Health’s notice, together with a list of entities entitled to lodge formal objections. The lack of an appeal route has also been raised by INFARMA, which, after the public consultation closed, called for the baskets to be removed from the draft.

Protecting the individual patient

The most important matter to be regulated remains the protection of health as the paramount value that the amendment is ultimately meant to serve. To this end, the drafters could add a transparent and fast procedure for exempting a patient from the basket mechanism where justified by the patient’s individual clinical profile, as well as a guarantee of continuity of treatment: the right to continue therapy with a given drug technology until the end of the treatment cycle if it has already been started. Physicians’ decisions on how to conduct treatment should be driven above all by the patient’s interest and should not have adverse financial consequences for the hospital if the chosen medicine is not the cheapest. If a hospital in which a physician individualised the therapy and gave substantive reasons for it in the medical record retained the right to full payment for the service without a reduced correction coefficient, the influence of economic considerations on treatment decisions would be significantly weakened.

Conclusion

The Ministry of Health’s aim of optimising the budget and freeing up funds for breakthrough innovations, including ATMPs and TLWI technologies, is justified from the perspective of public finance management. The analysis shows, however, that the drafters should do more to strike a balance between optimising public spending, physicians’ autonomy and patients’ right to personalised therapy. The mechanisms proposed in the current wording of the draft may bring hospitals’ financial constraints into conflict with physicians’ statutory and ethical duty to provide medical services with due diligence. Care must be taken to ensure that economic pressure on inpatient care does not result in merely formal improvements in access to advanced therapies. This can be achieved by supplementing the draft with the safeguards discussed above. Equivalence baskets could then benefit the public healthcare system on several levels without restricting the rights of patients, whom the Reimbursement Act is, after all, meant to protect.

Artykuł Baskets of Equivalent Therapeutic Technologies – Rationalising Spending or Restricting Treatment Choice? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Clinical research, diagnostic testing and commercialisation under Polish and EU law

Law as at 5 November 2026

Abstract

A change in an epigenetic clock may justify further investigation of a medicine. Its value as evidence of benefit depends on what the clock measures, the population in which it has been validated and whether treatment effects on the score predict effects on health. The same assay may be used to analyse archived samples, select participants for treatment or sell a test to consumers. Each use raises a different legal question. This article traces those questions from trial design through to commercial use, with particular attention to Polish law on medical experiments, performance studies, access to medical records and the use of data from non-commercial clinical trials.

Keywords  ageing biomarkers, geroprotectors, clinical trials, IVDR, biobanks, genetic data

What three years on a biological clock mean

Suppose researchers measure DNA methylation in volunteers’ blood before administering a substance and again six months later. In the intervention group, the mean score on the chosen clock falls by three years. The sponsor wants to describe the result as evidence that the product slows ageing. The first question concerns the comparator. Was the difference from placebo also three years, or does the figure describe only the change between two measurements in the same people? The second concerns the volunteers. Does a change of this size predict a later loss of independence, fewer hospital admissions or longer survival? Each claim calls for different evidence.[1]

A geroprotector, as used here, is a substance under investigation for its potential effect on biological processes associated with ageing. A model can be trained to estimate chronological age, mortality risk or the pace of physiological change. Two models that express their results in years can therefore be measuring different things. In an open-label pilot study in people with diabetic kidney disease, investigators reported fewer cells expressing markers of cellular senescence, including p16 and p21, in adipose tissue after dasatinib and quercetin. This provided evidence about a possible mechanism of these senolytic drugs. Establishing whether the intervention prolongs healthy life requires a study measuring that benefit or a reliable surrogate for it.[2]

The European Innovation Council recognised this problem in its Pathfinder challenge on Biotechnology for Healthy Ageing. For biomarker tools, the programme linked access to appropriate cohorts with the need to demonstrate a relationship between an ageing mechanism and clinical features. These conditions identify a research objective. Whether the results support a particular medicinal indication is a separate regulatory assessment.[3]

From a biomarker association to a clinical benefit

An ageing biomarker may identify a group at increased risk of functional decline. Such a prognostic marker makes events more likely to be observed during the study. A predictive marker helps identify patients likely to derive a greater effect from a particular treatment. A pharmacodynamic response marker serves another purpose. A change may show that the substance affects the biological pathway under investigation. If the sponsor uses that change to predict something that matters to patients, the marker is being proposed as a surrogate endpoint. The strength of that case depends on the biological rationale, the marker’s prognostic value and interventional evidence that treatment effects on the marker correspond to treatment effects on the clinical outcome.[4]

The CALERIE trial illustrates the distinction. In a post hoc analysis of samples from this randomised study of caloric restriction, the intervention slowed the pace of ageing measured by DunedinPACE. The authors found no significant change in the biological age estimates produced by PhenoAge and GrimAge. In a separate study, TranslAGE researchers applied 16 clocks to data from 51 interventional studies. Responsiveness varied with the intervention, population and length of follow-up. For a lawyer reviewing a regulatory dossier, the choice of clock is therefore material. Selecting the most favourable measure after inspecting the results weakens the inference, particularly when the investigators have made numerous comparisons. Whether the population studied resembles the population for the intended efficacy claim is a further question.[5]

A protocol should specify the algorithm version, tissue, sampling time, primary comparison and approach to multiplicity and missing measurements. A study of loss of independence also has to address what happens if a participant dies before the next functional assessment. An analysis confined to those who are well enough to attend the visit could give an overly favourable picture. ICH E9(R1) provides a way to link these decisions to the precise treatment effect the trial is intended to estimate. Choices made on this point can change the clinical meaning of the answer even if the assay is perfectly reproducible.[6]

Where a method is intended for use by several medicine developers, the European Medicines Agency (EMA) offers voluntary qualification within a defined context of use. Its Committee for Medicinal Products for Human Use (CHMP) may, for example, assess whether the tool is suitable for identifying a higher-risk population. Using the same tool as a primary endpoint requires a case for that additional purpose. Where the question concerns the design of one product development programme, the sponsor can seek scientific advice on the protocol.[7]

Classifying the substance and choosing the study design

The biological nature of ageing does not by itself determine product classification or establish a proposed indication. Under EU and Polish law, a substance may be a medicinal product because it is presented as treating or preventing disease. It may also qualify because it can be used to restore, correct or modify physiological functions through pharmacological, immunological or metabolic action. In Hecht-Pharma, the Court of Justice held that the product must be assessed individually, taking account of factors including composition, dose and effects under normal conditions of use. Giving medicines legislation priority in a borderline case still requires a finding that the product meets the definition of a medicine.[8]

This distinction affects population selection. A study of whether treatment delays mobility loss in people at increased risk can define an event and a period of observation. A project in healthy adults that measures only a cellular marker will answer a narrower question. Experience with metformin in a different indication contributes knowledge about the substance. A new use still requires its own assessment of dose, duration, population and benefit–risk balance. A clinical trial authorisation allows the evidence to be generated. Bringing a new medicine to market or adding an indication to an existing authorisation requires a separate procedure. The authority considers, among other matters, whether therapeutic efficacy is substantiated and the benefit–risk balance is favourable for the proposed use.[9]

The interventions in the protocol then determine the legal route. Under Regulation (EU) No 536/2014 (the Clinical Trials Regulation, or CTR), a clinical study of a medicinal product constitutes a clinical trial if any one of the statutory criteria is satisfied. They include advance assignment to a therapeutic strategy outside normal practice, a prescribing decision taken together with the decision to enrol the participant or diagnostic or monitoring procedures additional to normal care. Observing treatment prescribed independently of enrolment can constitute a non-interventional study if the other criteria are also absent. Extra blood draws required by the protocol therefore merit scrutiny even if the medicine is already available from a pharmacy.[10]

A low-intervention trial is still a clinical trial. Apart from placebos, the investigational medicines must be authorised. Their use must conform to the authorisation or be supported by published scientific evidence of safety and efficacy in at least one Member State concerned. Additional procedures must pose no more than minimal additional risk or burden compared with normal clinical practice. An earlier stage of a programme may involve animal experiments. In Poland, these require authorisation by the competent local ethics committee. The assessment considers replacement of animals by other methods, reduction of animal numbers and refinement of procedures.[11]

Protecting participants in a Polish clinical trial

Applications for medicinal product trials are submitted through the EU Clinical Trials Information System (CTIS). In a multinational trial, Part I of the assessment covers matters including the scientific rationale and benefit–risk balance. In Part II, each Member State concerned considers national matters including participant information, consent, recruitment and arrangements for compensation. The Polish decision is issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). The ethical assessment is carried out by the national bioethics committee or a designated committee on the statutory list.[12]

A healthy volunteer may have little prospect of a direct benefit from a preventive intervention. The application should explain what potential value to participants or public health justifies the foreseeable risks and inconvenience. In older populations, multimorbidity, concurrent medicines and the burden of study visits affect that assessment. EMA recommends the Short Physical Performance Battery to characterise physical frailty at baseline. It helps establish whom the study population represents. A proposal to use the same scale as the main measure of efficacy needs a justification appropriate to the indication.[13]

The English MET-PREVENT trial shows why that distinction matters. In older people with probable sarcopenia and physical prefrailty or frailty, metformin did not improve four-metre walking speed at four months compared with placebo. The authors also reported poor tolerability in this population. That finding concerns a particular dose, population and functional outcome. In another trial, a promising change in a laboratory marker would still have to be interpreted alongside tolerability, adverse events and the participant’s ability to function in daily life.[14]

Chronological age does not determine the ability to give informed consent. For participants who lack that capacity, Article 31 CTR requires, among other safeguards, consent from a legally designated representative, respect for the express wish of a participant capable of forming an opinion and a justification for studying that population. The sponsor must also plan safety oversight, reporting of suspected unexpected serious adverse reactions and publication of results with a lay summary, generally within one year of the end of the trial in all Member States concerned. Polish law addresses civil liability and insurance, with an exception to the sponsor’s insurance obligation for low-intervention trials. The Clinical Trials Compensation Fund provides a separate route to compensation, including for bodily injury or a health impairment resulting from trial participation.[15]

When a biomarker assay falls within the IVDR

Regulation (EU) 2017/746 (the IVDR) governs devices intended to examine specimens from the human body, including software with the relevant intended purpose. The biological properties of the marker and the intended use of the tool that measures it are distinct issues. A retrospective analysis of blinded samples may examine whether changes in methylation correlate with subsequent functional decline. Where the result plays no part in participant management, the assay may have an exclusively research purpose. If the same result determines enrolment, assignment to a medicine or discontinuation of treatment, a decision about an individual now depends on it. Assessment must take account of the manufacturer’s intended purpose, instructions, promotional statements and actual role in the protocol. A “research use only” label cannot resolve the issue on its own.[16]

Consider the clock again. Dividing participants into subgroups for later statistical analysis has different implications from withholding the medicine from an individual whose score falls below a threshold. Companion diagnostic (CDx) status has a narrower test. The device must be essential for the safe and effective use of a corresponding medicine and identify people likely to benefit or those at increased risk of serious adverse reactions. As a rule, a companion diagnostic is a class C device under IVDR rule 3(f). In the conformity assessment, the notified body consults a competent medicines authority or EMA, as appropriate for the medicinal product.[17]

The performance evaluation addresses the scientific validity of the association between the measured feature and a clinical condition, analytical performance and clinical performance. An assay can measure methylation accurately yet assign patients to the wrong treatment group, for example if the threshold was derived in a younger population. Documentation should address the consequences of false positive and false negative results. The intended use covered by an existing CE mark must be checked against the proposed new purpose. Evidence that the assay performs as intended does not establish that the medicine works.[18]

Under the standard Polish procedure, a medicinal product trial and a device performance study requiring authorisation are assessed separately. URPL specifies an ethics opinion and authorisation by its President for a CDx performance study using samples collected specifically for that purpose. CDx studies using only left-over samples are subject to notification. The EU COMBINE pilot coordinates reviews of selected multinational combined studies. Poland is not listed among the participating countries in Annex I to the phase two sponsor guide. A sponsor therefore needs to plan the Polish national route even where sites elsewhere in the same project participate in the pilot.[19]

Software and the result delivered to a patient

An ageing clock may be a statistical model, stand-alone medical software or a component of a diagnostic system. A program designed to interpret specimen results and provide medical information about an individual may fall under the IVDR. Software that draws on gait sensors and supports a diagnostic or therapeutic decision may instead fall under Regulation (EU) 2017/745 (the MDR). For a model that combines laboratory results, images and clinical history, the function of each module and the principal source of the information used for the decision matter. The manufacturer’s description should be tested against what users actually receive and what the product invites them to do.[20]

An application might provide general educational information on ageing. A different question arises if its report states that the customer’s profile warrants a particular therapy. Before deployment, the developer needs to establish the limits of validation, how uncertainty is communicated and how the algorithm performs across age groups and in people with multiple conditions. An update to the model or threshold may change how many patients are offered treatment. Preserving the trial version, recording changes and evaluating their effects makes it possible to reconstruct the basis for an individual decision.

If the software also meets the definition of an AI system, Article 6(1) of the AI Act requires a separate assessment. It covers an AI system that is a product, or a safety component of a product, subject to Union legislation listed in Annex I where third-party conformity assessment is required for that product. Regulation (EU) 2026/1744 moved the application of the high-risk requirements for this group to 2 August 2028. An exclusion for systems developed and put into service solely for scientific research and development requires reassessment when the system becomes part of a clinical offering. Medical device requirements apply on their own timetable.[21]

Polish laboratory medicine law regulates the activities of medical laboratories and the reporting of results to patients. Relevant duties concern staff qualifications, specimen identification, method validation, authorisation of results and quality standards. Genetic testing in healthcare may also engage Article 4 IVDR, including information about the nature and implications of testing and access to counselling for specified predispositions to conditions generally considered untreatable. If a hospital makes and uses its own assay, Article 5(5) IVDR calls for a separate assessment, including use within the health institution, no transfer of the device to another legal entity and an appropriate quality management system. Ordering a test online does not establish its regulatory status or the qualifications needed to interpret its result.[22]

Human samples and the limits of biobanking

The Polish Act on the Professions of Physician and Dentist treats research on biological material, including genetic material, taken from a person for scientific purposes as a medical experiment (Article 21(4)). Article 29a(2) deals separately with collection, processing, storage and distribution of material for scientific purposes. These biobanking activities are excluded from the definition. A biobank may thus preserve a sample under its procedures, while a subsequent project testing a specific hypothesis on that sample may require a favourable bioethics opinion, consent and insurance. Under this Polish regime a research experiment in a healthy or ill person may entail at most minimal risk proportionate to its potential scientific benefit. Article 23a excludes, among others, persons subject to a legal incapacitation order from such research experiments. These national conditions are distinct from the rules specific to medicinal product and device studies.[23]

Consider two plasma specimens stored in the same freezer. The first was drawn to establish an ageing research cohort and can be linked to its donor. The second is an anonymous remnant of routine diagnosis. In its TRANSMED guidance, the Polish Medical Research Agency distinguishes the original purpose of collection, the investigator’s access to the key and subsequent use of data in a clinical trial. These are practical pointers for assessing an individual project. Placing material in a biobank does not confer rights to carry out every future analysis. Article 28 of the Polish Act provides a particular route for scientific use of information from a medical experiment or screening where identification is impossible. That provision addresses information.[24]

Under Article 24(2)(7), participants in a medical experiment must be informed about foreseeable further use of results, data and material, including commercial use. For a sample bank, the practical decisions are whether new markers can be assayed, whether a specimen can be sent abroad, whether donors can be recontacted and whether an incidental finding with possible health implications will be returned. A research observation may first require clinical confirmation. The participant also needs a meaningful account of what withdrawal entails if material is still held, has been consumed in testing or has already contributed to aggregate results.[25]

In findings published on 22 October 2026, Poland’s Supreme Audit Office described genetic samples being sent to foreign laboratories without patients’ knowledge or consent. In a multicentre project, a material transfer agreement should identify the specimens and recipients, permitted analyses, conditions for onward transfer, return or destruction, and responsibility for breaching those limits. The parties must also establish the sender’s authority and check that the proposed transfer is consistent with what the donor was told. A signed agreement between institutions cannot supply permissions that neither institution holds.[26]

Participant data and access to European cohorts

A clock score linked to a participant may reveal information about present or future health. DNA analysis can also entail processing genetic data. The controller must identify each purpose and the relevant lawful basis under Article 6 and condition under Article 9(2) GDPR. Reliance on the scientific research condition in Article 9(2)(j) requires a basis in Union or Member State law and safeguards under Article 89. Coding limits the visibility of a participant’s identity. Where reidentification remains reasonably possible, the data remain protected. This matters when rare variants are combined with age, clinical history or a small recruitment site.[27]

The European Data Protection Board distinguishes informed consent to trial participation from the legal basis for processing personal data. The sponsor’s duties to ensure safety and reliability serve a different purpose from scientific analysis. Withdrawal ends further interventions covered by the participant’s decision, but does not automatically remove data already lawfully obtained. Article 58 CTR requires archiving of the trial master file for at least 25 years after the end of the trial, subject to any longer Union requirements. This period does not determine how long every specimen is to be retained. Article 28(2) CTR allows a separate request for consent to use data outside the protocol exclusively for scientific purposes.[28]

Access to the source records raises a further issue. Article 26(4) of Poland’s Act on Patients’ Rights permits disclosure of medical records to a higher education institution or research institute for scientific purposes without revealing information that identifies an individual. A company working with the university needs its own basis for access. Consortium partners should identify actual controller and processor roles, access to the key and all recipients. Processing likely to entail a high risk requires a data protection impact assessment. A transfer to a recipient outside the European Economic Area engages Chapter V GDPR.[29]

The European Health Data Space (EHDS) will facilitate secondary access to data. Most of Chapter IV will apply from 26 March 2029. Article 51(1)(q) covers data from biobanks, while the date for genetic, epigenomic and genomic data under point (f) is 26 March 2031. An applicant will need to specify the categories and a permitted purpose. If a biobank holds both clinical observations and genomic data, the two elements of the requested dataset need to be classified separately. The Regulation provides for data permits, a secure processing environment, an opt-out and a ban on use for advertising. To obtain pseudonymised data, a researcher must justify why anonymous data would not achieve the purpose. In 2026, citing the EHDS provides no immediate entitlement to a Polish cohort or to physical specimens.[30]

Who can use the results and seek patent protection

A joint university and biotechnology project needs to establish what each party brings to the research and what rights it can acquire. A laboratory may control the assay technique, a university the model code and a hospital the records and specimens entrusted to it for a limited purpose. A licence to use an algorithm alone confers no right to train it on another cohort, disclose data to an investor or submit them to a medicines authority. Rights to material and data must therefore be distinguished from rights to software and inventions, and from publication arrangements. The allocation should also allow the records needed for regulatory verification to be retained and made available.

Articles 5 and 6 of the Polish Clinical Trials Act impose a particular constraint. Under the ordinary definition of a non-commercial trial, the sponsor and any co-sponsors must fall within the statutory categories, which include universities, healthcare entities and investigators. The right to dispose of the trial data must belong exclusively to those entities. Article 5(1), point 3, excludes from this route trials undertaken as part of the scientific advice specified there or as part of a paediatric investigation plan. Article 6(1) restricts use of data to secure a marketing authorisation, to vary an authorisation or for marketing. It makes an exception for variations concerning the safety of the medicinal product. Article 6(2) and (3) prohibit transactions by the sponsor that enable the uses set out there and make contrary transactions void by operation of law.[31]

Article 6(4) disapplies paragraphs 1–3 to trials within Article 5(2). Such trials must be funded entirely from public funds and meet at least the requirements relating to eligible sponsors and control of the data. The mere existence of a grant therefore calls for further enquiry into the full budget, partner contributions and contractual terms. Article 7 permits free or discounted supply of the study medicine and scientific, technical or financial support from a manufacturer or marketing authorisation holder, provided the support is disclosed in the application and the relevant authorisation is obtained. Disclosure of such support does not in itself give that partner a right to use the data for registration. This matters when an investor seeks an option over the results before enrolment begins.[32]

For patent purposes, the discovery of a biological relationship must be distinguished from its technical application. A reagent kit, a new method of analysing a sample ex vivo or a defined further medical use of a known substance may be assessed. Novelty, inventive step and industrial application matter. For diagnostic methods, much turns on how the claims are framed and whether they encompass the required steps of diagnosis practised on the body. Publication disclosing the invention before a filing can destroy novelty. Consortium terms should allow time for filing while preserving the obligation to make trial results public.[33]

Communicating a result within the limits of the evidence

A participant report, a scientific abstract and a retail advertisement may cite the same number, but they invite different inferences. A paper can report the change on a named clock, a confidence interval, the comparator and disagreement between prespecified measures. On a package or sales page, “reverses ageing by three years” will ordinarily be understood as a statement about what the product does to a person. A footnote linking to a paper still leaves the advertiser to establish that the evidence supports the claim and that the advertising rules for the product permit it.

Polish Pharmaceutical Law prohibits, among other things, advertising medicines that are not authorised in Poland, using claims inconsistent with the summary of product characteristics in medicines advertising, and advertising prescription-only medicines to the public. For a test, Article 7 IVDR prohibits attributing functions or performance the device does not possess or suggesting uses outside the purpose covered by the conformity assessment. The Polish Medical Devices Act also requires public advertising to be understandable to a layperson and restricts public advertising of devices intended for professional users. It therefore matters whether a test campaign is directed to laboratories, prescribers or consumers.[34]

Food supplements are subject to EU health claims rules. A reference to general, non-specific health benefits must be accompanied by an authorised specific claim under Article 10(3) of Regulation (EC) No 1924/2006. As a rule, food information must not attribute disease prevention, treatment or cure to food. Claims about reducing a disease risk factor have a separate authorisation route under Article 14. For a new ingredient, the questions include whether it falls within a category in Article 3(2)(a) of Regulation (EU) 2015/2283, whether it was consumed to a significant degree in the EU before 15 May 1997, whether novel food authorisation is required and which conditions apply to its listing. Polish notification to the Chief Sanitary Inspector on first marketing a supplement is a market monitoring measure. It does not establish an anti-ageing effect.[35]

The practical value of an ageing biomarker is that a clinical question can be investigated before a distant patient outcome can be observed. In the opening example, a first paper can accurately report the difference in the clock score against the control. Using that score to decide who receives treatment requires validation of the test and the applicable regulatory route. Claiming that the therapy prolongs independent living requires evidence connecting its effect on the score with precisely that benefit. These decisions can be made in sequence. A programme designed on that basis preserves the value of the first observation while making clear what must be demonstrated next.

KG LEGAL KIELTYKA GLADKOWSKI advises international life sciences and biotechnology businesses on Polish and EU regulatory requirements, research arrangements and commercialisation. Recognised by The Legal 500 for Healthcare and Life Sciences and Data Privacy and Data Protection, our firm combines sector knowledge with experience in corporate matters, negotiations and disputes.

We support projects where clinical research, technology and sensitive data intersect, helping clients address the legal requirements relevant to their research activities and business operations in Poland.

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[1]     ICH E9, Statistical Principles for Clinical Trials, section 2.2.6 (surrogate variables), EMA.

[2]     L.J. Hickson et al., Senolytics decrease senescent cells in humans, EBioMedicine 47 (2019), pp. 446–456.

[3]     European Innovation Council, EIC Work Programme 2026, section II.2.2, Biotechnology for Healthy Ageing, objective 2.

[4]     ICH E9, Statistical Principles for Clinical Trials, section 2.2.6 (surrogate variables), EMA.

[5]     R. Waziry et al., Effect of long-term caloric restriction on DNA methylation measures of biological aging in healthy adults from the CALERIE trial, Nature Aging 3 (2023), pp. 248–257.  R. Sehgal et al., Responsiveness of epigenetic aging biomarkers to longevity interventions in humans, Nature Medicine 32 (2026), pp. 3477–3490.

[6]     ICH E9(R1), Addendum on Estimands and Sensitivity Analysis in Clinical Trials, sections A.3–A.5, EMA.

[7]     EMA, Qualification of novel methodologies for medicinal product development, procedural guidance for applicants, rev. 6 (2026).  EMA, Scientific advice and protocol assistance.

[8]     Directive 2001/83/EC on the Community code relating to medicinal products for human use, Articles 1(2) and 2(2).  Polish Pharmaceutical Law Act of 6 September 2001, Article 2 point 32 and Article 3a, consolidated text, Journal of Laws 2026, item 612, as amended.  CJEU, Hecht-Pharma, C-140/07, judgment of 15 January 2009, EU:C:2009:5, paras 29, 32 and 39–42.

[9]     Directive 2001/83/EC, Articles 6, 8 and 26.  EMA, Extensions of marketing authorisations: questions and answers, question 1.

[10]    Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (CTR), Articles 1 and 2(2), points 1–4.

[11]    CTR, Article 2(2), point 3.  Directive 2010/63/EU on the protection of animals used for scientific purposes, Articles 4, 36 and 38.  Polish Act of 15 January 2015 on the Protection of Animals Used for Scientific or Educational Purposes, Articles 3a and 42.

[12]    CTR, Articles 4–8 and Annex I.  Polish Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use, Articles 9 and 21–25, consolidated text, Journal of Laws 2026, item 2.

[13]    EMA/CHMP, Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials, EMA/CHMP/778709/2015, 9 January 2018, sections 5–6.  CTR, Articles 28–31 and Annex I.

[14]    M.D. Witham et al., Metformin and physical performance in older people with probable sarcopenia and physical prefrailty or frailty in England (MET-PREVENT), The Lancet Healthy Longevity 6 (2025), 100695.

[15]    CTR, Articles 31, 37, 41–43 and Annex V.  Polish Clinical Trials Act, Articles 39–44.

[16]    Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), Articles 1(3)(a) and 2, points 2 and 12.  MDCG 2022-10, Q&A on the interface between the CTR and the IVDR, May 2022, questions 5–7 and figure 1.

[17]    IVDR, Article 2 point 7 and Article 48, Annex VIII, rule 3(f), and Annex IX, section 5.2.  EMA, Companion diagnostics (in vitro diagnostics).

[18]    IVDR, Articles 56–58 and Annex XIII. See also MDCG 2022-10, question 7.

[19]    URPL, Performance studies of in vitro diagnostic medical devices (in Polish). See also the Polish Act of 7 April 2022 on Medical Devices, consolidated text, Journal of Laws 2024, item 1620, as amended.  URPL, Questions and answers, questions 4–5 on combined studies (in Polish).  European Commission, COMBINE Project 1, phase two sponsor guide, sections 1–2 and Annex I.

[20]    MDCG 2019-11 rev. 1, Guidance on Qualification and Classification of Software, June 2025.  Regulation (EU) 2017/745 (MDR), Article 2 point 1 and Annex VIII, rule 11. See also IVDR, Article 2 point 2.

[21]    Regulation (EU) 2024/1689 (AI Act), Articles 2(6) and (8), 3(1) and 6(1), and Annex I.  Regulation (EU) 2026/1744 (Digital Omnibus on AI), amendment to Article 113 of the AI Act, recital 38.

[22]    Polish Act of 15 September 2022 on Laboratory Medicine, consolidated text, Journal of Laws 2025, item 1295, as amended.  Polish Minister of Health Regulation of 30 June 2025 on laboratory quality standards, Journal of Laws 2025, item 961, Annex 3.  IVDR, Article 4, in particular paragraphs 2–3.  IVDR, Article 5(5), in particular points (a)–(c).

[23]    Polish Act of 5 December 1996 on the Professions of Physician and Dentist, Articles 21, 23, 23a, 23c, 25, 29 and 29a, consolidated text, Journal of Laws 2026, item 37, as amended.

[24]    Polish Medical Research Agency, TRANSMED I webinar answers (ABM/2024/8), p. 1, archived and coded specimens (in Polish).  Polish Act on the Professions of Physician and Dentist, Article 24(2), points 5 and 7, and Articles 25 and 28.

[25]    Polish Act on the Professions of Physician and Dentist, Article 24(2), points 5 and 7, and Articles 25 and 28.

[26]    Polish Supreme Audit Office (NIK), findings on genetic testing and safeguards for genetic material, 22 October 2026 (in Polish).

[27]    Regulation (EU) 2016/679 (GDPR), Article 4, points 5, 13 and 15, Articles 5, 6, 9 and 89, and recital 26.

[28]    EDPB, Opinion 3/2019 on the interplay between the CTR and the GDPR, 23 January 2019, sections 2–3.  CTR, Articles 28(2)–(3) and 58.

[29]    Polish Act of 6 November 2008 on Patients’ Rights and the Commissioner for Patients’ Rights, Article 26(4), consolidated text, Journal of Laws 2024, item 581, as amended.  GDPR, Articles 26, 28, 32 and 35, and Chapter V.

[30]    Regulation (EU) 2025/327 on the European Health Data Space, Articles 51, 53–54, 66, 68, 71, 73 and 105.

[31]    Polish Clinical Trials Act, Articles 5(1) and 6(1)–(3).

[32]    Polish Clinical Trials Act, Articles 5(2), 6(4) and 7.

[33]    Polish Industrial Property Act of 30 June 2000, Articles 24–29, consolidated text, Journal of Laws 2023, item 1170, as amended.  European Patent Office, Guidelines for Examination 2026, G-II, 4.2.1.3, referring to G 1/04 and Article 53(c) of the European Patent Convention.  European Patent Office, Guidelines for Examination 2026, G-VI, 6.1, Article 54(4)–(5) EPC.

[34]    Polish Pharmaceutical Law, Articles 52–57, in particular Articles 56 and 57(1).  Polish Medical Devices Act, Articles 54–55, read with Article 7 IVDR.

[35]    Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, Articles 2, 10 and 14.  Regulation (EU) No 1169/2011 on food information to consumers, Article 7(3)–(4).  Regulation (EU) 2015/2283 on novel foods, Articles 3, 6 and 10.  Polish Food and Nutrition Safety Act of 25 August 2006, Article 29, consolidated text, Journal of Laws 2026, item 1399.

Artykuł Ageing biomarkers as evidence of geroprotective efficacy pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

10 November 2026

From 11 November 2026, telecommunications undertakings in Poland must meet new technical and operational requirements for the interfaces that give law enforcement and security agencies access to communications and related data. Interfaces already running under existing agreements may stay on the previous standard, but for no longer than 36 months. The new rules add 5G standards, real-time delivery and a dedicated interface for retained data.

Who is affected

The rules concern telecommunications undertakings that perform their statutory duties through an interface agreed with the authorised agencies. This covers mobile and fixed operators, internet access providers and VoIP providers.

The duty itself comes from the Electronic Communications Law of 12 July 2024. Article 43 requires an undertaking to provide, at its own cost, the technical and organisational conditions for access to and recording of communications and related data. Article 45 adds a duty to prepare the conditions for making processed data available.

An interface is one permitted way of meeting those duties, not the only one. Where it is used, its operation is governed by an agreement between the undertaking and the agencies. That agreement must at least allocate interface costs and set a procedure for failures. Micro and small undertakings perform the duty in proportion to their scale.

The regulation lists nine authorised agencies: the Internal Security Agency (ABW), the Police, the Military Counterintelligence Service (SKW), the Military Gendarmerie, the Border Guard, the National Revenue Administration (KAS), the Central Anticorruption Bureau (CBA), the State Protection Service (SOP) and the Internal Supervision Bureau (BNW).

Two interfaces, two purposes

The Council of Ministers regulation of 29 October 2026 sets requirements for two IP-based interfaces between the operator’s system and the agencies’ monitoring systems.

Annex 1 contains the new requirements. Annex 2 preserves the previous standard for interfaces covered by the transition period.

What changes for lawful interception

The new standard moves from file transfer to streamed, real-time delivery and brings 5G into scope.

Several core rules carry over unchanged:

• Intercept related information must reach the agency no later than 10 minutes after the communication ends.
• Orders are executed automatically, without the operator’s staff.
• A semi-automatic mode needs the agency’s consent and gives authorised staff up to 24 hours to prepare the network.
• Activation, modification and deactivation orders carry an electronic signature.
• Data is deleted from the operator’s resources once delivered.

A 36-month transition, with limits

Existing lawful interception interfaces may keep to the previous standard until November 2029 at the latest. The relief has three conditions:

1. It covers LI HI interfaces only.
2. The interface must operate under an agreement concluded before 11 November 2026.
3. It applies only to the telecommunications services covered by that agreement.

A new agreement, or a new service added outside an existing one, falls under the new standard from the start. Operators planning 5G standalone launches or new VoIP products should check which side of the line each service sits on.

Retained data: no transition period

The transitional rule does not mention the HI A-B interface, so the new requirements apply to it from day one. The interface must follow ETSI TS 102 657, use TCP with ASN.1/BER encoding and require an electronic signature. It must be available at a single location for all agencies, with a separate Ethernet port for each.

Some optional features of the ETSI standard are switched off: request priorities, multi-part delivery and the mode in which the agency initiates delivery.

In practice, operators should confirm with the agencies whether and when they expect this interface to be used. During public consultation, an industry chamber stated that neither side had deployed HI A-B under the earlier rules.

Privacy points worth noting

The regulation is technical, but several provisions limit what the operator keeps and discloses:

• Deletion after delivery. The operator removes intercepted communications and related data once they are successfully handed over.
• Limited buffer. Undelivered data is held for 72 hours.
• Excluded data fields. The retained data interface does not carry date of birth, gender, identification number, authentication data, profession or telephony billing details.
• No identifying data in status replies. A reply to a status query contains only the interception identifier.
• Signed orders. Interception orders must carry an electronic signature based on certificates issued within a public key infrastructure.

These points belong in the operator’s records of processing and security documentation.

What operators should do now

1. Map existing agreements. List every agreement with an authorised agency, its date and the services it covers. This decides which interfaces qualify for the transition.
2. Plan the migration. Set a schedule to move legacy interfaces to the new standard before November 2029, with time for testing with each agency.
3. Review vendor contracts. Check whether suppliers of interception and mediation systems are bound to deliver compliance with the new ETSI versions, and who pays.
4. Revisit cost and failure clauses. Agreements with agencies must allocate interface costs and set a failure procedure. The 72-hour buffer and the codec rule are natural points to renegotiate.
5. Clarify the retained data interface. Ask the agencies about their plans for HI A-B, since no transition period applies.
6. Include the topic in transactions. Buyers of Polish telecommunications businesses should treat interface compliance and migration cost as a due diligence item.

KG Legal KIELTYKA GLADKOWSKI advises telecommunications and technology companies on Polish and EU regulatory requirements. Contact: office@kg-legal.pl.

Artykuł Poland updates lawful interception interface rules pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On 4 November 2026 the Polish statute of 18 September 2026 consenting to the ratification of the Treaty between the Republic of Poland and the United Kingdom on a Security and Defence Partnership, known as the Northolt Treaty, was signed. The remaining steps are ratification and the exchange of notifications between Warsaw and London; the Treaty enters into force 30 days after the later notification.

For defence companies, the headline is not only the bilateral mutual assistance clause. The Treaty commits both governments to align defence-industrial and export strategies, procure jointly, remove regulatory barriers to joint programmes and secure supply chains. The first implementing instrument, the Warsaw Defence Plan of 27 October 2026, already names concrete programmes: next-generation air defence missiles, large-calibre ammunition, drones and counter-drone systems, and the Miecznik frigates.

The Treaty at a glance

The Treaty was signed by Prime Ministers Donald Tusk and Keir Starmer on 27 May 2026 at RAF Northolt, the wartime base of the Polish 303 Squadron. It has 12 articles and builds on the 2017 UK-Poland Treaty on Defence and Security Cooperation and the 2023 Joint Declaration on the 2030 Strategic Partnership.

Article 8 allows the Treaty to be extended to Guernsey, Jersey and the Isle of Man by an exchange of notes.

Ratification: where things stand

Poland ratifies with prior consent given by statute, because the Treaty is a political and military alliance under Article 89(1)(1) of the Constitution and touches matters reserved to statute under Article 89(1)(5). The ratification statute has two articles: consent to ratification, and entry into force on the day after publication. The government shortened the vacatio legis to speed up implementation.

The UK Command Paper dates the Treaty “London, 26 May 2026”, while Polish documents use 27 May, the date of the signing ceremony. At the time of writing we have not seen confirmation that either party has deposited its notification, so the Treaty is not yet in force.

A bilateral mutual assistance clause

Under Article 2(5), if either party suffers an armed attack, the other commits to provide assistance, including by military means, in accordance with Article 5 of the North Atlantic Treaty. The clause adds a bilateral layer to NATO collective defence rather than replacing it, mirroring the treaties the UK signed with France and Germany and Poland’s 2025 Nancy Treaty with France.

Article 2 also commits both states to:

• interchangeability and interoperability of their armed forces across all domains, through joint training, education, exercises and multinational structures in both countries;
• providing the forces, capabilities and infrastructure needed for NATO defence plans, with a focus on the eastern flank;
• defence spending in line with NATO targets and innovative defence financing solutions;
• closer cooperation on cyber capabilities and on emerging technologies, including dual-use technologies, AI and space;
• a stronger liaison officer network and new agreements on the mobility of military personnel;
• an annual strategic dialogue of ministers, chiefs of defence and senior officials, including on nuclear matters within NATO.

The defence-industrial core

Article 2(6) is the provision defence companies should read first. Recognising the value of security of supply for national programmes and a reliable order pipeline for defence firms, the parties commit to:

1. greater alignment of their defence-industrial and export strategies, with future partnerships in mind;
2. developing and maintaining interchangeability capabilities;
3. joint procurement;
4. identifying and minimising regulatory barriers to joint programmes;
5. better dialogue and cooperation between their defence companies;
6. discussing supply chain risks and how to counter them.

Landmark projects and the Warsaw Defence Plan

On signature the governments published 14 priority projects. Those most relevant to industry are below, together with how the Warsaw Defence Plan of 27 October 2026 (the first phase of defence cooperation under the Treaty) takes them forward.

Other landmark projects cover sanctions coordination, a counter-hybrid cooperation agreement and working group, FIMI, irregular migration, science and technology (quantum, space), health security (including CBRN and medical evacuation), energy security and diplomatic exchanges.

Beyond the battlefield: pillars that touch defence supply chains

• Hybrid threats and sabotage (Art. 3(5)). The parties will share strategies against sabotage and the hostile use of AI and drones, and may support each other in responding to specific incidents. Defence sites and suppliers are obvious targets.
• Critical infrastructure (Art. 3(1), 3(7), 5(6)). Cooperation covers land and maritime infrastructure, including offshore energy assets, incident response and repair capabilities.
• Sanctions (Art. 1(6)). Closer coordination of sanctions implementation and enforcement, including on the shadow fleet. Expect tighter, more aligned UK and EU enforcement affecting dual-use and component flows.
• Customs and organised crime (Art. 3(2)). Joint action against serious cross-border crime, including advance cargo information and pre-arrival risk analysis, and illicit trade in firearms.
• Economic security (Art. 4). Dialogue on supply chain dependencies, dual-use technologies and research security, regular talks on barriers to trade and investment, and dual-use transport infrastructure for civil and military use.
• Energy (Art. 5). Support for civil nuclear power and steps to reduce Russian involvement in civil nuclear supply chains.

Legal nature: a framework, not a rulebook

The Polish government describes the Treaty as political in character. According to the explanatory memorandum, it concerns cooperation between state authorities and does not directly affect natural or legal persons, does not directly regulate matters governed by domestic law, and requires no implementing legislation. The Ministry for EU Affairs confirmed that it is compatible with EU law.

The Treaty creates no direct financial obligations. Any costs for the Ministry of National Defence will be met within the defence spending limit under Article 40 of the Homeland Defence Act of 11 March 2022, without additional budget requests.

In practice, this means that nothing changes overnight in procurement law, export control or security clearance rules. The opportunities will come through the implementing instruments: defence cooperation plans such as the Warsaw Defence Plan, programme-level agreements, and the project pipeline reviewed under the Article 6 governance mechanism. Existing instruments remain the operative legal base, notably the 2017 Treaty and the 2006 UK-Poland Agreement on the Mutual Protection of Classified Information (amended in 2017).

What this means for defence companies

1. Teaming and joint ventures. Joint procurement and aligned export strategies favour UK-Polish consortia. Structure IP ownership, background and foreground licences, work share and exit rights at the outset, and test the structure against Polish FDI screening rules where a UK investor takes a stake in a Polish defence entity.
2. Polish procurement. Joint programmes will still run through Polish defence and security procurement rules, government-to-government routes and, where relevant, offset arrangements. Map early which route a programme will use and what local content or technology transfer the Polish side will expect.
3. Export controls and licensing. Alignment of export strategies does not replace national licensing. Polish controls on strategic goods, UK export licences, ITAR content in shared supply chains and the Polish licensing regime for trade in arms all continue to apply; build licensing time into programme schedules.
4. Security of information. Joint work on missiles, frigates or cyber needs facility and personnel clearances on both sides under the 2006 classified information agreement. Start industrial security accreditation well before contract award.
5. Supply chain and sanctions compliance. Expect closer UK-Polish scrutiny of supply chain dependencies, Russian-origin inputs and sanctions circumvention. Refresh screening, end-use and end-user controls, and contractual audit rights.
6. EU funding interface. Poland’s programmes are also financed through EU instruments such as its SAFE loan agreement with the European Commission. UK participation in EU-funded procurement depends on separate EU-UK arrangements and eligibility rules, so check them for each programme.
7. Critical infrastructure and hybrid risk. Defence sites and suppliers fall within the Treaty’s hybrid and sabotage focus. Review cyber incident reporting duties, physical security and contractual allocation of hybrid-attack risk.

Outlook

Once notifications are exchanged, the Treaty will sit alongside Poland’s treaty with France and its planned agreement with Germany as a pillar of Warsaw’s bilateral security network inside NATO. The near-term signals to watch are the first biennial prime ministerial review under Article 6, new programme agreements under the Warsaw Defence Plan, and any new agreements on military mobility or the transfer of prisoners announced under Articles 2 and 3.

KG Legal advises Polish and foreign clients on corporate and M&A transactions, EU regulatory matters and cross-border disputes. If you are planning a UK-Polish teaming arrangement, a joint venture or an investment in the Polish defence sector, contact KG LEGAL KIELTYKA GLADKOWSKI at office@kg-legal.pl.

This article is for general information only and is not legal advice.

Sources

• Sejm print no. 2840: government bill and explanatory memorandum
• Treaty text, Polish version (Infor.pl, with link to the English version on gov.pl)
• UK: the projects the UK and Poland will deliver together
• UK (MoD): UK and Poland strengthen defences on Europe’s Eastern flank, Warsaw Defence Plan
• UK Parliament treaty tracker: Poland No. 1 (2026)
• PolsatNews: ratification statute signed, 4 November 2026
• Portal Samorządowy (PAP): ratification statute signed

Artykuł The Northolt Treaty: What the UK-Poland Security and Defence Partnership Means for the Defence Sector pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Technical debt, GDPR and NIS2 – how yesterday’s shortcuts turn into tomorrow’s liability

Why technical debt arises

Technical debt is a phenomenon that sooner or later affects almost every IT project. It consists in choosing a solution that is quicker to deliver but inferior in technical quality. A team usually “takes out” this loan under pressure from the business side, for which the key metric is time-to-market – the sooner the product reaches the market, the better.

In the short term this brings a quick win, but in the future the company has to start paying the “interest”. It shows up as ever higher system maintenance costs, a slowdown in the pace of work, and the mounting frustration of developers who, instead of developing the product, must keep fixing the same defects over and over. Although the term “technical debt” appears nowhere in legislation, concepts such as due diligence and the adequacy of technical measures in practice force companies to keep that debt from spiralling out of control.

The forms that technological neglect takes

Technical debt is not homogeneous; it accumulates in many places. One of the biggest problems is legacy code – code built on technologies that are no longer maintained. It often degenerates into so-called spaghetti code: a structure so tangled that a change in one place causes an unexpected failure in an entirely different part of the system.

Another barrier is the absence of automated tests, which forces the team into manual testing – where mistakes are easiest to make. Closely related is code duplication, that is, solving the same problem repeatedly in different parts of the application. Nor should the lack of documentation be forgotten, which gives rise to so-called tribal knowledge. When key employees leave, the organisation is left with a system that no one can operate or develop efficiently.

The consequences for business and cybersecurity

Technical debt is not merely an IT department problem – it strikes directly at the stability of the company. Outdated architecture leads to outages and performance degradation, which can result in breaches of SLA commitments and financial penalties. The greatest nightmare, however, are regressions: situations in which new features break functionality that previously worked correctly.

The most serious risks, though, are those to security. Failure to update components (third-party dependencies) exposes the company to zero-day attacks and to vulnerabilities catalogued in public CVE databases. Hackers routinely scan the internet for systems running old libraries for which security patches are no longer issued. Ignoring this problem is the simplest way to become an easy target.

Technical debt under the GDPR and the “state of the art” principle

The law today requires companies to take a proactive approach to risk. Under the GDPR (Article 32), controllers must implement measures that take account of the current state of the art. Using outdated encryption methods, or libraries that no longer receive updates, may amount to a breach of these provisions.

Technical debt also strikes at the principle of accountability. If, because of the poor state of its code, a company is unable to give effect efficiently to, say, the “right to be forgotten”, the supervisory authority may treat this as gross negligence. In the event of a data breach, the existence of substantial technical debt will be an aggravating circumstance – and may drastically increase the amount of the fine.

Management board liability: NIS2 and the Polish KSC Act

New regulations – the NIS2 Directive and the amended Polish Act on the National Cybersecurity System (KSC) implementing it, in force since 3 April 2026 – place responsibility for these matters directly on senior management. NIS2 puts strong emphasis on supply chain security and vulnerability management. If a system is so fragile that installing a patch risks bringing it down, the management board is caught in a trap: the law requires vulnerabilities to be patched, while the technical condition of the system makes that impossible.

Such omissions carry not only financial penalties but even a ban on holding managerial positions. Standards such as ISO/IEC 27001, ASVS and the OWASP guidelines are becoming the points of reference – ignoring them is treated as knowingly accepting an excessive level of risk.

Strategies and prevention

Managing technical debt does not mean halting all work; it means introducing healthy rules. Key among them is the boy scout rule – leave the code in a better state than you found it. It is also worth applying TDD (test-driven development), that is, writing tests before the code, which builds a “safety net”.

To combat vulnerabilities, SCA-class tools that automatically monitor external packages are indispensable. CI/CD pipelines with built-in static (SAST) and dynamic (DAST) analysis should be the standard. To stop knowledge leaking out of the company, it is worth adopting a docs-as-code model (documentation kept together with the code) and maintaining architecture decision records (ADRs). In this way it is possible to build a system that is not only modern but, above all, secure and legally compliant.

Artykuł Paying Interest on Bad Code: Why Technical Debt Has Become a Legal Problemh pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The legal framework following the 2021 amendment and the resolution of a panel of seven judges of the Polish Supreme Court of 15 May 2025 (III CZP 22/24)

For years, the summons to a settlement attempt was the cheapest way for creditors to “renew” the limitation period under Polish law – a single application was enough for a claim to gain another full period of actionability. Since 30 June 2022, the rules of the game have changed: the summons no longer interrupts the running of the limitation period, but merely suspends it for the duration of the conciliation proceedings (Article 121(6) of the Civil Code). The effects of applications filed under the former provisions – which the courts will continue to assess for years to come – have meanwhile been settled by the resolution of a panel of seven judges of the Polish Supreme Court of 15 May 2025 (III CZP 22/24). In this article, we explain what exactly has changed, how to defend against instrumental settlement summonses, and what a creditor planning to pursue a claim must bear in mind today.

I. Introduction

The summons to a settlement attempt (zawezwanie do próby ugodowej), governed by Articles 184-186 of the Code of Civil Procedure[1], is the simplest court-supervised mechanism for the amicable resolution of a civil dispute. For nearly two decades, however, the institution served in practice primarily a different purpose: it was an inexpensive and effective tool for interrupting the running of limitation periods. That state of affairs changed fundamentally on 30 June 2022, when the amendment to the Civil Code of 2 December 2021 entered into force[2]. Under Article 121(6) of the Civil Code, added at that time, a summons to a settlement attempt no longer interrupts the running of the limitation period, but merely suspends it for the duration of the conciliation proceedings.

The amendment did not, however, close the debate over the effects of summonses filed under the previous legal regime. Those disputes – concerning in particular the admissibility of examining the creditor’s actual purpose – were resolved only by the resolution of a panel of seven judges of the Supreme Court of 15 May 2025, case No. III CZP 22/24[3]. This article presents both legal regimes, discusses the evolution of the case law, and outlines the practical consequences of the current regulation for creditors and debtors.

II. The legal framework in force until 30 June 2022 – interruption of the limitation period

Before the 2021 Amendment, the Civil Code contained no provision expressly addressing the effect of a summons to a settlement attempt on the running of the limitation period. That effect was derived from Article 123 § 1(1) of the Civil Code, under which the running of the limitation period is interrupted by any act performed before a court or another authority appointed to hear cases or enforce claims of a given kind, or before an arbitral tribunal, undertaken directly in order to pursue, establish, satisfy or secure a claim.

Beginning with the resolution of the Supreme Court of 28 June 2006, case No. III CZP 42/06[4], the view became firmly established in the case law that a summons to a settlement attempt constitutes precisely such an act and consequently interrupts the running of the limitation period[5]. Interruption meant – pursuant to Article 124 § 1 of the Civil Code – that upon conclusion of the conciliation proceedings the limitation period began to run anew in its entirety. A creditor filing an application shortly before the expiry of the period thus gained another full limitation period, irrespective of whether a settlement was actually reached.

III. The summons as an abuse of rights – divergent lines of case law

The attractiveness of this mechanism quickly gave rise to the phenomenon of instrumental use of settlement summonses – in particular, the filing of successive applications in respect of the same claim solely in order to “renew” the limitation period repeatedly. The case law of the Supreme Court responded to this practice, but in an inconsistent manner, resulting in the emergence of two opposing lines of authority.

The restrictive line. In its judgment of 10 January 2017, case No. V CSK 204/16[6], the Supreme Court held that an act of the creditor interrupts the running of the limitation period only where it is undertaken directly in order to pursue, establish, satisfy or secure the claim. A summons whose sole purpose is to extend the period during which the claim remains actionable is contrary both to the underlying rationale of the institution of limitation and to the fundamental purpose of conciliation proceedings, which is to bring about a settlement. The court is in each case obliged to examine the actual purpose of the act, although – as the Court noted – there are no grounds for a generalised assumption that every successive summons serves solely to interrupt the limitation period. An analogous position was taken in the decision of 10 April 2018, case No. II CSK 694/17[7].

The most far-reaching procedural consequences were drawn by the Supreme Court in its judgment of 27 July 2018, case No. V CSK 384/17[8]. The Court held that a creditor who files an application not in order to conclude a settlement, but solely to interrupt the running of the limitation period, abuses a procedural right and acts contrary to good practice (Article 3 CCP). The court to which such an application is submitted should assess it not only in formal terms but also as to its admissibility and, upon finding an abuse, should reject the application by analogy to Article 199 § 1 in conjunction with Article 13 § 2 CCP, without allowing the conciliation proceedings to be conducted at all.

The formal line. A contrary view was expressed by the Supreme Court in its decision of 17 June 2021, case No. II CSKP 104/21[9]. According to that position, the qualification of an act as one “undertaken directly in order to pursue a claim” is general in nature and relates to the category of acts, not to the individual intentions of the applicant. Since the initiation of conciliation proceedings falls within the catalogue of acts referred to in Article 123 § 1(1) of the Civil Code, the creditor’s actual intentions are legally irrelevant, and the interrupting effect arises by operation of law (ex lege). The only relevant question is whether the application was filed effectively – that is, whether it was not returned or rejected and whether the conciliation proceedings were not discontinued.

Part of legal scholarship was likewise critical of the possibility of examining the purpose of a summons, pointing to the ambiguity of the criteria for assessing the applicant’s motivation and the absence of objective grounds on which it could be proven – all the more so given that, since the legislature requires the application to contain settlement proposals, the objective of reaching a settlement follows expressly from its very content[10].

IV. The resolution of the panel of seven judges of the Supreme Court of 15 May 2025, III CZP 22/24

The divergences described above were resolved by the resolution of a panel of seven judges of the Supreme Court of 15 May 2025, case No. III CZP 22/24, according to which, under the legal framework in force until 30 June 2022, an application for a summons to a settlement attempt interrupted the running of the limitation period of a claim, unless it follows from the circumstances in which the act was performed that it was not undertaken directly in order to pursue, establish, satisfy or secure the claim (Article 123 § 1(1) of the Civil Code).

The resolution is a compromise, yet in essence it rejects the automatism characteristic of the formal line. The Supreme Court emphasised that limitation is an important element of the legal system, ordering legal relations over time, and that a creditor should therefore not be able easily to avoid the consequences of its expiry. Accepting that the initiation of conciliation proceedings always interrupted the running of the limitation period would place an instrument designed to protect the debtor under the creditor’s exclusive control and would in effect circumvent the prohibition on extending limitation periods by legal act (Article 119 of the Civil Code). Condoning sham acts aimed solely at prolonging the debtor’s state of uncertainty would strike at the very ratio legis of the institution of limitation.

The wording of the operative part of the resolution (“unless it follows from the circumstances in which the act was performed…”) yields an important practical conclusion: the rule remains that the summons produces the effect of interrupting the limitation period, whereas the exclusion of that effect requires it to be demonstrated – on the basis of the circumstances of the specific case – that the summons was not aimed directly at the realisation of the claim. In practice, the burden of rebutting the effect therefore rests on the debtor challenging the interruption. Moreover, that assessment should be carried out not in the conciliation proceedings themselves, but in the subsequent proceedings on the merits in which the limitation defence is raised – the conciliation court has no instruments at its disposal to examine the objectives of the proceedings initiated by the application.

The significance of the resolution remains considerable today: although it concerns the pre-amendment legal framework, the length of limitation periods for property claims – in particular the six-year period – means that defences based on summonses filed before 30 June 2022 will continue to arise in litigation for many years to come.

V. The legal framework since 30 June 2022 – suspension of the limitation period

The principal objective of the 2021 Amendment was to curb the practice of abusing settlement summonses. As stated in the explanatory memorandum to the bill, in view of the controversies surrounding creditors’ abuse of the institution of the summons to a settlement attempt, it was decided to limit the effect of filing such an application – as well as of initiating out-of-court mediation – on the running of the limitation period to its suspension for the duration of the conciliation or mediation proceedings[11].

Implementing that objective, the legislature added points 5 and 6 to Article 121 of the Civil Code, under which the running of the limitation period does not commence, and if commenced is suspended: in respect of claims covered by a mediation agreement – for the duration of the mediation (point 5), and in respect of claims covered by an application for a summons to a settlement attempt – for the duration of the conciliation proceedings (point 6). At the same time, Article 123 § 1(3) of the Civil Code, which provided for the interruption of the limitation period by the initiation of mediation, was repealed.

The practical difference between the two regimes is fundamental. Suspension merely “stops the clock”: upon conclusion of the conciliation proceedings, the limitation period continues to run, extended only by the duration of those proceedings – not anew. A creditor filing an application shortly before the expiry of the limitation period therefore gains only as much time as the conciliation proceedings lasted. The summons has thus ceased to function as a tool for deferring the decision to bring an action and has regained its original, conciliatory character.

Suspension occurs irrespective of the outcome of the conciliation proceedings – both where they end with a settlement and where no settlement is reached. What remains applicable, however, are the situations developed under the previous legal framework in which no effect on the running of the limitation period arises at all: the return of the application, its rejection, and the discontinuation of the conciliation proceedings[12]. The transitional rule should also be borne in mind: conciliation proceedings commenced and not concluded before 30 June 2022 remain governed by the previous provisions[13].

VI. Abuse of rights after the amendment

Under the current legal framework, the question arises whether the body of case law concerning the examination of the purpose of a summons remains relevant. The answer is, in principle, in the negative. While Article 123 § 1(1) of the Civil Code makes the interrupting effect conditional upon the act being undertaken “directly in order to pursue, establish, satisfy or secure a claim”, Article 121(6) of the Civil Code contains no such requirement[14]. It follows from the literal wording of the provision that the suspension of the limitation period arises from the mere fact that the claim is covered by the application for a summons, for the duration of the conciliation proceedings – without any examination of the applicant’s motivation. Decisions focusing on the purpose requirement therefore become moot at the level of suspension.

This weakening of the purpose-based scrutiny is systemically consistent with the weakening of the effect itself: suspension produces consequences far less favourable to the creditor than the former interruption, so the scope for abuse is correspondingly narrower. The legislature did not, however, introduce a rule under which the repeated initiation of conciliation proceedings in respect of the same claim could result in suspension only once – it therefore cannot be ruled out that a second and subsequent conciliation proceedings will likewise cause the limitation period to be suspended[15]. In extreme cases of instrumental use of the institution, the debtor is left with the plea of abuse of procedural rights under Article 4¹ CCP, although arguments based on the absence of an intention to pursue the claim may prove ineffective precisely because no such requirement appears in the wording of Article 121(6) of the Civil Code.

VII. Practical aspects

An application for a summons to a settlement attempt – irrespective of subject-matter jurisdiction – is filed with the district court (sąd rejonowy) of general venue for the opposing party or, where there are no grounds for establishing that venue, with the district court for the place of residence or registered office of the summoning party (Article 185 § 1 CCP). The summons must concisely identify the case and present settlement proposals; Article 130 CCP applies mutatis mutandis to a summons failing to meet these requirements (Article 185 § 1¹ CCP). The requirement to present settlement proposals, introduced in 2019, is of more than merely formal significance – the precise identification of the claims covered by the application delimits the scope of the suspension of the limitation period, which extends only to the “claims covered by the application”.

Since 2019, the cost of using the institution has also risen significantly: the fee on the application amounts to one-fifth of the fee that would be payable on a statement of claim[16], whereas previously it was a fixed fee of no more than PLN 300. The increase in the fee, alongside the change in the substantive-law effect, constitutes the second pillar of discouraging the purely tactical use of settlement summonses. Finally, pursuant to Article 186 CCP, a party’s failure to appear entails cost consequences: if the summoning party fails to appear at the hearing, the court will, at the request of the opposing party, order the summoning party to reimburse the costs occasioned by the settlement attempt; if the opposing party fails to appear, the court will, at the request of the summoning party who subsequently brings an action, take the costs occasioned by the settlement attempt into account in the decision concluding the proceedings.

VIII. Conclusions

The current legal position may be summarised as follows. First, since 30 June 2022 a summons to a settlement attempt suspends – rather than interrupts – the running of the limitation period for the claims covered by the application, and does so solely for the duration of the conciliation proceedings (Article 121(6) of the Civil Code). Second, this effect arises irrespective of the applicant’s motivation, but does not arise where the application is returned or rejected or where the proceedings are discontinued. Third, with respect to summonses filed before 30 June 2022 – which will continue to be assessed in pending disputes for a long time to come – binding guidance is provided by resolution III CZP 22/24: the summons interrupted the running of the limitation period unless it follows from the circumstances of its filing that it was not aimed directly at the realisation of the claim, with that examination being carried out by the court in the proceedings on the merits.

For creditors, this means that the summons must be treated as a genuine conciliatory instrument rather than a substitute for a litigation decision: any calculation of the limitation period must today assume no more than a short-lived suspension of its running. For debtors, in turn, resolution III CZP 22/24 opens – in cases assessed under the former legal framework – a realistic avenue for contesting the effects of summonses filed solely in order to extend the actionability of a claim, provided that the relevant circumstances are demonstrated in the course of the proceedings.

[1]Act of 17 November 1964 – Code of Civil Procedure (consolidated text: Journal of Laws of 2024, item 1568, as amended), hereinafter: CCP.

[2]Act of 2 December 2021 amending the Act – Civil Code, the Act – Code of Civil Procedure and certain other acts (Journal of Laws of 2021, item 2459), hereinafter: the 2021 Amendment.

[3]Resolution of a panel of seven judges of the Supreme Court of 15 May 2025, case No. III CZP 22/24.

[4]Resolution of the Supreme Court of 28 June 2006, case No. III CZP 42/06, OSNC 2007, No. 4, item 54.

[5]Judgment of the Supreme Court of 25 November 2009, case No. II CSK 259/09; judgment of the Supreme Court of 20 July 2017, case No. I CSK 716/16.

[6]Judgment of the Supreme Court of 10 January 2017, case No. V CSK 204/16.

[7]Decision of the Supreme Court of 10 April 2018, case No. II CSK 694/17.

[8]Judgment of the Supreme Court of 27 July 2018, case No. V CSK 384/17.

[9]Decision of the Supreme Court of 17 June 2021, case No. II CSKP 104/21; similarly, judgment of the Supreme Court of 12 January 2023, case No. II CSKP 776/22.

[10]P. Buczkowski, Zawieszenie biegu przedawnienia w prawie cywilnym w świetle noweli z grudnia 2021 r. [Suspension of the running of limitation periods in civil law in light of the December 2021 amendment], “Ius Novum” 2022, No. 3, p. 96.

[11]Explanatory memorandum to the government bill of 2 December 2021 amending the Act – Civil Code, the Act – Code of Civil Procedure and certain other acts, Sejm paper No. 1344, 9th term of the Sejm.

[12]Cf. judgment of the Supreme Court of 27 July 2018, case No. V CSK 384/17 – the Court’s considerations concerning situations in which no effect on the running of the limitation period arises remain applicable, mutatis mutandis, under the current legal framework.

[13]Article 30 of the 2021 Amendment: mediations and conciliation proceedings commenced and not concluded before the date of entry into force of the Act remain governed by the previous provisions.

[14]Kodeks cywilny. Komentarz [Civil Code. Commentary], series ed. K. Osajda, volume ed. W. Borysiak, commentary on Article 121 of the Civil Code, point C.11.

[15]Kodeks cywilny. Komentarz [Civil Code. Commentary], series ed. K. Osajda, volume ed. W. Borysiak, commentary on Article 121 of the Civil Code, point C.12.

[16]Article 19(3)(3) of the Act of 28 July 2005 on court costs in civil cases (consolidated text: Journal of Laws of 2024, item 959, as amended), as amended by the Act of 4 July 2019 (Journal of Laws, item 1469).

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