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).

Artykuł The Summons to a Settlement Attempt and the Running of the Limitation Period – Polish perspectiveh pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Errors, bias, opacity, data security and the accountability gap – what patients, clinicians and regulators need to watch

Artificial intelligence is already reading scans, ranking medical literature, predicting kidney failure and managing hospital beds. Its potential to make medicine faster, more precise and more personalised seems almost limitless. Yet the same technology brings a distinct set of risks: algorithms that fail silently, tools used without adequate training, models that reproduce existing inequalities, decisions that no one can explain, patient data that is exposed or re-used, and a legal framework that still struggles to say who is responsible when something goes wrong. This article maps those risks and outlines what is needed to manage them.

Where AI is already used in medicine

Interest in the use of artificial intelligence (AI) in healthcare has grown rapidly in recent years. Medical science is constantly expanding its horizons and generating ever larger and more diverse volumes of information. AI plays a key role in this evolution, becoming increasingly integrated into medical practice and offering healthcare systems in Europe a way to respond to the pressures they face.

Today, AI is used in medicine mainly for the quantification of medical images, the automated analysis of genetic data, disease prediction, medical robotics, telemedicine and virtual assistants. The COVID-19 pandemic significantly accelerated the development and deployment of AI applications in medical and clinical settings, as AI technologies became a central element of the response to the global health crisis.

AI is now applied across radiology, ophthalmology, dermatology and pathology. In cardiology, it is transforming clinical practice through the automated processing of cardiac data: machine learning models improve the diagnosis of heart disease by analysing complex imaging such as echocardiograms and electrocardiograms, help assess cardiac risk and predict treatment outcomes, contributing to better patient care and a lower burden of cardiovascular disease. Although AI is less widespread in nephrology, progress is being made in the diagnosis of kidney disease. Machine learning models can analyse ultrasound images of the kidneys and histopathological findings to identify pathological changes and assess disease severity, and AI can predict acute kidney injury from clinical and laboratory data, enabling faster diagnosis and treatment of patients in potentially life-threatening conditions. In biomedical research, AI is used primarily to analyse scientific publications: platforms such as PubMed use machine learning algorithms to rank search results, and newer tools such as the Best Match algorithm improve access to clinical knowledge.

In surgery, decisions sometimes have to be made quickly and without complete certainty about the diagnosis or the patient’s likely response to treatment. A lack of data or insufficient evidence can push clinicians towards mental shortcuts and intuition, which may lead to errors and bias. Traditional decision-support tools often fail to account for these limitations. AI-based models show promising efficacy in predicting risk for individual patients, which may prove particularly valuable in cardiovascular medicine.

AI is not confined to clinical medicine; it is also used in healthcare administration. One argument for deploying AI in administrative work is that errors there are usually less critical than errors in the clinical setting. AI-based applications can play a key role in organising patient flow, for example by managing bed availability, which is an important factor in surgery cancellations. Another administrative area is clinical coding – the process of extracting information from clinical records and classifying it under systems such as the International Classification of Diseases (ICD) or diagnosis-related groups (DRGs). Coding accuracy is crucial for cost recovery, management and analytics. Although computer-assisted coding has existed for some time, AI can significantly increase the accuracy and transparency of the process.

Despite these benefits, concerns about the possible negative effects of AI in medicine have grown in recent years. This fast-developing field raises considerable concern among healthcare professionals, patients and the public regarding clinical safety, equal access, privacy and security, appropriate use, liability and regulation. These risks can lead not only to harm to patients and citizens but also to a loss of public trust in AI algorithms and in doctors themselves.

When the algorithm gets it wrong: AI errors

One of the main challenges is the unavoidable possibility of algorithmic error, which can have serious consequences for patients. Errors may have different causes and manifest themselves at different stages of the diagnostic and therapeutic process. A misdiagnosis may result in unnecessary treatment or in a serious illness being overlooked. In emergency departments, inappropriate interventions may follow from imprecise diagnoses or incorrect triage prioritisation.

An important aspect is the way data is collected and used in the machine learning process. Noise in input data, whether caused by technological imperfections or human factors, can significantly reduce the predictive accuracy of AI algorithms. Ultrasound imaging, for example, although widely used in clinical practice, is prone to operator-dependent scanning errors that can lead to incorrect results.

Dataset shift – a change in the statistical distribution of the data on which an algorithm was trained – is another major problem. It may result from differences between populations, from differing data acquisition protocols across medical facilities or from the use of different diagnostic technologies. A model trained on data from one type of scanner, for instance, may lose accuracy when applied to data from another.

AI algorithms may also have difficulty adapting to unexpected changes in the clinical environment. What a radiologist would immediately recognise as an artefact on an X-ray may be interpreted by an AI system as a pathological change, leading to false-positive results and unnecessary further investigation or intervention.

To minimise these risks, standardised methods for the assessment and approval of AI solutions by the competent regulatory authorities are essential. In keeping with the principles of ethics and safety, AI algorithms should be designed as tools that support doctors rather than replace them. It is also important that AI solutions remain dynamic, with the ability to keep learning from new data and clinical situations – under appropriate controls.

Implementing such solutions will, however, require significant investment in infrastructure and technology, as well as appropriate integration policies in healthcare facilities. Collaboration between all actors – scientists, physicians, regulators and technology manufacturers – will be crucial for the successful introduction of AI into healthcare.

The human factor: improper use of medical AI tools

The role of the human factor in the use of AI in medicine cannot be underestimated. Even the most advanced algorithms are prone to error, and their effectiveness depends on proper use by end users, including doctors, other medical staff and patients. Without adequate understanding and skill, there is a risk that AI tools will be used incorrectly, leading to wrong diagnoses, treatment plans and clinical decisions that endanger patients’ health.

Clinicians and medical staff must not only have access to AI technology but also be properly trained to use it. Current medical curricula often contain too little on artificial intelligence, leaving doctors to acquire new knowledge and skills quickly in order to use these tools effectively in practice. In addition, the absence of clinical experts from the design and development of AI technology can result in tools that are difficult to use and poorly matched to real clinical needs.

Patients, too, must be aware of and able to use medical AI appropriately. As more and more AI applications and tools become available to the general public, there is a risk that patients will rely on them without understanding their limitations and the uncertainty surrounding their accuracy. It is therefore important to inform patients about both the possibilities and the limits of AI in healthcare and to encourage a healthy, critical evaluation of the information these tools provide.

The development of medical AI applications also creates an urgent need for regulation and supervision. For years, many AI-based applications reached the market without sufficient evaluation of their clinical effectiveness and safety. The EU has now begun to close this gap: AI-enabled medical devices are subject to the Medical Devices Regulation (MDR), the AI Act (Regulation (EU) 2024/1689) classifies most of them as high-risk systems with phased-in obligations, and the European Health Data Space regulation sets rules for the secondary use of health data. Clear regulatory guidelines and assessment and approval procedures that reflect specific clinical and ethical requirements remain essential, however, and enhanced regulatory and supervisory efforts can help ensure that AI technologies are tailored to end-user needs and meet the highest standards of safety and effectiveness.

Ultimately, minimising the risk of error and misuse of medical AI requires the broad involvement of all stakeholders – physicians, medical staff, patients, regulators and technology manufacturers. Working together to develop, implement and evaluate AI in healthcare can benefit both patients and the healthcare system as a whole by improving diagnostic accuracy, treatment effectiveness and access to care.

Bias: when AI reinforces health inequalities

Inequality in healthcare is a complex, multi-factor problem. Many people experience discrimination based on gender, age, ethnicity, socio-economic status or geographical location. These inequalities may be systemic, resulting from socio-economic neglect, lack of access to healthcare or direct discrimination by medical staff.

One of the main sources of these inequalities is human bias, which can lead to patients being treated differently on the basis of characteristics such as race or gender. Research conducted in the United States has shown that Black patients often receive inferior medical care compared with white patients. Similarly, women frequently experience delayed diagnoses for certain conditions, such as endometriosis, and their pain is more likely than men’s to be attributed to psychological causes.

The introduction of AI into healthcare seems promising, but without proper regulation it may exacerbate these inequalities. Medical algorithms can be biased because they are trained on data that is incomplete, unrepresentative or itself the product of biased decisions. If diagnostic algorithms are trained mainly on data from white patients, for example, they may be less effective at diagnosing disease in patients of other ethnic backgrounds. There is also a risk of perpetuating existing inequalities where AI models are trained on data that reflects them.

Addressing these issues requires close supervision and evaluation of medical algorithms and assurance that training data is representative and balanced across population characteristics such as race, gender, age and socio-economic status. It is also necessary to involve a broad range of experts – sociologists, biomedical ethicists, public health professionals and patients – to ensure that AI models are fair and effective for all social groups.

The black box problem: lack of transparency

Amid growing interest in medical AI, an algorithm developed by Google for breast cancer screening sparked debate about the role these technologies can play in improving diagnosis and care. The algorithm delivered promising results, improving both the speed and reliability of screening and in some cases outperforming radiologists. Its ability to generalise to populations outside the regions on which it was trained attracted further interest.

The enthusiasm was accompanied by concern. The absence of details about the algorithm itself and of key technical descriptions led some to question the transparency and safety of the tool. This concern was echoed in the media and the AI community, where critics argued that a lack of full transparency could compromise both the usefulness and the safety of the algorithm.

Transparency in healthcare AI operates on two levels: traceability and explainability. Traceability refers to the documentation of the AI development process, including the model, the training data and post-deployment monitoring of the tool. In practice, existing tools are often delivered without full traceability, which undermines users’ trust.

Explainability concerns the transparency of the decisions AI makes. In the case of algorithms based on deep neural networks, often referred to as “black boxes”, the absence of this transparency makes it difficult for clinicians and other stakeholders to understand the basis on which a decision was reached.

Various mitigation measures have been proposed to improve transparency and trust. An “AI passport” documenting key information about a model, together with tools for tracking the use of algorithms after deployment, could significantly improve traceability. Involving clinical end users from the earliest stages of algorithm development can also help develop effective strategies for explaining AI decisions.

Finally, regulators have an important role to play. By treating traceability and explainability as prerequisites for certification, they can set standards that encourage greater transparency in the development and application of AI algorithms in medicine.

Privacy and data security

The growing use of AI in healthcare, particularly during and after the COVID-19 pandemic, has highlighted the risks to privacy, confidentiality and the protection of patient data. Lack of informed consent may lead to breaches such as the disclosure of protected data or the re-use of patient data for other purposes.

Opaque AI algorithms and complex consent forms limit patient autonomy and hinder shared decision-making with the physician. A well-known example is the 2016 case in which patient records held by a London NHS trust were transferred to DeepMind without the patients’ informed consent.

AI in healthcare also carries the risk of data breaches, which can lead to identity theft and other cyberattacks. In 2020, for instance, a data breach at Cense AI exposed sensitive data relating to more than 2.5 million patients.

The re-use of data is a further risk, potentially leading to unauthorised use of patient data for purposes unrelated to healthcare. There is a need to raise awareness and skills regarding privacy and security risks and to extend the regulatory and legal framework. Support for decentralised approaches to AI and continued research into the security of cloud-based systems are also crucial.

Who is responsible? The accountability gap

The concept of “algorithmic accountability” is gaining importance wherever AI is used, and especially in healthcare. It refers to the principle that people – not AI systems – are responsible for errors or improper actions of algorithms. The introduction of AI tools in medicine brings new challenges in this respect, and a sound solution to the question of responsibility is crucial for public acceptance of and trust in these technologies.

There is still considerable uncertainty as to who is responsible for AI-related medical errors, which calls for the adaptation of regulations and the legal framework to the specific characteristics of these technologies. One such challenge for policymakers and legislators is the “many hands” problem – the difficulty of allocating responsibility among the various entities involved in the development, implementation and use of AI. At EU level, the revised Product Liability Directive (Directive (EU) 2024/2853), which expressly covers software and AI systems, is a first step towards addressing this, while the proposed AI Liability Directive was withdrawn, leaving fault-based liability largely to national law.

A further difficulty lies in identifying the precise cause of an error involving medical AI. The cause may lie in the algorithm, in the data used to train it or in a misunderstanding of how the AI operates in clinical practice. The absence of uniform ethical and legal standards across the AI industry makes these problems harder to resolve.

Responsibility in medical AI is also closely linked to the clarity and transparency of algorithms: the less understandable an algorithm is, the harder it becomes to determine who is responsible. Proposals to address this include establishing processes that define the respective roles of AI developers and users, and setting up dedicated regulatory bodies.

Barriers to implementation

Over the past five years, numerous medical AI algorithms have been proposed for a wide range of healthcare applications. Yet even where these technologies are clinically proven, safe and ethical, their implementation faces many practical obstacles. Healthcare professionals are often slow to adopt new technologies in daily practice. The implementation phase is critical, and beyond the creation of the algorithm itself, other factors must be taken into account, such as the limitations and quality of medical data and changes in the doctor-patient relationship.

The quality of medical data is essential for the effective use of medical AI, but such data is often unstructured and noisy. It must therefore be verified, quality-controlled and labelled, which requires considerable time and money. In addition, the introduction of AI may change the relationship between patients and healthcare professionals, creating new challenges in communicating disease risk information and updating clinical guidelines.

Bringing AI into clinical practice also requires interoperability and integration with existing health systems. Manufacturers and healthcare organisations will need to establish standard operating procedures and work together to ensure that new AI tools interoperate with existing technologies such as genetic sequencing and electronic patient records.

Conclusion

The use of AI in medicine brings numerous benefits, but it also involves significant challenges and risks. Beyond technical aspects such as data quality and interoperability, changes in the relationship between patients and healthcare professionals and the need to update clinical guidelines must also be considered. Implementing AI in clinical practice requires collaboration between technology manufacturers and healthcare professionals to ensure the safe and effective integration of new tools into existing healthcare systems. Ultimately, a clear-eyed awareness of these risks is the precondition for harnessing the potential of AI to improve healthcare.

Artykuł Artificial Intelligence in Healthcare: the Risks Behind the Promise pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

A growing number of businesses are investing in artificial intelligence and expect to recover the cost of those projects through the research and development (R&D) tax relief. The Polish tax authorities and the Supreme Administrative Court, however, draw a clear line: integrating an off-the-shelf AI model or implementing a commercially available system – however advanced or “self-learning” – is not R&D activity. The relief is available only to those who create new technology themselves and bear genuine research risk. We explain how the tax authorities’ “two-step test” works, what the Frascati Manual and the case law of the Supreme Administrative Court say, which costs in IT projects qualify and which are traps – and how to document the work so that the deduction survives a tax audit.

Artificial intelligence in the enterprise and the R&D tax relief

In the era of digitalisation, artificial intelligence (AI) is becoming an integral part of how modern businesses operate. Deploying advanced algorithms, automating processes and building intelligent analytical systems all involve substantial investment. It is natural for businesses to look for ways to optimise that expenditure by claiming the research and development (R&D) tax relief. The practice of the tax authorities and the case law of the administrative courts show, however, that the line between an innovative implementation and qualifying R&D activity is a fine one, and crossing it requires meeting strict statutory criteria.

Legal basis of research and development activity

The R&D relief, governed by Article 18d of the Corporate Income Tax Act[1] (the “CIT Act”) and, correspondingly, Article 26e of the Personal Income Tax Act[2] (the “PIT Act”), allows specific categories of expenditure, known as eligible costs, to be deducted from the tax base. Although the mechanism is almost identical in both statutes – with minor adjustments such as the right of an “enterprise in succession” to continue deductions under the PIT Act – the key to claiming the relief lies in a proper understanding of the statutory definition of R&D activity itself.

Under Article 4a(26) of the CIT Act, research and development activity means creative activity comprising scientific research or development work, undertaken in a systematic manner in order to increase the stock of knowledge and to use that stock of knowledge to devise new applications. For an AI project to be covered by the relief, it must therefore cumulatively be creative in nature, be conducted methodically according to an established schedule, and generate new knowledge or lead to a new application of knowledge. The requirement to “increase the stock of knowledge” does not mean that the knowledge must be new on a global scale. According to the explanatory notes issued by the Minister of Finance, it is sufficient to develop a new solution or a new application of knowledge from the perspective of the enterprise, provided that the work is genuinely creative and involves real technological uncertainty[3].

The tax authorities’ two-step test and the OECD standards

When verifying entitlement to the deduction, the tax authorities apply a rigorous mechanism that may be described as a “two-step test”. First, they assess the nature of the work itself, examining whether it substantively meets the statutory definition of R&D. Only after this stage has been passed does the second step open up: financial qualification, i.e. verification of whether the expenditure incurred falls within the closed catalogue of eligible costs.

When interpreting these provisions, the Polish tax authorities and courts refer to the guidelines contained in the OECD’s Frascati Manual[4], which is widely used as an interpretative standard for assessing R&D activity. The Manual sets out five criteria that R&D activity must satisfy cumulatively. The work must be novel, i.e. aimed at findings that go beyond the existing knowledge in the relevant industry. It must be creative, based on original concepts rather than mechanical replication. The third, critically important element is uncertainty – at the outset of the project, the final outcome, the time required and the costs must be difficult to predict because of technological risk. The activity as a whole must be systematic (planned and budgeted), and its results – including negative ones – must be reproducible or transferable thanks to appropriate codification and documentation.

Implementation versus creation of technology

For a business’s tax security, it is fundamental to separate the implementation of ready-made solutions from genuine R&D work. Implementing commercially available tools such as ERP systems, SaaS platforms, RFID technology or pre-built AI models consists solely in adapting them to the individual needs of the enterprise. Such activities are not creative in nature and do not generate new resources of objective technical knowledge, and the risk involved is operational rather than research-related.

One can speak of R&D activity in the field of artificial intelligence only where the business acts as the creator of the technology rather than its user. Qualifying work will therefore include designing and training proprietary network architectures from scratch, modifying the core of algorithms to achieve properties previously unknown on the market, or building prototypes in an experimental environment to verify unique hypotheses. It should be stressed, however, that the use of off-the-shelf AI models does not automatically rule out the R&D relief. Where a business makes significant modifications to the architecture of such a model, develops its own training methods or devises new optimisation mechanisms, such work may well satisfy the criteria of R&D activity. The Director of the National Tax Information Office has already addressed AI-based projects directly in individual tax rulings, assessing them against the same criteria that apply to “conventional” IT projects[5].

An example of an implementation that does not qualify a business for the R&D relief is purchasing API access to a ready-made large language model and integrating it with the company’s own customer database in order to build a simple website chatbot. The work is then limited to parameterisation, adjusting the user interface (UX/UI) and preparing prompts – there is no technological uncertainty, only the operational risk of whether the implementation will be completed on time and within budget.

An example of creation, by contrast, is a situation in which a business uses an open-source AI model but its engineers substantially alter the model’s architecture, design a unique data-weighting algorithm to minimise so-called hallucinations in a highly specialised medical field, and run a series of experiments without knowing at the outset whether the model will achieve the precision required by the market. Here the risk is research-related: the project may fail, and yet its result – knowledge of which approaches do not work – still constitutes new technical knowledge.

The position of the Supreme Administrative Court

The line of case law of the Supreme Administrative Court (Naczelny Sąd Administracyjny, NSA) on the classification of IT implementations is unequivocal. Particularly instructive are the twin judgments of 25 August 2021, II FSK 138/19[6] and II FSK 139/19[7], in which the NSA examined the implementation of modern document workflow, warehouse management and sales systems. The Court firmly held that adapting existing, commercially available software to the needs of the taxpayer’s business does not constitute R&D activity, as it is not a creative process that expands the stock of knowledge.

The same issue was addressed in the earlier judgment of 9 October 2019, II FSK 3589/17[8], concerning the implementation of a highly advanced, “learning” APS-class production planning system. The taxpayer argued that the system made decisions autonomously and learned the specifics of the enterprise. The Court nevertheless held that purchasing even the most innovative, self-learning technology from a third party and configuring it over many months is still merely an implementation. The conclusion from the case law is clear: a purchased innovation does not turn the purchaser into an entity conducting R&D activity. The administrative courts consistently distinguish between acquiring and configuring ready-made solutions and independently creating new functionalities that actually lead to the creation of new technical knowledge. This is of particular importance in the context of AI, where the “intelligence” of the tool itself is often mistakenly equated with the innovativeness of the work performed by the taxpayer.

Eligible costs and pitfalls in IT projects

A positive substantive assessment of the project does not end the challenges. The next area of risk is the categorisation of expenditure. In practice, the most significant item for businesses claiming the relief is personnel costs. These cover the remuneration of employees under employment contracts and of persons performing R&D work under contracts of mandate or contracts for specific work, together with employer-funded social security contributions. Such expenditure is deducted in proportion to the time actually spent on R&D activity. It is worth remembering that these costs are deductible at 200%, which makes them the most valuable category of eligible costs[9]. Another important category is depreciation write-offs on fixed assets and intangible assets used in R&D activity.

It should also be borne in mind that the purchase of software cannot be treated as the acquisition of materials and raw materials within the meaning of the statute, since it concerns rights in intangible property. As regards the cost of cloud services (renting computing power), SaaS subscriptions and API access to AI models, the possibility of including them in the R&D relief is, as a rule, limited. In each case, this requires an analysis of the nature of the expenditure and the way it is recognised in the accounting books. Software may constitute an eligible cost essentially where the business acquires the economic copyright or a licence to it, recognises it in its records as an intangible asset and includes the depreciation write-offs in the relief. This is particularly relevant in AI projects, where the cost of computing power for model training is often one of the largest budget items – and, at the same time, one of the most difficult to claim under the relief.

How to document an AI project in case of a tax audit

Projects that make use of artificial intelligence open the way to the R&D relief provided that the business genuinely co-creates new technology, generates new knowledge through research experiments and bears real technological risk in doing so. The burden of demonstrating these circumstances lies with the taxpayer, so the documentation should be produced as the project progresses, not merely in response to a request from the tax authority.

To protect their interests, businesses should adopt several project management principles. First, the conceptual, uncertainty-laden research phase must be clearly separated from subsequent implementation and maintenance work – ideally at the level of the project structure and budget. Second, precise records of staff working time must be kept so that only the man-hours devoted to creative work are included in eligible costs. Third, the whole process must be supported by codification of the research process in line with the standard described in the Frascati Manual: from formulating the research hypothesis and describing the state of knowledge at the outset, through analysing the technological uncertainty and documenting the experiments performed (including unsuccessful ones), to a final report recording the newly acquired knowledge. In AI projects, versioned code repositories, model training logs and benchmark test protocols have particular evidential value, as they make it possible to demonstrate that the outcome was not known in advance.

Where there is doubt as to the classification of a specific project, it is worth considering applying for an individual tax ruling. A precise description of the facts, emphasising the element of uncertainty and the team’s creative contribution, is then crucial – it is precisely on this ground that most disputes over the R&D relief in IT projects are decided.

[1]Act of 15 February 1992 on Corporate Income Tax (consolidated text: Journal of Laws of 2026, item 554).

[2]Act of 26 July 1991 on Personal Income Tax (consolidated text: Journal of Laws of 2026, item 592).

[3]Tax explanatory notes of the Minister of Finance of 15 July 2019 on the preferential taxation of income generated by intellectual property rights (IP Box), paras 32–45 (definition of research and development activity common to the R&D relief and the IP Box regime).

[4]OECD (2015), Frascati Manual 2015: Guidelines for Collecting and Reporting Data on Research and Experimental Development, The Measurement of Scientific, Technological and Innovation Activities, OECD Publishing, Paris, https://doi.org/10.1787/9789264239012-en; Polish edition: OECD/GUS (2018), Warsaw.

[5]See, inter alia, individual tax rulings of the Director of the National Tax Information Office of 4 March 2024, 0111-KDIB1-3.4010.742.2023.2.JKU; of 25 April 2025, 0114-KDIP3-1.4011.236.2025.2.EC; and of 13 March 2026, 0111-KDIB1-3.4010.7.2026.3.AN.

[6]Judgment of the Supreme Administrative Court of 25 August 2021, II FSK 138/19, LEX no. 3265262.

[7]Judgment of the Supreme Administrative Court of 25 August 2021, II FSK 139/19, LEX no. 3252790.

[8]Judgment of the Supreme Administrative Court of 9 October 2019, II FSK 3589/17, LEX no. 2740353.

[9]Article 18d(7)(3) of the CIT Act and Article 26e(7)(3) of the PIT Act.

Artykuł A Purchased Innovation Is Not R&D. When Do AI Projects Qualify for the Polish R&D Tax Relief? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Selling used items on Allegro, Vinted , or OLX, renting apartments through Booking.com or Airbnb, or even providing services via online platforms – all of these activities can now fall within the reach of the tax administration. The DAC7 directive does not introduce a new tax, but it does oblige digital platform operators to provide tax authorities with detailed information about transactions and their participants. We explain who is subject to these new obligations, what data is submitted to the tax authorities, and when reporting may trigger tax investigations or audits.

Introduction to DAC7 reporting obligations

The DAC7 directive introduces new reporting obligations for digital online platforms (e.g., Allegro, Vinted, Booking.com, Uber). These provisions directly apply to users who offer goods, services, or property rentals through these portals. This topic may be important for sellers and service providers, as information about their earnings will now be reported to tax offices, giving them a new tool for verifying the accuracy of tax settlements.

General principles of reporting obligations and basic concepts

In accordance with the regulations on the exchange of tax information, the reporting platform operator becomes the main information intermediary. The platform itself is defined as software, a mobile application, or a website that enables communication between users for the purpose of executing transactions and payment arrangements. Such an entity is obligated to collect, verify, and transmit data about its users to the tax authorities.

So-called relevant activities, i.e., specific activities performed for remuneration, are subject to reporting. The Act includes:

1. making real estate (or parts thereof and adjacent premises) available;
2. services provided in person (task-based or time-based work);
3. sale of goods;
4. providing means of transport.

Reports are submitted to the office periodically for a given reporting period, which according to the regulations is a full calendar year.

Scope of data transferred

Reports sent to the tax office are in the form of XML files and contain identification and financial information.

First, the operator provides information about themselves: name, primary address (i.e., registered office address), and identification numbers, including the Taxpayer Identification Number ( TIN , e.g., NIP or PESEL) and identification number. Next, the portal provides details of the seller, i.e., the registered platform user who has performed transactions on the platform in the specified year:

1. For individuals, the report includes: name, surname, date of birth, main address, TIN and VAT numbers.
2. If the sale is conducted by an entity (defined as a legal person, an entity without legal personality, a trust or e.g. a civil partnership), the report includes the full name, numbers in the relevant register (e.g. KRS), registered office address and information on foreign establishments.

The financial section summarizes user activity. It includes the financial account identifier (TIN). Furthermore, remuneration is reported, which the law defines as payment in any form, less contributions, fees, commissions, and taxes withheld by the platform itself. The list also includes the number of completed transactions broken down by quarter. In the case of property rentals, data is reported separately for each property group (properties at the same address and owned by the same person). The report then includes the address, land and mortgage register numbers, and the number of days the property was available.

Reportable entities

Whether information is submitted to the tax administration depends on the amount of turnover. The regulations use the concept of an active seller, which means a person who performs services or sells goods and is entitled to remuneration for such services in a given year.

However, there is a category of so-called excluded sellers, whose data is not transferred to the tax office. This exclusion applies only to the sale of goods.

and takes place when, during a calendar year, the user meets two conditions simultaneously:

1. completes less than 30 transactions,
2. his total remuneration in this respect will not exceed the equivalent of EUR 2,000.

Exceeding even one of these thresholds causes the user to become a reportable seller (an active seller without the right to opt out), which means that full information about his or her transactions is sent to the office.

Use of data by tax authorities

The Head of the National Revenue Administration (KAS) is required to submit the collected data to the authorities of the countries where the sellers are tax residents within two months of the end of the reporting year. If the case concerns property rentals, the information is also sent to the country where the building is located. Information about portals exempt from reporting is, in turn, sent to the European Commission’s central register.

In Poland, tax authorities use the Central Tax Data Register (CRDP), where this information is collected and compared with other declarations. KAS’s activities are based on automated data processing and risk analysis. This includes profiling, which can have direct legal consequences for taxpayers. Additionally, the authorities use this data to monitor online platforms for compliance with prudential procedures. The tax administration is required to retain this information for at least five years.

Actions taken by tax authorities

Analysis of incoming information allows the tax authorities to detect irregularities. The following signals are of greatest interest to the authorities:

1. Discrepancies with annual tax returns – algorithms automatically compare earnings reported by the platform with taxpayer declarations (PIT-36, PIT-37, PIT-28). High sales without reporting these earnings raise suspicions of income concealment and result in the initiation of investigations.
2. Scale of activity – regular sale of a large number of items by a person not registered in CEIDG suggests organized business activity, which involves the obligation to pay social security contributions and higher taxes.
3. VAT exemption limits – offices monitor whether the total revenues from various portals do not approach the amount of PLN 200,000 per year, exceeding which results in the obligation to register for VAT.
4. Intensive rentals – in the case of rentals (e.g., Booking.com, Airbnb), a high number of booking days (e.g., over 180 days) without declaring income is alarming. The office also verifies the address to ensure the property is not subject to the higher property tax rate for businesses.
5. Undisclosed accounts – the identification of accounts makes the authorities aware of the existence of foreign accounts or electronic wallets (Revolut, Wise) that have not been reported to the tax office, which is often interpreted as an attempt to conceal turnover.
6. Cost to revenue ratio – abnormally high fees and commissions relative to turnover may suggest artificially lowering the tax base.

Verification and control process

When the data raises doubts in the tax authorities’ minds, the authorities initiate appropriate procedures. The regulations explicitly allow the Head of the National Revenue Administration to demand that banks disclose transaction histories to verify the accuracy of the reports (bypassing banking secrecy in this respect).

During an audit, officials often analyze a number of documents from the taxpayer:

1. History of bank accounts and payment systems – private and corporate accounts, as well as PayPal and PayU.
2. Platform dashboards – to confirm cancelled transactions, refunds and actual fees charged that reduce the final turnover.
3. Proof of purchase – invoices, receipts, sales contracts – necessary to reduce income by incurred expenses.
4. Logistics documentation – waybills and parcel dispatch records to verify the scale of shipments.
5. Evidence of a private sale – the authority may examine screenshots or listing descriptions. The sale of private property is not subject to tax, but the taxpayer must prove possession of the sold item for at least six months.
6. Company registers (for entrepreneurs) – Revenue and Expenditure Book and VAT registers in terms of consistency of entries with the data sent via the platform.

Consequences of detecting irregularities

There are consequences for users whose failure to comply with the regulations is identified by the authorities. If, during verification or audit, the tax authorities determine that sales conducted via online platforms constituted a business activity, the taxpayer may be required to submit appropriate tax settlements and, depending on the circumstances, retroactively register the business. This may result in the obligation to pay outstanding social security contributions with interest, the loss of entitlement to certain preferences, and the need to settle tax arrears, including VAT (if the statutory requirements are met). If the tax liability is found to be understated, the authorities may apply tax penalties as specified in the regulations and initiate proceedings for fiscal criminal liability.

Moreover, concealing income or providing false information in a tax return constitutes a fiscal offense or misdemeanor, punishable by a fine of up to 720 daily rates. The same penalty applies to obstructing a tax audit (e.g., refusing to provide account statements).

Administrative penalties will also be imposed on sellers more quickly if they fail to complete their information on the platform itself. Failure to respond to the platform’s requests within 60 days will force the platform to immediately suspend payment and block the user from further sales.

Limitations of DAC7 Reports

In practice, DAC7 reports provide only a selective picture of a taxpayer’s situation, as they only report gross revenue without taking into account the costs of obtaining it, such as the purchase price of the goods or their preparation. This prevents authorities from automatically determining taxable income based solely on the XML file. DAC7 reports do not include information on the period of possession of the sold items, and therefore do not, in themselves, allow tax authorities to determine whether the sale of private property benefits from income tax exemption after six months of acquisition. Furthermore, the reporting thresholds for the sale of goods and the fact that each platform reports information separately mean that the data submitted under DAC7 may not reflect the taxpayer’s full activity. However, this does not mean that tax authorities are unable to obtain such information from other sources permitted by applicable law. Consequently, by failing to consider the taxpayer’s full situation, this information does not reflect the scale of their burden and serves solely as an analytical signal for selecting individuals for verification activities, rather than a ready-made basis for tax assessment without the seller’s involvement and explanation.

Practical tips for sellers

Risk mitigation associated with DAC7 reporting is based on the following principles:

1. Monitoring sales – it is worth monitoring the number of transactions and the value of sales on an ongoing basis, including the reporting exclusion thresholds provided for in DAC7 for the sale of goods (fewer than 30 transactions and remuneration not exceeding EUR 2,000), as well as limits resulting from other regulations, in particular those relating to unregistered activities and VAT.
2. Collecting evidence when selling in person – in order to avoid paying income tax on the sale of used items, you should collect evidence (receipts, contracts, emails with old orders) proving that the item has been in the seller’s possession for at least 6 months.
3. Cost recording – keeping a list and collecting proof of expenses: invoices for courier shipments, fees for promoting offers, contracts for the purchase of goods.
4. Data transparency – regular updating and verification of identifiers on sales portals: PESEL, NIP, address.

Artykuł The tax authorities are looking into Allegro and Vinted – DAC7 changes the rules for online sales pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Legislative status as at 30 September 2026 | Government Bill UD447 | Sejm Paper No. 3148

Poland’s proposed reform of family foundation taxation would raise the cost of distributions and narrow exemptions for asset disposals, property letting and certain investment structures. Although the government has softened parts of its original proposal, the revised bill would still materially affect succession planning: its two-year holding period can last almost three years in practice, while protection for previously contributed assets would not preserve the existing tax rate on future distributions. For founders and beneficiaries, the detail of the transitional rules may be as important as the headline increase from 15% to 19%.

The government bill amending the Personal Income Tax Act and the Corporate Income Tax Act, registered as UD447, was submitted to the Sejm as Paper No. 3148 dated 29 September 2026. It proposes changes to the taxation of family foundations rather than a new Family Foundation Act. The proposed commencement date is 1 January 2027. The measures described below remain proposals and are not yet law. [1–2]

A two-year holding period measured from the end of the year

Proposed Article 6(8)(2) of the Corporate Income Tax Act would exclude revenue from the disposal of property contributed or transferred gratuitously to a family foundation from the foundation’s exemption if the disposal occurs before two years have elapsed from the end of the calendar year of contribution or transfer. An exception would apply to disposals made pursuant to an order of a public authority. The provision would not prohibit an earlier sale; it would remove the exemption for revenue from that transaction. [1, Article 2(1)]

For example, if shares were contributed on 15 February 2027, the period would expire at the end of 2029, with a sale from 1 January 2030 falling outside this particular restriction. The actual waiting period would therefore be almost three years. Referring simply to a “two-year holding period” obscures the practical effect of the calculation. Expiry of that period would not guarantee freedom from all taxes: the rules on distributions and the other conditions governing tax relief would remain relevant.

The scope of the rule is also important. It concerns contributed or gratuitously transferred property and does not impose a universal two-year holding requirement on every asset purchased by a foundation in the course of its investment activities. Under the transitional provision, the new rule would apply to property contributed or transferred from the foundation’s tax year beginning after 31 December 2026. [1, Article 3(2)(1)]

19% corporate income tax on benefits, dissolution distributions and hidden profits

The bill would increase the rate under Article 24q(1) of the Corporate Income Tax Act from 15% to 19%. The increase would cover benefits provided to beneficiaries, property distributed in connection with a foundation’s dissolution and so-called hidden profits. This is a tax payable by the foundation. The personal income tax treatment of the recipient remains a separate question. [1, Article 2(4)]

For a taxable base of PLN 1 million, the tax calculated at this rate would rise from PLN 150,000 to PLN 190,000 before any applicable deductions. The additional PLN 40,000 represents an increase of approximately 26.7% in the amount of tax. Financial projections should therefore distinguish between tax on the foundation’s activities, tax on distributions and any personal income tax payable by a beneficiary.

Property letting: purpose and structure will determine the exemption

The proposed amendment would exclude revenue from letting residential buildings, residential premises or parts thereof from the exemption unless the foundation lets them directly and exclusively for residential purposes. The foundation would bear the burden of proving that these conditions are met. A separate exclusion would cover other buildings, premises or parts thereof designated for overnight accommodation. [1, Article 2(1)]

Describing the proposal solely as a clarification of short-term letting would therefore understate its scope. The wording indicates that arrangements involving an operator, as well as the actual purpose for which premises are used, would also matter. The duration of a lease alone would not determine eligibility for the exemption. Foundations holding property should review both their contractual arrangements and how those arrangements operate in practice, including the evidence available to substantiate residential use.

An expanded definition of hidden profits and changes to loans

The definition of hidden profits would be extended to receivables owed by a founder, beneficiary or an entity related to either of them or to the foundation where those receivables are forgiven, become time-barred or are written off as uncollectible. Loan receivables would also be covered. The bill would prevent the same value from being classified again as hidden profits where it has already been caught by the specified provisions on loans. [1, Article 2(4)(b)]

The rules on unreturned loans would also extend to a broader range of borrowers. For loans granted for at least ten years, the proposed provisions would cover beneficiaries, founders and related individuals. Loans initially granted for a shorter period would be caught if extensions bring the final contractual term to at least ten years. In practice, foundations would need to review repayment schedules, extensions and outstanding receivables alongside their ordinary benefit payments.

Tax-transparent entities, CFC rules and exit tax

The bill would restrict the exemption for revenue obtained through tax-transparent entities to the extent that the revenue would not qualify for exemption if earned directly by the foundation. The rule would therefore depend on the nature of the underlying revenue rather than automatically taxing every receipt from every such entity. [1, proposed Article 6(8)(3) of the Corporate Income Tax Act]

Family foundations would also be brought within the controlled foreign company (CFC) and exit tax regimes. The bill provides specific deduction rules for CFC taxation and clarifies the consequences of transferring assets abroad where Poland loses specified taxing rights. Holding an interest in a foreign company would not, by itself, automatically trigger CFC taxation; the statutory conditions would need to be assessed. [1, Article 2(1)–(3)]

A broader personal income tax exemption for family members

The bill would extend the category of a founder’s family members eligible for the personal income tax exemption to include descendants of the founder’s siblings and descendants of the founder’s stepchildren. This would be particularly relevant to foundations established by siblings: a child of one founder is also a niece or nephew of the other. The exemption would continue to refer to the statutory asset-contribution proportion, making the identity of the founders and the composition of contributed assets relevant to the assessment. [1, Article 1]

Transitional rules: existing assets and the return of property

As a general rule, the corporate income tax amendments would apply from the foundation’s tax year beginning after 31 December 2026. A foundation whose tax year begins before 1 January 2027 and ends after 31 December 2026 would continue to apply the existing provisions until the end of that tax year. The personal income tax amendments would apply to income received from 1 January 2027. [1, Article 3(1)–(3)]

The bill also provides a special mechanism for returning certain real estate and property rights to the person who owned them immediately before their contribution or gratuitous transfer to the foundation before 1 January 2027. The deadline would generally be 31 December 2027 or, for the non-calendar tax year specified in the bill, twelve months after its end. The mechanism concerns residential property and property designated for overnight accommodation falling within the new rules. [1, Article 3(4)–(5)]

Qualifying returns would be excluded from Articles 24q and 24r of the Corporate Income Tax Act and benefit from the relevant personal income tax or inheritance and gift tax relief. The bill also addresses subsequent disposals of the returned property. This is a targeted transitional measure, rather than a general tax-free right to withdraw any asset from a foundation. The specified relief should not be equated with an automatic exemption from every other potential charge, such as VAT.

Implications for succession planning

In its current form, the bill preserves the family foundation as a succession vehicle while changing the economics of distributions and selected investments. A practical review should map each asset against its acquisition date and method, the proposed disposal timetable, any letting arrangements and relevant relationships with beneficiaries and related entities. Foundations with property portfolios, family loans or international structures would warrant particular attention.

A central distinction is between assets contributed in the past and distributions made in the future. Excluding previously contributed property from the new disposal restriction would not preserve the 15% rate for all future benefits financed from that property. The transitional provisions treat these events separately. Decisions should therefore be checked against the legislation as ultimately enacted and promulgated, since the bill may still change during the parliamentary process.

Sources

Artykuł Polish Family Foundations Face Higher Taxes Despite Concessions in Revised Bill pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Karolina Bednarska

Introduction – The Reform of the Polish National Labour Inspectorate: Key Changes in 2026

New provisions governing the operation of the Polish National Labour Inspectorate (Państwowa Inspekcja Pracy, hereinafter: “PIP”) have been in force since 8 July 2026. The Ministry of Family, Labour and Social Policy (hereinafter: “MRPiPS”) is changing the law in order to strengthen the protection of employee rights in Poland. The amendment does not alter the Labour Code itself; rather, it introduces tools for the effective and efficient enforcement of the law already in force. Minister Agnieszka Dziemianowicz-Bąk described the act as a further instrument protecting honest businesses against unfair competitors who for years have built their advantage at the expense of workers – preventing the artificial lowering of labour costs (social security contributions, taxes, paid leave). The changes also implement milestones of Poland’s National Recovery Plan (KPO) aimed at curbing the abuse of civil-law contracts and improving the protection of persons in employment. The Ministry’s measures are directed above all at limiting bogus self-employment and so-called “junk contracts”.

Following the entire legislative process – on the website of the Government Legislation Centre – one can see that the Ministry’s bill received mixed reviews; opinions were divided. The Association of Labour Inspectors of the Republic of Poland (hereinafter: “SIPRP”)[1] assessed the bill amending the Act on the National Labour Inspectorate rather sceptically, with criticism clearly predominating. Although the Association had for years called for a deep reform of the PIP, in its view the act in its present shape still requires improvement. The SIPRP considers that the new duties imposed on the Inspectorate are not matched by adequate tools to strengthen its position. It also emphasised repeatedly in its opinion that certain provisions are causing serious concern within the profession (for example, the modification of the rules on the conclusion of inspection proceedings – Article 11(7a) of the PIP Act), and that the bill lacked the solutions for which the profession had been waiting for years and for which it had appealed in vain (in the form of petitions and systemic postulates aimed at genuinely strengthening the position of the PIP). A similar tone marked the opinion prepared by the Trade Unions Forum (hereinafter: “FZZ”),[2] which stressed the lack of dialogue between the government side and civil society organisations. The solutions adopted are, in its view, deprived of the voice of the people who apply the provisions drawn up by the Ministry. Nevertheless, the FZZ notes certain solutions positively (for example, the shift from a model of immediate administrative authority to a two-stage procedure with an order to remedy infringements, and the transfer of decision-making competence to the higher, district level), while drawing attention to practical and logistical issues, such as a realistic estimate of costs, the need for staffing support (new posts at the PIP) and improvements in digitalisation and civil procedure, so that the courts do not become the “bottleneck” of the reform. The Polish Economic Society – Employers (hereinafter: “PTG”)[3] also spoke out on the reform of the National Labour Inspectorate. In its assessment, the government’s reforming measures create a risk of infringing economic freedom and freedom of contract. Part of the business community fears that officials will gain excessive discretionary power over what is, and what is not, a contract of mandate. Many entrepreneurs are concerned that the new provisions will strike at B2B arrangements which operate in accordance with the law, are fully lawful, and are chosen deliberately by specialists.

The opinions of these various organisations show clearly that the amendment of the provisions on the National Labour Inspectorate is not a reform to which the market and businesses can be indifferent. It represents a long-awaited chance to curb abuses and to improve the situation of persons engaged on fictitious civil-law contracts. Time will tell whether the new provisions prove an effective tool in the fight against abuses or – as business fears – a source of costly disputes and legal uncertainty.

Contracts under PIP scrutiny – what other powers do inspectors gain? What New Powers Does the PIP Have?

The most important reform of the PIP’s powers is the conferral on district labour inspectors (okręgowi inspektorzy pracy) of the power to issue decisions converting improperly concluded contracts into employment contracts. The inspectors’ decision will be preceded by a multi-stage process. First, where infringements are detected, the PIP issues an order to remedy the irregularities. The inspector sets an appropriate time limit for concluding an employment contract, or for arranging the actual terms of cooperation in such a way that they comply with the law. Importantly, following the change in the law the burden of proof has been reversed: it will not be the inspector who has to demonstrate that the arrangement is in fact an employment relationship; rather, the employer will have to defend itself against a finding that an employment relationship exists and prove that the relationship in question is genuinely an independent B2B arrangement.

If the irregularities are not remedied by the business, the PIP inspector applies to the District Labour Inspector for a decision converting the improperly concluded contract into an employment contract. Both the employer and the worker will be able to appeal against the decision to the labour court, which will stay its enforcement until judgment (unless the decision has been declared immediately enforceable). For the duration of the court proceedings, the amendment provides for the possibility of securing the claim: the contract between the parties may be varied, terminated by notice or dissolved only in accordance with the rules of labour law. Until the dispute is finally resolved, a person covered by such an interim measure cannot be deprived of protection merely because he or she formally concluded a civil-law contract. In the event of notice of termination or dissolution of the contract, that person is entitled to the judicial remedies provided for in labour law. These measures are intended to protect workers’ rights, since an employment contract guarantees, among other things: paid annual leave; paid maternity, paternity and parental leave; paid sick leave; and protection against unjustified dismissal and against termination of the contract from one day to the next. In practice this may materially change the total cost of engagement – overtime pay, and the calculation of social security (ZUS) contributions and personal income tax advances.

The PIP may inspect any company, enterprise or firm, regardless of its size or industry. Its inspections will not focus solely on an analysis of the shape of the contract – its name and its wording. The inspectors’ activities are to concentrate on what the cooperation between the “employer” and the “worker” looks like in practice. The key elements will be subordination, the place and time of performance of the work, the personal provision of services, the continuity of the cooperation, the manner of supervision, and who actually bears the economic risk and organises the work. Scrutiny in this area will be facilitated by the fact that, following the changes in the law, the PIP is able to carry out inspections remotely and without prior notice, drawing on information from the ZUS, CEIDG, KAS and KRUS systems. In practice, this synergy of supervisory authorities will mean that data on employment and business relationships will be cross-checked, and irregularities detected automatically. It is therefore worth putting documents and procedures in order before any inspection begins. Even if an employer amends the provisions of a contract in order to shield itself from reclassification as an employment contract, there is no guarantee that the PIP will not nevertheless change the contract by decision after analysing the particular case. If the inspectors find that the day-to-day working model resembles regular employment and that the relevant contractual clauses do not alter the facts on the ground, the National Labour Inspectorate will have grounds to convert such a contract.

The reform introduced by the MRPiPS is not intended to abolish either contracts of mandate or B2B contracts. Concluding such contracts remains lawful and they may still be used, but they must correspond to the real model of cooperation. The PIP’s new powers are meant to counteract pathologies in the labour market in which a civil-law contract is used as a form of engagement in place of an employment contract, even though the manner in which the work is performed points unmistakably to an employment relationship.

The act also introduces solutions such as an individual interpretation (advance ruling) procedure. An employer will be able to apply – the interpretations are issued by the Chief Labour Inspector – for confirmation that the way in which it engages its staff complies with the law. If irregularities come to light in the course of the proceedings, the authority will indicate how to bring the situation into conformity with the law. The interpretation is issued by way of a decision, against which an appeal lies to the court on the terms laid down in the Code of Civil Procedure. It is binding in principle, but it does not preclude an inspection if the facts established in its course differ from those described in the application. Compliance with the interpretation provides protection against administrative and financial sanctions and penalties within the scope covered by the interpretation. In addition, since the entry into force of the amendment the PIP has been able to conduct remote inspections, which is intended to streamline and speed up inspections; and the maximum fine that the PIP may impose in summary penal-ticket proceedings has been at least doubled – from PLN 2,000 to PLN 5,000, and up to PLN 10,000 in cases of repeat offending. The grant of these broad competences was accompanied by the imposition on the institution of a significant duty: the PIP must draw up annual and multi-annual action plans for targeted inspections on the basis of risk analysis.

The impact of the new regulations on businesses operating in Poland

The PIP reforms have a significant impact on business operations, including the activity of foreign entities employing or posting workers in Poland. The new inspection environment compels a far-reaching modification of organisational structures, compliance procedures, and the approach to legal risk management.

International capital groups and their subsidiaries should impose on the entities acting on their behalf in Poland corporate procedures governing the establishment of cooperation and the drafting of contracts with Polish personnel. A foreign company can no longer rely solely on the autonomy of local management without oversight. What is required is the establishment of a permanent audit trail, the appointment of dedicated HR managers, and the alignment of corporate policy with the realities of Polish legislation. Foreign enterprises must move away from flexible but risky models of cooperation based exclusively on civil-law (B2B) contracts for tasks of a continuous nature performed under supervision. This requires converting such relationships into standard employment wherever the hallmarks of an employment relationship are present.

Foreign employers who post their workers to Poland may be inspected by labour inspectors both as to the lawfulness of the posting (documentation, notifications in the EU systems) and as to whether a genuine act of posting actually took place (verification that the posting is not fictitious). Owing to the large number of reports concerning sham agencies, the PIP is also focusing its activity on the verification of such institutions; it is therefore important to maintain the consistency, continuity and credibility of documentation. A lack of consistency in documentation carries the risk of the workers being deemed to be employed directly in Poland, with all the financial consequences that entails.

Foreign entities engaging persons who perform remote work from Polish territory must take account of the question of the permanent place of performance of their worker’s duties, with a view to the correct settlement of taxes and social insurance. The cooperation agreement should set out the terms of engagement in detail, because the PIP – in addition to analysing employment contracts and their practical application – verifies whether remote work is not concealing a permanent branch of the foreign enterprise in Poland, a so-called permanent establishment for tax purposes, which is decisive for determining where the tax obligation lies.

Temporary employment agencies may also find themselves under the particular supervision of the National Labour Inspectorate. Concluding civil-law contracts for work of a continuous nature performed under the supervision of the user undertaking is contrary to the law and subject to rectification. Offering temporary work on the basis of civil-law contracts instead of temporary employment contracts exposes firms to immediate decisions changing the nature of the engagement and to the withdrawal of the agency’s operating licence.

Firms which use the services of contractors (independent providers rendering services under a B2B agreement or contract) or of outsourcing (companies to which selected tasks are contracted out) must pay close attention to clauses indicative of employee subordination. If a contractor performs repetitive tasks at a designated place and time under the direction of the principal, the contract may be challenged as a circumvention of labour law.

It becomes crucial to introduce detailed, consistent and transparent documentation: personnel files, working time records, documents confirming the actual performance of duties, and internal decision-making paths. Furthermore, international capital groups must implement advanced internal compliance procedures which align corporate policy with Polish labour law – something that requires constant monitoring of the conformity of HR practices with the legislation.

Changes in the law need not automatically mean risk, provided that the company prepares for them early and comprehensively. The key to certainty and peace of mind is, above all, preventive action and diligent documentation. To protect an enterprise against HR-related problems, the first step is to carry out a regular audit of all civil-law contracts and existing practices; this allows potential irregularities to be detected relatively quickly. The analysis covers an assessment of clauses concerning subordination, the place and time of performance of tasks, reporting rules, and the scope of the provider’s independence, making it possible to eliminate potential risk factors before an inspector takes up the matter. Once the audit has been completed, new contract templates should be implemented: a safe contract should clearly specify the scope of liability, the option of using subcontractors, the absence of organisational subordination, and the bearing of economic risk by the provider. Equally important is the gathering of evidence of the entire course of the cooperation between the parties (preferably in digital form). In the event of an inspection, it is precisely the organisational documentation that will be decisive.

If, however, the scope of duties and the manner of performing tasks point unequivocally to an employment relationship, the company must take the strategic decision to convert the defective contracts into employment contracts. Taking that decision sufficiently early may protect the firm from having to pay arrears of contributions with interest and from the imposition of sanctions. An alternative tool for contracts giving rise to doubt is to use the individual interpretation mechanism referred to in Article 14b of the amended PIP Act.

Regardless of the type of contract chosen, the inspectors’ attention may be drawn by a complaint lodged by a former associate after the relationship with the firm has ended. The longer the cooperation lasted, and the more it resembled regular employment, the higher the risk that the documentation presented will not withstand scrutiny by the authority. Serious doubts on the part of the PIP, ZUS and the tax office are also raised by the mass transfer of salaried employees onto B2B contracts or contracts of mandate, which tends to be interpreted as a circumvention of the law aimed at avoiding public-law burdens. It is also worth checking whether there is any divergence in the company’s records between the wording of the contract and internal documents: if the contract guarantees full freedom, but company regulations oblige associates to take part in training, annual appraisals or the use of the social benefits fund, the inspector will analyse these materials together – and internal reality will always prevail over what is written on paper.

Whatever the reason for the commencement of inspection activities by the National Labour Inspectorate, what is key for the business, and for the proper course of the visit, is to adopt an open and matter-of-fact attitude and to provide the inspector with appropriate conditions for the efficient verification of documents and the examination of witnesses. It should be remembered, however, that constructive cooperation does not mean the uncritical acceptance of every demand made. The business has every right to expect that all activities will be conducted strictly within the limits of the inspector’s authorisation, in accordance with the applicable procedure, and with respect for all the legal guarantees to which the inspected entity is entitled.

Inspection of the legality of employment

The new provisions focus on the elimination of the so-called grey zone and of abuses at the interface between civil law and labour law. The inspectors’ examination of the legal relationship linking the “employer” and the “worker” for lawfulness is carried out on the basis of the criteria in Article 22 of the Labour Code: what is decisive is solely the sum of the characteristics of the actual performance of the tasks, not the name of the contract or its formal provisions. An employment relationship rests on subordination (the giving of instructions as to the manner, place and time of performance of the work), the personal performance of work (no possibility of appointing a substitute without the employer’s consent), continuity and remuneration (pay disbursed at fixed intervals irrespective of the result or effect of the work), and the employer’s responsibility (provision of the tools of work, infrastructure, and so on). Faced with such rigorous criteria for the assessment of contracts, businesses are under urgent pressure to review their existing models of cooperation. Ignoring these regulations may lead to serious financial and legal consequences, which is why the implementation of proactive adjustment measures becomes crucial.

B2B contracts are currently the most frequently challenged form of cooperation. The PIP pays particular attention to elements such as:

• exclusivity – the service provider renders services to one entity only, which accounts for 100% of its revenue;
• fixed hours and compulsory presence at the premises of the ordering party, principal or client, with no possibility of remote work or a flexible schedule, even though the contract provides otherwise;
• incorporation into the company’s organisational structure – a specific assigned position, a business e-mail box on the company’s domain, conducting conversations with clients in the company’s name without disclosing the status of external provider, and so on;
• the ordering firm, principal or client supplies equipment, tools and company resources (e.g. a laptop, a business telephone, access to systems, software and infrastructure) on the same terms as to salaried employees;
• absence of any real economic risk – the provider issues an invoice for the same amount every month, regardless of the number of hours and the scope of the services performed; there are no contractual penalties; it bears no business costs apart from ZUS contributions; it invests no capital of its own;
• ongoing direction – the issuing of work instructions which cannot be refused.

The contract for a specific work (umowa o dzieło), in turn – even though it is a distinctive form of cooperation, since what counts is a specific and visible result – remains within the National Labour Inspectorate’s field of interest. Inspectors pay attention to elements such as:

• the result of the contract – if the “work” consists in the monthly provision of services, ongoing support and the like, a contract for a specific work will not be the correct form of cooperation; the work must be capable of being identified, verified and accepted on delivery;
• repetitiveness and continuity of performance – a “work” delivered every month, of the same value and of a similar scope, means that in practice we are dealing with a contract of mandate or an employment relationship;
• the work lacks the features of individual creativity, being a copy or a multiplication of something;
• there is constant supervision over the manner in which the work is created – the provider reports progress daily, takes part in briefings and receives instructions.

Following the amendment of the PIP Act, the contract most exposed to challenge is the contract of mandate (umowa zlecenia), since of all civil-law contracts its construction is the closest to an employment relationship. The difference lies in the degree of subordination and independence – and that is precisely what the inspector examines. The most frequently challenged elements are:

• a fixed rota and compulsory attendance;
• an obligation to perform the mandate in person, with no possibility of subcontracting;
• hourly settlement with a working time register (where the records serve not to settle the service but to control working time, this signals the possible existence of employer direction);
• an obligation to justify absences and to apply for leave (a break in the provision of services may be contractual, but its organisation should not replicate statutory annual leave);
• a fixed monthly remuneration independent of the scope of performance (regardless of the number of hours, the tasks performed or the results achieved);
• ongoing work instructions and daily supervision.

The key to avoiding adverse legal and financial consequences lies not in superficial touch-ups to the wording of contracts, but in a genuine reordering of day-to-day practices and in guaranteeing the actual independence of providers wherever civil-law contracts are used.

EU labour law and the PIP reform

The reform of the National Labour Inspectorate in Poland is closely linked to the harmonisation of Polish law with EU regulations. The Directive on improving working conditions in platform work (2024/2831) introduces a legal presumption of an employment relationship for persons working through online platforms. If the application controls and directs the work, the person is deemed to be an employee rather than self-employed – and the burden of proof rests on the platform. Nowadays this form of work is increasingly chosen by young people, which compels both the EU and the Polish legislator to take protective measures in this field. Once the directive is transposed into Polish law (the transposition deadline is 2 December 2026), the PIP will have a tool for enforcing this presumption in practice. The directive additionally prohibits the collection of certain personal data (for example, on emotional state) by algorithms and requires human oversight of decisions to block or suspend accounts. The introduction of these rules in the platform work directive forms part of the broader European digital package and is closely connected with the provisions of the Digital Services Act (DSA). While the directive protects labour rights and prevents algorithmic arbitrariness towards service providers, the DSA imposes on digital platforms general requirements of transparency, accountability and oversight of algorithms, which complement the protection of users and digital workers. As a result, the two acts together form a coherent system: the DSA looks after a safe and transparent digital environment at the level of the platform as a whole, while the directive translates those principles directly into work relationships and fair conditions of engagement.

Also important in the context of the PIP’s activity is Directive 2019/1152 on transparent and predictable working conditions. It introduced an information obligation (Article 29 of the Labour Code) under which, within 7 days of the employee being admitted to work, the employer must provide the employee with detailed information on the terms of employment. In this context labour inspectors may verify whether that information is complete and exhaustive – for example, whether it includes information on overtime and the compensation for it, the rules for moving from shift to shift (in the case of shift work), information on the right to training and on the company’s training policy, or the rules for determining the length of the probationary period and daily and weekly rest, and so on. Moreover, under this directive the inspectors have obtained tools to check whether the termination of an employment contract was not the consequence of the employee asserting rights due under the Labour Code or of lodging a complaint with the PIP; they may also examine clauses in employment contracts and workplace regulations for prohibited bans on working for other entities, review the correctness of the conclusion of probationary contracts, and check whether the employer reimburses the costs of, or correctly accounts for the working time spent on, compulsory training.

In the context of the posting of workers, the EU legislator has adopted two significant directives: Directive 96/71/EC and Directive 2018/957/EU amending it. One effect of the work on these directives, and of the accompanying EU enforcement framework, is an easier exchange of data between the PIP and the authorities of other Member States; moreover, it is on the basis of this framework that ZUS facilitates the verification of the pay and working conditions of cross-border workers. A directive of key importance, however, is the one on the protection of whistleblowers, which has been a direct impulse for the initiation of targeted inspections by the PIP. Directive (EU) 2019/1937 protects whistleblowers – persons who report breaches of the law – ensuring their safety from retaliation and guaranteeing the confidentiality of their identity. It guarantees protection against dismissal, demotion or other retaliatory measures on the part of the employer, as well as the confidentiality of the identity of the reporting person and of persons connected with them.

In the context of the EU directives mentioned above, an important European Union agency is the European Labour Authority (hereinafter: “ELA”), which forms a bridge connecting the National Labour Inspectorate with the inspectorates of other Member States. The Authority supports the PIP above all by organising and coordinating joint and concerted cross-border inspections, and by streamlining the exchange of information in cases of abuse concerning the posting of workers or bogus self-employment. The ELA’s activity also means that the Polish inspectorate gains real operational backing for the enforcement of the EU standards mentioned above in the international dimension.

The EU regulations presented here form a coherent, modern system of labour protection, with the result that the Polish labour inspectorate obtains better tools and its role correspondingly gains in importance. The PIP is ceasing to be merely an authority reacting to traditional shortcomings in production plants, and is becoming a modern guardian of the law, equipped with the tools to combat digital exploitation, opaque algorithms and cross-border abuses. The reform of the National Labour Inspectorate is thus a natural and necessary response to the challenges of today’s dynamically changing labour market.

Conclusion

The reform of the powers of the National Labour Inspectorate is one of the most important turning points in contemporary Polish employment policy, carrying with it both great hopes and considerable controversy. On the one hand, the new legal instruments – such as the possibility of converting civil-law contracts into employment by administrative decision – are meant genuinely to curb the abuse of “junk contracts” and to protect workers better. On the other hand, employers fear excessive bureaucracy, arbitrariness on the part of officials, and a restriction of the flexibility which has hitherto benefited more than one industry. The key to the success of the whole undertaking will therefore be the efficient staffing and preparation of the Inspectorate itself, together with a balanced social dialogue capable of reconciling the interests of business with respect for employee rights.

Implementing the changes described here requires not only legislative courage but also continuous monitoring of the economic effects the reform will have on small and medium-sized enterprises. It is worth remembering that the growth in the competences of supervisory authorities must go hand in hand with growth in their professionalism, in order to avoid a wave of unnecessary court disputes and the paralysis of business activity. Ultimately, the prospects facing the Polish labour market depend on whether the amended provisions become an effective tool for building fair relationships, or merely another bureaucratic challenge. The long-term effects of these measures will shape employment standards and the sense of social security of millions of citizens for years to come.

Bibliography

Government Legislation Centre, file of the draft act: https://legislacja.gov.pl/projekt/12401602/katalog/13153003

Act of 11 March 2026 amending the Act on the National Labour Inspectorate and certain other acts (Journal of Laws of 2026, item 473): https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20260000473/O/D20260473.pdf

Opinion of the Association of Labour Inspectors of the Republic of Poland on the draft act amending the Act on the National Labour Inspectorate and certain other acts – draft of 1 September 2025 (No UD283 in the list of legislative and programme works of the Council of Ministers): https://www.siprp.pl/wp-content/uploads/2025/09/opinia-SIPRP_1709.pdf (accessed 4 August 2026)

Trade Unions Forum (FZZ), Comparative analysis of the draft reforms of the National Labour Inspectorate: https://fzz.org.pl/wp-content/uploads/2026/02/Analiza-porownawcza-projektow-reformy-Panstwowej-Inspekcji-Pracy-.pdf (accessed 4 August 2026)

Act of 26 June 1974 – Labour Code (consolidated text: Journal of Laws of 2025, item 277, as amended).

Directive (EU) 2024/2831 of the European Parliament and of the Council of 23 October 2024 on improving working conditions in platform work (OJ EU L of 2024, item 2831).

Directive (EU) 2019/1152 of the European Parliament and of the Council of 20 June 2019 on transparent and predictable working conditions in the European Union (OJ EU L 186 of 2019, p. 105).

Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (OJ EU L 18 of 1997, p. 1, as amended).

Directive (EU) 2018/957 of the European Parliament and of the Council of 28 June 2018 amending Directive 96/71/EC concerning the posting of workers in the framework of the provision of services (OJ EU L 173 of 9 July 2018, p. 16).

Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ EU L 305 of 26 November 2019, p. 17).

Decision of the Supreme Court of 25 November 2025, I USK 433/24, LEX No 3945328.

European Labour Authority: https://www.ela.europa.eu/en

K. Lisiecka, M. Maksis, K. Polewka-Włoch, A. Szulc, Nowe uprawnienia PIP po zmianach 2026. Umowy cywilnoprawne w praktyce [The New Powers of the PIP after the 2026 Changes: Civil-Law Contracts in Practice], Warsaw 2026.

https://rpms.pl/umowy-b2b-zlecenie-2026-nowe-przepisy-ryzyko-uop

[1]A nationwide organisation associating primarily employees of, and labour inspectors connected with, the National Labour Inspectorate.

[2]One of the largest and most important trade union confederations in Poland, representing the interests of workers from various industries and sectors of the economy in dialogue with governments and employers.

[3]A nationwide, cross-sectoral employers’ association bringing together Polish entrepreneurs (both small and medium-sized firms and large enterprises).

Artykuł The Reform of the Powers of the Polish National Labour Inspectorate (PIP) pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

In legal and commercial practice, the notion of the “no-confidence protocol” (protokół nieufności) displays a specific semantic duality, which draws a clear boundary between the colloquial understanding of corporate institutions and the automated architecture of the ICT systems of the administration of justice. Verification of this term requires, above all, the rejection of any assumption as to its statutory origin, for a thorough dogmatic analysis leads to the unambiguous conclusion that managerial practice and the registration procedure are not one and the same.

Proceeding to a formal legal deconstruction, it must be stated categorically that no institution bearing the name “no-confidence protocol” has been provided for in the provisions of the Commercial Companies Code[1] or in the Act on the National Court Register[2]. Polish company law does not employ this terminology at any stage of the regulation of the functioning of the governing bodies of companies, which precludes treating this document as an autonomous instrument of a substantive or procedural character. This phenomenon illustrates a broader tendency for divergences to arise between the language of the law and the language of legal practice, brought about by the implementation of advanced IT solutions in the registry judiciary.

This conceptual duality means that the no-confidence protocol functions in practice as a category of a technical and systemic character, whose erroneous identification with institutions of corporate law results from the penetration of IT jargon into the language of business practice. The actual source of this concept, which appears in the Repository of Registry Files (Repozytorium Akt Rejestrowych), lies exclusively in the sphere of the technical operation of the ICT systems of the Ministry of Justice[3]. When applications for the entry or amendment of data concerning persons appointed to company bodies are examined, the IT System of the National Court Register automatically generates an internal verification document.

This protocol records the course of an algorithm which performs automated queries to external databases, including the National Criminal Register and the Register of Insolvent Debtors[4]. The purpose of this operation is the digital confirmation of the absence of negative circumstances precluding the performance of the function of a member of the management board or the supervisory board. Examples of such bars are the prohibitions set out in Article 18 § 2 of the Commercial Companies Code, whereby the legislature introduces an absolute prohibition on the holding of office by persons convicted by a final judgment of specified economic offences, fiscal-penal offences and offences against the credibility of documents.

A different matter is the practice of business, in which the term functions as a colloquial description of measures connected with the formal expression of a lack of confidence by the company’s owners. Shareholders sometimes use this label for resolutions of shareholders’ meetings concerning the refusal to grant discharge (absolutorium) or the adoption of a vote of no confidence in members of the management board[5]. Although these acts produce significant effects within the company and frequently lead to the immediate removal of managers, in the light of the settled case law of the Supreme Court they constitute an expression of the corporate rights of the shareholders, and not the implementation of an external registration procedure[6].

Summing up the issue under analysis, the conclusion may be formulated that the “no-confidence protocol” is a purely systemic concept which has become widespread in business language, causing misunderstandings among auditors and legal analysts. The contemporary verification of digital registry files requires a clear separation of the technical sphere of automated queries from the legal acts performed by the company’s bodies. Ignoring this distinction could lead to erroneous conclusions concerning the legal status of management board members, whereas the presence of this document in the Court Registers Portal is merely technical proof that the registry court has duly carried out the automated check required by law.

Origins and Circumstances of the Creation of Documents of a No-Confidence Character

An analysis of the reasons and circumstances in which traces of documents described as a “no-confidence protocol” appear in a company’s corporate history requires a clear separation of two distinct planes: the technological-registration plane and internal corporate practice. The first of these, systemic in character, is directly connected with the mechanisms of the operation of the Court Registers Portal and of the ICT system serving the National Court Register (SI KRS). When applications are filed – on forms KRS-Z3 or KRS-W3 – for the entry of newly appointed members of company bodies or for a change in the existing representation, the system obliges users to provide the candidates’ personal data, including their PESEL number. At this stage an automatic, systemic exchange of information takes place between the databases of the Minister of Justice and the National Criminal Register. This procedure serves the obligatory verification of the absence of convictions for the offences specified in Article 18 § 2 of the Commercial Companies Code, which constitute an absolute negative condition for holding office in the bodies of companies. The presence of a phrase such as “no-confidence protocol” in system metadata or in the history of operations on the files of a given registration case therefore constitutes a technical trace of the automated verification of credibility, of a clean criminal record or of internal ICT security algorithms, and not a physical document produced by participants in economic transactions.

Documents of this character have an entirely different origin where their source is sought on the corporate plane, where they take a material form, filed in the registry records by the company itself as annexes to applications. The circumstances of their preparation are almost invariably inseparably linked with deep decision-making, reputational and structural crises within the ownership structure, reflected in specific provisions of the Commercial Companies Code. The most frequent background is decision-making paralysis of the deadlock type, occurring in companies with a symmetrical balance of ownership power (e.g. a 50/50 shareholding structure), where the impossibility of forming a majority prevents the adoption of key resolutions, and one faction seeks formally to document the loss of confidence in, and the failings of, managers associated with its opponents. An equally dynamic catalyst is the detection of managerial abuse (malpractice), such as acting to the company’s detriment, the siphoning-off of assets through related-party transactions on non-market terms (tunneling) or gross breaches of budgetary discipline. In such circumstances, minority shareholders – exercising the control rights arising under Article 212 of the Commercial Companies Code – or supervisory bodies acting under Article 219 of the Code[7] initiate verification procedures, which often culminate in written reports or protocols expressly articulating charges and a lack of confidence. This situation is compounded by disputes over defects in the representation itself, in which the effectiveness of the appointment or removal of management board members is challenged, transferring the conflict from the company’s boardroom to the courts.

In the light of the settled line of Supreme Court case law, acts expressing shareholders’ lack of confidence in managers – most frequently manifested in a refusal to grant discharge – constitute a sovereign expression of the corporate rights of the company’s owners, and not the implementation of an external registration procedure. Of key importance in this respect is the judgment of the Supreme Court[8] in which the Court subjected the legal character of a failure to grant discharge to detailed analysis. Although the Supreme Court came out unequivocally against the concept of so-called negative resolutions, indicating that the non-adoption of a resolution granting discharge, for want of the required majority of votes “in favour”, is not equivalent to the formal adoption of a resolution “refusing” discharge, it simultaneously recognised the significance of that act in the sphere of facts and of public perception. A refusal to grant discharge, irrespective of the technical-legal form in which it occurs, is in commercial practice treated as a corporate vote of no confidence. The Supreme Court emphasised that this decision falls within the sphere of the discretionary power of the shareholders and rests on their subjective economic and legal assessment of the manager’s activity, provided that it does not bear the hallmarks of manifest harassment or bad faith, which could then justify protection of the aggrieved party’s personal rights on the basis of Article 24 of the Civil Code[9].

An independent substantive assessment of the phenomenon under analysis leads to the conclusion that the concept of the “no-confidence protocol” plays a dual, though asymmetrical, role in commercial practice. On the one hand, it constitutes striking evidence of the progressive digitisation and automation of registration procedures, in which algorithmic mechanisms generate systemic traces in order to protect the certainty of legal transactions and to verify the requirements of Article 18 § 2 of the Commercial Companies Code. On the other hand, in practical terms, the materialisation of such documents in a company’s files is a symptom of deep corporate pathology and of the collapse of the fiduciary relationship between capital and management. These documents – whether they take the form of minutes of a stormy supervisory board meeting or of an audit report of minority shareholders – are instruments of corporate warfare of high business significance. They mark the moment of transition from the amicable management of the company to open legal conflict, often preceding the immediate removal of management board members for important reasons (Article 203 § 1 or Article 368 § 4 of the Commercial Companies Code) and opening the way to actions for damages against managers under Article 293 or Article 483 of the Code[10]. For external participants in commercial dealings – including financial institutions and contractual counterparties – the disclosure of such documents, or of their systemic equivalents in the register, constitutes an unambiguous warning signal of elevated operational risk and of the potential loss of decision-making capacity by the entity concerned.

Significance in the Due Diligence Process – Warning Signals

The identification of a reference to, or of a document described as, a “no-confidence protocol” in the course of a professional due diligence review of a counterparty requires the auditor immediately to implement differentiated risk-verification paths, determined by the dual character of this phenomenon. The key task at the stage of documentation analysis is the precise separation of a routine systemic-technical trace from a material corporate document, since each of them generates a diametrically different impact on the stability and security of the planned contractual relationship.

Verification on the systemic plane, revealing the presence of a “no-confidence protocol” record in the metadata of the IT System of the National Court Register (SI KRS) or in the Repository of Registry Files, is, as a rule, a neutral signal. For the entity examining the counterparty’s legal condition, such an entry merely confirms the correct, automatic activation of control algorithms by the IT architecture of the Ministry of Justice, consisting in the querying of external databases, including the National Criminal Register and the Register of Insolvent Debtors. This activity serves the performance of the statutory obligation to examine the conditions of Article 18 § 2 of the Commercial Companies Code, guaranteeing that the persons notified for entry as the company’s representatives are not subject to a prohibition on serving as officers of company bodies. Provided that the registration proceedings ended with a final entry of the data applied for, a technological trace of this kind carries no independent transactional risk and attests merely to the completion of the standard verification procedure.

A completely different, critical significance attaches to the identification, in the registry files or in internal documentation, of a genuine corporate document reflecting a formalised conflict within the company’s ownership structures. Such a document may take the form of minutes of a meeting of the supervisory board or of the shareholders’ meeting at which charges against the management were openly formulated or discharge was refused. In this respect a direct link emerges with the interpretation adopted by the Supreme Court[11]: while the Court indicated that the non-adoption of a discharge resolution for want of the requisite majority of votes does not create a legal fiction in the form of a “negative resolution” refusing discharge, it simultaneously confirmed that in economic reality and in public perception such an act is unequivocally identified with a vote of no confidence. For the entity conducting due diligence, the discovery of a material protocol of such content constitutes a stark warning signal of the breakdown of the relationship of trust between capital and management, which implies three fundamental categories of legal and business risk.

The first of these is the risk of instability of the counterparty’s bodies and of uncertainty as to its representation. A deep corporate crisis, of which a no-confidence protocol is an expression, most frequently precedes or directly triggers sudden changes in the composition of the management board on the basis of Article 203 § 1 or Article 368 § 4 of the Commercial Companies Code. Contracts and declarations of will made by the company in such an unstable transitional period are highly exposed to subsequent contestation by warring shareholder factions. Litigation opponents may seek to undermine the effectiveness of legal acts by invoking defects in the convening of the bodies, the absence of due authority of the officers to act, or breaches of internal rules of representation, which strikes directly at the certainty of commercial transactions and at the legal security of the other party to the contract.

The second consequence is the direct risk of the company becoming entangled in lengthy and costly court proceedings. The existence of a corporate no-confidence document almost invariably heralds the imminent commencement of actions for the revocation or the declaration of the invalidity of resolutions of the owners’ bodies (Articles 249 and 252 of the Commercial Companies Code), the bringing of actions for damages against managers under Article 293 or Article 483 of the Code on account of alleged acts to the company’s detriment (malpractice or tunneling), and, in extreme cases, an application for the appointment of a court-appointed guardian (kurator) on the basis of Article 42 of the Civil Code. The prospect of years of litigation destabilises the counterparty’s organisational structure and generates risk striking at its market reputation.

The consequence of the above phenomena is the third plane, namely financial and operational risk. Ownership conflicts of an intensity requiring formalisation in the form of protocols of lack of confidence absorb key capital and the operational attention of the management, diverting it from the day-to-day running of the enterprise. This results in a drastic decline in the timeliness of contract performance, decision-making paralysis with respect to key investments, and loss of financial liquidity. In addition, where allegations of asset-stripping are confirmed, there is a real threat that security for damages claims will be established over, or enforcement levied against, key components of the counterparty’s assets, which may prevent it from performing its reciprocal obligations.

An independent substantive assessment of the phenomenon leads to the conclusion that the presence of the “no-confidence protocol” motif in the course of due diligence constitutes one of the most demanding qualitative diagnostic indicators. While its systemic dimension is merely a technological testimony to the transparency of the register and to the performance of its security procedures, its corporate dimension exposes a structural pathology threatening the legal existence of the enterprise. For a professional participant in commercial dealings to ignore a genuine, material vote-of-no-confidence document constitutes gross negligence, since in market reality signals with a stronger warning charge are rarely encountered. A correct interpretation of this phenomenon permits a strategic decision to renegotiate the terms of the transaction, to implement additional legal safeguards (e.g. bank guarantees or a submission to enforcement), or – where the conflict escalates – to withdraw from the contract altogether in order to protect one’s own capital.

The Judicial Perspective: Evidentiary and Practical Significance

An analysis of the adjudicative practice of the common courts and of the Supreme Court points to a highly pragmatic approach of the judiciary to documents described in commercial practice as “no-confidence protocols”. The term itself rarely appears directly in the operative parts of judicial decisions, since it is not an institution of statutory law. The courts treat it as an element of the description of the facts, reconstructed on the basis of the nomenclature adopted by the parties to the corporate dispute themselves. Of key importance to adjudicating panels, however, are the substantive content of such a statement and the procedural rigour attending its preparation, which are subject to meticulous verification in the course of specific contentious and registration proceedings.

The most frequent procedural background against which documents reflecting a vote of no confidence are assessed by the courts are cases for damages on account of the premature or defective removal of a management board member from office. Such a situation arises where a management contract or the company’s articles – taking advantage of the non-mandatory character of the statutory provisions – make the manager’s removal from the body before the end of the term of office conditional upon the existence of important reasons. In disputes of this type, the courts uniformly hold that a loss of confidence may not be of a purely subjective, arbitrary or casuistic character. In order to constitute an effective ground for terminating the legal relationship, or to justify a refusal of discharge, it must rest on objectively verifiable factual premises. In this context, a protocol containing a formalised expression of a lack of confidence becomes key evidentiary material, which the court assesses through the prism of the principle of the free evaluation of evidence. The judges examine whether the charges formulated in the protocol – such as mismanagement, failure to implement the strategy or gross breaches of budgetary discipline – were grounded in truth and whether they objectively gave the shareholders justified grounds for severing the corporate bond with the manager. This corresponds to the interpretative line presented, inter alia, in the judgment of the Supreme Court[12], in which it was indicated that although a refusal to grant discharge or a removal from office falls within the sphere of the sovereign and discretionary ownership rights of the shareholders, the motivation behind those acts may not bear the hallmarks of manifest harassment or bad faith, failing which the way is open to legal protection for the manager.

Alongside the strictly contentious sphere, the documents under discussion play an important role before the registry courts, where the procedural correctness of their preparation is examined. Registry courts, acting within the limits of their statutory powers of cognisance, examine whether the documents attached to an application demonstrate conformity, as to form and content, with the provisions of law. If a protocol reflecting a deep conflict within the company displays formal defects – such as the absence of required signatures, the improper convening of a meeting, failure to satisfy quorum requirements or the exclusion of a shareholder from the vote – the registry court refuses to enter the changes in the structure of the bodies. This temporarily sanctions and freezes the existing balance of power in the company’s representation, paralysing the personnel effects of the decisions taken.

An independent substantive assessment of this issue leads to the conclusion that a protocol of a no-confidence character performs the function of a kind of bridge between the dynamic, often emotional, sphere of internal ownership conflict and the formalised world of judicial procedure. Its evidentiary significance is fundamental, since it is precisely this document that verifies the shareholders’ intentions at the critical moment of corporate crisis. From the point of view of commercial practice, a defectively prepared protocol, or one based on unverified charges, becomes a powerful source of litigation risk for the company, opening the way for the removed manager to bring effective damages claims. For professional auditors and business advisers in the course of due diligence, an analysis of the manner of drafting and of the formal correctness of such documents constitutes a key element of the assessment of whether the changes in the company’s bodies will stand up in court, or whether they will be challenged, generating a prolonged state of legal uncertainty for the entity.

Practical Conclusions and Verification Recommendations

The identification, in the course of a due diligence procedure, of a trace of a document functioning as a “no-confidence protocol” obliges the analyst immediately to implement an in-depth audit verification algorithm aimed at precisely separating systemic risks from corporate ones. The first stage of this process is a formal audit of the registration case file, allowing it to be established whether the reference to this concept is merely a standard, automatically generated record of verification in the National Criminal Register pursuant to Article 18 § 2 of the Commercial Companies Code. If the case has been finally concluded with the entry of the newly appointed members of the representative body, and the record itself is of a purely technical, ICT character within the structure of SI KRS, that circumstance generates no independent transactional risk for the planned agreement. It should also be borne in mind that, in the process of verifying registry files, analysts may encounter judicial decisions of a purely procedural character; such acts must be clearly distinguished from rulings of a substantive-law character, which directly touch upon the essence of the functioning of the company’s bodies and affect the security of commercial transactions.

An entirely different audit procedure is activated where the examination shows that the document reflects a genuine ownership dispute and was physically filed by the company itself or by its shareholders. In such a scenario, the key step is to demand the production of the full corporate documentation directly from the counterparty, including in particular a copy of the notarial minutes of the relevant shareholders’ meeting or general meeting, together with the attendance list, the structure of the distribution of votes and the exact wording of any dissenting opinions filed. This corresponds with the practice arising from the judgment of the Supreme Court (case no. II CSKP 1330/22), which pointed to the economic and structural significance of a failure to grant discharge as an act directed at managers. A full analysis of the content of such a document allows the auditor to reconstruct the real causes of the corporate rift and to assess the substantive merits of the charges of mismanagement or abuse that have been raised.

The next, obligatory step within the verification algorithm is a comprehensive examination of pending disputes. A professional analyst should obtain from the counterparty’s incumbent management board a written statement, made under full liability in damages, confirming the absence of pending court proceedings aimed at challenging resolutions of the owners’ bodies. This verification must expressly cover claims for the revocation or the declaration of the invalidity of resolutions on the basis of Articles 249 and 252 of the Commercial Companies Code in relation to limited liability companies, and Articles 422 and 425 of the Code in the case of joint-stock companies. In parallel, it is advisable to conduct an independent search in the commercial divisions of the competent regional courts for any actions for the payment of damages, or for the shaping of a legal relationship, brought by former management board members removed in an atmosphere of conflict.

Where the steps taken reveal the existence of a genuine, smouldering corporate conflict, and business considerations imperatively require cooperation with the counterparty, it is necessary to implement radical risk-mitigation mechanisms through the introduction of specific contractual clauses. In such circumstances, the client’s legal interest is protected by requiring joint representation at the conclusion of the contract, by obtaining written statements from all warring shareholder factions confirming the full authority of the current management board, or by establishing joint and several security of a personal character. For example, a suretyship given by the natural persons controlling the company, or a submission to enforcement under Article 777 of the Code of Civil Procedure, makes the effective pursuit of claims independent of decision-making paralysis or of any degradation of the asset structure of the counterparty itself.

A substantive assessment of the issue under discussion leads to the conclusion that the implementation of a structured algorithm for the verification of the “no-confidence protocol” elevates the due diligence procedure from the level of a passive examination of documentation to the rank of a strategic predictive tool. The presence of a material vote of no confidence in a company’s history is rarely an incident of a purely historical character; most often it is a symptom of deep structural dysfunction which will, in all likelihood, materialise in the operational sphere. Consequently, the diligent performance of the audit recommendations described above not only protects the examining entity against the risk of concluding a contract affected by legal defects or by the sanction of invalidity, but also supplies invaluable asymmetric knowledge, enabling the renegotiation of the pricing terms of the transaction or the securing of above-standard safeguards for the performance of the obligation.

[1]Act of 15 September 2000 – Commercial Companies Code (consolidated text: Journal of Laws of 2024, item 18, as amended).

[2]Act of 20 August 1997 on the National Court Register (consolidated text: Journal of Laws of 2025, item 869, as amended).

[3]Technical specification of the ICT systems of the Department of Informatisation and Court Registers of the Ministry of Justice.

[4]Article 21a of the Act of 20 August 1997 on the National Court Register (consolidated text: Journal of Laws of 2025, item 869, as amended) in conjunction with the provisions of the Act of 24 May 2000 on the National Criminal Register (consolidated text: Journal of Laws of 2024, item 276, as amended).

[5]Judgment of the Supreme Court of 10 November 2022, case no. II CSKP 1330/22.

[6]Decision of the Supreme Court of 10 January 2019, case no. II CSK 345/18.

[7]Act of 15 September 2000 – Commercial Companies Code (consolidated text: Journal of Laws of 2024, item 18, as amended), Articles 212 and 219.

[8]Judgment of the Supreme Court of 10 November 2022, case no. II CSKP 1330/22.

[9]Act of 23 April 1964 – Civil Code (consolidated text: Journal of Laws of 2025, item 1071, as amended).

[10]Act of 15 September 2000 – Commercial Companies Code (consolidated text: Journal of Laws of 2024, item 18, as amended), Article 203 § 1, Article 368 § 4, Article 293 and Article 483.

[11]Judgment of the Supreme Court of 10 November 2022, case no. II CSKP 1330/22.

[12]Judgment of the Supreme Court of 10 November 2022, case no. II CSKP 1330/22.

Artykuł Legal Status and Definition of the Concept of the “No-Confidence Protocol” (protokół nieufności) pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

I. Introduction

The longevity economy is commonly estimated at several hundred billion dollars worldwide and continues to grow rapidly.[1] Venture capital flows into biotechnology companies that promise to slow, halt, or reverse aging. Clinics from Zurich to Seoul to Miami sell “longevity programmes.” Supplement brands attach the word “longevity” to products ranging from NAD precursors to collagen powders. And yet the word “longevity” does not exist as a legal category in European Union law. There is no definition, no register, no certification scheme, and no authority empowered to decide what may or may not describe itself as a longevity product, a longevity clinic, or a longevity company.

The gap between an enormous market and a non-existent legal definition is precisely where legal risk accumulates. Where there is no definition, there is classification risk, claims risk, and enforcement risk. There is also a phenomenon that this article, borrowing from the vocabulary of environmental marketing, calls “longevity washing.”

This article examines the longevity industry through the lens of EU regulatory law. The EU framework governs a market of some 450 million consumers and, because it is horizontal, sector-specific, and increasingly enforcement-oriented, it offers a useful point of comparison for practitioners in the United States, Asia, and Latin America. Part II explains why “longevity” is not a legal category and introduces the borderline-product problem that follows from that fact. Part III develops the concept of longevity washing and its consumer-facing, unfair-commercial-practice, and investor-facing dimensions. Part IV addresses the regulation of artificial intelligence in longevity research and diagnostics, including the revised timeline of the AI Act, the position of the European Medicines Agency on AI in the medicinal-product lifecycle, and the data-protection architecture formed by the GDPR and the European Health Data Space. Part V maps the sectoral “hot spots” across pharmaceuticals, medical devices, cosmetics, and food supplements. Part VI draws conclusions for practitioners.

II. “Longevity” in the Eyes of the Law: The Borderline-Product Problem

In EU regulatory law, aging is not a disease. The European Medicines Agency has never approved a medicinal product with “aging” as a therapeutic indication, and under Directive 2001/83/EC a medicinal product is defined by reference to the treatment or prevention of disease or the restoration, correction, or modification of physiological functions.[2] The position in the United States is comparable. The long-running debate around the Targeting Aging with Metformin (TAME) trial illustrates the point: its designers had to negotiate a trial protocol with the Food and Drug Administration that targets aging indirectly, through a composite of age-related diseases, precisely because “aging” itself is not an approvable indication.[3]

The consequence is profound. A company cannot lawfully market a product “to treat aging.” The entire longevity industry therefore operates in the space of indirect claims: “supports healthy aging,” “promotes cellular health,” “extends healthspan.” Each of those phrases pushes the product toward one of several very different regulatory regimes.

This is the borderline-product problem, and it is the single most important legal concept in the sector. The same molecule – an NAD precursor, for example – may be: a medicinal product, if it is presented as treating or preventing disease or exerts a significant pharmacological, immunological, or metabolic effect; a food supplement under Directive 2002/46/EC;[4] a novel food requiring pre-market authorisation under Regulation (EU) 2015/2283;[5] a cosmetic under Regulation (EC) No 1223/2009, if applied to the skin with a claim limited to appearance;[6] or a medical device. The last category is broader than it may appear: since the Medical Device Regulation (MDR) came into application, products listed in its Annex XVI – dermal fillers, certain energy-based aesthetic equipment – are regulated as devices even where they have no medical purpose at all.[7]

Classification does not follow the label a company chooses. It follows presentation, composition, and route of administration. The Court of Justice of the European Union has held for four decades that a product is a medicinal product “by presentation” where it is described or recommended as having properties for treating or preventing disease, irrespective of whether it actually has those properties; and that classification “by function” turns on a case-by-case scientific assessment of the product’s actual pharmacological, immunological, or metabolic action, not on the manufacturer’s intention.[8] Marketing language alone can therefore reclassify a product and, with it, the entire compliance burden: marketing authorisation, good manufacturing practice, pharmacovigilance, and advertising restrictions.

When a client says “we are a longevity company,” the first question counsel should ask is: which regime are you actually in? “Longevity” is a marketing word. The law knows only medicines, devices, foods, and cosmetics.

III. Longevity Washing: When the Claim Outruns the Science

Greenwashing – claiming environmental virtue one does not have – is a familiar concept. Longevity washing is its younger sibling: labelling a product, a clinic, a research programme, or an entire company as “longevity-focused” when the science, the indication, or the business model does not support that description. The practice matters legally for three reasons.

A. Consumer-Facing Claims

Under the Health Claims Regulation, any health claim made on a food – and food supplements are foods – must be specifically authorised and listed in the EU register.[9] Claims such as “slows aging,” “supports cellular repair,” or “extends lifespan” are not authorised health claims. National authorities in the EU and the United Kingdom have treated phrases such as “cellular repair” and even “healthy aging” as impermissible where they imply a physiological mechanism or a reduction of disease risk. A substantial part of the longevity supplement market is thus operating with claims that would not survive enforcement scrutiny.

B. Unfair Commercial Practices and the Greenwashing Template

The second layer is the general prohibition of misleading commercial practices under the Unfair Commercial Practices Directive (UCPD).[10] Here the EU has recently built an entire enforcement architecture against greenwashing that repays close study by anyone advising on health claims. The Empowering Consumers for the Green Transition Directive amends the UCPD to prohibit generic environmental claims – “eco-friendly,” “climate-neutral” – unless the trader can demonstrate recognised excellent environmental performance, and it adds a series of specific greenwashing practices to the UCPD’s blacklist. Its provisions apply across the Union from 27 September 2026.[11]

The Directive should be read as a template. If “climate-neutral” now requires substantiation, it is a very short doctrinal step for regulators and courts to demand the same of “clinically proven to slow biological aging.” The methodology of anti-greenwashing enforcement – generic claim, absence of substantiation, misleading omission – maps directly onto longevity claims. The UCPD’s general clauses on misleading actions and omissions already provide the legal basis; what the green-claims reform supplies is a worked example of how those clauses can be operationalised against vague virtue-signalling.

C. Investor-Facing Washing

The third dimension is of particular relevance to transactional lawyers. Start-ups increasingly brand themselves as “longevity biotech” because that is where the capital is, even when the underlying asset is a conventional dermatology product or a wellness application. For investors, this creates due-diligence risk: is the “longevity platform” in fact a regulated medicinal pipeline, with all the timeline and cost that implies, or a supplement business one enforcement letter away from relabelling? Misclassification discovered after investment is a valuation event. For the company, aggressive longevity framing in fundraising materials can generate liability under securities and misrepresentation rules in multiple jurisdictions. In due diligence on a longevity start-up, the regulatory classification memorandum is not an annex to the deal; it is the deal.

IV. Artificial Intelligence in Longevity Research and Diagnostics

The longevity field is arguably the most AI-dependent sector in the life sciences, for a simple reason: aging is not one target but thousands of interacting biological processes. A geroprotective drug cannot be designed the way an antibiotic is designed. The entire aging phenotype must be modelled, and that means machine learning on large multi-omic datasets. AI is not an add-on in longevity; it is the core methodology. That raises three distinct regulatory questions under EU law.

A. The AI Act

Regulation (EU) 2024/1689, the AI Act, is the most comprehensive horizontal AI regulation in force anywhere and applies to almost every AI system used in the longevity value chain.[12] It adopts a risk-based structure – prohibited practices, high-risk systems, transparency obligations, and minimal-risk systems – and the critical category for this sector is high-risk. An AI system that is itself a medical device, or a safety component of one, under the MDR or the In Vitro Diagnostic Regulation, and that is subject to third-party conformity assessment under those instruments, is high-risk under Article 6(1) and Annex I of the AI Act.[13] This captures, for example, an AI tool that estimates a patient’s “biological age” from a blood panel and uses that estimate to guide a clinical intervention; an AI-driven diagnostic that predicts age-related disease risk; and the software layer of many longevity-clinic platforms once it makes a diagnostic or prognostic claim.

High-risk status is not a prohibition; it is a compliance regime. It requires a risk-management system, data governance with representative and bias-tested training data, technical documentation, logging, human oversight, transparency to deployers, accuracy, robustness and cybersecurity, a conformity assessment, and post-market monitoring.[14] For most longevity start-ups this is a wholly new compliance layer on top of MDR conformity assessment, and the two must be coordinated.

The timeline has recently changed, and practitioners should update their advice accordingly. The original AI Act applied the high-risk obligations from 2 August 2026 for stand-alone systems listed in Annex III and from 2 August 2027 for AI embedded in products covered by Annex I, including medical devices. The Digital Omnibus on AI, adopted as Regulation (EU) 2026/1744 and in force since 27 July 2026, defers those dates to 2 December 2027 and 2 August 2028 respectively.[15] The deferral does not lighten the substantive regime; the prohibitions in Article 5, the obligations of providers of general-purpose AI models, and the transparency obligations of Article 50 (which apply from 2 August 2026) are unaffected. For longevity companies whose AI is a medical device, the practical effect is a compliance window of roughly two years, during which harmonised standards and notified-body capacity are expected to mature. The window is an opportunity to design AI Act compliance into the MDR technical file from the outset rather than to defer the exercise.

B. AI in Drug Discovery and the European Medicines Agency

The position for drug discovery is more nuanced. An AI model used purely internally to identify candidate molecules – the classic “AI for drug discovery” use case that dominates longevity-biotech pitch decks – is generally not, in itself, a high-risk AI system under the AI Act, because it does not make or materially influence decisions about individual patients. The regulatory question shifts instead to the European Medicines Agency. The EMA’s Reflection Paper on the use of AI in the medicinal product lifecycle sets out the Agency’s expectations from discovery through pharmacovigilance.[16] Its core message is that the burden of proof rests on the sponsor to demonstrate that the AI model is fit for its regulatory purpose. That entails documented data provenance, model validation, a degree of explainability appropriate to the stage of development, and lifecycle management of the model itself.

If a longevity company tells its investors that “our AI discovered this molecule,” the regulator will eventually ask to see the model, the training data, and the validation. Vague AI claims in fundraising materials do not survive regulatory scrutiny and, increasingly, do not survive investor due diligence either.

C. Data: The GDPR and the European Health Data Space

The third question concerns data, and it is here that longevity becomes uniquely difficult. Aging research is inherently longitudinal and multi-omic: genomic, epigenetic, and proteomic data, wearable data, and medical records, ideally across decades. Under the General Data Protection Regulation this is special-category data – health, genetic, and biometric data – and the available lawful bases are narrow.[17] The scientific-research provisions of Article 9(2)(j) and Article 89 assist, but they are implemented differently in each Member State, which produces real fragmentation for pan-European longevity cohorts.

The European Health Data Space Regulation adds a second layer.[18] It creates, for the first time, a mandatory EU-wide framework for the secondary use of electronic health data, administered by health-data-access bodies in each Member State. For longevity research the EHDS is potentially transformative, because it opens access to population-scale health data for research purposes. It also imposes strict conditions: purpose limitation, processing only within secure processing environments, a prohibition on re-identification, and specific prohibitions on using the data for advertising or marketing, for decisions detrimental to individuals such as insurance or employment decisions, or for developing products harmful to health.[19] The secondary-use chapter applies from March 2029 for most data categories, but the lead time is short in the context of longitudinal cohorts. Longevity companies that intend to monetise health data – and many do – should be mapping their data flows against the EHDS regime now.

V. Sector-by-Sector Regulatory Hot Spots

Four sectoral silos together make up the longevity industry, and the same start-up frequently straddles two or three of them without realising it. In each silo, specific “hot spots” – advertising, manufacturing standards, registration, and market withdrawal – recur in practice.

A. Pharmaceuticals

True longevity drugs – rapamycin analogues, senolytics, geroprotectors – sit squarely within Directive 2001/83/EC and its implementing rules, and will continue to do so under the new pharmaceutical package once it applies. Three practical hot spots stand out. First, off-label prescribing of rapamycin and metformin for longevity indications is widespread in private clinics across Europe. Off-label prescribing as such is a matter of clinical freedom, but off-label promotion by or on behalf of the marketing-authorisation holder is prohibited: advertising must conform to the summary of product characteristics, and advertising of unauthorised products or indications is not permitted.[20] Longevity clinics are increasingly the vehicle through which promotional messaging reaches patients, and enforcement authorities have begun to take notice. Second, good manufacturing practice: anything presented as a medicine must be manufactured under an EU manufacturing authorisation and EU GMP, with qualified persons and full traceability; compounding pharmacies producing “longevity peptides” have become a significant enforcement target. Third, unlicensed importation: a large part of the longevity-peptide market operates through personal importation and grey channels, and customs enforcement across the EU has visibly tightened.

B. Medical Devices

The MDR has fundamentally reshaped this space. Aesthetic devices – dermal fillers, energy-based devices used in longevity clinics, at-home devices marketed for “cellular rejuvenation” – are caught by Annex XVI even without a medical purpose. Three hot spots follow. Classification: many longevity wearables and applications become software as a medical device once they make a diagnostic or prognostic claim. Advertising: Article 7 of the MDR prohibits misleading claims and specifically prohibits ascribing to a device functions and properties it does not have, which operates in practice as a codified anti-washing rule for devices.[21] Registration and vigilance: the first four modules of the EUDAMED database – actor registration, UDI/device registration, notified bodies and certificates, and market surveillance – have been mandatory since 28 May 2026, with legacy devices to be registered by 28 November 2026; the vigilance module is not yet mandatory, so serious incidents and field safety corrective actions continue to be reported to national competent authorities.[22] Market withdrawals happen: a device sold as a “cellular biomarker analyser” without valid clinical evidence can be removed from the market by any national competent authority, and the MDR’s market-surveillance coordination means that one withdrawal can cascade across the Union.

C. Cosmetics and Aesthetic Products

The Cosmetics Regulation governs anti-aging creams, serums, and topical actives. Two hot spots dominate. The first is the Product Information File: the responsible person must hold a complete file including a safety assessment and substantiation of every claim. The second is the Claims Regulation, Commission Regulation (EU) No 655/2013, with its six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making.[23] A claim such as “reverses skin aging at the cellular level” fails the evidential-support criterion unless a robust dossier stands behind it. Enforcement is largely national, but the Cosmetic Products Notification Portal is EU-wide, and non-compliant products are routinely notified through the Safety Gate rapid-alert system.

D. Food Supplements and Novel Foods

It is in the food and supplement space that the longevity industry is most creative and most exposed. Directive 2002/46/EC governs vitamins and minerals in supplements; everything else falls under the general food law of Regulation (EC) No 178/2002[24] and, critically, the Novel Food Regulation. Nicotinamide mononucleotide (NMN), one of the most heavily marketed longevity molecules, is the paradigmatic case. NMN is treated as a novel food in the EU, which means it cannot lawfully be placed on the market as a supplement without pre-market authorisation by the Commission following an EFSA safety assessment. Nicotinamide riboside received such an authorisation in 2020.[25] NMN has not – although the picture is now moving. In March 2026 EFSA’s NDA Panel adopted a positive opinion on the safety of β-NMN in food supplements at up to 300 mg per day for adults, and the opinion was published in May 2026.[26] An EFSA opinion is a scientific assessment, not an authorisation; the Commission must still adopt an implementing act adding NMN to the Union list, and where the applicant has requested data protection the authorisation will initially be proprietary to that applicant’s specification. Until that act is adopted, NMN products on the shelves of European longevity clinics remain unauthorised novel foods. That is not a grey area; it is a non-compliant market operating in plain sight, and it is the kind of enforcement pipeline that eventually produces high-profile withdrawal actions. Once the Health Claims Regulation is added to the picture, the conclusion is unavoidable: the food and supplement leg of the longevity industry is the most legally exposed part of the entire sector.

VI. Conclusions

The longevity industry is a genuine scientific and commercial phenomenon, and much of the underlying research is serious. But lawyers advising companies, investors, clinicians, and, increasingly, regulators in this space must see it clearly: “longevity” is not a legal category. It is a marketing frame layered on top of four very different regulatory regimes. Three practical conclusions follow for anyone whose product touches European consumers.

First, always begin with classification. The word “longevity” conveys nothing about the applicable regime. Ask what the product is, how it is presented, and what it does, and let the regulatory regime follow from those answers.

Second, treat longevity claims the way green claims are now treated. The direction of enforcement is unmistakable. The Empowering Consumers for the Green Transition Directive, applicable from 27 September 2026, gives regulators a sharpened toolkit that will, sooner or later, be pointed at health and wellness claims. Substantiation is no longer optional.

Third, integrate AI Act compliance with sectoral compliance from the outset. For any longevity venture using AI in diagnostics or patient-facing decision support, the AI Act, the MDR, and the GDPR, soon joined by the European Health Data Space, form a single interlocking compliance architecture. The deferral of the AI Act’s high-risk obligations to 2027 and 2028 is a design window, not a reprieve. Retrofitting is expensive; designing for compliance is not.

The longevity industry will keep growing, and regulators will keep catching up. The lawyers who understand both the science and the sectoral map will be the ones clients call first.

[1] Longevity economy estimates vary widely by definition; see, e.g., the periodic longevity-market reports of Bank of America Global Research and McKinsey Health Institute. The figure is offered here as an order of magnitude, not a precise valuation.

[2] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, art. 1(2), 2001 O.J. (L 311) 67 [hereinafter Directive 2001/83]. At the time of writing, the new EU pharmaceutical package (a new directive on the Union code for medicinal products for human use and a new regulation on Union authorisation procedures) has been politically agreed and is in the final stage of formal adoption; the substantive rules discussed here are carried over into the new framework, which will apply after a transitional period of approximately two years from entry into force.

[3] See Nir Barzilai et al., Metformin as a Tool to Target Aging, 23 Cell Metabolism 1060 (2016) (describing the design of the Targeting Aging with Metformin (TAME) trial around a composite of age-related diseases).

[4] Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the Approximation of the Laws of the Member States Relating to Food Supplements, 2002 O.J. (L 183) 51.

[5] Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on Novel Foods, 2015 O.J. (L 327) 1 [hereinafter Novel Food Regulation].

[6] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products, 2009 O.J. (L 342) 59 [hereinafter Cosmetics Regulation].

[7] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, Annex XVI, 2017 O.J. (L 117) 1 [hereinafter MDR]; Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 Laying Down Common Specifications for the Groups of Products Without an Intended Medical Purpose Listed in Annex XVI, 2022 O.J. (L 311) 60.

[8] Case 227/82, Van Bennekom, ECLI:EU:C:1983:354 (establishing that a product is a medicinal product “by presentation” where it is described or recommended as having therapeutic or prophylactic properties, irrespective of its actual efficacy); Case C-319/05, Comm’n v. Germany, ECLI:EU:C:2007:678 (garlic capsules); Case C-140/07, Hecht-Pharma GmbH v. Staatliches Gewerbeaufsichtsamt Luneburg, ECLI:EU:C:2009:5 (classification “by function” requires a case-by-case assessment of pharmacological, immunological or metabolic properties). See also Directive 2001/83, supra note 2, art. 2(2) (in cases of doubt, the medicinal-products regime prevails).

[9] Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims Made on Foods, arts. 10, 13, 14, 2006 O.J. (L 404) 9 [hereinafter Health Claims Regulation]. The EU Register of nutrition and health claims is maintained by the European Commission.

[10] Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 Concerning Unfair Business-to-Consumer Commercial Practices in the Internal Market, 2005 O.J. (L 149) 22 [hereinafter UCPD].

[11] Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 Amending Directives 2005/29/EC and 2011/83/EU as Regards Empowering Consumers for the Green Transition, OJ L, 2024/825, 6.3.2024 [hereinafter ECGT Directive]. Member States were required to transpose the Directive by 27 March 2026; its provisions apply from 27 September 2026. The separate Green Claims Directive proposal, which would have introduced ex ante verification of explicit environmental claims, was withdrawn by the Commission in 2025 and is not discussed here.

[12] Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 Laying Down Harmonised Rules on Artificial Intelligence, OJ L, 2024/1689, 12.7.2024 [hereinafter AI Act].

[13] AI Act, supra note 12, art. 6(1) & Annex I, § A (listing the MDR and Regulation (EU) 2017/746 on in vitro diagnostic medical devices). The Annex I route applies where the AI system is a product, or a safety component of a product, that is itself subject to third-party conformity assessment under the listed Union harmonisation legislation.

[14] AI Act, supra note 12, arts. 9–15, 17, 43, 72.

[15] Regulation (EU) 2026/1744 of the European Parliament and of the Council Amending Regulation (EU) 2024/1689 as Regards the Simplification of Certain Obligations (“Digital Omnibus on AI”), OJ L, 2026/1744, 24.7.2026 (in force 27 July 2026). The Regulation defers the high-risk obligations for stand-alone (Annex III) systems to 2 December 2027 and for AI embedded in products covered by Annex I, including medical devices, to 2 August 2028; the Article 50 transparency obligations continue to apply from 2 August 2026.

[16] Eur. Medicines Agency, Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle, EMA/CHMP/CVMP/83833/2023 (adopted Sept. 2024).

[17] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data, arts. 9(2)(j), 89, 2016 O.J. (L 119) 1 [hereinafter GDPR].

[18] Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space, OJ L, 2025/327, 5.3.2025 [hereinafter EHDS Regulation]. The Regulation entered into force on 26 March 2025 and applies in stages: most provisions from 26 March 2027, and the core secondary-use chapter from 26 March 2029 (2031 for certain data categories). See id. art. 105.

[19] EHDS Regulation, supra note 18, arts. 50–54 (secure processing environments; permitted and prohibited purposes of secondary use).

[20] Directive 2001/83, supra note 2, art. 87(2) (all parts of advertising must comply with the particulars listed in the summary of product characteristics), arts. 40–53 (manufacturing authorisation and good manufacturing practice) and art. 87(1) (prohibition of advertising of medicinal products without a marketing authorisation).

[21] MDR, supra note 7, art. 7.

[22] Commission Decision (EU) 2025/2371 of 26 November 2025 (declaring the first four EUDAMED modules functional), OJ L, 2025/2371, 27.11.2025; Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024, OJ L, 2024/1860, 9.7.2024 (gradual roll-out of EUDAMED). The four modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) are mandatory from 28 May 2026; legacy devices remaining on the market must be registered by 28 November 2026. The vigilance and clinical-investigation modules are not yet mandatory, and serious incidents continue to be reported to national competent authorities.

[23] Cosmetics Regulation, supra note 6, arts. 11, 13, 20; Commission Regulation (EU) No 655/2013 of 10 July 2013 Laying Down Common Criteria for the Justification of Claims Used in Relation to Cosmetic Products, Annex, 2013 O.J. (L 190) 31.

[24] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 Laying Down the General Principles and Requirements of Food Law, 2002 O.J. (L 31) 1.

[25] Commission Implementing Regulation (EU) 2020/16 of 10 January 2020 Authorising the Placing on the Market of Nicotinamide Riboside Chloride as a Novel Food, 2020 O.J. (L 7) 6.

[26] EFSA Panel on Nutrition, Novel Foods and Food Allergens, Safety of Beta-Nicotinamide Mononucleotide (β-NMN) Pursuant to Regulation (EU) 2015/2283 and the Bioavailability of Nicotinamide from This Source in the Context of Directive 2002/46/EC, 24 EFSA J. e10007 (2026) (opinion adopted 4 March 2026, published 11 May 2026). Authorisation requires a Commission implementing act amending the Union list established by Commission Implementing Regulation (EU) 2017/2470; at the time of writing no such act has been published, and any authorisation granted on the basis of proprietary data will initially benefit only the applicant. See Novel Food Regulation, supra note 5, arts. 12, 26.

Artykuł Longevity Washing, AI and the Regulatory Fault Lines of the Longevity Industry: A European Perspective pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.