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.

Some hard numbers reveal the paradox: the EU has a highly developed research sector vs. the EU is a region with a challenging commercialization environment compared to other global leaders.

Biotechnology is one of the fastest-growing research and innovation sectors in the world today, and the European Union plays a significant role in this process. Over the past decade, the number of biotechnology researchers in the EU has nearly doubled, from approximately 42,000 in 2012 to over 81,000 in 2021, and the share of employment in this field has reached 17.2% of total R&D employment. These figures confirm that Europe has a strong scientific base and is systematically building capacity in technologies critical to health, industry, and food security.

However, when we look at what happens next – patents, technology scaling, and market penetration – the picture becomes less optimistic. The EU’s share of global biotech patents fell from 22.6% in 2001 to 18.3% in 2020, while the US still accounts for nearly 40% of global patent filings. On a per capita basis, the difference is even more pronounced: in 2020, the US had three times the number of biotech patents per million inhabitants than the EU.

However, it is worth breaking down this general picture into its first factors, because biotechnology is not a single sector, but a collection of very different areas that operate in different market and regulatory conditions.

Red biotechnology:

Red biotechnology, encompassing medical and pharmaceutical applications, is the largest and most capital-intensive segment of the entire sector. It is here that a significant portion of biotechnology patents worldwide are created. Between 2001 and 2020, medical-related technologies, including peptide preparations and antibody-based solutions, accounted for a significant portion of all patent applications in biotechnology.

Europe is scientifically strong in this area. Universities, research institutes, and clinical infrastructure are among the world’s leading. The problem arises at the commercialization stage. Drug development requires enormous financial resources, a long time frame, and a stable, predictable regulatory environment. Meanwhile, in the EU, these processes are often perceived as more complex and dispersed than in the US. As a result, many technologies developed in European laboratories reach the market under the auspices of American companies – through acquisitions, licensing, or transferring further stages of development outside of Europe.

White biotechnology:

White biotechnology, or industrial applications, is the largest category of biotechnology patents worldwide. Technologies such as processes based on microorganisms, enzymes, and biochemical tests collectively account for over one-third of all biotechnology patents filed between 2001 and 2020.

This is an area of particular importance from the perspective of industrial transformation and the green economy. Interestingly, it is in white biotechnology that Europe, alongside Japan and China, demonstrates relatively higher specialization than the United States. Despite this, the EU’s share of the global patent portfolio is not growing. Why? Scaling is again crucial. Industrial technologies require a rapid transition from pilot to large-scale production, which in turn depends on access to capital, infrastructure, and a single market. Regulatory fragmentation and national differences mean that European companies often develop more slowly than their competitors.

Green biotechnology

Green biotechnology, primarily related to agriculture and food security, accounts for the smallest portion of the patent portfolio – the number of applications in this area is relatively low both in the EU and globally. Despite this, the importance of this segment is growing.

Globally, China demonstrates a clear specialization in green biotechnology, while in the EU, only a few countries, such as the Netherlands, have a clear competitive advantage in this area. This demonstrates that the potential exists, but is not being utilized evenly. Mechanisms are lacking to develop these technologies across the EU and make them a real pillar of innovation.

Horizontal biotechnologies

Horizontal biotechnologies, which can be applied across multiple sectors simultaneously, account for a small percentage of patents (around 2%). However, their importance is greater than their scale suggests. These are often technologies that can accelerate innovation in other areas. The example of Great Britain demonstrates that even with a relatively small number of patents, high specialization can be achieved, although in this case we are also talking about a niche, not a mass market.

Analysis of individual areas of biotechnology leads to a common conclusion: regardless of the sector, the European Union is consistently building research and technological potential, but significantly underutilizes it during the growth and commercialization phases. In red biotechnology, barriers include long and costly market development paths; in white biotechnology, barriers include limited ability to rapidly scale industrial processes; in green biotechnology, barriers include low innovation rates and strong differences between Member States; and in horizontal biotechnologies, barriers include small scale despite high technological significance.

As a result, biotechnology in the European Union accounts for a patent portfolio close to the global average, while in other leading regions it accounts for a significantly larger share of total patent activity. At the same time, patent activity in the EU remains highly concentrated geographically in a few Member States, primarily Germany and France. This means that the potential of the single market as a development space is not being fully exploited.

In this context, the Biotech Act addresses the clearly defined gap between potential and utilization. It does this by introducing uniform definitions and procedures, reducing the need to navigate separate national systems. This eliminates the need for projects to undergo separate, uncoordinated administrative processes, and the time required to obtain key approvals is shortened. At the same time, the act facilitates access to financing and regulatory support, especially for SMEs, reducing the risks and costs of market entry. The Biotech Act aims to foster better links between the European research base and the market, strengthen commercialisation capacity and enable companies to develop within the single market rather than seeking more favourable conditions outside Europe.

All data used in this document come from: Grassano, N., Napolitano, L., M’barek, R., Rodriguez Cerezo, E., Lasarte Lopez, J., Exploring the global landscape of biotech innovation: preliminary insights from patent analysis, Joint Research Centre, European Commission , Luxembourg , Publications Office of the European Union, 2024.

Artykuł Biotech Act – why and for what purpose? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Biotechnologia.pl, which is the main polish media in biotechnology sector, recommends KG Legal’s article on its homepage.

Patent has its limitations, which are given in article 69 of the Polish Industrial Property Law. In our article we focused on two of them: research exemption and Bolar exemption, which are provided respectively in article 69 paragraph 1.3 “applying an invention in activities related to research and experiment for the purposes of analysis and teaching” and paragraph 1.4 “exploiting an invention to the extent necessary with a view to perform actions which are legally required to obtain an entry into a register or a licence, being a precondition for admitting certain products into trade given their purpose, in particular medicinal products”.

The article was prepared by our law firm and it discussess patent and patent exemptions, differences between research exemption and Bolar exemption, the relationship between commercialization of research and research exemption, as well as two ways of carrying out research on the basis of the research exemptions.

Artykuł KG Legal’s article is recommended by the main polish biotechnological media pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

See the link to the article in Polish: http://mojafirma.infor.pl/prawo-autorskie/patent/749659,2,Polskie-startupy-w-IT-i-biotechnologii-ochrona-prawna.html

The information was prepared by Kamil Trzaskoś of KG Legal Polish Law Firm. KG Legal provides specialised legal assistance to IT, Life Science as well as investment processes in Poland and organises networking between Polish and international companies and research centres.

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Artykuł Polish start-ups in new technologies and biotechnology and relevant Polish law pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Operation of the Garage LifeScience

In the second part of the programme, dr. Piotr Warchoł (also co-founder of Complexity Garage) introduced operation of the Garage. There are three categories of membership:

– regular

– academic

– commercial

The regular membership will gather mostly people unrelated with univerisites, but related with the DIY culture, that would create Open Space projects. To use the Garage they will have to pay a small fee.

The academic membership is free and is designed for scientific circles, researchers, which, from various reasons will not be able to carry out research at the University and also for students participating in competitions.

The last type of membership – commercial is directed to companies, that do not need or cannot afford laboratory for full-time. So it will be, mostly, microenterprises and start-ups. The fee will be proportional to time spent in Garage.

Cooperation between companies and Garage of LifeScience

There is also a possibility to establish a commercial partnership, that is intended for larger companies and organisations, which would have internships, workshops, trainings or projects, that, from various reasons, do not want to carry out in their laboratories. Financial conditions will depend on individual arrangements.

New and modern Laboratory in Cracow

Space laboratory is taken care by lab tutor, which is responsible also for contact with press. To get to the laboratory you must have an access card. If you are working on a project, you will have to go to reception each time and get an access card. The laboratory is equipped with fume hood, ultrasonic washer, vortex and many other devices. In case of need to use devices, that are not in Garage, there is a possibility to use apparatus of one of Garage’s partners.

How to get, with your project, into Garage?

As soon as Garage starts, there will be a constant recruitment of projects. The application form should contain:

• team of project
• goals of project
• schedule
• budget
• own resources
• needs of the project

Then, after the application, the Advisory Board will decide whether the project gain acceptance or not. After obtaining approval you have to sign regulations and ethical code.

First projects

At the end, dr. Warchoł gave examples of submitted projects to Garage Life Science. Here they are:

• elaboration of fluorescent labeling proctocol (FISH) single avian’s cells (in the scutellum germ of zebra finch) based on gender
• cel cultures and microfluidics
• expression, purifying and activity assays of protease TEV.

Creation of the Garage LifeScience is a chance for inventors and enthusiasts in the field of biotechnology to carry out projects (even those, that are forgotten, since there was not enough money to implement them), in an accessible form and on fair financial terms.

Artykuł Bio Hacker Space in Poland – Development of biotechnology in Krakow pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.