Life Science Law Update – Key developments for pharma & device companies in EU – Technologist

Life Sciences Regulatory

European Union

Pharma:

• European Commission adopts Recommendation to combat counterfeiting: Counterfeit products, especially pharmaceuticals, are on the rise in the EU, posing health risks. On 19 March, 2024, the EC adopted  recommendation on this topic: They include actions like establishing a single point of contact for IP enforcement, enhancing market surveillance, utilizing AI, and improving consumer education to identify and avoid counterfeit goods. The Recommendations are addressed to the EU Members States and encourage them to take implement the respective actions.

• European Commission’s communication outlines plans for biotech and biomanufacturing: Released on 20 March, 2024, it proposes targeted actions to enhance these sectors in the EU, citing their importance in addressing current challenges like human health. Proposed measures include legislative analysis for a potential EU Biotech Act (what would that entail), support for investments, AI adoption promotion, and enhanced international collaboration.

• European Parliament adopts updated Product Liability Directive: The directive, replacing the the Product Liability Directive 85/374/EEC of 1985 legislation, inter alia, expands the ‘product’ definition to include software and digital manufacturing files. Changes also oblige defendants (e.g. pharma and device companies) to disclose relevant evidence on their products, It further reduces the burden of proof for damages of claimants (e.g. patients). It is set to enter into force this year and will be transposed into national law by 2026.

• European Court of Justice clarifies rules for online sale of medicinal products: In Case C-606/21, on 29 February, 2024, the Court clarified conditions for Member States to prohibit services connecting pharmacists and customers online. It affirmed that such services fall under EU law’s ‘information society service’ concept. As a result, Member States cannot prohibit services of non-pharmacy providers which merely connect sellers and buyers. This may have a profound impact on marketplace companies which may now enter the market by connecting pharmacies and customers, even regarding Rx products.

• European Court of Justice mandates conflict-free consultations for EMA: In Case C-291/22 P, on 14 March, 2024, the Court ruled that the consultations of the Committee for Medicinal Products for Human Use (CHMP) with conflicted experts constitute a significant procedure violation. Such conflicts compromise CHMP’s impartiality and, by extension, EMA’s. This led to the Court annulling a Commission decision rejecting a company’s (Hopveus’) marketing authorization application based on the expert group’s decision.

• European Commission proposes Council Recommendation on vaccine-preventable cancers: Released on 31 January, 2024, as part of Europe’s Beating Cancer Plan, the Recommendation aims to enhance vaccination rates for HPV and HBV. Aligned with WHO targets, it proposes setting concrete vaccination goals, providing accessible and free vaccinations, and implementing monitoring systems. The proposal is now under negotiation in the Council.

• European Commission announces the conclusion of Regulation EU 2020/1043: Published on 6 March, 2024, the Notice confirms that the regulation, addressing clinical trials and supply of gene-modified COVID-19 products, is no longer in effect. Initially the regulation enacted in response to the pandemic, it allowed for clinical trials on GMO-based COVID-19 treatments without prior environmental risk assessments or consent.

• European Commission adopts revisions to streamline medicine authorisation lifecycle: On 11 March, 2024, the Commission approved amendments to Regulation (EC) 1234/2008. The changes aim to expedite variations to marketing authorisations and improve overall lifecycle management of medicines for greater efficiency.

Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach.

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Medical Devices:

• European Commission proposes an extension of transitional periods of the IVDR: Released on 23 January, 2024, the proposal aims to extend transitional periods in Regulation (EU) 2017/746 for certain in vitro diagnostic medical devices (IVDs). This extension, seeks to enhance patient care by ensuring continued availability of these products. Additionally, the proposed Regulation mandates advance notice to competent authorities from manufacturers and other economic operators in case of potential supply interruptions of critical medical devices to the EU market.

• Council approves the Commission’s proposal on earlier launch of EUDAMED and extension of the transitional periods for IVDs: On 21 February 2024, the Council of the EU approved the Commission’s proposals to a) launch EUDAMED sooner; b) extend the transitional periods for certain IVDs; and c) introduce an advance notice obligation for manufacturers of medical devices and other economic operators

• MedTech Europe reacts to the European Parliament’s endorsement of the draft AI Act: Following the Parliament’s endorsement on 13 March, 2024, MedTech Europe issued a press release expressing the Med Tech industry’s views on the agreed text. They urged EU regulators to align the AI Act’s requirements with sector-specific needs for consistency.

• COCIR published a position paper with recommendations on the alignment of the AI Act with the MDR and related concerns.

• The European Commission published the following MDCG guidance documents:

  
  

  • A set of 5 documents endorsed by the Medical Device Coordination Group (MDCG) to support medical device manufacturers fulfill post-market surveillance and vigilance reporting obligations (MDCG 2024-1-1; MDCG 2024-1-2; MDCG 2024-1-3; MDCG 2024-1-4; MDCG 2024-1);

  • An updated overview of language requirements for the information and instructions that accompany a device in a specific EU Member State;

  • A guidance on the content of Clinical Investigation Plan for clinical investigations of medical devices (MDCG 2024-3).

• Harmonized standards under MDR and IVDR: Two European Commission Implementing Decisions, EU 2024/815 and EU 2024/817, were issued to update EU medical device harmonized standards, each pertaining to the MDR and the IVDR respectively.

Authors: Fabien Roy, Anastasia Vernikou.

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Corporate Governance & Corporate Social Responsibility

Adoption of the CSDDD by EU Committees: The proposal for the Corporate Sustainability Due Diligence Directive (CSDDD) was adopted on 15 March 2024 by the Committee of Permanent Representatives in the European Union and on 19 March 2024 by the EU Parliament Legal Affairs Committee with significant changes compared to the draft of the EU Commission (COM(2022)71) presented in February 2022. The final adoption by the plenary of the European Parliament is expected shortly so that the CSDDD will likely be published still this year in the Official Gazette including a two-year transposition period for the Member States.

Authors: Lutz Angerer, Thomas Weber.

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Anti-Bribery and Anti-Corruption

• Strengthening Financial Security: The EU has reached a provisional agreement on tougher anti-money laundering laws to safeguard its internal market from financial crime and terrorism financing. The agreement seeks to harmonize existing regulations and eliminate loopholes exploited by criminals. The future European authority for anti-money laundering will be headquartered in Frankfurt and commence operations in mid-2025.

• Perception of the integrity of the European Union declined: Transparency International released its annual Corruption Perceptions Index ranking 180 countries and territories by their perceived levels of public sector corruption on a scale from 100 (very clean) to 0 (highly corrupt). While Western Europe and the European Union remains the top-scoring region, its regional average score dropped to 65 this year, as checks and balances weaken and political integrity erodes. Despite improvement in some countries, Sub-Saharan Africa maintains the lowest average at 33, with democracy and the rule of law under pressure.

Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach

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Competition and Antitrust

The European Commission published revised notice on market definition: This revision introduces significant changes, offering more detailed explanations on market definition principles and its application in enforcing competition rules. It places greater emphasis on non-price factors like innovation, supply reliability, and product/service quality. It provides clarity on forward-looking market definition, particularly in sectors undergoing structural shifts. The notice outlines criteria for evaluating innovation-driven markets, relevant to life sciences companies. The European Commission stresses that defining relevant markets helps identify competitors influencing commercial decisions and supply conditions. This approach also enables the calculation of market shares, crucial for assessing market power.

New antitrust probes:

• The Spanish competition authority probes potential abuse of dominance in drug and parapharmacy distribution. In February 2024 the Comisión Nacional de los Mercados y la Competencia (CNMC) conducted surprise inspections at pharmaceutical sector premises. These dawn-raids focus on alleged anti-competitive practices, including strategies to attract and retain pharmacy loyalty. CNMC has been scrutinizing the pharmaceutical sector’s business interactions, suspecting companies of sharing sensitive data. Recently, the CNMC initiated an inquiry into the pharmaceutical sales market to pharmacies. This follows an earlier investigation into potential anticompetitive behaviours in the digital pharmaceutical logistics tools supply market, which commenced a few months prior. If the investigation reveals that infringements of the prohibition on anticompetitive conduct have taken place, the involved companies will face fines of up to 10% of their annual turnover.

• Unannounced inspections carried out in the medical biology sector in France. After receiving authorisation from a judge for liberty and custody, the Investigation Services of the Autorité de la concurrence conducted surprise inspections on 14 March at the facilities of companies suspected of engaging in anticompetitive behaviour within the medical biology sector.

Authors: Falk Schöning, May Lyn Yuen.

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Data Privacy

• EU Parliament approved the AI Act: On 13 March 2024, the European Parliament approved the Artificial Intelligence (AI) Act approved. The Act is still subject to a final lawyer-linguist and will enter into force twenty days after its publication in the official Journal, and be fully applicable 24 months after its entry into force. In light of the extensive set of new obligations imposed on companies, and considering the broad extra-territorial scope of the regulation, we have analysed and outlined the requirements under the Act, as businesses in all sectors are required to adequately prepare for the new law (see our Article on Engage here for Part 1 and here for Part 2).

• EDPB Coordinated Enforcement Action 2024: In February 2024, the European Data Protection Board (EDPB) has kicked off its Coordinated Enforcement Framework action for 2024. Throughout the year, 31 Data Protection Authorities across the European Economic Area (EEA) will take part in this initiative on the implementation of the right of access according to Art. 15 GDPR.

• EDPB publishes report of Coordinated Enforcement Action of 2023: The EDPB adopted a report on the findings and recommendations of its second coordinated enforcement action, which focused on the designation and position of Data Protection Officers where 25 authorities across the EEA participated.

Authors: Stefan Schuppert, Theresa Mengler.

Intersection of Pharma, Health and Privacy

• Agreement on EHDS: On 15 March 2024, the European Parliament and the Council negotiators agreed on the creation of a European Health Data Space (EHDS). The EHDS will allow anonymised or pseudonymised health data, including health records, clinical trials, pathogens, health claims and reimbursements, genetic data, public health registry information, wellness data and information on healthcare resources, expenditure and financing, to be shared for public interest purposes. The provisional agreement still needs to be formally adopted by both institutions before it can enter into law.

Authors: Stefan Schuppert, Joerg Schickert, Sarah Zucht, Caroline Schmalenbach, Theresa Mengler.

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