Life Science Law Update – Key developments for pharma & device companies in EU and EU Big Five August 2023

• Life sciences regulatory: Both on an European as well as on a country level, initiatives are brought on their way to combat supply shortages. Also, the EMA is discussing key concepts for single-arm clinical trials. On a country level, we highlight relevant developments particularly for medicinal products.

• Corporate: The EU Commission has now presented a proposal for a directive to further expand and upgrade the use of digital tools and processes in company law; on a country level, Italy introduces updated rules on cross-border transactions and also other countries reveal developments for corporate (social responsibility) matters.

• Anti-corruption: The European Parliament adopted its position on the EU anti-money laundering package covering three directive proposals; on a country level, inter alia, for France, first reports on the new French anti-benefits regulation have been published and, for Germany, there have been some interesting developments on an industry code level.

• Competition and antitrust: We highlight inter alia that the European Commission has revised its safe harbor for R&D and specialization agreements, and has also adopted new guidelines for horizontal agreements.

• Data protection: The European Data Protection Board (EDPB) published three guidelines providing guidance on the data subjects’ right of access, identifying a controller or processor’s lead supervisory authority and data breach notification; further, we highlight three important judgements on key areas of data protection law compliance of the European Court of Justice (ECJ).

Life Sciences Regulatory

European Union

• EU: Pharmaceuticals: EMA and Heads of Medicines Agencies published Guidance “Good practices for industry for the prevention of human medicinal product shortages” to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. The guidance document provides ten recommendations for marketing authorisation holders, wholesalers, distributors and manufacturers to minimize the occurrence of medicine shortages and their impact, such as early notification of competent national authorities on potential or actual shortage (recommendation 1), developing of a shortage prevention plan (recommendation 4) and a shortage management plan (recommendation 5).
• EMA published its annual report 2022 which provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).
• EMA opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU).  Stakeholders are invited to send their comments via an online form by midnight (CET) on 30 September 2023.

Authors: Joerg Schickert, Daniela Troeppner, Sarah Zucht.

EU: Medical Devices

• Official Journal of the European Union published the Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council  on 21 June 2023. The transitional provisions included in the Regulation (EU) 2022/2346 are extended by 18 or 30 months. For products that were covered by MDD Certificates of Conformity the transitional period and the conditions are closely aligned with the Regulation (EU) 2017/745 as amended by Regulation (EU) 2023/607.

• European Commission published an Overview of Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 which is intended to facilitate the application of Regulation (EU) 2023/607 as regards to the transitional provisions for certain medical devices and in vitro diagnostic medical devices. It provides clarifications regarding the scope of the extension of the MDR transitional period, explanations for manufacturers on how to demonstrate that its legacy device is to benefit from the transitional period and other relevant information for medical device manufacturers relying on the transitional periods for their medical devices / in vitro diagnostics.

• MDCG published an update of its Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD on 12 May 2023 to align the guidance document to Regulation (EU) 2023/607 and provide clarification on the concept of ‘significant changes in the design and intended purpose’ under Article 120 (3c), point (b) MDR (last amended by Regulation (EU) 2023/607) which concerns manufacturers of legacy devices.

Authors: Joerg Schickert, Daniela Troeppner, Sarah Zucht.

France

• Supply Shortages in France: Given the current tenses in supplying medicinal products and medical devices in France, measures have been adopted in France to strengthen the regulations applicable to the supply of medical devices by a law dated 9 March 2023. A wide plan in order to fight against supply shortages of medicinal products has also been launched, and a list of essential medicinal products has been published on 13 June 2023. Following this publication, the government may adopt further measures, some of them aiming at relocating the manufacturing of these essential medicinal products.

• New regulation on influencers: A new law has been adopted on 9 June 2023 to reinforce rules applicable to influencers on social networks, following recent abuses, notably in relation to health care products and services. This law notably provides for a general prohibition to promote health care products and services on social networks, save for limited exceptions, which can be subject to the authorization of the French National Agency for Health Products’ and Medicines’ Safety (ANSM), under certain conditions.

Authors : Mikael Salmela, Josephine Pour.

Germany

• Combat of supply shortages regarding off-patent medicinal products and pediatric medicinal products: German Government passed draft act to combat of supply shortages of off-patent medicinal products and to improve the supply of pediatric medicinal products on 5 April 2023. The draft act inter alia foresees to relax pricing rules for pediatric medicinal products, simplify exchange rules for pharmacies, introduce the requirement to stock rebated medicinal products for three months, and improve supply through hospital pharmacies.

• Constitutional complaint filed by two major pharmaceutical companies with the Federal Constitutional Court in Karlsruhe against the Statutory Health Insurance Financial Stabilization Act (GKV-FinStG): The GKV-FinStG, which came into force in November 2022, inter alia introduced “drastic new measures” to limit costs in the health care system, also reforming the AMNOG system. The GKV-FinStG is criticized to put a disproportionate financial burden on the innovative pharma industry, even though the industry is not a cost driver in the first place.

• German implant registry, which is based on the German Act on Implant Registry (Implantateregistergesetz), is now fully functional: Some health care organizations already submitted first data to the registry; in the course of 2023 all other health care organizations are to be connected with the registry. Mandatory operation starts in January 2024 (further information here).

Authors : Joerg Schickert, Daniela Troeppner, Sarah Zucht.

Italy

• Developments on the Payback Mechanism for Companies Supplying Medical Devices: The Italian Government has implemented the payback mechanism for medical devices, originally introduced with Law Decree no. 78/2015, which requires companies supplying medical devices to pay back to Regions a percentage of their exceeding of the spending cap for the purchase of medical devices for the years 2015 to 2018. The original payment deadline, set in mid-January 2023, has been postponed several times and is now set for 31 July 2023. Also considering the relevant number of judicial appeals, the Italian Government – with Law Decree no. 34/2023 and Law Decree no. 51/2023 – has provided that in case of waiver of any judicial initiative regarding payback obligations for the years 2015 to 2018 (within the payment deadline), companies could benefit from a 52% discount from the original payback amount.

Authors: Christian di Mauro, Giuseppe Aminzade, Chiara Perolari.

Spain

• Update of framework on advertising of medicinal products: The Ministry of Health takes steps to update the regulatory framework applicable to the advertising of medicinal products which would inter alia bring a comprehensive update of the regulation on advertising of medicinal products towards the public and towards HCPs. Further, also the prior control by the health authorities in the advertising of medicinal products to the public shall be removed.

• New Spanish MDR: The new Spanish MDR aims to bring domestic regulations on medical devices in line with EU MDR and to develop those aspects that the EU MDR leaves to regulation at the national level, including rules on permitting, medical devices manufactured and used in a health center (known as ‘in house’).

• Update of framework on advertising of medical devices: Further, the Ministry of Health takes steps to also update the regulatory framework applicable to the advertising of medical devices. Apart from the references on medical device claims in the EU MDR and EU IVDR, this initiative aims to adapt, update and regulate in greater detail the legal framework applicable to the advertising of medical devices.

Authors: Inmaculada Lorenzo, Álvaro Abad.

UK

• Postponed updates on UK medical device legislation: The United Kingdom medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that the upcoming changes to UK medical device legislation will be pushed back from 1 July 2023 to 1 July 2024. The updated Medical Device Regulations 2002 (“UK MDR”) will be aligned with most of the key elements of the Regulation (EU) 2017/745 on medical devices (“EU MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“EU IVDR”). There will be transitional arrangements for existing CE/UKCA devices, until 30 June 2027 (medical devices) and 30 June 2029 (IVDS). The MHRA is still drafting the new legislation based on the Government’s consultation response published earlier this year and has indicated that the new legislation will now be published in Spring 2023. The delay will provide industry with more time to transition existing products to the new UK regime and for more Approved Bodies (the UK equivalent of EU Notified Bodies) to become approved to ease current capacity constraints.

Authors: Jane Summerfield, Bonella Ramsay, Alexandra Wood.

Corporate Governance & Corporate Social Responsibility

European Union

Following the Digitalisation Directive in 2019, the EU Commission has now presented a proposal for a directive to further expand and upgrade the use of digital tools and processes in company law (COM(2023) 177).

Authors: Lutz Angerer, Thomas Weber.

Germany

• An amendment to the German Anti-Money Laundering Act requires non-German entities holding real property in Germany or a certain participation (in a threshold relevant from the German Real Estate Transfer Tax perspective, simplified at least 90%) in companies holding real property in Germany to file their beneficial owners to the German transparency register. The filing had to occur no later than by 30 June 2023. If not already done, it should now be carefully checked whether filing obligations for non-German entities within the group might exist and, if so, to remedy the breach as soon as possible.

Authors: Lutz Angerer, Thomas Weber.

Italy

• With Legislative Decree no. 19/2023 the Italian legislator implemented the European Directive no. 2019/2121, providing for an organic and comprehensive regulation of cross-border extraordinary transactions, which entails also significant amendments to the procedure applicable to cross-border mergers. Also, specific provisions applying to (i) cross-border demergers and (ii) demerger by spin-off (scissione mediante scorporo) have been introduced to Italian law for the first time. The new provisions shall apply to cross-border extraordinary transactions whose plans will be published starting as of 3 July 2023.

Authors: Francesco Stella, Martina Di Nicola, Marina Massaro, Annalisa Ciaccio.

Spain

• On 13 March 2023, Law 2/2023 regulating the protection of people who report regulatory violations and the fight against corruption and transposing the EU Whistleblowing Directive came into force. Companies with more than 50 employees will have to implement an internal information system to facilitate the reporting of violations of any nature, as well as to ensure the protection of those using it.
• Art. 13 of Law 3,  by Royal Decree-Law 20/2022, of December 27, has been amended again. The extraordinary regime issued during the pandemic for the cause of dissolution due to severe losses (the so-called "moratorium") has been extended for two more years.

Authors: Alex Dolmans, Eduardo Pérez.

UK

• The UK Government has tabled some significant amendments to the Economic Crime and Corporate Transparency Bill (which serves to implement its plans to reform Companies House and to increase the transparency of UK corporate entities). These amendments include a new corporate offence of failure to prevent fraud (see for details factsheet) and a reform for the common law ‘identification’ doctrine to allow for the attribution of criminal liability to corporates where senior managers commit certain economic crime offences (see for details factsheet).

• On 24 May 2023, the Government published a Call for evidence: Non-financial reporting review, seeking views on the non-financial information which UK companies are required to include in their annual reports.  Responses to the call for evidence are requested by 16 August 2023.

• On 31 January 2023, the Government published Consultation: Strengthening the Reporting on Payment Practices and Performance Regulations 2017 which seeks views on its proposals to extend and improve the Reporting on Payment Practices and Performance Regulations 2017 (the “Regulations”), which are due to expire on 6 April 2024. The Regulations came into force in April 2017 and introduced a requirement for in-scope companies and LLPs to publicly report twice a year on their payment practices on a Government web service.

Authors: Tom Brassington, Danette Antao.

Anti-Bribery and Anti-Corruption

European Union

• Proposal of a new directive on combating corruption: On 3 May 2023 the European Commission’s proposed a new Directive (COM(2023) 234 final) in the area of criminal law in order to harmonize corruption offenses, sanctions, prevention and enforcement measures. Inter alia, the proposal provides for minimum standards to harmonize definitions and sanctions for active and passive bribery both in the private and public sectors, as well as of related offenses. Further, the proposal also aims to establish a dedicated Common Foreign and Security Policy (CFSP) sanctions regime to target serious acts of corruption worldwide.

• European Parliament adopts its position on the EU anti-money laundering package: The package includes a proposal for Regulation that establishes a new Authority for Anti-Money Laundering (COM(2021) 421 final), a Directive that leads to a revision of the existing anti-money laundering Directive (COM(2021) 423 final), and a new Regulation consisting of directly applicable rules for financial institutions and other so-called “obliged entities” (COM(2021) 420 final).

Authors: Joerg Schickert, Daniela Troeppner, Sarah Zucht.

France

• Publication of the first reports on the implementation of the new French anti-benefits regulation: The French anti-benefits regulation requires that every two years, the national boards of health care professionals' and the French Health Regional Agencies (together the “Competent Authorities”), in charge of controlling the submissions of benefits to a list of stakeholders, must publish a report assessing the implementation of the anti-benefits regulation. The Competent Authorities have therefore released their first report in March 2023. These reports provide for useful information on current market practices since the entry into force of the new anti-benefits regulation. It also enables to understand the position of the authorities on these market practices.

Authors : Mikael Salmela, Josephine Pour.

Germany

• Agreement reached on the Whistleblower Protection Act: Upon actions against Germany before the European Court of Justice to not implement the Whistleblowing Directive (EU) 2019/1937 within the envisaged timeframe and the corresponding German implementing Act (Hinweisgeberschutzgesetz) initially failed within the legislative process, now this German implementing Act was finally adopted.

• The FSA (the major German pharma industry association) decided in two cases on the appropriateness of event locations: One event location closely related to a well-known regional folk festival; the other event location related to a vaccination destination. In both cases, the FSA ruled that the event location was not solely for objective reasons, but also related to the attractiveness of this location.

• BVMed – Update limit hospitality: With effect as of 1 May 2023, the BVMed-Healthcare Compliance Committee also updated the upper limit for appropriate hospitality with regard to business meals and events from EUR 60 to EUR 75. The limit is now the same as set by the FSA Guidelines.

• German Parliament proposed reform on the German Lobby Register Act (LobbyRG): With the planned amendments, the German Government wants to tighten up the scope of application and the disclosure obligations in the Lobby Register Act.

Authors: Joerg Schickert, Daniela Troeppner, Sarah Zucht.

Italy

• Italy implements EU Whistleblowing Directive by Legislative Decree no. 24/2023: The new provisions will come into effect on 15 July 2023 for large companies. Businesses with up to 249 employees will be required to comply with the new obligations and implement their internal reporting channel starting from 17 December 2023. The Italian Anti-Corruption Authority will oversee compliance and may impose fines from €10.000 to Euro 50.000 for violations of the legislation.

Authors: Francesca Rolla, Alessandro Borrello

Competition and Antitrust

European Union:

• Revision of EU safe harbour for R&D and specialisation agreements: The European Commission has revised its safe harbour for R&D and specialisation agreements, and has also adopted new guidelines for horizontal agreements. <="mailto:Author"> The Commission’s new guidelines set out a number of new clarifications and guidance, for example on joint purchasing arrangements and information exchange. Some of the changes include a clearer definition of the types of R&D arrangements that can benefit from the safe harbour, although the 25% market share threshold that was in the previous block exemption remains in place.

• Eventual update planned on enforcement related to antitrust investigations: The European Commission is currently evaluating its key legislation regarding its enforcement powers in antitrust investigations, Regulation 1/2003, which sets out amongst others, dawn raid and information request powers. As part of this, the European Commissioner for Competition, Margrethe Vestager, has voiced support for further transparency on antitrust proceedings.

Authors: Falk Schöning, May Lyn Yuen.

Data Privacy

European Union:

• New guidelines of the European Data Protection Board: In April 2023, the European Data Protection Board (EDPB) published three final guidelines after public consultation, which provide more precise guidance on the data subjects’ right of access, identifying a controller or processor’s lead supervisory authority and data breach notification. Among other aspects, in its guidelines on data breach notification the EDPB clarified that the mere presence of a representative in a Member State of a controller who is not established within the EEA does not trigger the one-stop-shop system, and that for this reason the breach will need to be notified to every supervisory authority for which affected data subjects reside in their Member State.

• Important decisions of the ECJ related to data protection: On 4 May 2023, the European Court of Justice (ECJ) issued three important judgements on key areas of data protection law compliance. In the decisions the ECJ specified the scope the of the right to receive a copy pursuant to Art. 15(3) GDPR (C-487/21), ruled that a failure to comply with the obligation to maintain records of processing activities pursuant to Art. 30 GDPR and conclude a joint controller agreement pursuant to Art. 26 GDPR does not render the corresponding processing of personal data unlawful (C‑60/22), and specified the requirements for the right to compensation pursuant to Art. 82(1) GDPR (C–300/21), particularly clarifying that an infringement of the provisions of the GDPR is not sufficient to confer a right to compensation by itself, however at the same time ruling that Art. 82(1) GDPR must be interpreted as precluding a national rule or practice which makes compensation for non-material damage, subject to the condition that the damage suffered by the data subject has reached a certain degree of seriousness.

Editors

Joerg Schickert (Life Science & Compliance), Daniela Troeppner (Life Science & Compliance), Sarah Zucht (Life Science & Compliance), Thomas Weber (Corporate), Falk Schoening (Competition), Stefan Schuppert (Privacy).

Authors:

Lutz Angerer, Tom Brassington, Danette Antao, Alex Dolmans, Eduardo Pérez, Francesco Stella, Francesca Rolla, Alessandro Borrello, Martina Di Nicola, Marina Massaro, Annalisa Ciaccio, May Lyn Yuen, Mikael Samela, Josephine Pour, Immaculada Lorenzo, Álvaro Abad, Christian Di Mauro, Giuseppe Aminzade, Chiara Perolari, Jane Summerfield, Bonella Ramsay, Alexandra Wood, Theresa Mengler, and Ewgeni Polozov.