Life Sciences Regulatory
European Union
Pharmaceuticals:
- The EMA’s and HMA’s strategy for AI: On 18 December 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) released a strategic plan for artificial intelligence (AI) until 2028. The strategic plan outlines a united approach to optimize AI advantages for stakeholders and address associated risks in a collaborative manner.
- Feedback on specific adverse reaction follow-up questionnaires: The EMA is requesting feedback on a draft guideline that outlines when and how specific adverse reaction follow-up questionnaires (Specific AR FUQs) should be used in routine pharmacovigilance activities to collect important information that can impact the benefit-risk ratio of medicinal products. The public consultation will run until 9 February 2024.
- First version of Union list of critical medicines published: On 12 December 2023, the European Commission, the HMA and the EMA published the first version of the Union list of critical medicines. The Union list contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU/European Economic Area, for which continuity of supply is a priority and shortages should be avoided.
- EMA publishes comments on ICH Reflection paper on RWE: On 20 December 2023, the EMA published the comments received on the ICH Reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines.
- Regulation governing EMA fees: On 12 December 2023, the European Parliament adopted its first reading position on the proposal for a regulation on fees and charges payable to the EMA. The Council is also expected to formally adopt the Regulation at first reading at an upcoming meeting. The Regulation shall apply from 1 January 2025.
Authors: Fabien Roy, Anastasia Vernikou,
Medical Devices:
- Extension transition periods: On 6 January 2023 the Commission adopted an amendment to extend the transition period based on the risk class of the device under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) to address concerns about the capacity of Notified Bodies and the backlog of medical devices under transition. The amendment gives companies more time to obtain MDR/IVDR compliant certificates and allows existing devices to remain on the market without a mandatory 'sell-off' date.
- DG SANTE launces survey on availability of medical devices on the EU market: The European Commission’s Directorate-General for Health and Food Safety launched a survey related to the availability of medical devices in the EU. The survey facilitates monitoring of the availability of medical devices on the EU market.
- MedTech Europe publishes position paper regarding continuous supply of Class D IVDs: On 14 December 2023, MedTech Europe, the European medical device industry association, published a position paper providing recommendations on how to ensure the continuous supply of Class D in vitro diagnostic medical devices from the transition date of 26 May 2025.
- Open letter by medtech industry associations regarding Eudamed: On 18 December 2023, a set of EU medtech industry associations, including MedTech Europe, issued an open letter to the European Commission, urging the Commission to meet certain requirements prior to the mandatory implementation of any modules of the European medical devices database, Eudamed.
- Designation of new Notified Bodies: The recent designation of 4 new notified bodies under the MDR brings the total number of designated Notified Bodies to 43. The 12th Notified Body under the IVDR (NB 3018 Sertio Oy from Finland) was designated on 31 October 2023.
- New MDCG guidance 2023/6 on demonstration of equivalence for products without an intended medical purpose: On 14 December 2023, the MDCG published new guidance (MDCG 2023-6) concerning the demonstration of equivalence for Annex XVI products, i.e., products without an intended medical purpose, with other Annex XVI products, medical devices and dual purpose medical devices.
- New MDCG guidance 2023/7 on exemptions from the requirement to perform clinical investigations: On 21 December 2023, the MDCG published new guidance (MDCG 2023-7) concerning exemptions from the requirement to perform clinical investigations. This guidance clarifies the exemptions from the requirement to perform clinical investigations and the associated conditions related to the demonstration of equivalence for implantable and class III medical devices to be placed on the European market.
Authors: Fabien Roy, Joerg Schickert, Anastasia Vernikou, Caroline Schmalenbach
France:
- The French Social Security Financing Bill for 2024 has been finalized and carries out for several measures modifying the legal and regulatory requirements applicable to pharma and medical devices companies.
- Creation of a new tool to be made available to healthcare establishments with the aim of promoting responsible purchasing of medical devices, involving several medical devices’ stakeholders, focusing on decarbonization, environmental health and workplace quality of life. The evaluation system is currently being designed, and is expecting to be published by June 2024.
Authors : Mikael Salmela, Josephine Pour.
Germany:
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On December 14, 2023, the German Federal Parliament passed two laws to digitize healthcare. The Digital Act introduces electronic patient files and e-prescriptions, starting in 2025 for statutory health insurance holders. The Health Data Use Act aims to make health data more accessible for research and innovation, establishing a decentralized data infrastructure. While praised by some, doctors' associations criticize the legislation's perceived unrealistic deadlines.
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Also in December 2023, the German Federal Cabinet adopted a national pharmaceutical strategy to enhance Germany's attractiveness for the pharmaceutical industry. Supported by the Federal Ministries of Health, Economic Affairs, and Education and Research, the strategy focuses on accelerating clinical trials, strengthening approval structures, generally advancing digitalization in healthcare, providing incentives for pharmaceutical production, improving European R&D framework conditions, promoting innovation and research projects, and ensuring reliable framework conditions for pharmaceutical companies.
Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach.
Italy:
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On July 2023, the Italian Ministry of Health issued new guidelines governing advertisement activities of non-prescription medicinal products, reorganizing and reorganising all previously published guidelines into a single instrument. The guidelines provide instructions on how to properly carry out advertising activities (to obtain the relevant authorisation) on various communication channels, with a particular focus on social networks.
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The Regional Administrative Court of Lazio ordered the precautionary suspension (in July 2023) and raised to the Constitutional Court the issue of constitutional legitimacy (in November 2023) of the medical device payback legislation. According to such legislation, companies supplying medical devices must pay a percentage of the exceeding of the Italian Regions.
Authors: Christian di Mauro, Giuseppe Aminzade, Chiara Perolari, Angelo Forte.
Spain:
A 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’), reprocessing of single-use medical devices, national marketing registry, medical devices subject to prescription, language regime, clinical investigations, market surveillance and control or foreign trade.
Author: Álvaro Abad.
UK:
Government and industry have agreed a new five-year Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), which will come into force on 1 January 2024. Manufacturers or suppliers of branded medicines (including unbranded generics) sold to the NHS who choose not to join VPAG are by default subject to a statutory rebate scheme, which is also in the process of being updated with a further consultation expected in early 2024. The key change in VPAG is that for the first time rebate payments will be calculated using two affordability methods, one for newer medicines and one for older medicines, rather than the previous single rebate payment rebate which applied to all products
Authors: Jane Summerfield, Bonella Ramsay, Alexandra Wood.
Corporate Governance & Corporate Social Responsibility
European Union:
On 20 December 2023 the legislative package relating to the European Single Access Point (ESAP) was published in the EU Official Gazette. Such package comprises the ESAP Regulation (Regulation (EU) 2023/2859), which includes the principle provisions regarding the ESAP, as well as the ESAP Omnibus Regulation (Regulation (EU) 2023/2869) and the ESAP Omnibus Directive (Directive (EU) 2023/2864), which make necessary amendments to various EU legal acts. As from 2027, ESAP will provide a central access point regarding corporate data collected under 19 EU regulations and 16 EU directives and currently published in different ways (e.g. financial statements, prospectuses, ad hoc publications, information on related party transactions, remuneration policies and reports as well as information on participations).
Authors: Lutz Angerer, Thomas Weber.
Germany:
The Partnership Law Modernization Act entered into force with effect as of 1 January 2024. The Act results in a comprehensive reform of the law on partnerships the provisions of which partially were introduced more than 100 years ago. If not already done so, it should be checked whether the partnership agreements of German group entities organized as partnerships need to be adapted to the new regulations.
Authors: Lutz Angerer, Thomas Weber.
Italy:
Pursuant to decree of the Ministry of Enterprise dated 29 September 2023, Italian corporate entities have been required to communicate their Ultimate Beneficial Owner(s) (UBO) to the Companies’ Register. The deadline to comply with the filing obligation was initially set at 11 December 2023. However, based on an Order of the Lazio Regional Administrative Court of 7 December 2023, the effectiveness of the decree has been suspended until 27 March 2024. Corporate entities are also required to confirm every 12 months that UBO information has remained unchanged or, conversely, to provide the Register with updated information. Such confirmation may be made when filing with the Companies’ Register year-end financial statements. Also, should a change in UBO information occur during the year, new information shall be filed with the Companies’ Register within 30 days as of occurrence of the change.
Authors: Francesco Stella, Martina Di Nicola, Marina Massaro, Giuseppe Angio.
Spain
- The first book of the Royal Decree-Law 5/2023 transposing the Mobility Directive (EU) 2019/2121 as regards to intra-Community cross-border conversions, mergers and divisions was published on 29 June 2023, the provisions regulating structural changes (book I) came into force on 29 July 2023. For the draft terms (proyectos) approved prior to 29 July 2023, a transitional period is established by which the previous law will be applicable.
- On 12 July 2023, Royal Decree 609/2023, dated 11 July 2023, was published in the Official State Gazette (BOE), creating the Central Registry of Ultimate Beneficial Owner and approving its regulations. The companies are affected insofar as, on the occasion of filing their accounts, they must provide the identification data of their real owners, information that will be transmitted to the Central Registry. Failure to do so will result in the closure of the registry sheet as provided for in art. 378 RRM. In addition, when changes occur, the directors must declare them to the Commercial Registry within ten days at the latest from the day after they become aware of them.
Authors: Alex Dolmans, Eduardo Pérez.
UK
On 26 October 2023, the Economic Crime and Corporate Transparency Bill received Royal Assent, becoming the Economic Crime and Corporate Transparency Act 2023. The Act introduces a broad package of measures to tackle economic crime more effectively, including fundamental reforms that will expand the role and powers of the registrar of companies and modernize Companies House operations. An identity verification regime for new and existing directors, LLP members and people with significant control, together with other changes to improve corporate transparency, will have an impact on how every company in England and Wales is formed and administered. Many of these reforms will be effected through numerous amendments to the Companies Act 2006 and implemented through secondary legislation. UK entities should monitor developments in this area to ensure that they are ready to comply with the new requirements and processes when implemented.
Authors: Tom Brassington, Danette Antao.
Anti-Bribery and Anti-Corruption
European Union:
On 12 December 2023, the European Commission adopted a Defence of Democracy package. The centerpiece of the package is a legislative proposal aimed at enhancing transparency and democratic oversight of lobbying activities by third countries influencing policy and decision-making processes. The proposal, known as the Directive on Transparency of Interest Representation on behalf of Third Countries, mandates entities representing third countries to register in a transparency register. Key data on these representation activities will be made publicly available, and entities must maintain records for four years post-activity. The package also includes two recommendations for ensuring free and fair elections and encouraging citizen and civil society involvement in policymaking.
Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach.
Germany:
The German Whistleblower Protection Act became effective on 2 July 2023, after the European Commission initiated infringement proceedings against Germany for missing the implementation deadline of the Whistleblowing Directive (EU) 2019/1937. Companies with 250 or more employees and German subsidiaries of international corporate groups must establish internal reporting channels since 2 July 2023, under threat of fines starting from 1 December 2023. Smaller companies (50-249 employees) must comply from 17 December 2023. The Act includes confidentiality provisions to safeguard whistleblowers' identities. Since its introduction, the Federal Office of Justice's external whistleblowing office received 309 reports of suspected breaches as of 30 November 2023.
Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach.
Italy:
The Italian government has taken steps towards the full implementation of the so-called Italian Sunshine Act (Law. No. 62/2022), which introduces transparency and reporting obligations on companies in the life sciences and healthcare sector. In particular, the draft of the decree which will govern the operation of the electronic database (i.e., Sanità Trasparente) Health) managed by the Ministry of Health on which the transparency disclosures and communications has been published.
Author: Giuseppe Aminzade.
Competition and Antitrust
European Union:
On 19 October, the European Commission announced that it had fined five pharmaceutical companies a total of € 13,4 million for their roles in a cartel. Each participant in the cartel was either a producer or a distributor of an ingredient used in abdominal antispasmodic drugs and had co-ordinated to agree a minimum sale price for the ingredient, allocated supply quotas among themselves and exchanged commercially sensitive information. A sixth company participated in the infringements, but received full immunity under the leniency programme for reporting the cartel. Two further participants benefited from reductions under the leniency programme.
Authors: Falk Schöning, May Lyn Yuen.
Data Privacy
European Union:
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On 8 December the European Parliament and the Council negotiators have reached an agreement on the proposal on harmonised rules on artificial intelligence, the so-called artificial intelligence act (AI Act). The AI Act shall provide global AI governance in a similar way as the GDPR. Therefore, the complexities of the AI Act and the legal novelties that it introduces may create substantial challenges for providers and users of AI systems (please see our blog post on Engage for more details).
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The EU Health Data Space which aims to improve the use of health data for research, innovation and policymaking is one step closer to finalization. The European Parliament adopted its position regarding the EU health data space in December 2023, including requiring patient’s consent for sensitive data sets. The European Parliament will now start negotiations with the governments of the EU countries on the final legislative text. All member states should establish national health data access services by the end of 2025 and appoint a digital health authority to safeguard people's rights.
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On 27 Nov 2023, the draft of the Data Act was approved by the Council of the EU. After publication in the EU's official journal the Data Act will enter into force the twentieth day after the publication and shall in general apply from 20 months from the date of its entry into force. The Data Act itself will put obligations on manufacturers and service providers to allow users to access and reuse the data generated by the use of their connected products or services and to share that data with third parties. The Data Act will also act as the "basis" on which further sector specific legislation will be build, e.g. the Act on the EU Health Data Space.
Authors: Stefan Schuppert, Theresa Mengler.
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Next steps
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