Life Sciences Regulatory

Pharma and updates in the EU

• European Commission launched Alliance to tackle critical medicines shortages: On 24 April 2024, the European Commission's Health Emergency Preparedness and Response launched the Critical Medicines Alliance (CMA) to prevent shortages of critical medicines in the EU. The CMA includes authorities, industry, health care organizations, and civil society, aiming to enhance supply security and reduce dependencies. CMA will make strategic recommendations, identify investment projects, and explore market incentives.
• Clinical Trial Information System Transparency rules (CTIS) revised: On 18 June 2024, the EU has launched a new version of the CTIS to implement the updated transparency rules for the CTIS. It allows earlier and more efficient access to information about authorized clinical trials including a public searchable database for health care professionals, patients, and the general public.
• The European Medicines Agency (EMA) has updated its pre-authorization guidance to include the Joint Clinical Assessment (JCA) process: Initially, JCA will cover new cancer treatments and advanced therapy medicinal products, with orphan drugs and others included by 2030.

Device Updates in the EU

• Measures to prevent medical devices and In Vitro Diagnostics (IVD) shortages will enter into force soon. The rules extend the transition periods for certain IVDs, enable a gradual roll-out of the European database on medical devices (EUDAMED) database, and require manufacturers to notify authorities of potential shortages of critical devices.
• EMA published revised guidance addressing practical considerations for drug-device combinations: Updated Q&A clarifies issues related to changes in the medicinal component, including when a new or updated opinion from a Notified Body might be required for the device component.

• The Medical Devices Coordination Group (MDCG) recently released two new guidance documents:

  • Guidance on the content of the Investigator’s Brochure (IB) for clinical investigations of medical devices (MDCG 2024-5).

  • Guidance on the clinical evaluation of orphan medical devices (MDCG 2024-10), outlining criteria to determine when a medical device or its accessory qualifies as an “orphan device”.

National pharma and device updates

Germany:

• The German government decriminalized the controlled distribution of cannabis for personal use with a law effective 1 April 2024.
• On 8 February 2024, the German Federal Court of Justice ruled that pharmaceutical companies/wholesalers cannot offer discounts to pharmacies that lower the mandated minimum price of medicinal products. This decision reaffirms the Pharmaceutical Price Ordinance, which sets prices including a fixed surcharge and VAT; however, the legislator may practically revoke this ruling by way if a draft new law.

France:

On 21 February 2024, French ministers presented the 2024-2027 roadmap to ensure the availability of medicines and strengthen industrial sovereignty. The new plan introduces further measures to tackle shortages. In addition, a bill to combat drug shortages has been submitted to the Senate, despite warnings from the French National Union of the Pharmaceutical Industry about the potential negative impact. However, due to the dissolution of the National Assembly, all legislative work has been suspended. The future of the bill depends on the results of the upcoming elections and possible reintroduction.

UK:

• Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent on international recognition of medical devices. This intent sets out the MHRA’s current proposal for the international recognition (IRP) of medical devices and confirms that the final IRP framework will be released in 2025 together with the upcoming changes to the UK Medical Devices Regulations 2002.
• MHRA published Artificial Intelligence (AI) Regulatory Strategy and the steps it is taking to implement the UK Government’s AI White Paper, that was published last August.

Italy:

• On 3 January 2024, Italian Legislative Decree 218/2023 was published, aligning Italian legislation with EU Regulation 6/2019 on veterinary medicinal products, which addresses key issues such as marketing authorizations, clinical trials, advertising and homeopathic medicinal products.
• On 10 May 2024, the Italian Medicines Agency updated its Questions & Answers Document concerning authorization and registration procedures for manufacturing/importing active substances. The Q&As provide useful guidance to align inspection expectations, resolve ambiguities and uncertainties, and standardize inspections.

Spain:

Catalunya has released an updated edition of its Guide for the Promotion and Advertising of Medicinal Products. This guide is highly regarded in the pharmaceutical industry for ensuring compliance with promotional and advertising regulations. Key updates include consolidation of existing guidelines on digital promotion and advertising and detailed coverage of digital promotion methods. This edition will set the standard also for other regions in Spain.

Joerg Schickert, Sarah Zucht, Caroline Schmalenbach, Fabien Roy, Anastasia Vernikou, Mikael Salmela, Josephine Pour, Jane Summerfield, Alexandra Wood, Giuseppe Aminzade, Angelo Forte, Álvaro Abad

Keen to dive deeper into the latest European pharma and devices regulatory updates? Contact Joerg Schickert to subscribe to a more detailed quarterly report.

Corporate Governance & Corporate Social Responsibility

Corporate updates in the EU

Commission updates Accounting Directive Size Criteria: On 21 December 2023, the Accounting Directive regarding the adjustments of the size criteria for micro-, small-, medium-sized and large entities or groups was published. Member States shall bring into force necessary regulations to comply with the Directive by 24 December 2024 at the latest. Germany has done so. The changes to the size classes can have effects on the audit requirement for a company, the future requirement of sustainability reporting in the management report, and the requirement to prepare group annual financial statements. The specific accounting implications should be reviewed for the specific entities in each Member State separately.

National corporate updates

Germany: Thresholds for the classification of company size pursuant to the German Commercial Code increased with voluntary retro-active effect for the 2023 financial year.

France: Law no. 2024-537 of 13 June 2024 aimed at increasing the financing of businesses and the attractiveness of France includes three series of provisions: title I aims at strengthening business financing capacity, title II refers to the dematerialization of transferable securities, and title III focuses on making the France legal environment more attractive.

UK: Company law reform – fundamental changes to Companies House and corporate law in force from 4 March 2024. The reforms focuses in particular on the Registrar’s role and powers as well as on the regulation governing company names.

Italy: New provisions of law applicable to Italian limited liability companies introduced by Law no. 5 of 5 March 2024 aimed at easing access to capital markets for corporate entities.

Authors: Lutz Angerer, Thomas Weber, Tom Brassington, Danette Antao, Francesco Stella, Martina Di Nicola and Giuseppe Angio

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Anti-Bribery and Anti-Corruption

Anti-Bribery and Anti-Corruption updates in the EU:

On 14 June 2024, the Council of the European Union agreed on a new anti-corruption legislation to unify standards across the EU. The law will harmonize offence definitions, impose criminal penalties, and require member states to implement preventive measures and raise public awareness. It will criminalize bribery, misappropriation, trading in influence, obstruction of justice, and illicit enrichment. Negotiations with the European Parliament will follow to finalize the text.

National Anti-Bribery and Anti-Corruption updates

Germany: Higher civil court Karlsruhe ruled that DocMorris's is allowed to charge pharmacies a monthly fee to use its digital marketplace for selling prescription drugs. On the other hand, charging a 10% fee on the net sales of non-prescription medicines sold via the platform violates the German Pharmacy Act, says the court.

France: The French National Medical Council (CNOM) has updated its guidelines to the applications under the authorization regime on the benefits that are granted to the healthcare professionals. The guidelines adapts the amounts considered as Fair Market Value to economics metrics. The new amounts are maximum amounts acceptable to this authority, over which it retains the power to assess, adjust and monitor on a case-by-case basis. They have been applicable since the beginning of 2024.

Italy: The Italian Anti-Corruption Authority, overseeing compliance with the recently approved whistleblowing legislation, published a monitoring report on critical issues encountered by companies in applying the same. The report covers different key points of the new whistleblowing legislation, with the aim of assessing how companies have managed these issues and drafting new guidance documents in the future.

Authors: Joerg Schickert, Sarah Zucht, Caroline Schmalenbach,, Josephine Pour, Mikael Salmela, Giuseppe Aminzade, Angelo Forte

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Competition and Antitrust

In the second quarter of 2024, the European Commission and national competition authorities continued to actively enforce competition law in the life sciences sector. National authorities are also active, particularly in conducting dawn raids in several Member States.

• On 27 June 2024, the European Court of Justice handed down a judgment affirming that pay-for-delay agreements are “by object” (i.e. by their very nature) infringements of EU competition law.
• On 19 April 2024, the European Commission invited comments on commitments offered to address competition concerns regarding alleged disparagement of a competing treatment. The investigation, initiated in June 2022, found the company dominant in several national markets and potentially restricting competition by disseminating allegedly misleading information about the competing product’s safety.
• On 13 June 2024, the European Commission announced it has informed Alchem International Pvt. Ltd. and its subsidiary of its preliminary view that they breached EU antitrust rules by coordinating with other market participants to fix minimum sales prices and allocate quotas, and exchanged commercially sensitive information with competitors.
• On 6 June 2024, Italy’s antitrust regulator announced it has launched an investigation into several pharmaceutical companies for allegedly coordinating to delay the Italian launch of a medicinal product.
• In March 2024, the European Commission launched its first formal investigation into a potential abuse of a dominant market position against Zoetis – relating to the exclusionary termination of a pipeline product which was to be commercialized by a third party.

Authors: Falk Schöning, May Lyn Yuen.

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Data Privacy

• EU Parliament approved the AI Act: AI Act was adopted by Parliament in March 2024 and endorsed by Council in May 2024. The AI Act aims to ensure that AI systems placed on the EU market are safe and respect fundamental rights and EU values.
• The European Court of Justice (ECJ) publishes opinion on the interpretation of data concerning health: On 25 April 2024, the Court released the Advocate General’s Opinion for Case C-21/23 which concluded that customer data on online pharmacy platforms could only lead to vague or speculative inferences about an individual's health, and did not meet the criteria for "data concerning health" as defined in Art. 4(15) of the GDPR.

Authors: Stefan Schuppert, Theresa Mengler.

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