Life Sciences Regulatory
Pharma updates
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Revision of the Urban Wastewater Treatment Directive (UWWTD): The UWWTD aims to address emerging pollutants like pharmaceuticals, microplastics, and endocrine disruptors, which were not covered by the original directive. It mandates urban wastewater collection and treatment to better protect human health and the environment. An extended producer responsibility scheme requires pharmaceutical and cosmetic producers to cover at least 80% of the costs for removing micropollutants from wastewater. The Directive must be implemented by the Member States with deadlines ranging between 31 December 2033 and 31 December 2045. However, given the future cost burden we already see clients assessing the impact.
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Commission publishes new guidance on validity of clinical studies for Joint Clinical Assessments under the EU Health Technology Assessment Regulation (HTAR): This framework aims to enhance the availability of innovative health technologies, such as medicines and medical devices, for EU patients while reducing duplication of efforts among national HTA authorities and industry.
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Improved access to cancer medicines: A new OECD's analysis addresses challenges in ensuring equal access to cancer medicines within health systems. It suggests stimulating competition among oncology drug producers to create budget savings, which could be reinvested in new, beneficial treatments.
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Dutch EUR 2 Billion Initiative to boost Cancer Treatment Supply: The European Commission approved a EUR 2 billion Dutch measure to support the PALLAS project, led by the Nuclear Research and Consultancy Group. The project aims to produce medical radioisotopes for cancer diagnosis and treatment, contributing to the EU's Pharmaceutical Strategy by ensuring a secure supply of essential medicines. It involves building nuclear health center for processing medical isotopes into radio chemicals and radiopharmaceuticals.
Device updates
- Regulation amending MDR and IVDR published: On 9 July 2024, the Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices was published on the Official Journal of the European Union.
Authors: Joerg Schickert, Caroline Schmalenbach, Fabien Roy, Anastasia Vernikou
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Corporate Governance & Corporate Social Responsibility
The Corporate Sustainability Due Diligence Directive (CSDDD) entered into force on 25 July 2024: Member States are required to implement it by 26 July 2026. It applies to large EU companies (1,000+ employees and over €450 million in turnover) and certain non-EU companies. The CSDDD mandates a risk-based human rights and environmental due diligence process and a climate transition plan. Non-compliance can result in penalties, public naming, civil liability for damages, and requirements to disclose evidence for legal actions, including actions initiated by trade unions or NGOs on behalf of affected parties.
Authors: Lutz Angerer, Thomas Weber
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Anti-Bribery and Anti-Corruption
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Update on the legislative procedure of the Directive on combating corruption: The legislative procedure for the Directive on combating corruption is advancing, following the Council of the European Union's agreement, to establish unified minimum standards across Member States. The European Parliament must now confirm its position before trilogue negotiations can take place to finalize the proposal, replacing existing separate laws.
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Push for greater transparency in pharmaceutical pricing: An OECD report published on 11 September 2024, emphasizes the need for greater transparency in pharmaceutical pricing, following the 72nd World Health Assembly and the Oslo Medicines Initiative. The report explores which medicine prices should be disclosed and assesses the feasibility of sharing price information across OECD countries. It finds a significant interest among member countries in sharing net pharmaceutical prices through a closed network, with many expressing willingness to participate in a pilot program for this purpose.
Authors: Joerg Schickert, Caroline Schmalenbach
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Competition and Antitrust
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Teresa Ribera has been appointed as the new Competition Commissioner: European Commission President von der Leyen's outlines in her Mission Letter expectations for Ribera to modernize competition policy, particularly regarding merger control and challenges faced by SMEs, especially concerning foreign "killer acquisitions." The letter emphasizes strengthening the enforcement of competition rules related to state aid, foreign subsidies, anticompetitive agreements, and abuse of dominance.
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The European Commission launched a consultation draft on 1 August 2024 on guidelines addressing exclusionary conduct and abuse of dominance: These guidelines define concepts such as dominance and exclusionary effects, categorizing conduct into various groups. The Commission may presume exclusionary effects in cases of exclusive dealing or predatory pricing. For “naked restrictions”, where a dominant company makes payments conditional on the delay or withdrawal of competing products, exclusionary effects are almost always assumed. For other types of behavior, a thorough examination is required to determine whether they restrict competition on the merits and cause exclusionary effects.
Authors: May Lyn Yuen, Falk Schöning
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Intersection of Life Science and Data Privacy
- European Artificial Intelligence (AI) Act enters into force on 1 August 2024: The AI Act aims to ensure that AI systems in the EU are safe and uphold fundamental rights. It will be fully applicable 24 months after this date, while prohibitions on certain AI systems will be enforceable after six months. Regulations for general-purpose AI will take effect in 12 months, and the Commission aims to finalize the Code of Practice by April 2025. Key current action to take for our clients is to ensure to be aware when they use AI in their organization and to assess their legal role and risk level – and then act with a view to the AI Act coming into force.
Authors: Stefan Schuppert, Joerg Schickert, Theresa Mengler, Carolin Schmalenbach
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Data Privacy
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European Commission publishes FAQ on Data Act on 6 September 2024: The Data Act aims to ensure fairness in data value distribution and will take effect on September 12, 2025. The FAQs clarify key provisions, including the relationship between the Data Act and GDPR, access to IoT data, roles of users and data holders, and unfair practices in B2B data-sharing contracts.
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CJEU publishes decision on the interpretation of data concerning health: On 4 October 2024, the European Court of Justice (CJEU) ruled in Case C-21/23 that customer data collected by pharmacists, including names, addresses, and information for ordering non-prescription medicines online, qualifies as "health data" under the GDPR. This decision contradicts the Advocate General's opinion, stating that data can be classified as health data if the health of the individual can be inferred through association or deduction.
Authors: Stefan Schuppert, Theresa Mengler
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