Q4/ 2025 - Life Sciences Law Update

Pharma:

New EU ‘Pharma package': The new ‘Pharma Package' was now agreed by the Council and European Parliament. It introduces updated rules to improve patient access to medicines and to enhance fairness and competitiveness in the EU pharmaceutical sector, replacing Regulation (EC) No 726/2004 and amending Directive 2001/83/EG. Key measures include extended data exclusivity and market protection for new medicines, requirements for companies to ensure adequate supply. Medicines will benefit from 8 years of data protection plus 1 year of market protection, with the possibility of an additional year if they address unmet medical needs or meet special conditions, and another year for an additional indication, bringing the maximum protection period to 11 years.. Additionally, a transferable exclusivity voucher will incentivize the development of priority antibiotics to combat antimicrobial resistance. The final draft will be published following formal approval in the coming months.

New measures to make EU health sector more innovative, competitive and resilient, incl. the Biotech Act: The European Commission has proposed a package of measures to make the EU health sector more innovative, competitive, and resilient. Key elements include the Biotech Act to boost biotechnology and clinical trials (also allowing for funds for biotech research in the EU), the Safe Hearts Plan to tackle cardiovascular diseases through prevention and innovation, and reforms to medical device regulations to simplify procedures and speed up access to new technologies. The proposals will now be considered by the European Parliament and Council.

Germany:

Standard Contractual Clauses for the Conduct of Clinical Trials: As reported in our Q2 2025 Legal Watch Report, Germany has introduced standardized contractual clauses (SCCs) for the conduct of clinical trials. These SCCs are designed to establish uniform and legally secure contractual conditions between the sponsor, trial site, and investigator, thereby streamlining the contracting process and reducing legal uncertainties. From December 17, 2025, the regulation will automatically apply to all new clinical trial contracts. Exceptions are only permitted in rare cases and require the consent of both parties.

France:

Clinical trials fast-track: from 2026, France will introduce a national fast-track scheme to accelerate the authorisation of certain single-country clinical trials, including early-phase, first-in-class and trials targeting serious diseases with no available treatment, as well as trials involving adolescents. Inter alia, authorisation may be granted within 14 days where no questions are raised, or 49 days where questions arise, subject to prior eligibility confirmation by the French authority.

Spain:

Regulatory progress and digital health initiatives: Among the many initiatives currently underway, including greater flexibility in the reference pricing system and the approval of new regulations on medical cannabis and in vitro diagnostic medical devices. In addition, steps have already been taken to establish a Digital Health Law to provide Spain with a comprehensive legal framework aligned with the European Health Data Space.

Drug price disclosure: The Spanish Supreme Court will soon decide on the extent to which drug prices and public funding conditions must be disclosed, a key issue in Spanish pharmaceutical policy. This ruling will clarify the relationship between the Transparency Law and pharmaceutical regulations. 

Italy:

The Italian Medicines Agency redefines criteria for therapeutic innovativeness. In July 2025, the Italian Medicines Agency revised the framework for assessing the therapeutic innovativeness of medicinal products, updating the criteria for comparison with existing therapies and confirming innovation status as a key driver for reimbursement, fast-track access and dedicated funding in Italy.

Medical Devices:

Besides the EU initiative on introducing the Biotech Act, which also has implications for medical device development (see above under A):

• European Commission's amendments to MDR and IVDR: On 16 December 2025, the Commission proposed changes to simplify and reduce the complexity of medical device regulations, addressing industry and Member State concerns.
• Commission Implementing Regulation (EU) 2025/2086: Published on 20 October 2025, this regulation sets procedural rules for joint clinical assessments for certain medical devices, outlining cooperation between the Coordination Group, Commission, notified bodies, experts, and health technology developers.
• Mandatory EUDAMED modules from 28 May 2026: Four modules—Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance—will be required as of this date.
• Pilot coordinated assessment for investigations and studies: Member States, with Commission support, launched a pilot for joint review of clinical investigations and performance studies under MDR and IVDR.

New Medical Devices Coordination Group (MDCG) published new guidance:

• MDCG 2025-8: Implementation of UDI-DI for spectacle frames, lenses, and reading spectacles.
• MDCG 2025-9: Guidance for Breakthrough Devices under MDR and IVDR.
• MDCG 2025-10: Post-market surveillance of medical devices and IVDs.

Germany:

Draft law on the modernization of product liability law (Produkthaftungsrecht): On 11 September 2025, the Federal Ministry of Justice and Consumer Protection introduced a draft law to update product liability. The proposal extends liability to AI-related risks, software updates, cybersecurity, data loss, and digital services, while easing access to supplier information. These changes apply to medical devices, but for medicinal products, the special strict liability provisions of the German Medicinal Products Act continue to apply.

Italy:

New guidelines on advertising of medical devices adopted. In July 2025, the Italian Ministry of Health adopted new Guidelines on the advertising of medical devices, consolidating and updating the rules governing promotional activities and clarifying the authorisation process, including for online and social media communications.

UK :

Medicines and Healthcare products Regulatory Agency confirms key medical device regulatory reforms for 2026: The MHRA has released its responses to last year's Medical Device Regulations consultation, confirming key reforms for 2026. They include extending the sunset period for some EU laws, introducing international reliance routes for market approval, and adopting a risk-based classification for IVDs. UK Conformity Assessed marking will end once the UDI system is in place, with transition periods allowed. Further consultation on indefinite CE-mark recognition is planned. These changes aim to streamline regulation, but companies must stay updated, revise quality systems, and adjust regulatory strategies to maintain compliance in the UK market.

Status update on simplifications and delays for CSRD and CSDDD: Following the reported unexpected rejection by the EU Parliament of the position prepared by its JURI committee on 22 October 2025, the EU Parliament adopted its proposal for amendments to the CSRD and CSDDD with a number of changes to the proposal from the JURI committee on 13 November 2025. As a result of trilogue negotiations, on 9 December 2025 a provisional political agreement was reached based on which the EU Parliament formally approved the final text for the simplification directive on 16 December 2025. Such final text will now need to be approved by the Council as well, will subsequently be published in the Official Journal of the European Union and enter into force twenty days thereafter. Agreed amendments now include inter alia (i) for the CSRD further limiting the scope for EU companies (at least 1,000 employees and net turnover EUR 450m), simplification and reduction of reporting requirements, prohibition to obtain information only for CSRD reporting from entities in the value chain with less than 1,000 employees other than information to be specified in the sustainability standards for voluntary use and (ii) for the CSDDD further limiting the scope for EU companies (at least 5,000 employees and net turnover EUR 1.5bn), removal of requirements to adopt and implement a climate transition plan, change of diligence obligations to a risk-based approach, no EU harmonized civil law liability regime, deferral of transposition deadline to 26 July 2028.

No change to legal professional privilege under EU law: Under EU law, legal professional privilege only protects advice from external EU lawyers. While there have been recent discussions to extend the concept of legal privilege to in-house lawyer advice, the European Commission's evaluation has confirmed that there is no reason to depart from the current, well-established principle. Reiterating the concern that in-house lawyers are not “independent” by virtue of their employment within a company, the Commission stated that extending legal privilege to in-house lawyers would likely hamper the effective enforcement of the EU competition rules.

No change to legal professional privilege under EU law: Under EU law, legal professional privilege only protects advice from external EU lawyers. While there have been recent discussions to extend the concept of legal privilege to in-house lawyer advice, the European Commission's evaluation has confirmed that there is no reason to depart from the current, well-established principle. Reiterating the concern that in-house lawyers are not “independent” by virtue of their employment within a company, the Commission stated that extending legal privilege to in-house lawyers would likely hamper the effective enforcement of the EU competition rules.

EU legal opinion supports work email seizures in pharma competition cases: EU competition authorities may seize work emails without prior judicial approval, according to a legal opinion by Advocate General Laila Medina (23 Oct 2025). AG Medina emphasized that access to personal data must be limited, mostly when it allows drawing very precise conclusions about individuals, such as habits or private life. She noted that authorities seek business information to demonstrate anticompetitive conduct, and personal data in work emails are collected only on an ancillary basis.

European Commission confirms monitoring of competition issues in the pharma sector, including for below-threshold pharma deals: Citing a recent bid in the pharma sector between two rivals, a senior European Commission official has spoken about deals that should be scrutinized even though they do not meet the merger notification thresholds at a conference in Brussels in December 2025. For the moment, the EU is relying on national EU Member States to refer cases to the EU for review. The senior Commission official also referred to the monitoring of other practices in the pharma industry, including excessive pricing cases. 

First EU-wide Criminal Law Rules on Corruption Agreed: The Council and European Parliament have provisionally agreed on new EU standards to define and prosecute corruption offences. The law harmonises crimes like bribery, embezzlement, and obstruction of justice across Member States, introducing uniform penalties, including prison terms of three to five years and significant corporate fines. It also clarifies Member State jurisdiction, allows for extending jurisdiction abroad, and mandates prevention measures such as awareness campaigns, transparency, anti-corruption bodies, and whistle-blower protections. This directive updates previous EU rules to meet international standards.

Commission acts to ensure EU directive transposition against several Member States: By 10 July 2025, Member States must provide full access to beneficial ownership information for legal entities and trusts. Belgium, Denmark, Germany, Estonia, Greece, Italy, Cyprus, Croatia, Poland, Slovakia, and Sweden have not fully implemented the 6th Anti-Money Laundering Directive. The Commission urges these nations to promptly update their laws to meet EU standards.

Italy

Anti-Corruption authority adopts new whistleblowing guidelines: In November 2025, the Italian Anti-Corruption Authority adopted new Guidelines on internal whistleblowing reporting channels, providing practical guidance on how companies and public bodies must structure and manage internal reporting systems under Italian law implementing the EU Whistleblowing Directive.