European Union
EU Health Technology Assessment (HTA) for oncology medicinal products and ATMPs
Regulation (EU) 2021/2282 on health technology assessment (HTAR), which entered into force on January 11, 2022, applies from January 12, 2025 and will transform the way new treatments are evaluated in Europe. The benefits of new treatments will be assessed at European level for the first time. The HTAR introduces joint clinical assessments, which will be carried out in parallel with the European marketing authorization procedure. From 2025, oncology medicinal products and ATMPs will be evaluated under the HTAR, followed by orphan drugs from 2028, and finally all centrally authorized medicinal products from 2030.
EU Clinical Trials Regulation (CTR) transition period ends
The Clinical Trials Regulation (EU) No 536/2014 (CTR), which harmonizes clinical trials in the EU, already became applicable on January 31, 2022. After the end of a three-year transition period, all ongoing clinical trials in the EU must be transitioned to the CTR by January 31, 2025, including the corresponding submission in the Clinical Trials Information System (CTIS). Ongoing clinical trials that do not transition to the CTR by then will be non-compliant with the CTR.
Amendment of Variation Regulation (EC) No 1234/2008 to streamline variations for human medicines
On June 17, 2024, Commission Delegated Regulation (EU) 2024/1701, amending the Variation Regulation for medicinal products for human use, was published in the Official Journal of the EU. Effective from January 1, 2025, the amendment aims to establish a simpler, clearer and more flexible framework for variations. The amendment inter alia provides for more flexibility for grouping variations and allows minor type IA variations to be submitted collectively on an annual basis.
Ongoing legislative procedures
EU Pharma Package to revise EU pharma legislation
The EU Pharma Package, presented by the European Commission in April 2023, will completely revise the EU’s pharmaceutical legislation. After the European Parliament has adopted its final position in April 2024, a position by the Council of the EU can be expected in the first half of 2025. This will then be followed by trilogue negotiations between the European Commission, the Council and the European Parliament. Although it is unlikely that the new legislation will come into effect until 2028 or 2029, it will impact medicinal products which are currently under development.
Further reforms of MDR and IVDR suggested to prevent shortages
After the transitional periods of both the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) have already been extended several times due to ongoing capacity bottlenecks of the notified bodies, the European Parliament has called for reforms of MDR and IVDR. Based on the European Parliament’s resolution from October 2024, the European Commission shall address the most pressing challenges and bottlenecks of the regulations and propose “a systematic revision” of the legislation to avoid potential product shortages by the end of Q1 2025. The resolution inter alia suggests the implementation of binding timelines for conformity assessment procedures as well as the elimination of re-certification requirements in case of minor product updates.
Germany
Electronic Patient Record to boost digitalization in German healthcare system
The introduction of the new electronic patient record (elektronische Patientenakte – ePA) “for all” in January 2025 marks a significant step in the digitalization of the German healthcare system. After the ePA was originally introduced in 2021 on a voluntary basis, all statutory health insurance companies are now obliged to provide the ePA to all patients which do not actively object (opt-out). The ePA contains health information such as diagnoses, tests results or medication plans, which can be accessed by patients, treating physicians or hospitals and pharmacies. Besides, the mandatory use of the electronic prescription (E-Rezept) will be extended from prescription medicines to digital health applications (DiGAs) and narcotics in 2025, followed by remedies (Heilmittel) and medical aids (Hilfsmittel) in 2027.
Hospital Reform massively changing the remuneration system of German hospitals
The German hospital reform, effective from January 1, 2025 and to be implemented gradually until 2029, aims to ease financial pressure on hospitals and to improve quality and efficacy of hospitals in Germany. Instead of the current remuneration system of DRG-based flat-rate fees, hospitals will receive most of their remuneration for providing/ offering certain services (Vorhaltepauschalen). Hospitals will be assigned “service groups” that determine the services they can offer. Further implementing acts will be required to establish quality criteria for the different service groups and to allocate the service groups to individual hospitals.
Medical Research Act introducing confidential reimbursement prices
The Medical Research Act (Medizinforschungsgesetz – MFG) which entered into force in October 2024 aims to increase and expand Germany’s attractiveness as a location for pharmaceutical research and production, e.g., by simplifying and accelerating the assessment of clinical trials and by providing incentives for medical research conducted in Germany. Furthermore, the MFG introduces the possibility of keeping the reimbursement price negotiated between the pharmaceutical company and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) confidential under certain conditions. In order to achieve such confidentiality, the pharmaceutical company (1) needs to provide evidence that certain R&D activities are carried out in Germany and (2) needs to grant and additional 9% discount on the agreed reimbursement price. The confidentiality option will apply for a trial period until June 30, 2028 in the first place.
