Studies from 2024, such as the final report by IQVIA for EFPIA and Vaccines Europe, which refers to our article published in 2023 on current developments in the field of clinical drug trials in Germany, show a concerning trend: Europe as a pharmaceutical location, and Germany in particular, is becoming increasingly less attractive for conducting while countries in Asia and America continue to grow. The primary causes for this shift include more favourable regulatory and financial conditions as well as faster patient recruitment in Asia and America.
In Germany, the decline in clinical research and the associated challenges have long been attributed to lengthy negotiations between sponsors and institutions as well as strict data protection laws, which, among other things, make patient recruitment more difficult. With the new Medical Research Act, Germany now aims to implement targeted countermeasures to strengthen the competitiveness of Germany and render the development and authorization of medicinal products and medical devices in Germany more attractive.
Decline in Clinical Trials in Germany and Europe
The need to implement reforms to strengthen clinical research at both national and European level is impressively confirmed by the latest figures from the above mentioned final report. Between 2018 and 2023, the number of Phase I to IV commercial clinical trials conducted in Germany fell from 618 to 417, a decrease of 8 %. At European level, the global share of clinical trials conducted in European countries fell from 18% to 12% over the same period. A decline in multicentric trials was also observed in various European countries: Between 2018 and 2023, the proportion fell from 23% to 19%.
Reform Efforts in Germany in the Context of the Medical Research Act
The Medical Research Act, large parts of which came into force on 30 October 2024, aims to keep Germany competitive as a pharmaceutical location. In particular, it provides for changes that serve to accelerate approval procedures, streamline contract negotiations and improve coordination between authorities. These amendments affect, among other things, the German Medicinal Products Act, the German Regulation on Medicinal Products and Active Ingredient Manufacturing, the German Medical Devices Implementation Act as well as the German Radiation Protection Act.
Shorter Approval Process for Mononational Clinical Trials
A vital measure to strengthen the position of Germany as a center of research is accelerating the approval procedure for clinical trials that are conducted exclusively within the national framework.
An amendment to Section 40 para. 4 of the German Medicinal Products Act ("AMG") reduces the period for the assessment of the authorization application from 45 days to 26 days from the date of validation. This shortened period contributes significantly to enabling sponsors to begin the clinical trial sooner and, thus, strengthens Germany's competitiveness in the European and international context, as it incentivizes sponsors to carry out clinical trials in Germany due to the prospect of a quick decision.
Standard Contractual Clauses for Clinical Trials
Another key instrument of the German Medical Research Act is the introduction of standardized contract clauses in a new Section 42d AMG. As negotiations on the content of clinical trial agreements in Germany have been considered particularly time-consuming – especially in international comparison - standardized clauses are intended to further accelerate and simplify lengthy and complex contract negotiations between sponsors and institutions.
The standard contractual clauses regulate central issues of clinical study agreements such as the rights to research results, data protection, liability, insurance cover for study participants and the handling of confidential information. The Federal Government is authorized to define these clauses by statutory order with the approval of the Bundesrat. While to this date, the specific content of the standard contractual clauses has not been published, existing model contract clauses from associations such as the vfa (German Association of Research-Based Pharmaceutical Companies) could be used as a basis.
Despite the potential streamlining of contract negotiations through the introduction of standard contractual clauses, their use remains voluntary in Germany in order not to overly constrict the parties. Critics argue that the voluntary use of standard contractual clauses could potentially impair the intended increase in efficiency, as sponsors could still insist on extensive individual adjustments.
It remains to be seen whether the introduction of non-binding standard contractual clauses will have the desired effect. Experience from other countries such as Spain and France shows that mandatory standard contractual clauses offer considerable advantages in terms of accelerating contract negotiations. However, the concrete effect of the standard contractual clauses introduced in Germany can only be assessed more precisely once the federal government has finalized and published such clauses. Only then it can be possible to assess whether the rights of sponsors are adequately protected and whether the use of the clauses can be recommended in practice.
Specialized Ethics Committee for Special Procedures
Another key element of the German Medical Research Act is the establishment of a specialized ethics committee at the Federal Institute for Drugs and Medical Devices (BfArM) in accordance with Section 41c AMG. This interdisciplinary committee will be responsible for particularly demanding clinical trials from 1 July 2025. The aim is to speed up authorization procedures and meet the growing requirements in clinical research.
Direct Dispensing of Medicinal Products and Decentralised Clinical Trials
The amendment to Section 47 AMG as part of the German Medical Research Act establishes a new distribution channel for investigational and auxiliary medicinal products, which renders it admissible to dispense such medicinal products directly to trial participants. This step represents an important progress in the promotion of decentralized clinical trials, which have become increasingly important, particularly due to the experiences during the COVID-19 pandemic.
According to Section 47 para. 2a AMG, investigational medicinal products may now be supplied directly to participants by pharmaceutical companies, pharmacies or investigators under certain conditions. The prerequisite for this is that the pseudonymization of the participants is guaranteed, safety is ensured by suitable measures and the competent higher federal authority grants its approval.
In addition, the possibility of labelling investigational and auxiliary medicinal products in English in accordance with Section 10a para. 3 AMG has been created. This regulation reduces the effort required for relabelling and makes it easier to conduct international studies.
Conclusion
The German Medical Research Act contains numerous approaches to address the challenges that are causing Germany to lose its attractiveness as a center for developing and testing new medicinal products. Whether the measures of the German Medical Research Act render the desired effect of strengthening Germany’s position remains to be seen. The decisive factor will be how effective the measures prove to be in practice - for example, whether the standard contractual clauses are accepted by pharmaceutical companies and whether existing structural deficits can be adequately remedied.
