Draft of the Medical Research Act of 29 May 2024

On 6 June 2024, the German Bundestag held the first reading of the draft Medical Research Act (printed matter 20/11561). The Federal Government's bill was then referred to the lead Health Committee for detailed consultation. This law is intended to strengthen Germany's position in international cutting-edge research and make up for the backlog that has developed in recent years. The focus is on clinical research with medicinal products and radiation protection and, to a lesser extent, medical devices. The relevant laws will be amended for this purpose. In particular, the implementation of decentralised clinical investigations is to be facilitated across the board.

The new Medical Research Act will amend the following existing laws, in some cases extensively: Medicinal Products Act (AMG), Medical Devices Law Implementation Act (MPDG), Radiation Protection Act (StrlSchG), Medicinal Products and Active Substances Manufacturing Ordinance (AMWHV) and German) Social Code Book Five (SGB V).

Contents of the draft law

The key points of the draft law are

• Simplification and acceleration of authorisation procedures for clinical investigations while maintaining high safety standards
• Facilitation of decentralised clinical investigations by expanding the special distribution channel for investigational and auxiliary medicinal products
• Establishment of a specialised ethics committee for special procedures at the Federal Institute for Drugs and Medical Devices
• Improved coordination between the higher federal authorities responsible for drug authorisation
• Possibility of agreeing confidential reimbursement amounts for new medicinal products
• Dovetailing of procedures under radiation protection law with authorisation or notification procedures under pharmaceutical and medical device law and reduction of duplicate reviews by different ethics committees as well as shortening of review periods in radiation protection law
• Establishment of a specialised ethics committee for special procedures
• Creation of standard contractual clauses for the delimitation of responsibility and financing of clinical investigations

These measures are intended to strengthen the attractiveness of Germany as a centre of research and production, accelerate access to new therapeutic options and promote growth and employment.

Simplification and acceleration of authorisation procedures for clinical investigations

According to the draft bill, the authorisation procedures for clinical investigations are to be simplified and accelerated through the following measures, while at the same time maintaining high safety standards:

• Expansion of the special distribution channel for investigational and auxiliary medicinal products by amending Section 47 of the German Medicinal Products Act (AMG). This should enable the dispatch of investigational medicinal products directly to the participants.
• Simplification of the labelling of investigational and auxiliary medicinal products by supplementing Section 10a AMG. This facilitates the handling of decentralised studies.
• Acceleration of the authorisation of mononational clinical investigations by amending Section 40 (4) AMG. This is intended to simplify procedures for decentralised study designs.
• Shortening of test deadlines in radiation protection law and harmonisation with the deadlines for the approval of clinical investigations.
• Better coordination of authorisation procedures between the competent higher federal authorities, BfArM and Paul Ehrlich Institute (PEI).

Adaptation in relation to the MPDG

The following changes are planned with regard to the MPDG:

• Use of radiation requiring authorisation or notification in the context of a clinical investigation within the meaning of Article 2(45) of Regulation (EU) 2017/45 or other clinical investigation within the meaning of Section 3(4) or
• §32 Specialised ethics committee for special procedures to be newly established
• § Section 33 determines the responsibility of the newly established Specialised Ethics Committee for Special Procedures and application to the Ethics Committee: currently for companion diagnostics intended for the safe and effective use of an associated medicinal product and for which the Specialised Ethics Committee for Special Procedures is responsible in accordance with Section 41c of the German Medicinal Products Act (MPDG)
• Proposed amendment to Section 47 (3) MPDG extends the scope of the exemptions for certain other clinical investigations to the extent that the requirements of Sections 25 and 30 MPDG do not apply to medical devices with CE marking whose investigational use is within the scope of their intended purpose and whose use does not involve any additional invasive or stressful procedures.

Upcoming changes to other clinical investigations of medical devices

The planned law will result in changes for other clinical investigations (as defined in the Medical Devices Law Implementation Act (MPDG) in Section 3 (4), whereby the requirements for other clinical investigations are set out in Section 47.

The proposed amendment to Section 47 (3) MPDG expands the scope of exemptions for certain other clinical investigations. The amended sentence would then read: "Paragraphs 1 and 2 and Sections 25 and 30 do not apply to other clinical investigations that [...]". This amendment has the following effects:

• Extension of the exemptions: In addition to the existing exemptions from paragraphs 1 and 2 of Section 47, Sections 25 and 30 are now also exempted for certain other clinical investigations.

§ Section 25 MPDG: This paragraph refers to the requirements for clinical investigations, performance studies and other clinical investigations conducted exclusively at national level or at national level and in third countries, which now do not require a sponsor or a legal representative of the sponsor based in a Member State of the European Union or in another contracting state.

§ Section 30 regulates the qualifications and obligations of investigators, principal investigators and heads of a clinical trial, performance study or other clinical investigation

However, the exact effects depend on the specific form and interpretation of the law.

Own statement

As a specialist in digital clinical studies of medical devices, MEDIACC GmbH generally welcomes the German government's initiative to improve the framework conditions for clinical research in Germany. The current draft bill contains some promising approaches, but also raises critical questions.

In our view, the planned measures to reduce bureaucracy and speed up authorisation procedures for clinical investigations were urgently needed, but it remains to be seen to what extent they will actually lead to an increase in efficiency from the perspective of researchers and industry.

The measures to facilitate decentralised clinical investigations are a good step in the right direction, but raise too much hope under this heading and do not give those involved the hoped-for direction and relief to improve all digital processes. The draft law is strongly focussed on drug trials and is long overdue in regulating clinical research in relation to the Radiation Protection Act. In view of the increasing global importance of study designs with digital elements, the draft bill lacks concrete regulations on data protection and the promotion of digitalisation in clinical studies. There is a lack of innovative and secure regulations to make Germany attractive as a research country in international competition. The draft law contains important approaches for improving clinical research in Germany and it would be desirable if it could contribute to strengthening Germany as a centre of research.

May we also support you? Arrange a first non-binding appointment here.

(as of July 2024)