The German Medical Association (BÄK) and the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK) have adopted a procedure for the nationwide standardisation of professional advice on research projects in accordance with the (model) professional code of conduct for doctors working in Germany (MBO-Ä). For multi-centre non-interventional studies, a single vote from an ethics committee established under state law should now be sufficient. This procedure already applies to drug clinical trials, but did not apply to non-interventional studies of drugs [ref 1] [ref 2] [ref 3].

This procedural change by BÄK and AKEK represents a major advancement in streamlining the ethical review process for multi-centre non-interventional studies in Germany, transitioning from individual federal state ethics committee approvals to a unified, country-wide approval system.

Although, the procedural change is effective immediately, the statutes of the ethics committees and §15 of the medical professional code of each state will need to amended before implementation.

Date of application and implementation:

• In case of legal compatibility with national law = With immediate effect
  • The procedure is effective immediately, provided that the (professional) legal requirements of the ethics committees established under state law allow this. The wording of Section 15 of the MBO-Ä does not contradict the proposed procedure “One study – one vote”
• In case of need for legal changes = Follow-up vote in the transitional period
  • If (professional) legal requirements do not permit the immediate application of the procedure, a follow-up vote, i.e., a “second consultation”, is temporarily carried out for medical study participants. This means that the locally responsible ethics committee follows an existing vote without any additional examination, if possible, insofar as this is permitted under state law.
• Note for studies submitted under the old procedure = For all studies
  • For applications submitted under the old procedure, the old legal situation will continue to apply. Amendments to these studies will be discussed locally if local consultation is required under the relevant state and statutory law. It must be ensured that applicants receive a vote if this is legally required for them.

Further information can be found on the website of your local ethics committee.

Ref 1: Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK) – Press Release – One Study – One Vote: Uniform Procedure for Professional Advice on Research Projects Adopted (20 June 2024)

Link: https://www.akek.de/wp-content/uploads/2024-06-20_PM_Gemeinsame-PM_AKEK_Verfahrensvorschlag.pdf 

Ref 2: German Medical Association (BÄK) and the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK) Procedural Proposal for the Harmonisation of Professional Advice in Accordance with § 15 MBO-Ä

Link: https://www.bundesaerztekammer.de/fileadmin/user_upload/BAEK/Themen/Medizin_und_Ethik/2024-06-15_Verfahrensvorschlag_Harmonisierung_berufsrechtliche_Beratung_BAEK_AKEK.pdf 

Ref 3: (Model) Professional Code of Conduct for Doctors Working in Germany (MBO-Ä)

Link: https://www.bundesaerztekammer.de/themen/recht/berufsrecht 

BfArM – Federal Institute for Drugs and Medical Devices;NIS = Non-Interventional Study; PASS = Post-Authorisation Safety Study; PEI  = Paul-Ehrlich-Institute (PEI) = The Federal Institute for Vaccines and Biomedicines

Note – Numerical listings in the “Approvals” and “Other Start-Up Requirements” are not an indication of chronological order

• Study involves an approved medicinal product used as per approval.
• Observational (non-interventional) study design.
• Lead committee approval required.
• Prospective drug observation studies (AWBs) need to be notified to the competent authority (either BfArM or the PEI), as well as to (1) The Central Federation Association of the Statutory Health Insurance Funds (GKV), (2) The Federal Panel Doctors’ Association (KBV), and (3) The Association of Private Health Insurance Companies (PKV)
• Publishing the study data on a public register (e.g., HMA-EMA Catalogue of Real-World Data Studies) is mandatory for Prospective drug observation studies (AWBs) and post-authorisation safety studies (PASS)
• Retrospective drug observation studies (AWBs) and disease registries DO NOT need to be notified to the competent authority (either BfArM or the PEI), as well as to (1) The Central Federation Association of the Statutory Health Insurance Funds (GKV), (2) The Federal Panel Doctors’ Association (KBV), and (3) The Association of Private Health Insurance Companies (PKV)
• Publishing the study data on a public register (e.g., HMA-EMA Catalogue of Real-World Data Studies) is optional for Retrospective drug observation studies (AWBs)
• Other approvals required for imposed post-authorisation safety studies (PASS)