Recently, the German Federal Ministry of Health published a new draft law (“Viertes AMG-Änderungsgesetz”) which aims to amend several provisions of the German Drug Act (Arzneimittelgesetz) and other drug-related laws.

Most of the intended amendments result from an adjustment of German laws to the new European Clinical Trials Regulation (Regulation (EU) No. 536/2014). For instance, several provisions of the German Drug Act related to clinical trials (e.g., definitions) will then refer to the Clinical Trials Regulation or are amended accordingly. The German Ordinance on Good Clinical Practice (GCP-Verordnung) will cease to be in force. Furthermore, some amendments, particularly those that refer to the informed consent of study subjects, will go beyond the scope of the Clinical Trials Regulation.

For example, it is foreseen that the trial-related information are given to the study subject by a medical doctor and not “only” by a member of the investigating team. Also, clinical trials on incapacitated subjects may only be conducted in Germany if there are scientific grounds for expecting that participation in the clinical trial will produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved. In contrast to the Clinical Trials Regulation, under the new draft law it shall not be sufficient that such benefit exists for the population represented by the incapacitated subject concerned.

Besides, the new draft law includes transitional provisions for clinical trials. The current versions of the German Drug Act and the German Ordinance on Good Clinical Practice shall apply for another 3 years to clinical trials for which an authorization was requested within 6 months of the notification that the EU portal and the EU database have achieved full functionality. If such authorization is requested within 6-18 months of such functionality notification, the trial sponsor may choose whether the clinical trial shall be subject to the new or the old regulatory regime. In the latter case, the provisions of the German Drug Act and the German Ordinance on Good Clinical Practice shall apply for another 3 years.

In addition to these clinical trials-related amendments, the German Drug Act and other drug-related laws shall be changed. These amendments refer, inter alia, to pharmacovigilance and drug advertising rules. The existing pharmacovigilance rules are going to be expanded to cover specific measures related to the product surveillance of biological drugs (especially biosimilars) and their tracing and tracking. Additional changes of the German Radiation Protection Ordinance (Strahlenschutzverordnung) and the German X-Ray Regulation (Röntgenverordnung) are also intended, but not yet specified.

As a next step, the new draft has to be agreed upon by the German government. Afterwards, it will be subject to further parliamentary deliberations. It may be adopted during the next year, but will only take into effect after the EU portal and the EU database have achieved full functionality.

Pharmaceutical companies should carefully monitor this process as it will directly impact their regulatory obligations related to clinical trials in Germany – but also obligations beyond clinical trials.

Tags: Biological Drugs, Biosimilars, Clinical Trials, Clinical Trials Regulation, German Drug Act, Germany, legislative developments, life sciences, Medicinal Products, Pharmaceutical Companies
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Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem is a life sciences industry advisor with more than 25 years of professional experience. He has a broad practice that cuts across regulatory, compliance, IP, privacy and liability matters. Adem also provides strategic advice. He knows the life sciences sector also from…

Adem is a life sciences industry advisor with more than 25 years of professional experience. He has a broad practice that cuts across regulatory, compliance, IP, privacy and liability matters. Adem also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “Adem Koyuncu is one of the most intelligent lawyers I know.” (Legal 500 2023)
  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • “Great professional and human competence, good team player.” (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “He is an excellent dispute resolution lawyer and advises at the highest level, including, in particular, strategic advice.” (Legal 500 2023)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.” (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

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