On 11 November 2016, the German Parliament passed another new law amending different parts of the German Medicines Act (Arzneimittelgesetz) and the Act on Advertising for Healthcare Products (Heilmittelwerbegesetz). The law is titled “Viertes Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften“. The draft was deliberated in the health committee of the Federal Council (Bundesrat) on 30 November 2016 and it has become clear that the Federal Council will not object to it in its final deliberations later this month. Therefore, the new law will likely become effective at the beginning of 2017.

The new law especially amends the existing clinical trial rules so that German law will comply with the new Clinical Trials Regulation (EU) No 536/2014. The amendments  particularly affect the approval procedure for new studies and the competencies of the ethics committees and regulatory authorities. While currently, two full stand-alone approvals for a study are required (i.e., from the ethics committee and the competent authority), under the new law, certain parts of the ethics committee’s opinion may be overruled by the authority. In addition, a new federal ethics committee can be established by the regulatory authorities which would additionally lead to significant changes in the procedure.

One controversial issue in the new law was related to studies with incapacitated adults, for example, patients suffering from dementia, which implements a complicated mechanism to exceptionally enroll such patients into relevant studies. The amendment act further clarifies that incapacitated adults and minors may express their will to refrain from participating in a trial through any means which communicate this will.

With the new act, several other amendments will be enacted in other areas of the German pharmaceutical rules that go beyond clinical trials. These include, among other things, amendments to the

  • Requirements for the dispensing of prescription medicines.
  • Competencies to the regulatory authority to take measures against potentially counterfeited drugs and active substances.
  • Formal requirements for notifications about non-interventional studies.
  • Broadening of the regulatory authority’s pharmacovigilance tasks for biologic medicines.
  • Use of drugs or vaccines without authorization to participate in international humanitarian missions.
  • Advertising laws: The new law also identifies the promotion and sale of prescription medicines via teleshopping as unlawful advertising and further broadens the existing restrictions for the promotion of teleshopping. This ban includes the promotion of any medical treatment via teleshopping.

Most legislative amendments will become effective on the day after the new law’s publication in the German Federal Gazette (probably early 2017). The remaining parts, mainly the revisions of the clinical trial rules will become effective six months after the European Commission has issued the notice under Art. 82 (3) of the Clinical Trial Regulation (probably second half of 2018).

Source: The original draft bill and the accepted amendments are available here (German). A consolidated version is not yet available.

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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: