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.