legislative developments

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.
Continue Reading Another round of upcoming amendments to the medicines laws in Germany – Clinical Trials, Advertising, Biologics and more…

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.
Continue Reading Comprehensive Amendments of German Drug Laws upcoming

This article was originally posted on our sister blog Inside Medical Devices

On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the medical devices and IVD framework. The European Commission considers this as “a major step forward towards the adoption of new regulations on medical devices to help guarantee a high level of health and safety protection for EU citizens using these products.”

This agreement is based on the technical work of the Permanent Representatives Committee of EU countries which finalized the Council’s position on the draft Medical Devices and IVD Regulations on September 23, 2015. The core substance of the Council’s position was already agreed in a partial General Approach on the draft EU medical devices package on June 19, 2015 (for details please see our previous post of early September). The final agreement of October 2015 does not deviate from the substance of that partial agreement of June 2015. The main difference is that it includes a general approach on the recitals of the draft Regulations on medical devices and IVD. Preambles of EU legislative instruments do not have a binding effect; however, they are useful in the interpretation of rules and usually consulted by EU and Member State institutions and courts in their application of the law.
Continue Reading EU Agreement on a General Approach on the Medical Devices Package

This post was originally published on our sister blog Inside Medical Devices.

On June 19th, 2015, the Council of EU Ministers reached a partial General Approach on the review of the medical devices and in vitro medical devices (IVD) rules in the EU (an overview of the texts is accessible here).  The General Approach does not yet include the recitals to the new medical devices and IVD regulations.

The Council’s text on the new IVD Regulation significantly amends the Commission’s proposed definition of ‘companion diagnostics’, an evolution relevant to sponsors of both medicinal products and diagnostic devices.  The Council’s definition of companion diagnostics is almost identical to the definition used by the FDA, but significantly different from the European Commission’s proposal and the European Parliament’s suggested amendments.  An overview is set out below.
Continue Reading IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition