The G-BA has invited various experts on the topic of “The impact of the EU on the legal frame of the statutory health insurance system in Germany. Experts included Prof. Becker (Max-Planck-Institute), Prof. Ebsen (Goethe University Frankfurt a.M.), Prof. Straeter (Straeter law firm), ministerial officer Schulte (Ministry of Health), Prof. Schaefer (University of Applied Sciences Fulda) and the Head of the G-BA Prof. Hecken.
Various presentations were given with respect to the impact of the new medical device regulation and its potential impact especially on product scarcity. A special focus was also given on the joint EU-HTA recommended by the European Commission.
The conclusions across the speakers for the IVD regulation was that delivery bottlenecks are expected, as the number of Notified Bodies is not sufficient!
- “Notified Bodies”, which previously carried out the certification, are now accredited. Currently there are only 7 companies that are allowed to certify from 20.5.2020. The small number would delay the certification considerably.
- Previously, the state authorities were responsible for monitoring medical devices. From 25.5.2020, this will fall within the remit of the BfArm, i.e. the BfArm itself can withdraw medical devices from the market.
- British Standard Institution issues 2/3 of CE certificates in UK and is now accredited as Notified Body in Germany
On the EU joint HTA there were mainly still a lot of questions how that could finally be implemented in Germany. There are four key issues that are currently being discussed:
- Legally binding: alternative compromise ideas with more scope for the member states are currently being developed for this purpose.
- Judicial redress: would an EU HTA assessment be an administrative decision or a preparatory measure to a decision?
- Scope: newly authorised medicinal products (proposal D/F: selection of 10 products per year); medical devices (proposal D/F: selection of some high-risk products)
- Dispute resolution in proceedings: is a simple or qualified (55 % of Member States with 65 % population) sufficient?
Further insights into the procedure:
- Normally, the Council negotiates between Parliament and the Commission; this is the first time that parliament mediates between the Commission and the Council.
- Theoretically, failure would be possible, but would be a major setback for the EU.
- Agreement between Commission, EU Parliament and EU Council (“Trilogue”) expected in 2020
- Depending on how long the procedure will last, the question is which country as President of the Council will end the procedure: 1. HY 2020: Croatia; 2. HY: Germany
Prof. Hecken also made it quite clear that the draft regulation is too early for drugs. The results of EUnetHTA should have been awaited and evaluated until 2021. Additionally, there cannot be one EU evaluation without a common methodology paper. And the crucial questions remain: “What is the conclusion of the EU evaluation report? How legally binding will the recommendation / decision be? Will there be a regional scope to reflect the supply context?”