Federal Joint Committee (G-BA) discusses Europe’s influence on the German health care system with experts from science and politics

Tue, 2019 / 12 / 17
On the 2nd of December 2019, experts from science and politics were invited by the Federal Joint Committee (G-BA) to discuss current developments of the European regulations and their influence on the German health care system.

The competences of the European Union were clarified and the effects of the upcoming Medical Device Regulation (MDR) were critically debated. Furthermore, the idea of the harmonization of health technology assessment within the EU ("EU-HTA") was discussed from the German perspective. Another contribution was about the freedom of health care service providers in the context of consequences and limitations of the proportionality test for regulation of professions.

Prof. Dr. Ulrich Becker, director of the Department of Foreign and International Social Law at the Max Planck Institute for Social Law and Social Policy, and Prof. Dr. Ingwer Ebsen, Professor for Public Law at the Goethe University Frankfurt, discussed the European influence on the SHI. Especially through Article 168(4) AEUV, the European Union has a legislative delegation for measures ensuring high quality and safety standards of human products, medical devices, and pharmaceutical products although Article 168(7) guarantees at the same time the autonomy and thus the financing of the national health care systems. That includes, in particular, the access to pharmaceutical products and medical devices as well as the administration of the prices of these products in the respective member states. This conflict is the source for the discussion about the binding effect of European regulations for the national health care systems and institutions and market opportunities for health care companies.

According to Ortwin Schulte, head of the Department of the Permanent Representation of Germany to the EU, an agreement on the harmonization of HTA within the EU can be expected under the presidency of Germany in the second half of 2020, even though the proposal of the Commission from January 2018 will probably not lead to a compromise due to the objections of the Health Ministries from Germany, France, Spain, Poland, Czechia, and Bulgaria.

Professor Josef Hecken, impartial Chair of the Federal Joint Committee (G-BA), also expects an agreement within the Union during the upcoming year but considers the initiative for pharmaceutical products too early. EU-HTA was a "legitimate approach to accelerate the EU-wide access to new pharmaceutical drugs and medical devices for patients" and could eventually reduce the expenditure for pharmaceutical companies or manufacturers. However, the procedure would have to fulfill "tough" conditions, e.g. with respect to scientific questions and the preservation of the national institutions' authority for the assessment of an added benefit related to the national health care context.

SKC consulting has participated in the G-BA legal symposium and reports about the event in this blog series. We would be pleased to discuss the various topics with you.

Source: https://www.g-ba.de/service/veranstaltungen/rechtssymposium-europa/

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