Agreement on the harmonization of health technology assessment within the EU under the presidency of Germany likely in the second half of 2020

Ortwin Schulte, head of the Department of the Permanent Representation of Germany to the EU, provided information about the current status of the negotiations for the EU-wide harmonization of the various, differently performed HTA procedures for pharmaceutical products and medical devices at the symposium of the Federal Joint Committee (G-BA) on the 2nd December 2019 in Berlin. The first reading in the European Parliament was positive but the position of the European Parliament was contrary to the position of some national parliaments who are against a full harmonization. According to Schulte, after years of tough negotiations the political pressure for an agreement on the European level was very high. An agreement could be expected under the German presidency in the second half of 2020.

The Commission's proposal from January 2018 includes the legally binding effect of the European HTA based on Article 114 AEUV. In contrast, some member states wish for a consideration of national particularities citing Article 168 AEUV, which guarantees the continuance of the national health care system. From a German perspective, some "red lines" are to be debated, which were submitted in a collective letter from the health ministries of Germany, France, Spain, Poland, Czechia, and Bulgaria in December 2018. France, Germany, and Spain alone could build a blocking minority against the full harmonization with more than 35% of the voting rights so that the Commission's proposal would not end in a compromise.

Another point of discussion is the scope of application of the EU-HTA: while the Commission wants all newly approved drugs (approximately 45 per year) and a selection of medical devices, especially those considered high-risk products, to be assessed in a new coordinating group, Germany and France propose a selection of 10 drugs and the selection of medical devices on a case-by-case basis.

Ortwin Schulte concluded that the Commission's current proposal did not seem to be politically enforceable but with the new constellation of the Commission and the upcoming German presidency an agreement could be expected next year.

Author: Heike Kielhorn

source: https://www.g-ba.de/downloads/17-98-4918/04_Schulte_G-BA-EU-HTA-Dez-2019.pdf