Impartial Chair of the Federal Joint Committee (G-BA) considers EU-HTA a legitimate approach

All together, it 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.

According to Hecken, in order for the well-established AMNOG-procedure not to be hampered or replaced by an ineffective or inefficient EU procedure, EU-HTA must fulfill "tough" conditions:

• Scientific questions, for example concerning study requirements, methods, endpoints, or surrogate parameters, must be addressed uniformly.
• The fundamentals of the Social Insurance according to Article 168 should form the legal basis instead of internal market regulations to prevent an EU intervention with national health care regulations and goals.
• There should be an unconditional opt-out option after the determination of the appropriate comparative therapy. The standard of comparison would have to be determined on the national level.
• The differentiation between assessment and appraisal should be clear-cut. The national institutions' authority for the assessment of an added benefit related to the national health care context should be kept untouched.
• The EU-members build a Coordination Group for the joint assessment of technology, whose resolution must occur in consensus. The EU Commission must not have voting rights within the Coordination Group (no right of permission of the EU Commission, safeguard clause), which would enable the Commission to modify the general methodological standards and eventually override the Coordination Group's position.

Hecken expects an agreement within the EU in 2020. However, for the development of a "clean method", a final conclusion from the EuNetHTA program was still missing and other important topics, such as the role of national patient representatives and representatives of medical societies, remained to be clarified. In any case, according to Hecken, the initiative comes too early for medicinal products.

SKC consulting did participate 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/