Proposal of EU-commission for Europe-wide assessment – will HTA become centralized?
About the author
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
The term “health technology assessment” defines the assessment of an (added) value for new medicines and medical devices. The single member states of the EU are currently responsible for this matter, whilst a voluntary cooperation between the countries is encouraged by the EU. The legislative proposal of the EU intends to centralize the clinical assessment of new medicines and new medical devices Europe-wide. All other areas of HTA, like economic, social and ethical aspects, should further be subject to a voluntary cooperation.
With the implementation of the proposal, the EU expects a faster market access for innovative products and more transparency for patients and pharmaceutical companies, because the parallel processing of the same issues by different national health authorities would be omitted.
The representatives of the German pharma industry welcome the legislative proposal of the EU-commission. The pharmaceutical association (vfa) emphasizes the potential of a close cooperation between regulatory authorities and value assessment authorities. The German Medicines Manufacturers’ Association (BAH) praises the idea. Nevertheless, Dr. Martin Weiser, managing director of the BAH, also states that it is important “that reimbursement and price configuration of medicines continue to remain in national competences in order to consider local medical supply realities.”
The German health insurance cooperation (GKV-Spitzenverband) on the contrary is afraid of a reduction of the high standards, that exist in Germany due to the mandatory value assessment of medicinal products (according to AMNOG). The German Federal Joint Committee (G-BA) even appraised the proposal as a violation of the regulation by the EU-commission, because the EU has no regulating competence for the social insurances of the EU. “The competence for the regulation of the European market is no sufficient foundation for such an extensive and far-reaching regulation, which has direct and deep effects on the resource allocation of the national health systems and would control market access in a centralized way through this regulation.” said Josef Hecken, unbiased president of the G-BA.
The proposal will now be further discussed in the EU-parliament and the council of ministers. Hence, the process stays exciting. Even if the proposal is realized, central elements are still completely unclear: Does a positive assessment on a European level imply a compulsory market access for the whole of Europe? And vice versa would a negative assessment prohibit a market access on a Europe-wide level?
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BY Prof. Matthias P. Schönermark, M.D., Ph.D., Founder and Managing Director of SKC Beratungsgesellschaft mbH and Karolin Priese, SKC Beratungsgesellschaft mbH
Sources:
European Commission: Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member States
G-BA: Vorhaben der EU-Kommission zur Zentralisierung der Arzneimittelbewertungen zerstört funktionierende Verfahren der Mitgliedstaaten (German only)
GKV-Spitzenverband: EU will Bewertung von Arzneimitteln an sich ziehen (German only)
BAH: BAH begrüßt einheitliches Vorgehen bei der klinischen Bewertung von Arzneimitteln (German only)
vfa: Europa sorgt für frischen Wind in der Nutzenbewertungsdiskussion (German only)