Out-Law News 3 min. read
25 Jun 2021, 9:27 am
A trade body representing some of the world’s biggest pharmaceutical manufacturers has expressed its “regret” at an agreement reached by EU law makers on the reform of the current system of health technology assessments (HTAs).
The European Federation of Pharmaceutical Industries and Associations (EFPIA) was commenting after a political agreement was reached by the European Parliament and Council of Ministers on a new EU regulation on HTAs.
HTAs are holistic assessments of the medical, social, economic and ethical issues associated with introducing new health technologies, whether medicines, medical devices, surgical procedures or other measures for disease prevention, diagnosis or treatment used in healthcare. The assessments aim to establish, among other things, how effective prospective new health technologies are relative to those already on the market, as well as what added value they might deliver.
Currently in the EU, if a business wants to market a new health technology it must go through separate HTAs within each EU member state. Each HTA is conducted in accordance with different national processes and methodologies, and developers of health technologies are commonly confronted with multiple requests from assessment bodies for data and other evidence in support of their products.
The European Commission previously said that the different way in which HTAs are conducted “lead to differences in how evidence is considered in assessments” and that this can “contribute to delays and inequalities in availabilities of innovative health technologies for patients”. In early 2018 the Commission published a draft new EU regulation on HTAs seeking to address this problem with a more joined-up approach to HTAs across the EU. Under its proposals, it envisaged that a new coordination group comprised of representatives from national HTA authorities would carry out joint clinical assessments of, and scientific consultations on, new health technologies.
However, some EU member states pushed back on the Commission’s proposals, believing that they strayed into areas of health policy that each government within the EU was free to set itself. News that the Council of Ministers and European Parliament had reached a provisional compromise on the text was announced earlier this week, though full details of the agreed text have yet to be published.
The European Commission welcomed the political agreement of the EU’s two law-making bodies and said the regulation would “be a significant step forward to enable joint scientific assessments of promising treatments and medical devices at EU level”. EFPIA, though, expressed its concern with the compromise reached. According to a report by Euractiv, the new regulation provides for joint clinical assessments to be “annexed” to national HTAs.
In a statement, EFPIA said: “EFPIA strongly supports a system to pool resources and high level expertise so that medicines can be assessed jointly for their relative effectiveness on the basis of clinical evidence and that joint early scientific dialogue can take place with HTA agencies. However, we regret that a stronger framework for the use of joint clinical assessments could not be agreed upon. We maintain that the shape of the compromise risks introducing an unpredictable system whereby member states decide on a case-by-case basis if and how they commit themselves to use jointly conducted clinical assessments. This will create unnecessary administrative and regulatory barriers to patients’ access to new medicines introduced in Europe.”
“The failure to agree on a predictable, efficient, and non-duplicative system is a missed opportunity, coming at a time when science is radically changing treatment paradigms. Now, more than ever, Europe needs to speak with a coherent voice on clinical evidence in the best interests of patients and our healthcare systems,” it said.
Earlier this month, MedTech Europe, the trade association representing the medical technology industry in Europe, called on the EU law makers to ensure “predictable joint clinical assessments on selected medical technologies”, that the new regulation on HTAs “in no way interferes with regulatory assessments conducted” under EU medical device laws, and to “secure a pre-defined and clear purpose for how clinical assessment reports will be used, to meaningfully contribute to funding and/or investment decisions within the member states”.
The proposed new regulation still has to be formally adopted by the Council and the European Parliament before it can enter into force. The Commission had initially proposed that the provisions would take effect a further three years after the regulation enters into force.
EFPIA is an umbrella body that brings together 36 national trade associations, 39 leading pharmaceutical companies and a growing number of SMEs. Its board comprises representatives from companies such as AstraZeneca, Bayer, Eli Lilly, GSK, Johnson & Johnson, Merck, Novartis, Pfizer, Sanofi, Servier and Teva.
02 Feb 2018