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Focus on Regulation

The European Parliament adopted a report on the Commission Proposal for a Regulation on Health Technology Assessment

On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA). HTA is a multidisciplinary process or tool to analyse issues related to the use of a health technology. HTA is applied to assess the added value of a given health technology compared to other technologies for the same purpose. The Proposal covers new medicinal products and certain medical devices. It would provide the basis for permanent EU-level cooperation in four areas: joint clinical assessments; joint scientific consultations; identification of emerging health technologies; and voluntary cooperation on other aspects of HTA.

The proposal seeks to ensure that when HTA is performed, the methodologies and procedures applied are more predictable across the EU and that joint clinical assessments are not repeated at national level, thereby avoiding duplication and discrepancies. The Report recognises that current approaches lead to “higher costs for industry, delays in access to technologies and a negative effect on innovation.

In a statement, the European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomed various aspects of the draft Regulation. EFPIA strongly supports the original European Commission’ proposal to require EU Member States to use joint clinical assessments and not duplicate these in their national HTA processes.

Concerns have been raised by some EU Member States that joint clinical assessments might lead to the loss of control of a Member States’ ability to decide on prices. Deciding on reimbursement and pricing of medicinal products is a national competence of the Member States. EFPIA’s Director General explained that clinical assessments “feed directly into pricing mechanisms and that pricing is and should continue to be a national competence. It is inextricably linked to a country’s economic conditions and the organization of its healthcare system.”

The Director General considers, however, that the HTA Regulation is foremost a matter of defining on an EU level which evidence to expect from innovator companies: “Clinical assessments you can do across Europe, cost effectiveness has to be done country by country.” She feels that there is an opportunity to ensure that there is one EU wide, strong scientific basis for national HTA decisions. This is a basis that is founded on the right evidence to answer the research questions at hand. The combined pool of expertise from the EU Member States could only be to the benefit of all stakeholders involved, according to the Director General.

EFPIA stressed that some of the amendments introduced to the Proposal open a door for EU Member States to conduct their own “complementary assessment”. This could lead to additional hurdles, delays and waste of resources. The next step in the legislative procedure is the 1st reading in the European Parliament.