The European Commission announced on Wednesday agreed on a proposal to regulate Health Technology Assessment co-operation (HTA) aimed at promoting cooperation between the EU member states when evaluating health innovations and ensure greater access to information for all EU residents.
Member states will be able to “design policies based on more robust evidence” and have more effective tools at their disposal for manufacturers “who will never again have to adapt to different national procedures.”
According to the Commission, the proposal will affect new medicines and also certain medical devices, and serve as the basis for “permanent and sustainable cooperation at an EU level for joint clinical assessments in these areas”.
EU member states will be able to use common tools and procedures in areas that include joint clinical assessments, innovations, and consultations.”
Individual countries will continue to be responsible for pricing once the proposal enters into force. After the initial three year implementation period an additional three-year assessment will take place so EU members have enough time to make any alterations to the new system.
The measure was presented by Vice President Jyrki Katainen, who stressed that strengthening cooperation in the HTA field will be “a stimulus for innovation and will improve competitiveness within the medical industry, which is a fundamental part of our economy and contributes to around 10 percent of the EU GDP.
“What we propose is a regulatory framework that will benefit patients, while promoting innovation and improve the sustainability of our health systems,” said Katainen.
Health Commissioner Vytenis Andriukaitis said the proposal allows the European Commission the chance to promote a regulation that will improve health care for the benefit of patients and make the process more efficient for every citizen.