Medical Devices
(BRUSSELS) – A proposal to boost cooperation amongst EU Member States for assessing health technology will boost innovation and improve the competitiveness of Europe’s medical industry, says the Commission.
The Commission says greater transparency will empower patients, by ensuring their access to information on the added clinical value of new technology that could potentially benefit them. More assessments could lead to effective, innovative health tools reaching patients faster.
National authorities would be able to formulate policies for their health systems based on more robust evidence. Furthermore, manufacturers will no longer have to adapt to different national procedures.
“We are proposing a regulatory framework that will bring benefits to patients all over Europe,” said Commission vice-president Katainen, “whilst encouraging innovation, helping the take-up of high-quality medtech innovations and improving the sustainability of health systems across the EU.”
“I also expect this initiative to result in a more efficient use of resources by Member States through the pooling of resources and exchanges of expertise, thereby avoiding duplications in the assessment of the identical products,” said Health Commissioner Vytenis Andriukaitis.
The healthcare sector is an important part of the European economy and accounts for approximately 10 per cent of the EU’s GDP.
The proposed Regulation on Health Technology Assessment (HTA) covers new medicines and certain new medical devices, providing the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas. Member States will be able to use common HTA tools, methodologies and procedures across the EU, working together in four main areas:
1) on joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients;
2) on joint scientific consultations whereby developers can seek advice from HTA authorities;
3) on identification of emerging health technologies to identify promising technologies early; and 4) on continuing voluntary cooperation in other areas.
Individual EU countries will continue to be responsible for assessing non-clinical (e.g. economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement.
The proposal will now be discussed by the European Parliament and the Council of Ministers. It is expected that once it is adopted and enters into force, it will become applicable three years later. Following the date of application, a further three-year period is envisaged to allow for a phase-in approach for Member States to adapt to the new system.
Health Technology Assessment - background guide
