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The Knowledge-Sharing Platform

31 Jan 2018

Commission proposes to reinforce cooperation amongst Member States for assessing health technology

On 31 January 2018, the Commission put forward a proposal to boost cooperation amongst EU Member States for assessing health technology. After more than 20 years of voluntary cooperation in this area the Commission aims to achieve greater transparency to 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. The proposed measures should encourage innovation and help the take-up of high-quality medtech innovations .

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.

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.

EC Press Release

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