The European Union (EU) has instituted a proposal to boost cooperation among EU member states for assessing healthcare technologies. After all, EU officials say, more assessments could lead to effective, innovative health tools reaching patients faster. For national authorities, it means being 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.

“Reinforcing Health Technology Assessment cooperation at EU level boosts innovation and improves competitiveness of the medical industry,” European Commission Vice President Jyrki Katainen said in a statement. “We are proposing a regulatory framework that will bring benefits to patients all over Europe, while encouraging innovation, helping the take-up of high-quality medtech innovations and improving the sustainability of health systems across the EU.”

Vytenis Andriukaitis, the European commissioner for health and food safety, added: “The commission has put the wheels in motion for better quality, innovative healthcare for the benefit of patients, especially those with unmet medical needs. 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.”

The proposed Regulation on Health Technology Assessment (HTA) covers 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. Joint clinical assessments, focusing on the most innovative health technologies with the most potential impact for patients
  2. Joint scientific consultations, whereby developers can seek advice from HTA authorities
  3. Identifying emerging health technologies to identify promising technologies sooner
  4. Continuing voluntary cooperation in other areas

Moreover, European nations will continue to be responsible for assessing non-clinical aspects of health technology, and making decisions on pricing and reimbursement.

The next step is for the proposal to be discussed by the European Parliament and the Council of Ministers; once adopted and enforced, the proposal will be implemented 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.