E.U. Proposes Union-Wide Health Technology Assessments

Posted February 5, 2018

In a regulatory move intended to speed up access to new medical technologies, the European Union has announced plans to overhaul the assessment of health technology through the use of joint clinical assessments within its 28 constituent countries. The plan would reduce the overlapping—and sometimes competing requirements—that manufacturers face when their products are evaluated in individual E.U. member countries.

Currently, health innovators who have cleared E.U. regulatory hurdles must also submit clinical evidence to individual regulators, such as Germany’s Institute for Quality and Efficiency or France’s Haute Autorité de Santé. The proposed Regulation on Health Technology Assessment would allow union-wide pooling of resources and expertise to avoid “duplications in the assessment of the identical products,” said Vytenis Andriukaitis, European commissioner for health and food safety, in a statement.

Based on the proposal, E.U. member states will be able to use common health technology assessment (HTA) tools, methodologies, and procedures for:

  1. Joint clinical assessments, which are intended to focus 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. Identification of emerging health technologies to identify promising technologies earlier.
  4. Continuing voluntary cooperation in other areas.

The proposal could have far-reaching effects on the E.U. and world economy, as the healthcare industry is responsible for 10% of the union’s gross domestic product, according to the European Commission.

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

To become a reality, the proposed regulation will need to pass the European Parliament and the Council of Ministers, after which it would go through a three-year phase-in period. At that point, individual countries within the E.U. would still be responsible for nonclinical health technology assessments, such as measuring economic, social, or ethical impacts, as well as determining pricing and reimbursement, according to the European Commission.