E.U. Proposes New Policy for Reviewing Medicines

The European Commission proposed various steps to accelerate the approval of drugs and devices by E.U. member states. The proposed regulation on health-technology assessments would allow member states to identify emerging technologies; use common tools, methods, and procedures for joint clinical assessments and scientific consultations; and continue voluntary cooperation in other areas.

“The health-care sector is a crucial part of our economy [and] accounts for approximately 10 percent of the E.U.’s gross domestic product,” said Jyrki Katainen, European Commission Vice President for Jobs, Growth, Investment and Competitiveness, in a statement. The regulation “will bring benefits to patients all over Europe, while encouraging innovation.”

The proposal comes as drug makers are seeking ways to more readily gain needed regulatory approvals. In a statement, Nathalie Moll, head of the European Federation of Pharmaceutical Industries and Associations, called the proposal a “positive, collective step forward.” Joint clinical assessments, for instance, “will facilitate faster access, avoid duplication at a national level, and deliver greater consistency, clarity, and predictability for everyone involved in the process.”

Source: STAT News, January 31, 2018.