The European Commission on Thursday finalized rules on how it pools expertise from across the EU to assess the effectiveness of new drugs when compared to drugs already on the market. The rules are part of a broader initiative to bolster collaboration across the continent for evaluating and paying for new products.
Under the current framework, new health technologies undergo national-level assessments to determine their cost-effectiveness, which can be expensive and time-consuming. The new rules set timelines and concrete steps that member countries should follow when conducting joint assessments.
Under the finalized rules, the EC will distribute assessment reports to member countries following marketing authorization of a drug or biologic to assist them in determining how to handle the product in their own health systems.
The rules also lay out how the EC will coordinate with the European Medicines Agency on exchanging information and selecting experts and patients to consult with on the assessments.
The joint clinical assessment framework is one of six acts the EC has in the works as part of its Health Technology Assessment Regulation, which aims to create a more efficient pathway for assessing how well new medical products work compared to existing ones.
Stella Kyriakides, the EC’s Commissioner for Health and Food Safety, touted the new regulation as a way to more quickly authorize medical products and improve access across the European Union.
“We need to continue working together with Member States, health technology developers, patients, and experts from the scientific and clinical communities to make the most out of the EU’s health technology assessment framework,” she said in a statement.
The finalized rule comes after the EC released a draft version back in March.
Joint clinical assessments for medicines with new active substances for cancer treatments and for advanced therapy medicines will begin this upcoming January, the EC said.