EU Proposal Seeks To Address Borderline Product Classification ‘As Early As Possible'

Commentary was attributed to Covington in an article appearing in The Pink Sheet regarding The European Commission's proposal introducing a new mechanism for classifying whether a product under development is a medicine in situations where there are borderline issues.

As noted by Covington, “uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences for developers and innovators.”

Under the proposal, the EMA would be able to give its advice on whether a product is a medicine to developers or national competent authorities, Covington explained.

If an EU member state disagreed with an EMA recommendation, it would be able to “request the commission to decide whether the product is potentially a medicinal product, including an ATMP [advanced therapy medicinal product],” Covington stated.

Any decision by the commission would be “adopted by means of implementing acts, taking into account the scientific recommendations from the EMA,” Covington noted.

Covington added that the commission would also be able to ask the EMA for clarifications or send the recommendation back to the agency for further consideration. “According to the proposal, the Commission may do so where a ‘substantiated request’ from a Member State raises new scientific or technical questions or on its own initiative.”

Covington noted that for products based on substances of human origin (SoHO), the proposal “specifically identifies the SoHO Coordination Board, a new body that will be established by the SoHO Regulation.”

Covington also noted that the commission’s proposal for a SoHO Regulation “introduces an obligation on national competent authorities to consult authorities established in other relevant EU legislation (ie, medical devices, medicines, food) in cases where questions arise as to the regulatory status of a substance, product or activity.”

“The proposal for the SoHO Regulation is still going through the legislative process, so it is not clear how the borderline issues will be tackled in the final text,” Covington said. “Since the proposal for the SoHO Regulation and the proposals for the revision of the pharmaceutical rules are linked, the debate over the SoHO Regulation proposal should be closely monitored to anticipate possible changes to the proposed mechanism for medicinal products.”