French Legislation Comes in for Strong Criticism - Applied Clinical Trials

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French Legislation Comes in for Strong Criticism

Source: Applied Clinical Trials

The French government’s intention to broadly enlarge the use of off-label drugs for economic reasons, even if there is an approved drug available, is wrong, according to a statement issued by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

On Tuesday, the French National Assembly voted in support of the draft law proposal, which could allow doctors to use off-label drugs. even if there is an alternative drug approved. This draft law has still to be reviewed by the French Senate, and a review by the French Constitutional Court is also possible.

The draft law specifically references a Roche cancer drug  (Avastin) as an alternative eye treatment for wet age-related macular degeneration, an indication for which the drug is not approved and for which two authorized alternatives exist.

“A worrying trend is growing across Europe with governments bypassing important health safeguards and making public health decisions based purely on short-term economic considerations,” noted Richard Bergström, EFPIA Director General. “This move is a material breach of the regulatory framework created to preserve the highest standard of patient safety in Europe.”

The European Commission (EC) must address the issue urgently before it becomes more widespread, and EU member states should not be creating secondary, national marketing authorizations for reasons that undermine the EU regulatory framework and may put patients at risk and deliver only short-term economic gains, he said.

“If public authorities continue to promote off-label use of other, less costly, medicines that have not undergone stringent safety and efficacy assessments, pharmaceutical companies will be discouraged from undergoing the costly and time-consuming authorization process for new indications,” noted Bergström.

EFPIA wants the EC to ensure member states adhere to the European regulatory framework and that financial considerations do not take precedence over the safety of patients.

Read the full release here.

Editor's note: EUCOPE has also commented on the legislation. You can read their response here.

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