10 April 2024
Pharmaceuticals & healthcare

Good, but room for improvement: European doctors’ reaction to pharmaceutical legislation revision

The Standing Committee of European Doctors (CPME) welcomes the European Parliament reports of the revision of the EU General Pharmaceutical Legislation and provides recommendations for future negotiations to guarantee accessibility and effectiveness of medicines for patients.
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We welcome the strong focus on addressing medicine shortages and strengthening security of supply, especially by proposing earlier notifications, and an obligation to have shortage prevention plans in place. Improved communication about shortages and alternatives for prescribers is also a good development. Nevertheless, the security of supply could be further improved by establishing mandatory safety stocks of critical medicines at the company level.

Second, access to medicines for patients should not be determined by where they live. Therefore, we welcome the obligation for marketing authorisation holders to, in good faith, file for pricing and reimbursement of a medicine upon a request by a Member State as a step towards more equitable access for patients.

Third, the European Parliament position gives room to Member States to choose if the package leaflet should only be available online. While digitalisation offers opportunities to enhance information delivered to patients, we strongly believe that the electronic product information should never replace the paper version included in medicine packets, but remain complementary.

CPME President Dr Christiaan Keijzer said “We are hopeful that the pharmaceutical package reform contributes to more sustainable healthcare systems and helps patients to have timely access to the medicines they need. Addressing medicines shortages and security of supply is paramount.

“We also need an effective approach to antibiotic innovation. We believe the Transferable Exclusivity Voucher is not the way forward and are encouraged to see that other solutions are on the table.”

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