PGEU, the European Association representing Community Pharmacists, welcomes the Pharmaceutical Package released by the Commission today.

Anti-Counterfeiting
In the view of PGEU, it is vital to take action against the growing threat of counterfeit penetration of the regulated supply chain, and the Commission’s initiative is to be applauded. The proposal clearly recognises the key role the pharmacist plays as the last line of defence against harm caused by counterfeits. The addition of a safety feature to medicines packs, with the potential to authenticate the pack in the pharmacy, will be a major step forward in ensuring that patients will be protected against potentially lethal fakes. Although crucial issues like data privacy and cost will
need to be tackled, the PGEU looks forward to working with policy makers and stakeholders to develop practical solutions.

Pharmacovigilance
Europe’s pharmacists strongly favour all efforts to build a more robust and user-friendly Pharmacovigilance system. We are pleased to see the focus put on both strengthening transparency and communication on medicine’s safety issues, and strengthening the reporting system for adverse reactions by rationalising the current system and involving all stakeholders in pharmacovigilance. PGEU particularly welcomes the emphasis put on the Eudravigilance database as we believe it is important to provide access to a user-friendly Eudravigilance database, targeting not only experts on regulatory affairs but also health professionals in general and patients.

Information to Patients
PGEU welcomes the fact that the Commission has pulled back from some of the more extreme ideas floated in the original consultation on this issue. We particularly welcome the emphasis on quality criteria and the recognition of the key role of health professionals such as pharmacists in this area. PGEU made a significant contribution to the elaboration of the quality criteria in the Pharmaceutical Forum. We also applaud the fact that the Commission has recognised that there cannot be an information ‘free for all’ and that a degree of supervision of information, prior to
dissemination, is necessary if the public is to be effectively protected.

PGEU Secretary General Mr John Chave said “In broad terms this is a sensible package of proposals, and good news for Europe’s patients. On information to patients the Commission seems to have accepted that there are genuine dangers in a radical liberalisation of the current regime. On Counterfeiting, Europe’s pharmacists look forward to working with other stakeholders to make authentication practical, affordable and effective, while respecting confidentiality of data.”

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Information for Editors
The Pharmaceutical Group of the European Union (PGEU) is the European association representing community pharmacists. PGEU’s members are the national associations and professional bodies of pharmacists in 30 European countries, including EU Member States, EEA members and EU applicant countries.