Gareth Jones, public affairs manager at the NPA, considers three recent developments in European legislation

EU decision-making procedures are complex and often take a very long time. Taken in isolation, some of the issues discussed at European level may seem distant to the realities of pharmacy practice here in the UK. In fact, cumulatively, EU legislation has a big impact on business and practice in your community pharmacy.

Through membership of the Pharmaceutical Group of the European Union (PGEU) the NPA works at European level for the benefit of UK independent pharmacies. Recent developments have happened in the areas of medicine shortages, medical devices and veterinary medicines.

Medicine shortages

Representative bodies from across the supply chain at EU level are now meeting to address the issue of medicine shortages. Since January there have been a number of meetings of the stakeholder group, specifically to discuss information systems and improved communications. They have now agreed on an outline for best practice recommendations.

There will be proposals for ensuring that unreasonable delays to medicines supply can be reported and that information on shortages should be more accessible. Stakeholders will also agree on a code of ethics to address specific issues. It is hoped that the proposals will be approved and published later this year.

Medical devices

Medical device legislation covers a wide range of products, from blood glucose monitoring systems to first aid equipment. Like medicines, such products are increasingly subject to illegal trading. Current legislation is being revised which may place obligations on distributors (including pharmacists) and may also put forward the requirement to trace medicinal products using traceability systems in the pharmacy. We are calling for any new system to be compatible with the medicines authentication system, to minimise any new administrative burdens on pharmacy.

Veterinary medicines

The European Commission is proposing a significant reform of legislation on veterinary medicinal products. The proposal includes new provisions that will impact on pharmacy services, including: internet sales of veterinary medicines, the recognition of veterinary prescriptions for human medicines, and modifications to the provision on supply of veterinary medicines.

PGEU has outlined a number of necessary amendments, which include:

• Removing the need for a special licence for the retail of certain medicines
• Record keeping obligations to be at the discretion of the member state.

The European Parliament will be considering the amendments submitted by PGEU in September.