In December 2008, the European Commission adopted the 'Pharmaceuticals Package', consisting of three legislative proposals and a communication, with the overarching objective of ensuring that European patients continue to benefit from access to safe, innovative and accessible medicines produced by a competitive pharmaceutical industry.
The package included:
Information to Patients
The proposals concerning the provision of information to patients on prescription-only medicinal products have proven highly controversial. The proposals seek to address the increasing demand by patients for information on prescription-only medicinal products by ensuring equal access to high quality information across the EU.
However, a number of stakeholders question the ability of the pharmaceutical industry to provide balanced and unbiased information, and different approaches to patient information in different EU countries mean that it is difficult to see a way forward, and it likely that the status quo will remain for the forseeable future.
Counterfeit medicines and pharmacovigilance
By contrast, discussions on the proposals on counterfeit medicines and pharmacovigilance are progressing steadily. As regards counterfeit medicines, negotiations are focussing on finding appropriate measures to ensure the security of the supply chain and the authencity of medicines, without placing undue restrictions on trade. The discussions on pharmacovigilance are looking at streamlining systems to reduce duplication, whilst improving transparency and increasing the involvement of patients and the public in the monitoring of the safety of medicines.
Next steps
The NHS European Office will continue to monitor the pharmaceuticals package as it passes through the legislative process and we are working closely with the MHRA to ensure that the any new legislation complements the existing UK framework.