EMEA highlights legislation package for 2009

The European Commission promised the industry a number of "Christmas presents" in the form of the soon to be released "Pharma Package" at the annual EMEA Legislation Update held in London this month.

At the forum, hosted jointly by The Organisation for Professionals in Regulatory Affairs (TOPRA) and the EMEA, Irene Sacristan Sanchez from the European Commission, DG Enterprise & Industry Directorate F unit F2, highlighted three new legal proposals designed to enhance the safety and availability of medicines.

1. Safety of the supply chain - a proposal to make counterfeit medicines less likely.

2. Information to patients - to improve pharma's ability to communicate with patients.

3. Pharmacovigilance - to provide stronger public health protection through clarification of the rules.

The new Directive's proposal on information to patients is the most controversial element of the Commission's 'Pharma Package'. The new rules would maintain the general ban on direct advertising for prescription drugs but would allow the industry to provide "additional information" to the public via the media. Sacristan Sanchez said, however, that the European Parliament and EC held different positions on this matter and discussions are ongoing.

In addition to these proposals, she reminded delegates that the Variations Regulation, published in December 2008, would be effective in 2009.

This regulation aims to make the overall EU system simpler and more flexible. In particular it aims at amending the legal basis for the adoption of Community rules on variations in order to harmonise those rules for all authorised medicines in the EU.

Meanwhile, the specifically tailored legal framework for gene therapy, somatic cell therapy and tissue engineered products - known as advance therapies - will apply from 30 December. However some of the guidelines from the agency and the European Commission that will be used to implement the legislation are currently being revised.

Sacristan Sanchez also suggested that the EMEA's role had grown dramatically since its inception, and that as a consequence its organisation and structure was under review.