“The Devil is in the Detail” was the premise for the European Commission’s open discussion on the New Pharmaceutical Package

3 March 2009

Belgium 25-26 February - The first in-depth unveiling of the “Pharma Package”* and its implications were discussed at a meeting hosted by The Organisation for Professionals in Regulatory Affairs (TOPRA).

Attended by senior regulatory personnel from across the world, this was “the first and only opportunity to discuss the complete Pharma Package, which represents the most significant changes in pharmaceutical legislation in recent times.” commented Lynda Wight, Executive Director, TOPRA.

Following the political sensitivities around information to patients and the issues around counterfeiting, Martin Terberger, Head of Pharmaceuticals Unit (F2), European Commission, DG Enterprise and Industry, expressed his delight at finally being able to talk about the “Pharma Package”, but he warned: “Those who position themselves politically and who make statements before understanding the package put us in a difficult position. We are looking over 100 pages, and the devil is in the detail”.

Counterfeit Medicines

Irene Sacristan Sanchez from the European Commission announced that this proposal was speeded up to address the emerging health threat presented by counterfeit drugs in the legal supply chain, as well as illegal drug channels. Worryingly, it appears that there is a trend toward counterfeiting life-saving as well as life-style drugs as a lucrative business for those involved in other illegal activities such as terrorism.

Members of the panel, including a representative from Interpol who spoke about the work of International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and the challenge of trying to prevent fake drugs entering the legitimate supply chain, called for increased law enforcement, with significant penalties, as the most important measure, to be reviewed in the fight against counterfeit medicines.

Pharmacovigilance

Concerns of so-called ‘Pharmacovigilanties’ were raised over the Commission’s announcement of a new committee, responsible for providing scientific advice on pharmacovigilance. It would consist of 10 members appointed by the EMEA Management Board and 5 appointed by the Commission’s and thus not all member states would be represented. Irene Sacristan assured the meeting that the members would have a certain level of competence and that this committee would only make recommendations to CHMP or CMD and not take regulatory action itself. Val Simmons (Lilly) made a plea that no special national requirements be introduced.

Information to Patients

Exciting proposals for more direct patient information were tabled with strict criteria governing content and pre-vetting. However, there is absolute agreement that direct-to-customer advertising of prescription medicines will not be considered and any changes allowed to patient information will exclude TV and radio and limited to ‘health-related’ publications as defined by individual member states. Concerns stated by The European Consumers Association, patient groups and doctor’s representative CPME herald that controversy will continue to surround this proposal.

Ms Lenka Ticha, Chair of the Council Working Party for the Czech Republic Presidency, closed the meeting with the prediction that it would take at least 1½ years before we see the “Pharma Package” complete the legislative process and ensured everyone that the Council would not prolong it unnecessarily.

*The ‘Pharma package’ refers to the 10 December 2008 package comprising four elements:

Communication to launch reflections on ways to improve market access and to develop initiatives to boost EU pharmaceutical research.
Proposal to tackle the growing issues of Counterfeiting and illegal distribution of medicines.
Proposals to enable citizens to have access to high-quality information on prescription-only medicines
Proposals to improve patient protection by strengthening the EU system for the safety monitoring ('pharmacovigilance') of medicines.