Reforms Offer Good News for Trade

The European Commission's proposed pharmaceutical reform package has finally been unveiled—months later than scheduled. However, to the dismay of pharma companies, the section that would have effectively put an end to parallel trading in prescription medicines has been removed. The proposals are now being passed on to the European Parliament and Council of Ministers for further discussion and voting, but the earliest they could become law is 2010.

Sarah Houlton

An earlier draft banning the repackaging of medicines would have made it extremely difficult for traders to buy up drugs in "cheap" countries and sell them for a profit where prices are higher. (Drugs could not be sold in Sweden, for instance, with a carton and insert labelled in Greek.) Following pressure from the traders, this part of the proposal was dropped—causing delay in publishing the document.

Instead of a blanket ban on repackaging, all drug products will require barcodes or serial numbers, as well as tamper seals that a limited number of certified manufacturers will be allowed to use. This will include parallel traders, who won't be able to alter the blister packs that contain the pills, but the rest of the package will be fair game as long as the pack meets all the new requirements. The aim of this part of the legislation is to make it more difficult for counterfeiters to create legitimate-looking drug packaging.

There has been disappointment, however, that no Europe-wide strategy to regulate Internet drug sales will be implemented. The proposal calls for member states to address that issue individually, despite the fact that counterfeits are a particular problem in Internet-based pharmacies.

Two other parts of the proposal will likely result in legislation. One allows pharma companies to give the public limited information about their products, and another will strengthen the pharmacovigilance system within Europe.

This does not mean that Europe plans to go down the DTC route. However, companies would no longer be completely banned from disseminating factual information about their products, such as a summary of product characteristics, ADR warnings, prices, and notification of packaging changes. These would be allowed only via health-related Web sites and publications. Importantly, pharma companies would also be able to respond directly to inquiries about their products from the public. Currently, all pharma companies can do is point consumers in the direction of their doctors, even for answer to a factual question about mode of action or potential interactions—which the company is far better placed to answer.

The proposals for modifying the pharmacovigilance system state that member states should retain overall responsibility, but they should work together more often. EMEA will gain a new scientific committee, which will play a key role in pharmacovigilance assessments within the EU, and all ADR reports should be channelled through the centralized Eudravigilance database. There are also plans for a European Web portal for drug safety information.

A fourth, non-legislative, section of the reform package covers pricing and reimbursement, initiatives to boost pharma research in the EU, improved cooperation with other industrialized countries such as the US and Japan, and greater cooperation with emerging nations such as India, China, and Russia.

Although disappointed that the ban on repackaging is not included, the European trade association EFPIA has welcomed the proposals. Its current president, Bayer HealthCare CEO Arthur Higgins, said that the organization appreciates the fact that the Commission recognizes the importance of the pharma sector to Europe, and appreciates its focus on patient safety.

Sarah Houlton is Pharmaceutical Executive's global correspondent. She can be reached at sarah@owlmedia.co.uk