European Commission Publishes Package of Measures against Counterfeit Medicines

On 11 December 2008, the European Commission published a press release as well as three legislative proposals intended to improve the supply of safe, innovative and accessible medicinal products in Europe.

The essential message of the press release of 10 December 2008 is the statement by Commission Vice President Günter Verheugen: "We wish to restore the EU's traditional role as the pharmacy of the world." Problems as well as chances arise from the progressing globalisation of the pharmaceutical industry, which has consequences both for the patients and for the competitiveness of the industry. The proposals made by the Commission go beyond combating counterfeit medicines and include three legal proposals as well as further political initiatives, like joint action of the EU member states for a more transparent pricing of medicinal products, support of pharmaceutical research, a closer co-operation with the USA, Japan and Canada with regard to medicines safety as well as an intensified collaboration with Russia, India and China.

The legislative proposals encompass:

  • Making reliable and easily accessible information on prescription-only medicines available to the public, since currently there are still great differences in this area between the individual EU countries
  • Extending the EU system for the safety monitoring of medicines ("pharmacovigilance") so that harmonisation will help to avoid a duplication of effort and possible confusion with regard to responsibilities in the individual countries in the future.
  • Combating counterfeit medicines as well as illegal distribution of medicinal products

An overview of the various papers as well as detailed information can be found on the page of the European Commission.

The dangers to the European population caused by counterfeit or mislabelled medicines are taken very seriously by the Commission and are even compared to the "food-and-feed crisis" of the 1990s. Several scenarios that could become a reality if the Commission remained inactive have been gone through, and the resulting costs to the Community until 2020 have been estimated, with the total sum ranging between 9.5 billion EUR and 116 billion EUR. Against this background, the Commission will tackle among other things the following points intended to lead to an amendment of Directive 2001/83/EC:

  • Creating a legal basis for the Commission to be able to require specific safety features on the packaging of prescription-only medicinal products
  • Mandatory site inspections of supplying wholesalers, records of inspected wholesalers in a Community database and harmonised procedures for official inspectors
  • Stricter requirements on the import of active ingredients, among others the requirement to pharmaceutical manufacturers to inspect all producers of the active ingredients used

As for the safety features on medicinal products, the Commission remains quite vague. They mention the requirements of safety features for certain categories of medicinal products meant to ensure authenticity and traceability. Two examples of possible safety features are given: individual product codes (so-called mass serialisation, where each pack bears its own code that remains unmistakably traceable until it is handed over to the customer at the pharmacy) and product sealing, which would reveal any attempt to open the packaging. The technical requirements on product serialisation as proposed by EFPIA and implemented in Turkey are the subject of the conference ECA Tracking & Tracing.

The Commission back-pedaled on its earlier plan to impose a ban on repackaging (parallel trade). While the ban was still proposed in the discussion paper of March 2008, repackaging is now expressly mentioned as a viable option. The reason for this change is to be found in the imminent threat to about 9000 jobs in parallel trade in the EU as well as in higher costs for the health care system and for social insurance carriers currently benefiting from the cheaper parallel imports.

An item that is expressly excluded from the EU Commission's legislative proposals is the sale of medicinal products via the Internet. It shall remain up to the individual member states to impose bans or give permissions.

The legislative proposals are now being discussed at the European Parliament. They cannot come into force until 18 months after they have been passed by the EU Parliament, which is expected for 2010.

The concrete proposal for amending Directive 2001/83/EC can be found here.

Author:
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)

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