Brussels, 16/02/2011 (Agence Europe) - On Wednesday 16 February, the European Parliament approved a compromise negotiated in first reading with the Council of Ministers on the draft directive to prevent the sale of fake medicines in legal medicine distribution networks in Europe. The sale of medicines online will be covered by the new legislation that will also set new safety and traceability standards, and penalties against forgers in order to prevent the sale of fake medicines to people in the EU. The draft legislation was the subject of a report by Portuguese United Left MEP Marisa Matias and was approved by a landslide vote (500 to 14 with 7 abstentions).
The MEPs say that rules are needed for the online sale of medicines because this is one way that fake medicines enter the EU. Websites will have a special logo, recognisable across the EU, to help people identify whether they are related to an authorised pharmacy. All online pharmaceutical outlets will have to have a link to the website of the competent national authority. Various national websites will be connected to an EU website and Europeans will be informed of the dangers of buying medicines from illegal sources online.
The draft directive introduces safety measures for medicine packaging to ensure the authenticity and identification of individual packages and show whether the outer packaging has been falsified. A safety measure that has yet to be developed by the European Commission might, for example, include a code that can be read by pharmacists to see whether the product is the genuine article.
The rules will also apply to all prescribed medicine unless there is clearly no danger. They will apply to non-prescription medicine only where there is the risk of falsification. When medicines are re-packaged, safety measures will have to be replaced by equivalent measures. The current medicine distribution network is very complex and involves distributors (already covered by existing legislation) and medicine transport companies. Upon request from the MEPs, in the future anyone delivering medicines will have to join a register so that they can be removed from the register if they break the new rules.
Fake medicines account for nearly 10% of global medicines and are particularly prevalent in the developing world, but Europe is not immune because fake medicines account for 4.1% of the EU market and 34 million fake tablets were seized in the EU in 2008. (O.J./transl.fl)