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European Union: Draft Legislation on Online Sales of Medicines

(May 19, 2010) The European Union is currently working on drafting new legislation to regulate online sales of medicines. The subject had been omitted from a previous Directive on counterfeit medicines proposed by the European Commission in 2008, which is currently pending, as part of the Commission's “pharma package” to reform the pharmaceutical industry. (Press Release, European Parliament, Fake Medicines: MEPS Want to Target Online Sales (Apr. 27, 2010), available at

In the last few years, an increase in the amount of counterfeit medicine in Europe has been noted. Such medicines pose a serious risk to consumers and undermine the pharmaceutical industry. The products may contain counterfeit ingredients, no ingredients at all, or wrong doses of active ingredients. In 2009, the European Medicines Agency issued a warning during the swine flu epidemic about counterfeit vaccines and antiviral medicines marketed in Europe. (Criminal Cashing In on Fake Swine Flu Medicines, EURACTIV, Oct. 27, 2009, available at

At the end of April 2010, the Environment and Public Health Committee of the European Parliament introduced 15 amendments to the 2008 draft Directive. The amendments criminalize the marketing of counterfeit medicines, and especially online sales. Marisa Matias, the Portuguese Member of the Parliament, who chairs the above Committee, stated that without the amendment, “the Internet would have operated as the 'Trojan horse' for fake medicines. We can not leave the largest gateway for counterfeit drugs in Europe out of this legislation.” (Parliament Takes Aim at Illegal Online Pharmacies, EURACTIV, Apr. 28, 2010, available at

The proposed Directive for the first time uses the term “falsified medicinal product.” Its definition includes any medicinal product that provides information on that product's identity, name, composition, and source that could mislead the consumer. Generic medicines are excluded from the proposal.

Under the proposal, online pharmacies were distinguished as being legal or illegal. Only those pharmacies that are authorized by national authorities and that also carry an EU logo will be able to sell medicines online. The EU logo will serve to confirm the authenticity of the pharmacy. A central, national website would confirm the validity of the logo.

The Parliament also requested that the European Commission review the Directive to see whether its provisions should be extended to non-prescription medicines in the future. (Id.)