The European Commission has not taken full account of the impact its proposals to combat the counterfeit drugs trade will have on the prices and accessibility of medicines, say public health officials.

The Commission must ensure, in its proposed Directive on Falsified Medicines, that the cost of improved safety measures are not borne solely by patients, as this would increase existing health inequalities still further, according to the European Public Health Alliance (EPHA), which notes its particular concern that the Commission has failed to measure fully measurement the impact of its proposed actions on drug prices.

“Increased costs for the safety of medicines should not have repercussions on patients’ access to medicines. The costs implied by the new safety measures need to be spread throughout the whole supply chain, in order to avoid creating new barriers to the affordability of medicines and therefore increasing already rising health inequalities in Europe,” says EPHA.

The Association, which was commenting on the draft Directive currently under scrutiny by the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI), also sees the need for a clear definition of the products involved. The draft legislation’s current use of the term “falsified medicinal products” should be replaced by “counterfeit medicines,” accompanied by a clear and internationally-agreed definition of the term - including reference to the World Health Organisation (WHO) definition - as this would better encompass the criminal relevance of such activities. Also, the term is globally understood, says EPHA.

The group is also concerned that the draft, as it stands, could permit the seizure of legitimate generics while they are transit through the European Union (EU), an issue which has already caused protests from India and Brazil at the World Trade Organisation (WTO).

“In general terms, any issues regarding false labeling as to identity or source (counterfeiting), should not be confused with compliance to Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP),” says EPHA, adding: “patent infringements should be explicitly excluded from the definition and the regulation."

Earlier this month, European Industry Commissioner Guenter Verheugen said that the Commission was “extremely worried” about the growing numbers of counterfeit medicines arriving in Europe. In just two months, 34 million fake tablets at been seized at customs points in all EU member countries, a total which “exceeded our worst fears,” he told the German newspaper Die Welt.