Europe needs new legislation on counterfeiting, says EPHA

Contributing to the debate in the European Parliament and Council on the Falsified Medicines Directive from the so-called Pharmaceutical package, the European Public Health Alliance (EPHA) said that patients safety and the access to high- quality medicinal products represent key issues in pharmaceutical policy, but further legislation is required. In this context, the EPHA welcomes the Commission's legislative initiative aimed at combating counterfeit medicine, and more particularly for the following reasons:

' The risk of penetration of counterfeits into the legal supply chain is growing, even if the degree of such penetration has been modest and limited to certain countries up to now.

' Death and injury, untreated conditions, and a loss of confidence in the supply generally are examples of disastrous consequences of increased penetration of counterfeits in the supply chain. A precautionary approach is therefore necessary and action warranted before counterfeit penetration increases.

' Many measures aimed at increasing security in the supply chain imply relatively low burdens and can easily be achieved. Furthermore, they can be implemented without compromising the high degree of efficiency of the European supply chain, in particular the easy availability of reasonably priced medicines at short order.
EPHA concerns
The EPHA supports the majority of measures set out in the proposed Directive, saying it therefore limits its comments to those areas where it has concerns.

With respect to the need for a clear definition of falsified medicines first and foremost, the EPHA strongly calls for the insertion of a clear and internationally agreed definition for 'counterfeit medicines,' which should replace the terminology currently used in the draft directive, ie, 'falsified medicinal products,' as it would better encompass the criminal relevance of such activities and the term is globally understood. Even though this legislative proposal only has bearing in European Union jurisdictions, the phenomenon of propagation of counterfeit medicines presents a global bearing.

In this context, it suggests to include reference to the World Health Organization's definition of counterfeit medicinal products: 'А counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.'

Given the need to ensure that costs of improved safety measures are not solely born by patients and thus contribute to increasing health inequalities, the EPHA is particularly concerned by the lack of full measurement of the impact of the proposed actions from the draft legislation on the price of medicines. 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.