EGA Position On The EC's Proposal For A Falisifed Medicines Directive

Today generic medicines represent nearly 50% of all medicines dispensed in the EU. Thanks to their affordable price and the broad use of the International Nonproprietary Name (INN) (rather than brand names), generic medicines are at a very low risk of being counterfeited. To date, there have been no reported cases of counterfeited generic medicines in the EU.

Nevertheless, the European Generic medicines Association (EGA) welcomes the European Commission (EC) Proposal for a Directive on the falsification of medicines aimed at increasing patient safety.¹ Within the draft Directive, the EGA has identified two subjects of specific relevance to the European generic medicines industry; one relates to the integrity of the medicines supply chain of finished products and the other to quality aspects of APIs.

Integrity of the supply chain

The draft Directive proposes the implementation of a costly EU safety features system that requires considerable time for implementation (possibly more than 24 months) and that has also not been proven to stop counterfeiting or falsification. Consequently, the EGA supports the Commission's proposal to employ a riskbased approach to the assessment of medicines augmented by safety features by utilising available data on price, volume and past incidents within the EU. This approach, reinforced by the 27 April 2010 vote at the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI),² would concentrate efforts on the fight against the falsification of high-priced and highrisk products, with a special focus on the internet as a major supply channel for falsified medicines. According to the World Health Organisation (WHO), 50% of medicinal products purchased over the internet are falsified.

In order for the risk assessment to work well in practice, however, certain conditions must be guaranteed:

• It must be assured that the Directive provides for a "black list" approach with regards to risk assessment, which determines that only medicines at high risk of being falsified would require safety features. This would spare both the EC and National Assessing Authorities extra administrative, financial and human resource burdens. In contrast, the so-called "white list" approach, which provides that all products are high risk unless specifically excluded, makes implementing the safety features more difficult and threatens to create supply delays because all medicines would be considered for assessment.

• The explicit reference to generic medicines as "low risk" in article 54a (4) of the Directive, supported by the ENVI Committee vote, is instrumental in order to determine the level of risk of being counterfeited to which various medicines may be subject to. The lack of this specific reference would send an incorrect message to healthcare providers that all medicines are equal targets for counterfeiting, which, in turn, would open the door to patient compliance problems.

• Likewise, some flaws in the risk assessment criteria need to be corrected if we want to ensure patient safety. Formulations such as "the number of incidences of falsification in third countries..." are misleading because they compare the supply chains and quality control systems of the EU with those of other countries that, in some cases, may not demonstrate equivalent levels of safety and efficacy. The EGA considers this formulation as part of an intelligence gathering on falsification trends but not a criterion of the risk assessment.

Quality compliance

The EGA is in favour of the clarification and the strengthening of the current quality legal framework proposed in the EC's draft Directive, as the Directive reinforces existing audit systems and promotes international cooperation to control API and excipient production.

Similarly, the EGA supports the EC proposal to harmonise the rules for all operators within the production chain and distribution networks, both in the EU and worldwide, and for medicinal products and active substances entering the EU territory or being exported from the EU.

In line with the EC proposal and the vote in the ENVI Parliamentary Committee, the EGA opposes a mandatory EU inspection and certification system for all APIs. If introduced without adequate resources, this system could lead to severe shortages of medicines for EU patients and healthcare systems.

Next steps

The EGA is fully dedicated to protecting patient safety and recommends that the ongoing trialogues between the EC and Council and Parliament, as well as the vote in Plenary scheduled for 13 December 2010, follow the approach taken by the ENVI Committee at the European Parliament, which would guarantee pragmatic and efficient legislative measures in the fight against counterfeiting.

Finally, the EGA calls upon policy makers participating in the key negotiations on the dossier to ensure that any costs related to safety features will be proportional to the cost of medicines.

Ilina Markova is Assistant Manager Public Affairs at the European Generic Medicines Association, Belgium.

imarkova@egagenerics.com

References

1. European Commission, Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source (2008).

http://eur-lex.europa.eu

2. European Parliament, "Fake medicines: MEPs want to target online sales" (27 April, 2010).

www.europarl.europa.eu

Acknowledgements

With thanks to Hugo Carradinha (Senior Manager Health Economics Affairs, EGA) and Julie Maréchal-Jamil (Senior Manager Regulatory Affairs, EGA) for their kind assistance.

The European Generic medicines Association is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing high-quality affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the general pharmaceutical sector.

www.egagenerics.com