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.
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.