EPHA proposes improvements to medicines directive

The European Public Health Alliance (EPHA) has published its comments about the Falsified Medicines Directive, which is currently under debate by the European Parliament and Council. The EPHA welcomed the Directive because of the growing threat of counterfeit medicines and supported many of the Directive’s measures. However, it also listed several concerns and proposed improvements.

The EPHA’s primary concern was what it called the need for a clear and internationally agreed-upon definition of the term “counterfeit medicines.” The organization argued that the phrase “falsified medicinal products,” which currently appears in the draft Directive, does not sufficiently encompass the “criminal relevance” of counterfeiting. EPHA proposed that the Directive refer to the World Health Organization’s definition of counterfeit medicinal products, which describes them as products that are “deliberately and fraudulently mislabeled with respect to identity and/or source”.

The EPHA also said that patients must not bear the costs of improved safety measures alone as this arrangement would increase health inequalities. The organization claimed that the effect of the draft legislation’s proposed actions on the price of medicines had not been measured fully and argued that increased costs should not limit patients’ access to medicines. The EPHA proposed that the costs of the new safety measures be borne throughout the supply chain.

Another concern was the need to ensure that the Directive’s measures do not hinder competition or impose barriers to trade. The organization noted that the enforcement regulation has resulted in the seizures of legitimate generic medicines in transit and suggested that applying the proposed measures to medicines that will not be introduced into the EU would be problematic. The EPHA also proposed that the Directive explicitly distinguish between counterfeiting, compliance with GMP, and compliance with good distribution practice to maintain the appropriate scope for counterfeit regulation. The EPHA also said that patent infringements should be explicitly excluded from the definition and the regulation.

In addition, EPHA said it supported pharmacy-level authentication of medicines and called safety features such as barcodes and mass serialization of individual medicine packs “a strong line of attack against the counterfeiters” in its comments. The organization argued against a risk-based approach to authentication, claiming that it was not justified by arguments based on cost and was inconsistent with the idea of pre-emptive action on the basis of precaution. Categorizing medicines as high or low risk of being counterfeited could be counterproductive, according to the EPHA. “As long as opportunity costs remain sufficiently low for any medicine, including over the counter medicines, that medicine is at risk of being counterfeited,” said the organization in its comments.

Finally, the EPHA said that the Directive failed to mention the internet as a source of counterfeit medicines, and also ignored the fact that the worldwide web is the main distribution channel for them. Thus, it called the proposed initiatives “insufficient to protect consumers and patients from this source of danger” and called for European and international cooperation on regulating sales of drugs on the internet. The EPHA proposed measures such as the following:

• A ban on sponsored advertising of illegal pharmacies online
• The creation of certification systems for authorized online pharmacies in countries where online sales are legal
• Special initiatives to alert consumers of the risks of purchasing online medicines from unknown sources on the internet
• Education of consumers and patients about the dangers of counterfeit medicines and the hazards of buying prescription medicines from unregulated sources.

www.epha.org