Public health sector weighs in on EU proposals

Definitions, costs, barriers to trade, risk assessment and the Internet are the more problematic aspects of the European Commission's draft directive on medicines counterfeiting, according to a position statement by the European Public Health Alliance (EPHA).

What the EPHA does not doubt is the need for new legislation, given the potentially "disastrous consequences" of more counterfeit drugs entering the supply chain. Moreover, a number of security measures can be achieved relatively painlessly and "without compromising the high degree of efficiency of the European supply chain, in particular the easy availability of reasonably priced medicines at short order," it believes.

While the EPHA supports "the majority" of the Commission's proposals, it does have some qualms about specific elements of the draft directive.

"First and foremost" among these is the need for a clear and internationally agreed definition of counterfeit medicines, one that would "better encompass the criminal relevance of such activities."

Rather than referring to "falsified medicinal products" as the draft directive does, the Commission should insert a reference to the World Health Organization's definition of counterfeit medicines, namely products that are "deliberately and fraudulently mislabelled with respect to identity and source", the Alliance suggests.

Defining counterfeits has been one point of contention in the debate over perceived efforts to conflate trademark and patent rights, whereby brand owners are accused of piggybacking the threat of counterfeit medicines to squeeze the generics industry.

The EPHA pitches into this debate by insisting that the Commission's proposals must not "hinder competition or impose barriers to trade for third countries, as has happened with the enforcement regulation that has led to seizures of legitimate generic medicines in transit."

Generally speaking, the Alliance argues, "any issues regarding false labelling as to identity or source (counterfeiting) should not be confused with compliance to Good Manufacturing Practice or Good Distribution Practice."

Moreover, patent infringements "should be explicitly excluded from the definition and the regulation."

The EPHA is less sympathetic to the generics industry on the issue of risk-based safety features. For example, while there are "considerable costs" involved in introducing pharmacy-level authentication of medicines (which the Alliance supports "in principle"), the fixed costs "will remain broadly the same for a few products or for all", it comments.

"A restricted list of products therefore greatly reduces the proportionality of the costs."

The EPHA also contends that individual Member States have the right to determine their own level of healthcare protection, which includes choosing their own type of authentication or track-and-trace system.

Finally, it says, the risk-based approach is "inconsistent with the idea of pre-emptive action on the basis of precaution."

In other words, selective measures risk diverting attention to other possibilities, whose low-risk profile may actually make it easier for counterfeit versions to penetrate the supply chain.

"As long as opportunity costs remain sufficiently low for any medicine, including over-the-counter medicines, that medicine is at risk of being counterfeited," the EPHA states, adding that medical devices should not be ignored either.

As far as the costs of securing the supply chain go, the Alliance is particularly concerned about the "lack of full measurement of the impact of the proposed actions from the draft legislation on the price of medicines."

These costs need to be spread throughout the supply chain, avoiding any new barriers to the affordability of medicines that would aggravate "already rising health inequalities in Europe."

In keeping with many other stakeholders in the EU's drive against counterfeit medicines, the EPHA is disappointed with the omission from the draft directive of any concrete measures to stem Internet trade.

It does acknowledge that the EU institutions have limited options in this respect. Internet sales of prescription-only medicines are already illegal in most Member States and, even where those sales are legal, they tend to come from unlicensed sources.

All the same, the EPHA suggests, measures to tackle illegal internet trade could include:

• Stronger co-operation between the EU and individual member states, encompassing the public health community and other stakeholders;
• A ban on sponsored advertising of illegal pharmacies online;
• Certification systems for authorised online pharmacies in countries where internet sales of medicines are permitted;
• Initiatives to raise consumer awareness of the risks inherent in buying medicines from unknown sources online; and
• Educating consumers and patients about the hazards of counterfeit medicines.

Even if Internet pharmacies were subject to a licensing regime, there is a strong possibility this would lead to a "significant rise" in infiltration by counterfeits, as patients could not reliably to distinguish between licensed and unlicensed sites, the Alliance warns.

Fostering a culture of internet drug sales would inevitably exacerbate these vulnerabilities, it says, adding: "It is essential therefore that the existing restrictions in most Member States stay in place." 


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