The European Commission’s proposed directive to clamp down on counterfeit medicines “cannot ignore” the reality that a “huge percentage” of counterfeits are channelled through the internet, says the new rapporteur for the proposal in Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI).

Maria Matias was speaking at a meeting in Parliament on Making Patient Safety a Priority, organised by Aegate, the UK-based company that supplies a pharmacy-level authentication system to sift out counterfeit drugs from the legitimate supply chain.

While the proposed directive released in December 2008 addressed key points of vulnerability in the legal supply chain, the Commission left internet trade to the discretion of the member states, placing it in the wider context of whether national governments allowed sales of prescription medicines online. The issue had already been raised by Adamos Adamou, the previous ENVI rapporteur before the European parliamentary elections last June.

Introducing the meeting, MEP Jorgo Chatzimarkakis pointed to a study by the German Federal Criminal Police Office (Bundeskriminalamt), which found that 80% of counterfeit medicines penetrated the EU supply chain through the internet.

The Commission’s proposal should urge the member states to enforce domestic law on internet sales, Chatzimarkakis told the meeting. And countries that permitted internet pharmacies should establish a list of secure websites for the trade.

Legal basis
Other major “gaps” in the proposal highlighted by Matias included broadening its legal basis from the internal market provisions in Article 95 of the EC Treaty to Article 152 on human health protection.

The internal market rules were widely reckoned to have underpinned the Commission’s decision not to pursue a ban on repackaging of medicines as an entry point for counterfeits. A ban is still sought by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and is strongly resisted by the parallel import industry.

The new rapporteur mentioned parallel trade and repackaging as complex issues that needed to be addressed in the proposed directive. The question was whether or not the provisions for mandatory safety features should entail a ban on repackaging – although this was “work in progress”.

Defining the types of safety features required, and whether they should be risk-based, was another high priority, Matias emphasised. John Ricketts, associate director of government affairs for Lilly Europe, argued for a “compulsory minimum standard” of safety feature, comprising mass serialisation and tamper-evident pack seals. Further security measures would be necessary for those medicines deemed particularly at risk.

John Chave, secretary general of the Pharmaceutical Group of the European Union (PGEU), warned against undermining the precautionary approach demanded by the growing threat of counterfeits. “There’s a danger that if you single out certain medicines as risky, you merely push on the counterfeiters to other kinds of medicines,” he said.

A risk-based system might also confuse patients: “Do we create a sort of implied guarantee or warrantee that medicines that don’t have safety features are thereby safe and free from counterfeiting?”

But Hugo Carradhina, senior manager, health economics affairs for the European Generic Medicines Association, insisted the fight against counterfeiting should focus mainly on behavioural measures such as harmonising criminal law and toughening up requirements for wholesale licences.

Technical solutions should be considered only as a secondary line of defence, and then according to risk assessment based on past incidence and price. Given the low level of counterfeits in the legal supply chain and the ease with which safety features could be replicated, any mandatory features must be proportionate, Carradhina stressed – otherwise, “what we’re trying to do here is basically kill a mouse with a tank”.

While EFPIA is set to launch the pilot phase of its coding and identification solution – mass serialisation using a 2D data matrix barcode and pharmacy-level authentication – in Stockholm on 20 October, Aegate already has its end-to-end system up and running in four European markets.

Although there are clear parallels with the EFPIA system, one point of contention is what happens to the transactional data picked up in the authentication process. Aegate takes the view – as does PGEU – that these data belong to pharmacists. There are worries that, with an industry-led system, the data will be exploited commercially to secure marketing advantage.

A presentation by Professor Steven Simoens of Belgium’s Katholieke Universiteit Leuven testified to both the robustness of the AegateProtect service and its favourable cost-benefit profile. For example, a mystery shopper audit in a sample of Belgian community pharmacies using the system found it was 100% reliable, Professor Simoens reported.

Moreover, a cost-benefit analysis in a hypothetical market where five pharmacy software providers covered 10,000 pharmacies dispensing 400 million drug packs a year concluded that the authentication system would be cost-neutral in a scenario where just 0.47% of products were identified as recalled, expired or suspicious.