PGEU wants robust debate on safety features

There needs to be an open, transparent and "robust" debate about the type of safety features to be applied under the European Commission's draft directive on counterfeit medicines, and whether they should extend to all forms of prescription medicine, says a top official with the European association for community pharmacists.

Stakeholders in the Commission’s proposals should also give "serious consideration" to the costs of authenticating medicines at the point of dispensing, whether such a system should be national or transnational, and the vexed question of what happens to the transaction data generated in the process, believes John Chave, secretary general of the Pharmaceutical Group of the European Union (PGEU).

Chave was speaking to SecuringPharma.com shortly after presenting PGEU's viewpoint at a meeting organised in the European Parliament by the European Generic medicines Association (EGA). There, he emphasised the role of pharmacists as the "last line of defence" against counterfeit drugs in Europe.

Not surprisingly, EGA itself was keen to drive home the message that the draft directive, now with Parliament's Committee on the Environment, Public Health and Food Safety (ENVI), should avoid leaning too much on technological solutions. As the proposals stand, these provisions are subject to risk assessment and would likely exclude generics.

The EGA wants to keep it that way, insisting that no counterfeit generics have breached the supply chain in the EU 27 markets. Introducing the meeting in Brussels, MEP Antonyia Parvanova said she still had some doubts about industry's ability to absorb the costs of safety features such as mass serialisation without pushing up drug prices.

"It is therefore crucial to adopt a risk-based approach, looking at the price and cost-incidence when considering safety features, since crime organisations involved in the counterfeiting of medicines are looking at making money, and therefore they target products where they can effectively mislead consumers and make a significant margin," Parvanova commented.

PGEU, however, favours a "precautionary" approach that would extend to generics. The fact is, Chave explained, the "risk profile" of medicines has been raised in Europe, as it has in all areas of counterfeiting. But the ramifications are especially serious for medicines if people stop taking them or taking them properly. Moreover, there is evidence that generics are being counterfeited outside Europe, in countries such as Russia.

Chave has some sympathy with smaller generic operators whose margins are already being squeezed by downward pressure on prices. All the same, he added, there are already some very large and powerful companies operating in the sector and long-term industry consolidation could accelerate that trend.

The ultimate aim, Chave suggested, should be the most watertight system possible while making sure costs are proportionate to gains. Safety features and other measures, such as tightening up the supply chain, are not "mutually exclusive," he commented.

Pharmacists in most countries already work within a "very secure" chain, usually involving just two or three wholesalers, he insisted. But there are weaknesses in the system. While PGEU does not recommend any one system of purchasing, pharmacists should ensure they are sourcing from familiar suppliers – and the bulk of them already do, Chave believes.

The profession does see the authentication systems being promoted by Aegate and, latterly, the European Federation of Pharmaceutical Industries and Associations (EFPIA) as a viable means of stopping counterfeit medicines in the legal supply chain from getting to patients - and that is the "major priority," Chave says. There are also ancillary benefits for pharmacists in areas such as stock-taking or passing on safety messages to patients.

That does not necessarily rule out a track-and-trace system. Nonetheless, Chave pointed out, some question whether the added value of following drugs right through the supply chain is worth the associated technical challenges and extra costs. Here there is a degree of debate within PGEU, with some Southern European members inclining more towards a track-and-trace system, whereas in some other European countries this would be "currently unfeasible."

In countries where there is a mix of full- and short-line wholesalers, such as the UK,  track and trace would mean redesigning the whole system, Chave warned, adding that the issue would likely have to be resolved on a country-by-country basis.

Likewise the question of data ownership with an authentication system. The PGEU strongly believes it is not for industry to "expropriate" transactional data generated through authentication for commercial advantage. This has not been a problem with the AegateProtect system but has prompted concern as EFPIA pilots its own authentication solution in Swedish pharmacies.

According to Chave, however, the industry association has softened its stance on data ownership considerably over the last 18 months. The original intention was that industry access to transactional data would help pay for the system. Now EFPIA's position has shifted to squaring data ownership with national practices, he noted.

That would sit better with pharmacists, as different systems already apply where authentication is already in place to deter reimbursement fraud. In Spain, for example, pharmacists have been happy to see transactional data forwarded to the government, Chave pointed out.  

Clearly EFPIA needs the co-operation of pharmacists to make its system work. That said, PGEU has not come out in favour of the Aegate or the industry authentication model. What it has declared are basic principles such as making sure costs are proportionate, maintaining data protection and ensuring the authentication system is integrated into the regular pharmacy workflow.

The costs remain something of an unknown quantity: PGEU has not done its own calculations yet. In Chave's view, installing scanners to authenticate medicines - there would need to be about five per pharmacy on average in Europe, he believes - can be done quite cheaply. Software integration is also relatively painless but the real cost comes with constructing a database to back up the system.

One question to answer is whether this storage facility should be national or European, Chave pointed out, noting that EFPIA is insisting on intra-operability between any national systems.

For all these sticking points, and others such as the burning issue of counterfeit sales via the internet - something PGEU believes is best resolved by enforcing the widespread national restrictions on prescription drug sales online -on the whole association feels the Commission has come up with "constructive" and "sensible" measures to stem counterfeit trade, Chave said.

How quickly those measures can be pushed through is another source of tension. At the EGA meeting, Chave told SecuringPharma.com, ENVI committee rapporteur Marisa Matias suggested her report on the Commission's proposals would be forwarded for translation by 8 December 2009, with the prospect of a full plenary debate next spring.