Call for European harmonisation of waste pharmaceuticals

EU rules for waste medicines should be harmonised and strengthened, Health Care Without Harm (HCWH) has claimed, after a survey of six member states revealed a wide discrepancy in collection practices.

Under the 2004 medicinal products directive, member states must implement appropriate collection schemes for unused pharmaceutical products. But the directive gives no guidelines on how to implement such schemes.

European guidelines and an EU-level reporting mechanism are needed, the pressure group HCWH said on Monday. How they propose that should be funded is not mentioned, and probably not even though of. Almost certainly, the cost of harmonisation would be massive and unsupportable in most EU countries without a hefty subsidy from other members who at present are themselves feeling the pinch.

Consumer awareness of waste medicine collection schemes ranged from 37% in the UK to 85% in Portugal, HCWH found. The study pointed to a strong correlation between awareness and use of such schemes. But with a review of just 6 member states, the data cannot be clear as there are vast differences in performance between those member states and indeed all others. It is thus improbably that any review of just 6 member states can do anything more than to say there is room for [considerable] improvement – solutions really cannot be proposed from such a small sample and it is here that the pressure group mentality comes to the fore.

Member states continue to use different parameters for calculating the amounts of medical waste collected, four years after European Environment Agency research pointed to the problem, the pressure group noted.

“One cannot compare the 854 tonnes [of unused pharmaceuticals] collected in Portugal with the 572 tones of Belgium… In Portugal, the system collects medicine residues and all packaging…while in Belgium the value refers exclusively to medicine residues and inner packaging of medicines,” it said.

In most countries, pharmacies alone act as collection sites. But those where responsibility for the scheme is left in pharmacists’ hands tend to be more inefficient because the businesses are reluctant to take on the extra costs involved.

This is the case in Lithuania, where many pharmacists refuse to collect unused pharmaceuticals in spite of a legal obligation to do so.

HCWH recommends that member states deal with unused medicines by making greater use of producer responsibility schemes. Manufacturers are best equipped to dispose of pharmaceuticals because they are familiar with the chemistry of their products. And this would implement the polluter pays principle. That is a laudable solution and is one that has been implemented in several US states. However, it remains costly and managed in this way would increase drug product costs and reduce innovation and invention from the pharmaceutical sector. We care for the environment but the NHS cannot afford to pay those increased costs, nor manage the care of patients without research and development from the pharmaceutical sector. Once more, a nice idea but one that is never likely to work.

The pressure group is also calling for the environmental risks of pharmaceuticals to be taken into account in the cost-benefit analysis ahead of market authorisation. That too sounds fine and dandy but I wonder how they would feel, the HCWH staff and supporters if they or their nearest and dearest were desperately ill. The only drug that might save them is one having a significant environmental risk that shifts the cost-benefit balance to a point at which its use is unsustainable. Would they change their mind, of stick to their guns and slip away quietly for the sake of the environment? Make your won mind up.

This European Commission-funded research identifies one of many problems in EU member states. To improve, perhaps we need more incinerator capacity but HCWH would protest. Certainly there is much to do, and identifying current deficiencies is helpful, even if the solution proffered in itself unworkable.



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