It would be a serious mistake not have an EU-wide regulatory framework for internet pharmacies. Not achieving one would be just more evidence of the politics that infects all discussions of cross-border healthcare to the detriment of the patient and health consumer. Illegal drugs, fake drugs, reimported drugs, counterfeit drugs, substandard drugs, legitimate drugs — how is a consumer to tell the difference on the internet?
We need an EU-wide regulatory framework for a few pretty sensible reasons:
- EU wide standards would ensure a common standard of practice, and European citizens should expect no less.
- A key element of internet pharmacies is their cross-border character, and indeed whether they are inside or outside of the EU itself; the provenance of a medicine is integral to knowledge about its legitimacy and by breaking the information flow about specific medicines in a cross-border environment, the EU is putting people’s lives at unnecessary risk.
- Price differentials within the EU actually encourage internet pharmacy sales, as it is these price differentials that make internet medicines attractive to consumers, and which create the risk of buying counterfeits in the first place. It is also known that the cash market in medicines underlies the opportunities for criminal elements to insert fakes into the medicines supply chain. This will only become easier to do and harder to detect.
- Cross-border trade in medicines involves a lot of repackaging, relabeling, etc., which destroys or confuses such information as batch numbers and point of origin. This is essential core EU-wide information.
Leaving all this to different national regulators will simply play to the regulatory patch-work that characterises medicines regulation in the EU, and ensure that consumers will be confronted with varying degrees of protection, information and risk.
Despite protections from other EU directives on cross-border sales, medicines and the risk of counterfeits put the issue into a different situation as the efficacy of the medicines may only be determined after the patient has experienced the consequences to their health from the purchase of a fake medicine.
Member states are not that good at organising multi-lateral arrangements, so why should we expect them to be any better on medicines trade in a cross-border world? The complexity of the EU will now be sustenance to those who would wish to contaminate the medicines supply chain.
I am obviously trying to decouple the problem from the issue of parallel trade, and focus on the core elements of cross-border regulation. Parallel trade would be caught by a simple internet regulatory framework.
What would a solution look like?
Well, the opportunity to establish an EU Internet Pharmacy Imprimatur will be lost, as it would have been a key element in the solution. It would have established basic information about the legal status of the internet provider, and its legal dispensing practices, including handling of prescriptions. It would have given us pooled knowledge about all medicines, whether legal or not, with their origins and destinations being available in an EU-wide systematic manner. With common regulation would come shared knowledge of all regulated and licensed firms operating in the very complex medicines supply chain; this information is not shared across borders, with obvious consequences.
The push-back from industry on the technological side is understandable but to be regretted. it is possible to establish common technologies, and common data-gathering to make a sensible system work where costs are not onerous and patient safety is assured. The outcome to be achieved is common knowledge across the whole medicines supply chain in a cross-border world. In addition to the much-talked about radio frequency tags, and barcodes, there are other methods available or in development which offer additional opportunities and are likely to alter the impact of costs on industry. The current technologies are hardly longer term solutions anyway, but industry will need reasons to explore them.
A common regulatory framework for cross-border medicines trade over the internet is sensible, and does not really need the problem of counterfeits to be justified. Industry resistance needs to understand that consumers, who will be in the main buying these medicines, need assurances of appropriate dispensing, quality of the medicines, proper shipping, and expiry dates,for example. They also need to have named individuals if there are concerns, as mistakes can happen such as the wrong dosage being provided. As well, there are naming differences amongst member states of similar medicines, dosages and methods of delivery differ (e.g. tablets, suppositories, soluble, all in the same medicine reflecting cultural preferences), and so on.