Late last month, MEPs on the European Parliament committee responsible for health voted to include sales of pharmaceuticals over the internet in the European Commission’s draft directive on falsified medicines. With some surveys suggesting that more than 60% of drugs purchased online are fake, bringing internet sales under new mandatory safety rules for pharmaceuticals is aimed at reducing the supply of ‘potentially lethal’ fake medicines in the European Union.
But can regulation prevent ‘falsified’ medicines entering the supply chain? I spoke to Gary Noon, CEO of patient safety company Aegate for his expert opinion on the validity of the proposed legislation.
How can this new legislation be enforced?
Gary Noon: European legislation will establish some very important legal principles; first, that this is a matter of public health, which is of utmost priority, and second, that there can be no weaknesses across member states that could risk counterfeits being able to enter. By this the commission intends to establish a harmonized approach and a minimum standard of security measures that must be adopted. We believe this is extremely important legislation and, within the commission’s remit to provide member states with clarity, it will be enforceable.
I would, however, urge EU lawmakers to ensure that protection of the legal supply chain is not hindered or interrupted in any way by broadening the scope of this directive to encompass the complex issue of internet pharmacies. A phased approach to this legislation may be in the best interests of patients and the healthcare industry-focusing on the legal supply chain, with high street pharmacies, in particular, as a priority.
One of the aspects within the legislation will be a mechanism that can ensure patients do not receive falsified products by authenticating medicines before they reach the patient, ie, at the point of dispense. This is available today. Our own service, which is already fully operational in three member states and being installed in two others, enables individual medicinal packs to be authenticated by pharmacist before dispensing.
Is this truly a legal move or just an official call for better patient education?
GN: We very much hope that the legislation includes public education. These efforts will go some way to ensuring the public seek medicines from qualified health practitioners and help drive them away from unregulated internet sources.
Our research, carried out within five major European countries, identified that around 9% of consumers have purchased prescription drugs online at least once. This despite the dangers of doing so, and even though 69% of those surveyed agreed that it is “a bad idea or dangerous.”
Do you think legitimate pharmacies just need to catch up with their online counterparts and provide a convenient 21st century service?
GN: In our opinion there is much confusion relating to online pharmacies. Let’s be clear, illegal online pharmacies supplying fake medicines to the public is not 21st century medicine. Consumers need to be able to know without doubt what the reputable online sources of prescription medicines are.
Illegally operating internet pharmacies often do not require a prescription before a purchase can be made — they also do not have a bricks and mortar presence and neither is there likely to be a pharmacist employed. How to encourage patients to use mail order and high street pharmacies, rather than buying from dubious sources online? Aegate’s research revealed that only 4 per cent of consumers would continue to buy prescription medicines online if their traditional pharmacists had a specialist tool to confirm the authenticity of medicines — a reason to believe legitimate pharmacies can very quickly provide a 21st century service.