Aegate News

Against Falsified Medicines - a solution for Europe

As working groups within the European Council meet and discuss arguably the most important change to the way the pharmaceutical industry operates in order to protect patients from falsified medicines, few, if any, will realise the impact of any legislation as much as the 160,000 high street pharmacies who dispense medicines across Europe. It is, after all, the pharmacists themselves that are on the frontline, the last line of defence between the patient and the quality of the medicine.

At a recent stakeholder event hosted by the Pharmaceutical Group of the European Union (PGEU) and the Belgian Pharmacy Association (ABP), the issue was discussed at length from the perspective of pharmacists in Europe and it became clear that there are several key areas that all whom are driving the European Commission's proposal should be considering in more depth.

Maintaining dispensing efficiency, data confidentiality & proportional cost are essential ingredients to any solution

Medicines Authentication; a process of affixing every pack of medicine with a unique, machine readable number, rather like a passport number, that can enable the pack to be authenticated, forms an important aspect of the legislative text within the proposed amended directive.

Authentication as an approach has gained growing acceptance over the past few years, with organisations such as EFPIA and Aegate, both proving that this does protect patients, and raises the barriers against counterfeit medicines infiltrating the supply chain. PGEU indeed confirmed that their pharmacists are ready to accept authentication, as long as the tools to do so are correctly installed and standards are in place for operation.

John Chave, PGEU made it clear in the meeting that it is imperative that the process of authentication does not interfere with day-to-day operations of the pharmacy; rather it should enhance the healthcare that the pharmacist provides and support dispensing efficiency.

Data confidentiality is essential: The PGEU believe firmly that all transaction data generated by the pharmacist as part of the authentication process belongs solely to the pharmacist and must not be supplied for commercial gain to the pharmaceutical industry. Indeed this aspect is being clarified within amendments to the EU directive as we speak.

Equally important when considering the implementation of any safety feature is the proportion of cost to the price of the medicine. Harmonisation of the safety feature will, in addition, create economies of scale, further lowering the costs. Therefore The Commission's decision to select the technology is welcomed by the majority of stakeholders, provided of course that consultations are made with stakeholders when the selection is being considered.

However there is a sense of urgency about making this selection as deployment on manufacturing lines could take as long as 18-24 months, with companies awaiting clarification from The Commission before making the necessary investments.

PGEU noted that these factors are achievable and congratulated Aegate in demonstrating the possibilities to achieve seamless authentication processes inside the pharmacy management system, as well as their procedures for data confidentiality, that are currently operating in Belgium, Greece, Italy and soon to be installed in Germany.

Any solution must also include the wholesale and distribution chain

At the same event Aegate provided a live demonstration as to how an authentication system operates in practice. The demo also highlighted how patient safety can be achieved when moving a product between one EU country and another. Being able to check that products they have purchased are not falsified, is something the body representing the pharmaceutical wholesalers in Europe (GIRP), are keen to see is implemented. This additional layer of security within the supply chain is welcomed by pharmaceutical wholesalers, who believe that solutions enabling the traceability of medicines in case of the slightest doubt about their genuinity; is exactly what is needed" - a solution that increases security but with minimal interference of the speed of flow of medicines to pharmacies.

Maintaining an equivalent safety feature on the pack and creating a chain of custody is another essential element within the new directive. National standalone systems may be favoured by some member states but there will need to be some intra-operability to take account of the trade in importing and exporting medicines across Europe under the free movement of goods directive.

Armed with the correct tools, pharmacists and the supply and distribution chain can secure medicines at relatively low cost by implementing simple systems that take the economic attractiveness out of counterfeiting.

However the legislation moving through the European Parliament must address the concerns that all actors within the supply chain will have; which safety features will be mandatory, will the transaction data be kept confidential, will the cost of implementation be proportional to the price of the medicine? When all three questions are answered an effective barrier against patients receiving sub-standard medicines can be put in place.

Authentication, particularly at the point of dispense, has already been proven to be the most efficient, cost-effective, non invasive approach to ensuring patients have no reason to receive substandard (expired, recalled and counterfeit) medicines.