Everyone working in the UK pharmaceutical industry will be aware of the dangers posed by falsified medicines – fake drugs which are sold as authentic, authorised products, which pose a real risk to patients’ health.
In 2011 the EU took action to minimise the chances of counterfeit medicines entering into the medicines supply chain, publishing a Falsified Medicines Directive.
A key feature of the Directive is the introduction of a new system to authenticate and monitor medicines in the supply chain across the EU – the European Medicines Verification System (EMVS).
Under this new system, all European Union member states have been required to establish national medicines verification organisations (NMVOs) to administer the verification of medicines nationally. SecurMed Ltd, a not-for-profit organisation, will serve as the UK NMVO.
Under the terms of the EU Directive, marketing authorisation holders (MAHs) are required to bear the costs of establishing and managing the UK repository system.
The set-up costs for SecurMed as the NMVO are borne by all MAHs in the UK, from global pharmaceutical companies to small, independent UK businesses. This cost stands at £35,000 (around €40,000) for each company, with discounts of up to 52 percent available to companies who pay before February 2019.
These fees are applied at a flat rate to all MAHs, regardless of means. I have been contacted by a number of EMIG member companies – many of them small businesses – for whom these fees represent a significant financial outlay.
In response, EMIG has conducted our own review of fees charged by NMVOs across Europe – and has found that the UK NMVO’s maximum entrance fee level is the highest charged by any NMVO in Europe, and the maximum-discounted entrance fee is the second highest.
In France, the entrance fee stands at €20,000, and Germany’s highest fee is €30,000. This means that the UK companies are therefore paying thousands of pounds more than their competitors in France and Germany have to.
I of course understand that SecurMed must recover its setup costs from industry, but even so I believe that our members and other companies deserve an explanation for these differences. I wrote, therefore, to SecurMed last month to find out the answers to three important questions.
First, why are setup costs so much higher for UK businesses compared to France and Germany? Second, will companies here in the UK be compensated for the higher setup costs by lower, ongoing annual fees? And finally, why does SecurMed not seem to want to vary either the initial or ongoing fees according to company size?
These are important questions, but I have yet to receive satisfactory answers. I am writing this article now in the hope that SecurMed will respond, and that ultimately all companies – both large, but particularly small – will be charged fees which are sensible, fair and proportionate.
EMIG is a multi-stakeholder network and trade industry association that represents the interests of the full span of life sciences companies in the UK. Its members, range from new business start-ups focused on R&D, through to well-established companies delivering a wide range of essential medicines to patients.
Leslie Galloway is chairman of EMIG