Falsified medicines: the net tightens

In February 2015, a partnership of European pharmaceutical industry associations including EFPIA, the EGA and others has set up the European Medicines Verification Organisation (“EMVA”), to oversee the Europe-wide deployment of the European Standards Model to verify the authenticity of individual packs of medicinal products at the point where they are dispensed.

Background: the problem

History abounds with quack medicines sold to a gullible public desperate to believe that any wonderful and rare “snake oil” will cure them of their diverse ills. But no less of a problem, and almost as venerable, is the counterfeiting of genuine medicines. In the 17th century, for instance, widespread deliberate adulteration of Chinona bark (the natural source of quinine) undermined European public confidence in its efficacy as a treatment for malaria. With the increased number of medicines now manufactured and sold worldwide, it is unsurprising that the complex supply chains for many modern products are also targets for the unscrupulous in search of a quick profit regardless of the serious impact on public health. Although accurate figures are hard to come by, it is reported that up to 30% of medicines sold in Africa may be counterfeits, and even in the developed world incidents of counterfeiting occur – in 2012, falsified supplies of Avastin reached the US market via the UK.

Counterfeits are not substandard production quality pharmaceuticals, or drugs which infringe intellectual property rights; they may have nothing at all to do with the substance as which they are being marketed. This is therefore a significant problem facing both originator and generic companies, as well as prescribers, pharmacists and patients.

Regulatory response

In a sense, the entire regulatory framework surrounding the manufacture and sale of medicinal products in the European Union is a response to the problem of ineffective, potentially dangerous products of dubious quality being administered to the vulnerable, but until the passing of the 2011 Falsified Medicinal Products Directive there was no European legislation specifically addressing counterfeit medicines. 

This Directive stipulates that any medicinal product with a false representation of its identity (composition (including excipients), strength, name or packaging), source (manufacturer, country of origin or marketing authorisation holder (“MAH”)) or history is treated as a falsified medicinal product. The holder of a manufacturing authorisation is now responsible for using only active substances which have been manufactured and distributed in accordance with the relevant standards, Regulations on which were passed in July 2014. The manufacturing authorisation holder must also verify the authenticity and quality of those and the excipients, and that the manufacturers, importers and distributors from which it obtains active substances are registered with the competent authority of their Member State of establishment. It must inform the competent authority and MAH if it becomes aware of any suspicion of counterfeiting.

The verification of authenticity is to be handled by the addition of safety features, in addition to a tamper-evident device, to packaging. Where the legitimate supply chain has to remove the safety features – at an intermediate production stage for example – they must be replaced by equivalents. The Qualified Person must ensure that this takes place.What exactly the safety features are is left to delegated regulations, concepts for which – including barcodes and RFID tags – were the subject of extensive consultation in 2011. Unfortunately, no draft Regulations have yet been made public, although this was expected to have been done in 2014. 

The European Commission did, however, succeed in 2014 in implementing a common logo for use on legal pharmacy websites, intended to assist the public in knowing where it is safe to buy pharmaceuticals online. The would-be purchaser has to click on the logo when on the pharmacy website, and should be directed to that pharmacy’s entry on the national register, thereby verifying its legitimacy.

It is to be hoped that consumers will make the effort to do this verification – educating consumers, whose average attention span for terms and conditions on any website is fleeting, to say the least, as to the need to do so may be as difficult a task as getting the legislation passed in the first place. The European Medicines Agency has been tasked with raising public awareness.

In addition, as part of the broader reform of European trade mark law, the European Parliament in 2014 agreed to extend the effect of European trade marks such that they can in future be used to stop products which are in transit through the European Union rather than being destined for European hospitals, pharmacies or patients. This provision, which has not yet finally been passed as other aspects of the package are still under discussion, remains controversial, as customs actions in the past against legitimate generic medicines have raised tensions between, for instance, India and the European Union. Groups such as Médecins Sans Frontiersfear that further increasing the protection of brands may lead to further such over-enthusiastic seizures of products destined for the developing world.

Practical action

In parallel with the legislative activity, the European pharmaceutical industry have been working on a practical mechanism to make sure that medicinal products which reach patients are indeed genuine products. The system, known as the European Standards Model, was pilot tested in Sweden in 2009-10. It is now being prepared for use in Germany under the securPharm system, and will then be rolled out to other countries. It requires individual medicine packs to have a 2D matrix barcode based on international standards, containing as a minimum the product and batch numbers, expiry date and a random serial number. At the point of dispensing, the dispenser will scan the barcode to verify that the product is genuine. (A similar 2D bar-coding initiative has been announced for secondary packaging of drugs being exported from India, but its introduction in practice has been postponed several times.) But making such a system work across the entire European Union is no small task, and hence the establishment of the EMVO by industry, to ensure complete consistency from producer to patient.

Where next?

Since all of the implementing Regulations for the new falsified medicines regime have not yet been introduced, the system for verification will not become a reality for some time to come. Nevertheless, the building blocks are now in place and there is clearly both the political and commercial will to improve the standard of protection for patients to make it happen. Current estimates suggest 2017 may be the date by which the full implementation can be expected; until then, it is up to individual companies to do their best to keep their own production and supply arrangements secure in the face of a steadily increasing threat – or face the loss of reputation that can follow.

[1] Directive 2011/62 amending Directive 2001/83/EC, as regards the prevention of the entry into the legal supply chain of falsified medicinal products OJ L174/74 1.7.2011