Protecting the European supply chain
During the past few years, there has been a drive to adopt proactive measures to tackle the criminals behind counterfeit trade.
A major step forward was the 2006 launch of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), involving
the World Health Organization and major anticounterfeiting players.
Building on the work of IMPACT, the European Commission (EC) issued a memo in late 2008 that proposed amendments to Directive
2001/83/EC, relating to medicinal products for human use.2 One of the proposed measures in its policy concerns the pharmaceutical product itself; the European authorities would like
certain medicinal products to bear recognizable safety features that would help distinguish them from fakes. By setting out
a formal framework for these features, a system of legal standardization would be introduced across the region to encourage
the identification of fakes and enable traceability for determining their entry point into the supply chain. In several European
legal cases, where counterfeit medicines have been identified, the quality of reproduction was so high that experts acknowledged
that it was extremely difficult to distinguish them from genuine products.5 The proposed European safety feature system would involve individual product codes on packaging and tamper-resistant seals.
However, for these safety features to be effective, only certified manufacturing authorization holders would be allowed to
affix and modify them.
While the intent of the EC is appreciated by the pharmaceutical industry, the nature of trade in the EU poses some difficulties
for the proposed system. As EFPIA has highlighted, the fact that current EU rules allow situations where products can be reboxed,
relabelled or overstickered, and tablets removed from their blisters and reconditioned, complicates anticounterfeiting measures.7 The EC notes that these measures are in place to enable medicines destined for one member state to be sold in another; however,
these provisions also help parallel trade; a legal mechanism allowing the cross-border exchange of branded products based
on price differentials, which is fiercely opposed by the pharma industry. Companies have often cited parallel trade as a means
for counterfeit products to enter the European supply chain, but parallel traders have rejected this accusation. Therefore,
companies will be unhappy if anticounterfeiting security measures are restricted because of concerns regarding their impact
on parallel trade.
In its proposals, the EC has also described measures by which it hopes to better regulate pharmaceutical distributors. This
will involve inspections and mandatory audits of distributors, with the details being kept in a database managed by the EMEA.
In addition, any products entering the EU that are destined for transport to various member states or beyond will be subject
to stronger supervision. Unfortunately, these measures contain an area of weakness as they only apply to physical delivery
mechanisms. At present, the EC has steered away from measures targeting illegal medicines sold via the internet, stating that this is an area for individual member states to decide on their own. Until this grey area is addressed,
however, counterfeiters will consider to use it to their advantage — particularly as they can operate from third countries
outside of the EU, which makes legal action hard to enforce.
Although European governments and healthcare agencies have long recognized that counterfeit medicines represent a threat to
citizens in their countries, coordinated action has been limited. A new European-wide policy is anticipated in 2011, but this
only represents the start of tackling the issue of counterfeiting. In initial feedback, pharmaceutical companies have responded
positively to the EC's initiatives, but still have concerns that anticounterfeiting actions will not be harmonized across
There is also concern regarding costs. The cost of introducing the new policies has been estimated at €2 billion–4 billion
per year.5 Given the tendency of European governments to pressure the pharmaceutical industry with cost containment policies, companies
will want assurances that the costs of introducing anticounterfeiting measures will not be solely up to them.
As noted in an official analysis of the European proposals, it is not clear what effect they will have on the trade of counterfeit
medicines in the EU.5 An optimistic scenario suggests that eradication of counterfeiting by 2015 is a realistic target; however, the opposing
pessimistic view suggests that containment at 2011 levels is the best that can be achieved in the run-up to 2020.5 Despite the potential weaknesses of the EC's proposals, there is general agreement that action must be taken now before
an irreversible escalation of counterfeiting occurs.
Faiz Kermani is a freelance consultant and President of the Global Health Education Foundation, a charity that supports medical education
and medical research projects in developing countries. He is a member of Pharmaceutical Technology Europe's Editorial Advisory