Renewed EU action
The fact that counterfeit products have managed to enter highly regulated markets has led to renewed efforts to tackle counterfeiting.
Much hope has been placed in Europe's Falsified Medicines Directive, which will come into force in January 2013 and increase
controls across the EU. The Directive was approved by the European Parliament last year and introduces new rules that will
require prescription medicines to have safety features that enable verification of individual packs throughout the supply
chain (9). Under the new system, all importers, manufacturers and distributors will become brokers of medicinal products,
which confers greater responsibility on them to be vigilant and proactive. The Directive also targets illegal online pharmacies,
which remain a major threat. In the future, all websites offering medicines for sale will need to be clearly linked to the
website of the competent authority in that particular country. The regulatory body will also display a list of approved online
sales sites, which will be required to display a common, recognisable logo (9, 10).
The pharmaceutical industry has also been working on a number of initiatives with other stakeholders. In January 2012, the
European Federation of Pharmaceutical Industry Associations (EFPIA), the European umbrella organisation of pharmaceutical
full-line wholesalers (GIRP), the European Association of Euro-Pharmaceutical Companies (EAEPC) and the Pharmaceutical Group
of the European Union (PGEU), which represents pharmacists, issued a joint press release calling for practical and cost-effective
solutions to implement the requirements of the EU's Falsified Medicines Directive (11). The organisations have been developing
a European Stakeholder Model (ESM) that can be adapted to individual national systems. ESM employs a product verification
system that is run by pharmaceutical manufacturers, pharmacists and wholesalers, as well as parallel distributors. A unique
serial number will be featured on each product pack that can be checked with ease against a central database at the point
of dispensing. A pilot of the system was conducted in Sweden during 2009 to 2010 and a further pilot is planned for Germany
in 2013 (11).
Another major development that has received the industry's backing is the MEDICRIME Convention launched by the Council of
Europe. In December 2011, a high-level conference was held in Moscow where members signed up to binding international legal
agreements to combat counterfeiting. In particular, it was felt necessary to tighten the definition of what constituted a
counterfeit in order to fill gaps in certain national legislation. For example, in certain countries, it has been difficult
to bring legal action against those manufacturing, distributing and selling falsified medicines because the existing legislation
only covered breaches of trademark and patent legislation (12). EFPIA hopes that the timing of the MEDICRIME initiative will
boost efforts at the EU level and has also stated that it is ready to help any members in meeting their obligations for the
MEDICRIME Convention (12).
Outlook
The threat posed by counterfeits to the European supply chain cannot be underestimated and the number of cases in the UK alone
last year shows that counterfeiters are continuing their efforts to break into regulated markets. On a positive note, the
level of international cooperation to defeat the criminals behind counterfeiting is at an all-time high. The EU's Falsified
Medicines Directive, the MEDICRIME Convention and the ESM initiative by industry stakeholders are just some of the notable
cooperative measures that are set to improve protection of the supply chain.
References
1. WHO, "Medicines: spurious/falsely-labelled/ falsified/counterfeit (SFFC) medicines" (WHO website, 2010).
http://www.who.int, accessed 8 Feb. 2012
2. N. Siva, The Lancet
376 (9754), 1725 – 1726 (2010).
3. T. Symonds, "Fake medicine trade: UK crackdown on drug importers" (BBC News, 2011).
http://www.bbc.co.uk/, accessed 8 Feb. 2012
4. BBC News, "Man jailed for £4.7m counterfeit medicine fraud" (BBC News Website, 2011).
http://www.bbc.co.uk/, accessed 8 Feb. 2012
5. N. Siva, "How investigators unravelled Europe's biggest-ever fake-medicine scam" (Wired, 2011).
http://www.wired.co.uk/, accessed 8 Feb. 2012
6. P. Kemp, "Fake drugs given to NHS patients still untraced" (BBC News, 2012).
http://www.bbc.co.uk/, accessed 8 Feb. 2012
7. MHRA, "Counterfeit drug peddlers sentenced" (MHRA Press Release, 2011).
http://www.mhra.gov.uk/, accessed 8 Feb. 2012
8. P. Taylor, "Counterfeit Viread also on market, says MHRA" (Securing Pharma Website, 2011).
http://www.securingpharma.com/, accessed 8 Feb. 2012
9. G. MacDonald, "EU falsified meds act formally adopted" (In-Pharmatechnologist Website, 2011).
http://www.in-pharmatechnologist.com/, accessed 8 Feb. 2012
10. "Q&A: Directive on falsified medicines" (European Commission, 2011). http://europa.eu, accessed 8 Feb. 2012
11. EFPIA, "EAEPC-EFPIA-GIRP-PGEU working for better Patient Safety" (EFPIA Website, 2011).
http://www.efpia.eu, accessed 8 Feb. 2012
12. EFPIA, "MEDICRIME Convention Position Paper of the European Federation of Pharmaceutical Industries & Associations" (EFPIA
Website, 2011).
http://www.efpia.eu, accessed 8 Feb. 2012
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