Europe continues to battle counterfeiters - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Europe continues to battle counterfeiters
Governments, regulators and international agencies continue to defend against counterfeiters; in particular, the European Commission has outlined measures that may help to better regulate pharmaceutical distributors. There is still much work to be done, however, particularly when it comes to counterfeit drugs sold via the internet.


Pharmaceutical Technology Europe
Volume 21, Issue 12

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.

Outlook

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 the EU.8

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 Board.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology Europe,
Click here