The fight against counterfeit medicines is back in the headlines, with the announcement that INTERPOL and 29 of the world’s largest pharmaceutical companies have teamed up for a new campaign. The three-year campaign, which will receive €4.5 million in funding, will involve the creation of INTERPOL’s Pharmaceutical Crime Programme (1). The campaign is being designed to complement INTERPOL’s existing Medical Product Counterfeiting and Pharmaceutical Crime (MPCPC) unit. The new programme will cover a wide range of pharmaceutical crime including branded and generic drug counterfeiting. INTERPOL also aims to identify and dismantle the organised crime networks linked to this illegal, but lucrative activity. The new campaign was launched with considerable publicity and the belief of the pharmaceutical industry in the initiative was highlighted by the public statements issued by a number of company chief executives including Christopher Viehbacher of Sanofi (2). The European Federation of Pharmaceutical Industries and Associations (EFPIA) also released a statement strongly backing the initiative (3).
Ongoing anticounterfeiting initiatives
One of the frustrations for pharmaceutical companies is that when counterfeit products do appear on the European market, they have often originated from elsewhere in the world; only a global campaign against counterfeiters that involves multiple stakeholders stands any real chance of success. In the past, there was a tendency to believe that the European supply chain was somewhat impenetrable; however, incidences of counterfeit products reaching European countries continue to be on the rise. The constant need for vigilance to safeguard patients’ health has been highlighted by INTERPOL’s Pangea initiative to combat the online sale of counterfeit medicines. In October 2012, Pangea V involved INTERPOL, customs, police, regulatory authorities and other enforcement agencies from different countries (4).Pangea V was conducted in 100 countries, an increase from the 81 countries that participated in Pangea IV in 2011, and primarily targeted Internet pharmacies (4). Pangea’s global reach has expanded rapidly over the years. In 2008, Pangea I only featured eight countries and Pangea II in 2009 involved 25 countries (5). Pangea V led to the shutting of approximately 18000 online sites and the dismantling of a large number of payment-processing networks that operated through the illegal online pharmacies. This effort required close coordination with parties such as credit card companies. The scale of the counterfeit seizures illustrates the rate at which counterfeiting has continued to grow as a criminal activity. Pangea V resulted in the seizure of 3.75 million medicine units, which were valued at approximately US$10.5 million. What was shocking was that this seizure was a fourfold increase over that in the 2010 operation (4).
The UK’s Medicines and Healthcare Regulatory Agency (MHRA) played a major role in Pangea V. Together with the UK’s Border Force, the agency seized more than 2.3 million doses of unlicensed medicines, valued at approximately £3.8 million, which included 68000 doses of counterfeit pills (5). MHRA action also led to over 384 generic top-level domains in the UK being suspended and a further 120 domain names being shut down (5). In Northern Ireland, these raids resulted in the interception of the delivery of thousands of illegal prescription drugs to local addresses (6). The drugs included over 55000 benzodiazepines, a number of pain relief medicines and unidentified psychoactive substances (6). Health ministers warned the public not to be tempted by price cuts to seek medicines from unauthorised sources.
The MHRA has had a dedicated anticounterfeiting strategy for the UK since 2007, which has not only resulted in seizures of counterfeit medicines but also the conviction of criminals behind the distribution (7).
While the agency has achieved success with its strategy, it has observed a continuing attraction of the UK pharmaceutical market to counterfeiters and the increasing sophistication they are employing to break into the UK’s legitimate supply chain. Parallel-trade routes have been employed on a number of occasions as a means to reach the UK market via other EU markets and take advantage of economic conditions that have skewed exchange rates within the region (7). The only known case where the point of origin for such products was the UK was recorded in 2003.
In 2012, MHRA launched its second action plan, the Falsified Medical Products Strategy 2012-2015. A key part of the MHRA’s strategy is to collaborate with other stakeholders and to ensure international cooperation. The MHRA holds twice-yearly meetings of the Anti-Counterfeit Stakeholders (ACS) group, which involves pharmaceutical industry trade associations, wholesalers, parallel traders, generics manufacturers and other stakeholders with a focus on the UK market. At its core, the MHRA’s current strategy focuses on prevention, ensuring a timely and professional response to incidents and investigation, whereby relevant laws are used to prosecute those involved in illegal medicines trading. There has also been great emphasis on communication with the public to be vigilant regarding counterfeit medicines.
Individual pharmaceutical companies in Europe also run their own operations against counterfeiters. For example, Sanofi has been working with Air France on a communication campaign targeted at travellers (8). According to the Sanofi campaign, 27 million medical products were retained by Customs in the EU during 2011, which was nine times more than the figure in 2010 (8). The company also has its own anticounterfeiting laboratory, which it makes available to authorities wishing to analyse suspect products. To date, the laboratory has analysed more than 20000 such products.
In Germany, the major pharmaceutical industry and pharmacists associations started a nationwide pilot project in January 2013 to examine the efficiency of a new protection system against counterfeit drugs (9). Termed, securPharm, this software-driven system involves scanning a coded sales pack in the pharmacy to verify the authenticity of a medicine against an individual randomised package number before it is dispensed to patients. Supporters of the initiative believe that it might eventually serve as an example to other EU countries. However, one anticounterfeit technology supplier has criticised the technological approach of securPharm, stating that the data-matrix code involved is not forgery-proof (10).