A new report highlights a number of worrying trends emerging in regard to the increasing number of fake pharmaceuticals infiltrating supply chains around the globe.
"Today, few jurisdictions, whether developed or developing, are immune from counterfeit pharmaceuticals and the infringement of intellectual property rights", warned the report on counterfeiting released by the Organisation for Economic Co-operation and Development (OECD).
While the magnitude of counterfeit pharmaceuticals is still reported as low (less than one percent) in many developed countries, such as Australia, Canada, the EU, Japan, New Zealand and the US, they are becoming increasingly affected as the practice of global sourcing and manufacturing intensifies.
"A worrisome trend is that counterfeits are increasingly being detected as having entered the supply chain of some of the most regulated jurisdictions", said the OECD.
In a survey conducted by the organisation amongst pharmaceutical manufacturers in 2005, one company reported an increase in the existence of counterfeit active pharmaceutical ingredients (APIs) and increased difficulties in distinguishing between the genuine and the counterfeit material.
"An examination of the data also points to an increase in the number of incidents/activities reported and prosecuted in the last few years. For example, one source reports an increase in number of incidents of approximately 27 per cent between 2004 and 2005". However the organisation did concede that an increased awareness and vigilance of supply chain tampering may have contributed to an increase in detection.
In the OECD survey, one company said it detected counterfeit APIs originating in India in 33 countries. Another firm reported that counterfeits of its pharmaceutical products sourced in China were detected in 42 countries.
Meanwhile, developing countries have a counterfeit prevalence of 10-30 per cent or higher, according to 2006 World Health Organization (WHO) figures cited in the OECD report.
India has been pinpointed as by far the biggest culprit in making fake drugs - according to 2005 TAXUD statistics released by the European Commission, 75 per cent of the global cases of counterfeit medicines originated from India, 7 per cent from Egypt and 6 per cent from China.
In the case of finished products, a trend noted by the OECD is the increasing diversification of the types of products targeted. "Examination of data for the EU and North America reveals that counterfeiters have targeted a wide range of modern drugs in the areas of cancer (anti-tumor and anemia), erectile dysfunction, cardiology (cholesterol lowering and hypertension), hormones and steroids," the report said.
Genito-urinary medicines appear to be by far the most commonly-targeted drugs. The OECD indicated that there had been 253 reported incidences of counterfeiting involving this class of medicines, with the number jumping to 401 in 2005. Anti-infectives and central nervous system (CNS) drugs were the next most likely victims (172 and 147 incidents respectively).
The emergence of another new and troubling trend identified by the report is the increasing role the internet is playing in the spread of counterfeit products. In particular, the report highlighted the recent case of the obesity drug Rimonabant, which was falsely advertised for sale over the internet before it had even received EU marketing approval.
The OECD also released shocking pictures of the rudimentary methods and environments used in the production of counterfeit pharmaceuticals in both developing countries (depicted below), and developed countries, where the conditions were not much improved.
The organisation said that the criminals responsible for the manufacture and distribution of counterfeit drugs range from individuals including medical professionals such as pharmacists and physicians, to criminal groups, organized crime syndicates, rogue pharmaceutical companies, corrupt local and national officials and terrorist organisations.
The report is part of a project initiated by OECD in 2005 to assess economic the effects of counterfeit products and infringements on the intellectual property rights; review the trends and developments; and assesses what is being done to combat the illicit practices.
All three pictures are sourced from: Instituto Nacional de Medicamentos - ANMAT, 2006