The European Union should strengthen penalties against companies trading in counterfeit drugs, a report from the School of Pharmacy at the University of London recommends.
It also calls for better monitoring of trading of drugs and better provision of information to the public to try to combat the growing problem of counterfeit drugs.
The report warns that counterfeiting, which has been a major problem for some years in developing countries, is now increasing in Europe. Recent World Health Organization statistics show that 30% of drugs supplied in developing countries are fake.
The report documents cases showing that the problem applies to branded and generic products and ranges from the illegal use of copyrighted commercial brands to manufacture of fake drugs.
In some East European countries, such as Russia, about 10% of drugs are counterfeit, the report notes. In West European countries, such as the United Kingdom, less than 1% (by value) of drugs supplied are counterfeits, many of these being purchased on the internet.
However, three of the 25 cases currently being investigated by the UK Medicines and Healthcare Products Regulatory Agency involve fake drugs being supplied through the legal NHS medicines supply chain.
A confidential database, the counterfeiting incident system, showed that 18 European countries were involved in reported incidents of drug counterfeiting in 2005. Forty three cases were reported in 2004 and 130 in 2005. However, the authors say that these figures may represent the “tip of the iceberg.”
The report warns: “Secrecy and denial relating to the occurrence of medicines counterfeiting in Europe has been driven by commercial imperatives to protect brand identities and official interests in maintaining public and professional confidence in the quality of the generic and patented medicines available in Europe.”
Failure to control counterfeiting causes major problems for the safety of patients receiving these drugs and for the continuing development of new drugs, the report argues.
David Taylor, professor of pharmaceutical and public health at the School of Pharmacy and one of the report's authors, said, “Compared with the harm done by medicines counterfeiting in Africa and Asia, Europe is relatively safe. But there are growing risks, which will get worse if, for example, people believe that they cannot get new medicines that may benefit them for conditions such as cancer, dementia, or influenza from publicly funded services.”
The report reviews a number of cases in Europe over the past few years, including a case in Germany in 2003 in which authorities raided a major drug wholesaler, seizing counterfeit drugs for treating HIV and AIDS valued at almost €1m (£0.7m; $1.3m).
A total of 500 000 dosage units of counterfeit and illegal drugs, including erythropoietin and human growth hormone, were recovered in Spain in 2004.
Earlier this year the European Commission issued warnings that versions of rimonabant, a drug that was at the time being evaluated by the European Medicines Agency for the treatment of obesity, were being sold on several websites.
Professor Taylor warned that many health service providers encourage systems in which drugs are bought cheaply in parts of Europe where governments impose low prices and then sold on in new packages in EU member states where government controlled prices are higher.
“People think this saves money. But the evidence explored in our report indicates that it is in fact undermining European economic interests and may, on occasions, have created a pharmacy culture that increases the risk of counterfeit medicines.”
The report calls for stronger legal penalties for drug counterfeiting. It said that the supply chain in the EU might need to be strengthened further when countries such as Bulgaria, Romania, and Turkey join. Suggested strategies include shortening supply chains between manufacturers and pharmacies and use of “track and trace” technology that allows movements of products to be followed.
The report also says that Europe should consider the costs and benefits of precautionary measures such as suspending the free movement of drugs across its internal borders and eliminating inappropriate financial incentives for trading in drugs. It supports reform in other areas, ranging from more freedom in the regulated provision of information on drugs in Europe to better controls of internet pharmacies and of trading in drugs by entrepreneurs such as secondary wholesalers who buy drugs and sell them on.
The report was funded by an educational grant from the drug company Pfizer, but Professor Taylor said that the report represented his views and those of his coauthor, Natasha Campling.
Trick or Treat? Opportunities for European Action on Health Improvement, Pharmaceutical Innovation and the Threat of Medicines Counterfeiting (price £5) is available by emailing Natasha.Campling@pharmacy.ac.uk.