Fighting fake drugs: the role of WHO and pharma

Abstract

Counterfeit medicines pose a serious threat to public health. Up to 15% of all drugs sold worldwide are estimated to be fake. Last year, WHO, at the request of member states at the 2010 World Health Assembly (WHA), convened an intergovernmental working group on counterfeit medicines tasked with deciding the agency's role in tackling this global scourge. The intergovernmental group was required to make specific recommendations to this year's 64th WHA (May 16–24). They will, however, fail in this mission. Although mandated in May, 2010, the group met only once at the end of February this year and decided on one definite thing: they needed more time.How can the group be more productive this year? At the February meeting, some member states expressed their desire to draw up a legally binding international instrument designed to criminalise the manufacture, export, import, and trade of counterfeit medicines, effectively a global treaty against fake drugs. A treaty would make counterfeit medicines illegal and it should be pursued with vigour by this year's WHA, following the model of another successful WHO treaty, the Framework Convention on Tobacco Control.The drug industry has expressed support for such an agreement, but it could contribute much more to the fight against fake drugs. At present, all major drug companies notify the Pharmaceutical Security Institute about any counterfeiting that their surveillance operations detect, and it pools the information. The Institute's database, therefore, holds vital information about the global extent of counterfeiting, the categories of drugs being falsified, and the locations where fake drugs are being marketed. But the database is confidential. Evidence of a dangerous iatrogenic epidemic is thus being hidden by industry and this situation must change. The case for open data sharing in science is made in a Comment in today's issue; the Institute should take note.This year's WHA and the drug industry have a chance to take concrete steps within the coming months to combat the deadly trade in fake medicines. These opportunities should not be squandered. Counterfeit medicines pose a serious threat to public health. Up to 15% of all drugs sold worldwide are estimated to be fake. Last year, WHO, at the request of member states at the 2010 World Health Assembly (WHA), convened an intergovernmental working group on counterfeit medicines tasked with deciding the agency's role in tackling this global scourge. The intergovernmental group was required to make specific recommendations to this year's 64th WHA (May 16–24). They will, however, fail in this mission. Although mandated in May, 2010, the group met only once at the end of February this year and decided on one definite thing: they needed more time. How can the group be more productive this year? At the February meeting, some member states expressed their desire to draw up a legally binding international instrument designed to criminalise the manufacture, export, import, and trade of counterfeit medicines, effectively a global treaty against fake drugs. A treaty would make counterfeit medicines illegal and it should be pursued with vigour by this year's WHA, following the model of another successful WHO treaty, the Framework Convention on Tobacco Control. The drug industry has expressed support for such an agreement, but it could contribute much more to the fight against fake drugs. At present, all major drug companies notify the Pharmaceutical Security Institute about any counterfeiting that their surveillance operations detect, and it pools the information. The Institute's database, therefore, holds vital information about the global extent of counterfeiting, the categories of drugs being falsified, and the locations where fake drugs are being marketed. But the database is confidential. Evidence of a dangerous iatrogenic epidemic is thus being hidden by industry and this situation must change. The case for open data sharing in science is made in a Comment in today's issue; the Institute should take note. This year's WHA and the drug industry have a chance to take concrete steps within the coming months to combat the deadly trade in fake medicines. These opportunities should not be squandered. Science as a public enterprise: the case for open dataThe past half-century has seen a breathtaking surge in scientific discovery. We have put satellites into orbit and probed the universe; we have discovered the chemical structure of living organisms and learned to manipulate it; we have been able to read the Earth's history in minute detail from ice-sheet and ocean cores; and we have improved human and animal health through increasingly large epidemiological studies and clinical trials. All of these achievements have necessitated new ways of collecting, storing, manipulating, and transmitting information that far surpass anything previously dreamed of. Full-Text PDF Open Access