The Council on Foreign Relations has commissioned a researchers’ roundtable titled, “Building the Evidence Base: How Safe is the Global [Drug] Supply Chain?” Chaired by CFR Senior Global Health Fellow Laurie Garrett, the Global Drug Safety Roundtable’s remit is to examine important issues in five areas of global drug safety:
The group’s first meeting (December 5, 2011, in New York) examined the quality and quantity of data regarding unsafe drugs and medicines that are slipping past various stages of international and country scrutiny. These include mislabeled, substandard, contaminated, adulterated, expired and ineffective medications and vaccines, most of which are labeled as legitimate pharmaceutical or generic products. The speaker line-up included some of the leading specialists involved in investigating the prevalence and public health repercussions of fraudulent and substandard medicines around the world:
Viagra may own the dubious distinction of having set off this global wave but all sorts of medicines—even cheap ones—are now vulnerable to fakes. Malaria and TB drugs are among those causing most worry, both because of the huge number of people put directly in harm’s way by ineffective treatments for these diseases and because of the danger that use of medicines containing inadequate levels of the active ingredient will accelerate development of resistant disease organisms.
The speakers called the trend deeply worrying, as drugs are increasingly manufactured and distributed through a complex multinational web of producers and chemical brokers. This web is highly variable in quality controls and infiltrated by criminal activity. China is a production hub for the largest number of counterfeits, according to Clark, but supply chain breaches have been identified on every continent but Antarctica. Extremely weak regulatory systems in Asia, Africa and Latin America make those regions the most problematic. In Kenya for example, up to 30 percent of the pharmaceutical market is overtaken by counterfeit drugs. Middle income countries (e.g., BRICS) are the highest value market for counterfeiters, said Roger Bate, because economic resources have surged ahead of a lagging regulatory structure.
But needless deaths due to fake drugs have been documented even in the U.S. where strong(er) regulatory and market controls are in place. As Laurie Garrett and Yanzhong Huang write in a backgrounder prepared for the meeting, “The scale and pace of transformation of food and drug production and distribution has far outstripped the capacity of national regulatory agencies or law enforcement offices to verify authenticity and safety.“ Intellectual property violation and lost sales for legitimate producers are intertwined with enormous risks to public health.
The Global Drug Safety Roundtable Series will meet next on January 18 in CFR’s Washington offices, to discuss the public health implications of unsafe drugs. The 5-part series will conclude in April with production of a policy recommendation for the U.S.-hosted G8 Summit convening in June 2012.
GBCHealth invites members with an interest in obtaining more detailed information from these sessions—or in discussing these issues—to contact Pam Bolton (email@example.com) who will be happy to share her more detailed notes and impressions as well as facilitate putting members in touch with any of the speakers.