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Pharma Business WHO Comments Signal Support For Compulsory Licensing T By Gail Dutton, contributing editor he NIH recently made an unprecedented decision in granting the Lacks family some say in how the cervical cancer cells from the late Henrietta Lacks — the famed HeLa cell line — are used. A few months earlier, in May, controversy over ownership of a sample of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) erupted into a public spat involving the government of Saudi Arabia and Erasmus Medical Center in the Netherlands. In commenting, the WHO Director-General, Margaret Chan, demanded that labs not be allowed to profit from their work. The underlying issue in both situations is the right to profit from scientific discovery. The ramifications of these incidents may affect not only the use of biological samples but also countries' decisions to use compulsory licenses. DEVELOPING WORLD UNRECEPTIVE TO PHARMA PATENTS The WHO appears suspicious of profitbased businesses. As Chan said in her WHO speech in May, "Many of the risk factors for noncommunicable diseases are amplified by the products and practices of large and economically powerful forces. Market power readily translates into political power. When public health policies cross purposes with vested economic interests, we will face opposition, well-orchestrated opposition, and very well-funded opposition." India, with a strong generic pharmaceutical industry, is particularly receptive to the notion of constrained patentability for 46 LifeScienceLeader.com pharmaceutical products. Earlier in 2013, India's health ministry committee urged the government to exercise its compulsory licensing rights for Herceptin (trastuzumab). The Indian biopharmaceutical firm Biocon expects to complete Phase 3 trials of a biosimilar for trastuzumab this fiscal year, and Dr. Reddy's Laboratories and Intas Pharmaceuticals indicate they may begin clinical trials soon. One year earlier, in March 2012, India exercised a compulsory license for Nexavar (sorafenib) by Bayer, which was subsequently produced by the Indian firm NatcoPharma. When Roche relinquished its patent battles in India in August 2013, it cited India's intellectual property environment as a key factor in that decision. Indian generics firms may see a boost from tight patent requirements and the exercise of compulsory licensing, but the results are chilling for innovators operating in India. India's success in exercising march-in rights has been noted by other nations. South Africa has an active campaign, spearheaded by the Treatment Action Campaign (TAC) and Médecins Sans Frontières (MSF), to remodel its patent laws after the Indian laws. In an August memorandum to the South Africa December 2013 Department of Technology and Industry (DTI), TAC and MSF charged the lack of competitive markets in emerging regions enabled pharmaceutical companies to charge unaffordable prices that make life-saving medicines inaccessible. "Although other BRICS [Brazil, Russia, India, China, and South Africa] countries like India and Brazil have utilized these pro-public health safeguards, South Africa is lagging behind and has not amended its patent law to incorporate or implement TRIPS [Trade Related Aspects of Intellectual Property Rights] flexibilities," the TAC and MSF memo pointed out. It advocated a stringent patent examination process that "only grants patents on new drugs. If fewer secondary patents are granted, then more generic versions of medicines will be able to enter the market upon the expiry of compound patents, which will in turn drive down prices. Furthermore, when patents result in medicines being priced out of reach, actions that mitigate high prices, such as compulsory licensing, must be practically feasible to implement." It called on DTI to "broaden the grounds and facilitate the procedures for issuing compulsory licenses." Similar laws are enacted in China and are being planned in Argentina and the Philippines.