A/HRC/23/42 pharmaceutical promotion. However, these have been criticized as ineffective.90 The Special Rapporteur recommends formulating strong enforceable regulatory systems, with accountability measures, to discourage unethical marketing and promotion of medicines by pharmaceutical companies. G. Quality 61. According to the right-to-health framework, States are required to protect the population from unsafe and poor-quality medicines. Quality assurance for medicines includes such aspects as registration and marketing of good quality, safe and efficacious products under ethically and medically validated clinical trials, continuous regulation of the quality of production of medicines and prevention of sub-standard and spurious medicines from being sold on the market after registration. 62. Poor quality medicines are genuine products that do not meet quality specifications due to poor manufacturing practices. They can cause drug resistance, adverse effects and even death.91 Contrary to popular belief, recent studies indicate that there may be fewer poor quality medicines on the market than previously estimated.92 A potential explanation for this could be the tendency to conflate poor-quality with counterfeit medicines. 63. Accessibility of information with respect to the quality, safety and efficacy of medicines is necessary for the enjoyment of the right to health. Before acquiring marketing approval, pharmaceutical companies are legally required in most countries to provide data demonstrating the safety, quality and efficacy of new medicines, generated from medically and ethically valid clinical trials. However, during the Special Rapporteur’s consultations, diverse stakeholders noted non-transparency of clinical trial data as a concern. Trial data is not made public by pharmaceutical companies and regulators on the ground of protecting commercial information.93 Moreover, data relied upon for registration of medicines is often subject to publication bias (only positive results are published or are overrated), which is misleading and potentially harmful for patients.94 The Special Rapporteur notes with satisfaction that national and regional regulatory bodies are taking steps to make this data available through clinical trial registries. However, critics still point to content and functionality shortcomings in these registries.95 The Special Rapporteur encourages States to take regulatory measures to ensure that information on the safety, quality and efficacy of medicines, even if negative, is made publicly available in functional trial registries. 64. Poor-quality medicines are not related solely to imported medicines, as it is popularly perceived. Therefore quality inspections cannot be limited to border controls and inspections. It is important to have standard regulatory requirements for both domestically produced and imported medicines, along with regular inspections of production facilities and distribution chains for which persistent shortages have been reported. 90 91 92 93 94 95 Joel Lexchin, Voluntary Self-regulatory Codes: What Should We Expect? The American Journal of Bioethics , vol. 3, No. 3 (2003), pp. 49-50. P. N. Newton et al, “Impact of poor-quality medicines in the ‘developing’ world”, Trends in Pharmacological Sciences, vol. 31, No. 3 (2010) pp. 99-101. WHO, Survey of the quality of selected antimalarial medicines circulating in six countries of subSaharan Africa (2011), pp. 65-66. Ben Goldacre, Bad Pharma: How drug companies mislead doctors and harm patients, HarperCollins (2012). Ibid. Ibid. 19