A/61/338 69. Of course, this obligation is subject to the resources available in a particular country: Canada is obliged to ensure better access to a wider range of medicines than Chad. However, the obligation of both developed and developing States is subject to progressive realization: all States are required to ensure better access to a wider range of medicines in five years’ time than exists today. 70. To measure this progressive realization (or lack of it), States must develop disaggregated indicators and benchmarks for a reliable, efficient medicine supply system.45 These indicators have to reflect human rights features, for example, the degree to which the system ensures equal access for vulnerable groups (hence the need for disaggregated indicators), and provides effective monitoring and accountability mechanisms. Quality of medicines 71. International human rights standards are clear: a State has a legal obligation to ensure that medicines of good quality are available throughout its jurisdiction. Thus, effective medicine regulation is required to ensure the safety, efficacy, and quality of medicines available in both public and private sectors, as well as the accuracy and appropriateness of medicine information available to health professionals and the public. 72. While the safety and quality of medicines is a problem in many developed and developing States, the magnitude of the problem is much greater in developing countries, where poor quality medicines may be the only ones to reach the poor. In recent assessments carried out by WHO, 50-90 per cent of anti-malarial drug samples failed quality control tests, while more than half of antiretrovirals did not meet international standards. The sale of counterfeit and substandard medicines remains a global concern. 73. One third of States have either no medicine regulatory authority or inadequate capacity to regulate the medicines market. The absence of such an authority is clearly inconsistent with the right to the highest attainable standard of health. In line with their human rights responsibility of international assistance and cooperation, developed States should actively help developing countries establish appropriate medicine regulatory authorities. Financing of medicines 74. Whether a medicine is affordable depends upon many factors, including financing (i.e. how they are paid for) and pricing. There are different ways of financing medicines, including by way of public or private health insurance, patients’ fees, donations, loans, and so on. These are complex issues and here the Special Rapporteur confines himself to one point. Whatever the chosen financing arrangement, a State has a human rights obligation to ensure that medicines are economically accessible (i.e. affordable) to all. 75. In many high-income countries, over 70 per cent of medicines are publicly funded whereas in low- and middle-income countries public expenditure does not cover the basic medicine needs of the majority of the population. In these countries, patients themselves pay for 50 to 90 per cent of medicines. Where the cost of medicines is borne by households, it can further impoverish already disadvantaged populations, and inhibit equitable access to medicines. 06-51997 17

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