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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.
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