Actas - Consejo de los ADPIC - Ver detalles de la intervención/declaración

Mr. Martin Glass (Hong Kong, China)
World Health Organization (WHO)
F.5 Any alternatives to the use of the Paragraph 6 System to achieve the objective of access to medicines, procurement policies, and other related aspects affecting access to medicines
245. The representative of the WHO presented his organization's experience from a public health perspective. Among its most important missions was the improvement of access to quality essential health services and products, including essential medicines, vaccines, diagnostics, medical devices and equipment, especially for disadvantaged people. Reliable and sustainable access to health products was determined by different macro health system factors. These included strong, accountable and transparent health governance with well-developed health policies for national health systems, health financing, social protection mechanisms, trained and available health workforce, health care delivery infrastructure, and reliable health management and information systems. 246. He said that, more specifically, access to medicines was determined by four factors: (i)rational selection of medicines; (ii) affordable prices; (iii) sustainable financing; and (iv) reliable supply systems. The rational selection of medicines required a country to decide, according to well defined criteria, which medicines were most important to meet existing public health challenges. Through its model list of essential medicines, WHO provided guidance to member states in the development of their national essential medicine lists. An essential medicine had to be a safe and effective product and should represent the best rational choice, regardless of its price, to address a specific health problem. As regards affordable prices, while in high-income countries a high percentage of expenditures on medicines was publicly financed or reimbursed by health insurance, a high percentage of expenditure came directly from the pockets of patients in low- and many middle income countries. The public sector was not always a viable alternative. In a number of low- and middle income countries, the average availability of medicines in public health facilities turned around 35 per cent. When patients therefore had to turn to private pharmacies, the price of medicines became one of the most important determinants of access to medicines. With respect to sustainable financing, per capita expenditure on medicines in real terms remained regrettably very low in poor countries, despite governments spending a large proportion of recurrent health budgets on buying medicines. As regards reliable medicine supply systems, these included forecasting needs, procurement, storage, transportation and inventory keeping of medicines. All these areas remained weak in many developing countries. Without investing in and improving supply systems, access to medicines would remain a formidable challenge. 247. The representative of the WHO noted that his organization was involved with its member states in improving access to medicines in each of those four areas, both by developing norms and standards, and by providing direct technical assistance. It used availability and prices of medicines as indicators to measure access to medicines. Looking at access to high-priced patent-protected essential medicines, especially in countries with no or limited manufacturing capacity, he noted that more than 90 per cent of medicines on the WHO model list of essential medicines were not patent-protected. Nevertheless, a majority of patients in low-income countries continued to suffer and to die due to lack of access to treatment interventions, including lack of supply of generic medicines. Nearly 30,000 children died every day from diseases that could easily be treated if they had access to a range of basic patent-free essential medicines. Also 1.8 million children under the age of five years died every year of pneumonia alone that could be treated with cheap inexpensive antibiotics. Only 20 per cent of children received these antibiotics. This was a long and tragic list of circumstances where inexpensive generic medicines were available, but did not get to the people when they needed them the most. These issues needed urgent attention. 248. High prices of patent-protected essential medicines also constituted a barrier to access to medicines, especially in the case of second-line HIV/AIDS medicines and tuberculosis in Africa and other poor countries and for non-communicable diseases like cancer. Generic competition in the market was one of the most efficient mechanisms to bring prices down, as seen in the case of first-line antiretroviral medicines for the treatment of HIV/AIDS. Because of generic competition, the cost of one year of treatment for one patient with first-line antiretroviral medicines had dropped from more than USD 10,000 to around USD 100 between 2002 and 2010. This drastic decrease in the cost of medicines had resulted in increased access to those medicines. As of December 2009, an estimated 5.2 million people in low- and middle-income countries living with HIV had been receiving antiretroviral therapy, a twelve-fold increase since 2003. The importance of affordable prices of antiretroviral therapy would increase in the near future. Because of changes in the newly published WHO HIV treatment guidelines, the number of people for whom treatment would be needed could increase to 15 million. 249. The System addressed a very specific situation when a country without sufficient manufacturing capacity wanted to procure a patented medical product, and there were no generic producers in other countries that could supply the product. Other ways of obtaining the needed medicines could be explored before invoking the System, for example, through a search of therapeutic equivalents which were not patent-protected or through negotiation with the patent holder. However, where no other possibility existed, the System could be legitimately put into action to procure the needed medicines. The WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property had been very explicit about the right of the member states to make optimal use of TRIPS flexibilities. Element 5.2 of the Strategy had urged governments to "consider, where appropriate, taking necessary measures in countries with manufacturing capacity to facilitate through export, access to pharmaceutical products in countries with insufficient or no manufacturing capacity in the pharmaceutical sector in a manner consistent with the TRIPS Agreement, the Doha Declaration and the WTO Decision of 30 August 2003". 250. He noted that, although the System had rarely been used to date, it might be considered more frequently in the future, given the changing requirements for new medicines to treat diseases, and the implementation of the TRIPS Agreement in member states. A recent study had revealed that Indian generic manufacturers had accounted for more than 80 per cent of donor-funded annual purchase volumes of antiretroviral medicines between 2003 and 2008. The implementation of full patent protection for pharmaceutical products in India and the approaching expiry of transition periods in LDCs might make it more difficult in the future to procure generic versions of new medicines. Under such circumstances, the System might assume a greater significance. He confirmed that to date the WHO had not formally received any request from any member state for technical assistance in the use of the System. He concluded that access to medicines was determined by many factors and the situation was far from perfect even for those medicines which were not patent-protected. All possible legitimate measures had to be considered when access to patent-protected medicines of public health importance was at stake, especially when countries did not have sufficient local manufacturing capacity. In such situations, the System was definitely one of the possible options and it might become more important in the future.