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Access to medicines in the context of the right-to-health framework 2013, para. 6
- Paragraph text
- While States have the primary responsibility for enhancing access to medicines, it is a shared responsibility in which numerous national and international actors have a role to play. In its general comment No. 3 (1990) on the nature of States parties' obligations, the Committee on Economic, Social and Cultural Rights also stressed the obligation of States to take steps, individually and through international assistance and cooperation, especially economic and technical, towards the full realization of the rights recognized in the Covenant, including the right to health. Moreover, in the spirit of Articles 55 and 56 of the Charter of the United Nations, articles 2(1) and 23 of the Covenant, as well as the Alma-Ata Declaration on Primary Health Care, States should recognize the essential role of international cooperation and comply with their commitment to take joint and separate action to achieve the full realization of the right to health. According to the Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines, pharmaceutical companies should integrate human rights, including the right to health, into their strategies, policies, programmes, projects and activities.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Governance & Rule of Law
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 8
- Paragraph text
- Ensuring access to medicines also requires a functioning health system that encapsulates the key elements of the right to health: availability, accessibility, acceptability and quality. As part of the State obligation to fulfil the right to health and with a view to the progressive realization of access to affordable and quality medicines, the Special Rapporteur urges States to adopt a detailed national plan of action on medicines. The plan of action should be backed by a strong political will and commitment that prioritizes access to medicines within the public health budget and allocates resources accordingly. This is particularly pertinent in the context of the current global economic crisis, where some States are increasingly taking retrogressive measures such as reducing spending on health by reducing national health budgets. The Special Rapporteur stresses that States have the burden of proving that deliberately retrogressive measures have been introduced after careful consideration of all alternatives and that they are justified under full use of the State party's maximum available resources.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 9
- Paragraph text
- National plans should also include principles of non-discrimination, transparency and participation. Participation of all stakeholders, including vulnerable groups, in health-related decision-making is the cornerstone of the right-to-health framework. Participation provides individuals with an opportunity whereby they can advance their health rights. It is through participation and empowerment that individuals, patient groups and communities can claim their right to health and achieve improvements in accessing such essential medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 10
- Paragraph text
- Based on the submissions received from various stakeholders and following numerous consultations, the Special Rapporteur considers, henceforth, the main determinants of access to medicines in the context of the right to health.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 12
- Paragraph text
- Inadequate prioritization of health, insufficient resources and poor governance has increased the inability of governments to finance efficient health systems that enhance access to medicines, consequently increasing their dependence on out-of-pocket payments and international donor funding. Even where international donors like the United States President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to fight AIDS, Tuberculosis and Malaria have stepped in to fill this gap, they have only managed to reach a portion, though significant, of those who need these medicines due to limited budgets.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 13
- Paragraph text
- There are wide disparities between the global burden of disease and the global consumption of medicines. For example, in 2004, South-East Asia and Africa accounted for 54 per cent of the global burden of disease predominantly caused by communicable diseases. However the geographical breakdown (by main markets) of sales of new medicines launched during the period 2004-2008 indicates that North America, Europe and Japan accounted for 95 per cent of the sales, while Africa and Asia, representing more than two-thirds of the world population, only accounted for 5 per cent of the market. During this period 90 per cent of the global production of medicines was also concentrated in the developed regions of the world.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 14
- Paragraph text
- Manufacturing capacities in developing countries are limited to countries such as China, India, Brazil, South Africa, Thailand, Kenya, the Syrian Arab Republic and Egypt. Even in the developed world, large innovator multinational companies are concentrated in a small number of countries such as Switzerland, the United Kingdom, the United States, Germany, France and Japan. The Special Rapporteur recognizes that while factors such as inefficient procurement and poor distribution practices do determine the availability of medicines in a country, it may still be politically and strategically important for developing countries to ensure the security of access to medicines for their populations through local production.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Governance & Rule of Law
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 15
- Paragraph text
- Investing in local production as a long-term strategy holds the promise of improving medicines security in developing countries. Fulfilling this goal would require, inter alia, a coherent policy framework that explicitly links local production to improved access to medicines and is backed by strong political commitment. The Special Rapporteur notes with satisfaction that in this respect a regional plan of action was drawn up for local production of essential medicines aiming to promote access to medicines in the east African region by the East African Community.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Governance & Rule of Law
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 16
- Paragraph text
- There are, however, several challenges that need to be addressed in order to ensure sustainability of local production of essential medicines. In the short term, the pressures of reaching economies of scale and countering price competition from importers can mean higher prices for locally produced medicines. This results in a greater burden on the public health budgets of developing countries.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 18
- Paragraph text
- In complying with their obligation to ensure availability of medicines, States may consider the following policy options to develop an enabling environment that promotes the growth of local pharmaceutical industry: (i) levying taxes on imports of medicines that can be locally produced, except for active pharmaceutical ingredients which are generally not imported; (ii) providing subsidies; (iii) tax incentives; (iv) guaranteed government procurement to local manufacturers; and (v) a regulatory framework to increase local competitiveness. As highlighted during the Special Rapporteur's consultations, local production of medicines has indirect benefits, such as (i) promoting transfer of technology (ii) providing employment and capacity-building of local people through training programmes for local pharmacists (ii) microbiologists and technicians, and (iii) setting up local institutes of higher education and contributing to capacity-building of the regulatory agencies. Thus, opting for local generic production should be weighed and balanced against a number of benefits, including strategic security in medicines supply, which would be achieved in the long run as opposed to the higher prices in the short run.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 19
- Paragraph text
- States should also take advantage of flexibilities under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The 2001 Doha Declaration on TRIPS and Public Health reaffirms these flexibilities in support of World Trade Organization (WTO) members' right to protect public health and to promote access to medicines for all. Furthermore, paragraph 6(i) of the Decision of the General Council of 30 August 2003, under the Doha Declaration on TRIPS and Public Health, specifically allows least-developed countries (LDCs), more than half of whom are party to a regional trade agreement, to produce medicines locally in the public health interest, irrespective of patents on medicines, with the intention of making medicines more affordable by increasing economies of scale through regional sales.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Governance & Rule of Law
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 21
- Paragraph text
- States have a legal obligation under the right to health to ensure that production of essential medicines by the private sector does not threaten affordability and accessibility of medicines. Market monopoly or market domination combined with insufficiently competitive forces in the market to ensure efficient prices can result in monopolistic pricing leading to high cost of medicines. Hence, price regulation becomes critical. In some countries, however, the term "price control" has acquired a negative connotation, including that it affects revenue-induced innovation for pharmaceutical companies. In developed countries, where a substantial proportion of the population is covered by health insurance schemes, governments frequently apply price control mechanisms as part of the overall strategy to contain costs. The absence of price controls in developing countries causes grave problems if private-sector monopoly over manufacture and distribution of vital medicines remains unregulated. Such unfettered monopoly can lead to profit-maximizing pricing. In developing countries with high income-inequality it would mean that access to medicines is only affordable to the wealthy. States that inadequately use price controls to ensure affordability of medicines would fail in their obligation to use all available resources, including regulatory powers, to promote the right to health.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 22
- Paragraph text
- States which responded to the Special Rapporteur's survey reported on the use of price control mechanisms to promote affordability of medicines, particularly essential medicines. Accordingly, external reference pricing (ERP), therapeutic reference pricing (TRP), as well as the regulation of manufacturers' selling price and distributor's mark-ups, have been applied as the most common methods for setting a ceiling price for medicines. States also reported the use of competition law as the preferred indirect price control mechanism. Tax incentives to manufacturers, wholesalers and retailers and government subsidies to manufactures were indicated as other methods of indirect control used by States to control prices of medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Economic Rights
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 24
- Paragraph text
- The Special Rapporteur was informed that pharmaceutical companies adopt various methods to reduce price transparency in order to work around any loss incurred from ERP. They introduce their products in high-price markets first, to be used as reference countries, thus maximizing the price. Additionally, transparency is reduced when companies list high prices in a country while granting discounts and rebates on the condition of confidentiality.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Economic Rights
- Governance & Rule of Law
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 26
- Paragraph text
- About half of the surveyed States use TRP to set the ceiling price of medicines. TRP is applied generally in developed countries, where the reimbursement price of a medicine is fixed at the average or lowest price of other drugs in its therapeutic class that are available on the internal market. Manufacturers may price their medicines at a higher level and if the patient decides to purchase a medicine which is not covered by the reimbursement limit, they will have to pay the difference. States informed the Special Rapporteur that they offered alternatives to companies to set their prices below that limit, thus avoiding the extra cost to the patient. TRP allows doctors and patients to select the lowest price medicine from a range of alternatives within a therapeutic group, improving consumer awareness about options available and thereby helps increase transparency in the market.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 27
- Paragraph text
- States also exercise other forms of direct regulation through cost-based pricing, which is based on actual costs of production, a profit margin and a percentage, fixed or regressive, towards distributors' mark-ups. Determining actual costs of production, however, requires reliable and documented evidence of actual local costs of production, which is difficult to obtain given the global dimension of pharmaceutical production. Alternative methods to determine costs of production have included proxies, for example tax paid on manufacturing costs through excise returns and customs duties on landed costs of active pharmaceutical ingredients (APIs). Transparency in providing costs of production is important to ensuring fair pricing of medicines, while allowing for a profit margin that sustains the industry. However, accounting manipulations, use of transfer pricing by companies, and corruption in government agencies pose additional challenges to ensuring a transparent system of cost-based pricing.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Economic Rights
- Governance & Rule of Law
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 28
- Paragraph text
- In contrast to cost-based pricing, market-based pricing fixes the maximum retail price through an "average" formula for all brands in a therapeutic category that have a specific market share. Market-based pricing therefore tends to cap the price of medicines at the middle range between the highest and lowest price, making medicines more expensive in comparison to cost-based pricing.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 29
- Paragraph text
- In some States, the use of health insurance schemes to reimburse patients the cost of essential medicines is common and vital to ensuring access to affordable medicines for people. This is done through the subsidizing of prescription medicines, usually from a preferred list of medicines, with patients making a co-payment for the medicines and the State bearing the remaining cost. The Special Rapporteur notes that the trade policies of some countries are pushing trade partners to establish judicial or administrative forums to determine when a reimbursement price unlawfully restricts the "value" of a patent on a medicine, thereby restraining the listing of such a medicine on the reimbursement schemes. At best, compelling governments to establish such forums is a waste of crucial administrative resources that could be spent delivering health goods and services. The Special Rapporteur therefore advises States to guard against trade interests prevailing over primary and immediate obligations to ensure access to affordable medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 30
- Paragraph text
- Prices of medicines are also affected by high add-on costs. Distribution mark-ups can represent over 40 per cent of the price ultimately paid on medicines by consumers. States tend to regulate mark-ups in the distribution chain through varied incentives or disincentives for wholesalers, retailers, public sector, private sector and suppliers in general to ensure continuity of the supply chain and access for consumers. Most developing countries use fixed percentages to regulate mark-ups throughout the distribution chain. While this method can reduce the price of specific medicines, it may also encourage the sale of higher-priced medicines rather than low-cost generic ones. To address this shortcoming, some developing and many developed countries use regressive mark-ups: the higher the cost of the product, the lower the mark-up it attracts. Some States do not apply mark-ups to medicines on the essential medicines list, or reimbursable lists, or if they do, they apply mark-ups differentially based on whether it is a branded medicine or a generic.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 31
- Paragraph text
- States which responded to the Special Rapporteur's survey also recommended, as a good practice in reducing medicine prices, the regulation of the price at which manufacturers can sell medicines to intermediaries along with the regulation of distribution mark-ups in the supply chain. In this context, the Special Rapporteur urges States to assess the impact of distribution mark-up regulations on medicine prices while maintaining the viability of different actors in the supply chain to ensure security of the medicines supply chain.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Governance & Rule of Law
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 33
- Paragraph text
- At the same time, for 92 per cent of all States, tariffs contribute less than 0.1 per cent of their gross domestic product and hence hold little economic value. However to promote local production States may consider the strategic value of tariffs on particular medicines. For instance, tariffs on imported finished products that are already manufactured locally have a stronger economic and social basis in promoting local production. The Special Rapporteur therefore encourages States to revise tariff policies in light of the lack of evidence of their economic value to State revenues, whilst allowing for tariffs that incentivize local production.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Economic Rights
- Equality & Inclusion
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 34
- Paragraph text
- Taxes constitute the third largest component in price add-ons for medicines after the manufacturer's price and distribution mark-ups paid by the consumer. At the country level, the tax range for medicines is between 5 and 34 per cent. These can include State tax, stamp duties, community tax, State excise duties and freight tax. Taxes are applied variably depending on whether a medicine is locally produced or imported and sold in the in the public or private sector. Almost half of the States surveyed reported that taxes are not levied on medicines. Of those in which they are, some provide exemptions for medicines listed on the national essential medicines lists, donated medicines, antiretroviral drugs, imported generic medicines, cancer and diabetes medicines. The Special Rapporteur encourages States to refrain from taxing medicines, especially essential medicines, and instead consider other ways to generate revenue for health, such as so-called sin taxes - excise taxes levied on socially harmful goods such as tobacco, alcohol and junk foods.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- All
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 36
- Paragraph text
- As part of their obligation to ensure affordability of medicines, States employ competition laws to take action against companies that abuse a dominant position in the market. This would include measures against such practices as charging excessive prices, restricting other companies from accessing the market, collusive tender practices, and restrictive agreements. For example, in 2002, one country's competition commission found that charging excessively high prices for ARVs was an illegal abuse of market dominance.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Economic Rights
- Governance & Rule of Law
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 37
- Paragraph text
- During his consultations, the Special Rapporteur learnt that competition law is one of the most commonly used methods to reign in excessively high prices charged by pharmaceutical companies. States should apply competition law to monitoring mergers between generic and brand name pharmaceutical companies, which could potentially block future market competition. Competition law represents an accountability mechanism for legal redress under the right-to-health framework and provides a powerful tool to check wrongful practices by pharmaceutical companies that engage in anticompetitive practices, which can also negatively affect access to medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Governance & Rule of Law
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 38
- Paragraph text
- Competition laws that are well formulated and enforced could also counter anticompetitive practices at every stage of the pharmaceutical supply chain. For example, such laws can address attempts by originator companies to influence suppliers in order to restrict supply of active pharmaceutical ingredients to potential competitors, or prevent agreements between larger pharmaceutical companies from using distribution strategies that reduce wholesaler competition, which would restrict smaller companies' access to the market, adversely impacting on the price of medicines. States should also consider including representatives of civil society groups on the panels of competition authorities, which has been demonstrated to have positive results in reducing the prices of medicines in some States.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Governance & Rule of Law
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 39
- Paragraph text
- Evidence from developed and developing countries shows that competition, including among generic companies, can reduce the prices of essential medicines. In the context of ARV medicines, from 2000 to 2011, market competition induced by a significant number of generic companies in the market substantially reduced the prices of those medicines. With respect to improving affordability of essential medicines, competitive public procurement and generic substitution has also proved successful. The Special Rapporteur encourages States to enact competition laws and formulate policies for their effective enforcement in order to ensure affordable prices for essential medicines.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 41
- Paragraph text
- The NEMLs are based on the rationale that a limited range of priority medicines contributes to better health care and optimizes the use of financial resources in resource-limited settings. The NEML also serves as a guide for public procurement of medicines and provides guidance for local production of medicines. Notably, in both developed and developing countries NEMLs are used to guide cost-containment measures for pharmaceutical expenditures.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 42
- Paragraph text
- Under the right-to-health framework, the process of selection of essential medicines should be evidence-based, transparent and participatory. It should also be a part of the national plan of action on medicines, aimed at ensuring availability and affordability of medicines. The WHO EML is revised every two years by the Expert Committee on the Selection and Use of Essential Medicines (the Expert Committee). Revisions should be based on documentary evidence and include the participation of various groups, such as pharmaceutical companies and patients' groups, through a transparent application process. In contrast, responses to the questionnaire received from States revealed that civil society and community representatives were often excluded in the process of selecting essential medicines for NEMLs. Participation by civil society and communities can also contribute towards providing some evidence of health issues faced by the population.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 43
- Paragraph text
- Inclusion in the WHO EML implies that States should make medicines affordable for those who need it, including patented medicines. The Special Rapporteur is, however, aware of concerns about selective practices in including patented medicines in the WHO EML. In more recent versions of the WHO EML, some expensive patented ARVs, anti-malarial and anti-tuberculosis medicines have been included, while such key ARVs as Raltegravir, Darunavir and Etravirine have not. It is important therefore to ensure that the revisions to the WHO EML are conducted in an inclusive and transparent manner that addresses concerns of all groups. The Special Rapporteur also notes that in some States, patented medicines are included on the NEMLs to bring them within the purview of cost-control mechanisms that ensure their affordability. It has come to his attention however that some countries exclude patented medicines from the NEML, and thereby from cost-control measures to which they would otherwise be subject, which can detrimentally impact on the affordability to patients. Essential medicines, be they patented or off-patent, should be included in both the WHO EML and NEMLs in a timely manner where indicated by evidence of the burden of disease.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Equality & Inclusion
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph
Access to medicines in the context of the right-to-health framework 2013, para. 44
- Paragraph text
- Non-communicable diseases (NCD) also disproportionately impact developing countries, which face 80 per cent of the global NCD burden. However, only 22 per cent of the 359 essential medicines on the 2003 WHO EML relate to NCDs. Several applications for the treatment of mental health, cancers and cardiovascular diseases are pending review by the WHO Expert Committee. Underrepresentation of medicines for NCDs in the WHO EML also limits guidance for States in the development of their NEMLs.
- Body
- Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health
- Document type
- Special Procedures' report
- Topic(s)
- Health
- Person(s) affected
- N.A.
- Year
- 2013
Paragraph