World Health Organization members tonight approved a resolution aimed at improving access to essential medicines. Agreement came after a compromise on a proposed provision referencing other medicines that are not qualified as essential medicines.

The 67^th World Health Assembly took place from 19-24 May.

The latest available version of the adopted resolution on access to essential medicines, A67/B/CONF./6, is available here [pdf].

The Assembly had before it a draft resolution on access to medicines, as well as a secretariat report, document A67/30 [pdf].

The resolution includes a number of actions for governments to take on access to medicines, such as providing adequate resources for comprehensive national medicine policies, governance of pharmaceutical systems, and coordinate activities.

In committee today, there were a number of proposed amendments to the text. The key change was in provision OP1.2, on national policies. India proposed to add reference to “critical medicines,” so it would have stated:

“to improve national policies for selection of essential medicines, including critical medicines, particularly by using transparent, rigorous, evidence-based processes based on the methods of health technology assessment in selecting medicines for inclusion in the national essential medicines lists according to each country’s health needs and priorities.”

But the United States, Australia and Thailand opposed this proposal. Sources said what was underlying the debate was whether there could be recognition of other medicines not included on the WHO essential medicines list.

India said that many essential medicines do not include medicines which are critical for people in need, so it wanted not only essential medicines, but also other medicines which may be critical for countries, to be considered for inclusion.

It then offered an alternative wording to say, “essential medicines critical for public health needs.” The European Union, represented by Greece, suggested a slight change to this, to say, “their” public health needs.

But this proposal was also rejected by Thailand. After further consultations, the following language was agreed for OP1.2:

“to improve national policies for selection of essential medicines “which should include medicines critical to their priority public health needs….”

Also in the latest version of the draft decision, Oman came under pressure from developed countries for a proposal for Article OP2.9 that would have called for improved procedures to implement flexibilities within the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Several developed countries opposed it, leading Oman to withdraw it.

Access a Hot Topic at WHA

Member states in committee on 23 May discussed the original draft resolution, which originated at the January Executive Board meeting as document EB134.R16 [pdf].

Access to essential medicines was a hot topic at this Assembly, following recent outcry over unaffordable costs of new drugs against cancer and hepatitis C.

Access to essential medicines is also important for global efforts to move “towards universal health coverage and achieving the health-related Millennium Development Goals,” says the resolution.

The resolution urges member states to develop and provide adequate resources for “comprehensive national medicine policies, strengthened pharmaceutical regulatory, procurement and distributions systems and coordinated responses to address” the determinants of access to essential medicines to “improve their availability, affordability, quality and rational use.”

Member states are also urged to be transparent and use evidence-based national processes for the selection of essential medicines as well as to support research on the procurement, supply and rational use.

The resolution calls for sharing of best practices, the identification of key barriers, monitoring of shortages and the adaptation of “national legislation in order to make full use of the provisions contained in the TRIPS agreement, including the flexibilities recognized by the Doha Ministerial Declaration,” it says.

The director general is also asked to support national capacity building and policy making “with regard to regulation, financing, selection, procurement, distribution, pricing, reimbursement and use” of essential medicines, including technical support to member states wishing to make full use of TRIPs flexibilities.

Key Points from Delegations

A strategy highlighted by member states is the promotion of local and reasonable production of essential medicines.

“Local production wherever the economics of scale can be achieved may contribute to bringing down the prices of medicines,” said India. Therefore, “it is important to guide member states on this issue of promoting local production of medicines.” Ethiopia also supported the idea of strengthening capacity building and local production in developing countries.

India also urged reviewing the selection criteria for the WHO essential medicines list and promoting the right to benefit from science and technology to include essential medicines with therapeutic advantage.

Thailand said support is needed for the monitoring of medicines supply to identify causes of shortages. The delegate noted that there could be many causes for shortages, including “limited production, neglected diseases, and temporary stock-outs due to epidemics and changes in production lines.” Monitoring would help develop necessary strategies for the mitigation of problems caused by shortages, they said.

South Korea said it uses an integrated IT system to monitor supply of medicines and collect statistical data to identify problematic areas of drugs supply. Tanzania and Indonesia also said they have an electronic monitoring system, which they said enhances efficiency and transparency of supply.

The delegation of South Africa, on behalf of the African region, highlighted that “the high price of medicines, particularly in the private sector, is a key barrier to affordable essential medicines in developing countries,” adding that it can be “a question of life and death.” Many countries also identified unaffordable prices as one of the major barriers to access.

“While affordable prices are a key determinant in improving access to medicines, we should not forget that adequate, sustainable and equitable financing of medicines is also required,” South Africa said. “The WHO essential medicines committee may consider producing a list of medicines that are essential for public health however they are at an unaffordable price. This would direct other low cost manufacturers to focus on their product portfolio.”

South Africa suggested key strategies should be taken up by member states including: control of purchase price from manufacturers; full use of TRIPS flexibilities; systems to track availability; transparent regulatory systems for generic production; and generic substitution policies.

South Africa recalled that “a range of policy options is available to promote the use of generics.” Promoting competition is a key strategy for increasing generic production and improving the affordability of medicine, for example. In this context, patents have a dramatic impact on access to medicines when they prevent competition, the delegate said.

Thailand also proposed strategies such as price negotiations, bulk purchasing and the full use of TRIPS flexibilities. It further suggested price control and promoting local production, generic production and supporting technology transfer.

TRIPS Flexibilities under Attack?

Regarding the issue of intellectual property, Brazil said, “IP should not be an obstacle to national policies on access to medicines. Countries should therefore be able to use them in a way that is conducive to national circumstances.”

Malaysia said it fully supports the use of TRIPS flexibilities to increase access. It added that in 2003, Malaysia used TRIPS flexibilities to obtain antiretrovirals for HIV. It called upon the WHO to “render technical assistance and strongly support member states” on the appropriate use of TRIPS to manage practices and make medicines affordable.

Malaysia called for sharing practices on health technology assessment for evidence-based selection of essential medicines, and new highly priced innovative medicines, especially for treatment of cancer and rare diseases.

India said that “the full use of TRIPS flexibility has been under attack through a variety of strategies such TRIPS-plus provisions, bilateral trade agreements, investor state dispute settlements provisions, trade and investment agreement, as well as lobbying by countries to adopt TRIPS-plus provisions in their domestic laws.”

Bolivia expressed concern over the negative impact of bilateral agreements, such as the Trans-Pacific Partnership (TPP) agreement currently under negotiation, has on access to medicines.

India urged that “any attempt to hinder fully utilisation of TRIPS flexibilities must be strongly countered by WHO and member states.”

The United States stressed that the “vast majority” of medicines on the essential medicines list “are not under patent production.” They instead encouraged countries to examine local barriers to access, and encouraged the WHO to support countries in building systems to improve access and rational use.

Norway said that the challenges to access often relate to market failures due to low, unpredictable or fragmented demand. It expressed its support for global initiatives that help shape markets to increase access, such as the Medicines Patent Pool. Norway also reiterated its support for the Doha Declaration on TRIPS and Public Health, and reminded states that many other countries present here have also signed the declaration.

In the committee, India made its proposed amendment to add, after the word “essential medicines” the phrase “including critical medicines,” which was subsequently discussed and changed today.

The secretariat said it “will continue to support member states who have chosen to invest in local production of health technology” as a key to increasing access, including technology transfer.

Response from Civil Society

In its nongovernmental statement to the committee, the International Pharmaceutical Federation (IPF) focused on the importance of using medicines in a responsible manner. According to a recent survey, it said, “500 billion dollars could be nearly saved if responsible medicine is achieved.”

In this context, pharmacists appear to be key contributors to making these savings happen, the group said, adding that access to medicine should be “systematically combined with access to pharmaceutical expertise to ensure responsible use.”

The Global Health Council (GHC) noted that “one population facing the biggest challenges is children living with HIV,” and more attention should be given to this category under the actions of the resolution.

In order to fulfil the gaps in access and R&D, International Pharmaceutical Students Federation (IPSF) recommended that innovation to be driven “by novel business models delinking the cost of R&D from price of medicines.” There should be more open research initiatives and public-private partnerships, it said.

Medicus Mundi International and People’s Health Movement said the draft of the resolution “does not adequately address the issues of technology transfer and local manufacturing capacity.”

Médecins Sans Frontières (MSF) said “medicinesaffordability is still a critical problem,” and that “high prices keep medical tools out of the reach of MSF patients and governments,” especially in middle-income countries.

Affordability could be encouraged “through reform of patent laws and robust use of TRIPS flexibilities and other measures to foster generic competition,” MSF said.

MSF also proposed that the resolution could go further on three points: the WHO Prequalification programme scope should be extended to include viral hepatitis and non-communicable diseases; the WHO mandate should be strengthen to promote a reform of the current R&D system; and WHO should remain focused on the interventions best suited to achieve sustainable and member state-driven strategies to ensure affordable access.

With regard to free trade agreements, such as the Transatlantic Trade and Investment Partnership (TTIP), the International Federation of Medical Students Association (IFMSA) and Universities Allied for Essential Medicines (UAEM) argued that they threaten to limit access to essential medicines.

Governments must step out of their silos and take a proactive to integrate global health priorities into the trade negotiations, they said, demanding, “Do not let the world trade health for wealth.”

As an example, they pointed out that recently direct-acting treatments for hepatitis C, which are strongly recommended by new hepatitis C Guidelines, have been replaced in the Essential Medicines List by out-dated, less effective active drugs “because their off-patent pricing rendered them technically more cost effective.”

UAEM, Knowledge Ecology International (KEI), and the Young Professionals Chronic Disease Network (YP-CDN) issued a briefing note [pdf] on the subject.

“When the WHO considers measures to address the disparate needs of access to new diagnostics and treatments for cancer, it should devote more attention to the promising and logical proposals to delink R&D costs from product prices, and to provide incentives for treatments that are affordable and feasible in low resource settings,” they said.

“De-linkage proposals are designed to introduce new business models that reconcile both innovation and access,” they added. “The failures of the current business model to address equitable access to treatment in developing countries, as well as current restrictions on access even in high income countries, provide compelling rationales to move the de-linkage debate forward.”

Secretariat Report

Member states also noted the related secretariat report, A67/30. The report describes efforts, such as the WHO Model List of Essential Medicines, aimed at promoting better “management of medicines, more cost-effective use of resources and higher-quality health care, and their effective implementation [which] will increase access to medicines, avoid high out-of-pocket expenses, facilitate progress towards universal health coverage and achievement of the health-related [UN] Millennium Development goals, and ensure the effective treatment and care of noncommunicable diseases.”

The report says that despite efforts, “problems with the low availability and affordability of essential medicines in low and low-middle-income countries remain.” It also discusses strategies related to generics, pricing, reporting and data at the national level, and supplies, and lists a range of activities being undertaken to promote access to essential medicines. Examples are local innovation and universal health coverage.