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The members of the World Health Organization Executive Board tonight (24 January) agreed to create a roadmap on global shortages of, and access to, medicines and vaccines. WHO members proclaimed the urgent need to address prices and availability of safe and efficient medicines and vaccines, some requesting the recently elected director general of the organisation to help find solutions.

It used to be that the issue of access to medicines was mainly a problem of developing countries, but the cosponsors of the decision (EB142/CONF.4) [pdf] agreed upon today are a mix of developing, middle-income, and developed countries. The initial co-sponsors were Algeria, Brazil, Chile, Colombia, Costa Rica, the Netherlands and Portugal, and they were joined today by others, such as Thailand, Greece, Haiti, South Africa and Spain.

The decision, which has to be approved by the annual World Health Assembly (WHA) in May, calls for a roadmap that would include activities, actions and deliverables for the period 2019-2023 on access to medicines and vaccines. The roadmap would be submitted to the WHA in 2019.

The 142^nd session of the Executive Board meeting is taking place from 22-27 January.

Mariângela Batista Galvão Simão, assistant director-general for Drug Access, Vaccines and Pharmaceuticals, underlined the importance and the complexity of broadening access to safe, effective and affordable vaccines, medicines, and health technologies.

Decisions taken by the WHO Executive Board have effects in the world at large, she said, citing the WHO report [pdf] on access to essential medicines and vaccines, issued for the Board.

The report draws on a review of different documents produced over the years by the WHO, work by other United Nations bodies, including the report of the UN High-Level Panel on Access to Medicines, and work carried out by partners and non-state actors (academia, civil society, philanthropy, private sector) in relation with WHO.

She cited a number of actions from the report that could facilitate access to medicines, including fair pricing, procurement policies, rational use of medicines, and the use of the flexibilities included in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property (TRIPS).

In her closing remarks, she summarised some of what was discussed, noting items that she said are part of the report and should be part of the roadmap. Examples were: pooled procurement, transparency, intellectual property rights, R&D, TRIPS flexibilities, Doha Declaration, the Medicines Patent Pool as a voluntary licensing system, quality assurance, data collection, and falsified medicines.

She also said “roadmap” means to be focused on supporting countries’ needs, and that it needs to be action-oriented, when it is approved at the Health Assembly.

Prices of Medicines Too High, Most Say

The agenda items addressed jointly the issue of access to medicines and vaccines, and shortages. Most countries taking the floor today called for affordable, safe and efficient medicines and vaccines, in particular new lifesaving medicines, so that people can get treatments they need, and that health systems can be sustainable.

Malta for the European Union countries, as well as many others, underlined the “very high prices” of hepatitis C, cancer, medicines, and gene therapy, and asked for transparency and fair pricing. The Philippines said to build capacity for proper implementation of IP regimes in line with TRIPS so flexibilities can be used.

Zambia, for the African region, also advocated access to affordable medicines and noted the issue of quality of medicines, saying Africa is seeing a proliferation of falsified medicines. The delegate also underlined the importance of the TRIPS flexibilities. Some countries have enacted relevant IP laws but are not using them to address the access to medicines and vaccines issue, he said.

[update] In their statements during the Executive Board, several countries expressed support for the implementation of the recommendations made by the United Nations Secretary General’s High-Level Panel on Access to Medicines, such as Bolivia, India, Egypt, Brazil, Algeria, Portugal, Ghana, and Morocco. The United States said the High-Level Panel is inappropriate, echoing comments made by a US official speaking to a recent US industry event in Washington DC (IPW, WHO, 22 January 2018).

In the corridor, WHO Director General Tedros Adhanom Ghebreyesus (Dr. Tedros) told Intellectual Property Watch that the issue of access to medicines and intellectual property is a matter of balance. The world is getting smaller, he said, and balance is what is needed everywhere.

Netherlands, Brazil, Look to Dr Tedros for Help

The Netherlands had an equally clear position on the need to get moving on the issue of access to medicines. The delegate said all obstacles related to the lack of access should be addressed, including the difficult ones such as intellectual property. The Netherlands, he said, is considering using compulsory licences but legal and political difficulties make this difficult.

According to the delegate, the Netherlands will continue to prevent the inclusion of so-called TRIPS-plus measures in free trade agreements, and the new Dutch government will take firm action against high prices. The country, the delegate, said is looking to the WHO Director General to tackle this issue affecting all countries.

Brazil remarked that all items on the Board agenda depend on the availability of safe, efficient, and affordable medicines, vaccines, and other medical products. Brazil echoed the Netherlands in calling on the director general, to do away with “the high prices of medicines and stop people from dying before their time.”

A number of countries said the lack of access to medicines and vaccines would impact the achievement of the Universal Health Coverage and the UN Sustainable Development Goals. Some countries also highlighted the importance of transparency of the pharmaceutical value chain.

Most non-Executive Board Members denounced similar issues, such as Portugal, which said that transparency is a fundamental value of open, democratic societies. Research and development is costly and needs to be stimulated, the delegate said, but there is a need to know how costly it is and how it is reflected in the end price of the product.

Zambia, as well as Tanzania and India asked that the issue of shortages of medicines and vaccines and the issue of access be delinked in future agendas.

Roadmap Drafting Table

The United States did not comment on access issues in the country, but stated that the report suggests that the WHO may advocate outside of its core functions. The US said they were “disappointed” in the report going beyond WHO mandate to include intellectual property and international trade. On WHO advocacy out of its mandate, the US delegate was alluding to the mention in the WHO report of the UN High-Level Panel on Access to Medicines.

He underlined the importance of IP in innovation and said it is “alarming” that the “balancing [line] has disappeared.”

The US said it is critical to speak to all sides, underlining the importance of innovation and IP, and added that the High-Level Panel is not an appropriate starting point for discussing access to medicines.

The delegate insisted that the WHO director general should hold consultations with member states on the drafting of the roadmap, and this roadmap should focus on areas of consensus and common understanding of all member states.

The United Kingdom said actions relating to IP should be coordinated with the World Intellectual Property Organization and the World Trade Organization for policy coherence.

Japan said access to medicines is of high importance as a key component of the universal health coverage. They said they are concerned about use of the term “scaling up” and asked if that falls under the WHO mandate. They said the draft decision is helpful but some clarification is needed about the roadmap.

An international organisation source suggested to Intellectual Property Watch that the fact that member states would be invited to participate in the drafting of the roadmap might delay its establishment, especially with the US insisting that the roadmap should focus on areas of consensus.

Dr Tedros an Access to Medicines Proponent; ‘Agrees to Disagree’ with Industry

In closing the agenda item, Dr Tedros, who earlier in the day decided to skip traveling across country to the Davos World Economic Forum in order to stay at the Executive Board, had some remarks to share about access to medicines, especially with his goal of achieving universal health coverage.

“Universal health coverage without access to medicines is not there,” he said, adding that WHO will be strengthening its capacity, the cluster, which has a new team.

“On access to medicines, WHO has been, I don’t want to say ‘left behind’. It’s even more than that. WHO has been sidelined,” he said. This has to stop, as WHO has a role and is trying to contribute its share, he added.

Access to medicines cannot be addressed without having a holistic approach, said Dr. Tedros, and should also cover manufacturing of medicines in low and middle-income countries.

Since starting as head of the WHO last summer, Dr Tedros has met with industry twice, he said, having “very good discussions.”

“We agreed to disagree, so that’s healthy,” he said. “But we have committed on issues we agree on while also agreeing to disagree.” However, he said, industry and the WHO have agreed that progress can be made on issues they agree on. “Lack of engagement is not an option,” he said, addition he was comforted by the “candour and honest” discussions with industry.

The WHO representative of the Southeast Asia Regional Office (SEARO) said it is not only lower prices that are necessary to increase access, but that increased healthcare budgets would “really help with out-of-pocket costs.” She noted that SEARO members are major producers of generics.

For patented medicines, the aim is “fair price, fair profit,” the right balance between rewarding innovation, improving trade, and ensuring achievements of public health priorities, she said.

She also mentioned the TRIPS flexibilities and trade agreements, and said they are building a WHO platform. Areas she noted included: Improved data, rational use of medicines, quality-assured mechanisms, and best practices shared by member states. “Everyone everywhere should have access to quality medicines,” she said.

Civil Society Call for Action on Access

Many civil society organisations took the floor and many highlighted concern about drug shortages, support for the High-Level Panel, the importance of pursuing de-linkage of prices from R&D costs, addressing high prices, and public funds being used for R&D on products that then are sold back to governments and consumers at high prices.

Oxfam also insisted on the importance of transparency, saying that most decisions around medicines are shrouded in secrecy. The Oxfam representative said secrecy is hindering access to medicines regarding the cost of R&D, prices, patent information, and clinical trials.

Knowledge Ecology International said the WHO should begin work on evaluating the feasibility of delinking the incentives to invest in R&D from high prices.

Health Action International also underlined the issue of the lack of transparency of R&D cost production and prices, and “the misuse and abuse of intellectual property rights,” as negatively impacting access to medicines. The association also praised inter-country cooperation to share pricing information and participating in joint procurement schemes.