UN High-Level Panel, Medicines Access Find Foothold At World Health Assembly In May

World Health Organization member states seeking solutions for ensuring medicines access have been looking for ways to get a recent controversial report from the UN headquarters on the WHO agenda. The Executive Board this week heard concerns and left open the possibility that it will come up at the annual World Health Assembly in May.

It is generally held that prices of new medicines are escalating, putting a high burden on public health budgets and threaten many lives. The WHO Executive Board did not accede to the request by some WHO members to put the recommendations of the United Nations High Level Panel on Access to Medicines on the agenda. However, members were allowed to state their views on those recommendations last week. Most members agreed that some recommendations should be discussed, some others, such as the United States, were not in favour of any further action on the report.

The WHO Executive Board (EB) took place from 23-31 January. The Board is made up of 34 rotating members of the WHO.

Member states were allowed to make statements on the High-Level Panel (HLP) on 27 January under a related agenda item. The issue of the HLP came up again at the close of the meeting when the Board discussed the agenda of the upcoming World Health Assembly. In that debate, a compromise solution was found to allow further discussions on access to medicines at the Assembly.

The mandate of the HLP was to “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies,” and the recommendations contained in its report irritated some countries with a high reliance on intellectual property protection for their pharmaceutical products.

The call to discuss the HLP from countries like India and Brazil, which are not Executive Board members, at the outset of the meeting on 23 January went without effect (IPW, WHO, 23 January 2017). However, delegations were allowed to state their point of view on the HLP under the EB agenda item on the evaluation and review of the global strategy and plan of action on public health, innovation and intellectual property (GSPOA).

EU, Switzerland Take Note, Netherlands Speaks up

Although the European Union and Switzerland say they are committed to increasing access to affordable medicines, they did not support the report and said its mandate was too narrow. They also supported the current innovation model.

Malta, on behalf of the EU, said the current innovation model has “delivered constant progress in global public health leading to key new and improved treatments.” The EU, however, recognised the high prices of medicines, as was discussed in the report.

The EU and Switzerland said they would have favoured a more balanced approach to the report, including other dimensions than intellectual property, as access to medicines is a “complex” matter.

Switzerland said the issue of improving access to medicines, the strengthening of medical research worldwide, and protecting intellectual property as well as promoting human rights, are priorities for the country.

The Swiss delegate remarked on interesting proposals in the report, in particular the establishment of a publicly accessible database with information on the status of patents.

On the recommendations concerning IP rights, Switzerland said the report does not recognise the “central function of intellectual property rights in the promotion of research and development.”

Governments are free to use the TRIPS flexibilities, he remarked, warning that a weakening of the IP system, as suggested in several recommendations of the report, would in the longer term endanger biomedical innovation.

The Netherlands, however, said they are “more than ready to discuss the follow-up and recommendations” of the HLP “in an open and constructive manner.” “After all,” said the delegate, “the challenges described apply to all countries from all regions.”

“The proliferation of high cost medicines and rising drug prices are increasing the pressure on public health spending also in our country,” he said, adding that the Netherlands supports new business models as alternatives, such as the Medicines Patent Pool.

The Netherlands called for improving the legislative environment and preserving safeguards and flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). He also said the Netherlands “will continue its efforts to prevent so-called TRIPS-plus provisions in free trade agreements that are negotiated and to provide for safeguards against the abuse of IP measures and procedures for enforcing IP rights.”

The Netherlands is “convinced that a discussion is needed about the profit margin of pharmaceutical industry vis à vis other business sectors,” he added.

The US: No More Discussions on Report

The US also found the panel’s focused was too narrow. It is unprecedented at the EB for member states “to consider a report that call out policies of individual member states by name for criticism,” the delegate said.

“In several places, the panel report criticises US policies in ways that we believe are misguided,” he said, citing as example “the inappropriate criticism” referring to the US policy pertaining to the management of IP rights on research that begins in the public sector.

“This policy enacted under the Bayh Dole Act is arguably the most successful model in the world for developing new medicines through private-public partnerships. This policy has been adopted by several other governments currently sitting” at the Executive Board. “No one should be surprised therefore that we cannot accept any proposal to welcome or endorse this report or any mandate to take forward any consideration of its recommendations.”

Developing Countries: No Way Around Report

Developing countries which took the floor underlined what they see as a necessity that the HLP report should be discussed at the WHO. Not all recommendations should be followed to the letter, they said, but should be considered, and the panel report should be included in other initiatives promoting access to medicines.

Colombia, for example, suggested that the recommendations of the panel be included with other contributions, which are also undertaken.

Thailand remarked that “the majority of the report is acceptable and we should act on it.” The delegate also said that another high level panel was previously discussed at WHO and called for the same treatment for the HLP.

[Update] Brazil explained many ways the report is directly relevant to the work of WHO. The delegate said they are not seeking endorsement of the report but that WHO should be in a position to have a conversation about certain issues in the report. [end]

India said some of the HLP IP-related recommendations “merit immediate consideration,” such as creating new incentives for R&D, “beyond patent monopolies,” and the de-linkage of the price of medicines from the cost of R&D.

India proposed that the EB “should recommend to the 70th World Health Assembly to convene an open-ended meeting of Member States to discuss the recommendations of the UNHLP and other relevant recommendations in the report of the CEWG [WHO Consultative Expert Working Group on Research and Development: Financing and Coordination].

WHO Assistant DG Underlines WHO HLP-Related Activities

Assistant Director-General for Health Systems and Innovation Marie-Paule Kieny said the WHO participated in the HLP through its membership in the panel’s expert advisory group.

She also said that after the publication of the HLP report, the WHO convened an “all agency meeting” in December, including the UN Development Programme, UNAIDS, the UN Conference on Trade and Development, the WTO, the World Intellectual Property Organization, the UN High Commissioner on Human Rights, and UNITAID to discuss the different activities and plans for the future, including how to best follow up on the HLP report.

She said the WHO welcomes the HLP recommendation which says that all relevant international agencies should cooperate to support governments to apply patentability criteria that are sensitive to public health concerns.

Kieny also said the WHO welcomes the HLP’s call for more transparency on prices, and underlined that the WHO has been active in this area for years, adding that the issue of access of medicines is a complex one.

Access to Medicines on WHA Agenda with Shortages

Eritrea, on behalf of the Africa region, called for a separate agenda item on access to medicines, to be placed under the WHA draft agenda [pdf], item 14.3 (Addressing the global shortage of medicines and vaccines).

Board Chair Ray Busuttil, a consultant in public health in Malta. remarked that the WHA agenda was already very heavy and he should not like to add to it, and proposed to change the title of 14.3 to “addressing the global shortage of, and access to, medicines and vaccines,” combining the two issues under 14.3.

WHO Director Margaret Chan stepped into the discussion, underlining too that access to medicines “is a very complex and multifactorial issue,” and said that the secretariat would look at the record of member states statements and provide a new document under agenda item 14.3 to cover all both the shortage of and access to medicines, so to provide a platform for further interventions.

“It is about time we bring those things together and hear your views,” she said.

The EB approved this proposal and the WHA agenda is expected to be changed accordingly.

The 141st session of the Executive Board is expected to take place from 1-2 June.

 

Image Credits: Catherine Saez