Head Of WHO Health Systems Lays Out IP Issues At WHA

The annual World Health Assembly will address several issues related to intellectual property and innovation, Marie-Paule Kieny, assistant director-general for health systems and innovation at the World Health Organization, said in an interview this week. But a new initiative at WHO on fair pricing of medical products may not be among them in a significant way. [Update: the latest as of press time on the state of play on the UN High-Level Panel on Access to Medicines is provided below.]

In an interview with Intellectual Property Watch alongside the WHA (running from 22-31 May) on the morning of 25 May, Kieny highlighted two related issues that had already been decided, and listed some expected to come up today.

One issue was research and development for emergency preparedness, where she said her department is “very active” in moving ahead with the WHO R&D Blueprint (IPW, WHO, 24 May 2017).

They also are “very active” in two areas of antimicrobial resistance that are of interest to the cluster. One is about protection, prevention and control in order to remove secondary infection, especially in a hospital setting. The other is the development and stewardship framework, which is also an attempt to bring together the question of research and development, and access to antibiotics for those who need it, she said. This includes putting in place conditions for preservation of antibiotics so they don’t become useless quickly, she added.

Then coming up expected today is a range of issues under WHA agenda item 13 that are about health systems, several of them related to IP rights. One more prominent item on the agenda is on shortages, where there may be discussion of the recent report of the United Nations High-Level Panel on Access to Medicines, which includes a range of recommendations for improving medicines access that developing countries would like to discuss at the WHO.

Item 13.1 on human resources for health discusses that investment in health should not only be seen as a cost, but that that it will drive economic growth and employment, she said.

Item 13.2 on principles on the donation and management of blood addresses the controversial subject of products of human origin, any part of the human body, such as organ donation, stem cells. The principles are aimed at avoiding exploitation, including the principle of financial neutrality, that you should neither have a loss nor financial benefit when you give a part of your body, like plasma. Some countries have some financial payment for this. The principles envision that there might be reimbursement for costs such as missing work but it should not be a business and there should be management of donations so that there is no abuse, she said.

Agenda item 13.3, “Addressing the global shortage of, and access to, medicines and vaccines,” is where UN High-Level Panel on Access to Medicines is expected to come up. The original WHO paper in January was only about shortages, but Kieny said, “we are looking at how issues of shortages can be addressed because of requests of member states for a paper that would be more inclusive of access and covering also the High-Level Panel. We have added a whole chapter considering this.”

Some sources have indicated that an action may be proposed related to the High-Level Panel, while others have signalled that this might meet with opposition.

[Update:] At press time, India had taken the floor to request deferral of this agenda item until a later day to allow more time to work on building consensus on its proposal. The way forward to informally address this is under discussion on the floor. European countries resisted the idea demanding more information on what type of text India is seeking to work on, with Norway said it is a “highly complex and highly contentious” issue that should not be opened. The WHO legal counsel clarified that resolutions or decisions must have been submitted the end of the first day of the Assembly, but that the committee could draft language in the course of its work during the Assembly. The United States agreed to suspend the item so informal discussions on the issue can continue. Some countries have asked that if the topic is suspended, it should be clear what the process is, and as well it should happen this afternoon if possible to allow more senior officials to participate before leaving the WHA. The issue was deferred until 4:00 today. [end update]

[Second update, 4:30] India and the United States, with Colombia, have proposed this subject to be put on the agenda of the WHO Executive Board meeting next January.

Agenda item 13.4 on evaluation and review of global strategy and plan of action on public health, innovation and intellectual property is a longstanding IP issue.  Member states have agreed with an expert panel at WHO and will do exploration of value the global strategy has brought forward and come with a recommendation on what should be done, should it be expanded in time, are there any elements that should be changed, what is the progress, at global level as well as country implementation, Kieny said.

Another key issue is item 13.5, the follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). This includes a paper that looks at the Global Observatory on Health R&D, and at the establishment of an expert committee. This was submitted in January, and there are terms of reference of this committee.

The idea is to establish the committee before the end of this year so that it can start working, she said. There will still be discussion about a pooled fund that would be located at TDR that would help finance some of these projects, as well as discussion of a demonstration project. The expert group is proposed by the secretariat, coming out of an official process. Expert committees are “very formalized” at WHO, she said, so all the members have to be taken out of established panels. Member states propose names. Here this week members just have to approve the terms of reference so significant discussion is not expected.

Rather an agenda item, 15.6, on cancer prevention and control, under the noncommunicable diseases area, may be more likely to see discussions over issues such as pricing and delinkage of price from the cost of R&D, she said.

Also highly relevant is item 13.6 on the Member State mechanism on substandard and falsified medical products (to be changed from substandard/spurious/falsely-labelled/counterfeit). What was SSFFC, will be “SF” from now on, she noted.

Substandard is something non-voluntary while falsified would be a criminal act, said Kieny. “So either they are not suitable because of errors, lack of quality, or something which is an active forgering, she said. There is a lot of activity around the subject, such as surveys on the cost to public health, also in increasing reporting and the speediness of the reporting, she added.

Another health systems item, 13.7, on Promoting health of refugees and migrants is important but not related to IP.

Kieny also addressed the issue of fair pricing, under discussion at the WHO. This will be covered in an IP-Watch story to follow shortly.