“Post Mortem” of the 67th WHA
By Germán Velásquez
The sixty-seventh session of the World Health Assembly (WHA) was held in Geneva from 19 to 24 May 2014 . The delegations of 194 Member States of the World Health Organization (WHO) discussed around 75 agenda items, 15 decisions, and 20 resolutions during the week-long Assembly.
This article makes some “post mortem” comments based on the discussions on some of the critical issues on the agenda of the WHA.
The first general comment is that the agenda items reflected very little of what countries have been discussing since several years as WHO priorities. The agenda of the WHA should have 20, maximum 25 items reflecting the global health priorities. The least that can be said is that it is impossible to deal with 75 points, deeply and with seriousness.
With respect to the format and methodology of the event, substantive discussions were held in two large committees – Committee A (for technical issues) and Committee B (for administrative matters). While the substantive discussions were held in the Committees with the involvement of technical experts from various delegations, Ministers and heads of delegations simultaneously addressed their speeches to a few close friends in a largely empty plenary hall. However, this year there was a full plenary hall listening to the keynote speech of Melinda Gates to the WHA for over twenty minutes. The intervention of Melinda Gates was heavily criticized by NGOs present at the meeting: “We the undersigned organizations express our strong protest against the decision of the World Health Organization (WHO) to invite Melinda Gates (of the Bill and Melinda Gates Foundation – BMGF) as the keynote speaker at the 67th World Health Assembly, that begun in Geneva on 19th May. This is the third time in the last 10 years that someone from the BMGF and of the family has been an invited speaker at the WHA (Melinda Gates was preceded by her husband Bill Gates, in 2005 and 2011). Ms. Melinda Gates’ credentials as a leader in public health are unclear” (Open letter from Civil Society, 20 May 2014).
It is clear that the format and functioning of the WHA are not appropriate or effective for the annual deliberations that should guide the course of global health. Member States should consider the use of WHO’s treaty making powers ( under Article 19 of WHO Constitution) in this context. Serious consideration needs to be put into whether and if so how WHO’s treaty making and regulation making powers could be used to mandate necessary standards governing the priority global health issues.
As it often happens in the WHO governing bodies, the meeting witnessed divergent points of view among a small group of countries of the North and countries of the South. Following are some comments on some of the most important items on the agenda:
Framework of engagement with Non-State actors (Document A67/6, WHA67 agenda item 11.3)
Two days of informal consultations were held in Geneva in March 2014 on this issue which concluded with the agreement to entrust the WHO Secretariat to submit to the 67th session of the WHA a new version of the policy on engagement with non-state actors (NSAs), taking into consideration the comments from Member States. After 2 days of intensive deliberations in a drafting group during the WHA, Member States were unable to agree on a draft framework and policy on the organisation’s engagement with “non-State” actors. According to the WHO draft, NSAs include non-governmental organisations, private sector entities, philanthropic foundations and academic institutions. The draft document submitted by the WHO secretariat was sent back to regional committees for further discussions. The failure to approve this policy will take one more year without clear guidance in this substantial item which is at the core of WHO reforms. There is a concern therefore that the unapproved draft framework and policies could continue to “legitimize the status quo” and the influence of the private sector in the WHO would continue to grow.
Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG, Documents EB134/26 and EB134/27, WHA67 agenda item 15.2)
Switzerland surprisingly, almost as a “coup d’état”, submitted a decision, which was not foreseen. Led by the delegate of Bolivia, developing countries managed to include the request that the demonstration projects should not be linked with starting the negotiations for a binding R&D treaty. Until now the demonstration projects, introduced by the EU, USA and Switzerland, seem to be a strategy to delay the central recommendations of the CEWG report.
Substandard/spurious/falsely-labelled/falsified/counterfeit medical products (Document EB134/25, WHA67 agenda item 15.3)
No resolution was considered under this item and only a report was submitted to be noted by the Assembly. After more than 3 years of debate there has been very little progress in this process and doubts about the quality and legitimacy of generics persist.
Regulatory System Strengthening (Document A67/32, Resolutions EB134.R17 and EB134.R19, WHA67 agenda item 15.6)
On the issue of “Regulatory System Strengthening” two resolutions were approved. In the first resolution on “Regulatory System Strengthening for Medical Products” developing countries managed to delete reference to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH is basically an initiative of the US, Japan and the EU and the multinational pharmaceutical industry.
Most but not all references to harmonization were deleted. The preamble of the approved resolution said : “Noting with appreciation the many EXISTING national and regional efforts (…) such as the European Union regulatory framework for medical products, work under way in PAHO following its 2010 resolution CD50.R9, the African Medicines Regulatory Harmonization Initiative, and the regulatory harmonization and cooperation work in ASEAN”. Developing countries MUST watch that this is not a door left open to ICH in the next years.
Concerning the other resolution on the same agenda item – Access to biotherapeutic products including similar biotherapeutic products, acknowledging that national authorities may use different terminologies when referring to similar biotherapeutic products, under the leadership of Colombia and Argentina, developing countries managed to have the request to the Director for the revision of the “WHO Guidelines on evaluation of biosimilar products” issued by the WHO secretariat in 2009 approved, without the approval of the WHA.
Antimicrobial Drug Resistance (Documents A67/39 and EB134/2014/REC/1, WHA67 agenda item 16.5)
The WHA approved a resolution on antimicrobial resistance, which urges Member States to strengthen drug management systems, to support research to extend the lifespan of existing drugs, and to encourage the development of new diagnostics and treatment options. The WHA recognized the growing concern of antimicrobial resistance and urged governments to strengthen national action and international collaboration. The resolution also requested WHO Secretariat to develop a draft Global Action Plan to combat antimicrobial resistance, including antibiotic resistance for presentation to the World Health Assembly for approval next year.
It is time, better late than never, that WHO takes seriously an issue that NGO’s, like TWN, have been alerting the global community for more than 15 years.
Germán Velásquez is Special Advisor on Health and Development of the South Centre.
