Info Service on Health Issues (Jun16/10)
Geneva, 20 June (K M Gopakumar) – Southern Member States of the World Health Organization rejected global advanced market commitments (AMC), a proposal from the Secretariat to address the problem of global shortage of medicines.
The resolution on Global Shortage of Medicines and Vaccines (WHA 69.25) adopted at the 69th World Health Assembly (WHA) did not provide the mandate to the Secretariat to work on AMC. The 69th WHA was held on 23-28 May in Geneva.
Third World Network learned that at least 6 draft versions of the resolution were circulated since February until the adoption of the final version at an informal meeting of Member States on the morning of 28 May, the last day of the WHA. The adopted version is believed to be the 7th version.
The agenda item on global shortage of medicines was proposed by South Africa and the United States of America (USA). However, the original proposal for the agenda item was not placed before the Executive Board (EB).
The 138th EB session in January 2016 discussed the Secretariat’s paper (EB 138/41) dealing with shortage of medicines and shortage of medicines for children. On this issue the 69th WHA adopted a separated resolution titled “Promoting innovation and access to quality, safe, efficacious and affordable medicines for children” (WHA 69.20).
The Secretariat’s report circulated to the EB and WHA indirectly proposed the market-oriented solutions such as minimum global price or advanced market commitments to address the problem of shortage of medicines. The document for the WHA was titled “Addressing the global shortages of medicines, and the safety and accessibility of children’s medication.” (WHA 69/42)
The document stated: “The usual market approach to medicines supply through encouraging generic manufacturers to produce the medicines of interest has shown enormous benefits in lowering prices and increasing affordability. Too low prices, however, may drive manufacturers out of the market, and higher prices of alternative newer products may result in them being referentially supplied, with a decline in market for vital but cheaper medicines.”
Under the heading “New strategies to mitigate the risk of shortage” the report proposed: “At the global level, a set of essential medicines could be identified for which shortages have been reported or there exists a risk of shortages, and an international agreement about ensuring continuity of manufacturing and supply could be investigated”.
It further stated: “Questions that a general international agreement would have to resolve include: What is the core problem? What incentives are appropriate to create and maintain stability in the global market? Could a multiyear global advance purchase commitment be worked out? Would an agreed global minimum price that is commercially attractive help to keep a medicine on the market? How would such a price be set?”
The Secretariat’s report, however, left out the need to strengthen local production to address the shortage of medicines, an action point in the original joint proposal by South Africa and the USA. The original proposal stated:
“More importantly long term solutions to these shortages must be sought. These could include dialogue with manufacturers, changes to policy related to numerous critical points such as possible lifting of price controls, exploration of pooled procurement or other approaches to increase production incentives where appropriate, modifications to procurement practices and developing sustainable local manufacturing capacity that can reliably step in and respond to specific needs where global producers have failed to do so. Another essential element in addressing this challenge is increased regulatory capacity to ensure quality, safety and efficacy of all products whether locally produced or imported, promote rational drug use, and secure the supply chain”.
Often big pharmaceutical companies, including big generic companies, stand to benefit from global level advanced market commitments (AMC) because these require high levels of regulatory compliance thus favouring the bigger players. Further, AMC would affect local manufacturing in developing countries by eliminating the opportunity for the local firms to participate in public procurement due to supplies through AMC. This would create an import dependency.
draft resolution discussed on 28 May morning by the informal drafting
group indirectly proposed a mandate for the Secretariat to work towards
an international agreement to address the issue of medicines shortage.
It requested the Director-General “to identify medicines that are
at particular risk of being in short supply and develop strategies
According to observers, “develop strategies to facilitate their availability at an affordable price in collaboration with global partners” clearly gives a mandate to the Secretariat to work towards an international agreement containing AMC and global minimum price.
The same draft also urged Member States “to support reliable and sustainable supply of quality, off-patent medicines through adequate pricing and through effective enforcement of drug regulatory and supply chain security standards”. This is clearly meant to remove price controls or regulations on off-patent medicines.
The final version of the resolution does not contain both these paragraphs.
The attempt to provide a mandate to the Secretariat to work on AMC can be traced to the very first version of the draft resolution. The draft dated 19 February in operational paragraph 3.4 requested the Director-General “To identify essential medicines that are at particular risk of shortage and develop a market-based approach to ensure their availability in collaboration with global partners, including strategies for sustaining fair and affordable prices”. Terms such as “ market-based approach” convey a mandate to work on the international agreement consisting of global price and AMC.
China proposed deletion of term “market-based” from the draft resolution dated 21 May. This version also contained words such as “patient-centered”. It stated: “To identify essential medicines [China: and vulnerable medicines][Colombia: , including generic medicines]that are at particular risk of shortage and develop a [China, USA: patient-centered] [China: delete market-based] approach to ensure their availability in collaboration with global partners, including strategies for sustaining fair and affordable prices; …”
The draft version dated 18 May failed to remove the brackets but added a few more words on access and affordability. It read: “To identify medicines [and vulnerable medicines][, including generic medicines] that are at particular risk of shortage and develop a [patient-centered] [delete market-based] approach to ensure their availability in collaboration with global partners, including strategies for [ensuring access to medicines for all] sustaining fair and affordable prices; …”
The draft version of 25 May replaced the word “market-based approach” with “develop strategies”. The term “develop strategies” would still have provided a mandate to the Secretariat to work towards an international agreement consisting of global price and AMC. Operational paragraph 4 stated: “To identify medicines that are at particular risk of being in short supply and develop strategies to [ensure] / [facilitate] their availability at an affordable price in collaboration with global partners.”
The draft version dated 26 May showed the following text without brackets: “To identify medicines that are at particular risk of being in short supply and develop strategies to facilitate their availability at an affordable price in collaboration with global partners.”
28 May morning version stated: “to identify medicines that are at
particular risk of being in short supply and develop strategies to
Similarly, the draft versions also contained problematic provisions for the Secretariat to work on substandard/spurious/falsely labeled/falsified/counterfeit (SSFFC) medical products and supply chain regulations. Further, the resolution also proposed that the Secretariat work with global partners. The term “global partners” clearly includes pharmaceutical transnational corporations.
On the issue of SSFFC medical products the draft resolution dated 28May requested the Director-General: “to support Member States in the implementation of surveillance systems that will monitor and report supply and demand of medicines, using standardized formats throughout the supply chain, to predict needs and shortages, and that also reduce the risk of SSFFC medical products entering the supply chain”. Further, it requested the Director-General “to continue to support the Member State mechanism on SSFFC medical products”.
Regarding supply chain management, the draft version of 28May requested the Director-General “to prioritize, the development of new or updated procurement and supply chain guidelines for health products, to support the effective functioning of health systems and minimize the risk of shortages; …”
It also requested the Director-General “to work with global partners to strengthen systems for supply chain management for health products”.
The final version of the resolution provides a mandate to the Secretariat in the following areas to:
(1) Develop technical definitions, as needed, for medicines and vaccines shortages and stockouts, taking due account of access and affordability in consultation with Member State experts in keeping with WHO-established processes, and to submit a report on the definitions to the Seventieth World Health Assembly (2017), through the Executive Board;
(2) Develop an assessment of the magnitude and nature of the problem of shortages of medicines and vaccines;
(3) Support Member States in addressing the global challenges of medicines and vaccines shortages by developing a global medicine shortage notification system that would include information to better detect and understand the causes of medicines shortages;
(4) Report on progress on, and outcomes of, the implementation of this resolution to the Seventy-first World Health Assembly.