Info Service on Health Issues (Aug13/01)
‘Negotiating Better Global Health’: Pre WHA Advocacy session for Youth
On 19 May 2013, the International Federation of Medical Students’ Associations arranged for a half morning advocacy training session for medical students attending this year’s 66th World Health Assembly in Geneva from 20 – 28 May 2013. A young, energetic and ethnically diverse medical student group participated and interacted with a three person panel from WHO, MSF and the Harvard Law School.
The following is a write-up by Shila Kaur on the advocacy session, which was held at the Institute for Graduate Studies, Geneva.
With best wishes
‘Negotiating Better Global Health’: Pre WHA Advocacy session for Youth
By Shila Kaur
As a lead up to the 66th World Health Assembly, the International Federation of Medical Students’ Associations organized a series of advocacy and training sessions for medical students from around the world aimed at catalyzing interest in international health and policy concerns. As part of this, students participated at a half morning session entitled ‘Negotiating for Better Health’ during which presentations from WHO, MSF and Harvard Law School were heard.
Ms Katy Athersuch, Medical Information and Access Policy Adviser, Medecins Sans Frontieres (MSF) initiated the session by providing an overview of the problem and gaps with regards to the current medical innovations system as well as the Agenda of the World Health Organization’s Consultative Expert Working Group on Research and Innovation. Amongst the challenges MSF identified were that medicines were either unaffordable, unavailable or unsuitable.
In her opening slide Ms Athersuch quoted Dr James Orbinski, President of MSF International from 1998 – 2000 in his Nobel Peace Prize lecture delivered in 1999:
‘Today a growing injustice confronts us. More than 90% of all death and suffering from infectious diseases occurs in the developing world. Some of the reasons that people die from diseases like HIV/AIDS, tuberculosis, sleeping sickness and other tropical diseases is that life saving essential medicines are either too expensive, are not available because they are not seen as financially viable, or because there is virtually no new research and development for priority tropical diseases. This market failure is our next challenge. The challenge however is not ours alone. It is also for governments, international government institutions the pharmaceutical industry, and other NGOs to confront this injustice. What we as a civil society movement demand is change, not charity.’
According to MSF, tropical diseases (including malaria) and tuberculosis account for 12% of the global disease burden, while only 1.3% of new drugs are developed. However despite the progress in development of new drugs and approval, imbalances remain.
Amongst the problems that MSF aims to resolve are:
• Lack of needs-driven Innovation
• Lack of affordable Access
‘Innovation is pointless in the absence of favourable conditions for people to access existing, as well as new products,’ said Athersuch. She went on to state that
• Developing countries facing double burden of disease- R&D needs cover type I,II and III diseases- neglected populations not neglected diseases
• interest for MSF to champion innovative models of financing R&D that rewards innovation while facilitating access as we need new tools.
• MSF funding R&D when absolutely needed – Co founder of DNDi because of neglect on R&D for neglected tropical diseases
• MSF have been involved in clinical evaluation studies for product developments e.g testing of new HIV viral load POC test in Malawi and Uganda
‘The main explanation for this situation is the current predominant model of funding for research and development is definitely not adapted to neglected diseases,’ explained Athersuch. Under the current R&D framework, R&D costs are recovered by high prices on patent-protected products. Under this model, there is a link between R&D costs and drug prices.
‘The market for new products for Neglected Tropical Diseases is almost negligible because patients are predominantly poor,’ she added.
‘Pharmaceutical companies know this situation and they think that the market is too small to “recover” their discovery and development costs. It will be impossible for them to charge high prices on products, because patients cannot afford them. The absence of a sizeable market explains why pharmaceutical companies are reluctant to engage in the development of new products. The market is too small to be an incentive for research,’ lamented Athersuch.
In explaining the WHO’s CWEG agenda, she recounted the process beginning in 2003 when Resolution WHA56.27 was adopted through to Resolution WHA59.24 adopted in 2006, Resolution WHA61.21 adopted in 2008 and Resolution WHA 83.28 adopted in 2010. Despite new funders, funding and new products, progress has been ad hoc and inadequate and there has been no sustainable system to ensure adequate investment.
Athersuch informed that many challenges remain in research and development of new product including: a lack of new major scientific breakthroughs; R&D priorities that are set by a few OECD donors and foundations; major funding gaps for development of pipeline candidates; major regulatory and access challenges; lack of an incentive for private; limited leadership and involvement of endemic countries and lack of an overall coordination role by WHO.
Amongst the recommendations to meet those challenges were:
i. Mechanisms to stimulate development of health products for developing country health needs
• Open approaches including precompetitive R&D platforms, open source and open access schemes.
• Prizes, in particular milestone prizes.
• Equitable licensing and patent pools.
• Most of the money should be used within each individual country
• Countries should commit to spending at least 0.01% of GDP on government funded R&D for health needs of developing countries
• 20% of the funds raised should be channeled through a pooled mechanism
• Countries could raise money through direct and indirect taxes
• A global Health R&D Observatory to monitor/track: financial flows to R&D; the R&D pipeline; lessons learned
• Advisory mechanism: a network of research institutions and funders; an advisory committee
• WHO should play a central role in improving coordination and this should be considered a part of the WHO reform process.
The need for a coherent global framework to ensure the various recommendations are acted upon: coordination, financing and ‘open knowledge innovation’
Athersuch stressed the need to delink as a guiding principle in innovation. ‘In reconciling innovation and access, factors of affordability and accessibility must be immediate considerations when funding/ creating incentives for R&D. These must be included at all stages of research from the basic research through to product development and delivery. As de- linkage provides pathway to orient R&D towards health needs, it can and should apply across the full range ways of funding R&D, for example through grants, PDPS (push) and rewards at the end (pull).
She outlines several ways to translate health needs into action:
i. Establish an evidence-based inclusive process to set priorities for medical R&D
- This would require leadership from WHO through member state endorsement
- This links priority setting with financing
- Require the development of target product profiles for priorities
ii. Ensure money is used to stimulate R&D most effectively
- Support for models that allow limited funds to be fully maximised and provide opportunities for the emergence of lower cost manufacturers.
iii. Establish principles to ensure access to the fruits of R&D=Innovation with access
- Set norms that consider access and affordability as main considerations throughout the innovation process with particular emphasis on product developers who use public money for innovation.
Athersuch raised the idea of a Convention on R&D with global public leadership through government support as well as priority setting involving strong developing country input and WHO coordination. A Convention would also ensure financial sustainability, support open knowledge innovation, access and affordability as well as enhance innovation capacity in developing countries.
She alerted participants that the resolution for a Convention which would be tabled at the 66th WHA faced various challenges including unclear and unfinanced proposals on Observatory and pilot projects; delays in the reporting back on progress following the last meeting of the CEWG; and threats around the resolution being taken off the table altogether.
Finally she shared several possible demonstration projects that could test the push and pull mechanisms of the CEWG. These were: the Biomarker Prize for Chagas disease; new classes of antibiotics; better adapted vaccines which would be needle-free, heat stable and multi-antigenic; and TB diagnostic biomarkers for adults and children.
In his presentation on Implementing CEWG Recommendations, Steven Hoffman, Assistant Professor at McMaster University, Canada and Visiting Assistant Professor at Harvard School of Public Health led participants through the historical journey of the CEWG process which interestingly began in 1990 with the Commission on Health Research and Development followed by the WHO Ad Hoc Committee on Health Research in 1996 and then later the WHO Commission on Macroeconomics and Health in 2001. This later developed into Resolutions WHA56.27 tabled in 2003, WHA59.24 in 2006, WHA61.21 in 2008 and WHA63.28 in 2010. In 2012 Resolution WHA65.22 was tabled which basically urged members states to hold consultations and open-ended meetings to thoroughly analyse the CEWG report and the feasibility of operationalising its recommendations. This resolution became the prelude to a series of meetings culminating in its next tabling at the 66th WHA.
Mr Hoffman was of the view that all this talk which essentially began in the 1990s was coming towards a consensus; however the question was how to get to that point.
He impressed that the main consideration at the 66th WHA would be the most appropriate vehicle for delivery of the principles and content of the resolution provisions. He went on the share what could be a possible optimal mix of implementing mechanisms for supporting an international agreement that supports R&D. The agreement had to viewed within the context of major global health challenges that included pandemics, counterfeit drugs, universal coverage, chronic diseases, alcohol, maternal health, child survival, obesity, tobacco, disaster response, hunger and mental health.
Hoffman cautioned that all laws had direct and indirect costs; the direct costs of drafting/ratifying/enforcing involved countless meetings, air travel, legal fees, duplicative governance structures, conferences of parties and secretariats while indirect opportunity costs occupies resources, energy and rhetorical space as well as distracts from other important initiatives.
Apart from this, there were the social costs of laws had also to be borne in mind. Usually laws are often imposed by powerful states and legally oblige poor countries to implement ‘enlightened’ global policies at the expense of local priorities. In many cases the promised financial support is often not delivered. Apart from this, enforcement of these laws by NGOs is deemed foreign interference in national policy making processes.
Hoffman next shared criteria for evaluating new proposals on laws.
His parting messages were:
• the CEWG recommendations need a vehicle for implementation
• there are many options on the vehicle for implementation. International law is costly and its use must be justified based on its impact.
• In the absence of good data on impact, a decision framework or criteria is needed to aid global health decision-makers determine whether laws are worthwhile.
• International law is promising for CEWG recommendations but has its pitfalls.
• In view of this, it might be better to focus on accountability mechanisms.
In his off-the-cuff and final presentation of the morning’s session, Dr Zafar Mirza, Director, Department of Public Health, Innovation and Intellectual Property, WHO, led participants through the institutional processes at WHO on CEWG. Weaving an engaging tale from its initiation to its current form, Dr Zafar informed the background and need for innovation and access in view of gaps/lacks for the majority of the poor in developing countries.
‘One third of people in the world would have no access to medicines and health technology even when medicines are available,’ stated Dr Zafar. ‘Of the 50 national price surveys conducted globally, results indicate that 40% of the public health sector lacks essential medicines. Medical supply for overall healthcare therefore must be developed, and this is where innovation comes into the picture,’ he added.
He went on to explain the medical innovation process from point of inception and basic research, through to testing and screening, the three phases of developmental research and product launch. He pointed out the flaws in the operating model of medical innovation which he said was showing ‘signs of exhaustion” and offered that ‘this is the era for innovation for innovation’.
In telling his tale of the intricacies involved in the global process of getting from the expressed view by developing countries for the need for more relevant innovation, to the actual setting up of the CEWG and the current stalemate with regards to the appropriate vehicle for implementation, participants were walked through a virtual historical account of global health politics, from the standpoint of WHO.