E-DRUG: Comment on the Access to Medicines Roadmap
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Dear e-drug readers,
I commented on the Roadmap in a letter to DG Tedros and I share it with you. I wholeheartedly agree with other comments that there is inadequate consultation with civil society and the private sector.
We all have to work together to address the matter of access to medicines but absent a real opportunity for all concerned persons to contribute to the Roadmap, there is a real risk that at the end of the next five years we will not have made the progress that we all hope to make.
Michele Forzley
Here is the letter:
August 22, 2018
Dr Tedros Adhanom Ghebreyesus
Diretor-General
World Health Organization
(by email only)
Re: The Roadmap on Access to Medicines and Vaccines 2019-2023 needs major revision
Dear Dr Tedros:
As a global public health legal practitioner for the past 20 years, I have worked with Ministries of Health and medicines regulators across the globe; with WHO, donors and NGOs on health systems strengthening and medicines' access; attended as a delegate to the World Health Assembly; and I have taught international and comparative health law. As such, I'm writing to you informed by first-hand experience, both academic and from the field. While I am pleased that the Roadmap has been released for comment, I believe the zero draft is in need of major revision. I therefore write to share how I believe the draft could be made a far more effective tool to guide WHO's activities related to medicines' access.
What's missing from the Roadmap
I was struck by several deficiencies in the Roadmap, most notably the omission of any reference to universal health coverage, and its disconnect with GPW13. It lacks specificity and a strategic management approach; it doesn’t address the fundamental gaps in health system management; and it takes WHO in directions where it does not have technical leadership - while failing to focus on those in which it does.
UHC is the cornerstone both of your tenure as DG and of GPW13. As countries grapple with how to build and sustain their systems, the subject of medicines' access is inescapable. But apart from a brief mention in the introduction, the document contains no reference to the quintessential challenge - how can countries integrate medicines access into their national UHC programs. Some might argue that all the elements of the Roadmap are pieces of that story, but it is nonetheless devoid of any explanation of how WHO will provide the normative and technical guidance countries want and need in this domain. Moreover, it is not enough for WHO to simply list how it will measure progress. The Roadmap should show the relationship between the activities proposed and articulate how each relates to the core objective of sustainable universal health coverage.
The Roadmap is long on optimism and short on direction and process
For the Roadmap to guide WHO towards improving access and achieving the SDGs, there needs to be far more detail and specificity as to the what, when, how, and by whom the work will be done. The draft uses words like support, facilitate, encourage, promote, and explore to describe the deliverables. How is a deliverable such as encouragement to be identified measured, valued, and time-bounded? In the world of donor-funded activity, recipients are tasked with describing specifically what actions will be taken, by when, by whom, where and how. WHO should be required to be equally explicit, so that its actions can be tracked. In this era of accountability, and (what promises to be) a $10 billion-dollar budget- a reasonable share of which will go to medicines activities - nothing short of this level of accountability should be acceptable.
In addition to the lack of accountability, the Roadmap is missing a strategic management approach that would indicate that WHO has carefully considered and prioritized the proposed activities according to their relative effectiveness in achieving near, medium and long-term goals. The Roadmap reads more like a laundry list of aspirations than the strategic and operational plan it needs to be. In my view, WHO should circulate a draft workplan (which is what the Roadmap ought to be) that demonstrates it has a managerial understanding of what it is proposing. This requires, inter alia, the addition of an operational approach to the proposed activities, and a pragmatic staffing plan.
A strategic management overview should also synthesize the activities to avoid duplication, schedule them over the five-year timeline, and cost them. We do not have the costing information for these activities yet, so in effect the anticipated consultations will at best be only theoretical. Without a strategic management overview and detailed workplan, the draft cannot demonstrate that the money will be well spent. In addition, the Roadmap should be developed with input from across WHO, rather than by the Department of Essential Medicines & Health Products alone. In this way, the Roadmap can be fully integrated with GPW13, while at the same time demonstrating how the WHO can work as a cohesive institution.
Evidence-based policy should be the norm - for all medicines activities
The draft claims it is based on the approximately 100 WHA and regional committee resolutions from 2000-2017 listed in the WHA 71/12 <http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71_12-en.pdf>
report on the global shortage of, and access to, medicines and vaccines. But resolutions are not evidence of what works. If countries knew how to achieve effective medicines' access and had done so over the preceding 17 years, those resolutions might well offer guidance. But as WHA71/12 indicates, the reality is otherwise. Relying on those resolutions is not evidence based; rather, it is an example of doing the same thing over and over and expecting different results - which some would define as insanity. The priority activities should be those that are 'best buys' - those that represent good value for money because they support the development of self-sustaining health systems and because they are based on evidence rather than history.
Indeed, WHA 58 urged countries to create national infrastructures to promote evidence-based policy, public health, and healthcare delivery systems. In a recent BMJ article
<https://www.bmj.com/content/bmj/362/bmj.k2469.full.pdf>,
the authors found that formal infrastructure to develop evidence for policy-making is not currently in place in many countries in the Americas. Nor is it elsewhere, for that matter, thus it is essential that WHO model reliance on evidence for policy and operational decisions and develop the Roadmap accordingly. Otherwise, the proposed activities are at best speculative undertakings that though they may placate popular opinion, will achieve little more.
WHO should stick to domains that reflect its expertise
WHO should play to its strengths and its role as the leading normative institution in global health. The Roadmap should be benchmarked against these and any activity not in alignment should be avoided. It is inefficient for WHO to engage in activities for which it lacks adequate skill, or in which other organizations (public or private) have superior expertise, for example procurement and supply chain management; sustainable financing and resource mobilization; and trade and intellectual property issues.
The Roadmap should be organized according to those activities that are consistent with WHO's remit and expertise and on which it should take the lead, with others deferred to other competent organizations. Though this will no doubt be unpopular within the activist community, this is particularly true for issues around intellectual property and trade. There are at least four full-time staff devoted to intellectual property law and trade related work. The funding for these activities should be redeployed to work only WHO can do, ceding this space to WIPO and the WTO that are highly expert in these matters, and noting also that there is extensive literature on these topics to guide countries.
Furthermore, and perhaps most concerning, is that the Roadmap does not mention institutional capacity development, nor health and medicines system strengthening. Instead it just lists activities with no discernable order of importance and in 6th place we find regulatory systems strengthening which only refers to quality, safety and efficacy. As critical quality, etc., is to access, it is not enough by itself. Access happens where there is a functioning Ministry of Health and medicines regulator operating within the rule of law. For example, fair pricing won't work unless there is an adequate legal infrastructure and a thoughtful integration of pricing decisions within the health system. A Roadmap that just lists 'hot' topics instead of focusing on the foundations of a health system is like a two-legged stool - unstable and unsustainable. Unless we focus on moving all member states to be the best they can be, we won't achieve UHC or SDG 3 or 17.
Consultations must be open to all stakeholders, including civil society and the private sector
I strongly suggest that longer and broader consultation is essential to getting the Roadmap right. At present the proposed consultation with non-state actors is informal, by invitation only, and for just three and half hours. If WHO believes that the way forward should include non-state actors (including the private sector), then it must make good on this. The consultation should be open to all; and there should be an unrestricted on-line consultation that remains open for all of September and longer if need be. There are many who have significant experience in the field who can contribute substantially. This is important because in an environment of resource constraint, WHO can ill afford to overlook expertise that could otherwise be willingly made available to it. We also need new and fresh thinking to achieve SDG3, and the Roadmap should include activities to start a conversation on how we get there.
Improving the Roadmap will require some time, new thinking and substantial additional work, and it may well not be ready for January's Executive Board. What is critical is that WHO gets it right rather than 'on time' and those of us committed to improving global access to medicines are looking to you as Director General to navigate this.
Yours sincerely,
Michele Forzley
Michele Forzley JD, MPH
michele@micheleforzley.com