In these turbulent times, many people will agree that to the question recently asked by Fryatt et al. “Health sector governance: should we be investing more?”, the answer is definitely yes. The big issue then is: what kind of investments will make the difference?

Back in 2007, the WHO proposed a six building blocks’ framework to categorize and analyse health systems  : health financing, human resources for health, medicines and technologies, health information, health service delivery and governance. In this framework, health system governance was defined as: “Ensuring strategic frameworks exist and are combined with effective oversight, coalition-building, attention to system design and accountability”.  Since then, other definitions of governance have entered the literature, but for sake of simplicity we will stick to this one here for a moment and try to unpack what this definition really means in practice and what kind of actions it should ideally trigger in health systems.

First, we must admit that for the past decade, we have paid much attention to the first part of this definition: “ensuring strategic policy frameworks exist”. Communities of experts, donors and practitioners working to strengthen health systems and improve their performance have dedicated a great part of their work and resources to strengthening national and subnational capacities for strategic planning and policy-making. And surely, modernizing this planning process to meet the demands of fast-changing and diverse societies has been a challenge in its own right. As a consequence, until today, many health systems have a tendency to adopt a top-down planning approach whereby a central government (with or without the help of consultants) produces more or less visionary or conservative health sector strategic plans with varying levels of details.

But strategizing for health should not be a top-down approach. More and more people are convinced that robust national health strategies, policies and plans are to be developed through an inclusive process involving the diverse stakeholders and should contribute to health systems strengthening – including the population. Inclusive and participatory policy dialogue is at the core of strategic planning and policy formulation. Hence, building capacity for evidence-based, participatory and bottom-up planning has been at the focus of most governance investments in the recent past. This investment has also been extremely critical in providing a more solid base for donor coordination, harmonization and alignment. National health plans are a pre-requisite for effective coordination of health system strengthening interventions; support to the national health strategy is one of the seven behaviours of effective development cooperation, while Joint Assessment of National Health Strategies (JANS) is a well-established tool that promotes shared accountability in health systems.

Secondly, without denying the critical importance of policy-making capacity and strategic planning processes in the health sector, we must also acknowledge the need to examine more closely the latter part of the governance definition put forward by WHO in 2007: that is “effective oversight, coalition-building, system design and accountability”. Much less has happened in this respect in the recent past, although some authors in the health system literature have ventured this less travelled route: a recent systematic review identifies 16 frameworks for health systems governance published between 1994 and 2014, but only five of them have been applied in practice and only three considered governance at multiple levels of the health system. When travelled, the route therefore remains vastly theoretical; it is difficult to grasp what are the concrete actions that could benefit health system governance and improve health system performance. Nonetheless, some authors have attempted to incorporate key contemporary issues in the governance of health systems in their discourse: the role of the state vs. health markets, the role of ministries of health vs. other ministries, the diversity of actors in governance – public, private and civil society, the need to acknowledge the dynamic or organic nature of health systems and the implication of this on resilience and adaptability, the perspective of a rights-based approach to health. And for sure, addressing these issues, or at least attempting to consider them in the way we devise health system strengthening interventions will require much more than national health strategies, policies and plans. They also demand putting some emphasis on the institutions whose strength and power will ensure implementation of these plans and accountability towards their objectives: these institutions include broader governance principles such as the rule of law or democracy; public policies such as public financial management or decentralization; and organizational entities that govern the health sector such as ministries of health, public health agencies or health insurance organizations. To use the “hardware” / “software” metaphor now common in health systems research, a focus on institutions for health system governance requires investing in building or strengthening structures of government as well as in generating virtuous circles and positive outcomes through formal and informal processes, rules and incentives that play a role in policy implementation. Structures of governments – especially ministries of health and other health agencies, as well as relations between health system actors are at the core of the latter part of our definition of governance: “effective oversight, coalition-building, system design and accountability”,

In short: Promising innovations, new partnerships, platforms for intersectoral actions, innovations in applied policy research, and above all opportunities for dialogues between actors of the society – including first and foremost people for whom and by whom health systems are made : these are all crucial requirements of health systems governance for Universal Health Coverage.

The Health Systems Governance Collaborative was born from this urgent need for new collective action. The Collaborative is set up to work as a global network, made up of participants from various backgrounds: technical experts, agencies, policy makers, and citizens’ representatives. It is open to all stakeholders seriously interested in advancing health systems governance.  It seeks to provide a reflexive context for articulating locally relevant governance problems, and building theory from action and local practices. It is committed to develop a bold vision of collaboration, drawing actively on existing networks and communities of practice. The Collaborative is connected to the UHC2030 platform as one of the latter’s participating networks, to guarantee maximum synergy between local and global experiences. Two initial topics will be explored in the coming year; they reflect critical questions put forward by both scholars and practitioners in the field:

• The changing roles and governance capacities of ministries of health, as the main stewards of health systems in the 21^st century, faced with multiple local, national and global challenges and opportunities
• Frameworks, dimensions and measures of governance that will support an actionable governance agenda in the health system, similar to broader actionable governance indicators supporting advances in sustainable governance

This is a new initiative, but we hear it is much needed and we are committed to make it happen. So don’t hesitate to join the movement, together we are stronger!

So I went back to the document and checked the goals and targets again. Here’s how the main medicines target (Target 3b) reads:

 “Support the research and development of vaccines and medicines for communicable and non-communicable diseases that primarily target developing countries, provide access to affordable essential medicines and vaccines in accordance to the DOHA declaration on the TRIPS Agreement and Public Health, affirm the right of developing countries to use the full provision in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health and in particular provide access to medicines for all.”

Each time I read and read this target again, I hold my breath and I feel  I could use Tom Cruise / Ethan Hunt’s lung capacity, but then comes the indicator: “Proportion of population with access to affordable essential medicines” … and that’s when I start hearing offline voices (“Your mission, should you choose to accept it…”).  No matter how long I stare at the pdf, it won’t self-destruct: this is the medicines target and we’ll have to deliver. The question of course, as for the rest of the SDGs, is: how? And I feel this question is quite crucial when it comes to medicines as we, as a community, have a number of issues to solve before we can report on this indicator.

Access to medicines: DENIED! Passcode required!

First, we do have to acknowledge that we have a real semantic problem that divides the health system and the medicines communities, sometimes without even being noticed. Indeed, the definition of access to healthcare or essential health services and access to medicines doesn’t seem to be quite the same. Access to health services is measured in terms of utilization, and depends on availability of services, physical or geographical accessibility, affordability and acceptability. This definition implies that health services are of adequate quality and that access dimensions capture equity.  In the medicines community however, the same terminology is used to describe a different set of issues. The World Health Organization defines the term “access to medicines” under the heading of Trade, foreign policy, diplomacy and health. While the definition acknowledges that access to medicines depends on four factors (rational selection and use, affordable prices, sustainable financing and reliable health and supply systems), it focuses on affordable prices as the main factor affected by globalization and describes strategies to increase medicines affordability: pricing policies as well as some of the principles of the Doha declaration on patent protection, such as parallel imports or compulsory licensing.  A simple Google search on the term “access to medicines” will bring you the Access to Medicines Index as a top search result, followed by the MSF Access Campaign: the former measures the performance of top 20 pharmaceutical companies and ranks them against each other, while the latter is an advocacy campaign against high medicines prices and the lack of a Research and Development agenda geared towards the poorer countries’ needs.

Don’t get me wrong, these are absolutely crucial matters for developing countries and should be our collective responsibility, but it is important to highlight the misunderstanding that the wording “access to medicines” may carry between health system and medicines specialists. With the commonly accepted definition as above, we have to hold our breath and dive in the complexity of Trade-Related Aspects of Intellectual Property Rights (TRIPS), understand the jargon of these international treaties and then, as in many legal provisions, decipher the exceptions and exemptions: in this case the flexibilities introduced to protect public health rights. As important as it undoubtedly is, I am not sure that this stunt exercise will get us any closer to the health system bottlenecks that affect access to medicines: for example whether supply systems are effective, whether medicines are of acceptable quality, included in the benefit packages covered through health financing mechanisms, whether there are enough pharmacists in health facilities, whether they are adequately trained, whether providers and dispensers use medicines appropriately and whether people are satisfied. For this reason, some well advised scholars insist on using a more comprehensive terminology such as “access to and appropriate use of affordable quality medicines”. It doesn’t shorten what we have to say, and I’m sure Hollywood would stay far away from such a twisted caption, but it gives a better visual on what needs to be done. And it’s a lot.

Reform agenda: the Ghost Protocol?

If we agree that by “access to medicines for all”, we mean “access to and appropriate use of affordable medicines of good quality for all”, then the next step is therefore to acknowledge that the reform agenda that will allow such outcome is much broader than supporting countries to “use the full provision in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health”. Countries’ capacity to use TRIPS flexibilities is extremely important but only one of the many action points that will ensure that people access the medicines they need, in adequate quantity and quality, when they need them and without incurring financial hardship.

But wait, this last sentence is also a mouthful but it sounds quite familiar… If I am not mistaken, this is the definition of Universal Health Coverage (UHC) in which health services are replaced by essential medicines. And that’s not a coincidence: the medicines reform agenda in the next decades is a UHC agenda which should be embraced by the health system and the medicines community alike. Consequently, the real medicines target is more likely to be SDG Target 3.8 – “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” It might have been useful to line-up medicines-specific indicators to measure this target, both in terms of coverage and in terms of financial protection, especially as medicines account for up to 68% of total health expenditures and up to 90% of total medicines expenditures are out-of pocket. But given that there is only one health-related goal in the SDGs and a need to limit targets and indicators to a small and meaningful set, access to medicines may require a separate exercise of its own. The Lancet Commission on Essential Medicines Policies has taken up the challenge of developing an agenda on essential medicines for the next 20 years, with particular relevance to achieving UHC and sustainable development goals.

From pills to people

We can trust Lancet Commissions for being ambitious and taking up challenges that others have neglected in the past, while shedding light on issues previously overlooked or ignored. Lancet Commissions have helped fighting child mortality, reviving Primary Health Care and attracting attention on chronic non-communicable diseases at times when people were otherwise busy with HIV, malaria and TB.  This time around, the Lancet and everyone who has the ambition of writing an essential medicines agenda for the 21^st century must keep in mind that pharmaceutical systems and related reforms that will contribute to UHC and SDGs, are not just about pharmaceutical products but also and even mainly about a large set of actors – policy makers, bureaucrats, managers, prescribers and dispensers who work in regulatory agencies, financing agencies, private companies, warehouses, pharmacies, health facilities but also users who are patients, consumers and citizens. All these actors have competing and converging interests both on individual grounds and as they operate within different organizations with varying degrees of decision making power and access to information. Effective stewardship requires a fair balance of these interests, and a firm commitment to deliver on quality and equity in access. This is easier said than done: people are far trickier than pills; we have long mastered the science behind the latter while we had to travel as far as Cape Town to realise that health systems are social constructs requiring a people-centred approach and we are still documenting how this can effectively support health system strengthening. When it comes to pharmaceutical systems, the challenges are even bigger. First because we cannot simply let go of a focus on products: we still have to invest in producing and distributing effective and quality-assured medicines that will help the world fight the burden of both communicable and non-communicable diseases. Second because adding a focus on people will be more complex than potentially anticipated: the range of actors involved in pharmaceutical systems includes a pluralistic, often unregulated and sometimes very powerful private sector whose role has been quite neglected thus far. We should be ready to run an extra mile to bring them on board of the SDG plane as it takes off, not unlike Ethan Hunt and that insane plane stunt in Rogue Nation. Who knows, I might fall in love with the SDGs then, to substitute for my Tom Cruise crush of the 80s!

“Sound Choices” as we call it in house, unpacks for us capacity strengthening for health policy and systems research. There are only a few people who still believe that capacity strengthening is about bringing together students or health managers in a room and teach them. This is of course useful but often, it’s not enough. If you want to find out why it may not work, read “Sound Choices”, which teaches us some extremely useful basics.

We often tend to approach capacity strengthening with the preconception that who teaches knows and who is taught must learn, with information circulating in a single direction and sometimes in a paternalistic way. But “Sound Choices” says that capacity should not be built. Using this wording suggests “a process starting with a plain surface and involving step-by-step erection of a new structure, based on pre-conceived design”. On the contrary, we have to acknowledge the existing, the diversity and richness of experiences, the context, explicit and tacit knowledge, and new ways of sharing both. And therefore “strengthen” and “develop” rather than build.

Second, ”Sound Choices”, which was released in 2007, highlights that capacity strengthening efforts focus too heavily on individuals, neglecting institutions and the wider environment in which individuals evolve. In short, in capacity strengthening for HPSR, like for the rest of the health system, we need to think in terms of systems, move away from a tree-by-tree approach and have a look at the forest.

Third, “Sound Choices” presents the critical functions that allow evidence informed policy. These are a) research priority setting, b) knowledge generation and synthesis, c) evidence filtering and amplification and d) policy making processes. Obviously, capacities to perform each of these functions reside in organizations such as research institutions, funding bodies, civil society, the media, think tanks or government bodies. HPSR Capacity strengthening efforts should therefore target these organizations and reinforce their leadership, governance, resources and communication capacities in order to enable them in performing their functions.

This is a vast agenda, which the Alliance put forward for the HPSR community more than seven years ago. However, we have to acknowledge that so far, we (aka the HPSR community) have kept our traditional focus on knowledge generation and dissemination, the latter through the standard means of peer reviewed publications. Examples of investments in research institutions exist of course, and more recently also networks of institutions have been funded and have developed interesting activities. Examples of sharing knowledge through other ways than teaching, e.g. communities of practice, are also showing promising results. But again, our efforts have been mainly invested in individual’s capacities for HPSR. Despite their brilliant and most powerful presence in the three successive symposia, the dynamic network that they have created and maintain and the opportunity they provide for the young generation, the Emerging Voices venture for example, is still building the capacity of individual young researchers. We, at the Alliance, have heavily invested in capacity strengthening. Most of our research grants include a capacity strengthening component; we bring researchers together in protocol development workshops, support them in their research and nurture their publications. We have several other capacity strengthening initiatives too but these are often again focused on individuals. As the rest of the HRSR community, if we want to progress towards a longer term, more sustainable forms of capacity strengthening, if we want to bring about structural changes in the capacity of health systems to produce and use HPSR, we have to do things differently.

From 13-14 November, the Alliance convened a group of 18 leaders representing academic and research institutions and funding agencies to take part in a consultation on strengthening capacities of researchers and policy/decision makers in HPSR. The purpose of the expert consultation was to have a dialogue on emerging issues in capacity strengthening and to identify how the Alliance can best contribute to the development of HPSR capacity moving forward.  The experts reiterated that capacity should be strengthened across individual, institutional and system levels; that it should take into account the political context of HPSR. Efforts can support the development of teaching and training material, but should also focus on other capacity strengthening approaches such as credible career paths, mentoring roles, collaborations between health and social sciences. Finally, it is important to measure the outcomes and impact of capacity strengthening efforts, which require a monitoring and evaluation framework that would take in consideration the specificities of health policy and systems research, as opposed to clinical research. After all, the role of HPSR is to affect change in health systems, capacity strengthening efforts and associated M&E frameworks should take that goal in account. While the recommendations of the experts will guide the formulation of the Alliance’s strategic plan 2016-2020, the HPSR community should also consider the recommendations of essential guiding documents such as “Sound Choices”, and reflect on how they may want to orient capacity strengthening for HPSR in the future.