Let’s face it: I am a great fan of Mission: Impossible. It started with the TV series (and you may be surprised to learn that the great Leonard Nimoy himself even played in some episodes), and continued with the movies as yes, I am the generation of teenage girls that fell in love with Tom Cruise in Top Gun (and hopefully got over it). Above all, I love the fact that these guys work for the IMF (aka Impossible Missions Force). I am just back from a great summer holiday, during which I was lucky enough to watch the latest sequel featuring Cruise’s unbelievable apnoea stunt and ready to start working again on a paper I am planning to publish and which refers to the Sustainable Development Goals related to medicines.
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 21st 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!