My name is Jean-Hervé Bradol, and I’m a medical doctor. I’ve been working with Médecins Sans Frontières long enough to have been the Director of Operations in Paris when the Campaign for Access to Essential Medicines was launched in 1999, and as such I was a member of its first Steering Committee. I would like to take this opportunity to honour the memory of the Steering Committee colleagues with whom I worked at the time that are no longer with us. I am thinking, in particular, of Francine Matthys, Marcel Van Soest, and obviously Jacques Pinel. I would also like to take this opportunity to salute the other members who are still with us, people like Rafa Vilasanjuan and Jean-Marie Kindermans, with whom I worked for years on the issue of access to medicines.

1. Initial diagnosis and origins of the Campaign

So how did MSF come to be involved in this issue? For reasons both good and not so good. For reasons both operational and institutional. It’s not that institutional reasons are, in and of themselves, bad, but they are a little different. In the mid-1990s, our Cold War “refugee” programmes were in the process of closing, one after another. We had emerged from a global context of East-West confrontation, and the processes by which refugees were being produced were changing; you could say that MSF – and MSF France, in particular – was losing part of its operational “market” and so was looking for other areas of involvement. Responding to infectious diseases, both epidemic and endemic, was an obvious choice, because there were situations in the field that were starting to become really critical. One problem in particular was that there were some medicines that would have been very useful to us but were inaccessible due to very high prices. I’m thinking about antibiotics like second generation quinolones – Bayer’s ciprofloxacin, for example. Those very high prices were obviously often locked in by patents, by intellectual property rules. For years there was little to no generic production for certain types of drugs, so they remained very expensive, and that prevented us from using them. At that time, we needed ciprofloxacin throughout the Great Lakes region and East Africa to deal with huge outbreaks of infectious bloody diarrhoea caused by a bacterium susceptible only to second generation quinolones. Patients were dying because we didn’t have access to those types of drugs. In addition, new drugs that could have been produced through research weren’t being developed; there was what we call a fatal imbalance – that is that most, say 90%, of the research energy and funding was going to diseases affecting rich countries, with a morbid competition between pharmaceutical companies. They were all trying to fill the same niches by copying their competitors’ reference drugs. I’m thinking of the many copies of non-steroidal anti-inflammatory drugs that, even worse, turned out in the end to be toxic. So, as we said at the time, there was no research at all happening for 90% of the world’s population. Sometimes we were able to take advantage of veterinary research. Ivermectin, for example – which was a very useful drug in many fields at the time, in particular for river blindness, or onchocerciasis. Ivermectin was originally reserved for veterinary use and was donated by the manufacturer, Merck, in 1987. I’m also thinking of how we found new uses for older products – for example, using oily chloramphenicol to treat meningitis cases during outbreaks.

We also had to deal with the fact that useful, effective drugs were starting to disappear. For lack of a big enough market they were no longer being produced or distributed. With oily chloramphenicol, we realised at the time that the only manufacturer – who, if I remember correctly, was located in Lebanon – was in the process of halting production. The drug was therefore going to vanish at a time when it was the main antibiotic for controlling bacterial meningitis outbreaks. It was the same for the drugs used against sleeping sickness, melarsoprol and lomidine, which were also starting to disappear. The pharmaceutical company that distributed them didn’t have a big enough market to continue. When stocks were being liquidated in the mid-1990s, the only way the pharmaceutical companies would agree to continue providing the drugs for sleeping sickness was if our logistics hub would take charge of the worldwide distribution.

There were also essential medicines that had become ineffective but weren’t being replaced. During the 1990s and early 2000s there was a resurgence of malaria outbreaks, especially in Africa – in Sudan, Kenya, Ethiopia, and Burundi. The plasmodium falciparum responsible for the deadliest forms of malaria had become resistant to older drugs like chloroquine and Fansidar in a very high percentage of cases (one or two out of every three cases, depending on the situation). Yet no other treatment options were added to African national protocols until the mid-2000s. The same was true for antibiotics.We went from a world where co-trimoxazole – known by its brand name, Bactrim – was used for pretty much everything, from head to toe, for all types of infections, to falling victim to a lack of basic antibiotics once many organisms had developed resistance to co-trimoxazole. We found ourselves in a therapeutic stalemate for situations as simple as treating cystitis, i.e., bladder infections, in women.

There were also situations where medications that were essential were highly toxic and also losing their effectiveness. That was the case with the arsenic-based agents for sleeping sickness. Although the side effects were pretty dreadful, there were no other options at the time. We were killing from two to ten percent of our stage 2 sleeping sickness patients with melarsoprol. It was especially depressing in northern Uganda, when we – myself included – would inject dozens or even hundreds of patients with this type of drug and kill some percentage of them. And to make matters worse, as time went on the parasite – the trypanosome – became resistant to these arsenic derivatives, so the cost-benefit ratio of those highly toxic treatments was becoming worse and worse.

So, those were all situations we were starting to see at that time, and that we communicated to the outside world for the first time on MSF’s 25th anniversary (1996), at a medical symposium on the response to epidemics and infectious diseases. For the symposium’s fourth session, we invited Patrice Trouiller, a pharmacist from the CHU (University Hospital) de Grenoble, to explain the mechanisms at work in creating the shortages that I have just summarised briefly.

2. Determinants of the mid-1990s pharmaceutical landscape

When preparing this presentation, I tried to understand the major determinants that shaped this situation. I see four of them.

a. The first determinant is that infectious diseases are caused by living organisms. In that sense they are special diseases; viruses, fungi, bacteria, and parasites adapt to the therapeutic response to them and develop resistance. In the 1990s there were emerging diseases – HIV, obviously, but also others, like Ebola. In addition, diseases that we had believed to be under control, like TB and dengue, were re-emerging. It is often said that it was a time when we thought we could put an end to infectious diseases. In reality, throughout history there have been people determined to end these diseases – not just for health and medical reasons, but for political and economic ones as well. Despite the remarkable triumph over smallpox, there have always been people who realised that victory in this area would be hard to achieve (again, because we are attacking living organisms that learn how to defend themselves). In fact, the people who led the effort to eradicate smallpox worldwide, who were then tasked by the World Health Assembly with determining whether such eradication would be reproducible for other infections and other endemic outbreaks, answered “no”. They felt that smallpox had unique characteristics without which a victory in the form of eradication on a global scale would be hard to imagine. Those characteristics included smallpox’s very dramatic early clinical symptoms, the human-only reservoir for the virus, the existence of a particularly effective vaccine, and injection techniques well-suited to mass vaccination campaigns. The work’s authors concluded that there was little chance of finding those conditions again and so of being able to eradicate other infectious diseases. Meanwhile, in the 1990s some very powerful institutions – I’m talking about the United States National Academy of Medicine (with regard to medicine and health), and the CIA (with regard to public safety) – produced a report on the public safety threat posed by the HIV epidemic. There was an awakening regarding the urgency of re-energizing the fight against infectious diseases.

b. The second determinant was that at a time when there was little interest in finding new treatments for infectious diseases, and when the situation I described in the introduction was allowed to set in, what were we doing? We believed then in a big idea, in a definitive solution to health and medical inequality – the doctrine of health development. I think that as that period recedes further and further into the past it’s hard to conceive of what that might have been, but it was really very ambitious. At the 1978 Alma-Ata conference, the various healthcare actors present set a goal of “health for all by the year 2000”. A list of diseases and populations was prioritised according to epidemiological burden and possibilities for prevention and treatment, and a list of essential medicines was drawn up. The term “essential medicines” refers to the WHO’s effort to create a standardised list of medicines and the protocols for using them, which was a truly remarkable step forward. At the time, in France, the official dictionary of medicines, the VIDAL – the big red dictionary that many of us used – contained six thousand references. The WHO’s list of essential medicines has only a few hundred. So it was a much-welcome rationalisation that had a tangible, practical impact on prescription quality. There was also the aim of immunisation for all of the world’s children with the same six vaccines, which began in 1975 and expanded significantly in the 1980s. While MSF initially participated in that in some countries, such as Yemen, we soon realised we weren’t the best organisation for those types of development programmes. The experience did, however, help us incorporate and learn how to manage mass vaccination campaigns – something that might be useful in emergencies. The human resources most important to the health development objective were health workers – that is, health technicians, rather than nurses or doctors. Financing for the worldwide effort to reduce inequality came both from public funds and cost recovery. It was a time when governmental authorities no longer wanted to finance social and healthcare spending, so users were asked to cover some or all of the costs – something they had trouble doing in health programmes where patients were only half convinced of the utility. By the mid-1990s, that “health utopia”, as Rony Brauman put it, yielded both valuable working tools and frequent setbacks and failures. There were, for example, health systems where ineffective malaria drugs were being prescribed without any serious diagnosis. Most prescriptions for infectious diseases called for drugs that had become ineffective as resistance developed. So, there’s your answer: if we didn’t take an interest in the lack of health products and medicines effective against infections sooner, it was because we were busy with other things. We were busy participating in a massive development effort that was ultimately, at least in part, an illusion. We still believed in it, I’d say, when we were working in the field in the ‘80s and ‘90s. Some teams continued to believe in it into the early 2000s. I’m thinking about MSF teams in the DRC and Sierra Leone, who put respect for the standardisation sought by the national health authorities and the WHO above adopting new malaria treatment protocols. Even when we tried – like during the 2002 malaria epidemic in Burundi – to request exemptions from standardised protocols because of a massive deadly outbreak and the ineffectiveness of the current treatments, we were refused not just by the governments and international organisations like the WHO, but by our own colleagues as well. We faced a lot of reluctance from the latter because they felt that it side-tracked them from their primary goal, which was finding the solution to health inequality on a global scale, which was supposed to be health development in all its various components.

c. The third determinant was the triumph of liberalism and globalisation in the late ‘80s and early ‘90s. With the Cold War over, one economic system had achieved total victory over the other and there was a kind of euphoria among the international economic organisations. I’m thinking of the International Monetary Fund and World Bank’s “structural adjustment” policies, which bled entire sectors dry – healthcare, social assistance, education, and culture. It was felt that private initiatives should cover the expenditures in these sectors. All government and national organisation budgets for those sectors were scaled back, which was catastrophic for hospitals and clinics. Jean-Pierre Olivier de Sardan and Yannick Jaffré wrote a book about the impacts of those policies, entitled Une médecine inhospitalière, which describes these phenomena in West Africa. Those policies could also be seen in the globalisation of intellectual property rules for the pharmaceutical industry. The mechanisms that enabled generic drug production irrespective of patents were ending. We were, however, able to make generic antiretrovirals with some large Indian generics companies – for example CIPLA, with whom we had a very productive partnership in this area. All the opportunities, the exemptions, the small openings were coming to an end, as some powerful governments and multinational pharmaceutical companies were trying to globalise the intellectual property rules. It was a completely strategic objective for them, as U.S. Trade Representative Robert Zoellick said at the time, when ordering forty or so pharmaceutical companies suing the government of South Africa for failure to respect intellectual property rights to stop. He told them, if you do this you will create so much more hostility in the world that we won’t be able to globalise intellectual property rights. They had to agree to be a bit flexible with a few drugs, in order to achieve their aim of generalising the intellectual property rules for the pharmaceutical trade. It was also a time of simplistic ideas about public health and its economy. I view three as having acted as ideological drivers.

The first was that an ounce of prevention is worth a pound of cure. That old adage was singularly disproven by the experience with HIV, where there was no conflict between curing the disease with a curative treatment and preventing it, as had previously been the case with other diseases. Thus far, with HIV, looking for a treatment that, if not curative, is at least suspensory, has been a good idea because the attempt to halt disease progression has in many cases also interrupted virus transmission – between sex partners, in particular.

Another big idea that often slowed public health progress was that it’s better to be done with it once and for all. That’s the eradication fantasy. If national and international health authorities were to be believed, measles should have been eradicated by 2015. The corollary of that idea is that you must choose areas where you can envisage “being done with something once and for all”, and that those should take precedence.

The last big idea was that it’s better to limit health spending. Free-market thinking likens such spending to social assistance, which supposedly makes people dependent and lazy. But health care budgets had to be increased, for example, to treat malaria in sub-Saharan Africa by switching from chloroquine and Fansidar to a new generation of drugs, the artemisinin-based combination therapies. The cost of one treatment rose from a few dozen cents to a few euros. It took time to accept that increasing malaria-fighting budgets was essential. Bigger budgets were needed not just for the drug itself, but also for pairing effective treatment with effective diagnosis, which meant paying for rapid diagnostic tests. And then – even though it obviously couldn’t replace treatment – prevention (like distributing insecticide-treated mosquito nets) was still useful. All of that added to the budgets that had to be allocated to medical activities and public health, in a context where those expenditures were deemed harmful to the economy and the prevailing economic model.

d. The final determinant that I observed with regard to access to medicines was the negligence, and subsequent mobilisation, of the healthcare actors. In my opinion, we ourselves were our own biggest enemy to ensuring an array of effective medicines for the principal treatment indications of our medical practice. I give this example fairly often. In 2000, all the MSF medical directors issued a resolution that was published and sent to all field teams in three languages (English, French, and Spanish), where they claimed that antiretroviral use wouldn’t be possible in Africa – maybe not forever, but in the immediate future – despite the fact that sub-Saharan Africa was where the HIV pandemic was growing the fastest. The situation in southern and central Africa was dire. I’m just summarising, but you can see that the biggest enemy was us, in that situation. Many of us resigned ourselves to the shortage by saying “we aren’t working for the short term anyway, we’re working toward a comprehensive solution” – that is, the global health development plan. But at the same time, that negligence by the usual actors was accompanied by new forms of mobilisation and new alliances with new actors that made an enormous contribution. To fight HIV, we (it couldn’t hurt just this once) built and maintained productive relationships with patient, researcher, practitioner, and human rights organisations – LGBT rights organisations, in particular. We also renewed our alliances with people and organisations that had historically worked on access to medicines issues. I’m thinking of Ellen ’t Hoen, my eminent colleague from Health Action International – people who were working on these issues and who educated us about the mechanisms that lead to shortages. This determinant, which I would call subjective – our own beliefs, attitudes, and alliances – functioned both as a set of obstacles and advances. With sleeping sickness, for example, once we had alternatives to arsenic-based treatments it still took a huge amount of pressure to get our teams in Angola to accept them. They didn’t have much problem with prescribing melarsoprol, even though they killed some of their patients while trying to cure them of the parasitic infection. But again, we also got the opportunity to meet new partners who taught us how to advocate.

3. Concluding remarks

To finish, I’m going to offer a few points designed to stimulate reflection by mentioning some of the comments made at the time. I remember that when the Access Campaign’s sponsors and creators came to present it to the Board of Directors in Paris, some board members remarked that perhaps it would be better to talk about “neglected patients” than about “neglected diseases”. I think that intuition was a good one. Neglected patients and countries are one thing, but we don’t often think about the fact that, in absolute numbers, most of the world’s poor live in so-called “middle” countries in terms of income and economics. Members of the middle class can have very little access to the distribution networks for drugs that are absolutely essential to their lives and their survival. I’m thinking of cancer drugs right now. When we question our fellow doctors in middle-income countries, they all report how difficult it is – even when they have the budget for it – to access cancer drugs. I’m also thinking of specific patient populations for which we’ve always had to make a special effort – like drug users, where access-to-care issues due to their social situation are a more important consideration than anything disease-related. The same is true for people who engage in stigmatised sexual practices, including sex work, for whom we really have to mobilise because they often have significant health problems. It would be better to identify them by their social situation and the discrimination they face than as people with neglected diseases.

MSF’s Access Campaign still has some blind spots:

- Criminality in the pharmaceutical trade (poor quality, trafficking): The big pharmaceutical companies understand this well, since they play the “white knight” in this area.

- Drug safety: There’s a problem with liability – legal liability in case of an accident with the drugs. During the COVID-19 epidemic, the big pharmaceutical companies forced countries and private operators like us to assume legal liability in case of accidents with some of their products. How to respond? That’s a question we’re going to have to drill down into in the future, though this isn’t a new problem. During the H1N1 epidemic in 2010, countries like Poland didn’t buy any vaccines because they refused to assume liability in case of serious accidents.

- “Humanitarian marketing”: There have been efforts to develop certain products. Some products, however, need more social and political marketing. I’m thinking of products that haven’t been used enough – like Epicentre’s Africa-specific rotavirus vaccine, newer generation TB drugs, and therapeutic foods for malnutrition.

I’m going to end with the Campaign for Access to Essential Medicines itself. We created a new kind of institution, a totally worthwhile, productive innovation in the Médecins Sans Frontières universe. But it poses a problem that isn’t new – is this a never-ending campaign? Because a campaign is understood as something that’s time-limited, towards a specific objective. I believe that the people who started the campaign were thinking about a period of a few years – four or five years – which for many was the 2000-2005 Campaign. That ended long ago, and it’s impossible to have a permanent ongoing campaign without becoming a political actor proposing comprehensive, partisan solutions. One of the difficulties in how the campaign has evolved has been in accepting that we can’t have institutional sustainability without relying on an ideology that has little to do with addressing concrete problems – for which in many cases we have now found pragmatic solutions. Yet I think that we’re shifting in the direction of ideological activity; we saw this with COVID, where according to MSF and the Access Campaign the lack of vaccines in the Global South was caused by intellectual property rules. That claim, as it turned out, was totally unfounded. Know-how, not patents, was the most critical factor. Fairly early on, Moderna offered not to protect the patents for its COVID vaccine. MSF and the Access Campaign’s quasi-automatic reflex was to blame intellectual property, while a different mechanism was at work in that case. And then there was the almost automatic reaction that if a new product comes out, the whole world, the poorest – Africans, in particular – should get it on a large scale, unless they only needed it for limited categories of at-risk people. For once, a demographic inequality was working in their favour; their population is, on average, much younger than that of Western Europe or North America, which meant that the COVID epidemic in those countries took a completely different form and was far less severe. We would hear MSF and its Access Campaign saying in the media that it should only take a year to vaccinate 70% of the entire world with two doses. That was a ridiculous proposition, as it was neither desirable nor feasible. Furthermore, no one was asking the people in poor countries their opinion, despite the fact that many were reluctant to get vaccinated. When you’re trapped in an ideology, in automatic thinking, it’s hard to recognise and admit those kinds of errors. So, I’m ending on a slightly controversial note. But I would justify that by the fact that for MSF and the Access Campaign, controversy has always been a driving force.