by Piot, Peter
So I said, “Let’s go for a study. Just a pilot project—just to look at feasibility.” If we could prove that the medication could be properly administrated and utilized in developing countries, then, I felt, the moral case for action would be almost unassailable. The board agreed. We called it the Drug Access Initiative, and worked with Uganda, Vietnam, Chile, and Côte d’Ivoire. With the help of Brian Elliott, an Irish former pharmaceutical manager with unparalleled experience in Africa, Awa Coll-Seck sent people to all four countries to set up the projects, which were all very different. For example, in Uganda we actually had to provide $150,000 to set up a company called Medical Access Ltd. to import antiretrovirals, because the pharma companies had no confidence in the Ugandan central pharmaceutical body. (The company is still thriving.) It all went very slowly, as there was no precedent to follow, and at the same time we had to convince pharmaceutical companies to lower their prices.
Under growing pressure from public opinion, which was starting to question the high profit margins for pharmaceuticals, Richard Sykes, the tough CEO of GlaxoWellcome (a company which by then produced two antiretrovirals), was the first to agree to some modest price reduction early in 1997, apparently taking his own managers by surprise. Finally, in December 1997 Dr. Peter Mugyenyi, a good-humored army doctor in Kampala who doesn’t take no for an answer, began treating his first patient at the Kampala “Joint Clinical Research Center,” where he saw patients in tents.
We were getting a 40 percent discount on the antiretrovirals for the Drug Access Initiative: they were costing $7200 per person per year. It was still stratospherically expensive for any developing nation: a start, but not a solution. But UNAIDS had started Africa’s first antiretroviral treatment program, together with a program in Congo Brazzaville assisted by the French Red Cross and later followed by numerous NGOs, in particular Médecins Sans Frontières.
At an AIDS conference in Abidjan, Côte d’Ivoire, in December 1997, President Jacques Chirac of France proposed an international fund to provide antiretroviral drugs in Africa. At a dinner over a grilled “poulet bicyclette” (as free-range chickens are called in Cote d’Ivoire) with Dr. Bernard Kouchner, the popular founder of Médecins Sans Frontières and passionate spokesperson for humanitarian causes, we discussed how this “International Therapeutic Solidarity Fund” announced by Chirac would function. But unfortunately France did not provide adequate funding, and other donors, apart from tiny Luxembourg, rejected the whole enterprise, which was way ahead of its time.
I intensified discussions with senior people in the pharmaceutical industry, at first via Ben Plumley, who was head of a program at GlaxoWellcome called Positive Action, which was trying to establish better relations with activist groups by, among other things, giving them grants. These were not easy discussions. Pharma executives were very suspicious about the UN, and concerned that we would undermine their patents. It was also not easy to get their attention. At the turn of the century over 90 percent of antiretroviral sales were from just five Western countries, and Africa was terra incognita for them. But I needed to work it out. No company was producing all three drugs necessary to treat HIV infection, so I wanted to put GlaxoWellcome in a room with people from Merck, which also had an antiretroviral drug and had been under heavy attack in the United States from activists because of its high price, and Bristol-Meyers Squibb. (There were no generic medications then: this was 1997/1998.) But because of antitrust law the companies didn’t want to be in same room with each other to discuss price. I don’t have a legal mind, but I always supposed that antitrust laws exist to prevent upward price fixing, not what we were trying to achieve, which was lower prices.
In the meantime I went several times to Brazil, which by 1998 had begun producing generic antiretrovirals at Farmanguinhos, a state-owned company in Rio de Janeiro. When I first visited them, it was clear that they were struggling with international standards of pharmaceutical manufacturing, but they soon solved these problems. The experience of Brazil’s AIDS treatment with locally produced generics then folded into the body of evidence that argued for differential pricing of brand-name drugs, as our negotiations progressed.
WHO explicitly did not want to be associated with our efforts. The experts at WHO’s Program on Essential Drugs thought it was foolish to introduce high-tech medication in developing countries when they were struggling to distribute basic drugs for malaria. And the drug manufacturers still solidly opposed the proposal for differential pricing. They claimed this was above all because compliance with treatment would be inadequate, and that might generate resistance. But they were also concerned that if they provided the drugs at discount in Africa, they might be re-exported, and then pop up at low cost in the United States and Europe, undermining their business.
By the end of 1998, the first results of our four pilot programs for antiretroviral treatment in developing countries were beginning to come in. We had them very rigorously evaluated by independent agencies: the US Centers for Disease Control and the French National Agency for AIDS Research. The conclusion was that compliance in the developing world could in many cases actually be better than in Europe and North America. People, even in Africa, absolutely could read watches and they could very clearly see that the drugs were keeping them alive, so they were strongly motivated to adhere to the protocols. With minimal investment in refurbishing local health systems and training medical personnel, even very sophisticated treatment could be made to work and was saving lives. The real problems were money—no donor wanted to fund—and logistics; in Côte d’Ivoire in particular frequent stock-outs lead to very dangerous treatment interruptions for patients. (I received alarming phone calls from angry AIDS activists from Abijan at all times of the day to have me fix this.) All this meant that in the first year only 4000 patients benefited from the initiative.
These pilot projects whisked away what had been the main argument of the pharmaceutical companies and donors: that there was no point in bringing down the price of treatment, because compliance was impossible. From that point on, their only arguments were economic, thus exposing a certain amount of what was perceived by many people as greed.
Then in 1999 small quantities of the first generic versions of antiretrovirals were imported into Uganda and Côte d’Ivoire from the Indian company CIPLA and Spanish Combino Pharma. Yusuf Hamied, the agent provocateur of the Indian generics industry, popped up on the world scene. Hamied is the white-haired CEO and main owner of CIPLA, a company in Mumbai founded by his father. Thanks to Indian patent law, he and others were able to build a solid pharmaceutical production capacity, imitating medicines still under patent, which would have been illegal in other countries. CIPLA is now the largest supplier of antiretrovirals in the world. (I saw their products in the remotest areas of Africa.) The appearance of these Indian companies was a game-changer for widespread HIV treatment. However, I also learned that simplistic views about the “good” generic producers and the “bad” propriety-based companies were wrong. The companies just employed different business models, and by definition generics would not exist without the originals.
This combination of activism and media attention, pressure from the UN, demonstration that HIV treatment was feasible in Africa, and the appearance of competition from good-quality generics, created a climate amenable to serious negotiations with the drug companies. I was struck by the ignorance of many of these executives about the developing world. I understood why—these were small markets for them—but I thought it was vital to our cause that we put an end to it. So we suggested trips, meetings with patients, tours of some of the better projects in Africa. Ken Weg, the president of Bristol-Myers Squibb, was I think particularly affected by this experience, as was Ray Gilmartin of Merck: I could feel that they were both struggling with the ethics of the situation, though some of the other pharma men were entirely impervious to any argument outside profit and shareholders.
The new head of the World Health Organization, Dr. Gro Harlem Brundtland, h
elped me with these talks, a major and very welcome shift in WHO’s position. And Kofi Annan became very proactive. He took on AIDS as a personal cause and went far beyond his “terms of reference,” if I may dip into UN-speak. He convened several meetings with pharmaceutical CEOs, the first one in Amsterdam in April 2001 and then in New York, followed by a private dinner at his residence. Preparing these meetings was my job, together with my UNAIDS colleagues. It was nerve-wracking, as the companies had patent and antitrust lawyers and experienced public affairs people, and we had none of that kind of support. At some moment of the Amsterdam meeting a lawyer even interrupted Annan, invoking antitrust law. I found that a key tactic was to get the CEOs to the table on their own, they then seemed more open to dialogue and could make unorthodox decisions.
UNAIDS came under quite a lot of attack during this process, which took a number of years. In 1999, when generic companies began to enter the market in a more significant way, some activists criticized UNAIDS for engaging only with the big pharmaceutical companies. I freely admit that we initially did have concerns about introducing generic drugs into the process. Their manufacturing was not always up to international standards, and the legal framework for using them was still shaky at best. Groups like Médecins Sans Frontières, Health GAP, and Jamie Love’s Knowledge Ecology International—which argued that patent rights make medicines more expensive, are therefore evil, and should be eliminated—had some valid points in an ideal world, but they were not dealing with the urgency of reality, nor with the fact that we would need new HIV drugs when the older ones lost their effectiveness, which was more or less unavoidable.
We needed to put aside differences for the common purpose of defeating AIDS right now, and so long as they agreed with some basic principles then any groups, from religious groups to industry leaders and the most passionate activists, were welcome, indeed needed, at the table. So if ActUp didn’t want to sit down with Evil Big Pharma, so be it, but Big Pharma was still invited, and we would continue to also deal with ActUp. (Perhaps that sounds opportunistic, but I remembered what Deng Xiao Ping said when he opened China up for capitalism: “No matter whether the cat is white or black, so long as it catches mice.” I wanted results.) And, actually, I do think that intellectual property is fundamentally needed as an incentive for innovation—although you can argue that its use for public goods like drugs and vaccines requires a clause that permits access by the poor. So on this point, which was very controversial at the time, I split somewhat from the AIDS activist movement. This was just another example where the chameleon came in: I needed to keep my eyes fixed on the goal, which was maximal access to treatment, ASAP.
What I proposed to industry was a new social contract: in return for reasonable profits in high-income markets and a monopoly on new products (in other words, functioning patents), the pharmaceutical industry would invest in R&D for much-needed new medication, and provide new essential drugs immediately at cost (plus a small margin) to developing countries, instead of waiting for their patents to expire. I felt strongly that the poor should not pay for innovations that benefit the whole world.
I became a regular participant of the annual World Economic Forum in Davos and became deputy chair for global health under Mark Foster, a brilliant executive of Accenture, who introduced me to numerous health care executives. Gro Brundtland and I took advantage of the opportunity to directly make our case for lower prices at the forum in January 2001. Gro, a former prime minister of Norway, was a highly respected figure in Davos circles. We saw many pharmaceutical executives. One meeting was in a snowed-in mountain hotel with Merck CEO Ray Gilmartin, accompanied by Vice President Jeff Sturchio, who was a central figure in our ongoing negotiations. David Nabarro, who had been instrumental in setting up UNAIDS and was Brundtland’s chief of staff, and Ben Plumley, ex-Glaxco staff and who was now working with me, also attended the meeting. We were hopeful, because of Merck’s history with river blindness elimination in West Africa. Gro and I made our usual points, and basically Gilmartin told us that his shareholders would never accept an agreement to give the company’s expensive new medication away at cost. While the Merck team disappeared in the snow, Gro and I looked at each other, and said “another waste of our time.” But we were determined to continue with our campaign; too many lives were at stake.
A few weeks later, Ray Gilmartin flew especially to Geneva to meet with Brundtland. At the same time, Ken Weg from Bristol-Myers Squibb called both of us. They both had the same proposal. They were ready to discuss prices and how to deliver the drugs in low-income countries. Our meetings in Davos paid off after all.
The companies wanted assurances against re-exportation of the cheaper medicines to high-income markets, and some guaranteed financing. My position was that we should base our notion of a fair price on the prices that Brazilian, and now also Thai, manufacturers were proposing for their generics, because they provided an indication of the actual cost of manufacturing the medication. Meanwhile, the IFPMA in Geneva, which represented the proprietary pharmaceutical industry, tried to undermine the process through very hard-line public statements on intellectual property and against tiered pricing. Industry was clearly no longer united, and that was an opportunity.
We worked very hard, in an exceptional joint effort with WHO, where Jonathan Mann’s old right arm Daniel Tarantola led the effort with Ben Plumley and my chief of staff, Julia Cleves. In mid-2000, our negotiations with the drug companies finally began to bear fruit. Five companies (Boehringer Ingelheim, Bristol-Myers Squibb, Hofman-La Roche, GlaxoWellcome, and Merck) agreed to quite significant cuts in the price of HIV drugs for regions severely affected by the AIDS epidemic. We launched the Accelerating Access Initiative in May 2000, not alone as in 1997 with the Drug Access Initiative, but this time with WHO, UNICEF, the UN Population Fund UNFPA, and the World Bank. It was a paradigm shift, although the drugs, even priced at $1200 per patient per year—a 90 percent reduction from the price asked in Europe—remained excessively expensive for most developing countries.
The deal got major media coverage worldwide, and the expectations were so high it was frightening. Our big gap remained the absence of a funding mechanism: even with the price discounted, someone still had to pay. My bet was that with drastically reduced prices, we could now convince donors to pay for treatment. I learned once more that no good deed remains unpunished. At the World Health Assembly in Geneva, the same month of May 2000, the African ministers of health, led by the always confrontational South African Minister Manto Tshabalala-Msimang, rejected the initiative and objected that we had not consulted them—as if we could have negotiated price reductions with 45 ministers in the room. We clearly had a major communication challenge on our hands. I was double-gutted when Bernard Pécoul of Médecins Sans Frontières compared the project to “an elephant giving birth to a mouse.”
The immediate impact was disappointing. In the absence of international funding the uptake was poor. Senegal, and then Uganda and Rwanda were the first countries to use the mechanism. Access to treatment improved very rapidly in Senegal, but the country did not have as many people in need of treatment as the other two. We had made a mistake in accepting that the final price negotiations had to happen country by country, as industry wanted to keep control over the sensitive cost structure of their drugs. I sent battle-scarred staff members such as Julian Fleet, Jos Perriens (who had worked with me in Kinshasa), and Badara Sam to assist interested countries, and we shared very informally all the confidential price information we could get, so that people negotiating in country X would know what country Y was paying, a major asset in bargaining.
The European Commission then moved in with its own initiative, driven by Lieve Fransen, the Belgian epidemiologist who had worked with me in Kenya and Antwerp. We worked with them toward a very unusual round table in September 2000, which brought the Big Pharma CEOs together in a room with Yusuf Hamied and other generics manufacturers. Generics were no longer taboo. I was amazed that the chair of
the European Commission, Romani Prodi, was present throughout this unprecedented half-day meeting; he was accompanied by several of his commissioners, including Pascal Lamy, a remarkable representative of French Cartesian thinking and one of the sharpest brains I have met, who later became head of the World Trade Organization. All companies present agreed to the call for differential pricing, asking only for better predictability of demand for their drugs in order to plan production, guarantees against re-exportation of the cheaper drugs into high-income markets, and price protection in high-income countries. If European countries were to ask for the same price reductions as developing countries, then clearly the whole deal would collapse.
Despite all these meetings, I also continued to travel across the world to mobilize support and money. Still too few patients in Africa had access to treatment. We set up a system with WHO and Médecins Sans Frontières to monitor the price of antiretroviral drugs globally. It was a very worthwhile, but also very frustrating, exercise: in general there is not much openness about prices from either side of the transaction. We constantly had to intervene. For example, in December 2000, Glaxo attempted to block access to generic drugs in Ghana, even though the price of CIPLA’s generic was only slightly lower than Glaxo’s medication: $1.74 per day versus $2. In some low- and middle-income countries, in particular in Central America, the Middle East and Eastern Europe, prices for HIV drugs were even higher than in the United States often because of the middlemen. Thus in Uganda we found that in 2001 a drug called Sequinavir cost 17 percent more than in the United States. And there was still the pending lawsuit by pharmaceutical companies against the government of South Africa’s imports of generics. As long as that was not resolved, we could not be confident that they were committed to affordable treatment in developing countries.