Global Policy Forum

Apartheid of pharmacology

By Martine Bulard *

Twenty-two million people in Africa are seropositive - 65% of all the people infected with the Aids virus world wide. South Africa, which is particularly badly affected, has made fighting the scourge a priority. But rather than help, in their determination to protect their patents, the pharmaceutical laboratories are putting treatment beyond the reach of the poorest patients and countries.

Sleeping sickness, which is transmitted by the tsetse fly, is making a comeback, killing 150,000 people every year, especially in Africa. There is a treatment, eflornithine (Ornidyl), developed by the American firm Merell Dow in 1985. Costing a small fortune, it was beyond the reach of those most seriously affected and was subsequently abandoned. Having "inherited" the drug when it took the company over, Hoechst Marion Roussel has finally agreed to transfer marketing rights to the World Health Organisation (WHO). But the WHO lacks the resources to manufacture it. After three years of talks, the French humanitarian agency Médecins sans frontií¨res (MSF), together with other non-governmental organisations, is hoping that the product will be available, in some places at least, at the very start of this year. But if it is to continue to be available, a sponsor will have to be found. Microsoft Chairman Bill Gates is a possible candidate.

The remedy for bacterial meningitis, which is particularly prevalent in the countries of the South, has not been so lucky. Doctors saw chloramphenicol in oil as having the advantage of being both cheap and easy to use. In 1995 Roussel Uclaf (which merged with the Hoechst group in 1997 to form HMR) stopped making it. Initially, the International Development Association got it transferred to a laboratory in Malta. But now the money has run out.

The molecule to treat leishmaniosis, a common parasitic disease in Africa resulting in very severe skin lesions or death, is no more profitable. It exists in the laboratory, but has not gone into production because there is no guarantee of a "return on the investment". The list of molecules discovered but which got no further than the laboratory and of useful medicines abandoned is a long one. Dr Bernard Pécoul, MSF's drugs project coordinator, notes that, of 1,223 molecules placed on the market between 1975 and 1997, only 13 are aimed specifically at tropical diseases. And only five are the outcome of veterinary research (1).

Now that many diseases, such as malaria, sleeping sickness or tuberculosis, that had been thought to have been conquered are coming back in force, more virulent than before, the old medicines are no longer always effective, since more and more bacilli are showing multiple resistance, whilst the cost of new remedies is exorbitant. As a result, no serious research is being carried out into a vaccine to replace the good old BCG, even though eight million more people are infected every year. Of these, the number of patients - or should we say customers? -- able to pay is estimated by MSF at 400,000, way below the threshold required to launch an investment. Somewhere in the world, someone is dying of tuberculosis every ten seconds (2).

For a medicine to be produced commercially, not only does it need a large market (three quarters of the population), but it must also make money. A lot of money. As quickly as possible. As World Health Organisation (WHO) Director General Dr Gro Harlem Brundtland herself says, "More than a billion fellow human beings have been left behind in the health revolution" (3).

In fact four fifths of world health expenditure goes on one fifth of the world population. While drug sales in North America and, to a lesser extent, Europe, mushroomed between 1993 and 1999, in the countries of Africa and Asia (excluding Japan) they declined (see chart). In the case of Aids, the picture is even more devastating: 92% of the world population have to make do with only 8% of total expenditure.

"If the rich countries do nothing," Professor Franí§ois Bricaire, head of the parasitology and tropical diseases department of the Pitié-Salpíªtrií¨re Hospital in Paris, warns, "this human imbalance will result in an explosion. People know that, on the one hand, there are medicines to conquer the disease and that, on the other, they are denied them for lack of resources." For example, triple therapy (the combination of three types of antiretroviral drugs), which has cut the Aids mortality rate by 60% in the West, is virtually inaccessible in the countries of the South.

"We get patients coming to us from Africa who have saved every penny to pay for their treatment," Professor Bricaire adds. "We get them back on their feet knowing full well that most of them will not be able to afford to continue their treatment once they return home. And then there are those who arrive illegally. We cannot just abandon them to their fate, so we muddle through, but it is too random to be satisfactory."

Drugs are not everyday products

According to the World Bank, the number of Aids-related deaths in Africa will soon exceed the 20 million victims of the plague that ravaged Europe between 1347 and 1351 (4). With the simple difference that in those days they did not know how to handle the crisis. Today science is capable of dealing with epidemics. Many try to conceal this reality by highlighting the lack of a reliable health infrastructure in those countries.

They say that some long-term treatments like triple therapies against Aids would be impossible there, or even dangerous. The obstacles are real enough: in some countries, wars and population movements have destroyed the health care system; in others, the policies imposed by the International Monetary Fund and the World Bank have had much the same result by requiring drastic public expenditure cuts.

It is ironic to see the same people who helped to dismantle the health-care structures turning down emergency programmes on the strength of those systems' very shortcomings. Not only could health care networks be rebuilt, but there are already premises and staff (local and expatriate doctors and nurses) qualified to treat conventional infectious diseases and start long-term treatments for Aids. Provided they have access to the latest medicines at affordable prices.

The pharmaceutical industry does not seem to be about to turn over a new leaf. National Pharmaceutical Industry Association director-general Bernard Lemoine does not hide his annoyance at the campaign being waged on this issue. He stresses the positive things being done by the laboratories: temporary price reductions, donation of unused molecules, grants to foundations. But his conclusion is nevertheless final: "I don't see why special effort should be demanded from the pharmaceutical industry. Nobody asks Renault to give cars to people who haven't got one." But that is just it: drugs are not everyday products.

Not only do the pharmaceuticals companies set their own prices and select the markets that will push their share prices up, but they oppose every outside initiative. Before the first half of 1998 Thailand had only one drug, fluconazole, to treat cryptococcal meningitis, a fatal disease often associated with Aids; it was manufactured locally by the American laboratory Pfizer under the name Triflucan. It was effective, but extremely expensive: 12,000 bahts (around $330) for a pack of 50 tablets. For a patient starting treatment, that meant a monthly outlay of 15,000 bahts, one and a half times an executive's salary. Finally, two Thai companies managed to put on sale an equivalent product for 4,000 to 4,500 bahts a pack. Still too expensive for much of the population, but much more affordable than Triflucan. Six months later sales were banned: alerted by Pfizer, the United States government had threatened the Thai authorities that it would impose a duty on their main exports (timber, jewellery, microprocessors) if they did not stop making fluconazole.

South Africa almost suffered the same fate. In 1997 the government passed some health laws allowing local firms to produce treatments for Aids or to import them bypassing the big corporations' patents. At once the big American pharmaceutical companies, some of which have subsidiaries in the Cape, complained, then pressed their government to take reprisals of the same kind as inflicted on Thailand. Vice-president Al Gore, head of the US-South Africa Binational Commission, took the matter in hand himself.

As soon as the confrontation began, the Aids organisations (Act Up-New York) and James Love and Ralph Nader's Consumer Project on Technology began lobbying the US leadership. Gore was unable to hold a single public meeting for the presidential election without being questioned on the subject. This campaign, coupled with the South African government's tenacity, resulted in the Clinton administration abandoning all proceedings and retaliatory measures in September. The laboratories rushed to withdraw their complaints. True, it will probably be some time before South Africa produces its first generic medicine, but the first battle has been won.

To measure the scale of the victory, we must look at the changes made to the world trade rules since the World Trade Organisation (WTO) was set up (5). Up until 1994 every country was free to make its own health policy and produce generic medicines without waiting for the patent to fall into the public domain. India, Egypt and Argentina, for example, were able to pursue a policy of import substitution and create a local pharmaceutical industry.

Since 1994, the members of the WTO have had to submit to the so-called Trips agreements on trade-related aspects of intellectual property rights. Under this agreement it is, in general, no longer possible to manufacture a drug or buy it abroad without the permission (granted in return for payment of royalties) of the owner of the invention, who holds this power for 20 years. As a result of pressure from countries like Spain and Canada (6), however, the Trips do contain exception clauses: in the event of a medical emergency or hindrances to competition (inventor's refusal to sell or excessively high prices), every government is entitled to have recourse to "compulsory licences" and parallel imports. Compulsory licences allow a product to be manufactured without the inventor's consent, while parallel imports allow it to be bought wherever it is sold the cheapest.

South Africa, where according to the WHO one adult in six is seropositive, is an obvious case of medical emergency. The big pharmaceuticals corporations know that. But, as Pharmaceutical Research and Manufacturers of America (PhRMA) spokesman Jeffrey Trewhitt bitterly comments, these South African laws "could set a very, very bad precedent that could undermine legitimate patent protection around the world. The potential harm from these recent developments can be expected to reach into many other developing countries" (7).

Furthermore, all the emergent nations are subject to unbelievable pressures. Under WTO rules, India, where only one third of the population has access to drugs, should abandon price controls and the production of generic medicines. It is easy to see that this would result in small firms closing down and even fewer people having access to medical care. Yet the industry journal Pharmaceutiques says that "the reforms and the liberalisation that are under way are opening up new prospects for pharmaceutical laboratories" (8).

It is certainly too early to draw detailed lessons from the Trips agreements. But we already know the damage that was caused when the countries of Latin America were forced to deregulate in 1988. According to the WHO, drug prices escalated by 44% in Mexico, 24% in Brazil and 16.6% in Argentina in the space of four years.

But the pharmaceutical lobbies are hoping to use the WTO to get all exceptions to patent rights abolished. At the same time, they want greater access, without cost and without constraint, to the plant life of the developing countries, since knowledge of their genomes is one of the keys to future medicines. In other words, they want complete control over the raw materials and ever tighter protection for the discoveries made from those plants, making them inaccessible to the countries they came from (9).

In addition patents are being filed further and further upstream, which, Professor Axel Kahn, former chairman of the French National Consultative Committee on Ethics, explains, is "a considerable handicap on freedom to create". Until recently, he argues, "a distinction was made between knowledge that is discovered and belongs to us all and products or processes that are invented and can be patented" (10). Protecting earlier reduces the scope of common knowledge. At present, there is five to ten times more information on genomes in private, limited access, data banks that have to be paid for than is freely accessible in the public domain. As a result, a number of American doctors and researchers say in an open letter, the use of patents or the exorbitant cost of licences to prevent doctors and medical laboratories from conducting genetic tests is restricting access to care, lowering its quality and pushing up costs unreasonably (11).

We are moving towards a situation where a handful of firms have a monopoly on life and have seized control of genetic diversity. There is a great danger that the rich countries will officially become a technological and financial directorate, a sort of "G8" for drugs, deciding everything, from the level of research to whether or not a particular product will be launched. That would make the imbalances even worse: the developed countries, with plenty of money to spend, would have the latest treatments, very expensive and protected by intellectual property rights. The others could benefit from them when the patent rights were exhausted - 20 years and several hundred thousand deaths later.

Non-governmental organisations, associations of people suffering from various diseases, doctors and researchers are mobilising against these dangers. If they differ on strategy, all are agreed that at the very least the exceptions provided for in the current Trips agreements must be preserved in the millennium round talks. This basic minimum could, MSF suggests, give them time to get a "health exception", just as there is already a "cultural exception". Patent law cannot be placed above humanity's basic needs. It would be perfectly sensible to decide that human genome and biodiversity research should be "global public goods". Monuments like the Angkor Wat temple or cities such as Venice are considered part of human heritage. Why not human genetics? Likewise, a stop must be put to the plundering of the third world: not only should a fee be paid for using plants originating in those countries, but they should all be guaranteed the benefit of treatments developed from those plants.

Without waiting for that, how can we fight the epidemics that are devastating the peoples of the poor countries? Prices could be cut quickly to make drugs accessible without jeopardising the financial health of the pharmaceuticals corporations: those based in France, for example, spend nearly as much on advertising and promotion as on research: 11.3% as against 14% of turnover respectively (12).

German Velásquez, Sara Bennett and Jonathan Quick, who have been studying health care systems for the WHO for a long time, say that, unlike the rest of health care, the pharmaceuticals sector is experiencing serious problems owing to the lack of competition (13). This has an effect on prices. In fact two thirds of the world market are in the hands of about 20 large groups. And concentration is proceeding apace, as evidenced by the merger of HMR and Rhí´ne Poulenc, or the current link-up between Switzerland's Novartis and US giant Monsanto. Of the 25 drugs most widely sold, 20 are American. There is more or less a single world price, based on those charged in the US, which are among the highest in the world. Some, like Dr Pécoul, propose that a tax should therefore be levied on the pharmaceuticals companies' profits, the proceeds of which would go into a fund to pay for research into tropical diseases and the production of essential medicines.

Research hampered by patents

While the pharmaceuticals groups carry a tremendous responsibility, international organisations and governments must not be let off the hook. France, at least, has shown some signs of action: it has taken part in the United Nations Programme on HIV/Aids (UNAids); it was behind the creation of the International Therapeutic Solidarity Fund, which has brought a lot of hope to the poorer countries. But these programmes have come to a standstill. France has thrown in the towel, Europe is doing nothing and the US refuses to take part in most collective actions of any size.

For its part the WHO is now supporting countries making use of "compulsory licences", but it is still far behind what is needed. It remains prisoner to an opaque method of operating and an outdated view of its role. This hampers its ability to innovate and formulate new objectives for world health. Of course the lack of funding is just as crucial. But it would be possible to design emergency programmes making drugs available to health care professionals in the poor countries at cost price or less. The difference would be paid by the pharmaceuticals companies, the governments of the countries concerned and by the developed countries. After all, such a model was adopted in the 1950s and 1960s to fight smallpox, which has been eradicated since 1977.

"Financial prudence is not the real enemy," Nobel Prize-winning economist Amartya Sen explains, but "the use of public resources for purposes where the social benefits are very far from clear, such as the massive expenses that now go into the military in one poor country after another. It is an indication of the topsy-turvy world in which we live that the doctor, the schoolteacher or the nurse feels more threatened by financial conservatism than does the general and the air marshall" (14). And he adds: "the price of inaction and apathy can be illness and death".

(1) Bernard Pécoul, Pierre Chirac, Patrice Trouille, Jacques Pinel, "Access To Essential Drugs In Poor Countries. A Lost Battle?", Journal of the American Medical Association, Chicago, vol. 281, 27 January 1997. See also the dossier in the journal Messages, no. 102, January-February 1999, published by Médecins sans frontií¨res, 16 rue Saint Sabin, 75011 Paris. http//www.msf.org/Le Monde diplomatique

(2) Figures provided by the WHO. Note that 98.8% of victims live in third world countries.

(3) Dr Gro Harlem Brundtland, statement to the 52nd world health assembly, "Looking ahead for WHO after a year of change", World Health Report, WHO, Geneva, March 1999.

(4) "Intensifying action against HIV/AIDS in Africa", World Bank - Africa Region, Geneva, June 1999.

(5) See Le Monde diplomatique, November 1999. See also André Ferron, Philippe Herzog, Bernard Marx, "Pour un contrí´le social du cycle du Millénaire í  l'OMC", L'Option de Confrontations, Montreuil, November 1999.

(6) Spain did not fully recognise the patenting system for drugs until 1992, Canada in 1993.

(7) Quoted by Mike McKee, "Tripping over Trips", IP Magazine, San Francisco, September 1999. http://www.ipmag.com/

(8) Jean-Jacques Cristofari, "Facettes indiennes aux 23,700 firmes pharmaceutiques", Pharmaceutiques, Paris, no. 53, January 1998.

(9) Jean-Paul Maréchal, "Making merchandise of biodiversity", Le Monde diplomatique, English edition, July 1999.

(10) Axel Kahn, Et l'homme dans tout cela, NIL, Paris, to be published in February 2000.

(11) See The Guardian, London, 15 December 1999.

(12) "L'industrie pharmaceutique: réalités économiques 1999", document published by the Syndicat national de l'industrie pharmaceutique (SNIP), 88 rue de la Faisanderie, Paris.

(13) German Velásquez, Sarah Bennett and Jonathan D. Quick, "Rí´les des secteurs public et privé dans le domaine pharmaceutique. Incidences sur l'équité en matií¨re d'accí¨s et sur l'usage rationnel des médicaments", WHO, Geneva, 1997.

(14) Amartya Sen, "Health and development", keynote address to the 52nd world health assembly, Geneva, May 1999.

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