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Patents and the WTO

Where drug firms fear to tread
By Ivan Briscoe, UNESCO Courier journalist.
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In Burkina Faso, a young boy leads the way for his grandfather, who lost his sight because of river blindness disease.





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In Cambodia, tuberculosis victims receive care at the hospital in Sotnikum.




Patents and the WTO

For the major pharmaceutical firms, it is the formal ratification of their global rights. For public health activists, it risks becoming a byword for corporate control and moral indifference. Approved in 1995 at the creation of the World Trade Organization, the Trade and Related Intellectual Property Rights agreement—TRIPS for short—is sure to be at the heart of future debate over access to essential medicine.
The irony is that TRIPS is itself ambiguous over exactly how strong patents should become. By 2006, all 137 countries in the WTO must have implemented strong intellectual property rights guaranteeing 20-year monopolies on novel drugs. Several articles in the text, however, allow for loopholes like licensing a local version of a patented drug or importing from the cheapest foreign supplier in the event of a health emergency.
What this might all mean is as yet uncertain. So far, U.S. trade officials have interpreted the agreement as a leash on countries like Thailand and Argentina with flourishing generic pharmaceutical firms (cases against both Argentina and Brazil are pending before the WTO’s dispute settlement board). Former U.S. President Bill Clinton, however, seemed to veer towards the lenient interpretation in May 2000 by signing an executive order allowing African nations to flout pharmaceutical patent rights. The battle for TRIPS has just begun.

Access to medicines in poor countries has become a critical issue with the spread of AIDS and re-emergence of illnesses once thought to have been beaten. Can the profit-driven pharmaceutical industry offer any kind of response?

Where is a little, forgotten disease afoot, and a third of Faustino Torrico’s neighbours are infected. As a medical professor in the local university of Cochabamba, Bolivia, he would like to do more to help the afflicted, but the vicious blood-sucking bug that hosts Chagas disease has one insuperable defence against the world’s health industry. Trypanosoma cruzi likes its insect carriers to live in mud walls and roofs—it likes to feed on the poor.
As Torrico knows only too well, the numbers do not add up. He knows of some pills that could help the 450,000 infected people in his region—many of whom will see their hearts and guts irreparably perforated by the parasite—but they cost a dollar a go. That makes $90 million to treat Cochabamba alone, about 84 million more than his entire country’s six-year budget for treating Chagas disease.
The portents of such immense shortfalls are well known to the developing world’s health profession. For the 23 million AIDS victims in sub-Saharan Africa, they point to absent treatment, semi-legal scrambles for cheap pills and almost inevitable death. Similar tales can be told of malaria and tuberculosis. Yet these are the “big three” diseases: major world scourges, all of which (now including malaria) have at least a foothold in the rich nations and a claim on global attention. For Chagas in Bolivia, yellow fever in Guinea and sleeping sickness in Uganda, the pockets of exotically named illnesses are ringfenced by silence.
As for drugs, what there is tends to be expensive, ineffective or both. One recent study for the World Health Organization (WHO) revealed that between 1975 and 1997, 1,233 new chemical treatments were put on the market. Only 11 were for what are known as “tropical diseases.” Over half of those were initially designed for animals.
“If you look over the last 20 year, the share of developing countries in the world’s pharmaceutical consumption has actually dropped from a quarter to 20 percent. So in essence we have 75 percent of the world’s population consuming only about 20 percent of the world’s drugs in terms of value,” explains Jonathan Quick, head of the WHO’s essential medicines division.

The frantic search for market winners
Bridging this fracture between medical need and medical supply has become an urgent issue, pushed to the forefront of politicians’ minds by the ravages of AIDS on the African subcontinent and discussed at the G-8 table in Okinawa last July. Quite simply, the market-driven behaviour of the pharmaceutical industry seems to afford little space for the health needs of those too poor to buy pricey new drugs. The scale of the challenge is to bring profit and poverty together.
It is a task made that much harder by the fragmented nature of modern health. For previous generations, the most devastating infectious diseases—tuberculosis, smallpox, syphilis and polio—spanned the globe, paying little heed to geography or wealth. Now, however, rich and poor illnesses are clearly divisible. What kills in the west are chronic ailments such as heart disease, cancer and strokes. Poverty and poor healthcare, in contrast, have proved just the right environment for the emergence of new resistant strains in old pestilence. Over 70 percent of malaria sufferers in Sierra Leone, to take just one of many cases, enjoy no benefit from the old chloroquine prescription. For pharmaceutical companies, it is a sad fact that does little to interfere with market strategy.
From modest beginnings in the penicillin trade that followed the end of World War II, the industry has changed beyond recognition. Annual research and development in the sector now stands at $40 billion, overshadowing the work of public laboratories which in turn jostle to match the industry’s priorities. Impelled by a string of mergers and acquisitions, a pack of multi-billion dollar corporations currently dominates, all of them frantically searching to please shareholders, avoid takeover and find the holy grail—the drug that can net a billion dollars in sales a year until its 20-year patent expires.
Given the scale of their investments (an estimated $500 million per new drug), potential sales are clearly the key to choosing a field for research. According to Herman Mucke, a Vienna-based independent analyst of the industry, the craze of the moment is the central nervous system—the weak link in old people’s bodies, and thus a market winner in ageing Europe. “Lifestyle” drugs have also boomed since Pfizer unleashed Viagra. The sinking of considerable funds and talent has produced alluring new treatments for weight loss, face wrinkles and separation anxiety in pet animals. Tired of depending on stubborn health authorities and doctors’ prescriptions, the firms are even aiming straight at consumer desire in the style of a chain store. For the first ever time, a television advertisement was shown in Britain in 1999 “recommending” a visit to the doctor for sufferers of incontinence. Why? Heard of Pharmacia & Upjohn’s new drug?
“There’s no disputing that one old, fat, bald, fungus-ridden rich man who can’t get it up counts for more than half a billion people who are vulnerable to malaria,” intoned an article on the industry in the left-wing U.S. magazine The Nation.
Yet as the pharmaceutical industry is careful to argue, such criticisms mistake moral fury for fair assessment. The industry, after all, is in the private sector—from where it must attract consumers and recoup investment. For shareholders, there is no more reason for it to serve pills to the poor than for banks to hand out cash to the destitute or supermarkets to disburse food to the hungry. “Some individuals in various firms might be far-looking enough, but you know how these companies work: they have thousands of shareholders who tell the director that the only thing to worry about are profits and dividends. When those two drop, they are pensioned off and that’s it,” says Mucke.
In spite of such pressure, several companies have still co-operated in major public health ventures. The U.S. firm Merck, for instance, donated 65 million doses of the drug ivermectin over a decade, a vital part in largely successful efforts to eradicate river blindness disease in Africa. Several firms have also pledged to continue production of drugs to counter sleeping sickness.
But few health activists have any illusions about the firms’ warmth of heart. “The logic of the pharmaceutical industry is not the logic of social action,” states Jean-Marie Kindermans from Médecins Sans Frontières. In response, his globally respected organization has begun to fight for immediate measures to get existing drugs into the hands of those too poor to afford them.

Charitable agreements and generic drugs
A prime target are the people infected with HIV and AIDS in Africa. Peter Langi, a leading health official from Uganda (820,000 infected out of a population of 21 million), admits that “access to HIV drugs is minimal and they are very expensive. The medicine is only available from a few hospitals in the capital.” All five leading pharmaceutical firms agreed last May to cut the prices on AIDS drugs for Africa by 80 percent. Langi explains that in Uganda’s case a deal has just been struck to bring the price of the triple therapy antiretrovirals down to $140 a month. The only snag is that his government’s health budget stands at $12 per person per year.
For Médecins Sans Frontières, the message is clear: gentlemanly deals with the pharmaceutical firms are not enough. In the opinion of many public health activists, the firms are acting for the same strategic reasons that motivated their $20-million donation to the U.S. presidential election campaigns. Cut prices and giveaways, most recently seen in Pfizer’s pledge to hand South Africa free fluconazole (a cure for cryptococcal meningitis, the frequent result of AIDS infection), certainly look good on press releases. But generic versions of these same drugs are currently being manufactured by upstart firms in Brazil, India, Thailand and Argentina, sometimes at less than a fortieth of the big firms’ prices. Could it be that the giants’ charity is just a ploy to win plaudits, quash competition, and preserve their rights to worldwide patent protection (see box)?
“The solution for AIDS is not to have five big donors reducing their prices—we need pressure for a political agreement, not a charitable one,” declares Kindermans. Encouragement of cheap generics, relaxation of patent restrictions and differential pricing of medicines in poor and rich countries have all been pinpointed as critical steps. The goal is to bring the pharmaceutical industry to heel—to remind it that health, the condition for human life, can never be just another market.

Incentives to boost invention
But, as the WHO hastens to add, confrontation is not a solution. In the case of AIDS and patented drugs, says Quick, “we need change on all sides,” including business, politics and also consumers in rich countries, who may have to shoulder higher prices even though their pills are being transformed into just one more commodity. As for tuberculosis, malaria and those forgotten tropical diseases, grindingly slow research partnerships between public and private sectors still seem the only option. One major global malaria initiative, for example, envisages a new drug rolling off the production line in five years at a mere $150 million; industry has promised assistance “in kind.” And though several drugs to combat sleeping sickness are now being donated, one of the most promising patents, that for eflornithine, is stuck like a limpet to the WHO’s hands: no firm has yet agreed to risk the combustible production process.
The giant pharmaceuticals, meanwhile, are digging in. At the centre of their concern is the patent system—the axle of the entire industry. Scrap that or tinker with it, as more radical health activists demand, and firms risk terminal demise.
Instead, a defence has been mounted: developing countries are hampered more by bad healthcare than lack of pills. And if flourishing drugs firms are needed in poor countries, says Viren Mehta, head of the New York-based pharmaceutical analysts Mehta Partners, then strong patents and a dose of public funds are essential. “The pharmaceutical industry is at an inflection point. The new tool of biotechnology makes the future very exciting: it allows us to move beyond trial and error, start with a clean slate and begin to do fundamental research into the mechanisms of nature,” he argues. “If we look at it over two generations, what is needed are solutions that can be distributed in a cost-effective way. What we need from this science is a pill that can cure malaria in a safe, effective manner, a pill that can clean water, a pill that can make crops grow.
“If the results are protected for a short time in the private sector, it is a sufficiently attractive carrot which allows them to be widely available a generation later. But human nature being as it is, it is somehow not able to muster the power, energy and creativity when there is no return,” adds Mehta. The industry agrees: the way to beat market failure is through more markets. With the new patent regime, they say, a genuine research industry has taken root in Mexico and Brazil. Even some of India’s 28,000 copycat firms have turned to invention.
In terms of the incentives to invention, Mehta is almost certainly right. But so long as the good works of the pharmaceutical industry are an afterthought of revenue, the incentives to clear the parasites from Cochabamba’s roofs may well stay off sick.

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