Bitter medicine: why the developing world can't get drugs

Why has Medecins Sans Frontieres, for the first time ever, stepped outside its work in war zones, refugee camps and tent hospitals to take on the unfamiliar task of lobbying Governments and drug companies to bring cheaper medicines to the developing world?

It’s simple - because we’re doctors. It’s our duty to treat patients and we can’t. We’ve had to accept the bitter truth that many of the medications we hand out are second-rate, toxic or rendered ineffectual by drug resistance. Or, worse, that there’s a safe, effective cure but our patients go untreated because the drug is sold at first world prices and we’re not legally allowed to use a cheaper copy that could save their life. We are doctors but we come with empty hands.

Over the past 70 years an inequality in access to medicines has gradually developed as governments and intergovernmental institutions have incrementally ceded responsibility for global health to the private sector. Today, key health decisions are left in the hands of the pharmaceutical industry – decisions on which diseases will be researched, which compounds will be developed and manufactured, where the final drugs will be sold, and at what price they will be offered to consumers. The public sector monitors and measures global disease then throws up its hands and leaves it to the drug industry.

It wasn’t always like this. During the colonial era, the West maintained a network of influence in the "third world". The corollary of this presence was an active research and development (R&D) agenda into tropical diseases affecting our colonies. The pharmaceutical industry responded by delivering a string of innovative drugs – a TB vaccine in 1923; chloroquine for malaria in 1934; melarsoprol for sleeping sickness in 1949. But as the borders of colonialism receded, R&D receded with them, shrinking to match the footprint of the consumer market.

The no-mans land they left behind was never filled. No-one stepped in to fill the gap, neither Western governments nor UN agencies nor public donors. We buried our heads in the sand, chanting the mantra that patents alone will stimulate R&D; that market forces are sufficient to provide the cures we need.

But it’s painfully clear they don’t. Of the 1,223 new drugs developed between 1975 and 1996, only 11 were for tropical diseases. Of these 11, five were spin-offs from veterinary research (humans share some diseases with dogs and horses). A handful came from US military research during the Vietnam War when tropical diseases were, briefly, an issue. Three came from pharmaceutical industry R&D, often accidentally while looking for cures for Western diseases. The fact is that patents do stimulate research - but only into diseases of Western consumers.

The developing world was left behind by colonialism, frozen in medical time. MSF doctors still inject sleeping sickness patients with melarsoprol, an arsenic derivative so toxic that it melts plastic syringes and kills 1 in 20 patients. We hand out TB drugs developed 60 years ago because they’re all we have; and watch as malaria sufferers die, taking the chloroquine and Fansidar that no longer work against new strains of the parasite.

It gets worse. In 1995, all member countries of the World Trade Organisation signed up to TRIPS – a trade agreement giving protection to new inventions (intellectual property) such as videos, music and books. But TRIPS also regulates medicines – giving pharmaceutical companies a 20-year global monopoly on every new drug they invent. No-one else is allowed to sell a patented drug or make a cheaper version of it. And the drug company can sell it at whatever price the market will bear - not surprisingly, this means a very high price especially when it comes to cancer or AIDS. Life is worth a lot in the West, dwarfing the paltry incomes of cancer and AIDS patients in Uganda or Guatemala.

However, the governments of the world never intended to give drug companies a monopoly over life itself, so they included a series of "health exceptions" in TRIPS - safeguards that would allow developing countries to access cheaper drugs in a health emergency such as AIDS. These safeguards included parallel importing (shopping around for the cheapest version of a brand-name drug) and compulsory licencing (making or importing a generic version of a drug, while paying a royalty to the drug company who originally developed it). The health safeguards weren’t spelt out in detail but instead were drafted in fairly vague terms, a common diplomatic solution when conflicting interests make it difficult to reach a final agreement.

On paper it looked like a workable solution but in reality TRIPS turned out to be a giant exercise in pulling the wool over our own eyes. TRIPS was based on the premise that drug companies would get patent protection (a 20 year monopoly with health exceptions) in order to generate the profits they needed to undertake R&D. In other words, it was a social contract: patents in return for R&D.

We never admitted it, but we knew, even then, that what we really meant was patents in return for R&D in the West. Why would drug companies invest potential shareholder returns into R&D for diseases that only affected non-paying customers, the poorest of the world’s poor?

Worse, the "patents with health exceptions" concept turned out to be a chimera. Hiding behind the mantra that patents were the lifeblood of research, and taking advantage of the vague wording of the health exceptions, drug companies launched a whirlwind of activity after 1995, taking legal action nationally and in the WTO against any developing country that attempted to put the health exceptions into practice. The current court case in South Africa, where 39 drug companies are suing the South African Government, is only the last in a long line of legal battles (Brazil, Thailand, Guatemala ….) where drug companies have used protracted court cases, legal technicalities and the threat of trade sanctions to defeat any attempt to use the health exceptions.

So instead of our much vaunted social contract - partial patents in return for global R&D - we’ve signed up instead to global patents in return for partial R&D (in the West only). We’ve given drug companies a global 20-year monopoly and received nothing in return – they would have continued to do R&D in the West anyway, driven by the enormous profits new drugs can generate (in 1999, more than 20 drugs made over US$1 billion in sales each). Worse, we’ve suddenly realised that if anyone is going to cough up millions of dollars for R&D in the developing world, it’s going to be us.

The good news is that it’s not as hopeless as it seems. Practical solutions lie well within our grasp if we can summon up the political will to act.

Western governments, including the Australian Government, must insist that the narrow sectoral interests of the pharmaceutical industry are not allowed to undermine the TRIPS rules – we must support the TRIPS health safeguards and make sure they’re workable. The Australian Government should also take the lead in promoting model TRIPS legislation which developing countries could use without fear of litigation. The price of failure is not only millions of deaths in the developing world, but also the potential collapse of TRIPS and a certain repeat of the Seattle WTO meeting, fuelled by the developing world’s growing belief that international trade agreements are little more than instruments to deliver profits to the West.

Western Governments will have to finance R&D into developing country diseases – unless they can persuade or coerce the drug industry to keep up its end of the social contract. It’s likely the West will also need to finance a global procurement fund, similar to that proposed recently by the UK and Italy, to subsidise or purchase drugs for the poorest countries.

The pharmaceutical industry is part of the solution too. It should agree to recover R&D costs and make its profits in the West, rather than attempting to wring cost mark-ups from the poorest of the poor. Given the almost total absence of drug company R&D for the developing world it is brutal to suggest that developing world consumers should continue to pay price mark-ups that subsidise research for Western diseases. And finally, drug companies should play by the rules. The TRIPS health safeguards were put there in recognition of the right to life. No-one should be allowed to take that away.

If you want to support South Africa’s efforts to access affordable medicines, sign the Drop the Case petition on MSF’s website www.msf.org.