TCS Daily

Partners, Patents and Problems

By Richard Tren - May 22, 2003 12:00 AM

Roche, the Swiss research-based pharmaceutical firm, recently announced an unlikely partnership with Ranbaxy, a leading Indian generic drug producer. This partnership could be good news for many malaria patients who need new effective drugs and provides an interesting way forward for future research. Unfortunately, it doesn't tackle some of the more basic obstacles to drug access that plague most poor countries.

Under the deal that was brokered by the Geneva-based Medicines for Malaria Venture (MMV), Roche will provide its research free of charge to Ranbaxy so that the generics company can produce cheap versions of artemesinin drugs. Artemesinin-based drugs are derived from sweet wormwood, an ancient Chinese herbal remedy that is currently the most effective malaria therapy.

Most research-based pharmaceutical companies have come under strong criticism for not devoting more research funds to poverty diseases, such as malaria and TB. Yet MMV, which is a public-private partnership, has attracted a great deal of investment from private drug companies and is changing this. Although the MMV partnership is only a few years old, it is already producing some promising new leads for malaria drugs and the deal with Ranbaxy means that those drugs could be cheaply produced.

Novartis, another Swiss company, developed and patented its own artemesinin combination therapy, Coartem. The drug is expensive, yet some African countries have chosen to adopt it where other drugs are failing. Novartis is selling the drug at no profit to poor countries via the World Health Organization (WHO) and seeks to profit from sales in rich countries. South Africa has now introduced Coartem as has Zambia, one of Africa's poorest and least developed countries.

South Africa has the most sophisticated health infrastructure in Africa, yet was wise to buy the drug from Novartis and not cheap generic knock-offs. The logistical support, education and ongoing advice that are provided by Novartis have been essential in ensuring that the drug is used correctly and that resistance is kept to a minimum. So far there has been no significant treatment failure with Coartem, but poor use could encourage resistance-type failure. The importance of this kind of logistical support cannot be underestimated, especially in countries where the health infrastructure is poor.

Cheaply produced generic drugs can be crucial for any health system, yet the drug prices quoted by generics companies can be misleading. Reports are emerging that cheap generic AIDS drugs sold in Latin America are being supplied at higher costs than the brand name equivalents. The reason is the distributors add on hefty mark-ups and the generic producers do not exert any pressure on them to distribute the drugs at no profit, as do the research-based drug companies. In addition, the generic companies are not known to provide essential support in the way of patient and doctor education about the new therapies.

It is widely argued that drug patents are a major barrier to drug access in poor countries. This could be true in some countries and for some diseases, yet in most instances, patent protection is the last thing that stops people from getting life-saving medicines. Almost all, around 99 percent, of the WHO list of essential drugs are off patent and yet access to these drugs is abysmal in most of Africa. Decades of economic mismanagement, government corruption, a lack of health care infrastructure and grinding poverty means that most Africans are unlikely to be able to afford even the most basic drugs. According to the United Nations Development Program only 36 percent of people have access to essential drugs and in Malawi the figure is scarcely better at 44 percent.

So while drug patents rarely stop people from accessing drugs, they provide incentives to drug companies to engage in research. Patent protection for Roche's profitable drugs allows the company to engage in research in less profitable diseases, such as malaria, and to give their research away. Indeed all the private pharmaceutical companies that are involved with MMV benefit from patent protection around the globe and devote many millions to research and philanthropic activities in poor countries.

In India, the lack of patent protection for drug development hampers research for developing country diseases. India officially has two million cases of malaria every year; the real figure is widely estimated to be nearer 10 million. Yet while the country has a wealth of scientific knowledge, there is little original research to find cures for its own diseases. Part of this is because of the low profitability from this kind of research, but the absence of patent protection also plays a major part.

Developing countries are selling their scientists short when they fail to protect intellectual property and seek short term solutions to diseases that rely on cheap generic drugs. At the Multilateral Initiative on Malaria conference in Tanzania, Dr. Rob Ridely from the WHO was adamant that one of the most important things African countries could do to encourage greater research is to protect intellectual property.

Rich countries can provide incentives for research and development by giving tax breaks for research into poverty diseases and can also guarantee to buy the drugs once they are developed. Yet African governments have to seriously commit to building the basic infrastructure that is needed to deliver drugs and ensure that once produced, the medicines actually get to those in need.

The Roche - Ranbaxy deal is good news for malaria patients around the world. But ongoing research is essential, especially if resistance develops to the artemesinin drugs as it has to all the other malaria drugs. If research is to occur, rich and poor countries alike will have to work better with the major drug companies and provide more incentives for their continued involvement.

Richard Tren is a director of the South Africa based health advocacy group Africa Fighting Malaria.

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