The development of new medicines for the world’s poor

Wealthy governments have been slow to fund research that would benefit the poor of other nations, and diseases such tuberculosis, malaria, sleeping sickness and a host of others have gone largely ignored, while funds are poured into perfecting treatments for diabetes, obesity, anxiety and sleeplessness-ailments associated with the rich.

 

At present pharmaceutical companies have little financial incentive to develop the drugs most urgently needed by the world’s poor. In its place, they maximize profits by altering already existing medicines - and thus extending the time they can collect royalties on their production - or by developing drugs that target the ailments of those who can most afford them.

Traditionally patents and high drugs prices have been the incentive for Research and Development (R&D) investment on new medicines. High prices mean many people cannot afford them. Developing countries face a serious challenge combating killer diseases such as tuberculosis, HIV, sleeping sickness, typhoid fever, etc, whose patented products are scarce on the essential drugs list of the World Health Organization (WHO). The current system has failed quite dramatically in Africa. Even in industrialized countries, high prices and limited insurance coverage for the newest medicines also limit access. Using product prices as an incentive leads to too much investment in new medicines that offer only minor incremental benefits over existing medicines, while products that open up new paths for treatment are relatively under-rewarded.

A case that shows the failure of the patent reward system in the development of new, affordable drugs and diagnostics is the absence of a simple cheap TB test, at a time when the disease kills 4,500 people a day and is spreading alarmingly in conjunction with HIV/Aids.

R&D for new medicines is a lengthy, expensive process, particularly for clinical trials involving people. Public sector and donor investments in the form of grants are important for non-profit drug development, where government support is essential. But these partnerships make sure that development efforts for new drugs are focused on the projects with the highest probability of success. New mechanisms to develop medicines for neglected diseases have to be found.

Yet developing medicines for neglected diseases is not enough. The treatments must be made available, and a tangle of patent laws and international treaties often stand between crucial new medicines and those who need them. Even for researchers, the great numbers of patents they have to face constitute a real barrier.

New opening in the research and development of new medicines

In May 2008 after two years of difficult negotiations, the delegates at the annual Assembly of the World Health Organisation agreed on a global strategy with innovative schemes.  These open the way to reform the current system of medical research and development of new drugs that has largely failed to meet the needs of people in developing countries. 

The “Global Strategy on Public Health, Innovation and Intellectual Property” aims to promote new approaches to pharmaceutical R&D and encourages the development of medicines and other products that will meet priority health needs, and make those products available on an affordable basis. This is a major breakthrough for public health and diseases affecting developing countries and will benefit many millions of people for many years to come.

The strategy encourages governments to support new ways of stimulating research into, and development of, drugs, vaccines and devices for treating diseases neglected by the big pharmaceutical companies for whom they do not offer a profitable market opportunity. This is a big step forward for the WHO.

The current patent-monopoly system of R&D has treated innovation and access as contradictory objectives. With the approval of the new strategy, the nations of the world have for the first time acknowledged that innovation and access are complementary public health objectives.

A provision put forward by delegates from least-developed nations which sought to put the right to health before commercial interests was dropped from the final resolution before the full Assembly vote, after strong opposition from developed nations. This is why advocacy groups that work for “Access to essential medicines” welcome this initiative, however with certain reservation.

Governments have clearly called for the WHO to play a strategic and central role in intellectual property. “We need more money for R&D, but money is not the only answer - we also need new models for incentivising the R&D and ensuring access to new drugs and diagnostics” a delegate said.

The problem of financing essential health R&D remains. Members still have to agree on key aspects of the action plan accompanying the strategy, including estimated funding needs, sources of finance, and the contribution of new mechanisms to reward innovation. An expert group will examine proposals for new and innovative sources of funding. Such schemes could include prize funds to reward drug development, advance commitments to buy new drugs or vaccines, and patent pooling, where patent holders share technology to provide a common platform for further innovation. A concrete case could be the creation of a prize fund to boost the development of tuberculosis diagnostics. This group will finalise the plan of action for approval by the 2009 World Health Assembly.