The New Straits Times, December 5, 1999
LEADERS of Commonwealth nations in their recent meeting in South Africa reiterated that globalisation should ensure the provision of affordable drugs to the world's poor (NST, Nov. 16).
They asserted that essential drugs made in advanced economies were too costly for poor nations. They were concerned about the concentration of global research resources on drugs that offers the most lucrative financial returns.
According to Medecins Sans Frontieres (MSF), the 1999 Nobel Peace Prize winner, the search for cures to diseases that affect people in poor countries has come to a standstill. Of 1,233 new drugs brought to market between 1975 and 1997 only 13 were for tropical diseases.
The highly lucrative pharmaceutical industry concentrates on treatments for impotence and obesity, leaving diseases such as tuberculosis, malaria and sleeping sickness to archaic drugs developed 30-50 years ago.
The accessibility of one group of drugs hotly debated in view of the World Trade Organisation meetings in Seattle related to HIV/AIDS drugs.
The latest report released by the World Health Organisation and the Joint United Nations Programme on HIV/AIDS (UNAIDS) indicated that the number of HIV infections worldwide has reached the 50 million mark. As of 1999, more than 16 million people had died. Access to drug treatment and affordability are, therefore, crucial to save lives.
During the 5th International Congress on AIDS in Asia and the Pacific held in Kuala Lumpur in October, Prime Minister Datuk Seri Dr Mahathir Mohamad expressed his concern in what has been regarded as "the first time a developing country leader has made such a strong statement about drug access".
He said: "The high cost of HIV drugs means that most people in developing countries just cannot afford them. But this need not be so if developing countries can get together and challenge the pharmaceutical companies to reduce the prices or allow compulsory licensing of life-saving drugs.
"Compulsory licensing is allowed under the WTO but it is sad to see certain powerful countries aligning themselves with giant pharmaceutical companies to deny developing countries the right to produce cheaper drugs to save the lives of their people. Profit is taking precedence over peoples' lives.
"Access to care means not just access to the most sophisticated antiretroviral drugs but also to drugs to treat opportunistic infections. This is possible for many countries. Even if they can't afford the protease inhibitors."
In Thailand, the possibility of withdrawing the patents of highly priced drugs to break the monopoly is being explored.
A joint report by WHO and MSF in August concluded that the high cost in Thailand was linked directly to the monopoly derived from the exclusive rights held by the original drug manufacturers, either from the patent or during the safety monitoring programme.
A case in point is the newer drug, didanosine (ddI), considered important in the treatment of symptomatic HIV patients, but it remains unaffordable to most HIV-positive people. The price of didanosine is quoted as "high" when compared with the average income of Thai people.
Repeated attempts to negotiate with the manufacturers over the price have been unsuccessful. It has been proposed that the Thai Government consider compulsory licensing of the drug.
The Prime Minister acknowledges "... that pharmaceutical companies expend a lot of money on research and need to recoup in order to continue their research. But they should not try to recoup from the sufferings of the poor.
"The governments of the rich should bear most of the cost of such research. We understand that some countries are never as prosperous as they are now. Surely they can spare some of their wealth to reduce the burden of the poor people in poor countries."
MSF is also calling for direct EU involvement and financial support to stimulate research and development.
In this context, the manufacturer of didanosine (ddI) has been criticised over its claim that high research and development costs made it impossible to reduce the drug price. But it was argued that the cost of development was sponsored by the US National Institute of Health, and the drug company allegedly only changed the formulation of the drug licensed by the US-NIH using ingredients already available in the market.
Many are not convinced if such a level of "new" invention should carry such a high price tag.
Countries like Thailand and South Africa allow for government agencies to intervene in the making of products deemed to be public necessities even though they are patented. Otherwise patients in dire need will have to wait for decades for the price to come down. They may be dead in the meantime.
Indeed, according to the official WTO booklet for the Seattle meeting, the areas where trade aspects of intellectual property protection (TRIPS) is permissive regarding steps taken to broaden access to medical care, include: (a) exclusion of patents for medical treatment methods, (b) compulsory licensing of patents, (c) price controls, and (d) parallel imports.
In other words, the obligations of the TRIPS Agreement do not stand in the way of price controls and similar types of measures for pharmaceuticals.
In summary, the question of equity in the matter of essential drugs is of primary importance. This was recognised as an important component of healthcare by the World Health Organisation when it introduced the concept of essential drug.
There are not more than 400 drugs that are required by the majority of the population at affordable prices.
In the case of HIV/AIDS the drugs available also should be considered essential. The concept is now the cornerstone of a National Drug Policy as recommended by WHO.
It is in our national interest to implement such a concept throughout the healthcare system as soon as possible.
We should also support the exemption of all drugs essential to our healthcare, guided by the WHO Model list of essential medicines, from the patent system for developing countries like ours.
This should include the relevant drugs to treat HIV/AIDS cases so that public health takes precedence over excessive profiteering at the expense of the former. This is especially so for Malaysia, where more than 70 per cent of its drugs are still import-dependent.
The writer is head of the WHO Collaborating Centre for Drug Information, based at Universiti Sains Malaysia, and a member of WHO Expert Advisory Panel for Drug Management and Policies.
