"Check-up Your Medicine to Save Your Life"

No.7 Essential Drugs

Message from Aborad

Access to Medicines should not be Luxury for the Rich but a Right for All

Ellen't Hoen [1]
Coordinator, Globalisation Project of Medecins sans Frontieres Access to Essential Medicines Campaign

Infectious diseases kill 17 million people each year, and more than ninety percent of these deaths occur in the developing world [2]. The leading causes of illness and death in Africa, Asia and South America, regions that account for four-fifths of the world's population are HIV/AIDS, respiratory infections, malaria and tuberculosis.

In particular the magnitude of the AIDS crisis has drawn attention to the fact that millions of people in the developing world do not have access to the medicines that are needed to treat the diseases or alleviate suffering. Each day 8,000 people die of AIDS in the developing world. The reasons for the lack of access to essential medicines are manifold, but in many cases the high prices of drugs throw up a barrier to needed treatments. Prohibitive drug prices are often a result of strong intellectual property protection. Countries that attemp to bring the price of medicines down have come under pressure from industrialized countries and the pharmaceutical industry. The most notorious example is the court case brought in 2001 by 39 pharmaceutical companies against the South African government to stop the implementation of the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 (Amendment Act). *

Another reason for the unavailability of needed medicins is the fact that research and development (R&D) towards the health needs of people in developing countries has almost come to a standstill. Despite the enormous burden of disease, drug discovery and development targeted at infectious and parasitic diseases in poor countries has virtually ground to standstill [3]. Of the 1,223 new drugs approved between 1975 and 1997, 13 (less than 1%) were specifically to treat tropical diseases [4]. Developing countries where three-quaters of the world population lives account for less than 10% of the global pharmaceutical market. Money speaks louder than health needs when it comes to setting R&D priorities of the pharmaceutical industry.

Is the tide turning?

The debate on the need to take measures to increase access to the medicines for people in developing countries is taking on a global dimension. There are encouraging signals that the tide is turning.

The global debate on access to medicines has encouraged generic and brand name drug companies to offer key medicines at lower prices. Today, the cheapest generic antiretroviral combination therapy offered to developing countries costs a little over 200 USD. Three years ago the price of triple therapy was 15,000 USD.

This years updated 12th model list on essential medicines (EDL) of the World Health Organisation is another important step forward. The Essential Medicines Committee added 10 antiretrovirals to the core essential medicines list and highlighted the importance of fixed-dose combinations (FDCs) of certain antiretrovirals.

Previously essential medicines were often excluded from the WHO essential medicines list on the grounds that they were too expensive. This new policy is recognition of the fact that high prices should not be taken for granted and that countries are encouraged to take measures to bring th cost down. WHO is also helping countries to access more affordable medicines through the pre-qualification fo manufactures and through the publication of treatment guidelines to encourage the rational use of the medicines.

The 4th WTO Ministerial Conference in November 2001 in Doha adopted the "Declaration on TRIPS and Public Health", which affirmed the sovereign right of governments to take measures to protect public helath. The declaration is an important political and legal document that gives primacy to public health over private intellectual property and clarifies WTO Members' rights to override patents if they form a barrier to access to medicines. This is an important step to ensure that intellectual property protection serves the broader public interest beyond that of the commercial sector.

Challenge Remains

An area where attention is urgently needed is the lack of R&D into new drugs for specific health needs of the poor. Recent studies claim that the R&D cost of a commercial drug company per new pharmaceutical product is 802 million USD [5]. The Global Alliance for Turberculosis Drug Development, a not-for-profit entity for R&D for TB drugs, estimated that the total R&D cost for a new TB drug, including the cost of failure is between 115 million USD and 140 million USD [6]. The high R&D cost claimed by the commercial pharmaceutical sector poses some key questions: Is the present system for funding R&D the most efficient, and is it sufficient to rely on the intellectual property systems to fuel innovation? Clearly in the area of neglected diseases it is not. In an increasingly globalized economy additional international mechanisms need to be developed to address health needs in developing countries that are neglected by the market. This will be the key challenge for the coming years. Essential drugs should not be a luxury reserved for the wealthy but should be reinforced as a critical component of the human right to health.

[1]Medecins sans Frontieres, 8 rue Saint Sabin, 57544 Paris Cedex 11, France. www.accessmed-msf.org.
[2]World Health Organization. The World Health Report 2000. Geneva: WHO, 2000
[3]Pecoul B., Chirac P., Trouiller P., Pinel, J.(1999) Access to essential drugs in poor countries. A lost battle? JAMA, Vol:281;361-367
[4]Trouiller P, Olliaro P. (1999) Drug development output from 1975 to 1996: What proportion for tropical diseases? Int Journ Infect Diseases. Vol: 3: 61-63.
[5]See: http:www.tufts.edu/med/csdd/images/NewsRelease113001pm.pdf.
These data have come under heavy criticism.
See for example IRS Data Shows Drug Industry Cost Estimates Exaggerated. Press release by James Love. November 30, 2001.
See: http://lists.essential.org/pipermail/ip-health/2001-November/002481.html
See also the paper by James Love: "How much does it cost to develop a new drug" at http://www.cptech.org/ip/health/econ/howmuch.html
[6]See for details: http://www.tballiance.org/3_costs.cfm?rm=economics&sub=costs

*Editors' Note
See MSF's international website (http://www.msf.org/) for more information on the issues discussed above.
South Africa, where 4.7 million people out of the total population of 40 million are suffering from HIV/AIDS, revised its Pharmaceutical Affairs Law to enable easier access to essential drugs. However, 39 pharmaceutical companies sued the South Afircan government, in order to protect their intelectual property, claiming that the revision was against the constitution. The case was withdrawn in the end. However, this was not considered solely as South African's problem, but attracted world' attention as "North-South inequality of medicine".