ACCESS TO ESSENTIAL DRUGS IN POOR COUNTRIES innovative research and industry. To fund new research, industry needs commercially viable results. It is therefore vitally important that the pharmaceutical industry collaborates with organizations like WHO, UNICEF, and the World Bank to identify the challenges and get a clearer view of what they can achieve together in developing sustainable markets for new tropical pharmaceuticals. It must be remembered that those developing countries that are the main sources of cheap copies of patented drugs are nevertheless relatively poor. Enforcing the WTO regulations will remove a source of affordable copies of innovative quality drugs on which the poorest countries depend. Developing countries, particularly the less advanced, should be encouraged to take advantage of the limited alternatives offered by the WTO agreements. Specifically, they should be able to obtain compulsory licenses whereby national authorities allow local manufacturers to circumvent patent rights (with certain conditions and in return for the payment of royalties to the inventor, as stipulated in article 31 of the WTO agreements).33 Judiciously enforced, such an alternative seems to be the only recourse to balance the interests of the developing and developed world. WHO is in a unique position to argue the case for health at an international level. Health-related nongovernmental and consumer organizations certainly have a supportive role to play, but WHO is the only intergovernmental organization with a formal international mandate to protect and advance health internationally. While WHO's authority in this area has suffered in the last decades, part of WHO's strategy should now be to clearly and unambiguously put health first and provide leadership in promoting access to essential drugs. CONCLUSIONS Access to essential drugs is a basic human right often denied to people in poor countries. However, it would serve no purpose to demand new public health or human rights in a manner that would suggest that such rights will soon become a reality. The current situation points to the opposite. For a great proportion of the world, health conditions are worsening, and without fundamental change in the pharmaceutical market, perspectives for improvement are not encouraging. Acknowledgment: As a medical emergency organization present in 80 countries through 400 medical assistance projects, MSF undertakes to speak about the living conditions of those who cannot speak for themselves and to defend their right to vital health care. This article is mainly based on the field experience of MSF and our local partners. We wish to thank the many field volunteers who, in one way or another, have participated in gathering the information contained in this article. Special thanks to Nathan Ford for reviewing the manuscript. REFERENCES 1. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations Geneva, Switzerland: World Health Organization; 1996. WHO Technical Report Series 863. 2. Pinel J, Varaine F, Fermon F, Marchant G, Marioux G. Des faux vaccins anti-meningocoque lors d'une epidemie de meningite au Niger. Med Maladies Infect. 1997;27:1-563. 3. World Health Organization. Fake drugs: a scourge on the system. WHO Drug Inf. 1995;9:127-129. 4. O'Brien KL, Selanikio GD, Hecdivert C, et al. Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. JAMA. 1998; 279:1175-1180. 5. Shakoor O, Taylor RB, Behrens RH. Assessment of the incidence of substandard drugs in developing countries. Trop Med Int Health. 1997;2:839-845. 6. Pécoul 8, Varaine F, Keita M, et al. Long-acting chloramphenicol versus intravenous ampicillin for treatment of bacterial meningitis. Lancet. 1991;338:862-866. 7. World Health Organization. WHO response to meningitis epidemic In Africa, 1997. Bull Wkly Epidemiol Record. 1997;72:313-320. 8. Doua F, Boa FY, Schechter PJ, et al. Treatment of human late-stage gambiense trypanosomiasis with adifluoromethylornithine (eflornithine). Am J Trop Med Hyg. 1987:37:525-533. 9. Legros D, Enyaru JCK, Evans S, Maiso F. An outbreak of relapses among patients treated for T. b. gambiense trypanosomiasis in Arua, Northern Uganda. Paper presented at: 24th International Scientific Council for Trypanosomiasis Response and Control (ISCTRC); September 1997; Maputo, Mozambique. 10. Coll-Seck A, Sylla A, Over M, et al. Implications of therapies for developing countries. Paper presented at: XII International Conference on AIDS: June 28-July 3, 1998; Geneva, Switzerland. 11. Centers for Disease Control and Prevention Mortality From Dysentery in Africa: A Follow-up Study in Burundi. Atlanta, Ga: Centers for Disease Control and Prevention; 1993. CDC internal report. 12. Paquet C, Perea W, Grimont F, et al. Aetiology of haemorragic colitis epidemic in Africa. Lancet. 1993; 342:175. 13. Paquet C, Leborgne P, Sasse A, Varaine F. An outbreak of Shigella dysenteriae type 1 dysentery in a refugee camp in Rwanda. Sante. 1995;5:181-184. 14. Paquet C, Van Soest M. Mortality and malnutrition among Rwandan refugees in Zaire. Lancet. 1994; 344:823-824. 15. Essential Drugs Price List. Copenhagen, Denmark: UNICEF Supply Division; 1995. 16. Varaine F, Keita M, Kaninda AV, et al. Long acting chloramphenicol versus ceftriaxone for treatment of bacterial meningitis in children aged 2-35 months. Paper presented at Eighth International Congress on Infectious Diseases; May 15-18, 1998; Boston, Mass. 17. World Health Statistics Annual 1996. Geneva, Switzerland: World Health Organization; 1998. 18. Tandon BN, Acharya A, Tandon A. Epidemiology of hepatitis B virus infection in India. Epidemiol Infect. 1996;117:313-325. 19. Kaddar M. La mutation du marché mondial des vaccins. Rev Prescrire. 1995;157:844-847. 20. Crofton J, Chaulet P, Maher D. Principes pour la prise en charge de la tuberculose à bacilles résistants. Geneva, Switzerland: World Health Organization; 1997. WHO/TB/96.210 (rev 1). 21. Trouiller P. Recherche et développement pharmaceutiques en matière de maladies transmissibles dans la zone intertropicale. Sante. 1996;6:299-307. 22. Trouiller P, Rey JL, Olliaro P. Analysis of drug development patterns of six tropical diseases between 1975 and 1997. Paper presented at: Eighth International Congress on infectious Diseases; May 15-18, 1998; Boston, Mass. 23. Grabowski H. The effect of pharmacoeconomics on company research and development decisions. Pharmacoeconomics. 1997;5:389-397. 24. International Strategies for Tropical Diseases Treatments: Experiences With Praziquantel. Boston, Mass: Harvard School of Public Health; 1996. 25. World Health Organization. Counterfeit Drugs: Report of a WHO/IFPMA Workshop. Geneva, Switzerland: World Health Organization; 1992. WHO/ DMP/CFD/92. 26. World Health Organization. Recommendations from the ICDRA reinforce the mission of regulatory authorities. WHO Drug Information. 1996;4:182-185. 27. Correa C. The Uruguay Round and Drugs. Geneva, Switzerland: World Health Organization; 1997. 28. Intellectual Property: Patents and Pharmaceuticals. Geneva, Switzerland: International Federation of Pharmaceutical Manufacturers Associations; 1997. 29. Lanjouw JO. The Introduction of Pharmaceutical Product Patents in India: Heartless Exploitation of the Poor and Suffering? Cambridge, Mass: National Bureau of Economic Research; 1998. 30. Rozek RP, Berkowitz R. The Effects of Patent Protection on the Prices of Pharmaceutical Products. White Plains, NY: National Economic Research Associates; 1998. 31. Tropical Disease Research. From Investigation to Eradication: Tropical Diseases Research Twelfth Programme Report. Geneva, Switzerland: World Health Organization; 1995:9-36. 32. Oliaro P. Will the fight against tropical diseases benefit from orphan drug status? Trop Med Int Health. 1997;2:113-115. 33. Velasquez G, Boulet P. Globalization and Access to Drugs: Implications of the WTO/TRIPS Agreement. Geneva, Switzerland: World Health Organization; 1998. Printed and Published in the United States of America JAMA, January 27, 1999-Vol 281, No. 4 367 Mr. MICA. We will also, without objection, leave the record open for 3 weeks, as I said, for additional statements. And we will be asking questions. There being no further business to come before the subcommittee, this meeting is adjourned. [Whereupon, at 5:11 p.m., the subcommittee was adjourned.] [NOTE.-The report entitled, "Report on the Presidential Mission on Children Orphaned by AIDS in Sub-Saharan Africa: Findings and Plan of Action," may be found in subcommittee files.] [The prepared statements of Hon. Bernard Sanders and Hon. Henry A. Waxman, and additional information submitted for the hearing record follow:] SUBCOMMITTEE ON CRIMINAL JUSTICE, HUMAN RESOURCES CHAIR: PROGRESSIVE CAUCUS AND DRUG POLICY HEARING ON THE ROLE OF THE UNITED STATES IN COMBATING THE GLOBAL STATEMENT OF CONGRESSMAN BERNIE SANDERS (I-VT) July 22, 1999 Mr. Chairman, first let me thank you for calling this hearing today on the pressing issue of the role of the United States in combating the global spread of HIV and AIDS. At a time when scientists are discovering many breakthrough drugs which attempt to treat the AIDS virus, it is a tragedy that millions of people worldwide are unable to afford them. What is perhaps even more tragic is the fact that this problem could be easily remedied were it not for the intense lobbying by multinational pharmaceutical companies who strive not to help those in need, but instead look to make large scale profits. While more than 3 million people in South Africa alone are currently infected with the HIV virus, some drug companies are making profits of over $3 billion dollars per year at the people's expense. This has to change. Today HIV and AIDS are ravaging the global population. South Africa has a populace of 3.2 million infected citizens, which is nearly almost 10 percent of the total population. By its own governmental estimates, 20 percent of pregnant South African women are HIV-positive, creating millions of orphaned children each year. At the same time, the military has an infection rate of over 45 percent. This dire situation is expected to plunge the life expectancy a full twenty years, from 60 to 40 years by the year 2008. Unfortunately, the circumstances found in South Africa are not isolated occurrences. There are many countries all over the world which are currently experiencing similar epidemics. Thailand is faced with more than 800,000 infected people, tens of thousands of which have not yet reached adolescence. In less than a year, China's infected population is projected to reach one million. And the Middle East has seen the number of HIV cases double in the past two years. But the rates of HIV infection are only part of the problem with which we are now faced. The real complication lies not in the lack of medicines which can be found on the market to treat and lessen the effects of this terrible disease, but in the lack of affordable options to those countries and people which need to import such drugs. As it stands, countries like South Africa, Thailand and Israel are forced to pay exorbitant prices for prescription drugs like AZT. While methods to obtain lower-cost drugs are available under a World Trade Organization agreement called TRIPS (Trade Related Aspects of PRINTED ON RECYCLED PAPER International Property Rights), drug companies and the U.S. government are blocking South Africa, Israel, and Thailand from taking these WTO-approved steps to get these drugs to treat their citizens. In effect, this is barring the people in these countries from obtaining the medication they need to slow the AIDS outbreak. It is deeply disturbing to look closely at these facts. While 90 percent of all AIDS deaths are from subSaharan African countries, less than one percent of the world's AIDS drugs are sold there. Why? Because in countries like South Africa, where the annual per capita income is a meager $2,600, AIDS drugs can cost up to $1,000 for a month's supply. This is outrageous. Much of the blame for this problem lies at the feet of the pharmaceutical companies. Rather than lowering prices and helping save millions of lives every year, these companies are hiking up their prices and charging top dollar for their products. They place profit above human life. For example, AZT costs only 42 cents for 300 mg on the world market. However, the retail price is bumped up to $6 for the same amount here in the United States. When you apply those retail prices to millions of people, it is easy to see why some countries are unable to afford the drugs from the companies, despite the TRIPS agreement. And what happens to countries who practice "parallel importing," and do not purchase their AIDS drugs from drug companies, instead looking to buy them through cheaper sellers, often times other countries? Under direct pressure from the pharmaceutical industry, they are punished by the U.S. State Department. Countries who buy their prescription drugs elsewhere are penalized by the United States. These countries are faced with having their preferential tariff treatment withheld, and being placed on the "watch list" as free trade violators, all because the pharmaceutical companies do not wish to lose any of their tremendous profits. And what makes this situation even more appalling is the fact that parallel importing is legal under a 1995 WTO agreement. This agreement clearly states that countries may take measures to reduce the costs of importing prescription drugs, including purchasing them from other nations. But the pharmaceutical industry has lobbied so extensively that the State Department is buckling under their hold and aggressively disciplining countries that do not buy their prescription medicines through drug companies. Thus far, South Africa, Israel and Thailand have seen actions taken against them simply for trying to find an affordable way to save their citizens from AIDS and other diseases. It is high time that we take action to stop this injustice. That is why I offered an amendment to the State Department Authorization bill yesterday which would have made it casier for countries like South Africa to purchase affordable AIDS prescription medication. My amendment would have stopped the State Department from pursuing disciplinary actions against countries that seek to find cheaper ways to import these drugs. Unfortunately, it was defeated by a vote of 117 to 307. The pharmaceutical industry, which spent more money lobbying Congress than any other industry in the last election cycle, won this week's fight. But I assure you they will not win the battle. I will continue to fight to lower prescription drug costs in our nation and throughout the world in order to save the lives of those people living with AIDS and other diseases. STATEMENT OF CONGRESSMAN HENRY A. WAXMAN HOUSE GOVERNMENT REFORM SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY & HUMAN RESOURCES: HEARING ON THE U.S. ROLE IN COMBATTING THE GLOBAL HIV/AIDS EPIDEMIC Mr. Chairman, the topic of today's hearing is of tremendous importance to the I regret that this hearing only focuses on U.S. trade policies towards South Africa. But recent attention has focused instead on the actions taken by the U.S. Trade Representative regarding the South African Medicines Act of 1997. We should begin with a question - Why did South Africa adopt this law? The South African law is meant to expand access to HIV/AIDS drugs. According to South African Health Minister Nkosazana Zuma, one in eight South African adults is HIV-positive. In the past year and a half alone, the prevalence of HIV has increased by a third to affect 3.4 million South Africans. And if we look beyond South Africa's borders, 70 percent of all new HIV No one questions the need to sustain a rigorous international regime of intellectual But I am concerned by the unusually aggressive and confrontational posture taken |