Lapas attēli
PDF
ePub
[merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][merged small][ocr errors][merged small][ocr errors][merged small][merged small][merged small][ocr errors][merged small][merged small][merged small][merged small][merged small][merged small]

re Hearing on the U.S. role in combating the global HIV/AIDS epidemic before the Criminal Justice, Drug Policy, and Human Resources Subcommittee July 22, 1999

I want to begin by thanking you, Chairman Mica, for allowing me to make this
brief statement. I also want to commend you and Ranking Member Patsy Mink
for holding this very important and timely hearing today.

It is a sad fact, Mr. Chairman, that the HIV/AIDS virus has perhaps gone beyond
the epidemic realm around the world -- if such a thing is possible. As an
illustration of this fact, the New York Times recently confirmed that AIDS has
now become the leading killer in Africa, only 18 years after the first infection was
recognized. As the richest nation and sole reaming supper power in the world,
the United States must take a leadership role in fighting to eradicate this horrible
disease. It is true that we have done a lot, particularly through our efforts in our
foreign ald budget and our support of international organizations such as the
World bank and UNAIDS and others. But we can and must do more, if there are
to be any meaningful success in stopping this scourge.

But while this hearing today is very timely it is a good thing for us to examine
possible new approaches needed to combat this dreaded disease -- this isn't the
time to start casting stones or assigning blame. And I hope that this is not what
will result from this hearing today.

As Chair of the Congressional Black Caucus' Health Braintrust, I have been at
the forefront of the CBC's efforts to address the problems of AIDS/HIV
domestically because, as you know, the African-American community have also
been severely impacted by this disease. While we have had some success,
particularly through the appropriation of $156 million dollars last year ~ we still
have much to do.

65-308 D-00--8

PIENTED ON RECYCLED PAPER

At the same time, the CBC is also very concerned about the impact of this disease around the world. In this regard, I want to acknowledge the efforts of my colleague Jesse Jackson, Jr., who is among the witnesses you will hear from today. Congressman Jackson and others have been steadfast in their fight to have more done to address this problem globally.

I also want to applaud Vice President Gore for his efforts on this issue and for the role he played in getting the Administration to unvell a new $100 million initiative to combat HIV/AIDS in Africa. This new initiative, as you know, will double the existing efforts to prevent and treat AIDS in Africa.

Finally, I want to implore the members of the Subcommittee and all of my colleagues in the House to work with our friends in the pharmaceutical industry to address the challenges to affordable HIV drugs and other treatments getting to the people that need them the most.

Thank you again Mr. Chairman for allowing me to make this statement. I look forward to working with you and the members of your subcommittee in implementing the recommendations that will come from this hearing.

[ocr errors][merged small]
[blocks in formation]

Chairman of the Subcommittee on Criminal Justice, Drug Policy and Human Resources

of the Committee on Government Reform

House of Representatives

B373 Rayburn House Office Building

Washington, DC 20515

New York, July 19, 1999

Mr. Chairman,

Thank you, Chairman for convening a hearing before the subcommittee this Wednesday July 22, 1999 to discuss the US role in combating the global HIV/AIDS epidemic. This hearing has renewed our hope that efforts by Congress and the Administration will take further action on behalf of the millions worldwide affected by this epidemic.

The reality of the AIDS pandemic in Africa and Asia can be overwhelming. The staggering numbers lead some people to believe that no action--in the absence of an effective vaccine-could possibly make a dent in the suffering.

At Doctors Without Borders/Médecins Sans Frontières (MSF), our medical volunteers, with many Americans among them, and our local staff work with one patient at a time. We know that access to effective treatments can and does make a difference. The sad reality is that even in communities where there is sufficient health care infrastructure to administer life-saving therapies, people are dying of treatable infections because of the high prices of these treatments.

In the United States, AIDS care has been transformed with the availability of effective anti-HIV and anti-opportunistic infection treatments. At Doctors Without Borders, we believe that it is possible to share some of these advances with people in developing countries. What if penicillin had been patented-would we have let high prices keep it beyond the reach of entire countries? If the Salk vaccine had received an ironclad patent would we have allowed prices to prevent access?

Times have changed and we clearly understand the need to have patent protection as an incentive to drive investment dollars into research. But we also believe there are ways in which we can humanize the current global pharmacutical market without changing the existing global trade rules.

In an effort to support the pharmaceutical industry, the US government has been exacerbating rather than alleviating the pain caused by AIDS in poor countries.

Take the case of Thailand, a country in which Doctors Without Borders works with local Thai staff to care for people with AIDS. The Thai government had a system whereby it produced generic versions of drugs to treat life-threatening diseases. This system depended on the Pharmaceutical Patent Review Board which had the authority to collect economic data, including the production costs of pharmaceuticals.

The US government, claiming that the Review Board violated the rights of the US pharmaceutical industry, threatened Thailand with higher tariffs on imports of wood products and jewelry. This threat was made during the Asian financial crisis when Thailand was starved for export earnings. Thailand capitulated and therefore today only has access to AIDS antiretrovirals at global prices set by global drug companies-prices 90 percent higher than those of generic drugs (with the exception of AZT which is processed locally).

US trade pressure must stop. We must take the moral high ground and acknowledge that life-saving medicines should not be treated as non-essential goods.

Doctors Without Borders believes that the US and other wealthy nations need to state clearly that they are willing to shoulder more of the research and development burden than poor countries. This means that we should be willing to pay the existing high prices while encouraging drug companies to sell or license their products to poor countries at prices that cover manufacturing costs plus a reasonable profit margin.

Our demands are not radical when you consider that safety valves already exist in current global trade law that facilitate this dual pricing strategy. We ask only that the US government stop trying to prevent poor countries from enacting these legal provisions such as parallel imports and compulsory licensing.

The drug industry claims that without high prices in poor countries they will not be able to fund research and development. This argument falls flat when you consider that at current prices a tiny minority of people is currently buying these treatments. IMS, an authority on pharmaceutical marketing, estimates that by the year 2002 Asian countries will account for only seven percent of the worldwide market.

The US government must stop supporting a policy that benefits the pharmaceutical industry at the expense of people with life-threatening diseases. We believe it is possible to strike a more humane balance.

Daniel Berman, Doctors Without Borders/Médecins Sans Frontières

Reprinted from JAMA The Journal of the American Medical Association January 27, 1999 Volume 281 Copyright 1999. American Medical Association

SPECIAL

COMMUNICATION

Access to Essential Drugs in Poor Countries

A Lost Battle?

Bernard Pécoul, MD, MPH Pierre Chirac, PharmD Patrice Trouiller, PharmD Jacques Pinel, PharmD

T

HE EFFECTIVENESS OF DRUGS DE

pends on a long chain of factors: research and develop ment (R&D) of an appropriate pharmaceutical agent, production, quality control, distribution, inventory control, reliable information for health care professionals and the general public, diagnosis, prescription, financial accessibility, drug dispensing, observance, and pharmacovigilance. At each level, those involved may have conflicting interests, and poor populations are the first to suffer the effects of frail links in this long chain. Today, entire populations lack access to essential quality drugs, and the situation appears to be deteriorating, further marginalizing much of the world's population.

Essential drugs are the foundation for nearly every public health program aimed at reducing morbidity and mortality in the developing world, and pharmaceutical expenditure can account for a high proportion of the total health expenditure of a country. Important health programs that rely on essential drugs include child survival programs, antenatal care, treatment of enteric and respiratory pathogens, and control of tuberculosis and malaria. Other major public bealth issues exist for which there is no effective pharmaceutical treatment.

This article focuses on 4 main issues associated with the inaccessibility of drugs for populations in greatest need: (1) poor-quality and counterfeit drugs; (2) lack of availability of essential drugs

Drugs offer a simple, cost-effective solution to many health problems, provided they are available, affordable, and properly used. However, effective treatment is lacking in poor countries for many diseases, including African trypanosomiasis, Shigella dysentery, leishmaniasis, tuberculosis, and bacterial meningitis. Treatment may be precluded because no effective drug exists, it is too expensive, or it has been withdrawn from the market. Moreover, research and development in tropical diseases have come to a near standstill. This article focuses on the problems of access to quality drugs for the treatment of diseases that predominantly affect the developing world: (1) poor-quality and counterfeit drugs; (2) lack of availability of essential drugs due to fluctuating production or prohibitive cost; (3) need to develop field-based drug research to determine optimum utilization and remotivate research and development for new drugs for the developing world; and (4) potential consequences of recent World Trade Organization agreements on the availability of old and new drugs. These problems are not independent and unrelated but are a result of the fundamental nature of the pharmaceutical market and the way it is regulated.

JAMA. 1999;281:361-367

due to fluctuating production or prohibitive cost, (3) need to develop field-based drug research to determine optimum utilization and remotivate R&D programs for new drugs for the developing world; and (4) potential consequences of the recent World Trade Organization (WTO) agreements on the availability of old and new drugs. For all these issues, practical recommendations to improve the situation are proposed.

The lack of access to essential drugs or vaccines because of economic reasons raises new human rights issues in a world that remains divided among wealthy countries, developing countries, and the rest of the world. Yet, financial access to drugs does not nec essarily mean correct use. Continuous training for health care professionals, dissemination of reliable pharmacological data, and improvement of the management of drugs are fundamental steps in improving the quality of care in the developing world.

THE PROBLEMS

www.jama.com

Examples of problems related to development and access to drugs and the magnitude of the public health problems concerned are given in TABLE 1.

Counterfeit and
Substandard Products

Drug products must be produced according to good manufacturing practices. Unfortunately, many developing countries do not have the technical, financial, or human resources required for the application of such standards, and some developed countries may be less strict when the product being manufactured is destined for exportation. Today, the quality of drugs and, therefore, their effectiveness and safety are less and

Author Affiliations: Fondation Médecins Sans Frontières, Paris, France.

Corresponding Author and Reprints: Bernard Pécoul, MD, MPH, Médecins Sans Frontières, 8 rue St Sabin, 75011 Paris, France (e-mail: office@paris.msf.org).

JAMA, January 27, 1999-Vol 281, No. 4 361

« iepriekšējāTurpināt »