Battling HIV/AIDS: Bank Offers Practical Advice To Poor Countries To Widen Access To Life-Saving Drugs

BANGKOK, July 13, 2004 — With relatively few AIDS-infected people currently being treated with life-saving drugs in developing countries, the World Bank says that growing efforts to expand access to anti-retroviral medicines face serious economic, legal, and medical obstacles. To help developing countries overcome these barriers, the Bank has released a practical, step-by-step, procurement guide for developing countries at the 15th International AIDS Conference in Thailand, (July 11-16), while noting that costs of providing anti-retroviral drugs (ARVs), and other medicines for HIV-related illnesses, are still very high, and are likely to remain so for some time.

According to Battling HIV/AIDS: A Decision-Maker's Guide to the Procurement of Medicines and Related Supplies, even when developing countries take full advantage of the lowest possible prices on the global market, the annual cost of treating people with anti-retroviral drugs (ARVs) is much higher than the national healthcare budget of most poor countries. Furthermore, if many of these countries are unable to buy low-cost drugs because of patent restrictions, or they encounter drug resistance and have to resort to more expensive alternative medicines, substantially higher prices could again be the end result.

"With forty million people worldwide currently living with HIV/AIDS, and another 45 million potentially at risk of infection by 2010, HIV/AIDS is not just a critical health problem - it is a defining development problem of our time," says Jean-Louis Sarbib, the World Bank's Senior Vice President for Human Development. "We hope this guidebook will help developing countries deal with the enormous complexities associated with drug procurement, a key link in the HIV/AIDS treatment chain, and will ease the burden of public health officials and treatment providers in developing countries as they struggle to provide life-saving therapy to all who need it."

Widening access to treatment faces serious problems

Most people with HIV live in poorer countries or in marginal groups and do not have access to treatment. Of the roughly 40 million people living with HIV in developing countries, six million urgently need treatment. However, by 2003, only 7 percent actually had the drugs they needed to survive. With greater numbers of infected people needing treatment in poor countries, the World Bank, and other development agencies are committed to expanding access to anti-retroviral treatment as an important element of their support for improving public health and containing the HIV epidemic, while continuing to amplify the continuing importance of prevention and care.

"As the AIDS agenda world-wide moves from advocacy to implementation, it is imperative that the international development community moves quickly to expand access to antiretroviral treatment so that it reaches poor people and marginalized sections of society" says Debrework Zewdie, Director of the World Bank's Global HIV/AIDS Program, and architect of a new Bank partnership with the Global Fund, UNICEF, and the Clinton Foundation to help developing countries buy high-quality AIDS medicines at low prices. "Considering that treatment is a long-term commitment to people living with AIDS, developing countries need to go about it in a systematic manner, making sure, for example, that they have solid procurement and supply chain systems, so that treatment is sustainable and life-saving ."

Zewdie says widening access to ARVs and other HIV-related medicines will need to overcome serious practical challenges. Poor countries and communities have many other competing priorities. Insufficient money, limited technical know-how, and too few skilled workers, mean that many countries face problems in reaching existing goals for health services and social support. Lack of infrastructure is not a reason to delay ART, but expanding access must include measures to improve the general context of health care and support. And such plans have to be developed within the local context to be acceptable and effective.

Planners and decision-makers must have a clear understanding of the importance of treatment in tackling HIV and ensure that specific services and facilities be included in efforts to expand treatment. These should include:

ARV prices a roadblock

Despite some dramatic reductions in the past three years, the costs associated with ARVs and other medicines for HIV-related problems are still very high and may remain so in the future. Even the lowest available prices are unaffordable for most patients in the developing world, where about 3 billion people live on less than $2 a day. For governments in poor countries, the purchase price for ARVs directly affects the number of patients that can be treated. And lower prices leave more money for investing in complementary health infrastructure needed for effective treatment.

Prices for ARVs can vary substantially, with markedly different prices for the same drugs sold by the same manufacturer under similar conditions across countries. Prices may vary by as much as 300 percent in the developing world alone.

In addition, prices can also vary substantially over time, due to improvements in production technologies and more competition. For example, four years ago, triple cocktail ART was priced at $10,000–15,000 per patient per year in the United States. Today, the same therapy can cost as little as $200–300, if sourced from the Indian pharmaceutical industry. New and more expensive ARVs are needed as patients develop resistance to first-line ARVs. Research into new drugs to combat HIV is ongoing, and two new classes of ARVs are showing some promising results. So-called 'fusion inhibitors' interfere with HIV's ability to enter human cells, and enfuvirtide (Fuzeon) is the first of this class to be placed on the market, but it is currently priced too high for widespread use. 'Integrase inhibitors' interfere with HIV's ability to insert its genes inside normal DNA in human cells.

The World Bank strongly supports expanding access to high-quality, inexpensive AIDS drugs, and relies on the World Health Organization to assess the quality of the drugs and the suppliers of those drugs. Bank funds can be used to buy generic ARVs as long as the drugs in question have been pre-qualified by the WHO, the country is acting according to its own laws, and in the context of international laws in reaching an agreement to purchase ARVs.

ARVs and intellectual property rights

The procurement of HIV/AIDS–related medicines and supplies is directly affected by intellectual property rights, most notably patents. The subject of intellectual property is very complex, and are confusing even to the most highly trained specialists. Yet procurement authorities cannot avoid the subject. When supplies of low-cost, high-quality medicines are sought from "generic" producers, holders of patents on those same medicines may object. But procurement authorities may be able to overcome patent obstacles by using "flexibilities" established by international agreement. These flexibilities were recently affirmed in August, 2003, by the World Trade Organization (WTO) as it addressed the relationship between intellectual property rights and public health.

The acquisition of HIV/AIDS-related medicines or supplies is complicated by the fact that intellectual property rights are generally granted for a particular country (or region). The presence or absence of a patent in one country does not ensure the presence or absence of a patent in another country. Even though a medicine, such as an ARV, may be off patent in India, it may not be in South Africa. Because of this, a patent holder in an importing country may object to the import of a medicine that has been lawfully produced and sold (is generic) in an exporting country, based on a patent in the importing country. Whether the patent holder in the importing country will be able to block importation and distribution depends on various factors, including the legislation of the importing country, steps the government has taken or may take under that legislation, and the character of the purchase transaction. This is why it is important for governments to pay close attention to including new WTO flexibilities in their national legal framework; that is, to allow for actions that are important to protecting public health.

"Every nation has an inherent right to protect the health of its people, and intellectual property rules cannot take away this fundamental right,"says Yolanda Tayler, editor of the new handbook, Battling HIV/AIDS, and a Senior HIV/AIDS Procurement Officer with the World Bank. "But governments in developing countries owe it to themselves and their citizens in need of anti-retroviral treatment to get early clarification of the intellectual property rights situation, registration requirements, and import regulations, to prevent frustration, wasted time and money, and possible litigation."

Tayler says procurement is only one link in this large network of factors affecting the HIV epidemic. Yet, it is clearly vital. Successful treatment depends on continuous, reliable supplies of the necessary medicines and related commodities. Without sustained access to anti-retrovirals, the challenge of treatment cannot be met - and the ravages of the epidemic will continue

What is the World Bank doing to expand access to treatment?

The Bank supports a comprehensive approach to fighting HIV/AIDS and poverty consisting of HIV prevention, care and treatment. This approach emphasizes partnerships with national governments, the private sector, communities, non-governmental organizations (NGOs) and people living with HIV/AIDS.

The Bank supports treatment programs in Africa, the Caribbean, and now in Asia (beginning with Bhutan, Sri Lanka, and Thailand). In addition, the Bank: