Introduction

Of the more than 36 million people living with HIV/AIDS today, over 95% live in developing countries. Many of them do not have access to even the basic drugs needed to treat HIV-related infections and other conditions. In many of the poorest countries, essential drugs including painkillers, antibiotics, and antituberculosis drugs are in desperately short supply.

Access to antiretroviral drugs is even more limited. In developing countries, less than 10% of people with HIV/AIDS have access to antiretroviral therapy. In Africa - where 25 million people are living with HIV/AIDS - it is estimated that only 10,000 to 25,000 people are currently receiving antiretroviral therapy.

The high price of many AIDS drugs - especially antiretroviral drugs - is one of the main barriers to their availability in developing countries^*. Factors related to affordability may include: patents; limited volume; limited competition; import duties and tariffs; local taxes; and mark-ups for wholesaling, distribution, and dispensing.

* UN agencies and partners are working together to help expand access to the full range of HIV-related drugs, within the context of local health care systems and national HIV/AIDS plans and priorities. A four-part strategy has been adopted to guide and coordinate action on access to HIV-related drugs: (1) rational selection and use of HIV-related drugs (2) affordable prices (3) sustainable financing and (4) reliable health and supply systems.

However, even where less expensive alternatives exist, many decision-makers do not have the information they need to identify those manufacturers which can supply these drugs. They require easier access to comparative prices.

This report sets out to provide that data - providing market information that can be used to help procurement agencies make informed decisions on the source of drugs and serve as the basis for negotiating affordable prices. The aim is to help increase access to drugs for people in developing countries living with HIV/AIDS.

The report is based on surveys of over 200 pharmaceutical manufacturers in 40 countries world wide. It is the latest in a series of reports launched in 2000 and issued twice each year by UNICEF, the UNAIDS Secretariat, WHO, and Mcins Sans Frontis. In addition, the report includes data on prices supplied by manufacturers interested in supplying HIV-related drugs and diagnostics at reduced prices through the Accelerating Access initiative. This initiative was launched by UNICEF, UNFPA, WHO, the World Bank, and the UNAIDS Secretariat in May 2000 in response to an offer from five pharmaceutical manufacturers to supply antiretroviral drugs at reduced prices for use in developing countries. In October 2000, expressions of interest were sought from both research-based and generic pharmaceutical manufacturers interested in becoming potential suppliers of a range of defined products, including antriretroviral drugs, treatment for opportunistic infections, and diagnostics.

Since October 2000, the report has included information on the availability and price range of antiretroviral drugs for use in combination therapy. Of these, two - zidovudine and nevirapine, which are used to prevent mother-to-child transmission of HIV - have so far been included in the WHO Model List of Essential Drugs (MEDL 1999). The report also includes information on essential drugs used to treat a wide range of opportunistic infections, pain-relieving drugs for use in palliative care, and drugs for the treatment of HIV/AIDS-related cancers. And for the first time, it provides information on the range of test kits available for diagnosis of HIV.

Because HIV is a relatively new infection, many of the drugs developed specifically to treat HIV/AIDS are still under patent protection in some countries and marketed at very high prices. However, the report reveals that most of these drugs - including antiretroviral drugs - are also available on the international market as less expensive generic drugs. In addition, some of the major pharmaceutical manufacturers have offered donations of individual drugs - for example, antiretroviral drugs to prevent mother-to-child transmission of HIV - as well as significant reductions on the price of some expensive patented drugs for use exclusively in developing countries. These offers are summarized in the report.

The data provided by manufacturers serve to highlight the multiplicity of suppliers and the very wide variation in the price of some essential HIV/AIDS drugs on the international market. Without this information, there is a risk that low-income countries may be paying more than they need to obtain essential drugs. The biggest price variations highlighted in the report are among the antibacterial drugs used to treat opportunistic infections. For example, ciprofloxacin - used to treat salmonellosis and shigellosis - could be bought for one fiftieth of the maximum price. And among the antiviral drugs, the price of aciclovir varied seventy-fold.

Although the report provides data on the different sources and price range of HIV/AIDS drugs, the information provided is far from complete. Of the over 200 companies contacted during the survey in mid-2000, less than 20% replied with the full information requested. And of the 36 who responded to the request for expressions of interest only 10 replied with sufficient information to be included in this report. Those companies which did not reply or which provided incomplete information have not been included in the listings. The database will be updated as more information is made available.

A major problem in obtaining market information is the complexity of pricing strategies adopted by international pharmaceutical companies. Some drug companies negotiate price reductions on a product-by-product and country-by-country basis. As a result, comparative price information is not easy to obtain.

The report points out that lower-cost copies of drugs^* patented in some countries are produced in and exported by countries where the drugs have not been patented. They can be imported for use in other countries provided those drugs are not patented in those countries.

* Globalization, TRIPS and Access to Pharmaceuticals. WHO Policy Perspectives on Medicines, No. 3. March 2001 revised. http://www.who.int/medicines/

Countries that are not WTO Members and which do not provide patent protection for pharmaceuticals or where such protection has not been sought, and WTO Members that are not obligated to provide pharmaceutical patent protection till 2005 or 2006 or where such protection has not been sought will be able to continue to produce or import generic drugs of assured quality despite the protection that has to be afforded pursuant to the international trade agreement known as the TRIPS Agreement (an acronym for the Agreement on Trade-Related Aspects of Intellectual Property Rights).

The TRIPS Agreement provides transitional periods during which countries are required to bring their national legislation and practices into conformity with its provisions. The latest dates for WTO members were/are: 1996 for developed countries; 2000 for developing countries (as a general rule) and countries in transition; 2005 for the introduction of product patent protection by developing countries in areas of technology (including pharma-ceuticals) not already so protected; and 2006 for least-developed countries (with the possibility of an extension).

TRIPS specifically recognizes the economic, financial, administrative, and technical contraints of the least developed countries. It therefore provides the possibility for further extension of the transitional period.

From the public health sector’s perspective, intellectual property standards, including those specified in TRIPS, should take protection of public health into account. However, the full application of current standards - historically derived from those of developed countries - is not necessarily appropriate for countries struggling to meet health and development needs. Developing countries can therefore use the flexibility of TRIPS provisions and its safeguards to protect public health.

This means that, under certain conditions, the TRIPS Agreement enables governments to authorize the use - manufacture, sale, and import - of patented drugs against the will of the patent owner. In certain circumstances - in the event of a national emergency, non-commercial public use, or remedying anti-competitive practices - some conditions are relaxed. Many enacted such provisions in their national legislation.