PRICING STUDY AZT

Over 33.4 million people are infected with HIV world-wide

AIDS is responsible for 2.5 million deaths every year

Over 95% of cases are found in developing countries

Since the discovery of AIDS in the beginning of the 1980's more than 15 antiretroviral (ARV) drugs have been brought onto the market.

All ARV drugs are still under patent and unaffordable for the vast major of people living with AIDS

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AZT (Zidovudine) by Glaxo Wellcome is the first ARV drug discovered

It is an effective drug in both the treatment of HIV/AIDS and the reduction of mother-to-child transmission

AZT appeared on the market in 1987 as one of the highest priced drugs ever marketed

Its patent expires in 2005

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Study concerning the availability and price of AZT

Not a comprehensive study

Comparative overview of AZT prices from different suppliers in different countries

AIM OF THE STUDY

Illustrate the DIFFERENCE OF PRICES of AZT, depending on the country, supplier and existence of competitors

Provide information in order to FACILITATE THE NEGOTIATION of prices

Provide information concerning ALTERNATIVE SOURCES of AZT

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RESULTS

SEVEN alternative manufacturers of the RAW PRODUCT

India, Canada, Spain, Brazil

THIRTEEN alternative manufacturers of the FINISHED PRODUCT

India, Canada, Spain, Thailand, Brazil, US and in Honduras

The PRICES for 100mg capsules (Bulk) vary from

0.37 USD to 2.06 USD

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The VARIATIONS of prices depend on multiple factors but are mostly linked to:

The PATENT SITUATION in the country

The existence of ALTERNATIVE products (COMPETITION)

The LOCAL CAPACITY to produce

The POLICY and CAPACITY of NEGOTIATION of the Ministry of Health

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CONCLUSIONS AND RECOMMENDATIONS

AZT is an ESSENTIAL drug

Price of AZT excludes it from the national list for essential drug list of many countries

The price limits the use of AZT

AZT co-developed by the US National Cancer Institute

R&D was subsidised

AZT was granted the advantages of an orphan drug

A private company has enjoyed 12 years of market exclusivity and continues holding the patent until the year 2005.

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The major determining factor of the price:

EXISTENCE OF ALTERNATIVE PRODUCTS

PATENT SITUATION

EXISTENCE OF LOCAL CAPACITY FOR PHARMACEUTICAL PRODUCTION

POSSIBILITY TO IMPORT ALTERNATIVE AZT PRODUCTS

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CAPACITY OF NEGOTIATION

Patent protection of medicines is contained within the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreements of the World Trade Organisation (WTO).

LEGAL MECHANISMS (Article 31) in order to COMPENSATE EXCEPTIONALLY for the market MONOPOLY OFFERED BY PATENT PROTECTION.

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The possibilities open to countries for the production and import of drugs are determined by the legal environment of their country.

For countries still not compliant with TRIPS:

Negotiate the price with the patent holder

Register the products of generic manufacturers

For countries that already recognise product patents:

Negotiate an affordable price with Glaxo Wellcome

Glaxo Wellcome could agree on a voluntary license

If none of these measures are successful, a compulsory license should be sought