Need a national consultation on ' Access to HIV medication in India'

[Guest guest]

Dear Forum members,

It may be of interest to note that gloabl trade laws have a greater

impact on who gets HIV medicines in India. We may be able to claim

that we have made substantial gains in the area of HIV prevention.

But one should remember that HIV prevention projects are not a

substitute for treatment for people living with HIV/AIDS. Indian AIDS

NGO, organizations of people living with HIV/AIDS and policy makers

may have to take a close look on the issue of how HIV medications are

produced and marketed in India. Many of the Indian drug companies do

have the technical capacity to produce HIV medications in India.

However, we have yet to examine the barriers of trade laws, and how

it affect access to HIV medication in India.

As there are many issues related to the trade on HIV/AIDS medications

in India are not yet clear, we urgently need an national consultation

on 'issues related to access to HIV medication in India'.

The following is an article on how Access to fluconazole in less-

developed countries are affected by trade laws.

Thanks.

Joe

joe@...

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Access to fluconazole in less-developed countries

Sir--When life-saving medicines are unaffordable because of high

prices resulting from exclusive marketing rights (patents),

intellectual property protection threatens people's health. If the

price of medicines puts them out of reach of those in need, national

governments should be encouraged to produce or import generic

versions, as is their right within international World Trade

Organisation agreements.1 This issue has been highlighted through the

high price of fluconazole in South Africa.2 Médecins Sans

Frontières

(MSF) assessed the price variation of fluconazole and investigated

alternative sources in different countries to help to increase access

to life-saving drugs. Affordable fluconazole has been introduced in

MSF projects in Cambodia and Guatemala. We would like to extend this

example to other countries.

Fluconazole is a key drug in the treatment of cryptococcal meningitis.

This disorder affects around one in ten people who have AIDS. In some

countries, the prevalence is up to 25%. Without treatment, life

expectancy is less than 1 month. The recommended regimen is 400 mg

fluconazole daily for 12 weeks, followed by lifelong maintenance

therapy (200 mg daily).3

In many countries that recognise medicine patents, Pfizer has had a

market monopoly for fluconazole for the past 12 years. Their patent

will not expire before 2004 in the USA and even later in some

countries. Worldwide sales of Pfizer's fluconazole made US$1002

million in 1999 (www.pfizer.com accessed Nov 28, 2000). Pfizer sells

fluconazole in less-developed countries at the same prices as those

in more-developed countries and has so far refused to offer voluntary

licences in poor countries so that other health ministeries could

arrange for production or importation of an affordable generic

supply.

We limited the study to eight countries where MSF runs HIV and AIDS

programmes or that produce, and so could supply, fluconazole. In those

countries where fluconazole is not patented, we obtained generic and

Pfizer's private wholesale prices. In all cases, generic drug supplies

came from manufacturers that have Good Manufacturing Practices

approval and have their product registered in the country of origin.

The comparison of prices is shown in the table. If South Africa were

to import generic fluconazole from Thailand, the cost of 1 year's

maintenance treatment would drop from $2970 to $104. This change would

have a striking effect on access and adherence to treatment.

Manufacturer (country of production) Country of distribution Price per

unit (US$)

Biolab (Thailand) Thailand 0.29

Cipla (India) India 0.64

Bussie (Colombia) Guatemala (negotiated) 3.00

Pfizer Thailand 6.20

Vita (Spain) Spain 6.29

Pfizer South Africa 8.25

Pfizer Kenya 10.50

Pfizer Spain 10.57

Pfizer Guatemala (negotiated) 11.84

Pfizer USA 12.20

Pfizer Guatemala (not negotiated) 27.60

Wholesale prices of 200 mg fluconazole capsules in June, 2000

In less-developed countries, where fluconazole is patent-protected,

Pfizer should lower the price to generic levels so that people can

access this life-saving treatment, but so far has refused to do so. In

South Africa, the Treatment Access Campaign (a local activist group)

asked for a price reduction or a voluntary licence to allow generic

production. This request was supported internationally by MSF. Pfizer

responded by announcing that it would provide a donation,4 but no drug

has yet reached patients.

An adequate response to the overwhelming burden of infectious diseases

will never be possible through limited donations from multinational

pharmaceutical companies. Ultimately, the power to ensure access to

affordable essential medicines remains with national governments that

can negotiate prices based on comparative price data, register generic

producers when possible, and issue compulsory licences when necessary.

International organisations such as WHO and UNAIDS have an important

role in gathering objective price data and providing technical support

to activate World Trade Organisation safeguards to override patents

when necessary.

____________________

The Lancet. Volume 356, Number 9247 16 December 2000

*Carmen -Casas, Pierre Chirac, Berman, Ford

Médecins Sans Frontières, 1211 Geneva, Switzerland

(e-mail:access@...)

1 WHO. Globalization and Access to Drugs: implications of the

WTO/TRIPS agreement/WHO/DAP.98.9. Geneva: WHO, 1997.

2 Baleta A. AIDS activists force attention to fluconazole in South

Africa. Lancet 2000; 356: 1584.

3 WHO, Drugs used in HIV-related infections, WHO model prescribing

information, DMP/DSI/99.2, Geneva: WHO, 1999.

4 Waldholz M. Pfizer plans to provide Diflucan drug at no cost to

South Africans with AIDS. Wall Street Journal 2000; March 4.