[Pharm-policy] Access to fluconazole in less-developed countries

[James Love]

-------- Original Message --------
Subject: [919] Access to fluconazole in less-developed countries
Date: Mon, 08 Jan 2001 01:37:06 MET
From: TREATMENT-ACCESS - TREATMENT-ACCESS <treatment-access@hivnet.ch>
Reply-To: <treatment-access@hivnet.ch>
To: Treatment-access <treatment-access@hivnet.ch>

The Lancet
Volume 356, Number 9247 16 December 2000

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. 

*Carmen Perez-Casas, Pierre Chirac, Daniel Berman, Nathan Ford 

Médecins Sans Frontières, 1211 Geneva, Switzerland
(e-mail:access@geneva.msf.org) 

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. 

Cross-posted from the HEALTHGAP Mailing List healthgap@critpath.org
Taken from:
http://www.thelancet.com/journal/vol356/iss9247/full/llan.356.9247.correspondence.14614.1


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