SUMMARY

Fluconazole has become a drug of particular media interest due to the sensitive situation of anti-AIDS medications and their pricing in third world countries.  This position was escalated when in October 2000, the South African AIDS activist group, Treatment Action Campaign (TAC) launched a Defiance Campaign Against Patent Abuse by smuggling fluconazole, an otherwise unaffordable drug, into the country.  TAC even has the support of proffesionals in the country to secure access to life-saving AIDS medications.  The TAC defiance campaign is not the first effort by South African activists to access fluconazole and other essential, life-saving medications used to treat HIV and AIDS-related illnesses for fractional prices.  Pfizer has made drug donations but no substancial action has been taken to make the drug available.The Defiance Campaign is an important, precedent-setting challenge to the pharmaceutical industry and the intellectual property laws used to protect its profits.

DEMANDS:


BACKGROUND

In March, 2000, TAC and its U.S. ally, the Health GAP coaltion challenged Pfizer to lower the price of fluconazole, or to release the patent on the drug, which would allow South Africa to legally produce a generic version of the drug, or to import a low-cost, generic version from another country. Both generic production and third-party importation are legal under international trade laws.
In April, in response to international activist pressure, Pfizer broke news in April of a restricted "donation program" not to the South Africa activists or the South African government, but to the Wall Street Journal. Pfizer offered to provide fluconazole to HIV-infected individuals with cryptococcal meningitis who could not afford the drug. There was no indication of how long the donation would last, or how much of the drug would be made available. The offer has since proved to be an empty public relations strategy on the part of a multibillion dollar corporation.

Eight months later, Pfizer had not shipped a single fluconazole tablet to South Africa.

People in South Africa continue to die from conditions that can be treated, and prevented, with fluconazole.

Cryptococcal meningitis is the most frequent systemic fungal infection among HIV-infected persons.
Without treatment, life expectancy is probably less than a month. UNAIDS, October 1998.

On average this opportunistic infection affects 9% of people living with AIDS. In some countries the prevalence is much higher (19% in Zaire, 20-25% in Thailand).

Crytococcosis is relatively easy to diagnose. However, treatment (...) and secondary chemoprophylaxis are often impossible in developing countries because of the high cost and limited availability of the drugs required. UNAIDS, October 1998.

Price of Fluconazole

Fluconazole was patented in 1983 by Pfizer in the form of 200-mg tablets (brand name Diflucanâ). The patent will not expire before January 29, 2004 in USA (2005 in some countries like France). For those countries in which it is patent protected, fluconazole cannot be imported or produced by anyone but Pfizer.

Current price of Diflucanâ offered by wholesalers ranges from $US 9.34 per 200 mg capsule in the private sector in South Africa, to $US 27.60 in the private sector in Guatemala.

In countries where the patent is not recognized, alternative sources of fluconazole exist; in these countries patent law was not in force when Pfizer was granted the patent in 1983. In India fluconazole is produced locally by various generic drug manufacturers as Cipla, who sells fluconazole at $US 0.64 per 200 mg capsule. Similarly, In Thailand fluconazole is not patented. However, under pressure from the US, the Thai Food and Drug Administration implemented a process called the Safety Monitoring Programme, which effectively conferred a period of market exclusivity as a patent would. Thus, the generic local industry was not allowed to produce this molecule until last year 1998. Before that time, Pfizer price per capsule 200 mg was around $US 7, after fluconazole was released from the Safety Monitoring Programme, three Thai companies began to produce it. Against this competition, Pfizers decreased their price to $US 3.60. Nevertheless, the current price of the generic product is significantly cheaper. For example, Biolabís price is six times cheaper (August 1999: $US 0.60 per capsule of 200 mg). This obviously makes an enormous difference in compliance to a patient who must take a capsule everyday of his/her life.

It also underlines the effect of competition on drug pricing, particularly in a country like Thailand where there is no governmental control on pharmaceutical prices. This is even true in Europe: for example, in Spain, benefiting from its previous Patent Act (which did not recognize product patent but process patent), there is local production of fluconazole; the cost being 20% less than Pfizers price.
 
Table 1. Wholesaler prices of fluconazole capsules in September 1999 in US$

Manufacturer; country of

production

Brand name Country Price per unit

(US $)

BIOLAB 

(Thailand)

Biozole  Thailand 0.60 
CIPLA 

(India)

Forcan  India 0.64
PFIZER Diflucan  Thailand 3.60
PFIZER Diflucan  South Africa 9.34
PFIZER Diflucan  USA 10.00
PFIZER Diflucan  Kenya 10.50
VITA 

(Spain)

Loitin  Spain 10.63
PFIZER Diflucan  Guatemala (public sector) 11.90
PFIZER Diflucan  France 12.60
PFIZER Diflucan  Spain 13.37
PFIZER Diflucan  Guatemala 

(private sector)

27.60

At the level of the national health expenditure, the price is of course crucial: in 1995, fluconazole was the 5th Thai drug expenditure, with around $US 4 million Pfizerís fluconazole world sales were $US 881 million in 1997.

Consequences of price differences of fluconazole

Using the above prices, if South Africa imported generic fluconazole from Thailand the national cost of treating 10.000 patients of cryptococcal meningitis in South Africa will decrease from $US 34.80 million to $US 2.16 million per year of maintenance treatment.

In other words, each year, with a given budget of $US 2.16 million, South Africa would be able to treat 620 patients with Pfizerís fluconazole but 10, 000 patients with generic fluconazole imported from Thailand. This means 9,380 lives saved each year for the same budget.
 
Table 3. Savings for the cryptococcal meningitis maintenance treatment when different sources of fluconazole are available

Source; Country Cost of maintenance treatment ($US) per year per 10,000 patients Number of patients treated per year with a budget of 2.16 million US$
Biolab, Thailand 2.16 million 10,000
Pfizer, South Africa 34.80 million  620

Conclusions

World-wide, there is a problem of access to life-saving drugs for the majority of AIDS patients. Most of these drugs are still patent protected marketed at prohibitive price for developing countries.  This limited study of fluconazole pricing in different countries presented here illustrates the critical influence a patent can play in access to medicines.

Hopefully these recommendations can be implemented as soon as possible as many people still continue to suffer or die needlessly due to the politics of the drug.