Avian flu: Bending the law to save life

Maya Lestari, Jakarta

Drug patents give to an inventor for a term of years the exclusive right to make, use or sell their invention -- meaning that other companies cannot make or market the drug until the patent expires.

The World Health Organization (WHO) has recommended that susceptible countries, including Indonesia, stockpile the oral antiviral drug oseltamivir, the only drug recommended by the WHO for the treatment of infection caused by avian influenza.

Roche, the patent holder of oseltamivir (marketed as Tamiflu) has increased production capacity to meet the demand. However, the supply cannot meet the required demand of countries wanting to stockpile Tamiflu for the impending epidemic.

In her last days in office, then president Megawati Soekarnoputri signed a presidential decree on compulsory licensing. The decree basically dictated that, in the event of a public health emergency, the government reserved the right to disregard patent protection and produce (or have someone produce on its behalf) the drug.

Interestingly, within a month of the decree's issuance, the then-minister of health Sujudi applied the ruling to the production of two anti-HIV drugs. With the approval of the ministers of finance and health, the patent rights to the antiretroviral drugs were legally infringed, the first time ever in Indonesia for anti-HIV drugs. The government asked a state- owned pharmaceutical firm (Kimia Farma) to manufacture the drugs on its behalf and marketed the drugs at a much reduced price.

The pharma companies whose patent rights had been infringed were, of course, not happy.

However, the law clearly stipulates that should the pharma companies bring the Indonesian government to court, the legal battle will not postpone the implementation of the compulsory licensing. Hence, the outcome of the legal process would affect merely the amount of compensation and/or fee. The production can still go.

An analogy of HIV/AIDS and avian influenza:

It is obvious that bird flu presents one of the biggest public health threats since the last three global flu epidemics (1918, 1957 and 1968). Avian flu is also more infectious than HIV and probably more fatal. It merits a coordinated approach.

So far, Indonesia has received 40,000 doses of oseltamivir from WHO (adequate for about 4,000 patients). Australia has also donated 40,000 doses to the government. However, the country's needs are much higher than that.

Oseltamivir is a neuramidase inhibitor, which interrupts the budding and release of new viruses from the infected human cells. Hence, the drug is only effective when given to patients who have early acute infections (within three days from the time the virus enters the host) and loses its effectiveness as infection progress.

So the key to containing a potential outbreak in a sub- district within Indonesia is to identify and confirm rapidly the suspected avian influenza cases, provide drugs to the confirmed patients and possibly to high-risk individuals near the victims as prevention.

This require the availability of a huge amount of oseltamivir, distributed to cities throughout the country. The stockpile must not stay in Jakarta because the drug would lose its efficacy as the days went by.

In anticipation of a possible global pandemic, the Ministry of Health should capitalize on Presidential Decree 2004 on Government Licensing to mass produce oseltamivir locally. One of the state-owned pharmaceutical companies would be able to import bulk raw materials, manufacture and market oseltamivir for the government without fear of patent infringement and legal prosecution.

The general public would benefit from the containment of the disease should a pandemic occur, and farmers specifically would indirectly benefit through fewer poultry culls. It should be noted that the United States also has such compulsory licensing provisions and is probably the biggest user of compulsory licensing.

The writer is an Alumni of the School of Dentistry, Specializing in Prosthetic Dentistry, University of Indonesia (2004) and can be reached at drgmayalestari@yahoo.com