Bending the law to save lives: Avian flu in Indonesia

Bending the law to save lives: Avian flu in Indonesia

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