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Jakarta
chooses saving patients' lives over protecting patents
The
Indonesian government hopes to implement one of the largest ever examples of
"compulsory licensing," which will enable the generic manufacture of
drugs still under patent. Advocates of the move say the reduced drug costs
achieved through compulsory licensing have been instrumental in reducing HIV
mortality rates in Indonesia.
"One
of the major reasons for decreased HIV mortality rates is the provision of
anti-retroviral [ARV] treatment, and if [Indonesia] can't afford the
anti-retroviral treatment, the mortality rate will return" to the higher
levels of previous years, Samsuridjal Djauzi, chairman of the Indonesian
Association of Physicians in AIDS Care, told IRIN.
The latest
use of compulsory licensing - Indonesia's third to date - will allow the
government to expand its access to the second-line ARVs, he said, including
tenofovir, emtricitabine, and lopinavir/ritonavir.
Under the
World Trade Organization's Trade Related Aspects of Intellectual Property
Rights (TRIPS), countries can override patents for public health purposes by
issuing compulsory licenses that enable the generic manufacture of drugs still
under patent.
"Urgent
need"
In this
latest move, a September 2012 presidential decree announced the government
would procure generic equivalents of the international patents for seven
HIV/AIDS and hepatitis B medicines, citing the "urgent need" to
control these diseases.
"The
implementation of the third compulsory licensing depends on the
capability/readiness of the manufacturer [Kimia Farma]. I estimate efavirenz
[another HIV medication on the list] will be available in the next three to six
months. For other drugs, [we] will need more time," Djauzi said.
According
to UNAIDS, an estimated 380,000 people are living with HIV/AIDS in Indonesia.
The number may not appear alarming considering that Indonesia is a developing
country with nearly 250 million people, but the prevalence rate is now 25
percent higher than it was a decade ago.
The spread
of HIV is attributed to low condom use and epidemic-level infection rates -
36.4 percent - among injecting drug users, experts say.
The cost of
normal treatment is around US$90 per person per month, Usep Solehudin, who
coordinates free distribution of ARVs for some 120 patients at a clinic in
Jakarta called Yayasan Pelita Ilmu (YPI), told IRIN. This is beyond the means
of most of his patients, whose incomes are generally $100 to $200 per month.
"The
patients would not otherwise be able to buy it [the ARVs] because they cannot
afford it," he said. "They would just ignore their health."
Jakarta
first used compulsory licensing in 2004, ushering in increased medication
access.
The number
of Indonesians receiving ARVs has quadrupled since 2008, to 30,000 today, and
the government is looking to maintain this rate of expansion, said Cho Kah Sin,
country director of UNAIDS in Indonesia.
The latest
government license focuses on second-line ARVs, which are prescribed to
patients who have developed resistance to first-line treatment. Resistance in a
population tends to develop within several years of a drug's introduction. The
government is therefore expecting that increasing numbers of Indonesians with
HIV will require second-line treatment, said Cho Kah Sin.
Innovation
at risk?
Critics of
compulsory licensing say its usage undermines medical innovation.
"Systematic
issuance of compulsory licenses sets a negative precedent and can reduce the
incentive to invest in the research and development of new medicines that
address unmet medical needs," said Andrew Jenner, director of innovation,
intellectual property and trade at the Switzerland-based International
Federation of Pharmaceutical Manufacturers and Associations, in a written
statement to IRIN.
"We
believe that negotiated approaches, such as tiered pricing and voluntary
licensing, are generally more effective and sustainable, both medically and
economically," said Jenner, whose organization represents four
pharmaceutical companies whose medicines are to be generically replicated by
Indonesia. Tiered pricing is the practice of setting different prices for
different markets.
Others
studies, however, argue there is no empirical evidence that patents increase
innovation and productivity. Peter Maybarduk, who directs the Global Access to
Medicines Program for Public Citizen, a US-based NGO, advocates wider use of
"compulsory licensing" by developing countries. "We don't think
compulsory licensing should only be used in the most dire scenarios," he
said.
Switzerland-based
Michelle Childs, who heads the Campaign for Access to Essential Medicine for
Médecins Sans Frontières, agrees: "If there is a clash between access to
[essential] medicines and patent rights... the primacy of access should be
promoted," she said.
Maura Linda
Sitanggang, director-general of the pharmaceutical department at Indonesia's
Ministry of Health, did not respond to requests for an interview.
(IRIN is a
service of the United Nations Office for the Coordination of Humanitarian
Affairs. This report does not necessarily reflect the views of the United
Nations)
