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From: PlusNews <[email protected]>
Date: Mon, Mar 25, 2013 at 5:32 PM
Subject: Indonesia to override patents for live-saving medicines
To: Elisabeth Janaina <[email protected]>


Indonesia to override patents for live-saving medicines

JAKARTA, 25 March 2013 (PLUSNEWS) - 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 Association of Indonesian Physicians Concerned about HIV/AIDS,
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 [
http://www.ihs.com/products/global-insight/industry-economic-report.aspx?id=1065972339
] 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] [
http://www.ihs.com/products/global-insight/industry-economic-report.aspx?id=1065972339
] will be available in the next three to six months. For other drugs,
[we] will need more time," Djauzi said.

According to UNAIDS, [
http://www.unaids.org/en/regionscountries/countries/indonesia/] 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 [ http://pubs.aeaweb.org/doi/pdfplus/10.1257/jep.27.1.3
], however, argue there is no empirical evidence that patents increase
innovation and productivity.

Peter Maybarduk, who directs the Global Access to Medicines Programme
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.

bb/ds/rz
[END]

This report online: http://www.plusnews.org/report.aspx?reportID=97728



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