[Ip-health] Access to medicines: Indonesia opens great precedent, Brazil is moving in the wrong direction.

Pedro Villardi pvillardi at gmail.com
Mon Oct 29 11:55:43 PDT 2012


It is becoming public a measure adopted by Indonesia, the fourth most
populous country in the world, to enable greater access to treatment for
AIDS and Hepatitis B in the country. In September, the President Dr. H.
Susilo Bambang Yudhoyono signed a decree authorizing the government to use
patents of seven drugs for HIV/AIDS and Hepatitis B. If this measure is
actually implemented, the government can buy cheaper versions of these
drugs to use in the country health programs. This way Indonesian government
will prevent high prices due to monopolies created by patents of
multinational companies like Gilead, Bristol, Boeringher, Glaxo, Merck and
Abbott from affecting the government's ability to fulfill its obligations
towards the right to health.

The Working Group on Intellectual Property of the Brazilian Network for the
Integration of Peoples (GTPI/Rebrip, acronym in Portuguese) supports the
initiative of the Indonesian government and congratulates activists working
in the country making the government more sensitive about the importance of
ensuring access to medicines, especially activists from the International
Treatment Preparedness Coalition and (ITPC) Indonesia, which has struggled
for compulsory licensing of patented drugs for second-line HIV/AIDS
treatment, some of which can cost $ 2,000 per patient/year.

According to UNICEF, it is estimated that 310,000 people live with HIV in
Indonesia. Among the 70,000 people who need antiretroviral treatment, only
23.000 have access today. Moreover, the country has one of the highest
growth rates of the epidemic across Asia. Much of the funding for the fight
against AIDS in the country comes from international sources such as the
Global Fund to Fights AIDS, Tuberculosis and Malaria. However, the
reduction in international contributions resulting from retreats of donors,
can threaten the supply of treatment. The Indonesian government has
invested more resources in the national response to the epidemic, but
without the adoption of measures to reduce the costs of treatment, such as
governmental use, it becomes impossible to promote access for all who need
it.

This is a clear example that countries can and should make use of legal
mechanisms so that public health needs prevail over commercial rights.
These mechanisms are foreseen in the TRIPS Agreement of the World Trade
Organization (WTO) and are known by the term "flexibility" or "public
health safeguards", and their use is recommended by the World Health
Organization (WHO) and by others agencies of the United Nations (UN) to
guarantee access to health. The government's use of these mechanisms, and
has already been used in Indonesia in 2004 and in 2007 (for the anti-AIDS
drug efavirenz, lamivudine and nevirapine). The presidential decree of 2012
adds six more drugs to the list: abacavir, didanosine, tenofovir, and the
combinations: lopinavir + ritonavir, tenofovir + emtricitabine and
tenofovir + emtricitabine + efavirenz.


The measure adopted by Indonesia is one of the most extensive use of a
measure to protect public health since the establishment of the TRIPS
Agreement in 1995. This is an important precedent for other countries,
especially in the current situation, when an escalation of prices of
anti-AIDS drugs threatens the sustainability of the response to the
epidemic in many parts of the world. Without the "flexibilities" as the
government use of patents, it is likely that governments can not afford the
cost of access to treatment programs for their populations.

The measure adopted in Indonesia is part of a resurgence of global use of
flexibilities. Earlier this year, India issued its first compulsory
license, reducing a 97% the price of the anti-cancer drug price sorafenib.
Also this year, China made amendments in its intellectual property law to
allow the government to issue compulsory licenses to local generic
producers can manufacture drugs still under patent in cases of national
emergency or public interest.

Brazil, which has always been taken as a reference in defending the use of
flexibilities, is now in the wrong side of the road, heading to the
opposite direction of this increasing use of flexibilities as a model
capable of ensuring the sustainability of universal access programs.

Instead, the country invests in negotiating voluntary licenses of
technology transfer with patent holders as a model that could combine
secure access and industrial development. This change in policy direction
is worrying, as it lacks information about the contracts of transfer of
technology and about how they can ensure that the expenditures to transfer
the technology will not threat universal access. Despite the lack of
transparency, there are indications that Brazil would be paying a very high
price for technology transfer and also that the technology would be
transferred gradually and slowly. Despite all that, the strategy adopted by
the Ministry of Health, which aims to reduce the trade deficit in the
sector through incentives for national industry, could be combined with the
strategic use of flexibilities as advocated by the country in the
international arena, such as compulsory licensing, when possible, but this
does not seem to be the predominant political will.

Furthermore, it is noteworthy that even with different provision,
legislation in most industrialized countries and developing countries -
USA, Germany, Spain, UK, Canada, Australia, China, Indonesia, India,
Malaysia, to name a few, foreseen ther government use of patents. The
Brazilian patent law, Law 9279 of May 14, 1996, in turn, includes important
safeguards such as compulsory licensing, but is silent as to safeguard
represented by governmental use.

We hope that the precedent set by Indonesia also serves to engender a
discussion on reform of Brazilian legislation on industrial property to
include mechanisms such as governmental use of patents and other measures
that could be used to leverage public policy and meet important social
needs in the public health sphere, and also of culture, education, food
security, among others, when the protection of intellectual property is an
obstacle to its implementation.

The GTPI conducted a study to find out if provisions to protect public
health are foreseen in the Brazilian intellectual property law, with
analysis of the law bills on the issue and recommendations for legislative
changes that could enhance the promotion of access to treatment and the
right health in Brazil. Results can be found (in Portuguese) at:
www.deolhonaspatentes.org.br > “observatório de patentes” > “no
Legislativo”.

*What is the difference between compulsory license and governmental use?*
*
*
*Through the "government use of patents" the Government has the right to
use or authorize others to use on its behalf and for specific purposes of
the Government, any patent granted by him, whether product or process, and
upon notice to the inventor establishment of adequate compensation. Note
that this compensation is not equivalent to "royalties" commonly fixed in
voluntary or compulsory licensing that has commercial objectives. Here it
comes to establishing just compensation to the inventor, which is unrelated
aspects of profit, always present in commercial operations. The fundamental
difference between compulsory licensing and government use is that the
governmental use is restricted to a specific use of the government,
especially not commercial. The Government, or its contractors or
authorized, can not sell the product object of government use and thus are
unable to compete with the patent holder.*



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