PHM-Exch> Access to medicines: Indonesia opens great precedent, Brazil is moving in the wrong direction.

[Claudio Schuftan]

>From David G Legge <dglegge01 at gmail.com>

>
> From: ip-health-bounces at lists.keionline.org
>
>
> 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.
>
> 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.
>
> *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.*/listinfo/ip-health_lists.keionline.org<http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org>
>
>
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