[Ip-health] Luis Villarroel (Inside Views) for Intellectual Property Watch: New Health Ministry Of Chile Reaffirms Path To Compulsory Licence For Hepatitis C Drugs

Thiru Balasubramaniam thiru at keionline.org
Wed Sep 5 08:26:14 PDT 2018


New Health Ministry Of Chile Reaffirms Path To Compulsory Licence For
Hepatitis C Drugs


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not associated with Intellectual Property Watch. IP-Watch expressly
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Last week, Chilean Health Minister Emilio Santelices, appointed by
President Piñera – who took office this year – rejected an attempt from
company Gilead and a Big Pharma-related association of international drug
makers in Chile to put down the resolution 399/2018 declaring public health
justifications for the issuing of compulsory licences for sofosbuvir to
treat a hepatitis C epidemic in Chile, that was issued by the previous
government of Michele Bachelet.

Luis Villarroel, Director of Innovarte, and Giorgio Jackson, Chair of the
Technology Comittee of the Chilean House of Representatives, with Hep C
patients and other supporters presenting request at the presidential
palace.(January 2018)

Resolution 399/2018 was granted taking into account the thousands of
Chileans infected by hepatitis C and the barrier to treating them all with
the required drugs that is marketed in Chile at an unaffordable price by

The hepatitis C treatment with sofosbuvir, because of the price, until last
year was excluded from the publicly funded drugs provided by the Ministry
of Health. And after a big campaign from patients, it was included, but
only for 350 patients, excluding the thousands of others in need.

After President Piñera took office, and with the swinging from a
left-oriented government to one on the right, Gilead and Pharma displayed a
number of lobbying efforts, ranging from expensive law firms in Chile to
calls to foreign governments, to invalidate the declaration of public
health need for a compulsory licence.

Among these efforts, Gilead lawyers presented a reconsideration request to
the Ministry of Health arguing it did not meet legal grounds, particularly
because it was taking into account the price of the drugs as part of the
justification, and in their view that was not possible according their
interpretation of TRIPS.

Innovarte, the Chilean NGO which started the process in Chile for the
declaration of public health need at the Ministry of Health, and Giorgio
Jackson, member of the Chilean Congress who has led the support for it from
Congress, rebutted Gilead’s allegations. They raised the freedoms granted
in World Trade Organization Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) as well as in the Doha Declaration on
TRIPS and Public Health, and asked the ministry to upheld the declaration.

Finally, the Minister of Health, Emilio Santelices, with Resolution
1165/2018 last week put an end to the controversy and rejected the Gilead
and Pharma allegation, upholding the Resolution 399.

This decision is particularly important not only from the humanitarian and
legal point of view, but from a political point of view. It reflects the
national consensus not only from the left parties but also from the right
in Chile to put first the life and health of Chilean patients despite the
lobbying and pressures to stop the use of legal right to declare a public
health need for a compulsory licence.

The current state of play in Chile also should be seen as a success for
international collaboration among local and international civil society, as
in this process Innovarte and other stakeholders have benefited from the
expertise and support from Knowledge Ecology International and DNDi [Drugs
for Neglected Diseases initiative], and other organisations including
intergovernmental organisations, who in one form or another have provided
support to overcome the lack of experience on this matter on local

Gilead still might try to overturn the decision, taking the case to
national courts, but is unlikely to succeed. Instead, what would be more
logical on their side would be to offer the Ministry of Health a voluntary
licence like the one offered in India and other countries to make such
medicines affordable and avoid the fear of a precedent in the region.

A copy of the resolution and other legal documents related to this process
may be downloaded in Spanish in this link.

Luis Villarroel is the Director of Corporacion INNOVARTE, leading the
process for the compulsory license in Chile.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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