[Ip-health] Chile Ministry of Health Takes Next Step Toward Compulsory License on HCV Drugs, Announces Public Health Justifications

Andrew Goldman andrew.goldman at keionline.org
Sat Mar 10 11:38:28 PST 2018

In an order dated the 9th of March, 2018, Minister Carmen Castillo Taucher
of Chile’s Ministry of Health has announced that there are sufficient
public health reasons to support a compulsory license on medicines for the
hepatitis C virus (HCV), as requested by Corporacion Innovarte, Fundacion
Renacer, members of the Chilean Congress including Giorgio Jackson, Karla
Rubilar, Miguel Angel Alvarado, and Gabriel Boric, and patients in March
2017. The announcement is Ordinario A15 No.1135.

The determination of public health justifications is not the compulsory
license itself, but rather satisfies the requirement under Article 51(2) of
the Chilean Law of Industrial Property No.19.039, allowing non-voluntary
licenses for reasons of public health.

This document from the Chilean Ministry comes in the wake of two votes from
the Chilean Camera de Diputados calling for the government to use
compulsory licenses for HCV medicines — the first in January 2017, and the
second in January 2018 — as well as international support from civil
society, including a letter from 29 NGOs around the world, and additional
constructive technical assistance from groups such as Knowledge Ecology
International, DNDi, and South Centre. It also follows a series of actions
by elected officials and governments around the world to confront the high
prices of patented HCV medicines, including the recent government use
license in Malaysia for sofosbuvir, a request by 18 Democratic members of
the U.S. House of Representatives for the government to use its authority
under 28 U.S.C. § 1498 for HCV drugs, and Resolution Number 005246 of 2017
by Colombia’s Ministry of Health to explore whether there are public
interest reasons for a compulsory license on HCV drugs (as requested by
Colombian civil society groups including iFARMA and Mision Salud).


Almost as an aside, the announcement includes one paragraph that mentions
that the Chilean IP office (INAPI) notified the Ministry of Health that
there were no patent applications or patents for enzalutamide (Xtandi),
which was also part of the initial compulsory licensing request. Because
there are no patents or patent applications, the Ministry announced that
they therefore would not be declaring public health justifications for a
compulsory license on that drug. This does suggest, however, that without
patent issues, a generic manufacturer could enter the Chilean market to
increase affordable access to the important prostate cancer medicine, and
also illustrates the importance of and public interest in greater
transparency of patent landscapes.

James Love, Director of Knowledge Ecology International: “The decision by
the Ministry of Health is a long overdue but welcome endorsement for using
compulsory licenses on the patents for HCV drugs in order to expand access
and, in particular, to ensure that every person who is infected can be
treated. The United States should follow this example, and resist requests
by drug companies to block it.”

Luis Villaroel, Corporacion Innovarte: “I’m delighted this declaration
opens the door for a compulsory license that will save the lives of
hundreds of Chilean patients and also shows that Chile is starting to learn
that TRIPS flexibilities are an important tool to promote development and
the well-being of the people.”


Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670 <(202)%20332-2670>

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