[Ip-health] Brazilian CSO file unprecedented complaint to the Brazilian Antitrust Authority (CADE)

Pedro Villardi pedro at abiaids.org.br
Tue Oct 22 13:17:27 PDT 2019

Hi all,

>From Brazil, we would like to share this news about an action using
competition law, to denounce Gilead's actions in the country. If you have
any questions, please reach out.

GTPI team

*Rio de Janeiro and Brasilia, 22nd October 2019 - FOR IMMEDIATE RELEASE*

*Unprecedented complaint to the Brazilian Antitrust Authority (CADE)
denounces abuse on hepatitis C drug pricing*
*Based on a study conducted by researchers of the University of São Paulo,
civil society organizations call for an action to punish violations by the
pharmaceutical company Gilead.*

Nine civil society organizations, including Médecins Sans
Frontières/Doctors Without Borders (MSF) and the Brazilian Institute of
Consumer Protection (Idec), together with the Federal Public Defender's
Office (DPU), filed a complaint in the Brazilian Antitrust Authority (Cade)
on Monday, October 21, against the pharmaceutical company Gilead for abuse
of dominant position related to the drug sofosbuvir. The action is
groundbreaking as it is the first one on excessive prices and the first
proposed by patient and consumer groups in Cade´s history. According to the
organizations, abusive prices charged for medicines that include sofosbuvir
in their composition have prevented thousands of people from accessing
effective hepatitis C treatment.

The entities call the Brazilian antitrust body to fine Gilead and to
impose, through an injunction, the compulsory licensing of sofosbuvir. The
measure would suspend Gilead's drug patent and allow the production and
commercialization of the medicine by other companies, increasing
competition and thereby expanding access to the cure for hundreds of
thousands of people suffering from the disease in Brazil. The Ministry of
Health estimates that about 700,000 people need hepatitis C treatment in
the country, but by June 2019, only 102,000 patients had been treated with
the newest and most effective drugs, including sofosbuvir. Among all kinds
of hepatitis, type C is the most prevalent and lethal in Brazil.

Along with MSF, Idec, and DPU, the document is signed by the Brazilian
Interdisciplinary AIDS Association (Abia), the Human Rights Advocacy
Collective (CADHu), Grupo de Incentivo à Vida (GIV), São Paulo State AIDS
NGO Forum (Foaesp), Rio Grande do Sul AIDS NGO Forum , AIDS Prevention
Support Group (Gapa / BA), Grupo Solidariedade à Vida and Universities
Allied for Essential Medicines (Uaem - Brazil).

The representation to Cade is based on a study conducted by researchers of
the Law and Poverty Group of the USP (University of São Paulo) law school,
and coordinated by professors Calixto Salomão Filho and Carlos Portugal
Gouvêa. The study concluded that since the launch of the drug in Brazil, in
2015, Gilead has been systematically abusing its dominant market position,
with severe economic and social consequences.

Between 2015 and 2018, the study points to a “de facto monopoly” period
when Gilead supplied 99.96% of the sofosbuvir sold in the country. During
this period, the average price charged ranged from R$ 179.41 (US$ 45) to R$
639.29 (US$ 160) per pill of sofosbuvir-containing drugs, resulting in a
revenue of R$ 1.4 billion (US$ 350 million) for purchases made by the
Brazilian Government alone. In the same period, however, treatment was
rationed because of high prices, preventing a huge contingent of people
from being treated and cured. Between 2015 and 2017 there were almost 6,000
deaths from hepatitis C in the country.

Between July 2018 and January 2019, USP researchers point to a brief period
of competition, in which the amount charged by Gilead fell 89.9%, to R$
64.84 (US$ 16). After the patent granting and until June 22 of this year
(end of the period analyzed by the study), the average price rose to R$
986.57, an increase of 1,421.5% per pill of sofosbuvir-containing drugs.
This is considered a period of formal monopoly, in which “arbitrary price
increases” were observed.

"The study shows how a brief period of competition was able to drive prices
down significantly, which made clear how the company has the capacity to
practice more affordable prices and does practice them when there are other
options on the market", warns Idec’s lawyer and health researcher Ana
Carolina Navarrete. “As a consumer protection entity, we know that
competition is a powerful tool for price reductions. In this case, the
monopoly, besides being unjustified, results in high prices that benefit
nobody other than the company”, she reinforces.

The text of the complaint explains that "the unlawful conduct" carried
out by Gilead" serious and clearly affects the public interest."
“There are hundreds of thousands of infected people with poor access to
treatment or totally deprived of it, disrespecting the principle of
universal access, that is a pillar of the Brazilian public health system.
We have a history of deaths, rationed distribution and waiting lines for a
medicine that can cure the disease and is effectively recommended by WHO to
address a serious global health threat,” says attorney Eloisa Machado of
the Human Rights Advocacy Collective (CADHu), one of the civil society

One of the authors of the representation, the humanitarian organization
Médecins Sans Frontières/Doctors Without Borders (MSF) has been
successfully treating hepatitis C in 18 projects in 14 countries. MSF uses
drug combinations that often include generic versions of sofosbuvir. This
year, MSF purchased complete treatments containing sofosbuvir for US$ 0.89
per unit, about R$ 3.60. “MSF is a witness that high prices are behind the
limited or non-existent supply of medicines in many countries. More than 65
million people are still untreated in the world. We defend access for all”,
said Ana de Lemos, MSF-Brazil Executive Director.

In the current pace, Brazil will not meet its goal, in alignment with WHO’s
global strategy to fight the disease, that is to treat 657,000 people by
2030. The next purchase of hepatitis C treatments by the Ministry of Health
will take place in 2019.

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