PHM-Exch> How to balance competition policies and intellectual property in the pharmaceutical industry

Sun Oct 29 00:39:55 PDT 2023

From: South Centre <south at southcentre.int>

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*SouthNews No. 466, 27 October 2023*

*How to balance competition policies and intellectual property in the
pharmaceutical industry is part of debate co-organized by the South Centre
and the Administrative Council for Economic Defense (CADE) in Brasília*

*By Vitor Ido*

The South Centre and the Administrative Council for Economic Defense (CADE,
the competition authority of Brazil) co-organized on 18 August 2023 a
public discussion on the interface between competition policies and
intellectual property (IP) in the pharmaceutical industry. The event took
place in CADE’s headquarters in the Brazilian capital, Brasília, and
online. The discussion addressed the role of IP and how can competition law
and policy be tailored to achieve access to health technologies,
particularly in the context of developing countries, as well as the
potential pitfalls and difficulties of such an approach.

*The South Centre continues to provide no-cost, tailored, and confidential
technical assistance on issues related to intellectual property and public
health. Beneficiaries include developing countries’ officials, including
competition authorities, medicine regulatory agencies, IP offices, judicial
authorities, and administrative bodies. For more information, please refer
to our dedicated website: **https://ipaccessmeds.southcentre.int/*
<https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=9170122f96&e=4415b83dfc>*
. *

The speakers represented the following institutions: CADE, the South
Centre, the Ministry of Finance, the Brazilian IP office (INPI), Fiocruz
(Oswaldo Cruz Foundation, Brazil’s leading public health institute
affiliated to the Ministry of Health), the Ministry of Development,
Industry, Trade and Services, and the National Health Surveillance Agency
(Anvisa). Around 100 participants from the in-person and online audience
included members of other Brazilian ministries and agencies, as well as
pharmaceutical industry representatives (both originator and generics),
civil servants and private attorneys. Accordingly, the session was an
opportunity for a wide diversity of views to be presented on the topic of
IP and competition.

There is ample policy space for all countries to make use of competition
law and policy to promote access to medicines, and there is a clear
emerging global trend in that regard, in both developed and developing
countries. Therefore, developing countries can craft pro-health competition
policies in full respect of international law requirements.  The
presentations by *Dr. Carlos Correa*, *Executive Director of the South
Centre*, and by *Dr. Vitor Ido*, *Programme Officer of the Health,
Intellectual Property and Biodiversity Programme of the South Centre*,
focused on how this can be concretely implemented (including doctrines,
enactment of guidelines, pharmaceutical sector inquiries, among others),
while also highlighting the important record of CADE in addressing these
issues and the value of the precedents it has set for other Latin American
jurisdictions and even beyond.

The session was opened by *CADE’s Deputy Chief Economist* who noted that
inter-institutional cooperation in the field of access to medicines is
important. He commented on the interplay between competition and IP, and
particularly how the debate has concrete implications to real-life
situations and access to medicines of citizens. He insisted on the
importance of access to databases and the need to find solutions to improve
access to cheaper and high-quality medicines.

*Dr. Carlos Correa* made a presentation on how competition law and policy
has been increasingly deployed around the world to address anti-competitive
practices in the pharmaceutical sector. He insisted on the important role
of Brazil, a country with a strong institutional capacity in the antitrust
realm, and how countries do not need to follow the doctrines that the US
and the EU have already established – while also noting that such
jurisdictions have extensively made use of competition law to address
anti-competitive practices in the pharmaceutical sector. The role of legal
doctrines that can be adopted by competition authorities and the
possibilities to scrutinize IP anti-competitive practices should be further
explored to ensure access to medicines. For example, the use of the
‘essential facilities’ doctrine and the option not to follow the approach
of the “Chicago School” can be beneficial to that aim.

*Dr. Vitor Ido* noted that given the global trend of expanded use of
competition law and policy, there is further space for more institutional
development. This is particularly true in light of the increased number of
anti-competitive conducts identified, such as pay-for-delay agreements,
patent thickets, evergreening, sham litigation and excessive pricing. By
making reference to a few landmark cases, he noted the variety of remedies
that can be applied, as well as other tools such as the launch of
pharmaceutical sector inquiries and the adoption of guidelines which
generate more legal certainty for economic actors and business relations
and more consistent policy approaches. In such regard, some difficulties
will need to be overcome, including problems of capacity of authorities,
the disparity of power and access to data between pharmaceutical companies,
civil society and authorities, as well as undue economic and political
influences.

*Dr. Júlio Cesar Castelo Branco Reis Moreira, President of the INPI
(Brazilian IP office),* focused his presentation on the recent activities
by INPI in the field of patents, which have, *inter alia*, substantially
reduced the backlog of patent applications, and reiterated the importance
laid by the institute to IP, including to attract more foreign investments
and innovation.

* Ministry of Finance* noted the position the government has had on IP and
its entanglements with innovation policies, as well as the need for a
better regulatory environment for the pharmaceutical sector.

* Ministry of Development, Industry, Trade and Services* explained the
composition and the work of the Interministerial group on IP, which
regularly discusses various IP issues, and the Ministry’s position on
various IP topics, including avoiding TRIPS Plus measures in free trade
agreements.

* FIOCRUZ, Oswaldo Cruz Foundation,* recalled the centrality of the right
to health and the constitutional mandate on public health. He presented the
broad international context and the importance of competition to promote
access. He recalled a 2017 event organized by Fiocruz reuniting IP offices,
competition authorities and Health Ministries and invited the participants
of this event to envision a second round of it.

* ANVISA (Brazilian Health Regulatory Agency) *explained how ANVISA deals
with marketing approvals of medicines in Brazil and exposed some of the
ways it intersects with competition. One example under discussion in Brazil
is the approval of skinny labeling, which could facilitate entry of
generics into markets.

As a general conclusion of the session, more inter-agency cooperation was
deemed to be required, including at the international level. The complex
interface between IP, medicines’ regulatory approval, public health,
medicine price regulation, consumer protection and competition, needs to be
further explored. Institutional solutions that include further dialogues
will be required. The South Centre stands ready to continue cooperating
with CADE and other Brazilian institutions on this matter.

*Author: Vitor Ido, Programme Officer of the Health, Intellectual Property
and Biodiversity Programme of the South Centre.*

*SouthNews is an e-newsletter service of the South Centre providing
information and news on topical issues from a South perspective.To view
other articles in SouthNews, please click **here*
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*.For more information, please contact Anna Bernardo of the South Centre:
Email **abernardo at southcentre.int* <abernardo at southcentre.int>*.*

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