[Ip-health] European Commission publishes negotiating proposals for EU-Indonesia trade deal

Baker, Brook b.baker at northeastern.edu
Thu Feb 9 07:23:29 PST 2017

It is important to note that the EU proposals on IP are TRIPS-plus in multiple regards and would surely reduce policy space in Indonesia and negatively impact access to affordable medicines.  Even a preliminary review of the proposal reveals:

1.  A requirement to make all reasonable efforts to abide with the WIPO Patent Law Treaty, which risks enshrining lower standards of patentability.

2.  Mandatory patent term extensions to compensate for regulatory delay in granting marketing approval of medicines with a proposed minimum 15 year term of effective patent coverage.

3.  An additional mandatory patent term extension in the case of pediatric studies.

4.  Enhanced enforcement measures in terms of:  intermediary liability, mandatory provisional measures, border measures involving suspected patent violations, and lost-profit damages.

5.  National and regional exhaustion of rights only, limiting right of parallel importation.

Although lip service is paid to preserving TRIPS-flexibilities and self-congratulations about preserving compulsory licensing rights enshrined in the Doha Declaration, the EU proposals are profoundly TRIPS-plus. The impacts of patent term extensions and data/marketing exclusivities based on registration-related data/decisions on access to more affordable generic medicines will be profound.  The number of years of TRIPS-plus protections has not yet been finally determined, but the pretense of protecting access-to-medicines must be condemned.


Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker at neu.edu
From: Ip-health <ip-health-bounces at lists.keionline.org> on behalf of Alienor DEVALIERE <Alienor.DEVALIERE at msf.org>
Sent: Thursday, February 9, 2017 3:48:57 AM
To: ip-health at lists.keionline.org
Subject: [Ip-health] European Commission publishes negotiating proposals for EU-Indonesia trade deal

Hi All,

FYI, the European Commission has published 9 proposals<http://trade.ec.europa.eu/doclib/press/index.cfm?id=1620> for a trade agreement with Indonesia.

You can find here is the EU text proposal on the IP chapter (sub-section 5 on patents / section C on enforcement of IP rights / section D on border enforcements): http://trade.ec.europa.eu/doclib/docs/2017/february/tradoc_155281.pdf

And here is the factsheet on EU proposal on IPR: http://trade.ec.europa.eu/doclib/docs/2017/february/tradoc_155292.pdf
Interesting to note that the EU expressly mentions its support to the TRIPS flexibilities and compulsory licensing.

Aspect related to access to medicines:

"Ensuring access to medicines is very important for the EU and Indonesia. The EU has consistently sought to address the complex challenges involved and has supported its partner in reforming and strengthening its health care system.
As it is important to ensure that IPRs do not hinder access to medicines, a number of exceptions have been proposed in the IPR legislation, particularly through some of the so-called "TRIPS flexibilities" to protect public health. The "TRIPS flexibilities" include for
Example that the EU and Indonesia will keep the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted. The EU proposal on intellectual property includes an explicit reference to the Doha Declaration that recognises such flexibilities. Both parties will also keep the right to determine what counts as national emergency or extreme emergency. This will make it easier for them to issue a compulsory license in these special situations. The proposal makes sure that the flexibilities granted by the TRIPS Agreement, especially regarding patents on medicines, can be fully used. This means
the IPR chapter will always support the rights and flexibilities of World Trade Organization (WTO) members as recognised in the
Doha Declaration. »

Commission publishes negotiating proposals for EU-Indonesia trade deal

The European Commission published today nine initial European proposals<http://trade.ec.europa.eu/doclib/press/index.cfm?id=1621> for the trade agreement under negotiation with Indonesia. Together with the proposals, the Commission has made available the report from the second round of talks that took place in Indonesia between 24 and 27 January. The texts now made available represent the EU's initial negotiating position, and its publication is part of the Commission's commitment for a more transparent trade and investment policy. Trade Commissioner Cecilia Malmström said: "The EU's aim in these trade talks is to build bridges with Indonesia, a country of over 250 million people and the largest market of Southeast Asia. Our ambition is to conclude an agreement that makes trade and investment easier and covers a broad range of issues, including rules on sustainable development." Amongst other things, the texts presented by the EU in the negotiations so far aim to: increase participation of European companies in Indonesian public tenders and vice versa; increase cooperation on imports requirements related to food safety, plant and animal health; broaden protection of traditional European products, known as 'geographical indications'; reduce unnecessary overlapping regulatory barriers to trade and increase the part of trade benefits that go to small companies. At the same time, the agreement will uphold levels of consumer, worker and environment protection and promote sustainable development. Further EU proposals will be made available as the negotiations progress on the Transparency in Action<http://trade.ec.europa.eu/doclib/press/index.cfm?id=1395>  portal, where EU proposals from other negotiations are already published since October 2015. The negotiations with Indonesia were launched in July<http://trade.ec.europa.eu/doclib/press/index.cfm?id=1528> of last year. More information on the recent round is available in a blogpost<http://ec.europa.eu/commission/2014-2019/malmstrom/blog/eu-and-indonesia-talks-move_en> by Commissioner Malmström.

Aliénor Devalière
EU Policy and Advocacy Advisor
Médecins Sans Frontières - Access Campaign
Tel: +32 24 74 75 24
Mobile: +32 476 86 32 54
Email: alienor.devaliere at brussels.msf.org<mailto:alienor.devaliere at brussels.msf.org>

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