[Ip-health] Commissioner Malmström’s response to Civil Society concerns over the Third Country Report on the Protection of IPRs

Thiru Balasubramaniam thiru at keionline.org
Thu May 17 07:10:40 PDT 2018


Commissioner Malmström’s response to Civil Society concerns over the Third
Country Report on the Protection of IPRs

On 16 April 2018, KEI Europe and 32 groups wrote a letter to the European
Commission’s Trade Commissioner, Cecilia Malmström, expressing concerns
over the Commission’s plans to create an EU Watch List. In the letter, we
noted that although the European Union has publicly committed its
commitment to support the right of third countries to use the public health
safeguards of the WTO TRIPS Agreement, the “Third Country Report on the
protection and enforcement of intellectual property rights in third
countries” challenged these very safeguards by targeting third countries
for enacting policies on: 1) strict patentability criteria (Argentina,
Brazil, India, Indonesia, and Russia), 2) local working provisions (Ecuador
and Indonesia), and 3) compulsory licensing (Ecuador,India and Ukraine). On
17 April 2018, the European Commission’s Directorate-General for Trade
responded to our request and indicate that they would be willing meeting
with civil society representatives on 15 May 2018.

On Tuesday, 15 May 2018, a small group of civil society representatives
(KEI Europe, Health Action International, and European Alliance for
Responsible R&D and Affordable Medicines) met with two members of Cecilia
Malmström’s cabinet -Maria Åsenius, Head of Cabinet and Pedro Velasco
Martins – Member of Cabinet – to discuss the concerns expressed in our
letter. At this meeting, Commissioner Malmström’s Cabinet handed over
Malmström’s official response

Commissioner Malmström’s letter made it clear that the Watch List (to be
published in the second half of 2018) intended to “identify concrete
physical and online marketplaces, located outside the EU,which engage in or
facilitate IP infringements, in particular counterfeiting and piracy” would
not list countries and was to be was to be distinguished from the Third
Country Report (published in February 2018).

As you know, the Watch List initiative is part of the Commission’s Strategy
announced in the 2017 Communication “A balanced intellectual property
enforcement system responding to today’s societal challenges”, which was
designed to step up efforts to combat counterfeiting and piracy. With the
planned Watch List the Commission intends to identify concrete physical and
online marketplaces,located outside the EU,which engage in or facilitate IP
infringements,in particular counterfeiting and piracy. The Watch List will
not list countries, but only concrete online and physical
marketplaces(websites,market halls,street markets). (Source: Official
Response of Cecilia Malmström to Civil Society Letter Expressing Concerns
Over the EU Watch List, 15 May 2018).

DG Trade spelled out that the objective of the Third Country report was to
identify countries outside the European Union where the “level of
intellectual property protection and enforcement gives rise to the greatest
level of concern.” The Third Country Report was informed by a variety of
sources including customs authorities in the EU, statistical data collected
from the OECD and EUIPO, WTO Trade Policy Reviews, IPR dialogues, and “data
on actions against IPR infringements published by third country
governments.” (Source: Ibid).

In the letter, Commissioner Malmström asserted the following:

We would like to underline that nothing in the Third Country Report can be
interpreted as restricting the TRIPS flexibilities or limiting access to
medicines. On the contrary,the Commission points at measures introduced by
third countries,undermining the current international legal framework,which
safeguards access to genuine medicines. (Source: Ibid).

However, this was followed by a blistering attack on practices including
local working requirements, patentability criteria, and applying “criteria
for the issuance of compulsory licences which seem not to respect the
international legal framework on access to medicines and public health.”

For instance, some of the listed countries apply a controversial local
working requirement, which requires all foreign pharmaceutical companies to
manufacture the patented medicines or use the patented process in their
territory. These rules appear to discriminate imported patented products
against domestically produced goods under patent protection. Also, some of
the listed countries exclude from patentability certain classes of
medicinal products or apply additional patentability criteria, which are
questionable under the TRIPS Agreement. These legislative practices
undermine incremental innovation and research in, *inter alia*, new uses of
already known medicines (follow-up) pharmaceuticals, new uses, new
combinations), which can provide benefits to patients. Finally, a number of
the listed countries apply criteria for the issuance of compulsory licences
which seem not to respect the international legal framework on access to
medicines and public health. These controversial legal practices applied by
the countries mentioned in the Third Country Report seriously undermines
incentives for innovation and research, or even to place the products on
the respective markets, with detrimental effects for patients in need. We
believe that the Third Country Report can be used as a tool to address
these practices. (Source: Ibid).

The full contents of Commissioner Malmström’s letter can be found here:

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

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