[Ip-health] KEI Europe: Leaked EU action plan on intellectual property – Of COVID-19, TRIPS, EU BARDA, march-in rights, patent pools, and compulsory licensing

Thiru Balasubramaniam thiru at keionline.org
Tue Nov 24 02:58:56 PST 2020


Leaked EU action plan on intellectual property – Of COVID-19, TRIPS, EU
BARDA, march-in rights, patent pools, and compulsory licensing
Access to Medicines
<https://keieurope.org/category/access-to-medicines/>, Intellectual
Property Rights
<https://keieurope.org/category/intellectual-property-rights/> / By Thiru
Balasubramaniam <https://keieurope.org/author/thiru-balasubramaniam/>

On Friday, 20 November 2020, Politico published an advanced copy of the
European Union’s “intellectual property action plan to support the EU’s
recovery and resilience”. This twenty page document is a communication from
the European Commission to the European Parliament, the Council, the
European Economic and Social Committee and the Committee of the Regions.

In light of multilateral engagement at the World Health Organization (WHO)
and the World Trade Organization (WTO) on the COVID-19 response, the action
plan’s strategy for “Better tools to share critical IP in times of crisis”
is instructive.

The COVID-19 pandemic highlights the importance of an effective IP system,
offering strong incentives to innovate, as well as effective tools to share
out IP for technologies needed to cope with the crisis. R&D funding as well
as IP incentives play a critical role to ensure the rapid development and
availability of new technologies, such as vaccines or new treatments. At
the same time, we need to ensure that new technologies, once developed, can
also be rapidly deployed, not only in Europe but also on a global basis. In
addition, access to existing technologies that are critical, such as IP
related to existing medicines or protective gear for instance, should be
granted when this is needed to secure supplies and cope with shortages,
whilst at the same time ensuring a return on investment.
(EU IP Action Plan, page 11, November 2020)

The Commission provided the following perspectives on patent pools and
voluntary licensing.

“In this context, the Commission supports voluntary pooling and licensing
of intellectual property related to COVID-19 therapeutics and vaccines, in
line with the recent resolution of the World Health Assembly to promote
equitable global access as well as a fair return on investments. Such
schemes should be based on a voluntary participation, ensuring equitable
access within clear boundaries and allowing IP owners to recoup investments
in a balanced way.”

“Building on various experiences with pledges and patent pools, the
Commission is working on mechanisms that would enable and incentivise the
rapid pooling of critical IP in times of crisis, whilst guaranteeing that
such voluntary and temporary pooling preserves strong protection of IP.
This would offer interested parties the IP tools they need to quickly ramp
up the production of IP-protected technologies, including via repurposing

In relation to the exigent stress test imposed by the COVID-19 pandemic on
the architecture of the TRIPS Agreement, the Commission noted:

“Going forward however, the Commission sees a need to have better tools in
place to cope with crisis situations. The Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) allows states to limit IP
protection where necessary to cope with crisis situations. The TRIPS
framework is fit for purpose, but can be implemented in a more effective

Following on from President Ursula von der Leyen’s State of the Union
<https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_20_1655> call
for the establishment of an EU BARDA, the EU’s IP action anticipated the
development of an “effective framework for march-in rights, that should
guarantee that publicly funded IP is available in case of critical
shortages”. How the European Union designs and implements march-in rights
will be crucial.

In relation to compulsory licensing, while the Commission expressed the
view that compulsory licensing should be used as a “means of last resort
and a safety net when all other efforts to make IP available have failed”,
the Commission urged its Member States to establish fast-track procedures
to issue compulsory licenses in emergency situations; presumably this would
apply to the current COVID-19 pandemic.

Finally, the Commission sees the need to ensure that effective systems for
issuing compulsory licenses are in place, to be used as a means of last
resort and a safety net, when all other efforts to make IP available have
failed. In Europe, compulsory licensing is mainly governed by national law.
The Commission calls on the Member States to ensure that the tools they
have are as effective as possible, for instance, by putting in place
fast-track procedures for issuing compulsory licenses in emergency
situations. In addition, it sees a need for a stronger co-ordination in
this area, to avoid distortive effects on innovation and trade, but also to
ensure that national measures are as effective as possible. Early
co-ordination and information sharing between Member States, e.g. on the
duration of and royalties on any such licenses, should help secure maximum
benefits whilst at the same time avoiding excessive distortions. The
Commission will explore with Member States the possibility of creating an
emergency co-ordination mechanism, to be triggered at short notice when
Member States consider issuing a compulsory license.
(EU IP Action Plan, page 12, November 2020)

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

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