[Ip-health] KEI Europe comments on the European Health Emergency Preparedness and Response Authority (HERA) roadmap

Thiru Balasubramaniam thiru at keionline.org
Wed Feb 24 22:35:04 PST 2021


24 February 2021

Whilst calls for better coordination in the EU pandemic response are
welcome, HERA must put the global right to health, rather than regional
biosecurity concerns, at its heart. Rapid operationalisation, as demanded
by global public health needs, must not and need not come at the cost of
ossifying poor practices into governance frameworks. The EU should, when
possible, require collaboration and sharing of knowledge and resources,
rather than secrecy, hoarding of manufacturing know-how, and blocking
access to biologic resources. The lack of global solidarity, particularly
as developing countries, appears to be a common thread throughout this
proposal, which is regrettable.

Licensing practices

The new voluntary licensing mechanism should not have a geographic limit.
The EU needs to address its relationship to the WHO COVID-19 Technology
Access Pool (C-TAP) and the work of the Medicines Patent Pool.

In addition to the immense public investment through funding of early stage
research, and de-risking of investments through advance purchasing
agreements, HERA needs to attach clauses guaranteeing downstream access and
affordability, as well as the transfer of manufacturing know-how to third
parties to achieve greater scale and faster delivery of products.  The EU
should endeavor to be more inclusive as regards access, not just for member
states, and to constructively address the disparities in access in
developing countries, including by the transfer of manufacturing know-how

Public-private collaboration can be both useful and necessary.  The
licensing agreements should seek to achieve broad public rights in both
foreground and background intellectual property, and when possible, enable
data, inventions and know-how to immediately enter the public domain as
global public goods.

Licensing agreements should include adequate step-in rights in case of
later breach of access protections, and when possible, reach-through
clauses such that further licensing retains the aforementioned protections.
The license should require the waiver of supplementary patent protections
and excessive regulatory protections.  Exclusive rights in regulatory test
data should be waived by the licensee, but the licensing of rights in data
can be remunerative on reasonable terms.


Opacity of contracts generates information asymmetries that often benefit
drug and vaccine companies the most, unduly protect government and
Commission officials from criticism from the public if the negotiated
instruments have shortcomings, and create uncertainty and mystery as
regards important policies embraced.

With the exception of Germany and Hungary, all EU member states have agreed
to the WHO transparency resolution (WHA 72.8), and the specific
transparency norms in the resolution should be honored, including
transparency of net prices, patent landscapes, units sold, sales revenues,
subsidies and incentives, registration status in countries, the costs of
human subject clinical trials and the outcomes from trials.

Technology transfer

We support greater EU manufacturing capability, but implemented with the
goal of enhancing development and capacity globally.


The role of HERA extends to well beyond the end of the COVID-19 pandemic.
The EU needs to explore the future mechanisms to fund incentives to invest
in the development of drugs, vaccines and other countermeasures, that are
delinked from exclusive rights or high prices, and which are consistent
with sharing access to manufacturing know-how and cell lines and rights in
inventions, data and inventions. And if the knowledge resources are to
become global public goods, the financing of such incentives should also be
global, or at least, among a community of like minded countries larger than
the EU.


EU members need to notify the WTO they are opting back into TRIPS 31bis as
importing countries.  See:  https://www.keionline.org/32707

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

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