[Ip-health] Intervention HAI, KEI, Berne Declaration - WHA66: follow up of CEWG report

Tessel Mellema tessel at haieurope.org
Fri May 24 08:23:40 PDT 2013

Dear all, 


please find below the intervention made this afternoon on behalf of
Health Action International, KEI and the Berne Declaration on the follow
up of the CEWG report.


WHA66 - Intervention agenda item 17.2: follow up of the CEWG report 

Health Action International, KEI and the Berne Declaration


The Consultative Expert Working Group on Research and Development (CEWG)
produced a report in April last year which expressed the urgent need to
repair a broken R&D system with a comprehensive solution in the form of
a global framework.

The draft resolution does not provide a clear agenda towards this and
suffers from lack of ambition, lack of clarity, and lack of concrete
commitments. It does contain valuable elements that can be used as
stepping stones towards a R&D framework. We welcome the commitment to an
R&D observatory and the demonstration projects.

However, we are concerned about the losing sight of the core principles
and norms that should govern public health R&D. The CEWG report
contained three key recommendations to ensure needs driven R&D and
affordable access to medical products from the start of the innovation
process. The first is the need to de-link the costs of R&D from the
price of the end product. The second is to conduct R&D through open
knowledge innovation - including open collaboration in the R&D process
and generating knowledge as a public good.  The third is to create new
global norms to ensure sustainable financing of R&D for health care

Any project that comes out of this process to improve global health R&D
should advance work on these norms and principles. Otherwise, the post
CEWG process risks being reduced to a weak coordination mechanism that
puts little money into an existing system that is broken. The
demonstration projects be used to operationalize the concrete push and
pull mechanisms that according to the CEWG best incorporate these
principles of de-linkage and knowledge sharing.

As regards the R&D observatory, it should identify and provide guidance
on the priority areas of needs-driven R&D, and to the extent possible
and appropriate, data needs to be publicly accessible. The observatory
should collect economic, legal, scientific and health impact data on R&D
spending by both state and non-state actors. It could be more ambitious
and also collect actual research data. To start, any data, compound or
technology resulting from the demonstration projects could then be
included in the open databases managed by the observatory.

These proposed actions, even when seen in an optimistic light, should be
seen as stepping stones towards a comprehensive solution addressing a
broad range of diseases and conditions. 

We call upon Member States to begin discussions on a framework for
coordination, norm setting and financing for R&D by 2014. Given the
widespread recognition of the urgency of this problem, we cannot afford
to postpone this to 2016.

On the US proposal, we should avoid repeating the mistakes of the first
Expert Working Group. Any advisory group on this process should be
either consultative with governments or inter-governmental. When other
stakeholders are involved this should concern a variety of stakeholders,
including civil society.



Tessel Mellema

Policy Advisor- Trade, Innovation & Access to Medicines


Health Action International (HAI) Europe

Overtoom 60 II, 1054 HK Amsterdam 

t. +31 20 683 3684

e. tessel at haieurope.org <mailto:tessel at haieurope.org>  

w. www.haieurope.org <http://www.haieurope.org/> 


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