On 8 July 2011, the WHO Consultative Expert Working Group on R&D
Financing and Coordination (CEWG) held an open session to brief the public on
their preliminary assessments and recommendations.
To access the
slide presentation presented by the Chair (John Arne Røttingen, Norway) and
Vice-Chair (Claudia Inês Chamas, Brazil), please click on the following link: http://www.who.int/phi/news/Open_Session_July_v3.pdf
The Chair open
the session with some administrative details; he noted that Dr Christy Hanson
from the USA has withdrawn from the group due to time constraints and that two
members, Ms Hilda Harb from Lebanon and Prof Steve Morgan from Canada, could
not attend the 2nd meeting of the CEWG for personal reasons. With respect to
disclosures and conflict of interest, there were no new disclosures or material
changes.
The Chair noted
that in the CEWG call for proposals, 21 new submissions were received. The WHO
Secretariat "documented the 22 grouped proposals (from 109 individual
proposals/mechanisms) mentioned in EWG report using the CEWG proposal
template" which included a "description for each of the CEWG criteria
and the evidence base". Each expert was assigned proposals, "both
grouped EWG and new submissions) using the CEWG criteria which can be found
here: http://www.who.int/phi/PHI_cewg_inception_report_2011_en.pdf
These criteria
include the following:
·potential
public health impact in developing countries
·rational and
equitable use of resources/efficiency considerations
·cost-effectiveness
·technical
feasibility, scaling-up potential, replicability, speed of implementation
·financial
feasibility and sustainability
·additionality
·intellectual
property management issues
·potential for
de-linking research and development costs and the price of products
·equity/distributive
effect, including on availability and affordability of products and impact
on access and delivery
·accountability/participation
in governance and decision-making
·impact on
capacity building in, and transfer of technology to, developing countries
·potential
synergy with other mechanisms/potential for combining with others.
The Chair noted
that each "proposal was appraised by one group member in accordance with
the CEWG criteria" followed by a secondary appraisal by a second member.
After the appraisal process, each proposal was then discussed within the group
as a whole to determine the next steps.
The Chair
provided the following landscape of 22 EWG grouped proposals plus 15 new
submissions considered by the CEWG:
·Biomedical
research and development treaty (including submissions from Health Action
International, Initiative for Health & Equity in Society, KEI, MSF, TWN)
·Direct grants
to small companies and for trials in developing countries (including
submissions from CILFA and GFHR)
·Equitable
Licensing (submitted by Pharma-Kampagne)
·Green
intellectual property (including the submission from International Bank for
Innovation)
·Health impact
fund (including the submission from Incentive for Global Health)
·Neglected
disease tax breaks for companies
·New donor funds
for health research and development
·New indirect
taxes
·Open source
·Orphan drug
legislation
·Patent pools
(UNITAID model)
·Precompetitive
research and development platforms (including submission from UAEM)
·Priority review
voucher
·Prizes,
milestone and end (including submissions from Bioventures for global health and
KEI)
·Pooled
funds-related proposals (including submissions from Novartis, DNDi and India
Drug Action Network, Centad, Berne Declaration, Initiative for Health &
Equity in Society, TWN)
·Reduction of
patents` duration to prevent collusion at industry level (submitted by Euromed
Management School, Northwestern University)
·Regulatory
harmonization
·Removal of data
exclusivity
·Taxation of
repatriated pharmaceutical industry profits
·Transferable
intellectual property rights
·Voluntary
contributions from businesses and consumers)
The CEWG determined
that the following six submissions fell outside the scope of the CEWG` as
mandated by WHA 63.24:
Employees´ food safety knowledge and
practices in foodservice operations serving high risk populations (Paez &
Ortiz)
Optimal hedging against the premature obsolescence of
available treatments (Leoni & Luchini)
Software for improving Maternal, Neonatal and Child
Health Services in Pakistan (WHO Pakistan)
The CEWG then
classified proposals into three categories 1) Proposals meeting most criteria,
2) Proposals meeting fewer criteria and 3) Proposals meeting most criteria, but
where CEWG need to do more work.
·Tax breaks,
orphan drug like legislation (for countries to consider)
·Removal of data
exclusivity
·Green IP (a new
indirect tax)
·Priority review
voucher, transferable IPR
·Health Impact
Fund – need pilot to examine value based rewards (health impact)
·Advance
procurement agreements (AMC)
·Regulatory
harmonization
·Reduction of
patents` duration
Proposals
meeting most criteria, but where CEWG need to do more work
·R&D
treaty/A global framework for R&D
·Pooling of
funds (for PDPs, other etc)
·Sources of
funding (taxes, voluntary contributions etc)
·Coordination
(regional networks e.g. ANDI, etc)
Some
preliminary recommendations on global mechanisms
·CEWG intends to
recommend strengthening global financing and coordination mechanisms for
R&D for health needs of developing countries under the auspices of WHO
·CEWG intends to
recommend that formal intergovernmental negotiations begin for a binding global
instrument for R&D and innovation for health
The Chair of
the CEWG noted that the 3rd and final meeting of the CEWG would take place in
Geneva, Switzerland on 17-18 November 2011.