Consultative expert working group

download report

Transcript Consultative expert working group

Consultative expert
working group - proposals
Barcelona 04.10.2011
Four proposals for innovative
A new indirect tax
Voluntary contributions from businesses
and consumers
Taxation of repatriated pharmaceutical
industry profits
New donor funds for health research and
Further proposals sought
Open forum during the first meeting of the
Submissions received in response to the
CEWG's call for submission of proposals
Overview of assessment which were
included in July meeting for further
analysis with some explanation what the
mechanisms could imply
Intellectual property rights management
Equitable Licensing
Open source
Removal of data exclusivity
Transferable intellectual property rights
Patent pools (UNITAID model)
Green intellectual property
Public financing
Direct grants to small companies and for trials in developing countries
Prizes, milestone and end
Pooled funds-related proposals
Precompetitive research and development platforms
Health impact fund
Neglected disease tax breaks for companies
Marketing approval
Orphan drug legislation
Priority review voucher
Regulatory harmonization
Global more complex issues
Coordination mechanisms
Biomedical research and development treaty
Proposals 1
 Open
– Collaborators forgo patents as outputs
are based on public domain allowing
collaboration through open access
research sites
 Equitable
– Research and development financing
licensing terms allow for access to
products, data or R&D
Proposals 2
 Green intellectual property
– The proposal for Green Intellectual Property proposes in principle
to introduce charges for patenting and a 10% premium for profits
gained from patents so as to fund access to products and support
 Removal/use of data exclusivity
– Data exclusivity means that for a period of several years from the
date an originator non-biological product is approved for
marketing, no other company may seek regulatory approval of an
equivalent product based on data submitted by the originator
company without the latter’s approval.
– The effect of data exclusivity is to prevent, for a period of time,
the entry of generic competition, even if the originator product is
not protected by a valid patent.
Proposals 3
Transferable intellectual property rights
– The idea is that a reward would be offered to companies which developed a
product to fight neglected diseases in the form of an extension of market
exclusivity which could be used on another top selling product.
– TIPR will work by extending market exclusivity for top selling products in
developed country markets.
Patent pools - UNITAID model
– Its objectives are to accelerate availability of new generic ARVs in developing
countries, stimulate R&D where patents are owned by different holders and
facilitate adapted formulations of medicines (e.g. children). These objectives
are tackled through pooling different related patents that the patent holders
supply voluntarily to the Pool. Developing countries based manufacturers may
obtain a license of any patent in the pool against negotiated royalties and use it
to develop new or produce cheaper products.
Proposals 4
Pooled funding and PDPs
– Funds in support of product development
– Importance of how organised, IPR managed
– Direct grants to small and medium sized
entreprises for R&D to bring a potential new
medicine through Phase 1 trials, at which
stage it may be possible to attract commercial
funding in one form or another
Proposal 5
 Prizes
(end and milestone)
– There are basically two kind of prizes – for reaching specified
milestones in the R&D process, or for reaching a specified
endpoint such as a new diagnostic, vaccine or medicine with a
specified profile in terms of performance, cost, efficacy and/or
other important characteristics.
 Purchase
or procurement
– Purchase or procurement agreements are contracts between a
purchaser, normally a government or an international financing
agency, and suppliers which involve some form of guarantee as
regards price and/or volume, includes Advance Market
Commitments (AMCs).
Proposals 6
 Neglected
disease tax breaks for
– This proposal is a provision in tax laws allowing companies to set
expenditures on R & D for neglected diseases against their tax
 Health impact fund
– Firms may register a product to HIF. By registering, a firm agrees
to provide its medicine at a price near the cost of production
anywhere it is needed. In exchange, they will be paid by the
Fund annually for ten years based on the HIF’s assessment of
the actual health impact (quality adjusted life-years gained) of the
Proposals 7
Orphan drug legislation
– An orphan drug is a pharmaceutical product that has been developed
specifically to treat a rare medical condition, the condition itself being referred
to as an orphan disease.
– In the US and EU it is easier to gain marketing approval for an orphan drug,
and there may be other financial incentives, such as financial support to R&D
and extended exclusivity periods
Priority review voucher
– In the US scheme, those who obtain marketing approval from the Food and
Drug Administration (FDA) for a product to treat or prevent one of 16 neglected
tropical diseases are entitled to receive a priority review voucher (PRV) which
entitles the bearer to receive priority review of another product that would not
otherwise qualify for priority review.
– By this means a company could advance the approval of a potentially
“blockbuster” product with correspondingly increased revenues
Proposal 8
 Precompetitive
– Support to precompetitive R&D open to
various stakeholders, different forms
and levels of engagement
Regulatory harmonization
– Proposal is based on implied benefits
from shorter regulatory approval times
and aligning requirements of developing
countries for regulatory approval
Research proposal 9
Biomedical R&D Treaty
– Different levels of ambition from framework type of measures
and strenghtening normative committments to more
comprehensive global delinking R&D from prices of products
(earlier specific proposals on R&D Treaty)
– Coordination on R&D priority setting
– Coordination on information sharing (open source and precompetitive for
R&D), capacity building and technology transfer
– Coordination in tracking and evaluating investments related to R&D and
– the role and capacities of WHO in this process
 Funding
– product development partnerships
– direct grants to companies and trials in
developing countries
– prizes
– purchase of procurement agreements
 Efficiency
– precompetitive R&D platforms
– regulatory harmonisation