[Ip-health] ​What's wrong with current system of funding R&D, and what are ideas for reforms?

Jamie Love james.love at keionline.org
Wed Oct 21 10:50:25 PDT 2015


http://keionline.org/node/2350


​What's wrong with current system of funding R&D, and what are ideas for
reforms?

21. October 2015

I was recently asked by OSF to write a two page document that described
"what was wrong with the current system of funding R&D?" and to offer some
"important ideas for change." This was my two page submission.

-------------------------------------

What is wrong with the current system for funding R&D? What are the most
important ideas for change?
(In two pages, for OSF meeting on drug development)

James Love
October 20, 2015

1. What is wrong with the current system for funding R&D?

The current system for funding R&D is so complex it is a challenge to
describe its flaws in few words. At present there are a diverse set of
funding mechanisms, including research grants and contracts from
governments and charities, tax credits and other subsidies, and a variety
of incentive mechanisms to induce private sector investments. The
incentives include the grant of patents on new inventions plus a growing
set of sui generis intellectual property rights and regulatory policies
designed to create, broaden and/or extend the term of legal monopolies. The
sui generis rights include exclusive rights associated with test data,
paediatric testing market exclusivity extensions, orphan drug exclusivity,
patent extensions for regulatory delays, and the new similar sets of
exclusive rights associated with the 21st Century Cures and Dormant Therapy
legislation.

The problem with the current system of research grants and contracts is
that (a) the amount of funding is inadequate, (b) the amount of funding for
certain medically important areas is particularly neglected, (c) the
intellectual property rights associated with the public sector funding
often vest with the researchers (rather than the funders) and end up being
licensed as a monopoly to a company that prices products unreasonably (in
several dimensions), (d) there is a lack of transparency over research
outcomes and issues such as the costs of conducting clinical trials from
publicly funding research, (e) inadequate funding of transitional and late
stage research and development, (f) inadquate competition in the management
of grants and contracts, and (g) there are no global mechanisms to address
the free riding issue, resulting in underfunding.

Tax Credits are problematic because (a) there is no transparency regarding
how much is claimed for tax credits for specific drugs or taxpayers, (b)
tax credits often (i.e. US R&D or Orphan Drug Tax Credit) do not result in
public interest obligations of the recipient of the subsidy (unlike
grants), and (c) there is no global mechanism to share the cost of the tax
credits.

The problem with the patent system is that (a) there is often little
relationship between patentability criteria and the costs and risks of drug
development, (b) the monopoly leads to excessive prices, (c) the amount of
money invested in R&D is only a small fraction of the increased
prices,[footnote [1]] (d) patents do not reward many socially important R&D
activities, including in particular those that expand access to knowledge,
(e) patents sometimes discourage investments by companies, some potential
rivals, that cannot obtain affordable patents licenses, or where
transaction costs of licensing are high, (f) there is inadequate
transparency of patent landscapes and insight into which products the
patents are relevant to, (g) the grant of a monopoly is not a useful
incentive for inventions that address the needs of poor people living in
poor countries, (h) it is very costly to resolve disputes over the
standards for granting patents or determining if patents have been
infringed, and the (i) the exclusive marketing rights induce excessive
investment into products that merely match outcomes, and wasteful spending
on marketing.

The problems with test data include many of those associated with the
patent system, but also include conflicts of medical ethics, by
inducing/requiring companies to replicate clinical tests on humans when
results are known, and because in many legal systems there are no
exceptions to the rights, unlike patents. For other sui generis rights,
such as orphan drug or paediatric exclusivity, many of the problems of the
patent system are also present, including excessive pricing, and there is
no relationship between the amount of money for R&D the sui generis system
induce, and the costs to consumer, and often the costs are not shared
globally.

2. What is a better R&D funding system?

There are several areas where the global system for funding R&D needs to be
improved. The current system of trade agreement obligations designed to
expand intellectual property rights, and more generally promote higher
prices, could be replaced with global agreements that focus on R&D funding,
and which provide more flexibility on how to supply that funding. The
2002-2005 proposals for a large R&D treaty were about eliminating IPR
obligations if a country could satisfy a different standard for R&D
funding, using the TRIPS as a fallback mechanism only if a country failed
to fund a sufficient amount of R&D through other means. There are also
other approaches that can be explored, including the proposal for a WTO
agreement on the supply of public goods, or including R&D funding in new
agreements negotiated within the WHO or in various regional or bilateral
negotiations, including the TTIP. The challenge for such international
agreements is finding the best starting points and mixes of R&D targets
that appeal to the countries that are currently most focused on the IPR
agreements. In the present environment, this mix should include projects of
more universal interest, for example, expanding the funding basis for
projects like the UK’s 100,000 Genomes Project, R&D for new antibiotic
drugs, Ebola treatments and vaccines, or very large inducement prizes for
new low cost and efficient point-of-care diagnostics.

The tax credit system should be reformed by requiring transparency of the
amount of the credit earned (something done for tax credits in other
areas)[footnote [2]], attaching Bayh-Dole-like public interest provisions
to the credit, and creating mechanisms to globalize the costs of the tax
expenditures. This is actually potentially quite an important way to
address the issue of funding clinical trials, without high drug prices. Tax
credits for orphan products, now only provided by the United States, cover
50 percent of the costs of qualifying trials, and were available to 8 of 9
new cancer drugs approved in 2014.

The most important reform in funding R&D will be to de-link the incentives
from high drug prices, through innovation inducement prizes. The first
serious proposal on how this might be done was the 2005 Sanders Medical
Innovation Prize Fund bill, which has been revised and improved, most
recently in 2013 as S.627 (113th Congress) and S. 626 (113th): Prize Fund
for HIV/AIDS Act. By delinking R&D incentives from prices, prescribing
decisions become more rational and access is more fair. With delinkage,
incentives can target important goals such as products that improve rather
than match outcomes and address research priorities from a health
perspective. Delinkage with evidence based rewards can reduce wasteful
marketing spending, and IPR systems can be reformed without putting at risk
R&D funding.

Prizes should be implemented in a three-part system: end product prizes,
interim results prizes and open source dividends. Each has its own role to
play, the most controversial but most important being the end product
prize, which can be a replacement for the monopoly granted by patents and
other IPR. The open source dividend would also be revolutionary. The least
controversial and least transformative are the interim results prizes,
including so called milestone prizes.

Without full delinkage, some of the benefits can be obtained through a
pricing system that explicitly considers three factors: (1) the benefits of
the product, (2) the risk adjusted costs of R&D and (3) the budget
constraints of the health system. Any pricing system that does not consider
(3) will lead to the rationing of access to medicines, and any system that
addresses either (1) or (2) but not both is sub-optimal. In general, policy
makers should seek rewards that maximize innovation benefits, without
breaching budget constraints or inducing rationing of access (all of this
easier with full delinkage).

Interim results innovation inducement prizes and grants for open source
medical research can, and in some cases should, be managed through more
decentralized systems, including the competitive intermediaries described
in the more recent Sanders innovation inducement prize fund bills.

Footnotes

1. See discussion in "Talking Drug Prices, Pt 4 Drug pricing is out of
control, what should be done?", PLOS Blogs. October 19, 2015.

2. 2014. Alternatives to the Patent System that are used to Support R&D
Efforts, Including both Push and Pull Mechanisms, with a Special Focus on
Innovation-Inducement Prizes and Open Source Development Models, World
Intellectual Property Organization, CDIP/14/INF/12, September 19.

Attachment whatswrong-whatcanbefixed20oct2015.pdf
​

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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