[Ip-health] Bridges: The Importance of the WHO Global Strategy Public Health

[Judit Rius Sanjuan]

http://ictsd.net/i/news/bridges/27665/

News and Analysis =95 Volume 12 =95 Number 4 =95 August 2008
ICTSD's BRIDGES Review
The Importance of the WHO Global Strategy Public Health
By Ellen =91t Hoen

One of the key negotiators in the talks that ultimately led to the
newly adopted Global Strategy on Public Health, Innovation and
Intellectual Property recently wrote to tell me that his services were
no longer required because the job was done. Can we agree on this
statement?

Undoutedly not. True, the negotiators of the intergovernmental working
group (IGWG) on this issue left us with a finalised Global Strategy,
packed with action points that could fundamentally change how health
research and development (R&D) is conducted =96 both in the way it is
prioritised to ensure that it responds to real needs and in the way it
is financed so that products that are developed are made accessible to
those who need them.

That is considerable progress =96 historical even. But the job is far
from done. Real change, which after all will be the ultimate benchmark
of the IGWG=92s success, will depend on how forcefully the World Health
Organisation (WHO) and its member states will implement the strategy
and translate it into action.

Of course, the IGWG did not work in a vacuum; its deliberations built
on the work of others. The analysis of the current intellectual
property (IP) and medical innovation environment made by the blue-
ribbon Commission on Intellectual Property Rights, Innovation and
Health (CIPIH) showed that something is fundamentally wrong with the
way new health care products are developed and brought on to the
market. In its 60 recommendations to start addressing both the access
problems caused by the current IP environment and the lack of
innovation, in particular for diseases that affect people in
developing countries, the commission provided a firm basis for the
IGWG to do its work.

Some of the forcefulness of the CIPIH=92s evidence-based work was lost
in translation as, inevitably, the action proposed by the working
group reflects the compromises needed to keep everyone at the
negotiation table. For example, where the Global Strategy states that
intellectual property rights (IPRs) are an =93important incentive for
the development of new health-care products=94, the prestigious
commission preceding it actually found =93no evidence that the
implementation of the TRIPS Agreement in developing countries will
significantly boost R&D in pharmaceuticals=94 and that =91insufficient
market incentives=92 were the decisive factor. The contrast could not be
starker.

Still, the days of uncritical celebration of ever higher levels of IP
as the one and only way to ensure innovation seem to be over. Here,
the Global Strategy is a forceful call for change. It contains
proposals for patent pools for upstream and downstream technologies to
increase access and innovation, promotes the use of compulsory
licensing to encourage competition in the pharmaceutical generics
market, rejects TRIPS-plus measures in trade agreements, and
encourages the development of new incentive mechanisms, such as prizes
and government involvement setting in R&D priorities.

More ambitiously, the Global Strategy opens the door for fundamental
change in two key areas.

Relationship between Cost and Price
First, building on World Health Assembly =96 the WHO=92s highest decision-
making body =96resolution 60.30, it calls for the development of
proposals for health-needs-driven R&D, including =93addressing the de-
linkage of the costs of research and development and the price of
health products.=94

Such a decoupling would break the cycle of financing R&D through high
drug prices. As long as research and development depend on the ability
to charge high prices, steering the current market-opportunity-driven
R&D towards a more health-needs-driven approach will remain wishful
thinking. It will also make it impossible to bring drug prices
sustainably down, except through painstaking drug-by-drug, country-by-
country battles.

Prizes are one way to achieve the delinking cost from price.1 Barbados
and Bolivia made proposals to the IGWG for prizes to reward
innovation. They suggested to start exploring multiple prizes: for the
development of a low-cost rapid diagnostic test for tuberculosis; for
new treatments for Chagas disease; for a priority medicines and
vaccines prize fund to reward mechanisms for new cancer treatments in
developing countries; and for a licensed products prize fund for
donors.2 The strategy commits WHO member states to pursuing ideas such
as these.

What is crucial is that on such issues, the strategy is likely to act
as a catalyst for change by a range of different actors. Although the
plan of action detailing how the Global Strategy will be implemented
is not finalised, the very existence of the strategy is likely to
create a certain momentum, or indeed resonance, to inspire other
actors to grasp the thornier issues of access to medicines and IP.

One example is UNITAID, which is contemplating setting up a
pharmaceutical patent pool, both to boost access to new antiretroviral
(ARV) drugs to treat AIDS in developing countries and to develop fixed-
dose combination and pediatric formulations of triple ARV therapy,
even when the patents of the individual drugs are held by different
entities.

The strategy=92s call to explore new and alternative incentives for
health R&D is also stimulating debate among academics and industry. In
particular, the idea of awarding prizes, rather than monopolies, is
gaining ground.3 At a recent expert roundtable convened by M=E9decins
sans Fronti=E8res, tuberculosis researchers, economists and campaigners
showed considerable interest in a proposal for a prize that would
encourage the development of an easy-to-use point-of-care TB
diagnostic test that would also be effective in diagnosing TB in
people living with HIV/AIDS.

In sum, the idea of moving away from monopolies to awarding and
incentivising innovation differently is gaining ground. This principle
of de-linking R&D costs from the price is also practiced by not-for-
profit developers such as the Drugs for Neglected Diseased Initiative,
which pays for the R&D upfront and has a no patent policy with regard
to the products that result from the research. This makes products
available as generics from day one of marketing.

Elsewhere, Novartis has proposed to create a global fund for R&D for
neglected diseases to support not-for-profit innovation. The proposal
includes centralised portfolio and IP management. Beneficiaries of the
fund would be required to license their intellectual property
exclusively to the funding body for the neglected disease, but would
have the right to exploit their IP in more affluent markets, provided
that royalties are paid to the fund. If the new compound presents
advantages in the treatment of a disease with greater commercial
value, the inventor or company would compensate the fund for data
developed with financing meant for neglected diseases.4

Of course, the Novartis proposal focuses solely on neglected diseases
and suggests only limited changes to the global R&D system.
Nevertheless, the condition of access to the IP generated by the
funded research to enable low-cost production and wide dissemination
of the products is a clear recognition of the access problems created
by IPRs. This is a new sound coming from the pharmaceutical industry.

TRIPS or Treaty?
The second fundamental change that the strategy may usher in is that
it raises the possibility of intergovernmental talks about an
essential health and biomedical treaty to change the rules of medical
research and development.

Today=92s predominant global R&D treaty, the WTO=92s TRIPS Agreement, is
based on granting monopolies as the main incentive for innovation; its
provisions for technology transfer are limited. If one asks whether
the TRIPS Agreement would come into being today, knowing what we know
now about access and innovation, even its most ardent proponents would
likely say no.

When WTO TRIPS Agrrement was negotiated, there was no public debate,
the scale of the AIDS epidemic in developing countries was not known,
and the understanding of the technical and legal details among health
groups was virtually non-existent. In contrast, industrial interests
were strongly represented and played a critical role in drafting the
text and lobbying for its support.

Conversely, if today the parties to the TRIPS Agreement set out to
design an international agreement on essential health R&D, the
incentives would add to those in TRIPS and would likely be much more
diverse and differ from those found in the TRIPS Agreement.

This concept is at the heart of the proposals by Love and Hubbard for
a new trade framework focused on equitable contribution to the cost of
R&D through any means =96 not exclusively through the granting of patent
monopoly rights.5 As a result, new products would be more widely
accessible and not tied up in 20 year patents. There would be a market
for R&D, and a separate, competitive market for production and sales
in which all products may be generics. An R&D contribution norm
established by an international treaty would ensure that the financial
resources for R&D would be available, but these funds would no longer
depend on high prices and thus rationing of the products.

Moving the debate from IP to R&D would affect countries=92 ability to
shape the dynamics in trade agreements. When the talks are no longer
centred on how high IP standards should be but, rather, on how can
each country contribute to essential health innovation to benefit all,
the discussion will change. In trade talks TRIPS-plus demands will
become harder to maintain.

Where Next for the Worl Health Organisation?
The Global Strategy is, after the 2001 Doha WTO Declaration on TRIPS
and Public Health, the most important multilateral attempt to alter IP
policies so they respond better to real health needs. This time, the
health authorities are leading the negotiations; the process takes
place at World Health Organisation, not the World Trade Organisation.
The strategy=92s success will thus depend on the WHO=92s forcefulness and
resolve.

However, the organisation=92s role in all this remains highly
controversial. In addition, countries have yet to fully agree who are
the key stakeholders that should implement the different elements of
the action plan for the strategy.

That the WHO has so far failed to acknowledge, translate and publish
Bolivia and Barbados=92 prize fund proposals, although they were tabled
in direct response to a 2007 World Health Assembly Resolution, does
not bode well in this respect. Nor does the haggling seen during the
negotiations over the WHO=92s mandate in the area of IP.

The Global Strategy is about action. The WHO, as the most important
public health agency in the world, should take a leading role. Without
forceful implementation, the strategy will remain nothing but a
declaration of good intentions. Of those, the world has seen enough.

Ellen =91t Hoen is Director for Policy Advocacy of M=E9decins sans
Fronti=E8res (MSF) Access to Essential Medicines Campaign.

endnotes

1 Stiglitz, Joseph. 2007. Prizes, Not Patents. 2007. http://www.project-syn=
dicate.org/commentary/stiglitz81
2 Working document proposed by Barbados and Bolivia. 17 April 2008. http://=
www.keionline.org/
3 See supra note 1.
4 Paul Herrling, R&D and Sustainable, Predictable Financing of R&D for
Neglected Diseases, note presented at the KEI, MSF, Global Forum for
Health Research meeting on 28 March 2007 in Geneva.
5 Hubbard, T. and Love, J. A New Trade Framework for Global Healthcare
R&D. PLoS Biol. 2004; 2:E52.

Judit Rius Sanjuan
Attorney
Knowledge Ecology International / Essential Information
www.keionline.org / www.cptech.org
Phone: +1.202.332.2670, x18