[Ip-health] The role of universities and NGOs in a new research and development system

Chris Redd reddchris40 at gmail.com
Tue Nov 18 00:36:46 PST 2014


http://globalhealth.thelancet.com/2014/11/17/role-universities-and-ngos-new-research-and-development-system

On May 14, 2014, a British Parliamentary Committee on Science and
Technology wrote to the minister in charge of science and universities,
David Willetts, to warn against Pfizer’s mooted takeover of AstraZeneca.
The $69 billion bid stirred controversy in the UK, because it was seen as a
threat to British science and the public interest. These discussions
approached the fundamental problems of our research and development (R&D)
system, exposing serious concerns about all aspects of the pharmaceutical
business model. More recently, Ebola and antibiotic resistance have kept
our attention on the pitfalls of commercially driven drug development.
Coupling that with soaring prices on new drugs for cancer and hepatitis C,
one sees a growing consensus across all sectors on the need to change. An
international coalition of patients, clinicians, students, civil society,
and politicians is beginning to face up to a system that is desperately
close to breaking.

The words
<http://www.who.int/medicines/areas/human_rights/A_HRC_11_12_Add_2.pdf?ua=1> of
Paul Hunt, former UN Special Rapporteur on the right to the highest
attainable standard of health, seem finally to be striking home.
Pharmaceutical companies exist to fulfil a function in society, Hunt said
in 2009, and so “they must demonstrably do everything possible… to fulfil
their social function and human rights responsibilities.”Following this
logic, a system which does not honour human rights is dysfunctional and is
one we need to change.

Current attitudes are summed up in a recent report
<http://www.bioin.or.kr/InnoDS/data/upload/policy/1338878866998.pdf> from
the UN Conference on Trade and Development, which concludes that the R&D
system is simply falling apart, even citing pharma executives in its
analysis. On the global scene, progress has been made too. The WHO has
finally begun to implement the suggestions of the Consultative Expert
Working G <http://www.who.int/phi/CEWG_Report_5_April_2012.pdf>roup.
<http://www.who.int/phi/CEWG_Report_5_April_2012.pdf> At the 67th World
Health Assembly, the four demonstration projects, albeit less-innovative
ones <http://www.twnside.org.sg/title2/health.info/2014/hi140101.htm>, were
approved, and a resolution was adopted for the establishment of a pooled
funding mechanism <http://keionline.org/node/2076>.

The non-profit sector has already begun to move into this space, with DNDi
<http://www.dndi.org/>exemplifying a burgeoning non-profit sector in drug
development. Other notable examples include Bioventures for Global Health
<http://www.bvgh.org/Who-We-Are/Vision-Mission-and-Values.aspx>, and
the Medicines
for Malaria Venture <http://www.mmv.org/>. The public-private partnership
(PPP) model has been shown
<http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0020302#pmed-0020302-g004>
to
be effective - if only because there is no other way to access the vast
drug libraries of pharmaceutical companies. Even within the PPP model,
reflecting a broader theme, commercialisation is seen as a tiny motivating
factor. Some of the most promising cases of drug development are the open
source
<http://www.plosntds.org/article/info%3Adoi%2F10.1371%2Fjournal.pntd.0001827>
initiatives,
which abandon the traditional paradigm of patent monopolies in search of a
more collaborative approach.

At the same time, a competing dialogue has been developing. ‘Encouraging a
British Invention Revolution
<https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/249720/bis-13-1241-encouraging-a-british-invention-revolution-andrew-witty-review-R1.pdf>’
by Sir Andrew Witty, CEO of GlaxoSmithKline and Chancellor of the
University of Nottingham, was published this summer. The report,
commissioned by the UK government, calls for universities to serve a third
function in addition to education and research: to facilitate economic
growth as a core strategic goal.

Witty’s report represents a secondary discussion on new R&D, and one which
must be given due attention. While to some they may seem innocent and
well-meaning, arguments like this are behind legislation such as the
Bayh-Dole Act in the US, which has driven universities to patent their
research. Making university research funding dependent upon the economic
growth it produces is tantamount to tying the research agenda to profit.
Under the watches of pseudo-democratic organisations such as the World
Trade Organization, this model is exported the world over, often in
exchange for supposedly favourable trade agreements.

Universities, as centres of public science, must not be co-opted by
commercial interests under the guise of economic growth. The Manchester
Manifesto  <http://www.isei.manchester.ac.uk/TheManchesterManifesto.pdf>emphasises
the reciprocal relationship between science and society, working together
to further public understanding and promote mutual benefit. Universities
have a social function, which is demonstrably not to make money. The steps
they can take to honour human rights, forexample
<http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1508789/>, stretch far and
wide.

And yet universities themselves have been sluggish to respond. In the UK,
six universities have spoken publicly about the need to balance commercial
interests with ethical ones, starting with Edinburgh
<http://www.theguardian.com/science/2009/apr/26/cheaper-medicines-edinburgh-university>
in
2009, and most recently including the University of Exeter this August
<http://medicine.exeter.ac.uk/news/title_407662_en.html>.

These statements, however, were the result of student activism
<http://uaem.org/> rather than episodes of altruism. Furthermore, it seems
absurd that universities don’t *already *consider the ethical aspects to
their decisions. Finally, these commitments are often vague and
non-binding, lacking in concrete steps and processes of reporting or
evaluation. Unfortunately, universities in the rest of the world are not
doing much better. At the moment, the most comprehensive data
<http://globalhealthgrades.org/> on the subject show that, by and large,
(US) universities are falling short.

There are signs, at least in the licensing of health technology patents,
that things are beginning to change. In July, a report
<http://appg-tb.org.uk/images/reports/Dying%20for%20a%20Cure%20-%20Research%20and%20Development%20for%20Global%20Health.pdf>
by
the UK All Party Parliamentary Group on Tuberculosis called for socially
responsible licensing to be implemented across all UK research funding. On
the international level, India and others have spoken in the World Trade
Organization at length to try to reframe the way universities are perceived
in R&D.

One of the best examples of the importance of the public versus private
science debate is the Human Genome Project. It may seem absurd, but Sir
John Sulston and colleagues were actually
<http://genome.wellcome.ac.uk/doc_WTVM051500.html>forced into a race to
keep the Human Genome in the public domain. Fortunately, they succeeded in
safeguarding this knowledge for society, and taught us a lesson we must not
forget.

In the first Access 2 Medicines week (Nov 1-7, 2014), members of
Universities Allied for Essential Medicines attempted to bring this debate
to the public by providing a platform for all parties to add their voice to
the discussion. With their petition
<https://www.change.org/p/commit-to-needs-driven-research-and-guarantee-access-to-medicines>,
they hope to convince universities that, as hubs of innovation,
universities have the potential and responsibility to deliver great
advances in global health, and that they can lead the way in establishing a
new, open R&D paradigm based on collaboration.



More information about the Ip-health mailing list