[Ip-health] Health Policy Watch: “Delinkage” Of Medicines R&D From Patent Incentives Stirs Debate at Human Rights Council

Thiru Balasubramaniam thiru at keionline.org
Thu Jul 4 14:29:27 PDT 2019


“Delinkage” Of Medicines R&D From Patent Incentives Stirs Debate at Human
Rights Council

04/07/2019 by Elaine Ruth Fletcher

Only a month after a hotly-contested World Health Assembly resolution
touched off a debate around “price transparency” as a way to improve access
to medicines, a new controversy over how to stimulate access has emerged in
another UN Forum, the Human Rights Council.

This time the debate is around ways to “delink” incentives for the research
and development of new medicines from patent systems that “reward”
companies or institutions investing in the drug’s development with a legal
monopoly over sales of the end-product for years to come.

The sensitive “delinkage” issue is part of a draft Human Rights Council
(HRC) resolution on “Access to medicines and vaccines in the context of the
right of everyone to the enjoyment of the highest attainable standard of
physical and mental health”, under consideration at this month’s session in

Human Right Council, 2016 session. UN Photo / Jean-Marc Ferré

“Delinkage” has become an mantra for many civil society and patient
advocacy groups, as well as some governments, which perceive exclusive
patent rights as a key driver in rising drug prices, limiting access to new
treatments. The term broadly refers to alternative incentives or rewards
that reduce reliance on patents as a means of financing R&D, yielding
products that are cheaper and more readily available.

The draft HRC resolution on medicines access, due for its final review on
11 July, is backed by a core group of countries including Brazil, China,
Egypt, India, Indonesia, Senegal, South Africa and Thailand.
Representatives of that group point out that the recently contested
delinkage paragraph was part of an already-approved 2016 version of the
same resolution, and is merely being reaffirmed again in year’s year’s
updated draft, which now has 27 co-sponsors in all.

“The Human Rights Council brings this resolution up every three years,
because it is viewed as worthy in this context, to have a human rights
perspective on access to medicines,” said Brazil’s representative Clara
Solon in a public HRC consultation Tuesday.

The text calls upon countries:  “to continue to collaborate, as
appropriate, on models and approaches that support the delinkage of the
cost of new research and development from the prices of medicines, vaccines
and diagnostics for diseases that predominantly affect developing
countries, including emerging and neglected tropical diseases, so as to
ensure their sustained accessibility, affordability and availability and to
ensure access to treatment for all those in need;”

Two other paragraphs [8,9]  ”encourage” governments, international
organizations, NGOs, researchers and the private sector to pursue
alternative R&D incentives, in terms such as the following:

“…improved existing and alternative frameworks to adequately reward
innovation, pricing and affordability of health products….” and:
“…to redouble efforts to achieve a continuous  supply  of  quality,  safe,
 effective  and  affordable health  products  through  research  and
 development  that  meets public health needs, for the efficient
application and management of intellectual property standards, to carry out
evidence-based selection of health products and seek fair and affordable

Delinkage Supporters and Critics

Support for  “delinkage” principles has been growing over the past decade,
led by figures ranging from US Presidential hopeful Bernie Sanders to Nobel
Prize winning economist Joseph Stiglitz and Bernard Pecoul of the
Geneva-based Drugs for Neglected Disease Initiative. Countries supporting
the idea have included India, The Netherlands, and the Group of 77,
representing some 134 developing nations. Some private sector voices,
notably former GlaxoSmithKline CEO, Sir Andrew Witty, have also expressed
support for innovative ways to fund R&D.

The advocates assert that the current R&D system, based around granting
exclusive patent rights for new drugs, is breaking down. Newly patented
drugs that are coming onto the market are increasingly priced in a range
that stretches the budgets of high-income countries, while leaving middle-
and low-income countries out of the loop altogether.

The problem is particularly acute for drugs treating non-communicable
diseases such as cancer, where new therapies can carry a $US 100,000+
annual price tag. And particularly if public funds or tax breaks are
invested in drug R&D, then rewards other than exclusive patent monopolies
should be considered for the final drug products, advocates assert.

“Access will always be unequal without the delinkage of R&D costs from the
prices of drugs, vaccines, cell and gene therapies, diagnostic tests and
other health technologies and services,” remarked Thiru Balasubramanian, of
Knowledge Ecology International in an interview. One of the groups that
participated in last week’s HRC consultations, KEI has been a flagbearer of
the delinkage concept.

At the same time some key developed countries, including Switzerland,
Japan, Australia, and the European Union representative at the HRC, contend
that existing patent systems remain the backbone stimulating R&D
investments, and that the HRC resolution treads too far into territory
outside of its traditional domain. They have asked for deletions or major
changes in the paragraphs that reference “delinkage” as well as references
to alternative R&D incentives.

“Delinkage is stated too broadly. As supporters of the global IP system
[for medicine patents], we want to make sure that it keeps performing,
while finding solutions in areas where it is not working. But we are very
worried about taking a one-size-fits-all approach,” Nora Kronig, head of
International Affairs at the Swiss Federal Office of Public Health, told
Health Policy Watch.

“Looking at access to medicines broadly, there are a lot of elements that
come into the chain. For instance, if you don’t have robust regulatory
systems people can’t get medicines either. It is also untrue to talk about
market failure with respect to the whole access to medicines issue,” she

While critics are increasingly adamant that the current system is cracking,
“saying that that there is a global market failure on access to medicines
generally is not accurate,” argues Kronig. “We are fully open to discuss
possibilities where things are not working to find solutions to improve
access to medical products, but what we are very worried about is to
undermine a largely functional system to offset unquestioned distortions in
sub-sectors of the markets for medicines.”

Informal Consultations on Draft

At Tuesday’s informal consultations on the draft, other countries expressed
concerns that the Human Rights Council may be duplicating work already
being carried out by the World Health Organization and the World Health
Assembly body of WHO member states.

“We share concerns about how we are use these very overstretched
platforms,” said Canada’s delegate. “While still recognizing there is a
role for human rights, … we would like to refrain from re-negotiating
thoughts and technical issues that are already being discussed in other
fora such as WHO and WHA.”

The final text of the HRC draft resolution, obtained by Health Policy
Watch, reflects slight modifications in the disputed paragraphs, although
terms like “delinkage” remain along with reference to alternative
incentives for drug R&D.

Besides the core group, other co-sponsors of the resolution, so far,
include HRC members from: Bangladesh, Iraq, Peru, Philippines, Qatar, Saudi
Arabia, Tunisia, and Uruguay.  UN member states and observers that are not
officially members of the HRC can still co-sponsor HRC resolutions, and
such supporters include: Algeria, Bolivia, Ecuador, Eswatini, Ethiopia,
Haiti, Kuwait, Mongolia, Turkey, the United Arab Emirates and Palestine.

Talks with other countries will continue up until next Thursday, when the
final resolution is formally reviewed by the HRC.  But the essence of the
three contested paragraphs would not change or be removed, core sponsors

“The resolution has one paragraph mentioning de-linkage, and some European
countries don’t like this,” said one delegate, who asked not to be named.

“But the resolution is not about delinkage, it touches on many aspects of
access to medicine, including delinkage and alternative frameworks [for
R&D], but we also talk about rights to health, health literacy, many other
issues.  It is very broad text.

“We are not planning to make more changes in the text, but we will work
very hard to add more cosponsors as well as to try to avoid public
objections to the final text,” the delegate added. “But if it comes to it,
we will have a vote.”

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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