[Ip-health] Health Policy Watch: Drug R&D, Sexual & Reproductive Health Scrutinised In Draft UHC Declaration

Thiru Balasubramaniam thiru at keionline.org
Sat Jul 20 01:21:32 PDT 2019


Drug R&D, Sexual & Reproductive Health Scrutinised In Draft UHC Declaration
19/07/2019 by David Branigan

Disclosure of costs for drug research and development (R&D) and
“alternative financing mechanisms” for new health products remain
outstanding points to be resolved by countries in finalising a draft United
Nations General Assembly political declaration on universal health coverage

A final draft of the declaration had been expected this week, but as of
Friday afternoon, language on sexual and reproductive health and rights
(SRHR) and drug development issues appeared to be unresolved in the draft
text, obtained by Health Policy Watch.

Observers close to the negotiations told Health Policy Watch that they
feared that disputes over the SRHR language in particular could extend
finalising the declaration beyond this month.

If negotiations around SRHR become divisive, sources warned that the
timeline for finalising the declaration could even extend into September,
just ahead of the UN General Assembly High-Level meeting on UHC.

That language has been controversial in light of opposition by the US as
well as some developing countries to any references to sexual or
reproductive health that could imply access to abortion.

Additionally, the Group of 77 (G77), a coalition of 134 developing nations,
have experienced sharp differences of opinion on both access to abortion
and contraception, and members have decided not to vote as a bloc on the
issue, sources said.

United Nations Headquarters in New York

The 12 July draft text of the UHC declaration, obtained by Health Policy
Watch and confirmed as authentic by two sources, includes some bracketed
text, indicating outright disagreement, and highlighted text, indicating
language still up for discussion. The reference to transparency of the
“costs” of R&D is bracketed, and much of the language on alternative
financing mechanisms for research and development is highlighted.

Despite intense debates over sexual and reproductive health and rights in
recent UN fora, the paragraph on SRHR includes no brackets or highlighting,
and has remained unchanged from the initial “zero” draft of the text issued
in late May.

However, some negotiators still see potential controversy “looming” over
the sensitive SRHR language, and say that the timeline for finalising the
declaration will largely be determined by the progress of negotiations on
this issue.

Other aspects of the declaration, for which there appears to be no
controversy, include:

Increasing investment in primary health care as the vehicle for UHC;
Strengthening health systems to more comprehensively prevent and treat
communicable and non-communicable diseases;
Addressing environmental factors that negatively affect health including
the impacts of climate change;
Improving emergency preparedness and response systems;
Ensuring affordable access to health services, including “essential, safe,
affordable, effective and quality medicines and vaccines.”

Once finalised, the declaration will be issued at the UN General Assembly
High-Level Meeting on UHC on 23 September in New York.

R&D Transparency, Alternative Financing for Innovation Still Up for

This year has already seen intensive debates over the public disclosure of
medicines prices and research and development costs at the World Health
Assembly (WHA) in May. That was followed by debate last week at the UN
Human Rights Council (HRC) over “delinkage” of R&D costs from the price of

In both fora, several high-income countries had distanced themselves from
language in the final adopted texts. In the case of the WHA resolution, the
United Kingdom, Germany and Hungary “disassociated” themselves altogether
from the final resolution. In the case of the HRC resolution, Japan
protested the delinkage clauses.

Sources noted that a similar dynamic could arise with the UHC declaration,
as these debates continue as core aspects of member state negotiations in
yet another UN forum.

In the UHC draft declaration, paragraph 11.e of the preamble – which is
reportedly still up for discussion – recognises that “the high prices for
some health products, and inequitable access to such products within and
among countries, as well as financial hardships associated with high prices
of health products continue to impede progress towards achieving universal
health coverage.”

In the so-called operative paragraphs of the resolution, disagreement is
said to revolve around a reference in paragraph 47 calling for “increasing
transparency of prices [and cost],” of research and development – something
which many pharmaceutical companies consider to be proprietary information.

Paragraph 50, which encourages “the use, where appropriate, of alternative
financing mechanisms for research and development as a driver of innovation
for new medicines and new uses for medicines,” also appears to be the focus
of significant discussion, as the entire paragraph is highlighted.

It refers to the concept of delinkage, encouraging support for “voluntary
initiatives and incentive mechanisms that separate the cost of investment
in research and development from the price and volume of sales, to
facilitate equitable and affordable access to new tools and other results
to be gained through research and development.”

According to sources close to the negotiations, this paragraph uses the
term “separate” rather than “delink,” to avoid any negative association the
term could carry among proponents of traditional R&D systems, which rely on
exclusive patents to create incentives for private sector investment in R&D.

By instead relying on alternative financing mechanisms to incentivise
innovation, such as cash prizes and upfront funding, delinkage provides an
alternative to traditional R&D incentives based on exclusive patents, known
to create monopolies that drive up drug prices.

In addition to separating price, this paragraph also calls for separating
the “volume of sales” from the cost of R&D investment, referring to the
critical need to develop new antibiotics while at the same time limiting
their use to treat drug-resistant infections caused by antimicrobial

Lastly, this paragraph mentions that these alternative financing mechanisms
be applied “[in potential areas where market failure exists],” which is in
brackets, indicating disagreement.

According to sources, critics of traditional R&D systems that incentivise
innovation through exclusive patents put this phrase in brackets. They
consider the concept of isolated market failures of this R&D system –
resulting in neglected diseases and insufficient R&D of new antibiotics –
to be inadequate to address the broader reforms they think are needed
across the R&D landscape.

Paragraph 48, which references member states’ rights to flexibly apply
intellectual property rules for the protection of public health, so far
remains unchanged. This is likely due to the fact that this same language
was already agreed-upon in the 2018 Un General Assembly declaration on
tuberculosis (TB), so the precedent had already been set. These
flexibilities enable countries to legally produce affordable generic
versions of patented drugs for the purposes of safeguarding public health.

In paragraph 49, the recognition that public health-driven research and
development should be guided by the principles of “safety, affordability,
effectiveness, efficiency, [and] equity,” was added without controversy,
sources said.

Sexual and Reproductive Health and Rights Yet to Be Negotiated?

Currently, the paragraph on sexual and reproductive health and rights in
the 12 July draft of the UHC declaration remains unchanged from the zero
draft of the declaration, issued just after the close of the World Health
Assembly in May.

However, if a disagreement erupts over the SRHR language, it would likely
be even deeper than that over the issue of drug R&D. Sources warned that
the timeline for finalising the declaration could be delayed beyond the
tentative July deadline, and even run the risk of extending into September
just ahead of the high-level meeting on UHC.

This was the experience in the negotiations to finalise the 2018 UN
declaration on TB – which were stalled by disagreement over the language on
intellectual property flexibilities – in the lead-up to the UN High-Level
Meeting on Tuberculosis last September.

The United States and some developing countries have previously spoken out
against the language on SRHR in the UHC declaration, saying that it can be
broadly interpreted to include abortion, and that it encourages countries
to change their laws on abortion.

At a WHA meeting on UHC in May, the US emphasised that a country “should
develop approaches to make progress on UHC within its own cultural,
economic, political, and structural realities and priorities.” The
Philippines, where abortion is illegal, supported this position.

At recent negotiations in the Human Rights Council over a resolution on
ending early and childhood marriage, a number of countries from the Middle
East, Africa and South-East Asia objected to language ensuring freedom for
girls to be informed about and make choices on their own sexual and
reproductive health.

In the current draft, the paragraph on SRHR reads as follows:

“65.     Ensure universal access to sexual and reproductive health and
reproductive rights in accordance with the Programme of Action of the
International Conference on Population and Development and the Beijing
Platform for Action and the outcome documents of their review conferences,
including universal access to sexual and reproductive health-care services,
including for family planning, information and education, and the
integration of reproductive health into national strategies and programmes,
and recognizing that the human rights of women include their right to have
control over and decide freely and responsibly on all matters related to
their sexuality, including sexual and reproductive health, free of
coercion, discrimination and violence, as a contribution to the achievement
of gender equality and the empowerment of women and the realization of
their human rights;”

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

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