[Ip-health] IP-Watch: Vision, Urgency Of UN High Level Panel On Access To Medicines Begins To Take Shape

Thiru Balasubramaniam thiru at keionline.org
Fri Feb 5 07:54:04 PST 2016


http://www.ip-watch.org/2016/02/05/vision-urgency-of-un-high-level-panel-on-access-to-medicines-begins-to-take-shape/

Vision, Urgency Of UN High Level Panel On Access To Medicines Begins To
Take Shape

05/02/2016 BY WILLIAM NEW, INTELLECTUAL PROPERTY WATCH

NEW YORK — It came as a surprise to some when the United Nations Secretary
General’s office announced in November the setting up of a high level panel
to urgently address access to medicines and other health technologies.
After all, UN agencies in Geneva, most notably the World Health
Organization, have been working on these issues for years.

Yesterday at the UN in New York, an event was held to explain some of the
vision and urgency behind the setting up of the panel, which includes an
expert committee of representatives of some 10 international organisations
and others. It also includes an open online call for contributed ideas
until 18 February, and two public hearings.

The cross-cutting, 16-member panel was named in December and its report is
due on 30 June. The High Level Panel on Access to Medicines website is
UNSGAccessMeds.org. The panel shows geographical, racial and gender
diversity. It includes representatives from various agencies,
nongovernmental organisations, academia and pharmaceutical industry
(innovator and generic). It is chaired by former Swiss President Ruth
Dreifuss and former Botswana President Festus Gontebanye Mogae.

Panellist and chair of the expert advisory group Michael Kirby, a retired
Justice of the High Court of Australia who has served on many UN expert or
reference groups, yesterday painted some of the vision and history that led
to the panel’s formation. But while he was optimistic and firm about the
panel’s purpose, he also found himself defending its independence and
legitimacy after “grave” concerns were raised at the lunch by a delegate of
the United States mission.

“There is no reason why we should not succeed,” said Kirby, “except the
challenges are enormous and the time is brief.”

“These are not just issues of the United States,” he said. “These are
issues of the world.”

If one were to look for the “trigger” that led to establishing the panel,
he said, it would be the approval by UN member states last autumn of the
2030 Sustainable Development Goals, especially the third one, which is on
health.

Panellists were appointed in November to carry out a review and look at
solutions to “remedy policy coherence” in delivering access to medicines.
This big-picture initiative cuts across numerous fields such as innovation,
international trade law, public health, human rights and more. It was noted
that while the name of the panel refers to access to medicines, it also
refers to vaccines, diagnostics, and other health technologies.

Kirby noted the short time-frame, but said, “Six months is short but not
impossible.” He pointed to a secretary general’s report on human rights
abuses in North Korea on which he worked that also was done in six months
and has become the “gold standard” in that area.

The panel wants “to get as many proposals as we can,” he said, and will
address the preparation of the report in a “transparent and open-minded
way.”

But addressing some questions that have begun to surface about the panel,
Kirby said if anyone thinks the group is coming having “already written the
report,” that is not the case. “We are approaching our task with an open
mind,” he said.

Kirby and others were coming from a morning meeting with industry. There,
he said, GlaxoSmithKline CEO Andrew Witty called it a “well-timed
investigation” and that “the time is now.”

Seeking Sustainable Solutions

Panel member Sakiko Fukuda-Parr of Japan, a development economist and
professor at the New School in New York, and director and lead author of
the UNDP Human Development Reports, discussed the Sustainable Development
Goals (SDGs). She said she has been focusing on goal-setting, social and
economic sustainability, and the ability to harness knowledge.

Several speakers noted the different nature of the SDGs from the preceding
Millennium Development Goals (MDGs). Fukuda-Parr said the SDGs are “not an
aid agenda for donors,” and are not North-South, but rather about leaving
no one behind and creating a sustainable world for all. Health is important
for inclusive and sustainable growth, she said.

Fukuda-Parr said it is particularly important that the panel is starting
with a call for proposals, and noted that “this is not a process where are
saying we don’t know enough.”

She and others emphasised that the initiative specifically draws on all the
past work done on this issue. What is needed is “agreement on priority
actions that are implementable.” They are addressing two categories of
issues: quick fixes and long-term, incremental changes, she said.

Tenu Avafia, team leader: Human Rights, Law and Treatment Access, HIV,
Health and Development Group at the   the UN Development Programme (UNDP),
which along with UNAIDS is organising the panel initiative, spoke on the
modalities of the panel’s work, and the secretariat to the panel. He
recalled that the panel was called for in the 2012 report of the Global
Commission on HIV and Law, which included recommendations on intellectual
property and its role in boosting innovation and access to medicines. This
included a recommendation for the secretary general to set up the high
level panel.

Also tied to creation of the panel was the Synthesis Report of the
Secretary General on the Post-2015 Development Agenda.

And the third pillar leading to the panel was the September 2015 adoption
of the UN SDGs.

Avafia said there is an emphasis on the panel not recreating previous work
but rather building on it. The expert committee includes as many as 10
institutions, and experts named for a range of particular expertise.

Authors of contributions will be invited to the two “global dialogues” on
the day before each public hearing, being held in March in London and
Johannesburg. Then comes the process of forging the key elements of the
report, he said, with the aim of handing it to the secretary general by 30
June.

The panel may also request contributions from key organisations, such as
the World Health Organization, World Trade Organization and World
Intellectual Property Organization.

US Opposition

In the questions and answers, Laurie Phipps of the US mission to the UN let
loose a volley of concerns about the secretary-general’s panel, going so
far as to raise a question of its legitimacy.

“The United States has grave concerns about the lack of transparency and
consultation with stakeholders and governments in the process thus far, the
short timeframe established for soliciting input and producing a final
report, the lack of clarity on its intent, the narrow focus of the panel,
the apparent prejudice in the panel’s assumptions, and the risk of overlap
or incoherence in the UN system,” she said. “The issue of access to
medicines is important for all countries, thus such a high-level effort
should have full legitimacy and provide real and practical solutions.”

She said the US was “surprised” to learn of the November announcement, and
said it was “our understanding” that “many member states were also unaware
of this initiative” and further that the US has “heard repeatedly of
concerns for a narrow approach around the issue.” She did not name any
other countries or the sources of concerns, however.

Phipps specifically charged that “appropriate protocol was not followed in
this instance” for consultation or information prior to the panel’s
formation. In addition, she said the US has “been told” that the WHO, WTO
and WIPO were not consulted prior to the panel’s formation, and were only
belatedly added, which “does not compensate for their lack of involvement
in the development of the focus of the panel or the panel’s composition.”
Those three Geneva-based institutions did not appear to raise these
concerns in their presentations to the panel on Monday in Geneva, however
(IPW, Public Health, 1 February 2016).

In addition, the US said it has “learned” that two panel members and one
“prominent” member of the expert group have expressed concerns to the panel
co-chairs that the intent of the panel is not consistent with what was
originally communicated to them, as it has been significantly narrowed and
is “based on a number of assumptions not shared by all panel members.”

Furthermore, the US argued that the panel is a duplication of effort as the
WHO is working on an evaluation of its Global Strategy and Plan of Action
on Public Health, Innovation, and Intellectual Property. That slow-moving
strategy and plan of action, dates back to 2008 and it is unclear whether
it has made any significant progress on the problem. As Phipps pointed, the
WHO is just now beginning to collect data on it and then will go through
the member-state driven process of a “policy analysis” of it.

She also raised concern about narrowness of focus, where the panel seems to
be focused only on promoting access to innovative medicines without looking
at the “systems that have been established to promote innovation.”

“Access to medicines is about more than price, profits, or intellectual
property. Governments deal with the multi-faceted challenges by making
choices on procurement, taxes, tariffs, health systems and service
delivery, rational use, and more,” she said.

Initial Response

Kirby responded by first saying that member states much take any complaints
to the secretary general’s office, not to the appointees. He also said the
statement had not been sent ahead of time so he had not had time to
consider the concerns before now. He asked that it be submitted and a more
formal response would be offered.

But in general, he said that regardless, the panellists were appointed and
will carry out their duty. He also said the issue has been known since the
2012 Global Commission report, on which he was a commissioner, and said
that the panel process is transparent, including public hearings.

Kirby further said the panel is not member-state driven, and is not about
one country. He added that the issue is in fact the subject of “lively
debate” in the United States itself, as he noticed large news articles even
in his two days in the country (he came from Australia). At the time of the
panel, for instance, the US Congress was holding a high-intensity debate on
the very issue of pricing of medicines.

“Nobody can say they were not on notice about this,” said Kirby. “The fact
is it has been created, with a number of people of integrity and ability.”
He added that he thought “the secretary-general is to be congratulated” for
the urgency he has placed on the issue.

The lunch event was cosponsored by France and Uruguay. Fabienne Bartoli of
the French mission noted the success of prior activities such as GAVI, the
vaccine alliance, but noted the short timeframe for this report.

Uruguay Amb. Elbio Rosselli described a model in his country for social
insurance as well as a change in the management model in which the National
Board of Health was created to agree and sign the contracts with providers.

Uruguay has considered introducing generic drugs, ensuring the
bioequivalence and biosimilarity of medicines.



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