[Ip-health] Roadblocks ahead on the WHO Roadmap on Access to Medicines and Vaccines?

Thiru Balasubramaniam thiru at keionline.org
Wed Nov 21 13:08:13 PST 2018


https://www.keionline.org/29227Posted on November 21, 2018

By Katy Athersuch [1] and Thiru Balasubramaniam

In May 2018, the World Health Assembly (WHA) adopted decision WHA71(8)
requesting WHO’s Director-General to “elaborate a roadmap, in consultation
with Member States, outlining the programming of WHO’s work on access to
medicines and vaccines for the period 2019-2023, including activities,
actions and deliverables” (Source: Decision WHA71(8), 25 May 2018
<http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71(8)-en.pdf>). Decision
WHA71(8) requests the WHO Secretariat to “submit this roadmap report to the
Seventy-second World Health Assembly [May 2019] for its consideration in
2019, through the Executive Board at its 144th session” in January 2019.
The proposed WHO roadmap will serve as the implementation plan for the
organization’s activities, actions and deliverables on access to medicines
and vaccines from 2019-2023. The WHO roadmap is intended to complement the
Global Programme of Work (GPW) 2019-2023. In the words of the WHO, the
overall mission of WHO identified in the GPW is three-fold:

(i) promote health, (ii) keep the world safe and (iii) serve the
vulnerable. Specifically, these goals are the “triple billion” to be
achieved by 2023: 1 billion more people enjoying better health and
well‐being, 1 billion more people protected from health emergencies, and 1
billion more people benefitting from universal health coverage (Zero draft,
Roadmap for access 2019-2023
<http://www.who.int/medicines/access_use/Roadmap_for_access_zero_draft.pdf>
).”

In July 2018, WHO published the zero draft of the roadmap on access to
medicines. In its rationale for designing a roadmap, WHO stated:

Access to medicines and vaccines is a multidimensional problem. It
therefore requires comprehensive national policies and strategies, together
with legal and regulatory frameworks that meet health system needs and
cover the entire product lifecycle—from R&D to quality assurance,
regulatory approvals and market authorization, supply chain management, and
prescribing, dispensing and use. These policies and strategies should
balance public health needs with economic and social development
objectives, and promote collaboration with other sectors, partners and
stakeholders.

WHO takes a comprehensive health systems approach to increasing access to
health products. Activities are guided by a series of World Health Assembly
and Regional Committee resolutions spanning the decade from 2007 to 2017
and earlier. These resolutions, numbering almost 100 (Annex 1) were used to
develop the report on ‘Addressing the global shortage of, and access to,
medicines and vaccines’ presented to the 71st World Health Assembly in May
2018 (Ibid).

The roadmap contains ten areas of action for prioritization: 1) Research
and Development for medicines and vaccines that meet public health needs,
2) Fair pricing and financing policies, 3) Application and management of
intellectual property to contribute to innovation and promote public
health, 4) Procurement and supply chain management, 5) Appropriate
prescribing, dispensing and use, 6) Health workforce capacity for access to
medicines and vaccines, 7) Preparedness for emergencies, 8) Collecting,
monitoring and using key data, 9) Good governance, and 10) Regulatory
systems that ensure quality, safety and efficacy of medicines and vaccines.

>From 9 July 2018 to 16 August 2018, the WHO secretariat held an online
consultation for its Member States to provide contributions;
non-governmental organizations and intergovernmental organizations were not
provided such recourse. Consequently, sixteen public health groups
(including Knowledge Ecology International) wrote an open letter
<https://www.keionline.org/wp-content/uploads/2018/08/Letter-to-Dr.-Tedros-on-the-WHO-Roadmap-on-Access-to-Medicines-and-Vaccines-2019-2023.pdf>
to
Director-General Dr. Tedros Adhanom Ghebreyesus on 3 August 2018 expressing
their priorities in relation to 5 topics: 1) Transparency, 2) Excessive
Pricing, 3) Biologics, 4) Intellectual Property Rights, and 5) Delinkage.

Fifty-six member states completed WHO’s online survey to evaluate the zero
draft of the roadmap on access to medicines and vaccines; seven
countries (Burundi,
Germany, India, Panama, the United States, the United Kingdom and Zimbabwe)
<https://www.keionline.org/http://www.who.int/medicines/access_use/Compilation-MSContributions-20September2018.pdf?ua=1>
provided
additional written comments .

What is particularly striking in reviewing the feedback submitted, is the
degree to which the United States appears to be out on a limb and isolated
in its positions compared to most other Member States including those
considered ‘traditional allies’ such as European Union Member States, Japan
and Switzerland.

This blog post will zero in on three topics where divergences were
particularly striking:

A) Research and Development for medicines and vaccines that meet public
health needs
B) Fair pricing and financing policies, and
C) Application and management of intellectual property to contribute to
innovation and promote public health.

In the area of research and development for medicines and vaccines that
meet public health needs, of the 56 Member States that responded, only two
stated that they did not consider that this should part of the roadmap: the
United States and Panama. The United States opposed the inclusion of this
workstream claiming, WHO’s “expertise and capacity” in R&D in medicines and
vaccines was “extremely limited in this area”. The United States held that
WHO should “prioritize work on specific, measurable activities that would
have a high and immediate impact on global access to medicines.”

The United States does not believe that this issue should be included in
the Roadmap, because it should not be one of WHO’s core activities on
access to medicines. Given WHO’s many competing priorities, WHO should use
this Roadmap to prioritize work on specific, measurable, activities that
would have a high and immediate impact on global access to medicines.
Additionally, the United States does not believe that this item is a
consensus-based area of work. Many other actors are working in this space
and WHO’s expertise and capacity is extremely limited in this area,
limiting the potential impact of any actions under this item (Ibid).

While Germany supports the inclusion of the activity areas on ‘Research and
development for medicines and vaccines that meets public health needs’,
they stated that research prioritization and activities related to unifying
principles for biomedical R&D, designing R&D models or sustainable
financing mechanisms models should not be included into the roadmap.
Germany proposed introducing regular reporting by Member States on concrete
capacity development activities through their international cooperation in
this field.

The United Kingdom approved the inclusion of R&D for medicines and vaccines
that meet public health needs, they stressed that the roadmap should “cover
more on commercialisation and market entry (Ibid).” The United Kingdom
welcomed the action point to “develop sustainable financing mechanisms
models for R&D where the market does not attract sufficient investments”
and indicated its commitment to seeing successful models developed (Ibid).
The United Kingdom called for strengthening the WHO’s gap analysis on R&D
for antibiotic pipelines.

With respect to fair pricing and financing, the United States and Panama
were again the only two Member States that did not support the inclusion of
this activity area as framed. Instead the United States proposed that
pricing and financing be addressed separately. On pricing, the United
States called for WHO to engage in work on pricing and reimbursement
policies including value-based pricing and maintained that term fair
pricing did not “have a commonly understood definition and seems inherently
subjective (Ibid).”

On fair pricing and financing policies, Germany supported the inclusion of
the activity area and stated that the listed activities are sufficient to
ensure impact. In terms of deliverables they suggested adding the
following, ‘support development of policy guidance for the control of price
developments along the supply chain.’ The United Kingdom underscored that
fair pricing was the “core dimension of access to medicines (Ibid).” On
fair pricing in relation to antimicrobial resistance (AMR), the United
Kingdom proposed that the “explanatory text could be enhanced by stating
that lack of affordability is a driver of AMR” and that “patients may go
untreated (resulting in infection of others), their treatment may be
foreshortened, or they may receive / use a sub-optimal drug for financial
reasons (Ibid).”

The United States opposed the inclusion of the application and management
of intellectual property to contribute and promote public health in the
roadmap given “WHO’s many competing priorities, as well as the work in this
area by other organizations”. Furthermore, the United States asserted that
there was no consensus on this area of work. It is important to note that
the United States was one of only three Member States who shared this
position. 48 Member States responded favourably to the inclusion of this
activity area, whereas five were unsure.

With respect to the management of intellectual property, the United Kingdom
stressed that the development of best practice should be a “Member State
driven process” performed in conjunction through the trilateral cooperation
of WHO, WIPO, and WTO.

The Roadmap will come before the Executive Board in January 2019. An
updated draft, incorporating the comments and feedback gathered from Member
States and non-state actors is expected to be released in December this
year. It remains to be seen what speed bumps and roadblocks may arise, but
we hope the Roadmap will provide a clear plan setting out the WHO’s
activities, actions and deliverables on access to medicines and vaccines
between now and 2023.
------------------------------

*Endnotes*

[1] Katy Athersuch, Senior Policy Adviser – Medical Innovation & Access,
Médecins Sans Frontières- Access Campaign


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


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