[Ip-health] Italy and 11 co-sponsors introduce transparency resolution text to WHA72

James Love james.love at keionline.org
Mon May 20 11:36:15 PDT 2019


Politico has published a copy of the new draft of the World Health Assembly
(WHA) transparency resolution. The Politico account cites the disclosure of
clinical trial costs as one area for transparency that is strongly opposed
by the pharmaceutical industry (and governments responsive to the pharma
industry lobbies).

Over all, the newest version of the resolution contains several changes,
following informal negotiations on the text, but is still quite strong --
in some areas stronger than the previous version, and in others more
nuanced and flexible for governments.

Negotiations on the text will continue through the week. In the several
days, a number of countries have announced support for the proposal, in
whole or in part.  Today there was a side event sponsored by the Republic
of Korea, Italy and 14 other countries, where the transparency resolution
was discussed extensively, by governments, often by Ministers, in a
positive light.  The side event was held in a large room, but ran out of
chairs, and many participants, if they could get in at all, had to stand.

Civil society activists in France appear to have had considerable influence
on the French position, and some of the most aggressive opponents of a
restitution on transparency have moderated their opposition, or announced
they support a resolution on transparency, at this WHA.  The US has been
more constructive than expected earlier.  Germany and the UK are among the
strongest opponents of the resolution, and some countries still see
anything dealing with R&D cost transparency as a threat to drug company

This is just the opening of the negotiations, and the pharma lobby against
transparency is quite strong, well funded, and well organized, working
closely with several governments to weaken, delay or block the resolution,
or elements of the transparency proposals.

Disclosure of clinical trial costs, the major R&D cost factor and one that
is straightforward to assign to specific products, remains a major area of
controversy, and drug companies are concerned that if the actual costs are
disclosed, their narratives about massive R&D costs will undermined, by

The drug companies have sought to raise, through government delegations
responsive to drug company lobbies, a number of process related maneuvers
designed to bog the progress down with proposed bad faith amendments,
procedural hurdles, and perhaps to extend the negotiations into the
weekend, when many countries will no longer have subject matter experts
available.  At the same time, the civil society lobby on behalf of robust
transparency has  been impressive in its energy, breadth and strength.


Improving the transparency of markets for medicines, vaccines, and other
health-related products and other technologies to be discussed at the 72nd
session of the WHA to be held on 20-28 May 2019

Draft resolution proposed by Italy, Greece, Egypt, Malaysia, Portugal,
Serbia, Slovenia, South Africa, Spain, Tunisia, Turkey, Uganda
Provisional Agenda Item 11.7
VERSION 20 May 2019
The Seventy-Second World Health Assembly

1. Having considered the Report by the Director-General on Access to
medicines and vaccines (document A72/17) and its annex “Draft Road Map for
access to medicines, vaccines, and other health products” and the Report by
the Director-General on Medicines vaccines and health products, Cancer
medicines (document EB144/18), pursuant to resolution WHA70.12;

2. Recognizing that improving access to health-related products and other
technologies is a multi-dimensional challenge that requires action at, and
adequate knowledge of, their entire value chain and life cycle, from
research and development to quality assurance, regulatory capacity, supply
chain management and use;

3. Recognizing the critical role played by health products and services
innovation in bringing new treatments and value to patients and healthcare
systems around the world;

4. Concerned about the high prices for some medicines, vaccines, cell and
gene therapies, diagnostic tests and other health-related products and
services, and the inequitable access within and among Member States as well
as the financial hardships associated with high prices which can impede
progress toward Universal Health Coverage.

5. Recognizing that publicly-available data on prices and costs are scarce
and that the availability of price and cost information is important for
facilitating Member States’ efforts towards the introduction of and
affordable access to new medicines, vaccines, cell and gene therapies,
diagnostic tests and other health-related products and services

6. Seeking to enhance the publicly available information on the actual
prices applied in different sectors, in different countries, recognizing
differences in health systems and differential pricing systems;

7. Commending the productive discussions at the last Fair Pricing Forum in
South Africa regarding the promotion of greater transparency around prices
of medicines, vaccines, cell and gene therapies, diagnostic tests and other
health technologies, especially through sharing of information in order to
stimulate the development of healthy and competitive global markets;

8. Noting the importance of both public and private sector funding for
research and development of medicines, vaccines, cell and gene therapies,
diagnostic tests, and other health technologies, and seeking to improve the
level of information about them, in accordance with national legislations,
concerning the allocation of investments and the costs for research and
development, including costs incurred for conducting the  clinical trials
involving human subjects in order to obtain marketing approval,
reimbursement or coverage for products or services;

9. Seeking to progressively enhance the publicly available information on
the costs throughout the value chain of medicines, vaccines, cell and gene
therapies and diagnostic tests and other health products and services and
the patent landscape of medical technologies, while welcoming recent
initiatives to achieve this goal;

10. Noting the latest Declaration of Helsinki, which promotes making
publicly available the results of clinical trials, including negative and
inconclusive as well as positive results, and noting that public access to
complete and comprehensive data on clinical trials is important for
promoting the advancement in science and successful treatment of patients,
provided the need for protection of personal patient information;

11. Agreeing that policies that influence the pricing of health products
and services or the appropriate rewards for successful research outcomes
should consider and can be better evaluated when there is reliable,
transparent and sufficiently detailed data on the costs of R&D inputs
(including information on the role of public funding and subsidies), and
the medical benefits and added therapeutic value of products;

12. Seeking to have better evidence of the units sold and reaching patients
in different markets in order to evaluate the efficacy of health systems
and the impact of the variety of barriers to access health related products
and services.

1. URGES Member States, within the context of their own legal system and
practice, to:

Opt 1.1. Undertake measures to publicly share information on prices and
reimbursement cost of medicines, vaccines, cell and gene-based therapies
and other health technologies;

Opt 1.2. Require the dissemination of results and costs from human subject
clinical trials regardless of outcome or whether the results will support
an application for marketing approval, while also taking appropriate steps
to promote patient confidentiality;

Opt 1.3. Require the following information be made public for medicines,
vaccines cell and gene-based therapies and other relevant technologies;

a) Annual Reports on sales revenues, prices and units sold,

b) Annual Reports on marketing costs incurred for each registered product
or procedure,

c) The costs directly associated with each clinical trial used to support
the marketing authorization of a product or procedure, separately, and

d) All grants, tax credits or any other public sector subsidies and
incentives relating to the initial regulatory approval and annually on the
subsequent development of a product or service;

Opt 1.4. Improve the transparency of the patent landscape of medical
technologies, including but not limited to biologic drugs, vaccines and
cell and gene therapies and diagnostic tests.

Opt 1.5. Report to the WHA 73 on the use of generic and/or biosimilar
products and health services, and the policies and information that
governments have used to enable early market entry, substitution and uptake
of such products and services, including in particular those recommended by
WHO in its guidelines.

Opt 1.6. Collaborate on the production of and open dissemination of
research and know-how regarding the developing, manufacturing and supply of
medicines, vaccines, cell and gene therapies and diagnostic tests, and help
build national capacities of especially the LMIC countries and for diseases
that primarily affect them, supported by WHO.

2. REQUESTS the WHO Director-General to:

Opt 2.1. Support Member States by providing tools and, upon their request,
guidance, in collecting and analysing information on prices, costs and
clinical trials outcome data for relevant policy development and
implementation towards Universal Health Coverage (UHC);

Opt 2.2 Support Member States, especially the LMIC countries, in
partnership with relevant stakeholders, to promote access to research and
the know-how to manufacture and otherwise provide generic medicines,
medicines, vaccines, cell and gene therapies, diagnostic tests and other
products and services.

Opt 2.3 Collect and analyse clinical trial data with regard to medicines
and the procurement prices of medicines and vaccines from national and
international agencies.

Opt 2.4 Propose a model/concept for the possible creation of a web-based
tool for national governments to share information, where appropriate, on
medicines prices, revenues, units sold, patent landscapes, R&D costs, the
public sector investments and subsidies for R&D, marketing costs, and other
related information, on a voluntary basis.

Opt 2.5. Create a forum for relevant experts and stakeholders, consistent
with FENSA, to develop, suitable options for alternative incentive
frameworks to patent or regulatory monopolies for new medicines and
vaccines that could better serve the need of Member States to attain
Universal Health Coverage and the need to adequately reward innovation,
utilizing information from expanded transparency of markets health-related

Opt 2.6 Create a biennial forum on the transparency of markets for
medicines, vaccines and diagnostics, to evaluate progress toward the
progressive expansion of transparency,

Opt 2.7 Continue its efforts to periodically convene a Fair Pricing Forum
with all relevant stakeholders to discuss affordability and transparency of
prices and costs relating to health-related products and services.

Opt 2.8 Formalize the biennial Fair Pricing Forum which creates a critical
opportunity to discuss transparency of markets for medicines, vaccines,
cell and gene therapies and diagnostics, and to evaluate progress toward
the progressive expansion of transparency.

Opt 2.9 Provide a report to the 146th session of the Executive Board on the
measures that are needed for the WHO Global Observatory on Health R&D to
enhance the reporting on pre-clinical investments in R&D by both the public
and the private sectors.

Opt 2.10 Submit a report to the EB 146 and EB 147 on progress in
implementing this resolution.

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