[Ip-health] Current verison of the WHA resolution on transparency, that will be discussed in May in Geneva

James Love james.love at keionline.org
Tue Apr 30 13:25:23 PDT 2019


Health Policy Watch has published the most recent version of the
transparency resolution that will be discussed the last week in May at the
WHO's World Health Assembly.

The new text has several changes, and 9 new co-sponsors.  Some other
governments may also co-sponsor.

The WHO has scheduled two informal negotiations on the resolution for May 7
and 10, in Geneva.

On the whole, I think this version is stronger and sharper in its focus
than the previous draft.  One element that is gone, however, concerns trade
agreements.

The HPW story, including its analysis is here:

https://www.healthpolicy-watch.org/drug-price-transparency-10-countries-back-world-health-assembly-resolution/

Below is the new resolution text:

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Improving the transparency of markets for medicines, vaccines and other
health-related 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, Malaysia, Portugal, Serbia,
Slovenia, South Africa, Spain, Turkey, Uganda

Provisional Agenda Item 11.7

The Seventy-Second World Health Assembly

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 A72/xx), pursuant to resolution WHA70.12;

Concerned about the high prices for new medicines, vaccines, diagnostic
tests, and the unequal access and financial hardships associated with high
prices;

Noting with concern that the high prices of medicines impede progress for
the many countries that have committed to the attainment of Universal
Health Coverage (UHC);

Reaffirming the consensus reached at the last Fair Pricing Forum in South
Africa to promote greater transparency around prices of medicines, vaccines
and health technologies applied in different Member States, especially
through sharing of information in order to stimulate the development of
healthy and competitive global markets;

Noting the importance of public and private sector funding of research and
development of medicines, vaccines and other health technologies, and
seeking to improve the transparency of information concerning the
allocation of investments and the costs for research and development
directly associated with each specific product, including costs incurred
for patient enrollment and costs associated with conducting the trials,
such as data collection and management and analysis of results

Seeking to enhance the publicly available information on the costs of
manufacturing of medicines, vaccines and health technologies, and the
patent landscape of medical technologies;

Noting with concern that despite the latest Declaration of Helsinki
outlining the ethical imperative to make publicly available the results of
all clinical trials, including negative and inconclusive as well as
positive results, the public access to complete and comprehensive data on
clinical trials is still limited, and that this in fact reduces access to
knowledge that is critical for advances in science, which has direct and
negative consequences on the knowledge about the safety and efficacy of
medicines that are prescribed to patients;

Agreeing that policies that influence the pricing of health technologies or
the appropriate rewards for successful research outcomes 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), the medical benefits and added therapeutic
value of products;

1. URGES Member States to:

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

2. Require that all human subject clinical trial results be reported
publicly, including the costs incurred to undertake each trial and the
direct funding, tax credits or other subsidies contributions received from
governments;

3. Require as a condition of registration 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 R&D costs directly associated with each clinical trial used to
support the registration 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 procedure;

4. Improve the transparency of the patent landscape of medical
technologies, using approaches that do not create barriers to generic
competition through sharing complete and up to date information;

2. REQUESTS the WHO Director-General to:

1. Support Member States in collecting, analysing and creating standards
for information on prices, reimbursement costs, clinical trials outcome
data and costs for relevant policy development and implementation towards
Universal Health Coverage (UHC);

2. Create a web-based tool for national governments to share information on
medicines prices, revenues, R&D costs, the public sector investments and
subsidies for R&D, marketing costs, and other related information;

3. Create a forum for relevant experts to develop, with industry
representatives, payers, patients, charities and health NGOs, suitable
options for alternative incentive frameworks to patent 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;

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

5. 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.

-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
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