[Ip-health] WHO: No “Fair Price” without access and transparency, say CSOs

K.M. Gopakumar kumargopakm at gmail.com
Tue Apr 23 11:42:25 PDT 2019


http://www.twn.my/title2/intellectual_property/info.service/2019/ip190402.htm

*WHO: No “Fair Price” without access and transparency, say CSOs*

Geneva, 19 April (TWN): A joint statement
<http://wp.twnnews.net/sendpress/eyJpZCI6IjU3MzQwIiwicmVwb3J0IjoiNzA4IiwidmlldyI6InRyYWNrZXIiLCJ1cmwiOiJodHRwczpcL1wvd3d3Lm1zZi5vcmcuemFcL3N0b3JpZXMtbmV3c1wvcHJlc3MtcmVsZWFzZXNcL25vLWZhaXItcHJpY2VzLW1lZGljaW5lLXdpdGhvdXQtYWNjZXNzLWFuZC10cmFuc3BhcmVuY3kifQ/>
signed by 64 civil society organizations (CSOs) stated that there cannot be
fair prices of medicines without affordable access and transparency of
research and development (R&D) outlays, manufacturing costs, and pricing
decisions.


The statement was issued on 10 April on the occasion of the World Health
Organization’s second Fair Pricing Forum (11-13 April) in Johannesburg,
South Africa. The event was organized in cooperation with the Government of
South Africa.


According to the WHO, the Forum “aimed to provide a global platform for a
frank discussion among all stakeholders – including governments, civil
society organizations and the pharmaceutical industry – in order to
identify strategies to reduce medicine prices and expand access for all.”
The First Fair Pricing Forum was held in the Netherlands in 2017.


“A medicine price cannot be considered fair if people or the government
cannot afford it,” declares the CSO statement. It further states that the
lack of affordability “would compromise human rights including the right to
life, the right to enjoy the benefits of scientific progress and its
applications, and the right to health.”


Further, the statement also stresses: “Transparency is required throughout
the R&D process from the start of basic research to the final delivery of
medical products to patients. Some governments and most pharmaceutical
corporations try to justify high prices by citing the need to recoup R&D
outlays. Yet, pharmaceutical companies refuse to provide details of these
R&D outlays and of related support from the public and charitable entities.”


The statement also points out that “some governments and pharmaceutical
companies are actively opposing various efforts at enforcing greater
transparency (as per various bills in the United States and a transparency
proposal from the Italian government to be considered at the upcoming May
2019 World Health Assembly).”


[Italy has proposed a draft resolution
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for the consideration of the World Health Assembly. Among other things, the
draft resolution urges that WHO Member States: “Requires as a condition of
registration for drugs and vaccines annual reports on (a) sales revenues;
(b) prices and quantities, outlays on marketing; (c) R&D costs including
enrolment and outlays on each clinical trials separately; (d) grants, tax
credits, grants or any other public sector subsidies and incentives
relating to the development of the product”.

It also requests the Director-General of WHO, among other things, “to
collect and analyse data on health technologies of public health importance
including but not limited to (a) actual cots on R&D of specific drugs and
vaccines including the enrolment and cost of individual clinical trials;
(b) actual manufacturing cost of specific drugs and vaccines; (c)
manufacturing know-how; (d) the landscape of patents, including information
about disputes about the validity and/or relevance of asserted patents”.]

CSOs rejected WHO’s definition of Fair Price used in the Roadmap for Access
to Medicines, vaccines and other health products (EB 144/17)”. The WHO
definition states that a “Fair price is one that is affordable for health
systems and patients and that at the same time provides sufficient market
incentive for industry to invest in innovation.”

According to the statement, this definition has the following major
drawbacks:

   - It does not require transparency of R&D costs and price setting
   decisions. This means that the public will still have to trust
   pharmaceutical companies’ price setting;
   - It does not account for the substantial role of the public sector in
   funding R&D. This must be considered in defining fair prices to ensure the
   public does not pay twice, and receives a public return on public
   investments;
   - It pre-supposes that R&D is always to be paid for through end prices
   of medicines. The definition thus excludes development models based on the
   principles of de-linkage, in which R&D would be incentivized through
   grants, subsidies and innovation inducement prizes, rather than
   monopoly-based high prices.

The WHO statement
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issued at the conclusion of the second fair pricing forum quoted Dr
Mariângela Simão, WHO Assistant Director-General for Medicines and Health
Products: “Medical innovation has little social value if most people cannot
access its benefits … This is a global human rights issue – everyone has a
right to access quality healthcare.”


According to the WHO statement, “The affordability of medicines has long
been a concern for developing countries, but today it is also a global one.
Each year, 100 million people fall into poverty because they have to pay
for medicines out-of-pocket”. It states that the high-income countries are
also facing the problem of access to medicines due to high prices and
forced “to ration medicines for cancer, hepatitis C and rare diseases”.


A WHO press release stated that the organization would launch an online
consultation in the coming week to collect views and suggestions for a
definition of what actually constitutes a ‘fair price’ from relevant
stakeholders.+


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