[Ip-health] KEI Statement on Adoption of the WHA72 Transparency Resolution

Claire Cassedy claire.cassedy at keionline.org
Tue May 28 09:37:21 PDT 2019


https://www.keionline.org/30887

KEI Statement on Adoption of the WHA72 Transparency Resolution

Posted on May 28, 2019 by James Love

Today the World Health Assembly (WHA) approved A72/A/CONF./2 Rev.1 as a
resolution, titled “Improving the transparency of markets for medicines,
vaccines, and other health products.”

Link to the resolution:
http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_ACONF2Rev1-en.pdf

When the text was available, I sent out a quick take on the final text in
this Twitter thread, highlighting several disappointments, but also
offering positive overall assessments.

Link to the Twitter thread:
https://twitter.com/jamie_love/status/1133253379126419456

The resolution was first sent to the World Health Organization (WHO) on
February 1, 2019, and was the subject of dozens of consultations and
negotiations leading up the WHA (which began on May 20, 2019), and included
7 days of informal and then formal negotiations totaling over 70 hours by
some counts, at the WHA.

The resolution sought to create obligations on medical technology companies
to disclose different types of information, including by country: prices,
revenues, units sold, marketing costs and patent landscapes, as well as
information on clinical trial outcomes and costs, and government R&D
subsidies.

Italy was the primary sponsor of the resolution, and was a strong and
effective leader throughout the negotiations. At least 20 countries joined
in sponsoring the resolution, including 7 members of the European Union.

The final resolution was considerably weaker than the initial proposal, due
to countries such as the United States, Germany, the United Kingdom, Japan,
Denmark, Switzerland and Sweden, and even countries like Australia, Canada,
Belgium, the Netherlands, Hungary, Poland, and Bulgaria, opposed various
elements of the resolution.

The United States, Japan and Switzerland eventually came to support price
transparency proposals, while opposing transparency of R&D costs, and the
Netherlands took similar positions.

Germany, Sweden, Denmark and the UK opposed nearly every transparency
proposal.

We have several versions of the negotiating text here:
https://www.keionline.org/transparency/wha72

More background information is available here:
https://www.keionline.org/transparency

What was accomplished? Despite the many compromises brokered in order to
gain a broad consensus (all Member States except Germany, the United
Kingdom, and Hungary ended up supporting the resolution), the text was
consequential. The biggest achievement was the agreement that member states
should “Take appropriate measures to publicly share information on net
prices,” but there was also much more achieved, scattered throughout the
document, in different paragraphs, on various transparency targets or
topics.

The resolution creates a mandate for Member States and the WHO to create
systems to collect and share information about prices, sales, units sold,
patents, public and private sector R&D costs, R&D subsidies and other items.

The price transparency issue was perhaps the most concrete issue for many
government negotiators, and here the resolution represents an impressive
achievement, at a time when non-disclosure agreements have become
increasingly common and problematic.

The largest failure was in the area of clinical trials costs. This was
strongly opposed by US Health and Human Services Secretary Alex Azar (the
former President of Lilly USA), and a few other countries. There was broad
and enthusiastic support for the disclosure of trial costs from many
countries, but a small number of industry-friendly countries blocked a
consensus on mandates for trial cost disclosures.

Health groups and activists working on this issue were very happy to see
the final version approved at the WHA, despite disappointment at the
compromises that were necessary to reach approval. This resolution is an
important first step in making markets more transparent, and is the
beginning rather than the end of a process. KEI expects groups to redouble
their efforts on the R&D transparency issues (the ‘forbidden knowledge’ per
these negotiations), particularly since it is increasingly obvious that the
industry itself thinks it has a lot to hide, and their narratives on R&D
costs are not consistent with facts.

Health groups and civil society in general played a large role in the
negotiations, as was evident from the bitter complaints about criticisms of
countries’ anti-transparency positions coming from Germany, Sweden and
other countries that were the subject of social media and news reporting
generated by activists (more on this here: https://www.keionline.org/30884).
France switched its position entirely after an extensive campaign by NGOs
and activists, and Germany left the negotiations after its’
anti-transparency positions were publicized in Germany.

There are many people in NGOs, governments, and as individuals, who did a
lot of work to move this forward — a big sprawling community that wants to
pull back the curtain of secrecy and have more transparency. This
resolution is a pretty good start, while there is, of course, a lot more to
do to increase transparency, particularly on R&D costs.


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