[Ip-health] Comments on the process for the WHO transparency resolution

James Love james.love at keionline.org
Sun May 26 03:24:59 PDT 2019

As the #TransparencyResolution finally moves onto the #WHA72 agenda, I
would like to offer a few comments on the process.

We have copies of six versions of the negotiating text, including the
original proposal, made by Italy on February 1st, 2019, the revised version
presented to WHO by the 11 cosponsors on April 29, the two versions
emerging from the WHO informals on May 7 and May 10, the revised proposal
submitted by the sponsors on May 20th, 2019 and the version published by
the WHO on its web page (for one day before it disappeared) reflecting the
negotiations through Wednesday evening, May 22..

They are all here: https://www.keionline.org/transparency/wha72

Several other documents mentioned below are here:

On Monday, May 27th, 2019, the resolution will have been before delegates,
with the text changing in response to extensive bilateral, regional and
multilateral negotiations, for four months.

Under the rules, the resolution could have been introduced on the first day
of the World Health Assembly, May 20.  It was presented to countries four
months ago.

Italy discussed the resolution with Geneva delegates on several occasions,
and the European Union held several extensive discussions among member
states.  These included presentations to all health ministers, all drug
regulators, and the Beneluxa Initiative countries working on drug pricing.

In addition to government to government negotiations, there have been
extensive discussions involving civil society. I had several talks with the
US government beginning the first week in February through the run up to
the negations, including with HHS, USPTO, State and the White House
National Security Council.

In February, KEI published a 40 page memo provide citations to 41
resolutions, EU directives, expert reports and other documents, setting or
proposing norms on transparency: https://bit.ly/30GZGe4

KEI encouraged the sponsors to make some changes in the resolution to
accommodate some of the concerns raised by USPTO and HHS,

On March 6th, 2019, 83 groups and 20 well known academic and health experts
sent an open letter to delegates, supporting the transparency resolution.

Oxfam, MSF, UAEM, HAI and more than a dozen NGOs in several countries, as
well as dozens of public health experts and activists, contacted national
delegations to discuss the resolution.

The resolution was the main topic of debate at the WHO Fair Pricing Forum
from April 11th, 2019 to April 13th, 2019 in South Africa, where drug
companies also presented their opposition to transparency of prices or R&D
costs, and health groups and governments, including Italy, discussed the
specifics in the resolution, and it was a prominent demand by the activist
demonstration organized by TAC and the South Africa Cancer Alliance.

I personally attended a major conference on access to medicine in Dublin a
few days later when the transparency resolution was the main topic of

A critical element of civil society engagement has always been to have
access to the negotiating text, and information about country positions.

One of the most disappointing aspects of the negotiation in Geneva this
week was the bitter attack on transparency of the negotiating text and the
country position.   It is very important for everyone to see what is
actually being proposed, and to provide feedback, both technical and
political feedback.

Everyone knows that drug companies have opposed every single item in the
transparency resolution.

The only reason why the positions have changed in several countries is
because of the engagement and advocacy of civil society groups and experts,
and the fact that when reported by news organizations, it is clear that
there is deep public support for making markets for drugs and other health
technologies more transparent.   The civil society engagement in Europe,
Africa and Latin America was particularly impressive, but every phone call,
email, blog and tweet had a significant impact on national delegations, and
this only could happen with transparency of negotiating texts and
information about country positions.   MSF had a brilliant social media
campaign on the resolution, and often it featured powerful graphics that
featured pictures of the actual negotiating text, with brackets and county

The two worst versions of the text were the May 7 version after the first
WHO informal, and version for the end of May 22 (published the next morning
by WHO).

The May 7 negotiating text, with country positions, was made public on May
8.  On May 9, the next day, some 75 groups and 49 individuals sent a harsh
letter to delegates, saying they were appalled at proposals put forth at
informal negotiations at the WHO on Tuesday May 7, 2019, which, “would make
this resolution confusing, weak and practically useless in many areas.”

On May 10, the text improved.

The WHO published the May 22 negotiating text the morning of May 23,  the
same day, 49 groups and 11 individuals sent an open letter to delegates
with this closing paragraph:

"Also, if the delegates are unable to reach consensus in the drafting group
on the WHO transparency resolution, as a result of the objections of a few
countries who seem determined to favor secrecy over transparency, and
ignorance and propaganda over facts and objective evidence, we ask that the
advocates of transparency submit a strong version of the resolution for a
vote before the 72nd World Health Assembly."

On May 24, coalition of 66 countries in Africa sent letters to Germany, the
UK and France, asking they stop blocking progress on transparency, (see
twitter feed of https://twitter.com/HealthGAP for details).

News Coverage

Reporting by traditional news organizations, like Reuters, Politico, Health
Policy Watch, and many many national publications that covered the
negotiations, were able to offer sharper and more informed stories to their
readers when they had access to the negotiating text and country
positions.  Many stories would have never been written if the negotiating
text had not been public.

Subject matter

The resolution was never only about price transparency, although price
transparency was and is a core and compelling objective. Other items that
shape prices, such as secrecy around R&D costs  (largely narrowed in
resolution to clinical trial costs) and patent landscapes, and information
about public sector subsidies and patent landscapes were seen as important.
Data on clinical trial outcomes, and units sold (available in the private
IQVIA database now, but often invisible to academics, patients, NGOs and
health policy makers), are also important.

We are waiting to see the text, which is now ironically secret.  But we
expect that this effort, led by Italy, and strongly supported by Brazil,
India, Spain, South Africa, Norway, Thailand and many other countries, and
with constructive engagement by Switzerland and the United States, among
the several countries that have large domestic pharma industries, will move
this issue forward.

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

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