Comments on the transparency resolution negotiation process

An earler version of this was posted to ip-health.

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:

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 Valletta group countries working on drug pricing. (Italy asked the Beneluxa initiative countries for the opportunities to present, but they did not respond).

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:

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 discussion.

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 positions. 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 positions.

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.

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 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.