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 made available, I sent out a quick take 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, that 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 trial 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.