Disease unites the world. So does the impact of unbridled capitalism. Rich and poor countries alike, came together this week to take first steps to understand why medicines cost as much as they do. The 72nd World Health Assembly that convened in Geneva, adopted a resolution to push for greater transparency around the prices of drugs, but fought shy to endorse costs associated with research and development and clinical trials.
Countries, of course, can implement national policies that can go further than the letter of the resolution with respect to the disclosure of costs of R&D and clinical trials. For example, Thailand has said that it reserves the right to go beyond the resolution in terms of disclosure of R&D costs.
In an unusual move, a few countries (UK, Germany, Hungary) disassociated themselves from the resolution.
For those who did and for others, the resolution will shine light on the opaque processes on how medicine prices are published, negotiated and protected. The resolution hopes that “availability of comparable price information may facilitate efforts towards affordable and equitable access to health products”.
Global health media was awash with the news of a “watered-down” version of the transparency resolution. Activists may quibble on the scope of the resolution itself. The final version of the resolution was softer on the language around costs of clinical trials and R&D costs. The agreed text was the result of more than 70 hours of negotiations during the World Health Assembly, and in addition to formal consultations since February 2019, when Italy first proposed the resolution. But to be sure, the stream of information that the resolution seeks to make way for, might open the floodgates on transparency in the pharmaceutical sector.
And why not, everyone, not just patients, stand to gain from more transparency. Information, after all is power. And transparency is good for governance.
Shareholders for example, will benefit from more information on costs of clinical trials, James Love of Knowledge Ecology International said. For smaller companies, such costs are material to share price, he added.
Activists are optimistic. This is the first time the WHO has been asked to engage in transparency as cross cutting issue, and it can be seen as a solid start, Love said on Twitter.
The resolution makes a slew of “requests” to the WHO secretariat, including to analyse the availability of data on inputs throughout the value chain (including on clinical trial data and price information). It says WHO must analyse relevant information about the transparency of markets for health products, including investments, incentives, and subsidies. It further asks WHO to support research and monitor the impact of price transparency on affordability and availability of health products, including the effect on differential pricing, especially in Low and Middle Income Countries.
Member states have been asked, among other areas, to work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives.
How the negotiations played out
Negotiations around the resolution captured attention for much of the duration of the Assembly, even so far as threatening to precipitate into a vote on the matter. There were murmurs that the UK would force a vote on it. There was a collective sigh of relief and applause in Committee A, when countries let the resolution pass without objection. Few countries did put their statements on record raising procedural and substantive issues on the resolution.
How did this ambitious, high-stakes resolution that has now been referred as a milestone and a game-changer, pass muster?
A number of factors came together to bring this into fruition – a “huge” engagement by ministries of health, an active NGO army, social media chatter and blow by blow news coverage even before the resolution was passed, according to those present. It is understood that while there was no “advance” plan of action, activists noted how civil society organizations came together organically and engaged with respective governments to support the resolution – particularly in Germany and France. In addition, more than sixty NGOs from sub-Saharan Africa wrote to the UK government to support the resolution.
“It is easy for an NGO to talk about transparency. But it is very difficult for a government to do so. There was enormous pressure on Italy, by other member states including Germany, UK, Sweden, Denmark. As a member of the European Union, it is not that easy to push through something like this,” Love said.
Personalities make a difference during such negotiations. Sources said that the chair of the drafting group on the resolution, Luca Li Bassi, the General Director of the Italian Drug Agency (AIFA), also on board of the European Medicines Agency, was fully engaged and was present every single day. He also had the backing of his minister of health Dr Guilia Grillo. As many as 19 other countries eventually became co-sponsors of the resolution.
In their statements after the adoption of the resolution, several countries, including Germany, UK, Australia, France, Belgium, New Zealand, Sweden and Canada expressed concerns and disappointment on the processes of tabling the resolution. The UK said that more time should have been allowed to consider the complexities and potential wide-ranging ramifications on price transparency.
Some countries were of the view that the resolution should have been brought up at the Executive Board meeting earlier in January this year. They also expressed displeasure on the way the discussions around the resolution surfaced in public especially on social media. Ironically, this was even as there were calls to make the country positions public when the negotiations were underway.
Whether or not some member states approve of it, international diplomacy will continue to be impacted by public participation, especially online. (A press conference by Italy’s Minister of Health Dr Giulia Grillo on the transparency proposal was broadcast live on the Ministry’s YouTube channel in February this year.)
These are the new rules of engagement, which are likely here to stay. It may not always be possible to control the message any more. (The hashtag of the week, at least for global health geeks was #TransparencyResolution)
Is the resolution really watered down?
As has been reported, stronger commitments around transparency of costs of clinical trials weakened as the negotiations evolved. In addition, the text does not make distinction between health “technologies” and “products”. Experts believe that this could have implications that could result in higher patent protection.
However, it is expected that the resolution could help open future discussions on costs of R&D and even costs of clinical trials. If costs of clinical trials are made public even in one country, say the US, it would be useful across other jurisdictions.
“The beauty of something like this is, even if there are 50 countries disclosing prices, that is sufficient to help us get a better picture. Currently there is hardly any information or transparency around prices. You just need a critical mass of countries to come on board,” Love of KEI said. “I think we are winning the hearts and minds around this conversation on drug prices. The industry will fight back, but I do not think they will be able to stop us,” he added.
Transparency is the djinn that will not go back into the bottle. The industry will no doubt fight back and want to stanch this.
While transparency itself is not the magic potion to reduce drug prices, the resolution, if implemented well, will gather evidence to address information asymmetry that favors sellers of drugs while negotiating drugs prices in secret, experts have said. “Better information on prices agreed in other countries strengthens the negotiating leverage of buyers (e.g. through reference pricing policies)”, a global health expert said last week.
The negotiations around the resolution, also demonstrate the role of WHO in convening these discussions and getting member states together to take responsibility to fix intractable problems in global health today. Brazil said that this resolution showed that WHO is able live up to its mandate to improve access to medicines and contribute to the goal of Universal Health Coverage.
Multilateralism has won this round.