[Ip-health] Priti Patnaik in IHP: WHO transparency resolution seeks to dispel opacity around drug prices and sheds light on international policy-making

Thiru Balasubramaniam thiru at keionline.org
Thu May 30 23:03:44 PDT 2019


WHO transparency resolution seeks to dispel opacity around drug prices and
sheds light on international policy-making

By Priti Patnaik on May 31, 2019

Priti is an Independent Journalist & Researcher

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

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

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.

What next?

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.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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