[Ip-health] POLITICO Pro Morning Health Care: Italy's transparency push

James Love james.love at keionline.org
Fri Feb 15 05:58:52 PST 2019


Just a quick response to the Politico take on the Pharma objections to
transparency.   None of the information about the very low list or net
prices of drugs around the world have had an impact on U.S. prices, so
far.  Particularly irrelevant in the U.S. are low prices from low income
countries, such as the PEPFAR prices.

And while an individual country has an incentive to sign non-disclosure
agreements on prices, it is hard to see that having the whole world
confused and uninformed about prices is the best possible environment for
the public, or how ignorance can contribute to thoughtful policy making.

There is a collective action aspect to transparency.  Market dynamics are
different if everyone discloses, than is the case if only one or a few
countries disclose.  Also, the Italy resolution is about more than just
prices, or R&D costs, and addresses a number of other issues, all of which
collectively can give policy makers and the public a better idea about the
value chain for drug development, distribution and access.

The R&D transparency issues are very important in any evaluation of the
incentive system, or consideration of any useful reforms.  When it comes to
risk adjustments for trials, there is generally more information about
phase and likelihood of approval risks for trials, right now, but not much
transparency of trial costs.  DiMasi reported his very high estimates of
trial costs, but refused to disclose in his 2016 paper the number of
patients in the trials in his sample, something he had done in his earlier
2003 paper.  (http://drugdatabase.info/estimates-of-drug-development-costs/).
 In 2017, the U.S Senate Finance Committee proposed making the U.S. Orphan
Drug Tax Credit transparent as to the drug, disease and taxpayer, for
trials that succeeded or failed.   The NIH used to publish the costs of its
cancer drug trials, including costs per patient, but no longer does, and
the NIH and BARDA now withhold the costs of trials they conduct and or
fund.  There is no excuse for making trial costs some mystery, for drugs
that are routinely priced higher than the cost of an automobile, or in some
cases more than the price of a house.  Drug manufacturers have plenty of
opportunities to offer analysis of how to make adjustments for risks or
capital costs, but the aggregated and raw data needs to be there for
everyone else to make their own evaluation of the facts.  Making access to
facts of R&D costs exclusive to drug developers is asking for trouble

Jamie


----------------
*Secrets with purpose: *We didn’t hear back immediately from innovative Pharma
organizations. But they argue that keeping prices confidential is the only
way they can offer better deals to poorer countries — especially amid
rhetoric from U.S. President Donald Trump about pegging American prices to
international reference prices. Research is expensive and experiments often
fail, so it’s not fair to look just at the cost of R&D for a particular
drug to justify its cost, they contend.

On Fri, Feb 15, 2019 at 1:53 AM Thiru Balasubramaniam <thiru at keionline.org>
wrote:

> February 15, 2019
>
> By Sarah Wheaton
>
> *DRUG PRICING — ITALY EYES GLOBAL TRANSPARENCY PUSH:* With the backing of
> 5Stars Health Minister Giulia Grillo, Italy is poised to become a new
> champion of the international campaign for drug pricing transparency.
>
> Italy is considering putting forward a draft resolution at May’s World
> Health Assembly that would give the World Health Organization an
> “authoritative mandate to strengthen WHO’s technical work” on transparency
> of both R&D costs and drug prices, Grillo wrote in a letter to World Health
> Organization Director General Tedros Adhanom Ghebreyesus. Dated February 1,
> the letter
> <
> https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=b56eda69d4&e=3e3aedc8a6
> >
>  and draft resolution
> <
> https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=8526ee4717&e=3e3aedc8a6
> >
> have
> been making the rounds among governments and civil society groups.
>
> The resolution would task the WHO with collecting and analyzing outcomes of
> clinical trials and adverse outcome reports; providing a venue for
> governments to share drug pricing information, revenue, R&D costs, public
> subsidies, etc.; and providing information on patents and related disputes.
>
> *Cancer report reverberates*: The WHO’s technical report on cancer drug
> pricing
> <
> https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=dacfb3938e&e=3e3aedc8a6
> >
> — which
> global innovative pharma lobby boss Thomas Cueni bashed as “deeply flawed
> <
> https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=e7314c2f60&e=3e3aedc8a6
> >”
> — is a major motivator for Italy. Grillo called it a “tour-de-force.”
>
> *Access campaigners cheer:* Italy, which is also a key force in the
> Valletta Declaration joint procurement group, appears to be joining the
> Netherlands and Austria as the countries taking a harder line on Big
> Pharma.
>
> “Italy is among the countries in Europe struggling to provide universal
> access to the best medical technologies. It is no long possible to avoid
> debates about reforms of prices and incentives,” said James Love, director
> of NGO Knowledge Ecology International. “The transparency initiative is a
> necessary measure to have an intelligent discussion about both prices and
> incentives.”
>
> “The fact an EU member state is taking this bold step and already gathering
> support from states and civil society is meaningful,” said Jaume Vidal, a
> policy adviser with Health Action International. Opposing greater
> transparency “is to be on the wrong side of history,” he added.
>
> *Secrets with purpose: *We didn’t hear back immediately from innovative
> Pharma organizations. But they argue that keeping prices confidential is
> the only way they can offer better deals to poorer countries — especially
> amid rhetoric from U.S. President Donald Trump about pegging American
> prices to international reference prices. Research is expensive and
> experiments often fail, so it’s not fair to look just at the cost of R&D
> for a particular drug to justify its cost, they contend.
>
>
>
>
>
> --
> Thiru Balasubramaniam
> Geneva Representative
> Knowledge Ecology International
> 41 22 791 6727
> thiru at keionline.org
> _______________________________________________
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> Ip-health at lists.keionline.org
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>


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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