[Ip-health] Stat+ - Pharma pushes back against setting international standards for drug-pricing transparency

Thiru Balasubramaniam thiru at keionline.org
Wed May 8 15:01:51 PDT 2019



Pharma pushes back against setting international standards for drug-pricing
By ED SILVERMAN @Pharmalot MAY 8, 2019

As a World Health Assembly meeting nears, several European countries are
proposing numerous changes that patient advocates argue would water down a
resolution designed to create more transparency around prescription drug

At a planning session earlier this week, nearly a dozen countries —
particularly Germany, Denmark, the U.K., and Sweden — offered a bevy of
subtle and not-so-subtle suggestions for softening language used to
describe pricing as well as for disclosing R&D costs, patent holdings, and
clinical trial results, among other things. A final version, which must
still be crafted, will be vetted at the WHA meeting that starts on May 20
in Geneva.

The effort comes three months after Italian health minister Giulia Grillo
introduced the resolution and argued that “international action is required
to improve transparency” in order to widen access to pharmaceuticals. The
resolution is actually one of several initiatives being pursued by
cash-strapped governments to control their drug spending, but has
far-reaching implications.

If enacted, the World Health Organization would have a mandate to collect
and analyze data on clinical trial outcomes, assess patents, and provide a
forum for countries to share information on prices, R&D and marketing
costs, R&D subsidies, and public sector investments. In effect, the
proposal would set an international standard.

Even as the pharmaceutical industry faces intensifying criticism from some
governments over pricing, the industry is increasingly pushing back against
such efforts. In the U.S., for instance, the U.S. Trade Representative is
regularly enlisted to persuade governments to boost patent enforcement. One
patient advocate says drug makers are now urging countries where industry
has a large presence to blunt the resolution.

“A handful of European countries with strong pharma lobbies are trying to
destroy it because there must be a concern that transparency leads to lower
drug prices,” said Jamie Love of Knowledge Ecology International, which
crafted a side-by-side comparison of the resolution and the proposed
changes. “If they succeed, they would largely remove transparency from the


So what kinds of changes were suggested?

As an example, one goal in the resolution would have countries “undertake
measures to publicly share information on prices and reimbursement cost of
medicines, vaccines, cell and gene-based therapies, and other health
technologies.” The proposed changes, however, would substitute “publicly
share information” with “consider measures to facilitate information


The U.S., Australia, and Denmark, meanwhile, suggested eliminating yet
another goal, which would require drug makers – as a condition for
registering their medicines – to provide annual reports on sales, prices,
units sold, marketing costs for each registered medicine, R&D costs
associated with each clinical trial used to support registration , and all
grants, tax credits or any public subsidies and incentives pertaining to
regulatory approval.

Elsewhere, the preamble to the resolution states that “the high prices of
medicines impede progress for the many countries that have committed to the
attainment of Universal Health Coverage.” Germany suggested inserting the
word ‘can’ in front of ‘impede.’ Another proposed change in that section
would make transparency surrounding R&D costs voluntary.

Whether any of these changes will stick, however, is uncertain.

Another planning session is scheduled for this coming Friday. The challenge
for the Italian government and the other nine countries that are
co-sponsoring the resolution is to retain as much of the original text as
possible so that a negotiation plays out at the May 20 WHA meeting, where
more countries and non-government organizations that are sympathetic to the
resolution will be in attendance.

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

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