[Ip-health] Medicines Law & Policy: Dutch Minister of Health writes open letter to pharma, threatens to name and shame

Thiru Balasubramaniam thiru at keionline.org
Wed Aug 28 07:36:00 PDT 2019


Dutch Minister of Health writes open letter to pharma, threatens to name
and shame

By Ellen 't Hoen -August 28, 2019

“Dear Pharma,” writes the Dutch Minister of Health, Bruno Bruins in an open
letter in the daily newspaper the Volkskrant, “Last week two messages
jumped out for me in the press. One nice message: two new important cancer
drugs are included in the basic [coverage] package. The second worrying:
healthcare costs are unaffordable for more and more Dutch people.”

Bruins mentions the fact that treatments with a price tag of over € 100,000
are no longer a rarity. He points to the two million Euro treatment,
Zolgensma, for a rare muscle disease, to show what is in store for the
future. ”What particularly bothers me,” he writes, “is that we are not
allowed to know why we have to pay so much. We simply get no explanation,
no insight into the price structure.” He criticises companies for not
taking their responsibility in ensuring that health care remains affordable
and particularly takes to task those companies that increase their
medicines prices not “because they have to. But because they can.”

The letter is part of the minister’s preparations for a meeting with an
as-yet unnamed company which has increased the price of one of its products
to about € 150,000. He is demanding from the company an explanation for
this price hike as well as public disclosure of this explanation. He
threatens to name and shame the company when it fails to do this. (Some
speculate that this is about the company Leadiant, which we have written
about here.)

The Vereniging Innovatieve Geneesmiddelen, the pharmaceutical lobby group
in the Netherlands, tweetedthat their members do not recognise themselves
in the minister’s description. BIO Holland, which represents the biotech
industry, under the somewhat flippant headline ‘Bruno#doeslief’ (which
translates to ‘Bruno be sweet’) also expressed feelings of hurt but went on
to pose some interesting questions: “What exactly does that transparency
entail that you request? How much detail are you looking for? When are you
satisfied? And when do you find a pharmaceutical story actually plausible?
In short: which conditions and criteria must our pricing exactly meet in
order for you to get the coveted “socially responsible” stamp?”

These are interesting questions, and it may surprise some that to answer
them we are not entirely in uncharted territory. For example, the EU rules
on orphan medicinal products allow the application for an orphan
designation when the return on investment is expected to be insufficient to
justify the necessary investment. In order to substantiate the claim that
the expected return on investment is insufficient, the regulation specifies
a list of all the information necessary to make that assessment. This list
includes data on past and expected future development, production and
marketing costs, details of grants and tax incentives received and an
estimate and justification for expected future revenues. A European
Commission notice further indicates that the assessment would be made “…on
the basis of all past and future development costs and expected revenues.”
(For more details see our briefing document.) These requirements could
guide the transparency demands of the minister and help formulate a
‘sufficiency norm’ to set fair medicines prices and lower those that can no
longer be justified. Some new pharmaceutical rule-making at the EU level is
likely to be needed and the ongoing pharmaceutical incentive review offers
a pathway to do exactly that. The minister has already forged alliances
with other EU countries to tackle high drug prices. This alliance should
also take on board the much needed legislative changes. As the minister
writes, prices are increased not because, “you have to but because you
can.” In other words, because the rules allow it. Time has perhaps come to
rewrite some of these rules.

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

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