[Ip-health] Published today: A contribution to the EU's review of pharmaceutical incentives

Kaitlin Mara kaitlinmara at medicineslawandpolicy.net
Mon Jun 3 04:57:06 PDT 2019

Dear all,

I'm writing to share with you a new set of briefing papers from Medicines
Law & Policy that provide recommendations to help the European Union (EU)
tackle high medicines prices brought about by market monopolies. These
papers were presented to EU policy makers this morning in Brussels in
conjunction with the European Public Health Alliance.

The briefing papers are now available online here:

They are a contribution to the EU's review of mechanisms meant to stimulate
innovation by rewarding innovators with temporary monopolies over their
innovations. The European Council announced the review after noticing “an
increasing number of examples of market failure in a number of Member
States, where patients access to effective and affordable essential
medicines is endangered by very high and unsustainable price levels.”

“The pharmaceutical industry now benefits from a web of protections in the
EU that together delay market competition for long periods and allow
companies to set profit-maximising prices that are unaffordable for many,
said Ellen ‘t Hoen of Medicines Law & Policy, one of the papers’ authors.
“Companies obtain those rights without needing to demonstrate that their
turnover is insufficient to recoup investments and make new ones. We offer
recommendations to ensure that adequate incentives for pharmaceutical
innovation exist while access to these innovations is not jeopardised,” she

The briefing documents make the following overall conclusions:
 - Adequate incentives for research and development are important, but
there must be a clearer link between risk and reward.
 - Historical reasons underpinning the EU’s generous data and market
exclusivity system are no longer valid.
 - The idea of ‘sufficient’ profit should guide policymakers, with
‘sufficiency’ estimates driven by the transparency of cost and pricing.
 - Flexibilities inherent in patent law should not be rendered ineffective
by exclusive rights granted through the medicines regulatory system.
 - The EU should not use trade agreements to demand third countries
implement more stringent intellectual property protection than they are
required under WTO rules.


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