[Ip-health] IP-Watch: Leaked EU Document Lays Out Major Evaluation Of EU Drug Pricing

Thiru Balasubramaniam thiru at keionline.org
Thu May 26 22:23:28 PDT 2016


http://www.ip-watch.org/2016/05/25/leaked-european-council-document-on-major-evaluation-of-eu-drug-affordability
Leaked EU Document Lays Out Major Evaluation Of EU Drug Pricing

25/05/2016 BY WILLIAM NEW <http://www.ip-watch.org/author/william/>,
INTELLECTUAL PROPERTY WATCH

The 28 European Union member governments are preparing to request the
European Commission to conduct an in-depth evaluation of the availability
and affordability of EU medicinal products that could possibly lead to
changes in R&D and pricing models. An apparent first-of-its-kind, the
assessment would look at market and data exclusivity, supplementary
protection certificates, and intellectual property issues, according to an
alleged copy of the draft Council conclusions document obtained by
*Intellectual
Property Watch*.

The draft European Council conclusions on strengthening the
checks-and-balances in the EU pharmaceutical system, dated 24 May, is available
here
<http://www.ip-watch.org/weblog/wp-content/uploads/2016/05/EU-Council-Conclusions-2nd-draft.docx>
 [pdf].

It appears to be on the agenda for a 27 May meeting of the Working Party on
Pharmaceuticals and Medical Devices. It states that the text was proposed
by the Council presidency, the Netherlands, which had made medicines access
a top priority.

The document shows changes made from an earlier version, seemingly
reflecting member state comments from the first version.

The proposal could potentially lead to changes in EU policy. The final
provision, Article 41, includes the action to: “Based on the above, discuss
the outcome and possible remedies proposed by the Commission in the Working
Party on Pharmaceuticals and Medical Devices.”

It invites the European Commission to work to streamline implementation of
legislation on orphan medicinal products and, “if necessary consider
revision of the legal framework on orphan medicinal products.”

And it calls for, by early 2018, an “in-depth evaluation” that scrutinises
the system of incentives and marketing in relation to medicinal products,
working with EU competition authorities to take aim at market abuse,
excessive pricing and other market restrictions.

The text stresses the importance of innovation but seeks to tighten abuse
of the system. EU countries have been hit by cases of excessively high drug
prices in recent months.

The text includes a recently added clause reinforcing the importance of IP
rights:

“*6a*. RECOGNISES that a balanced and strong, functioning and effective
intellectual property environment is an essential element in supporting and
promoting access to innovative, safe, effective and quality medicinal
products in the European Union;”

But it also notes ongoing problems of market failure for some medicines:

“15. NOTES WITH CONCERN *that market failure occurs in* an increasing
number of *examples of market failure in a number of* Member States, *in
particular in those situations* where patients access to effective and
affordable essential medicines is endangered by *very high and*
 unsustainable *or excessive* price levels, market withdrawal of products
that are out-of-patent, or when new products are not introduced to national
markets for business economic reasons, *such as low volumes or portfolio
rationalisation*, and that *cannot be influence by*individual governments *have
limited influence in such circumstances*;”

The document also reinforces member states’ authority and offers some
suggestions for the national level in relation to the EU.



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