[Ip-health] IP-Watch: European Council Approves First-Ever Analysis Of Drug Prices With Look At IP Rights

Thiru Balasubramaniam thiru at keionline.org
Sat Jun 18 03:42:14 PDT 2016


European Council Approves First-Ever Analysis Of Drug Prices With Look At
IP Rights


The 28 European Union governments today were expected to give final
approval to a first-ever plan to analyse medicines competition in Europe,
with reference to drug prices, generics and biosimilars, and intellectual
property rights. The final version was watered after what sources said was
heavy industry lobbying, compared to a leaked version published in
Intellectual Property Watch two weeks ago, but still retains some strong
provisions regarding pricing and competition.

Under the presidency of the Netherlands, the Council Conclusions, available
here, were published this week and the 28 health ministers are expected to
approve it when they meet in Luxembourg on 17 June, according to sources.

[Note: this article will be updated shortly.]

The earlier leaked document is available in this story (IPW, Europe, 25 May

The conclusions call for the European Commission to conduct an “overview,”
an “evidence based analysis,” and a “report on recent competition cases.”
It is believed the Commission was reluctant to engage in these
requirements. Some conditions and limits have been added to what remedies
could be taken as a result of the outcome of the analysis.

Another sensitive area, orphan drugs, was stripped from the conclusions,
but may continue to come up, according to a source.

The conclusions address access to medicines, for example stating that the
European Council:

NOTES WITH CONCERN 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, market withdrawal of products that are out-of-patent, or when new
products are not introduced to national markets for business economic
strategies and that individual governments have sometimes limited influence
in such circumstances;
NOTES the increasing trend of marketing authorisation of new medicinal
products for small indications, including, in some cases, the authorisation
of a single product for ‘segmented’ patient groups within a disease area
and the authorisation of one substance for several rare diseases and in
this respect NOTES WITH CONCERN that companies may seek very high prices
while the added value of some of these products is not always clear;
RECOGNISES that special attention should be given to the access to
medicines for patients in smaller Member States;
UNDERLINES the importance of timely availability of generics and
biosimilars in order to facilitate patients’ access to pharmaceutical
therapies and to improve the sustainability of national health systems;
STRESSES that both public and private investments are essential for the
research and development of innovative medicinal products. In those cases
where public investment has played a major role in the development of
certain innovative medicinal products, a fair share of the return on
investment in such products should preferably be used for further
innovative research in the public health interest for example through
agreements made on benefit sharing during the research phase;
STRESSES that the functioning of the pharmaceutical system in the EU and
its Member States depends on a delicate balance and a complex set of
interactions between marketing authorisation and measures to promote
innovation, the pharmaceutical market, and national approaches on pricing,
reimbursement and assessment of medicinal products and that several Member
States expressed concerns that this system may be imbalanced and that it
may not always promote the best possible outcome for patients and society;

The European Commission is called upon to:

Pursue the ongoing activities to streamline the implementation of the
current legislation on orphan medicinal products and to ascertain correct
application of the current rules and fair distribution of incentives and
rewards and if necessary consider revision of the regulatory framework on
orphan medicinal products without discouraging the development of medicinal
products needed for the treatment of rare diseases.
Prepare as soon as possible and with the close involvement of the Member
States, while fully respecting Member States competences, the following:

an overview of the current EU legislative instruments and related
incentives that aim to facilitate the investment in the development of
medicinal products and the marketing authorization of medicinal products
given to the holders of a marketing authorisation as implemented within the
EU: Supplementary Protection Certificates (Regulation EC 469/2009),
medicinal products for human use (Directive 2001/83/EC and Regulation EC
726/2004), orphan medicinal products (Regulation EC 141/2000) and
paediatrics (Regulation EC 1901/2006);
an evidence based analysis of the impact of the incentives in these EU
legislative instruments, as implemented, on innovation, as well as on the
availability, inter aliasupply shortages and deferred or missed market
launches, and accessibility of medicinal products, including high priced
essential medicinal products for conditions that pose a high burden for
patients and health systems as well as availability of generic medicinal
products. Among those incentives, particular attention should be given to
the purpose of supplementary protection certificates as defined in the
relevant EU legislative instrument and the use of the “Bolar” patent
exemption[7], the data exclusivity for medicinal products and the market
exclusivity for orphan medicinal products.

Where relevant, the analysis of impacts should also address – inter alia –
the development of medicinal products and the effects of the pricing
strategies of industry in relation to these incentives.

The Commission will conduct the analysis on the basis of the information
that is made available or gathered, including from the Member States and
other relevant sources.

To this end, the Commission should prepare by the end of 2016 a timetable
and methodology for conducting the analysis as mentioned in this paragraph.

Continue and where possible intensify, including through a report on recent
competition cases following the pharma sector inquiry of 2008/ 2009, the
merger enforcement pursuant to the EC Merger Regulation (Regulation
139/2004) and the monitoring, methods development and investigation – in
cooperation with national competition authorities in the European
Competition Network (ECN) – of potential cases of market abuse, excessive
pricing as well as other market restrictions specifically relevant to the
pharmaceutical companies operating within the EU, such in accordance with
Articles 101 and 102 of the Treaty on Functioning of the European Union.
Based on the above mentioned overview, analysis and report in paragraphs 39
and 40, and taking into account the international commitments of the EU and
– inter alia– also the needs of the patient, health systems and the
competitiveness of the EU based pharmaceutical sector, discuss the outcome
and possible solutions proposed by the Commission in the Working Party on
Pharmaceuticals and Medical Devices and, when public health issues are
concerned, the Working Party on Public Health at Senior Level.”

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