Ref. Ares(2019)631504 - 04/02/2019
Ares(2016)3612211
Ms. Elżbieta Bieńkowska
Commissioner for Internal Market, Industry,
Entrepreneurship and SMEs
Brussels, 17 July 2016
Dear Commissioner,
We would like to thank you for the meeting that took place 30th of June.
We particularly appreciated the opportunity to discuss some of the key issues that can significantly contribute
to the development and growth of the generic and biosimilar medicines industry, the manufacturing waiver
during the SPC period in Europe and the clarification of the scope of the Bolar clause, as part of ‘A Single Market
Strategy for Europe - Analysis and Evidence’.
In addition, we have very much appreciated the chance to highlight the important elements of the EPSCO Council
Conclusions from June 2016 - “
Strengthening the balance in the pharmaceutical system in the EU and its Member
States”, related to generic, biosimilar and value added medicines, a key responsibility for DG GROW.
1. Manufacturing waiver during the SPC period in Europe
Background: The Supplementary Protection Certificate (SPC) in the EU promotes outsourcing of the European
pharmaceutical industrial base, undermining Europe’s industrial competitiveness. The European generic,
biosimilar and value added medicines industries have extensive manufacturing capabilities throughout Europe,
but cannot capitalise on the opportunities opening up worldwide.
An SPC manufacturing waiver allowing to produce generic and biosimilar medicines in Europe for the purpose
of exporting to countries without SPC or where it has expired earlier would have a huge impact in terms of new
investments in R&D and manufacturing, employment and economic growth. In no way will it undermine or
change the existing IPR equilibrium on the EU market.
A targeted SPC Manufacturing Waiver amendment should be rapidly introduced to the SPC Regulation. This
should not be linked to other legislative processes (e.g. wider IP/ SPC revision) as any delay in the process
further contributes to the outsourcing of European manufacturing.
Key discussion points and agreed actions:
The European Parliament amendment to the Report on the Single Market Strategy (Comi Report – 26 May 2016)
has taken a clear position in support of a quick introduction of the SPC manufacturing waiver “
Urges the
Commission to introduce and implement before 2019 an SPC manufacturing waiver to boost the competitiveness
of the European Generics and Biosimilar Industry in a global environment (..)”
Medicines for Europe highly appreciates your understanding of urgency to amend the legislation as a stand-
alone process. The rapid launch of the impact assessment and the public consultation would be necessary to
achieve this objective.
Rue d’Arlon 50 - 1000 Brussels - Belgium
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www.medicinesforeurope.com
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Medicines from Europe will strongly engage in supporting advocacy at the level of European Commission and
national governments to increase an understanding of this important provision for growth and jobs in the
European pharmaceutical sector.
2. Clarifying the scope of the Bolar clause
Background:
There are differences among Member States on how they have implemented the Bolar exemption, with some
Member States adopting a wider interpretation that covers all medicines, while others adopting a narrower
interpretation (difference re API, export, third parties development, clinical studies for innovative drugs, HTA
purpose etc). It creates uncertainty concerning the lawfulness of offering, manufacturing, selling and even
buying patented APIs for regulatory or R&D purposes, even though the latter are supposed to be covered by
the Bolar exception. This situation affects equally generic manufacturers and API suppliers.
Key discussion points:
Medicines for Europe supports the European Commission in its effort to broaden the scope of the Bolar clause
and harmonise its application in EU member states as a part of the Single Market Strategy. Suggestions for
clarification of the scope were proposed. The open question was raised about the process to be initiated by the
EC to clarify the scope (e.g. long term- legislative change of the art 10.6 of Dir 2001/83; short term: eventual
Commission Communication clarifying the scope). Commissioner Bienkowska recommended to contact a
person responsible in the DG GROW to discuss possible options.
Agreed action
-
Medicines for Europe to engage in technical discussion with a person responsible in the DG GROW
3. EPSCO Council Conclusions - Strengthening the balance in the pharmaceutical system in the EU and its
Member States
Background:
During the recent The Hague meeting of the health ministers and industry stakeholders regarding pricing of
medicines the primary focus was on the price of new compound/new indication. Medicines for Europe brought
a very important dimension to the discussion on pricing indicating the significant value that generics, value added
and biosimilar medicines have in balancing the healthcare spend and creating patients access to the medicines:
Generic and biosimilar products offer better access for patients and savings for payers. In 2014, according
to IMS, European healthcare systems would have paid Euro 100 bn more for medicines without generic
competition. Meanwhile access to medicines has increased by 100% for seven key therapy areas thanks
to generic medicine competition.
It is therefore important to assure generic and biosimilar products can be effectively brought to market
immediately after patent expiry of original product. Today, many mechanisms like patent linkage,
arbitration regulations, slow pricing and reimbursement processes are causing delays of up to 18 months
for effective commercial launch of generics and biosimilars
patients • quality • value • sustainability • partnership
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Current pricing and reimbursement regulations in member states typically apply a reference price either
to original or product. With the industry moving into more value added products, which bring important
improvements to treatments for patients and healthcare professions, we need support in developing a
“third pathway” for pricing and reimbursement of such products, which require substantially more
investment behind pharmaceutical and clinical development – ranging from few dozen to 200 mn Euro
Action: While we appreciate the fact that our views were incorporated into the Council Conclusion paper,
we would welcome the continued support of the Commissioner to help us drive this conclusions towards
effective implementation. We are ready to discuss with DG GROW how to progress the Council
conclusion proposals including through dialogue with the Commission and Council recognising the
different EU and national competences in this area.
In conclusion, Europe has the capacity to lead in delivering economic growth and jobs in the
pharmaceutical sector if the right framework is in place. We look forward to partner with you over the
next years to achieve this common objective.
Yours faithfully,
Jacek Glinka
President, Medicines for Europe
patients • quality • value • sustainability • partnership
Electronically signed on 04/02/2019 15:18 (UTC+01) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563
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