Ref. Ares(2018)6622688 - 21/12/2018
We would be delighted if you were available for a meeting with AbbVie in the
coming weeks to discuss the matter in person
Following the publication of an inception impact assessment at the beginning of
2017 and a public consultation, we understand the Commission is seriously
considering proposing a legislative initiative in the coming weeks or months to
introduce an exemption to the intellectual property rights granted by the
Supplementary Protection Certificate (Regulation (EC) no 469/2009), also known as
the “SPC waiver”.
We understand that, in essence, the initiative would aim to overcome market access
issues that the EU generics industry may face by weakening EU intellectual property
rights for the EU research-driven industry. We believe, however, that this approach
unnecessarily pitches European healthcare industries against each other in a way
that will prove to be both ineffective and counter-productive, for a number of
reasons: 1. Wrong instrument and unclear benefits:
(a) Inside the EU, we have serious doubts that an SPC waiver would
improve access to generics, as there currently is no market failure.
According to Medicines for Europe, the generic medicines industry is
the main provider of medicines in the EU, accounting for 56% of
dispensed medicines. By 2020, generic medicines are even expected to
make up 70-80% of the medicines used in Europe, and research shows
that EU generic manufacturers are often first to market under the
current set-up and therewith in a good position to compete for the
European market with international peers (c.f. Point C:
report 120917 v3 10217-002.pdf).
(b) Outside the EU, an SPC waiver would not help gain access to any
important market which is currently closed to EU generics
manufacturers. If low market penetration was caused by IPR-related
hurdles, one would expect a large number of unsuccessful attempts by
EU generic manufacturers to obtain licenses for export. We are not
aware of this. However, it is known that a number of export markets
have put in place trade barriers, such as localisation requirements, and
often sport significant local production capacities for generics (e.g.
Brazil: 90%, China: over 56% etc.) SPC waivers would not help overcome
either of these challenges. We are therefore confident that a thorough
assessment of policy options to enhance generic penetration in third
markets would generate alternative measures which yield more
benefits for EU generics manufacturers while being less intrusive for EU
(c) Overall, it remains highly doubtful that the proposed measure would
generate net economic benefits for Europe.
2. Inconsistent with established trade policy and possible counter-measures:
The introduction of an SPC waiver would be incompatible with a number of EU
FTAs which provide for a patent extension mechanism that shall confer the
same rights as the original patent. It would also undermine the well-established
EU trade position which speaks out in favour of IPR and against localisation
policies. It is worth noting that the draft proposal already raised concerns in the
United States, triggering deliberations about Section 301 measures.
3. Downside risks of incomplete impact assessments:
A weakening of Intellectual
Property Rights could potentially undermine EU research-based jobs and
investments as well as patient access to new therapies. From a procedural
perspective, it is worth recalling that the European Commission is preparing a
comprehensive review of the incentives for European pharmaceutical industry.
In line with better regulation principles, we feel this review should be
thoroughly completed, rather than isolating individual measures for what be a
hastened, ill-prepared and surely controversial, political debate before the end
of this term.
I attach some materials for your perusal in case this is of interest. Thank you in
advance for your kind response.
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