Dies ist eine HTML Version eines Anhanges der Informationsfreiheitsanfrage 'DG SANTE contacts with industry re. Supplementary Protection Certificates (SPCs) manufacturing waiver'.

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 
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
research-based industries.  
(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.   
Kind regards,  
gplus europe is the trading name of: G Plus Limited, registered in England & Wales No. 
4085569 and G Plus Europe Limited registered in England & Wales No. 4547776, with 
registered Office address: 85 Strand, London WC2R ODW (United Kingdom). With branch 
offices at 42, Rue Breydel, B - 1040 Brussels (Belgium), Friedrichstraße 200 10117 Berlin 
(Deutschland), Bankside 2, 90 - 100 Southwark st., London SE1 0SW (United Kingdom) and 1, 
rue d'Argenson 75008 Paris (France)