Ref. Ares(2018)1350285 - 12/03/2018
Ref. Ares(2019)631504 - 04/02/2019
Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Innovation and Advanced Manufacturing
Mr Alexander Natz
Rue Marie de Bourgogne 58
1000 Bruxelles (email : [correo electrónico])
Dear Mr Natz,
Thank you for your letter of 16 February 2018 to Commissioner Bieńkowska, in which you
reiterate your concerns of 24 January regarding the on-going reflections of the Commission
relating to Supplementary Protection Certificates
. The Commissioner has asked me to
respond on her behalf.
As our Director-General, Lowri Evans, wrote to you on 7 March, no decision has yet been
taken regarding a Commission initiative in this respect.
In line with our Better Regulation and impact assessment rules, the Commission services are
analysing a broad range of sources of information and evidence, not limited to the CRA
study, but including a number of originators-sponsored studies such as the OHE-EFPIA
study or the one prepared by Pugatch Consilium.
Please rest assured that we are treating all parts of the pharmaceutical industry equally, and
any additional input from small and mid-sized companies, including EUCOPE members,
will be duly considered.
European Commission, 1049 Brussels, BELGIUM - Tel. +32 22991111
N105 – 09/90 – Tel. +
- [correo electrónico]
Electronically signed on 12/03/2018 10:45 (UTC+01) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563
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