Ref. Ares(2015)5696780 - 09/12/2015
Ref. Ares(2017)3665888 - 20/07/2017
Report of the meeting between Cécile Billaux (CAB) and Adrian van den Hoven (European
Generic Medicines Association) - 16 October 2015
Present: Cécile Billaux (CAB), 4.1(b)
(DG Trade B3),
Adrian van den Hoven (Director General – European Generic Medicines Association (EGA)), Erick
Tyssier (Head of Government Affairs Europe – Teva Pharmaceuticals Europe)
The EGA wished to discuss three points:
The Supplementary Protection Certificate (SPC) Export (Manufacturing) Exception
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The Transatlantic Trade and Investment Partnership (TTIP)
The US Food and Drug Administration (FDA) had formally adopted guidance on developing and
testing biosimilars. This is a very welcome development and is the result of fruitful cooperation
between the European Medicines Agency (EMA) and the FDA. The EGA would welcome if the same
were to be done for complex generics – where the companies face the same problem of duplication.
Generally, EGA argues that there is a need to lower development costs in order to have
sustainability. The EU is currently competitive in complex generics and it should be kept that way.
This latter issue is supported by the European Consumer Organisation (BEUC). There is effectively no
NGO counter-argument. Furthermore it is also a useful pro-TTIP argument as it facilitates access to
medicines.
4.1(a)
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Although progress can be made in other contexts, EGA view TTIP as an umbrella that covers all these
various issues.
4.1(a)
.
Mutual Recognition/Reliance/Good Manufacturing Practice (GMP)
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