Ref. Ares(2016)1203951 - 09/03/2016
environment, notably EMA, IMI and the new European patent with unitary effect/
the Unified Patent Court
• Acknowledged COM's work in different activities while pointing out that more
needs to be done...
• Considered what has been done only a good starting point for being more
comprehensive in the next steps in a sector-specific industrial policy initiative on
life sciences/pharma
• Urged the COM services to assume an active role in future activities in the field
of pharmaceuticals
• Underlined the urgency of a comprehensive discussion on pharma-related topics
in light of the:
1. the uncoordinated responses given by MS and the subsequent market
distortions (including the enforcement of the Transparency Directive)
2. the US approach which allegedly is more innovation-friendly.
• Elaborated on the importance of TTIP and in particular the wish to have a sector-
specific annex stating provisions on the transparency of pricing/reimbursement
decisions taken by MS (in line with the FTA with Korea) and a higher degree of
regulatory consistency (e.g. through joint scientific advice by EMA and FDA)
during the development of a medicinal product.
• Mentioned the less developed degree of cooperation between industry and
academia in Europe, particularly in the southern MS and the limited access to
capital as a consequence of this cultural silo mentality. Consequently Europa is
not able to capitalize on its strengths to the full extent.
COM’s Key Messages:
• Informed the guests about the general political priorities for the new Commission,
its structure, and the prominent role DG GROW plays.
• Pointed out increasing investments is a priority and President Juncker's explicit
reference to the importance of the internal market with a strong industrial base.
• Highlighted that the importance of the pharmaceutical industry has been
acknowledged in the Staff Working Document on the pharmaceutical industry
and by Commissioner Bieńkowska herself and is reflected in the formalised
intensified working relationship between DG GROW and SANTE on pharma
files.
• Signalled that the COM is still at the beginning of its mandate and is exploring
the next concrete steps, e.g. stock-taking exercises on individual industries over
the whole value chain in order to identify strengths and weaknesses
• Explained the rationale behind pharma annexes in FTAs, i.e. that provisions
covering pricing/reimbursement require the existence of the concept of public
universal healthcare systems in both parties (or in case of a lower level of
economic development rudimentary systems reflecting the spirit of the European
model) and pointed out that the COM did not have the intention to include
provisions on the transparency of pricing/reimbursement in TTIP given the
fundamental philosophical and practical differences in organising healthcare
2
between EU MS and the US. Furthermore it was clearly stated that the US-Korea
agreement could not serve as a blueprint since it explicitly exempts even the
limited systems like Medicaid and Medicare from being subjected to the
provisions.
Contact:
, GROW/I3, Tel.
/
@ec.europa.eu
Copies:
D. Calleja, G. Cozigou,
,
,
3