Ref. Ares(2014)3575542 - 28/10/2014
Ref. Ares(2016)6183596 - 28/10/2016
Meeting with European Social Insurance Platform (ESIP)
(21/10/2014)
Participants:
(TRADE)
(TRADE)
(ENTR)
(ESIP)
(AOK Statutory Health Insurance Germany)
(ESIP)
Summary: The European Social Insurance Platform (ESIP) represents over 40 national social security
organisations across 16 Member States. Main objectives of the organisation are to preserve
high-profile social security for Europe, to reinforce solidarity-based social insurance systems
and to maintain European social protection quality. ESIP is following closely TTIP. A
position paper will be available soon. ESIP presented its ideas regarding TTIP, in particular
on Intellectual Property Rights; biosimilars
; pricing and reimbursement; EMA policy on the
disclosure of clinical trial data and advertising and internet sales.
In general terms ESIP expressed the hope that TTIP does not limit Member States' control of
their own health care strategies and that TTIP does not undermine EU health systems quality.
Commission noted interest to engage with the European Social Insurance Platform and the
wish that the organisation puts forward its main interests in this area. The Commission is
interested, in particular, to get an insight of the areas ESIP thinks should be brought to the
negotiations table i.e. the offensive interests and by which means TTIP could bring benefits to
patients and improve access to medicines.
Intellectual Property Rights
• ESIP noted that in their view patent protection rights should not be harmonised
between EU and US and that patent protection in the EU should not be further
extended (important impact on availability of generic medicines).
• The Commission noted that discussions on IPR are still focusing on a detailed
exchange of information between regulators. Textual discussions or exchange of texts
have not taken place. It is still uncertain what will be US requests in this area.
However, taking into account of the US position in other negotiation agreements
possible areas of interest to US can be anticipated (e.g. patent linkage, patent
extension for administrative delays). EU is not interested in extending the duration of
its patent protection.
Biosimilars
• ESIP noted interest in Biosimilars regulatory convergence and inquired about the US
guidelines on naming and labelling of Biosimiars.
• ESIP asked if there were intentions to work with US on patent protection for
biosimilars (biologicals)
• Commission noted that bilateral cooperation (notably on guidelines for the approval of
biosimilars) is one of EU priorities in the pharma sector (as highlighted in the EU
position paper). The US Guidelines on naming and labelling of Biosimiars are not yet
available (US still reflecting on direction to be taken). Patent protection for biologicals
is up to 11 years in EU and up to 12 years in US. There is no intention for
harmonisation.
Pricing and Reimbursement:
• ESIP noted concerns with the eventuality of including in TTIP, provisions on
transparency in pricing and reimbursement decisions. In their view such provisions
could limit the freedom of member states to control their own medicines policies,
including cost containment strategies.
• Commission noted that provisions on transparency in pricing and reimbursement
decisions do not figure among EU priorities for this sector. The transparency annex
with South Korea is not the benchmark to be used in the case of the US.
Disclosure of Clinical Trial Data
• ESIP noted that the Guidelines published by EMA on 2nd October represent an
important compromise between different stakeholders. TTIP should not in any way
disrupt the levels of transparency already achieved in Europe.
• Commission noted that there are no intentions to revise the Clinical Trials Regulation
(entering in force in 2016) nor recent EMA policy on publication of clinical data.
Advertising and Internet sales
• ESIP noted that US policy that allows pharmaceuticals companies to advertise directly
to consumers should not be brought into Europe through TTIP. The same for internet
sales: EU approach should be kept.
• Commission noted those matters have not been discussed in TTIP.