Ref. Ares(2015)5067397 - 13/11/2015
Ref. Ares(2016)6036878 - 20/10/2016
TTIP Meeting with BEUC on TTIP & Health 10/07/2015
2015 06 23 ttip_health_beuc_position.pdf
DG TRADE, SANTE and GROW met with BEUC on TTIP & Health on 10/07/2015
BEUC is the European Consumer organisation and is part of TTIP Advisory Group
• BEUC submitted a position paper on TTIP and heath on 23/06/2015
• BEUC noted that there is no particular need to promote regulatory
cooperation in this area in TTIP given the fact that in many aspects the EU
and the US are already engaged in global or bilateral cooperation. COM
noted that despite the existing regulatory cooperation there are a number
of areas that have not yet been fully explored such as biosimilars and
generics. TTIP could serve as an impetus for the existing cooperation
without replacing it.
• BEUC expressed support for the mutual recognition of Good Manufacturing
Practices (GMP) (more effective use of regulatory resources). COM noted
that intensive work is taking place in order to assess the equivalence of EU
and US GMP systems. Legal texts have not yet been drafted.
• BEUC enquired whether clinical trials data received or held by the EMA will
continue being subject to European legislation or will be treated by the US
legal environment in terms of disclosure. COM indicated that the EMA
policy and the implementation of the clinical trial regulation will not be
negotiated in TTIP. More specifically, COM clarified that information
received from a US manufacturer for the purposes of a marketing
authorization in the EU will be treated in line with EU rules on the matter
and vice versa. COM highlighted that clear distinction has to be made
between exchange of information among regulators and data disclosure to
• BEUC opposes any potential extension of the intellectual property
protection as well as wants to see the high-level of EU standards
maintained. COM noted that IP on pharmaceuticals do not constitute areas
of possible offensive interest to the EU contrary to the issues of
geographical indications or copyright where EU has offensive interests.
COM highlighted that issues that would require changes to EU law such as
patent linkage should not be discussed in TTIP. There is no legal text
available and EU position is expressed in the IPR position paper and fact
sheet available on the web.
• BEUC reiterated that EU governments should maintain full autonomy to
make pricing and reimbursement decisions about medicines and medical
devices. COM underlined that EU has no intention to include transparency
provisions within the TTIP given the diverging health care systems.
• BEUC noted that it does not want to see the EU approaches to the
promotion of pharmaceuticals changed according to US-style medicine
promotion. COM noted that medicinal products advertising is not being
discussed within TTIP.
• BEUC welcomed the main elements of possible cooperation on medical
devices as outlined in the EU position paper but expressed concerns about
the fact that harmonisation of the approval systems being ruled out.
According to BEUC US has a safer marketing authorisation system compared
to the EU especially in terms of the high risk devices. COM noted that EU
system is very solid, provides for adequate consumer protection and
provides for wide access to innovative products.