This is an HTML version of an attachment to the Freedom of Information request 'TTIP lobbying'.



Ref. Ares(2015)5067397 - 13/11/2015
Ref. Ares(2016)6036878 - 20/10/2016
To: 
 (TRADE); 
 (TRADE); 
 
 (GROW); 
 (GROW); 
 (TRADE) 
Cc: 
 (TRADE); 
 (TRADE); TRADE 
TTIP TRANSPARENCY 
Subject: 
TTIP Meeting with BEUC on TTIP & Health 10/07/2015 
Attachments: 
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 
(attached) 
•  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 
the public. 
•  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.   
 
 
Participants: 


 (DG TRADE); 
 (DG SANTE);  

 (DG GROW) 

 (BEUC)