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




Ref. Ares(2015)2250923 - 29/05/2015
Ref. Ares(2017)3665888 - 20/07/2017
EUROPEAN COMMISSION 
Directorate-General for Trade 
Directorate F -  WTO, Legal Affairs and Trade in Goods 
TRADE F.3 Tariff and Non–Tariff Negotiations, Rules of Origin 
Meeting with GIRP (European Association of Pharmaceutical Full-line Wholesalers) on TTIP 
regulatory issues  
09/04/2015 
Participants: 
• 

 (DG TRADE); 
 (DG GROW) 
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• Monika Derecque-Pois, Director General (GIRP);
, Deputy Director General 
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(GIRP);
, Head of Corporate Legal (Celesio); 
 (GIRP)
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Summary: 
On the 9th of April 2015, the European Commission met with the European Association of 
Pharmaceutical Full-line Wholesalers (GIRP) to discuss the ongoing negotiations for the Transatlantic 
Trade and Investment Partnership (TTIP). 
The members of the GIRP expressed their interest in discussing the potential impact of TTIP on issues 
such as access to medicines, medical devices as well as quality and safety standards. 
GIRP representatives gave some background information on the daily business of the 
Association as well as on pharmaceutical wholesaling.
 GIRP represents the national associations of 
over 750 pharmaceutical full-line wholesalers serving 32 European countries, including major pan-
European pharmaceutical full-line wholesaling companies. (e.g. Celesio). GIRP members create a vital 
link in healthcare by providing to pharmacies a full range of product including medical devices, food 
supplements, cosmetics as well as medicines. Furthermore, GIRP members play a substantial role in 
safeguarding European citizens from medicines shortages in cases of threat. 
COM gave a general overview of the content and the state of play of TTIP negotiations. It was 
explained that several sectors are being negotiated including the health care sector, which is deemed to 
be particularly challenging as health related aspects could appear in different chapters of the 
agreement. A number of position papers have already been issued (available in web). Those resulted 
from a close cooperation among stakeholders of the area, including pharmaceutical and health 
regulators of both Parties (contributions from several stakeholders have been assessed by COM based 
on feasibility and reasonability). COM noted that food supplements have not been discussed under 
TTIP and are not on the discussion table. 
Several questions were raised by GIRP among them on the timing of the finalisation of TTIP 
negotiations. COM answered that negotiations are unlikely to be finalised by the end of this year. 

On the question of whether EU legislation can be influenced by TTIP, COM answered that the final 
decision making fall within the competence of the EU regulators. Any future revision of EU 
Regulations/Directives has to go through the normal EU legislative process. 
As regards the potential prospects of harmonisation, COM explained giving the example of GMP 
inspections that in several areas mutual recognition agreement can be concluded after an assessment of 
equivalence. However, as regards medical product authorisations the concept of a product already 
authorised in one region being automatically authorised in the other one is not possible nor being 
discussed.  
Regarding  TTIP’s potential effects on the parallel trade market  and on the guidelines on Good 
Distribution Practice of medicinal product for human use (GDP)
, COM clarified that nothing is 
going to be changed in these areas.  
As regards the potential inclusion of pricing and reimbursement transparency provisions in TTIP
COM underlined that this issue 
 is not endorsed by the EU.
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With regard to the potential legal provisions to be made for the delivery of health care services
COM informed the attendees about the publicly available comprehensive documents (e.g. fact sheet on 
services) regarding the handling of services. COM mentioned that given the sensitivity of the health 
care services they are exempted from the national treatment obligations hence the EU and its MS have 
the right to restrict the provision of cross-border health services. 
On Unique Device Identification (UDI) and interoperability of databases for medical devices, COM 
explained that both the EU and the US side are committed to develop their UDI systems aligned to 
IMDRS guidelines. The US has already developed and implemented their US UDI system as well as 
their database that are in application since September 2014. The EU has intention to implement its 
own compatible system but that requires the EU Regulation on medical devices to be adopted. In 
addition, GIRP has expressed its concern about the potential growing role of serialisation, namely 
taking serialisation approach to all classes of medical devices is not endorsed by the industry.  
Finally, GIRP informed COM about a conference on health care organised by GIRP on the 13th of 
November 2015 in Brussels with the presence of several stakeholders from the industry. GIRP noted 
that any representatives of COM dealing with health care in the frame of TTIP would be welcome in 
this event. COM noted that a public debate on TTIP and health is expected to be organised on the 
27th of May in Brussels
, where several questions can be asked by the attendees to the TTIP 
negotiators.