Ref. Ares(2015)2250923 - 29/05/2015
Ref. Ares(2017)3665888 - 20/07/2017
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
• Monika Derecque-Pois, Director General (GIRP);
, Deputy Director General
, Head of Corporate Legal (Celesio);
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
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.
Art. 4.1(a) third indent
Art. 4.1(a) third indent
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