Ref. Ares(2015)5632972 - 07/12/2015
Ref. Ares(2016)6036878 - 20/10/2016
EUROPEAN COMMISSION
Directorate-General for Trade
Directorate F - WTO, Legal Affairs & Trade in Goods
Unit F3: Tariff and Non-Tariff Negotiations, Rules of
Origin
Participation as speaker on the 2nd Annual EU-US Trade Conference
Sector-specific breakout session: Chemicals and Pharmaceuticals
Brussels, 5th February 2015
Participants:
(Grayling),
(DG TRADE),
(DG
GROW),
(US Food and Drug Administration),
(Pharmaceutical
Group of the European Union (PGEU)),
(Pfizer),
(Cefic).
Summary:
The 2nd Annual EU-US Trade Conference on TTIP was organised by ''Forum Europe'' on
5th February 2015. The conference featured a combination of plenary sessions and sector-
specific breakouts and brought around 250 stakeholders together. I attended the breakout
session on chemicals and pharmaceuticals where the following issues were discussed:
• To what extent is regulatory convergence in the area of chemicals and
pharmaceuticals possible, and what challenges remain for this to become a
reality?
• Where this is not possible, how can negotiators work to allow mutual recognition
of standards within existing regulatory frameworks?
• What will be the impact of easier market access on both American and European
SMEs?
• How will the potential convergence of regulation affect consumers, in terms of
both standards and prices?
I have provided a general introduction on the TTIP negotiations and current state of play,
highlighted consultation mechanisms in place (EP, MSs, advisory group, industry and
civil society, etc.), transparency provisions (position papers in the web), gave an
overview of the structure of the negotiations (the three pillars), the role of the regulators
in the negotiations and stressed the importance for the EU of the sectoral aspects of the
negotiations – non-tariff barriers.
I noted that in the pharmaceutical sector regulatory cooperation between EU and US is
very well established both at bilateral level as well as at multilateral level, notably via the
ICH. Many regulatory aspects are already aligned. However there are still many areas
Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11.
that can be tackled. The different topics that are part of the negotiation were briefly
presented: Good Manufacturing Practices (GMP) inspections, Biosimilars, exchange of
confidential/trade secret information, generics and paediatrics. Finally, I noted that the
regulatory power will remain in the hands of the regulators.
(US Food and Drug Administration) reiterated historical cooperation
between EU and US and FDA engagement in the negotiations. He noted that horizontal
provisions are the foundation for ensuring opportunities for stakeholders to comment on
regulations and standards and therefore permit that more issues will be aligned in the
future. The objective of TTIP is to increase regulatory compatibility, regulatory
efficiencies while upholding to high level of health protection. He noted that we are
looking into our practices and on how to align existing and new regulatory areas (e.g.
biosimilars). As regards GMP, both sides are assessing equivalence of the systems. How
to better cooperate within ICH is also in the radar. For the US, and important area is the
transparency on pricing and reimbursement decisions. Discussions are going well but
there are no legal texts available (looking into what would be the appropriate legal
obligations).
(Pharmaceutical Group of the European Union (PGEU)) noted TTIP was
not the good instrument to deal with transparency on pricing and reimbursement
decisions. Therefore, PGEU and many other stakeholders strongly object to transparency
provisions on pricing being included in TTIP. Affordability of medicines is a very
important issue for many stakeholders as well as the EMA policy on disclosure of
clinical trials data (TTIP should not interfere/damage this process).
(Pfizer), presented EPFIA priorities for TTIP notably mutual recognition
of GMP inspections, paediatrics (timing of clinical trials submission), new emerging
areas (keep structure in place to allow evolution of science), IPR (promote IPR principles
globally), early resolution mechanism (patents) and market access (transparency on
pricing and reimbursement decisions).
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