Ref. Ares(2015)1077544 - 11/03/2015
Ref. Ares(2016)6036878 - 20/10/2016
Annual Conference on EU Law in the Pharmaceuticals Sector in 2015
26-27/02/2015
Panel on EU pharmaceuticals law
"The negotiation of a Transatlantic Trade and Partnership: Implications for the
pharmaceuticals sector" -
Presentation
The presentation touched upon the following aspects: TTIP objectives, TTIP negotiation
structure and negotiation team, consultation and information mechanisms and details
on pharmaceuticals – regulatory component.
As regards general objectives, it was noted that TTIP will be an ambitious but balanced
agreement (tariff and non-tariff aspects). It will strengthen the economic partnership
(growth and job creation). It is expected that TTIP will positively influence the
development of regulations and standards worldwide based on high levels of consumer
and environmental protection. As the tariffs are very low in average - most TTIP benefits
will steam from reducing Non-Tariff Barriers (NTBs).
Negotiations are organised around tree pillars: Market access (tariffs, Services,
Investment, Public Procurement, etc.), Regulatory Component
(Regulatory coherence,
TBT,SPS, Sectors (9)) and Rules (IPR, RoO, Dispute Settlement, Sustainable
Development, Customs, Energy and raw materials, SMEs, GIs). There is a strong
presence of regulators (DG SANTE, DG GROWTH, DG AGRI, DG TAXUD, COMP, etc.) in the
negotiations (co-leadership).
Extensive consultation and information mechanisms have been developed. Member
States are informed/consulted before and after each negotiation round, European
Parliament is keep regularly informed and Advisory Group has been established
(consumer and health organisations are represented). In addition civil society meetings
and stakeholder events (at margins of negotiations sessions) take place as well as
meetings with different stakeholders and participation of negotiators in conferences and
seminars. Finally there is extensive information available in the Web site including
position papers, fact sheets and legal texts.
Pharmaceuticals: is an important sector in our bilateral trade (
13.1% of EU imports from
US (21 b) and 10.6% of US imports from EU (29.5 b). Most pharma products already at 0%
tariff (WTO Pharmaceuticals agreement) - TTIP added value lies on regulatory
convergence. There is a long tradition of regulatory cooperation at international (ICH)
and bilateral level (EMA/FDA) but a lot can still be done. Main priorities being
discussed are:
the recognition of Good Manufacturing Practice's inspections,
collaboration on innovative areas – Biosimilars and Generics – shape int. practice.
Increased exchange of conf. information between regulators
Paediatrics
Collaboration on state of the art – latest science available
An update of the state of play of the pharmaceuticals regulatory discussions on GMP,
Biosimilars and generics was provided
Discussion
There were only few questions asked. One was on impact of TTIP on the provision of
public health services. The participant was referred to the letter from the Chief
negotiators to UK on the matter. The letter explains COM stance on the matter.
On pricing and reimbursement provisions, there was a question on why this area was
not being considered by the Commission in TTIP. An explanation on why the COM
considers that TTIP should not contain provisions on transparency of pricing and
reimbursement was provided.