Big Pharma´s leaked wish list for TTIP EU-US trade pact

PhRMA/EFPIA priorities for TTIP.

I. Regulatory issues :

Greater regulatory convergence:
Ø  a built-in agenda allowing for progressive greater regulatory convergence over time.
Ø  a Working Group on Pharmaceutical and Medical Devices as platform to discuss implementation issues and address joint approaches to future compatibility topics.

Single development plans
Ø  for submission in EU&US for pediatrics;
Ø  extend the current EMA/FDA parallel SA
Ø  adopt the EMA/FDA pilot project for parallel assessment of Quality by design (QbD) application
Ø  address duplicative clinical testing requirements (via revision of ICH E5)

Other areas of convergence
Ø  establish harmonized list of clinical trial result data fields & agree on which may be disclosed to public (uniform protection of confidential commercial info & trade secrets)
Ø  develop therapeutic area guidelines (beginning with specific treatment areas)
Ø  EU and US to ensure that national/regional coding systems are based on common standards for the use of unique identifiers, developed using non-proprietary, harmonised international standards.
Ø  add a pharmacovigilance cluster to conduct work on post-marketing testing & risk management requirements
Ø  establish common framework & methodology for benefit-risk assessment, but retaining authority to make different risk assessment judgments
Ø  mutual recognition of GMP inspections


Ø  PhRMA: seek patent term adjustments for patent office delays in the EU
Ø  PhRMA: seek forms of patent linkage in the EU
Ø  EU/US aligned approach re disclosure of clinical trials data (impact on commercial opportunities in third countries should also be considered)
Ø  Harmonization on the grace period
Ø  EU/US systems should be open to further adaptation to incentivize research into unmet needs
Ø  Include commitment to shared principles regarding patentability standards
Ø  Extension of data exclusivity(DE) on biologics in EU up to 12 years (despite in US it is 4ys DE and 8ys Market Exclusivity)
Ø  Establish a benchmark for not limiting the use of trademarks other than to protect public health

III. Market Access & Transparency:

Ø  P&R policies should take into account innovation
Ø  when products are grouped for P&R purposes, it should only take into account bioequivalent products
Ø  when external reference pricing, only countries that are similar in terms of their socio-economic level, purchasing power, populations, disease burdens and health care system should be taken into account; bailout countries while they are undergoing fiscal restructuring programmes should be excluded from any referencing
Ø  any reimbursement controls/determinations should apply only to products dispensed and reimbursed in that Party
Ø  To avoid that pricing & reimbursement (P&R) policies hamper trade between EU/US
Ø  include a pharma annex on P&R policies that promote transparency principles in processes & and reward innovation
Ø  Procedural safeguard in government P&R
Ø  specified time-limits for pricing and/or reimbursement decisions
Ø  individual decisions containing a statement of reasons based on objective and verifiable criteria provided to applicants
Ø  legal remedies for applicants

IV. Other chapters:

Ø  Public Procurement: building on GPA, a comprehensive chapter with rules on transparency & non-discrimination of public proc. practices at federal & sub-federal level (offensive interest for EU)
Ø  Customs: full liberalization of tariffs and  pursuit of simplified and rational RoO based on common defined chemicals & pharmaceutical processing activities
Ø  Third countries: coordinated approach for trade policy objectives in third countries: joint principles on regulatory harmonization, transparency measures, IP and tariff elimination and coordinated approach to be leveraged at multilateral level when feasible: WTO, OECD, ICH, WIPO