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




Ref. Ares(2015)4588765 - 26/10/2015
Ref. Ares(2016)6036878 - 20/10/2016
EUROPEAN COMMISSION 
Directorate-General for Trade 
 
Directorate E - Neighbouring countries, USA and Canada 
  USA and Canada 
 
Brussels,  
USA and Canada  
 
 
 

TTIP Meeting with Johnson & Johnson 
19 January 2015 
 
 
Participants: 
 
 (CAB-MALMSTROM)  
 (TRADE F.3) 
 
Karen Licitra - Johnson &Johnson Corporate Vice President 
  
 
 
 
  
Summary: 
 
Johnson & Johnson produces a wide range of pharmaceutical products, medical devices and 
cosmetics/consumer products. J&J mission is to provide high quality health care around the 
world. Sales: over $71 billion in worldwide sales in 2013 ($28.1 billion on pharmaceuticals, 
$28.5 billion on medical devices and $14.7 billion on the consumer products segment). 45% 
of business takes place in the EU. J&J has 47 manufacturing sites in the EU and 8 R&D 
centres. There are 130.000 employees globally amongst those 30.000 in the EU. 
 
J&J noted strong support for TTIP agenda and in particular for the regulatory convergence 
objective. J&J is seeking increased efficiency in product approvals on both sides of the 
Atlantic and improved access to innovation. TTIP is seen as a unique opportunity. In this 
context, J&J would like to see: 
 
On pharmaceuticals: 
•  Mutual Recognition Agreement on Good Manufacturing Practices (GMP) inspections 
•  Harmonization of Clinical Trials Data fields (EU and US data bases are slightly 
different) 
•  Harmonization of Paediatrics study Plans  (to avoid duplication of clinical trials) 
•  Provisions on transparency of pricing and reimbursement decisions 
•  Reiteration of IPR protection principles 
 
On Medical Devices: 

•  Work on Unique Device Identification (UDI) (in particular EU to follow international 
practice in this area – IMDRF) 
•  Work on Data Submission (notably common interoperable data bases - increased level 
of ambition) 
•  Recognition of international standards and processes – quality management systems 
 
On Cosmetics: 
•  Collaboration (and recognition) of ingredients safety assessment 
•  Recognition of ingredients testing results  
•  Approximation/harmonization of labelling requirements  
•  Possible work on the definition of cosmetics (some products are considered cosmetics 
in the EU and in the US are classified as Over The Counter (OTC) Drugs which has 
regulatory consequences) 
 
 
COM noted that regulatory component of TTIP is very important and work is going in several 
areas. COM is engaged with a number of stakeholders from Industry to NGOs, Members of 
the European Parliament and civil society in general. Transparency efforts have been stepped 
up and a number of position papers are available to the public in the web site. Commissioner 
Malmström is heavily involved in TTIP and is engaging in many EU Member States with 
civil society and business organisations to explain the state of play of negotiations and discuss 
concerns around TTIP. 
 
There are some areas where work between regulators is progressing well and concrete 
outcomes are expected (e.g. GMP). However, there are other areas where a concrete outcome 
would be difficult (if they require legislative changes in one of the parties). There are also 
areas which are politically sensitive and COM does not anticipate any outcome in TTIP in this 
respect (e.g. pricing and reimbursement).