TTIP and Health stakeholders meeting 27-5-15


This TTIP stakeholders meeting took place at the Charlemagne Building of the European Commission on Wednesday, 27th of May of 2015 dealt with the issues of cosmetics, health-care systems and pharmaceuticals. The meeting was led by DG Trade with participation of others from DG Santé and DG Grow.
It was attended by around 140 industry, trade-union and NGO representatives.

On the issue of cosmetics the TACD representative asked about the lack of existing safety regulation and the possible impact of very different chemical and other regulations between the US and the EU, as well as asking about the EU´s application of the precautionary principle in TTIP in future regulatory cooperation. Animal welfare representatives also questioned the application of the EU´s animal testing prohibition while the US has no such prohibition. The EC assured the audience that no cosmetic product would enter the EU market if it did not comply with EU law, including nanotech labeling requirements. They insisted on there being no mutual recognition of US-EU products nor any weakening of the EU´s precautionary principle.

On health-care services a number of public service union member expressed fears, given the great differences between EU and US health systems, about the privatization of health services, out-sourcing and more expensive procurement. The EC denied any move toward privatization and explained their “negative list” of public services excluded from the TTIP agreement.

On medical devices the industry representatives expressed the wish that there would be “mutual recognition” between products approved in the US and EU with simplification of regulatory requirements while the BEUC representative said that any harmonization should be based on the safer US system of independent evaluation.

On pharmaceuticals the European Pharma representative expressed their wish-list for TTIP: de-regulation and simplification of market authorization process and clinical trials for quicker access to the market of “innovative products” (in US 21st Century Cures Act and EU “adaptive licensing” , greater harmonization of IPR enforcement, specially dealing with 3rd countries and convergence of clinical trial transparency rules between FDA and EMA, joint inspections of 3rd country pharma production and strong regulatory cooperation on any new pharma legislation.

The TACD representative expressed concerns over the possible legislation chill on new legislation in favor of consumers and patients as well as the possible negative impact on clinical trial transparency due to trade secret rules and possible new barriers to the negotiating position of States on pricing and reimbursement of biomedical products. Any early market authorization should not sacrifice the independent evaluation of the safety and efficacy of new drugs.

The European Commission denied that there would be any “mutual recognition” between FDA and EMA approved drugs, insisted that clinical trial transparency would be upheld, that there would be no chill on new innovation models for access to medicines, that there would be no mention of pricing and reimbursement in TTIP and the the IPR chapter has not been considered yet in the talks but no great content is envisioned. No clear explanation was given to questions about how the regulatory cooperation structure and how it would work to evaluate new legislative proposals.

In short, there was little new information about the negotiations revealed in this meeting.