EU‑Canada negotiations for a Comprehensive Economic and Trade Agreement: levelling the playing field for the life science industry

15.6.2012

Question for written answer P-005968/2012
to the Commission
Rule 117
Silvana Koch-Mehrin (ALDE)

The Comprehensive Economic and Trade Agreement (CETA) currently being negotiated between the EU and Canada has the potential to boost bilateral trade by 20 %, bringing considerable benefits to both parties by creating a level playing field on both sides of the Atlantic.

According to some recent reports, there is a significant gap between the two trading partners in terms of market access delays for the life science sector. For example, approval times for medicines in Canada between 2006 and 2010 were on average more than five months (165 days) longer than in the EU. In 2009 and 2010, this gap increased further.

In addition to slower access to new medicines for Canadian patients, this regulatory delay makes it harder for EU‑based life science companies to maintain their existing footprints in Canada and to bring in new investments. To compensate for such time losses in Europe, the EU offers a restoration mechanism. No such mechanism exists in Canada; indeed, it is among only three of the 34 OECD nations that do not provide compensation for time spent complying with regulatory requirements or for clinical development.

Is the Commission aware of the significant gap between the two trading partners and the disincentive this creates for EU companies operating and investing in Canada?

Does the Commission agree that this imbalance and the lack of a level playing field should be corrected?

Is the Commission addressing this situation as part of the current CETA negotiations, under the intellectual property chapter?

OJ C 182 E, 27/06/2013