Monitoring of genetically modified plant by notifiers after patent expiration

8.11.2016

Question for written answer E-008429-16
to the Commission
Rule 130
Bart Staes (Verts/ALE) , Maria Heubuch (Verts/ALE) , Martin Häusling (Verts/ALE)

Authorisations for dissemination or for placing on the market of genetically modified organisms (GMOs) are submitted, pursuant to both Directive 2001/18 and Regulation (EC) 1829/2003, to the establishment by the notifiers of a monitoring plan with a view to detecting the effects of the GMO or GMOs concerned on animal and human health or the environment.

These monitoring plans are critical to avoid any unforeseen effects of these organisms after their release.

These GMOs are submitted for patenting, the patents being limited in time (typically 20 years). When a patent expires, the GMO concerned may be used by other interested parties, which may result in the creation of different generic varieties.

1. Is the notifier requested to continue full monitoring programmes when the patent on a GMO has expired?

2. When the patent on a GMO expires, is the notifier requested to continue full monitoring programmes for any generic varieties of that GMO grown in the EU?

3. What action will the Commission take regarding cases of inadequate monitoring?