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?
The conditions associated with the authorisation of the cultivation of a genetically modified plant, such as monitoring requirements, apply irrespective of whether the patent on that genetically modified plant is still valid or has expired. Therefore, these conditions continue to apply after the expiration of a patent, as long as the authorisation concerned remains applicable.
The expiration of the patents on certain genetically modified plants opens the possibility for more operators to place on the market varieties of those plants, as no licencing agreement with the ex-patent holder is required anymore. The Commission has taken this into account in the draft authorisations for cultivation it submitted to the relevant Committees in 2016. In particular, those draft authorisations ensure that the required monitoring will have an adequate coverage of the genetically modified maize cultivated.
The action to be taken in case of inadequate monitoring would depend on the exact circumstances, nature and gravity of the case. Those factors would also determine whether action should be taken at Union level or at Member State level: while the Union legislation on Genetically Modified Organisms foresees the possibility for the Commission to amend, revoke or suspend an authorisation, the enforcement of the Union legislation is primarily the responsibility of the Member States(1).