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    Michiel Korthals said:

    Thanks for this relevant and interesting ethical problem. I am wondering whether you can comment upon another type of barrier that can block the production and commercial introduction of generic medicines or crops (or the use of formerly patent protected traits in crops) by poor countries or small companies. I am referring to the ownerships regulations with respect to biosafety dossiers concerning patented traits. These ownerships regulations are not limited to the restricted period of patent rights concerning the same traits. In fact responsibility regulations regarding biosafety dossiers do not have any time limit and this can have a blocking effect in further innovatory activities, in particular for poor countries and small companies. So it is not only that the normal provisions of the Cartagena Protocol on Biosafety can restrict, as Andrew Bennett director of the Syngenta Foundation for Sustainable Agriculture argues: “There is a growing constraint arising from the provisions of the Cartagena Protocol on Biosafety, which add stewardship responsibilities and liability and risk considerations that the technology ‘giver’ must take into account when entering into a partnership or granting licenses,” (http://www.ifpri.org/blog/can-public-and-private-sectors-work-together-poor?print). Bennett is right that the cost of developing biosafety dossiers can be huge. However, there is more, because of the lack of a time limit and the duty to make public the biosafety dossiers, companies even can destroy the dossiers after the patent regarding the patented trait has been expired. The strict stewardship regulations regarding biosafety dossiers without time limit can in my view have monopolizing effects. Can that indeed be the case?

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    Hennie Groenewald said:

    @MK I’m not 100% sure about all your questions but I’ll try and shed some light on the issue.

    1)      1) Yes, it is expensive to develop a comprehensive regulatory dossier and, yes, it has become another tool through which a particular company could get a competitive advantage. But… all but what is considered to be confidential business information (CBI) is publicly available in South Africa (SA), so the dossier can’t be “destroyed”. Also, the regulatory “unit” is the GM event, so any subsequent use of the event (under licence or potentially later, off patent) by other companies will fall under the original safety assessment/”dossier”, so “generic GM companies” theoretically won’t have to develop a complete new dossier. Generic medicine regulations are a good comparator but we just don’t have the systems in place for GM products yet. Finally, in my opinion even some of what was originally considered to be CBI could be made public once the trait is off patent, but it’s too early to know if this could be feasible/allowed – policies still have to be developed.

    2)      2) Liability is a different story… SA doesn’t have an official “off patent policy” in place yet but I would guess the sentiment would be that the originator of the trade will remain liable… which of course opens a can of worms like all liability issues do…

    3)      3) I agree with your last statement re the possible negative impacts of excessive stewardship and liability policies. Unfortunately in many developing countries GM technology is currently seen as an “outside” technology from which it should “protect” itself (including economically) and many regulatory systems are developed on this premise, making the local development of relevant technologies almost impossible…