Genetic Engineering in Plant Resourcesx

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					«Genetic Engineering in Plant
Resources -
Challenges for the Legal
Order»

Swiss Society for Agricultural Economics
and Rural Sociology
Seminar, 1-2 April 2009, Naters/Brig
Susette Biber-Klemm
Dr. iur., MAE
World Trade Institute, Berne
             NCCR International Trade
               IP9: Biotechnology
  Thomas Cottier and Susette   Lead; Rights to TK, PGR
  Biber-Klemm                  and AnGR, ABS
  Michelangelo Temmerman:      Intellectual Property Rights
  PhD                          in HGR; PGR and AnGR
  Sufian Jusoh: PhD            Liability
  Michael Burkard: PhD         Risk assessment
  Cintia Busse: Research       IPRs in HGRs
  Assistant
  Ana Jetvic: Research         Research exemption
  Assistant

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Ich beschränke meine Überlegungen auf Gentechnologie im Sinne von Gentransfer: Identifikation, Isolation von Genen und deren Übertragung in andere, auch




         01.05.2009                                                                                                               3
Three statements

  Genetic engineering is – still – a young technology

  Genetic engineering means working with living material

  Genetic engineering brings about a new dimension of
  „property“ in living resources




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Three statements

   Genetic engineering is – still – a young technology
   Genetic engineering means working with living material
   Genetic engineering brings about a new dimension of
   „property“ in living resources



Assessment and management of risk and application of
the precautionary principle are important elements of the
legal order regarding genetic engineering

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Three statements

 Genetic engineering is – still - a young technology
 Genetic engineering means working with living material
 Genetic engineering brings about a new dimension of
 „property“ in living resources

 This implies specific risks.
 The legal order answers with precautionary measures in
 the Convention on Biological Diversity –
 And with attempts to resolve conflicts between risk
 prevention and free trade in the framework of the World
 Trade Order.
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The CBD´s precautionary approach to biosafety

  Cartagena Protocol on Biosafety to the Convention
  on Biological Diversity
  Rules for the safe transfer, handling and use of GMOs In
  particular for transboundary movements
       Advanced Informed Agreement procedure
       Simplified procedure for agricultural commodities
       Decision on the basis of risk assessments
       Obligation to have risk manageement measures in place
   Risk assessment
        scientific basis
        according to recognized risk assessment techniques
        Incl. risks to human health
                                                               7
01.05.2009
Trade Law Aspects: the SPS

  Agreement on the Application of Sanitary and
  Phytosanitary Measures
       Forbids measures which result in discrimination or disguised
       protectionism
       Defines legitimate measures to protect human, animal and plant
       life or health from risks from additives , contaminants, toxic
       substances etc. in food or drink.
       Criteria for measures:
             Based on science
             Imposed to the extent necessary.




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Trade Law Aspects: the TBT

Agreement on Technical Barriers to Trade
  Applies to technical regulations and standards; e.g.
  Labelling schemes
  Criteria
        Necessity: not more trade restrictive than necessary
        Legitimate objective: n
             national security, prevention of deceptive practices, protection of human
             health or safety, animal or plant life or health, protection of the environment
        Proportionality: duration; intensity of measures



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Results

1.   There is a discrepancy in the risk assessment and
     management prescriptions between the WTOs
     Agreements and the Cartagena Protocol.
2.   SPS is ill fitted to deal with new technologies like
     modern biotechnology or nanotechnology
3.   There is no possibility to take economic and social
     factors into account in risk management.




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Three basic statements
  Genetic engineering is – still – a young technology
  Genetic engineering means working with living material
  Genetic engineering brings about a new dimension of
  „property“ in living natural and genetically engineered
  resources

In the international legal order, new systems of property rights
are created:
The Plant Breeders Rights (UPOV), the obligation to create a
system for patenting microbiological resources and at least a
sui-generis rights for plants in TRIPS; and the Sovereignty over
natural resources and the system of ABS in the CBD
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The CBDs approach to ownership of
genetic resources

 Sovereignty of States over their genetic resources
 System of Access and Benefit Sharing
      Prior informed consent, mutually agreed terms, fair and
      equitable sharing of benefits
      Covers all genetic resources (except human genetic
      resources)
      Concretized by “Bonn Guidelines” (2002)
      To be implemented by the “International Regime” (2010)


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The specific system for Plant Genetic
Resources for Food and Agriculture
 International Treaty for Plant Genetic Resources for
 Food and Agriculture
 ABS system adapted to the specific needs of plant
 breeding : free exchange
      Multilateral system for facilitated access (64 crops)
  but:
      Crops not included in the system are under the CBDs ABS
      system
       Access to in-situ resources (landraces) according to national
      legislation
         ? Rights of farmers to their landraces?
         ? Implementation of Farmers Rights?
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Patenting
  Questions regarding patenting of
  biotechnological inventions:
  Scope of the patents
        progeny?
        all eventual uses of isolated gene sequence?
  Inventive step?
  Ability to assess prior art?
  Control of legitimate access?

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Results
  Property rights related to genetic resources and
  innovation in genetic engineering are in need to
  be further developed and differentiated.
  A better balance between the rights to grassroot
  innovation and innovation in highly technological
  R&D processes is to be found .
  Ways must be found to more strongly anker
  benefit sharing obligations (incl. e.g. access to
  technology, technology transfer) in the system

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Conclusions
From the viewpoint of the international legal order, genetic engineering is still
a “new” technology


              Solutions found in some areas.
                Cartagena Protocol
                International Treaty on PGRFA
             Some progress in other areas.
                International Regime to ABS
             Adaptations needed in WTO law.
                SPS?
                TRIPS?

And what about the implementation of these rules?

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    Genetic engineering IS a challenge
     for the (international) legal order


         THANK YOU FOR YOUR ATTENTION
       AND FOR QUESTIONS AND DISCUSSION

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