Challenges of biotechnology in international trade regulation

doi:10.1017/CBO9780511792496.009

7 - Challenges of biotechnology in international trade regulation

from PART II - Reforming specific areas of trade regulation

Published online by Cambridge University Press: 26 April 2011

Susette Biber-Klemm ,

Michael Burkard ,

Thomas Cottier ,

Sufian Jusoh and

Michelangelo Temmerman

Edited by

Thomas Cottier and

Panagiotis Delimatsis

Show author details

Susette Biber-Klemm: Affiliation:
University of Bern, Switzerland
Michael Burkard: Affiliation:
University of Bern, Switzerland
Thomas Cottier: Affiliation:
University of Bern, Switzerland
Sufian Jusoh: Affiliation:
University of Bern, Switzerland
Michelangelo Temmerman: Affiliation:
University of Bern, Switzerland
Thomas Cottier: Affiliation:
World Trade Institute
Panagiotis Delimatsis: Affiliation:
Universiteit van Tilburg, The Netherlands

Book contents

Get access

Summary

KEY MESSAGES

Biotechnology and multilayered governance

∙ Biotechnology offers an interesting case study in multilayered governance. While some regulatory aspects are best dealt with by harmonisation, other areas are best left to regulatory competition in light of diverging ethical perceptions and attitudes towards the potential risks of the technology.

∙ Coherent regulation combines harmonised and decentralised regulation in the field, depending upon the regulatory area.

Human rights and biotechnology

∙ Human rights cut both ways in substantive terms, with the exception of a clear ban on biological warfare. They both support and limit recourse to biotechnology. Human rights shape the process of balancing interests and values but do not offer clear guidance in the field.

∙ Human rights are of prime importance in procedural terms. They help in shaping appropriate legal avenues and participation in assessing biotechnology in research and commercial use.

Intellectual property rights and biotechnology

∙ Appropriate regulation of intellectual property rights in biotechnology varies and is not uniform.

Human genetic engineering is best dealt with by domestic regulation on the basis of broadly harmonised principles of intellectual property rights. Pluralist values and diverging ethical and moral perceptions of genetic engineering, and the advantages of making progress by trial and error, outweigh the advantages of harmonised rules and enhanced market access in international law.

∙ Animal genetic resources (AnGR) are key to modern breeding and biodiversity. They call for a new and appropriate regime. Analogies to plant genetic resources need to be looked at with caution as animal-related regulation functions against a fundamentally different background. […]

Type: Chapter
Information: The Prospects of International Trade Regulation
From Fragmentation to Coherence
, pp. 284 - 320

DOI: https://doi.org/10.1017/CBO9780511792496.009 [Opens in a new window]

Publisher: Cambridge University Press

Print publication year: 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Book purchase

Temporarily unavailable

References

Anderson, Robert and Gallini, Nancy, ‘Competition policy, intellectual property rights and efficiency: An introduction to the issues,’ in Anderson, R. D. and Gallini, N. T. (eds.), Competition Policy and Intellectual Property Rights in the Knowledge-Based Economy (Cambridge University Press, 1998).Google Scholar

Anderson, Simon, ‘Animal genetic resources and livelihoods’ (2003) 45 Ecological Economics331–339.CrossRef Google Scholar

Anderson, Simon and Centonze, Roberto, ‘Property rights and the management of animal genetic resources’ (2007) 35 World Development1529–1541.CrossRef Google Scholar

Andrén, Robert and Parish, Bill, ‘Risk assessment’, in Bail, Christoph, Falkner, Robert and Marquard, Helen (eds.), The Cartagena Protocol on Biosafety: Reconciling Trade in Biotechnology with Environment & Development? (London: Earthscan, 2002).Google Scholar

Arsanjani, Mahnoush, ‘Negotiating the UN Declaration on Human Cloning’ (2006) 100 American Journal of International Law164.CrossRef Google Scholar

Biber-Klemm, Susette, ‘Trade in breeds at risk’ NCCR Trade Regulation Working Paper, forthcoming, on file with author.

Biber-Klemm, Susette and Cottier, Thomas (eds.), Rights to Plant Genetic Resources and Traditional Knowledge: Basic Issues and Perspectives (CABI Publishing, 2006).CrossRef Google Scholar

Bostyn, Sven, ‘Patenting DNA sequences (polynucleotides) and scope of protection in the European Union: An evaluation, background study for the European Commission’, Office for Official Publication of the European Communities, 2004.

Caulfield, Timothy, Cook-Deegan, Robert, Kieff, Scott and Walsh, John, ‘Evidence and anecdotes: An analysis of human gene patenting controversies’ (2006) 24 Nature Biotechnology1091–1094.CrossRef Google Scholar PubMed

,Codex Alimentarius Commission. Procedural Manual (Rome: Food and Agriculture Organization of the United Nations, 17th edn, 2007).Google Scholar

,Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, adopted 1998 by the Fourth Ministerial Conference of the United Nations Economic Commission for Europe (UNECE) in Aarhus, Denmark.

,Convention on Biodiversity. ‘Report of the Fourth Meeting of the Conference of the Parties to the Convention on Biological Diversity Serving as the Meeting of the Parties to the Cartagena Protocol on Biosafety’ (25 June 2008), UNEP/CBD/BS/COP-MOP/4.

Cottier, Thomas, ‘Implications for trade law and policy: Towards convergence and integration’, in Bail, Christoph, Falkner, Robert and Marquard, Helen (eds.) The Cartagena Protocol on Biosafety: Reconciling trade in Biotechnology with Environment and Development (London: Earthscan, 2002).Google Scholar

Cottier, Thomas, ‘From progressive liberalisation to progressive regulation in WTO law’ (2006) 9 Journal of International Economic Law779–821.CrossRef Google Scholar

Cottier, Thomas, ‘Genetic engineering, trade and human rights’, in Francioni, F. (ed.), Studies in International Law No. 13, Biotechnologies and International Human Rights (Oxford: Hart Publishing, 2007), pp. 275–314.Google Scholar

Cottier, Thomas, Temmerman, Michelangelo, Jusoh, Sufian and Dolotbaeva, Aida, The Research Exemption in Patent Law (forthcoming).

Epprecht, Thomas, Cartagena Protocol on Biosafety: Insurance Industry and Art 27 (Liability and Redress) of the Cartagena Protocol (Zurich: Swiss Reinsurance Company, 2002).Google Scholar

,European Patent Office, Guidelines for Examination, June 2005, available at www.epo.org/patents/law/legal-texts/html/guiex/e/c_ii_4_1.htm (last accessed 29 April 2008).

Fairman, Robyn, Mead, Carl and Williams, Peter, Environmental Risk Assessment. Approaches, Experiences and Information Sources (Copenhagen: European Environmental Agency, 1998).Google Scholar

Feldthusen, Bruce, Economic Negligence (Ottawa: Carswell, 2nd edn, 1989).Google Scholar

,Food and Agriculture Organization of the United Nations, The State of the World's Animal Genetic Resources for Food and Agriculture (Rome: Food and Agriculture Organization of the United Nations, 2007).Google Scholar

Furrow, Barry, ‘Governing science: Public risks and private remedies’ (1983) 131 University of Pennsylvania Law Review1403, 1466.CrossRef Google Scholar

Gura, Susanne, Livestock Genetic Companies: Concentration and Proprietary Strategies of an Emerging Power in the Global Food Economy (Ober-Ramstadt: League for Pastoral Peoples and Indigenous Livestock Development, 2007).Google Scholar

,International Law Association, International Law on Biotechnology: Conference Report Rio de Janeiro 2008, available at: www.ila-hq.org/en/committees/draft_committee_reports_rio_2008.cfm (last accessed 9 February 2009).

,International Law Commission, Report of the Study Group on Fragmentation of International Law, 54th Session of the International Law Commission, Geneva, 29 April–7 June and 22 July–16 August 2002, CN.4/L.628.

Jusoh, Sufian, Biotechnology Law and Regulation: The ASEAN Perspective (London: Cameron May, 2006).Google Scholar

Jusoh, Sufian, ‘Developing biotechnology legal system in developing countries: The case for Malaysia’ (2006) 3 Journal of International Biotechnology Law161–183.Google Scholar

Karapinar, Baris and Temmerman, Michelangelo, ‘Benefiting from biotechnology: Promoting small-farm competitiveness and intellectual property rights’ (2007) 4 African Technology Development Journal3.Google Scholar

Karapinar, Baris and Temmerman, Michelangelo, ‘Benefiting from biotechnology: Pro-poor IPRs and public-private partnerships’ (2008) 27 Biotechnology Law Report189.CrossRef Google Scholar

Köller-Rollefson, Ilse, ‘Keepers of genes: The interdependence between pastoralists, breeds, access to the commons, and livelihoods’, Sadri Rajasthan, the LIFE Network (2007), available online at: www.pastoralpeoples.org/docs/keepersofgenes_web.pdf (last accessed 22 February 2009).

Lesser, William, ‘Animal variety protection: A proposal for a US model law’ (1993) 76 Journal of Patent and Trademark Office Society697–715.Google Scholar

Molinuevo, Hector, Genética bovina y producción en pastoreo (Buenos Aires: INTA, 2005).Google Scholar

Newell, Peter and Glover, Dominic, ‘Business and biotechnology: Regulation and the politics of influence’ (July 2003), IDS Working Paper 192.Google Scholar

Nieman, Heiner, Kues, Wilfried and Carnwath, Joseph, ‘Transgene farm animals: Current status and perspectives for agriculture and biomedicine’, in Engelhard, M, Hagen, K and Boysen, M (eds.), Genetic Engineering in Livestock. New Applications and Interdisciplinary Perspectives (Berlin/Heidelberg: Springer, 2009).Google Scholar

Palmiter, Richard, Chen, Howard and Brinster, Ralph, ‘Differential regulation of metallothionein-thymidine kinase fusion genes in transgenic mice and their offspring’ (1982) 29 Cell701–710.CrossRef Google Scholar PubMed

Schefer, Markus, ‘Human Rights and Patenting the Results of Research on Human Material’, Paper presented at the NCCR Workshop ‘Human Rights in the Patent Procedure’, Bern, 28 March 2007.

Schumpeter, Jose, Capitalism, Socialism and Democracy (New York: Harper and Row, 3rd edn, 1950).Google Scholar

Sommer, Tine, ‘Patenting the animal kingdom? From cross-breeding to genetic make-up and biomedical research’ (2008) 39 International Review of Intellectual Property and Competition Law2.Google Scholar

Straus, Joseph, ‘Genomics and the food industry: Outlook from an intellectual property perspective’, in Vaver, D. and Bently, L. (eds.), Intellectual Property in the New Millennium: Essays in Honour of William R. Cornish (Cambridge University Press, 2004), p. 134.Google Scholar

Temmerman, Michelangelo, ‘Die Patentierbarkeit von gentechnischen Erfindungen auf internationaler Ebene’ (August 2006) Die Volkswirtschaft13–17.Google Scholar

Temmerman, Michelangelo, ‘The patentability of plant genetic inventions’ NCCR Trade Regulation Working Paper 2007/04 (Bern, 2007), available at: www.nccr-trade.org and at http://www.ssrn.com/

Thorstenson, Anna, ‘Patentability of human genetic stem cells: Finding the balance between the moral hazard in Europe and the wide scope in US’, University of Lund, Spring 2007 available at: www.essays.se/essay/2f3a87a000.

Tvedt, Morten and Finckenhagen, Magnus, ‘Scope of process patents in farm animal breeding’ (2008) 11 Journal of World Intellectual Property203–228.CrossRef Google Scholar

Tvedt, Morten, Hiemstra, Sipke, Drucker, Adam, Louwaars, Nielset al., Legal Aspects of Exchange, Use and Conservation of Farm Animal Genetic Resources, Fridtjof Nansens Institutt, FNI Report 1/2007, available at: www.fni.no/doc&pdf/FNI-R0107.pdf.

,United States Patent & Trademark Office, Manual of Patent Examining Procedure (September 2007).

Verbeure, Birgit, Matthijs, Gert and Overwalle, Geertrui, Analysing DNA patents in relation with diagnostic genetic testing (2006) 14 European Journal of Human Genetics26.CrossRef Google Scholar PubMed

Verrier, Etienne, Tixier-Boichars, M., Bernigaud, R. and Naves, M., ‘Conservation and value of local livestock breeds: usefulness of niche products and/or adaptation to specific environments’, FAO Animal Resources Information (2005), available online at: www.fao.org/docrep/008/a0070t/a0070t07.htm.

Whish, Richard. Competition Law (Oxford University Press, 6th edn, 2009).Google Scholar