From International Ethics to European Union Policy: A Case Study on Biopiracy in the EU's Biotechnology Directive

• Published date: 01 July 2006
• Author: EMILIE CLOATRE
• Date: 01 July 2006
• DOI: http://doi.org/10.1111/j.1467-9930.2006.00230.x

LAW & POLICY, Vol. 28, No. 3, July 2006 ISSN 0265–8240

© 2006 The Author

Journal compilation © 2006 Baldy Center for Law and Social Policy

Blackwell Publishing LtdOxford, UKLAPOLaw & Policy0265-8240© 2006 Baldy Center for Law and Social PolicyJuly 2006283

Original ArticleLAW & POLICY July 2006Cloatre BIOPIRACY IN THE EU’s BIOTECHNOLOGY DIRECTIVE

From International Ethics to European Union

Policy: A Case Study on Biopiracy in the EU’s

Biotechnology Directive

EMILIE CLOATRE

This article explores how the question of biopiracy, and the rights of indigenous

people in the context of patents over natural resources related to traditional

knowledge became articulated within the European Union’s law and policy process.

It presents how this issue was first introduced into the EU during the negotiation

on the Directive 98/44/EC, and which mechanisms transformed this ethical issue

into a policy concern. Analyzing the history of this issue within that of Directive

98/44/EC offers significant opportunities for testing the appropriateness of multi-

level governance and policy-network theories to empirical sociolegal research in

the EU context.

I. INTRODUCTION

The European Union’s Directive 98/44/EC on the Legal Protection of Biotech-

nological Inventions is a text of essential importance for biotechnology in the

EU from both a legal and a socio-ethical point of view. The focus of this article

is on one aspect of the Biotechnology Directive: the provision concerning

“biopiracy” and the rights of indigenous people in the context of patents

over natural resources related to traditional knowledge. The article seeks to

explore how the question of biopiracy became articulated within the EU’s

law and policymaking processes. Tracing the history of the negotiation of the

Biotechnology Directive also offers significant opportunities for demonstrating

how specific empirical research can be best explained through the use of multi-

level governance and policy-networks theories.

This article is based on a MA thesis submitted in September 2002 at the University of Nottingham,

UK, Institute for Genetics, Biorisks and Society. Many thanks to Professor Tamara K. Hervey

for her supervision and support during my MA, and her help with this article. I am also very grateful

to Dr. Paul Martin for his co-supervision during my MA and Professor Robert Dingwall for

his help with this article. Thanks also to all those who were interviewed during this research.

Address correspondence to Emilie Cloatre, Institute for the Study of Genetics, Biorisk,

and Society, Law & Social Science Building, West Wing, University of Nottingham,

University Park, Nottingham NG7 2RD, UK. Telephone: +44 (0) 115 84 67618; e-mail:

emilie.cloatre@nottingham.ac.uk

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LAW & POLICY July 2006

© 2006 The Author

Journal compilation © 2006 Baldy Center for Law and Social Policy

For many years, the biotechnological industry has complained of not having

an appropriate and harmonized patent protection in the EU. Directive 98/44/

EC constituted the legal answer to this demand. However, the debate on the

legal protection of biotechnological inventions raised many ethical issues.

For this reason, the directive took almost ten years to be adopted. In addition,

in the EU system, a directive is a legal text adopted as compulsory guidelines

for Member States, but which needs to be transposed into national law within

a specific deadline. Transposition of the text at national level created further

debates within Member States.

Directive 98/44/EC has been discussed by many commentators in relation

to the crucial ethical issues it raises. Most debates have revolved in particular

around issues of “patenting on life,” and relative to the status of the human body.

However, other important ethical issues also appeared during the debates

on the directive, and these have sometimes been forgotten in later discussion.

One of those is the patenting of elements linked to traditional knowledge and

genetic resources from developing countries. This issue has been urgently

debated within developing countries, and at the international level, where

legal frameworks have been developed to try to remedy some of the local

concerns. However, in 1998 it was a fairly new issue on the European scene.

Considering the evolution of this matter from an ethical issue to a policy con-

cern, and identifying the factors that participated in this evolution, opened

interesting perspectives for empirical testing of theories of policymaking.

Several specialized NGOs outlined the importance of biopiracy during the

negotiations and provoked a real debate on the question. The first concrete

outcome of their work was a parliamentary proposal integrating an article

aimed at reducing risks of biopiracy, as will be explained below. The proposed

article, however, was not integrated as such in the modified proposal sub-

mitted by the European Commission, and the final outcome of the debates

was the integration of a similar disposition in a non-binding recital. Even if

this result appears to be of limited legal effect, the simple fact that the question

was debated in Europe and even generated some parliamentary proposals

is of real importance in terms of the integration of the issue on the EU

policy agenda. In particular, the limited acknowledgement of the issue of

biopiracy in intellectual property law in the EU, as well as the strong inter-

national legal barriers existing in the area, appeared to be significant limits

to interest groups’ hopes for reform.

By presenting the ways in which biopiracy was considered during the

negotiation on Directive 98/44/EC, and how this issue became embodied

into political discourses and into the final text of the directive, this article will

highlight how multilevel governance approaches and policy-network theory are

both highly complementary and valuable in empirical analysis of EU policy-

making. The need to analyse policymaking in the EU as a dynamic process

at several levels—supranational and national, official and unofficial—in order

to include all relevant elements in empirical research will be emphasized, and

the importance of multilevel governance in that regard will be highlighted.