The Cartagena Protocol on Biosafety

Reconciling Trade in Biotechnology with Environment and Development

Christoph Bail, Robert Falkner, Helen Marquard

• Publisher: Routledge
• Year: 2014
• Topic: Politics & International Relations
• eBook ISBN:
  9781136534386
• Subtopic: Environmental Law
• Index: Politics & International Relations

Modern biotechnology - the controversial manipulation of genes in living organisms - has far-reaching implications for agriculture, human health, trade and the environment. Against the odds, an international treaty governing biosafety and trade in biotechnology was adopted in 2000. The Cartagena Protocol on Biosafety of the Convention on Biological Diversity deals with one of the most important and challenging issues thrown up by developments in biotechnology. This volume is a comprehensive review of the protocol and the process that led to its adoption. It includes contributions from many of the key players involved and analyses the commercial and political interests at stake, the operations and implications of the protocol, and prospects for the future.

Part I
Background:
the road to the Cartagena Protocol and beyond

1 Negotiating the biosafety protocol: the international process

Robert Falkner

When the first meeting of the Open-ended Ad Hoc Biosafety Working Group (BSWG) opened in Aarhus, Denmark on 22 July 1996, the world hardly took notice of the gathering of diplomats, scientists, environmentalists and industry representatives that had begun work on a global biosafety agreement. Less than four years later, in January 2000, the media spotlight was strongly focused on the final round of negotiations in Montreal, which produced the Cartagena Protocol on Biosafety. In these few years, the biosafety talks had emerged from relative obscurity to the centre stage of international environmental diplomacy. The question of how to protect the environment and human health from the potential danger of genetically modified organisms (GMOs) – or living modified organisms (LMOs), the term used in the biosafety agreement – had become a fiercely contested issue at the crossroads of global environmental policy, international trade and economic development.

Reaching agreement on the biosafety protocol seemed a daunting task at times. In the first two years of the talks, delegates tried mainly to define key terms, to set up a ‘wish list’ of elements to be included in the agreement and to ensure that their national positions were reflected in the draft protocol. The actual bargaining process over its content began in earnest only in 1998, and quickly ran into the ground when the parties failed to reach a compromise in February 1999 at the Cartagena meeting, scheduled to adopt the protocol. It took another year and a series of formal and informal meetings to overcome the final hurdles to a successful conclusion of the talks.

In a sense, the biosafety talks followed the path of other multilateral environmental negotiations. They were characterized by similar kinds of debate – over the scientific aspects of the environmental issue at hand, over the economic costs of environmental action and over the ramifications of the proposed environmental measures for international commerce and economic development. And, just like the international agreements on ozone layer protection (the Montreal Protocol) and climate change (the Kyoto Protocol), the biosafety protocol grew out of a previously negotiated agreement, the Convention on Biological Diversity (CBD). The biosafety protocol was intended to minimize risks from LMOs to biodiversity and thus provide the first concrete international agreement to implement aspects of the CBD.

In another sense, the biosafety talks were a unique experience that broke new ground in global environmental diplomacy. Unlike other multilateral environmental agreements (MEAs), the Cartagena Protocol was negotiated without evidence of concrete environmental damage resulting from the release of LMOs into the environment. What is more, the scientific community was deeply divided over the potential risks involved. Thus the biosafety agreement is a truly precautionary instrument, setting rules for decision-making that seek to minimize the risk of future, potential, damage. This precautionary character goes some way in explaining the difficulties encountered in reaching agreement on the protocol. Although most countries accepted the need for precautionary action, some feared that the biosafety regime would unnecessarily slow down progress in biotechnological development and hamper international trade in biotechnology.

The initial driving force behind the biosafety talks came from the developing countries. In a striking reversal of roles in MEA negotiations, most developed countries initially found themselves reacting to demands from the developing world for a biosafety agreement with comprehensive coverage and strong trade-related environmental measures. The early biosafety talks were characterized by a North–South division, with some developed countries expressing scepticism, and even outright opposition, to many of the provisions that now make up the protocol. As soon as the talks got under way, however, the positions taken by individual countries became more diverse, and rifts began to appear both within the developing world and among developed countries. The evolving negotiating dynamic revealed a more complex mixture of interests that could no longer be subsumed under the conventional categories of ‘Northern’ or ‘Southern’ positions.

A development that helped to create growing interest in the biosafety talks, but eventually threatened their successful conclusion, was the emerging focus on trade in agricultural commodities. In 1996, at the time of the first Biosafety Working Group meeting, LMOs were only about to enter agricultural markets in a small number of countries. At this stage, few expected the prospective biosafety agreement to have a significant impact on trade in agricultural commodities. But in less than two years, the growing presence of genetically modified (GM) soybeans and corn (maize) in international trade forced biosafety negotiators to reassess their positions in the light of the commercial stakes involved. Many observers felt that the biosafety talks were increasingly being driven by economic arguments over trade, not by concerns for the protection of biodiversity. And looming in the background was the wider conflict between MEAs and international trade rules that was being fought out in the World Trade Organization (WTO) and in other international fora.

The trade dimensions of the biosafety agreement came to the fore not least because of the increasing politicization of agricultural biotechnology during the late 1990s. Starting in Europe but soon spreading to other parts of the world, a broad movement critical of agrobiotechnology formed and left its mark on the biosafety talks. Responding to growing concern among consumers about the safety of GM food, European regulatory authorities imposed a de facto moratorium on the commercialization of GM crops in 1998 and then introduced mandatory GM labelling requirements. With North American exports of GM crops and other commodities sharply in decline, the transatlantic conflict over agricultural biotechnology began to spill over into the biosafety talks, pitting the EU against the United States and Canada.

Against this background of an intensifying North–South and transatlantic conflict, the adoption of the Cartagena Protocol in January 2000 was indeed a remarkable achievement. The final agreement reached in Montreal was based on a broad compromise among the major negotiating groups. All parties gained something; all had to give up something. The protocol also contains some ambiguous language and areas that need to be negotiated further in the near future. But it stands as the first internationally agreed biosafety agreement that, once ratified by a minimum of 50 countries, will be the only legally binding framework in this area.

The remainder of this chapter provides as background a brief overview of the negotiating process that led to the adoption of the Cartagena Protocol. Subsequent chapters will analyse country positions and specific aspects of the biosafety talks.

Establishing a negotiating mandate

Efforts to create international biosafety rules began in the 1980s, when modern biotechnology was still in its infancy but showing signs of progressing towards the commercialization of genetically modified organisms and products. A growing number of scientists, politicians and environmentalists were calling for international efforts to regulate the new technology. For example, the authors of Our Common Future (1987), the widely read report by the World Commission on Environment and Development (WCED), while recognizing the potential benefits of biotechnology, urged that ‘new life forms produced by genetic engineering should be carefully tested and assessed for their potential impact on health and on the maintenance of genetic diversity and ecological balance before they are introduced to the market, and thus to the environment’.¹

At the end of the 1980s, preparations for the UN Conference on Environment and Development (UNCED) in Rio de Janeiro provided an opportunity to introduce safety in biotechnology to the agenda of biodiversity protection. It was mainly the developing world, with some support from European countries, that demanded the inclusion of biotechnology and biosafety issues in the negotiations on the Convention on Biological Diversity, which was to be signed at the Rio ‘Earth Summit’ in 1992.

The preparatory meetings that drafted the convention were characterized by disputes and divisions that would later resurface during the negotiations on the biosafety agreement. Several developing countries, concerned about becoming the testing ground for potentially unsafe biotechnological developments, led the effort to include comprehensive biosafety provisions in the CBD. The European Community supported the inclusion of biosafety concerns in principle, but the United States, with support from Japan, strongly opposed these proposals on the grounds that special biosafety rules were not required for biotechnology and would interfere with international trade in biotech-nology.² As a compromise, the negotiating parties agreed on a provision in Article 19(3) of the CBD that merely requires the parties to consider ‘the need for and modalities of a biosafety protocol’ (see Appendix 3).

Several parties to the CBD expressed an interest in developing an international biosafety agreement at the first meeting of the Intergovernmental Committee of the CBD in October 1993 and at the first meeting of the Conference of the Parties (COP-1) in December 1994, but a formal negotiating mandate was not adopted until COP-2 in Jakarta, Indonesia in November 1995. Again, it was mainly the developing countries that argued for a comprehensive international legal instrument on biosafety. Most developed countries, particularly those that possessed advanced industrial resources in biotechnology (e.g. the United States), either opposed the idea of a formal biosafety agreement or preferred to limit its scope strictly while continuing with parallel work on the so-called UNEP International Technical Guidelines on Safety in Biotechnology. A compromise was eventually reached at COP-2 that called upon the parties to develop a biosafety protocol to prevent adverse effects on biological diversity (Decision II/5, see Appendix 4). The negotiating mandate included the wider definition of the scope of the protocol that the G-77 countries had demanded (‘safe transfer, handling and use of living modified organisms’), but also reflected the developed countries’ desire to focus specifically on the transboundary movement of LMOs (see chapter by La Vina). These North–South divisions over the scope of the protocol were to become one of the defining characteristics of the subsequent negotiating process.

BSWG-1: a slow start

At COP-2, Denmark had offered to host the first meeting of the Working Group on Biosafety, which took place from 22 to 26 July 1996 in Aarhus. More than 90 delegations – parties and non-parties to the CBD – attended the meeting. Also represented were observers from international organizations, NGOs and industry, who were allowed to make interventions in the discussions. This extensive participation by civil society and corporate actors marked the beginning of a relatively transparent negotiation process.

Much of the work of BSWG-1 was based on the UNEP International Technical Guidelines for Safety in Biotechnology³ and the report of a meeting of biosafety experts in Madrid in July 1995 that had been convened in preparation for COP-2 in Jakarta. The delegations at the Madrid meeting consisted of government-appointed experts whose task it was to debate the possible components of a future biosafety protocol. Unable to reach agreement, they produced a list of consensual and non-consensual elements of a protocol, which was passed on to COP-2. This list then became an important starting point for the discussions at the first BSWG meeting.⁴

BSWG-1 did not signify the beginning of the negotiation process as such, however, as the discussions in Aarhus were concerned with defining the key issues and concepts of international biosafety regulation. The negotiating mandate itself had given little guidance about the content and form of the prospective biosafety agreement, and it was politically not feasible for the CBD Secretariat to produce a draft protocol. It was thus up to the delegates of the first working group meeting to create a ‘wish list’ of items to be included in a biosafety agreement.⁵ Moreover, many delegations had arrived at Aarhus without having fully developed a consistent national position, let alone having coordinated their position with their regional partners. In a sense, therefore, the meeting also provided a forum for clarifying and defining country and regional positions.

The plenary elected Veit Köster of Denmark as chairman of the meeting; he was to continue to chair subsequent BSWG meetings, although he was never given an explicit mandate for the entire BSWG process. Köster had already gained considerable experience in this area, having chaired several biosafety-related meetings in the context of the CBD negotiations from 1988 onwards. He was acutely aware that broad agreement was needed on the purpose and content of the biosafety protocol if the talks were to be successful. In order to facilitate the search for consensus in as many areas as possible, he impressed upon delegates the need to abstain from actual negotiations. From time to time, Köster would use his prerogative to summarize the proceedings, e.g. in the form of aides-mémoire at BSGW-2, to inject into the process a stronger focus on the central areas of contention. But while the BSWG process was in the ‘pre-negotiation’ phase – at least until BSWG-4, and arguably until the last BSWG meeting in 1999 – the delegates were allowed to maintain their national positions by inserting ‘bracketed text’⁶ into the draft agreement.

Although the delegates to BSWG-1 expressed a wide range of positions on all matters concerning the biosafety agreement, certain divisions that had emerged during the negotiations on the CBD and the Jakarta mandate resurfaced during the Aarhus meeting. Broadly speaking, the developing countries argued for a comprehensive regulatory regime that would include references to socio-economic aspects, a liability regime and a financial mechanism. They saw the biosafety protocol as an instrument to deal with not only the transboundary movement of LMOs but also their safe handling and use in a national context. They argued too for the inclusion of products derived from LMOs, ‘products thereof’, in the regulatory framework. In contrast, most developed countries, which had their own national biosafety regulations in place, wanted to restrict the scope of the protocol to the transboundary movement of LMOs; they were sceptical about Southern demands for liability rules and socio-economic considerations.

In addition to these North–South divisions, differences of position emerged within the developed and developing countries. Within the G-77, the African countries, led by Ethiopia, put forward the most far-reaching proposal for international biosafety regulations, while some of the Latin American countries, which were in the process of developing their own biotechnology sector, placed greater emphasis on the potential benefits from agricultural biotechnology. Among the developed countries, the United States continued to be the most sceptical with regard to the need for a comprehensive biosafety protocol, and suggested a stronger focus on information-sharing and helping countries with capacity-building, while the Nordic states were more inclined to support the G-77’s position. The EU member states were still defining a common position, and some European countries continued to favour a two-track process of developing a biosafety regime while supporting the recently adopted UNEP Guidelines.

BSWG-2: more of the same

The second BSWG meeting, held in Montreal from 12 to 16 May 1997, continued discussions on the topics that had been addressed at BSWG-1. The parties were still preoccupied with clarifying key issues and concepts and did not actually negotiate on any of the elements of the proposed agreement. In order to structure the discussion, Köster tabled a number of aides-mémoire, informal discussion papers, which specified the questions he wanted the parties to address. He then consolidated the texts submitted by delegates in response to his aides-mémoire into draft element papers, which were then amended by the parties and, with the approval of the plenary, attached to the report of BSWG-2. Gradually, the structure of the biosafety protocol began to emerge.

BSWG-2 also saw the creation of new organizational structures for the biosafety talks. The parties turned the bureau that had been formed at BSWG-1 into a permanent body for the entire BSWG process. It consisted of 10 delegates, who acted as a steering group for the BSWG proceedings. Furthermore, a contact group was formed to focus on definitions of those terms that lay at the heart of the prospective biosafety agreement. This group got off to a good start and was able to produce some results early on (see Willemse's contribution in this volume). Discussions of other topics, however, including the scope of the protocol, the advance informed agreement (AIA) procedure, liability and socioeconomic considerations, proved to be more contentious. They would hold up progress in subsequent meetings of the Biosafety Working Group.

BSWG-3: a structure emerges

The third meeting of the BSWG was held from 13 to 17 October 1997, again in Montreal, the seat of the CBD Secretariat. As in the previous meeting, Veit Köster continued to insist that delegates discuss issues for consideration under the protocol without entering into actual negotiations. His aim was that this meeting should produce legal texts for a summary draft protocol that would become the basis for negotiating the final agreement.

Slowly but steadily, the biosafety treaty began to take shape. During the preparations for BSWG-3, four ‘component parts’ had been identified that became the basis for drafting the protocol: first, articles or issues addressed by country submissions; second, draft articles developed by the Secretariat concerning institutional matters; third, definitions and annexes compiled by the Secretariat on the basis of country submissions; and fourth, any outst...

Table of contents

• Front Cover
• Half Title
• Front Matter
• Title Page
• Copyright
• Contents
• Foreword
• Preface
• Acknowledgments
• About the authors
• Chronology of events
• Acronyms and abbreviations
• Part I: Background: the road to the Cartagena Protocol and beyond
• Part II: The making of the protocol: actors’ perspectives on the negotiations
• Part III: Key elements of the protocol
• Part IV: Implications for environment, trade and development: an assessment
• Part V: Appendices
• Glossary
• Index