Example 1 – Lack of Clarity about Which Rules are Applicable

Lack of coherence among the regulations can leave it unclear which rules should be applied in particular cases. To illustrate this problem, when deciding to allow the export of a genetically engineered bacterium , states may be unclear whether they should be applying rules on trade, on disease control, on arms control, on transport of dangerous goods or on conservation of biodiversity, or a combination of some or all of these regulations.

This is particularly problematic where there is no referencing between the regulations. It is, for example, made clear in the Cartagena Protocol that it does not cover ‘living modified organisms which are pharmaceuticals for humans that are addressed by other relevant agreements and organisations’ (Article 5), but it does not say what these agreements are, or whether any environmental impacts need to be taken into account when applying the other agreements. Referring back to Table 8.1 in Chapter 8, in relation to this example, it can be seen that there are no references from the arms control regulations to the other regulations; no references between the trade and the environmental regulations; and only limited references between the health regulations and trade regulations.

The implications of this are that states may be unaware of the full range of rules that apply, unclear which rules they should apply and unsure which rules other states will choose to apply to a particular case. This creates difficulties for defining rights and obligations, for coordinating behaviour and for providing predictability. Uncertainty is likely to increase in such situations as states cannot predict the behaviour of others. (Joyner 2005, p. 7) explains the key role of certainty about behaviour in achieving predictability through international law:

A lack of order often stems from uncertainty about the future conduct of others … decision makers need knowledge about the current state of affairs to make informed decisions. A government's decisions are intended to preclude unwanted future effects and to facilitate desired future ends and objectives. International law, framed by legal rules for state conduct, remains the principal channel for furnishing these expectations about future state behaviour.

Example 2 – Existence of Different Dispute Settlement Mechanisms

Where different dispute settlement mechanisms exist within a set of regulations – as they do in the international biotechnology regulations – then states could choose to move disputes to the forum which they believe best suits their side of the case. This could make the resolution of conflicts difficult. It may also be difficult for the dispute settlement body associated with one regulation to resolve conflicts between states on issues where another regulation contradicts or overlaps. There is the potential scenario of one body making a ruling that effectively goes against the provisions or principles of another regulation.

In the biotechnology area a problematic case might be a dispute on intellectual property rights and genetically engineered plants (this has already proved to be a controversial area). Such a dispute might, potentially, be dealt with by the World Trade Organisation's (WTO) dispute settlement body under the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement (Part V, Article 64); the dispute settlement procedures of the International Treaty on Plant Genetic Resources (Article 22); or the dispute settlement procedure suggested by the Bonn Guidelines (Section V, point E); or indeed of those incorporated into the future international regime on access and benefit-sharing , currently under negotiation under the Convention on Biodiversity's Conference of the Parties.

Example 3 – Competition over Values

Fragmentation of the regulations could encourage (particularly powerful) states or regional blocs to compete over values by forum-shifting (explained in Chapter 4). This creates uncertainty for other states and, where the principles that underlie the regulations are put in contention, fragmentation may increase. An illustration here is the different approaches to genetically modified foods taken by the United States and the European Union (EU) (which can be summarised as producer protection versus consumer protection). The US approach appears to be better reflected by the rules of the WTO; the EU's by the Codex Alimentarius (Ching 2005).

Example 4 – Contradictory Provisions

Provisions in the regulations which are, or can be interpreted as, being contradictory will also leave states unclear as to which rules to apply, and will affect coordination and predictability of behaviour. This is also a problem in terms of shaping expectations. As Joyner explains ‘rules provide expectations. If all governments follow the same rules in their relations, they would then know what to expect from one another’ (2005, p. 15). Unfortunately this will often not be the case in the governance of biotechnology. A prominent example here is the treatment of living modified organisms (LMOs) – does a state have the right to block imports of LMOs on socio-economic grounds as implied by the Cartagena Protocol, or is this right precluded by the WTO agreements? (Murphy Winter 2001, p. 90), when discussing the role of the WTO agreements in addressing concerns about biotechnology, concluded that: ‘The potential for conflict with other treaty regimes is significant.’

Example 5 – Overlap of Provisions

Partly as a result of the regulations developing separately from one another there are some areas of overlap, for example in provisions on scientific and technical assistance to developing countries. Such overlaps may result in duplication of efforts. For example, one state might provide scientific knowledge under the technical assistance or benefit-sharing provisions of the International Treaty on Plant Genetic Resources (Articles 8 and 13) and another state might provide the same knowledge under the benefit-sharing provisions of the Bonn Guidelines (Appendix II) or under the technical assistance provisions of the International Plant Protection Convention (Article XX). Such duplication will undermine the functions of reducing costs and increasing efficiency.

Example 6 – Lack of Clarity on Prohibitions

Where one regulation can be interpreted as allowing an action that is prohibited by another regulation then activities may not be effectively constrained and again this will not reduce uncertainty or enhance predictability of state behaviour. For example, therapeutic human cloning appears to be permitted (subject to certain constraints) under Article 11 of the Universal Declaration on the Human Genome and Human Rights – ‘Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted.’ However, the prohibition on human cloning contained in the UN Declaration on Human Cloning is interpreted by many states as including therapeutic cloning as well as reproductive cloning – ‘Member States are called on to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life’ (point b).

It is clear that the lack of coherence among the international biotechnology regulations challenges their ability to effectively fulfil several key functions of international regulation. In regard to those listed above, Table 11.2 provides a summary of likely areas of difficulty.

Promotion of Benefits

Just as there are contradictions in the provisions of the regulations, there are different perspectives on what ought to be prioritised as a benefit – and some of these may at times conflict. For example, should free trade (as outlined in the Sanitary and Phytosanitary and Technical Barriers to Trade Agreements) be prioritised over the protection of biodiversity (the focus of the Convention on Biodiversity and Cartagena Protocol)? Should providing rewards for innovation (as implied in the TRIPS Agreement) be prioritised over maintaining certain resources as the common heritage of mankind (as suggested in the International Treaty on Plant Genetic Resources)? When should freedom of scientific research be prioritised over the ethical, moral and cultural values of societies? These examples are all representative of ongoing wider debates between and within states and societies and it is perhaps unrealistic to expect regulation to have resolved them – but some certainty needs to be provided if benefits are to be appropriately prioritised and promoted. It is also important that actions are coordinated. For example how should the potential benefit of increased food security through provision of genetically modified food aid be coordinated with environmental and health concerns?

Prevention or Minimisation of Negative Impacts

There are similar differences of perspective reflected in the regulations about what should be prioritised as negative impacts to be avoided. For example under the TRIPS Agreement innovators not being properly rewarded for the development of a novel (genetically engineered) crop would be a negative impact. However, under another agreement, the International Treaty on Plant Genetic Resources, the restriction of access to a plant genetic resource within its multilateral system that might result from a patent is viewed as a negative impact (Article 12.3(d)). There is no guidance as yet, as to how such issues ought to be balanced.

Identification, Assessment and Management of Risks

In trying to reach an optimal promotion of benefits and avoidance of negative impacts, effective risk identification, assessment and management are very important. Lack of coherence among the regulations could also pose problems here. It may be unclear to states what standards they should apply; how they should make their assessments; what types of assessments will be viewed as legitimate; whether they are allowed to use the precautionary principle; and whether they can include assessment of risks to social values or to economic development.

Promotion of Capacity-building

In order to be able to effectively identify, assess and manage risks, promote benefits and avoid negative impacts, states need to have the institutions, mechanisms, knowledge and funds to do so. This makes capacity-building very important for the effective governance of biotechnology. Many of the regulations have provisions that support capacity-building, particularly through financial and technical assistance, technology transfer and information exchange. However, there are still problems caused by the regulations’ lack of coherence. If states are unclear about what their obligations are under the regulations, about what they should be promoting and avoiding, about what they are permitted and/or obliged to do in terms of risk assessment and management – then they are also likely to be unclear about what sort of mechanisms and institutions they need and what national legal measures they should put in place to implement the international regulations – particularly if they are worried that the legislation they put in place to implement one international regulation will be challenged under another international regulation.