ICTSD Outputs and Activities on Biotechnology, Trade and Sustainble Development

Biotechnology: Addressing Key Trade and Sustainability Issues

B.3 Cartagena Protocol on Biosafety

Q16 Is the Cartagena Protocol on Biosafety compatible with WTO rules?

As mentioned, several WTO agreements are relevant to the transboundary movement of GMOs (see Q8). All of these agreements may thus, to varying degrees, affect the implementation of the Biosafety Protocol.

The SPS Agreement seems to have raised the most concerns regarding the compatibility of the Protocol with WTO rules, for several reasons. First, the scope of the SPS Agreement would seem the most akin to that of the Protocol. National measures taken to implement the Protocol are likely to have a range of purposes. Nevertheless, because they will ultimately aim to prevent “adverse effects on the conservation and sustainable use of biological diversity”, they are also likely to focus on a particular risk to plants or animals, and thus be considered SPS measures under the SPS Agreement. For example, a decision to ban a particular strain of Bt cotton under the AIA procedure, while essentially responding to overarching environmental concerns, may endeavour concretely to prevent the crop from promoting resistance to Bt in insects and contributing to a pest problem. Second, due to the Protocol also adopting a science-based approach, comparisons between the two regimes are inevitable. Indeed, the use of risk assessments in both instruments is remarkably similar, although it is not certain whether measures taken under the Protocol would fulfil the requirements of the SPS Agreement. Similar concerns arise in relation to the role of precaution in the Protocol vis-à-vis the SPS Agreement – these concerns are analysed in Q17.

In regard to risk assessment requirements, the Protocol obliges the decisions of importing countries in the context of the AIA procedure to be in accordance with risk assessments carried out in a scientifically sound manner and taking into account recognised risk assessment techniques. The SPS Agreement, on its part, requires Members to base their sanitary or phytosanitary measures on a risk assessment, as appropriate to the circumstances, and taking into account risk assessment techniques developed by the relevant international organisations. The question, however, is whether the SPS Agreement approach is wide enough to encompass that of the Protocol, which allows countries to consider, in addition to the risk assessment, a broader range of concerns, including “socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biological diversity.” In this regard, many commentators point to the fairly expansive concept of risk assessment established by WTO jurisprudence, which would promote compatibility (Oliva, 2004). In one case, the Appellate Body affirmed that the fact that a risk assessment was a “scientific process” did not mean that all matters not susceptible to quantitative analysis were excluded from its scope (WTO, 1998, para. 187). Nevertheless, other recent cases, including EC-Biotech, are seen as establishing a trend to restrict the scope of risk assessments under the SPS Agreement.

The GATT, which applies to all international trade in goods between WTO Members, should also be analysed. As mentioned in Q9, two of the core principles of the GATT – the national treatment and the most favoured nation obligations – require countries to grant equal treatment (in terms of laws and regulations, for instance) to products of national and foreign origin, and products originating in or destined for the territories of different WTO Members, considered ‘like products’. These requirements may be relevant for measures implementing the Biosafety Protocol, for example, in the following two situations. First, the Biosafety Protocol does not require the domestic trade of LMOs to be regulated in the same way as international trade of LMOs. As a result, if a country were implementing the Biosafety Protocol but not regulating its national market in the same manner, it would arguably be violating the national treatment obligation of the GATT. Second, if a WTO Panel or Appellate Body were to consider LMOs ‘like products’ in relation to their conventional counterparts, then the different treatment given by Country A, implementing the Biosafety Protocol, to the LMO shipments from Country B with respect to the shipment of conventional products from Country C, could be argued to violate the most-favoured-nation obligation.

Of course, even if these measures implementing the Biosafety Protocol were found to violate the national treatment and most-favoured-nation requirements, they might nevertheless be justified under Article XX of the GATT. Article XX establishes a number of general exceptions to the GATT for measures that are, for example, necessary to protect human, animal or plant life or health or relating to the conservation of exhaustible natural resources if such measures are made effective in conjunction with restrictions on domestic production or consumption. These measures, nevertheless, would have to not be applied in a manner that would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade. No measure implementing an MEA has ever been challenged, and thus no defence on Article XX grounds has been attempted in this context. Nevertheless, given the emphasis by the Appellate Body in other cases on international co-operation as the best strategy to address environmental concerns, this line of argument has significant merit.

As mentioned above, the provisions of the TBT Agreement do not apply to sanitary and phytosanitary measures; it is thus unclear to what extent measures implementing the Biosafety Protocol would fall under the TBT Agreement. For example, Article 18 of the Biosafety Protocol, which deals with handling, transport, packaging and identification, clearly states that such measures are required “in order to avoid adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health”.
If the TBT Agreement were found applicable to measures implementing the Biosafety Protocol, an important consideration for a WTO Panel would be whether the Biosafety Protocol could be considered an international standard. In the TBT Agreement, regulations in accordance with international standards are rebuttably presumed not to create an unnecessary obstacle to international trade. If the Biosafety Protocol were not found to be such a standard, then many of the issues raised by the GATT – explained above – would be relevant, including national treatment, most-favoured-nation, and general exceptions, as well as other TBT requirements relating to notifications.