Harmonisation, diversity and uncertainty in international biosafety regulation

The Cartagena Protocol provides countries with an opportunity to assess the risks associated with a GMO before authorising it to be imported for the first time. Some aspects of the new regime still remain to be worked out and developing countries face particular challenges in the implementation of the Protocol; they need to decide how to address a number of issues left to national discretion, and how to balance their rights and obligations under the Protocol with their commitments under the WTO.The paper explores the issues of regulatory harmonisation and diversity:regulatory harmonisation is often considered to be a positive end in itself, largely because it provides greater predictability in international trade. It is promoted and underpinned by international agreements such as the Biosafety Protocol and the WTO Agreementspressure for international harmonisation also comes from domestic constituencies within developing countries. In some cases, interest groups have criticised their own governments for the slow implementation of regulations or for the lengthy assessment and approval processhowever, accommodating diverse national and local priorities and realities that go beyond ecological differences must also be considered, such as diversity in agricultural practices, capacities in biotechnology, and in socioeconomic conditions in different countries and among different communitiespublic consultation is required under the Biosafety Protocol, but few countries (including developed countries) have yet undertaken the necessary consultationsIn conclusion the paper argues that additional flexibility in the application of international trade disciplines are desirable in any assessment of biosafety measures applied by developing countries. Accommodating national diversity in the face of a relatively new technology represents a challenge not only for the Protocol and for national biosafety authorities, but also for the international trade regime.[Adapted from author]