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Key Regulatory Issues  
Developed countries have accumulated experiences in regulating biotechnology, including gene technology, ranging from voluntary to legally binding measures; from sectoral to holistic approaches.

The challenge for developing countries and countries with economies in transition is to build on existing experiences, identifying their strengths and weaknesses, and taking into full account the growing body, and gaps, in scientific and socio-economic knowledge of biosafety and biotechnology.

A holistic and comprehensive regulatory approach to ensure biosafety would be based on the precautionary principle, covering the entire range of activities from research and development of GMOs to their commercialization, and post-release monitoring.

Sound science draws a clear line between “containment” and “release” so that an activity whereby a GMO or parts thereof comes into contact with the environment will be classified as a release. Regulations and measures for release will then apply.

Information disclosure to the public generates feedback, including scientific and technical inputs from independent scientists and researchers in the field of biosafety, which is crucial for sound regulation.

There are ongoing discussions in many countries and at the regional and international level on the scope of information that should be disclosed to the public. Technology developers and private biotechnology companies are claiming broader protection of data, beyond that of traditional trade secrets and confidential business information. The provision of the Cartagena Protocol on Biosafety for claims to “confidential information”, if inappropriately implemented, can deprive the public of necessary information to ensure biosafety.

National regulations will thus need to ensure information disclosure, from both the private and public sector technology developers.
 
 
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