Law Library of Congress Publishes Report on Selected Issues in Biotechnology Regulation

The Law Library of Congress published a November 2023 report entitled Selected Issues in Biotechnology Regulation: Australia, Belgium, Brazil, Canada, China, England, European Union, Germany, India, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, Taiwan that provides an overview of the main statutes and policies governing selected issues on the development of biotechnology products, particularly those derived from genetically modified organisms (GMO) and genetic engineering. The comparative summary provides the following information:

• Definitions of Key Terms Regarding Biotechnologies: According to the report, each of the surveyed jurisdictions has a variety of official sources governing biotechnology matters, and a number of these sources provide definitions, including “genetic engineering” and “genetically modified organisms.” Brazil, China, Germany, and the European Union (EU) have policy documents that also define the term “bioeconomy,” while Australia, Belgium, Mexico, New Zealand, and South Africa have government statements that address “bioeconomy” “in a way that advances environmental protection objectives, including sustainable development and renewable resources.” The report notes that Canada, England, India, Japan, Singapore, South Korea, and Taiwan “do not appear to have defined bioeconomy by law or in policy documents.”

• Cross-Border Cooperation: According to the report, the jurisdictions covered are signatory parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, with the exceptions of Australia, Singapore, and Taiwan. The protocol is an international treaty governing the movements of modified organisms derived from modern biotechnology from one jurisdiction to another. The report states that “[f]urthermore, some of the surveyed countries have entered into relevant bilateral and regional agreements and engage in pertinent fora.”

• Data Collection and Sharing and Patent Rules on Collaborative Projects: The covered jurisdictions have legal requirements addressing collection and transfer of personal information. Some countries, such as China, Mexico, and New Zealand, have general intellectual property (IP) rules indicating that collaborating parties may apply for a patent. According to the report, “Australia’s IP regulator provides guidance on ‘IP management for collaborations’ for researchers” that includes model terms and contracts. With respect to guidance on collaboration projects to develop biotechnological products, the report states that the United Kingdom (UK) “provides several sample agreements to help facilitate collaboration on biotechnology projects among academia, institutions, and private industry, both within the UK and overseas.” The report notes that patent rules or guidance specifically addressing collaborative biotechnology inventions could not be located in the rest of the jurisdictions surveyed (i.e., Belgium, Brazil, Canada, the EU, Germany, India, Japan, Singapore, South Africa, South Korea, and Taiwan).