About this module
This Module introduces users to the different components of a regulatory framework aimed at safeguarding human health and the environment when working with biological material and/or applying biotechnology. A functional framework comprises: legal documents (such as policy, legislation, guidelines and decisions), authorities, advisory bodies and enforcement mechanisms.
Such a framework reflects government policy, which should be in agreement with societal priorities and values. It guides and sets standards that, once reduced into legislation, become enforceable. It enables implementation through authorities and is applicable to people in public life, private initiatives and a large diversity of stakeholders.
Major focus of the Module and main goals
Irrespective of the user's background and previous experience, when dealing with biological materials and/or biotechnology, it is important to understand your legal responsibilities and their societal ramifications. Upon completion of the Module, the user will:
- Understand the importance of realising the goals set by policy,
- Be provided with the tools to evaluate different legal instruments, from the international context down to domestic regulation; and
- Appreciate the relevance of a functional regulatory framework.
A thorough comprehension of such processes will empower all stakeholders, be they regulators, advisors, applicants or other interested parties, to effectively participate in regulatory decision-making that enables the deployment of biotechnology while safeguarding human health and the environment.