Influencing international science legislation
Two AHRC-funded Research Centres involving a collaboration with the Argentinian Ministry of Science, Technology and Innovative Production (MOST) served as key drivers in the formation of regulatory structures and norms, helping to overcome state non-intervention in the regulation of regenerative medicine in Argentina. The research exposed a strong appetite for top-down legal intervention, which fuelled support for changes to the Argentinian Civil Code that occurred in October 2014 and came into effect on 1st January 2015. The new Argentinian Civil Code confirms that life begins with conception and introduces rules about human participants’ research as part of the general law for the first time. This, in turn, paves the way for new provisions for research with tissues and cells, currently being prepared by the MOST.
The two overlapping projects undertaken between 2006 and 2012 by Dr Shawn Harmon and Professor Graeme Laurie at the University of Edinburgh explored legal gaps in the Argentine regulation of human tissues and cells use and advanced medicinal products. Through empirical evidence and normative and institutional recommendations, the research influenced the policy programme of the Advisory Commission on Regenerative Medicine and Cellular Therapies. This led to the construction of a legal framework for stem cells research and therapies which was integrated into a proposal to modify the Civil Code of Argentina. The research also provided regulators with evidence that stakeholders viewed guidance on medical regulation and oversight as essential, which formed part of Argentinian Congress recommendations for a central regulatory authority.
Overall the research played an important role in overcoming the impasse in health research regulation in Argentina, constituting the first thorough consideration of appropriate regulatory models in the field and contributing to a proposed model law in medical research regulation.
This case study was featured within the AHRC 2014/15 impact report.
Gateway to Research Project Link: The AHRC Research Centre for Studies in Intellectual Property and Technology Law (Apr 07 - Jun 12)