Research Case Study: Moral and Legal Aspects of Stem Cell Research in Argentina
An AHRC and ESRC-funded Edinburgh Law School research project led by Professor Graeme Laurie and Dr Shawn Harmon in collaboration with the Argentinian Ministry of Science, Technology and Innovative Production (MOST) from 2007-2012, has served in helping to overcome state non-intervention in the regulation of regenerative medicine in Argentina. As a direct result of engagement with the stakeholders in law/policy, medical and scientific communities, the research exposed a strong appetite for top-down legal intervention. This fuelled support for changes to the Argentinian Civil Code that occurred in October 2014, coming into effect on 1st January 2015. The new 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.
A series of international workshops held in collaboration with the MOST provided a research method and resulted in more open debate than had previously been achieved in Argentina.
Evidence was gathered through interactive workshops and follow-up face-to-face meetings. The first workshop in 2007 examined normative possibilities and the UK experience in regenerative medicine, focusing on legal lessons learned. The second workshop in 2008 examined human tissue use and regulation, identifying gaps in the Argentine framework. The third workshop in 2009 looked at what to include in an Argentine law. The fourth workshop in 2010 examined biobanks and the regulation of human tissues and cells, and the fifth in 2011 was a comparative exploration of the regulation of advanced medicinal products. Parallel semi-structured qualitative interviews were conducted with key stakeholders. Data and recommendations were disseminated in reports and policy briefs and considered by the Ministers of Science and Health and by representatives of INCUCAI (Argentine Human Transplantation Authority) and ANMAT (Argentine Medicines and Medical Devices Regulator). All parties took part in the iterative process of research design and the production of key findings.
Through the systematic engagement of the research community and law and policy makers, the partnership between Edinburgh and Argentinian research regulators overcame a long-standing impasse in Argentina respecting state non-intervention in the regulation of regenerative medicine.