Regulation of biobanks in Mexico: Ethical and Legal issues

This thesis investigates the governance of biobanks in Mexico, exploring elements of legislative reform for the improvement of current legal and ethical guidance. It argues that the great benefits to be obtained from research using biobanks (e.g. personalised or stratified medicine) are at risk of being undermined by the absence of clear legal pathways. A number of legal and ethical issues have emerged from the different aspects of biobanks. Diverse theoretical approaches are reflected in academic literature and heterogeneous legislation of biobanks around the world. Specific binding rules have worked for some, whereas self-regulation has proven suitable for others. Social solidarity has played a key role in innovative biobanking law and decision making, in which traditional governance approaches have become more reflexive, involving not only law and policymakers, but also the public. A detailed legal analysis revealed significant gaps within the complex Mexican laws governing biobanks; this has caused confusion. Areas of concern were identified in relation to the ethical management of research samples and the protection of donors’ rights. This is concerning in Mexico where economic interests influence legal reform, giving way to opportunistic actions by the international pharmaceutical industry and leaving vulnerable populations unprotected. The greatest challenges for Mexican legislators are finding ways to respond to legal gaps with new laws and improving the effectiveness of existing rules. Due to the scarcity of literature on the topic, interviews were conducted with representative actors in strategic areas. Participation in the European Union research network BTCure enabled the inclusion of a study investigating how European experiences can be valuable examples for Mexico to follow. The results of this research indicate ways forward for Mexican governance, which are expected to influence further legislative reforms of biobanks.