SUMMARY

The Biomedical Research Law Project composes the first normative initiative that rules biomedical research and its incidence over the inherent human rights within the Spanish set of laws, according to the guideline stated by the Council of Europe on the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine.

This text, composed of 88 articles, regulates the donation and use of ovocites, preembryos, embryos, human fetuses and the treatment of biological samples with biomedical research purposes, the biobanks and organisms like the Spanish Committee of Bioethics. Notwithstanding, the following reflections are focused on a very specific point of this extensive normative, involving the management of genetic information and the carrying out of tests within this field. Therefore, the Biomedical Research Law Project becomes an essential text giving answer to a legal omission, affecting healthcare information as a whole and more evidently a highly specific field like this of genetic data.

The parameter previously stated by the Law 41/2002 of 14th November, Regulatory of the patient’s autonomy and the rights and obligations regarding the clinical information and documentation, and by the Organic Law 15/1999 of 13th December, on the Personal data protection, are evident through the whole series of articles, which makes clear paramount issues like the personal character, that in connection with the latter referred law, is granted to the genetic information, which implies the subduing of its use and management to the principles of the regulatory normative of personal data protection.

The dignity of the individual, whose warranty is the aim of the Law Project, is found in the principles of information and consent that rule the use of genetic data, that must be only managed within the field of the healthcare or along the research activity, being specially relevant the principle of processing data for a specific purpose as the warrant of the individual’s total control over the use and destination of personal information.

The following analysis will focus on these matters, starting from a previous exposition on how peculiar the genetic information is with respect to the remaining healthcare data, to which it belongs.