Since the birth of the first child with the help of artificial insemination till today, that the methods of assisted reproduction are being widely applied all over the world, 35 years have passed. During this period of time a debate regarding the necessity of laws and regulations governing the application of the methods of assisted reproduction and the protection of the genetic material in the laboratories has arisen. The need of regulatory legislature also became apparent through the appreciation of the risks associated with the application of the methods of assisted reproduction. These methods pose serious threats to the health and even the life of both the mother- and the child-to-be, risks that have often been underestimated or downplayed throughout the first years of application of the methods. The high cost associated with assisted reproduction was another, rather significant factor, calling for the development of regulatory legislature. Crucial legal issues that arise by the application of the methods of assisted reproduction and ethical aspects contribute equally in the formation of the regulatory legislature. The key issue of the legal status of the genetic material of the embryo, the recognition or non of the genetic material’s legal rights are only some of the issues in dispute arising from the application of the methods of assisted reproduction. Moreover, in the development of the regulatory legislature a rather important factor has been the realization of the need to preserve the child’s-to-be benefits by adopting specific restrictions on the choice of persons that wish to have a child. Lastly, given the fact that this particular medical application has a significant impact on family relationships and creates various relationship issues, especially when third persons participate to the reproduction procedure (e.g. heterologous insemination, surrogate motherhood), a legislature governing the process was deemed necessary. In this context the European countries have instituted laws governing the application of methods of assisted reproduction at the European and the national level. These laws, however, were brought into power at different time points across the various countries, depending on the progress in each country. The strictness or leniency of these laws reflected each country’s position on crucial issues associated with implementation of assisted reproduction, such as the determination of the specific time-point at which life begins, the nature of the genetic material, the fertilized egg and the embryo, the freedom to perform research etc. At the same time, the treaty of Oviedo (1997), being a framework, deals with a vast number of issues, associated with the application of Biotechnology on humans. Methods of assisted reproduction, however, are only cited in articles 14 and 18, the former prohibiting the use of the methods for selection of a future’s child sex, and the latter outlawing the creation of human embryos for research purposes. The limited reference of the methods of assisted reproduction in the Oviedo Treaty should be associated with the fact that differences in the national and cultural heritage did not allow to reach a consensus on a number of issues. Divergences between national legislatures give rise to problems of particular importance, especially to those associated with the application and control of assisted human reproduction and in vitro research on embryos. Problems arising from the ongoing development of biotechnology in this field of research can not be eliminated. Although, common components of national laws can be found in order to limit them.
The research will have the following objectives: (1) to identify the problems described above and their consequences in the society and living conditions, (2) to record the causes of these problems, (3) to submit proposals -widely accepted in EU- to effectively counteract the problems. In this context, the research proposal includes: Identification of the key points of current legislature regarding methods of assisted reproduction and protection of the genetic material in Europe. The research will examine specific groups of countries. Using these criteria, the Swedish legislature was selected from the countries of Northern Europe, the German and French from the countries of Central Europe and the Greek and Italian from the countries of Southern Europe. It will also extend to the Anglo-Saxon Law of England. n addition to the recording of the regulatory legislation, the research proposal will include: (a) the recording of case law, which has been created during the past 15 years, since signing the Oviedo treaty, (b) the recording of the opinions of the Heads of the Bioethics Committees of these countries on the problems, which the existing legislature has created during its application, as well as their suggestions on how to improve it, (c) the recording of the corresponding opinions of the Heads of National Agencies of Medically Assisted Reproduction, where they are operative or have at least been for some time-interval, (d) the recording of the opinions of scientific societies or groups of citizens on studying and putting forward any problems associated with the assisted reproduction and protection of the genetic material, (e) the recording of the opinion of the Head of a Center of Assisted Reproduction, (f) the collection and study of the relative bibliography, as well as of all associated decisions and reports, by the Bioethics Committees or the National Agencies of Medically Assisted Reproduction. Upon completion of individual national searches, results collection and evaluation, all proposals will be recorded and comparison with data from other countries will follow. Research will not be limited to national legislation. It is also necessary to record the case law of the European Court of Human Rights on issues associated with the assisted reproduction and protection of the genetic material. Finally, the research will be enriched by seeking and recording views of international associations dealing with the ethical and legal aspects of assisted reproduction, such as the European Society of Human Reproduction and Embryology (ESHRE), and representatives of the International Federation of Fertility Societies (IFFS). Based on the above information, specific proposals with broad consensus in EU will be submitted, as well as proposals that is necessary to be adopted, according to the latest findings of medicine for the protection of the expectant mother and the child to be born.
The research will be carried out through the use of two questionnaires. The questionnaires will allow gathering of the necessary key-points in a unified way. More specifically: The first questionnaire will focus on the content of the national legislature on assisted human reproduction and research on genetic material in the aforementioned European countries. This questionnaire will be filled in by five young researchers, doing field research in collaboration with faculty members of the countries, where the research will take place. The second questionnaire will be aimed at reference persons, whose opinion will be requested on the enacted legislation and the problems it may cause. Furthermore, their input as to what can be done to deal with these problems will be requested. A form for the recording of jurisprudence (case law) of individual countries will also be prepared. The questionnaires will be prepared by the five researchers under the supervision of the principal investigators. Before the questionnaires are finalized, each researcher will fill in the questionnaires with data from the Greek legislature, three times, so as to familiarize with the questionnaires and optimize their content. The researchers will then visit each of the selected countries to gather the necessary data. The first questionnaire will be filled in by the researcher, in collaboration with faculty members of the host country. An interview with the person of reference will be held for the second questionnaire.
More information about the research results can be found on the project’s website: