The new opportunities and challenges arising from reproductive technology, stem cell research, cloning, gene therapy, pre-implantation/pre-symptomatic genetic diagnosis and other biotechnological developments have raised expectations and concerns in large sectors of public opinion.

Civil society all over the world is not only optimistic about the hopes and promises of these biotechnological developments, it is also concerned about the risks and dangers. For this reason, governments all over the world are struggling to formulate regulations to steer these developments in a direction which respects human dignity.

The Church's latest contribution to the international debate on bioethics is the 'Instruction on Certain Bioethical Questions', Dignitas Personae (The Dignity of the Human Person), issued on December 12, 2008, by the Congregation for the Doctrine of Faith with the approval of Pope Benedict XVI.

This document, which brings the Instruction Donum Vitae (The Gift of Life, 1987) up to date in light of biotechnological advances over the last 20 years, seeks to enlighten the public conscience on certain bioethical issues, particularly those related to human embryo research, and to encourage biomedical research respectful of the dignity of every human being and of procreation. It is another prophetic stance in favour of the 'culture of life' in today's postmodern society which is profuse with the destructive seeds of the 'culture of death'.

The relevance of Dignitas Personae to the contemporary debate of human embryonic research is quite evident in view of the hypes and false hopes diffused by the international media on the therapeutic results of human embryonic stem cells. Successful therapies are reported from the use of adult stem cell research rather than from human embryonic stem cells.

The three major reasons which the scientific community and pharmaceutical companies have brought to justify human embryo research, namely toxicity testing, basic research and therapies, can now be achieved by Induced Pluripotent Stem Cells which Japanese physician Shinya Yamanaka and his team have generated from adult stem cells. The use of human embryonic stem cells as an alternative to animal experimentation is ethically repugnant.

The anthropological issues raised by Dignitas Personae are timely and prophetic. Some critics have interpreted this document as Church interference in the freedom of life sciences and biotechnology. Dignitas Personae categorically rejects such a false interpretation of the Church's genuine interest to be an active participant in the social dialogue on the benefits and threats of biotechnology in today's pluralistic, secular and democratic society.

The principle of respect for human life is strongly rooted in European tradition. Article 2 of the European Convention on Human Rights (1950) states that no one shall be deprived of his/her life intentionally. Moreover, the Charter of Fundamental Rights of the Reform Treaty explicitly states that the European Union (EU) is founded on the values of respect for human dignity and respect for human rights.

Among the rights listed, the right to life is prominent. Dignitas Personae acknowledges as real progress this recognition of the value and dignity of every person as the foundation of the rights and ethical imperatives by which society has been, and continues to be structured.

In spite of this fundamental principle, Europe is fraught with divergent views on the ethical legitimacy of research on human embryos. Some claim that these divergences are 'intrinsic' and therefore irreconcilable, while others argue that common positions are achievable while respecting the pluralism of European societies as a practical solution.

The two European institutions which deal with bioethical issues are the Council of Europe (CoE) and the EU. Whereas the former has 47 member states with some 800 million citizens, the latter encompasses 27 member states with almost 500 million citizens. The CoE publishes primarily non-binding statements and recommendations on bioethics, but also drafts conventions which become legally binding upon ratification of its member states.

The EU does not have a competence on questions of bioethics; it respects the decision of each member state in bioethical issues in accordance with the principle of subsidiarity. However, in different policy areas where the EU has competence to legislate, the EU may adopt legislation which concerns bioethics which would be binding on member states. Therefore, references to the moral status of the human embryo and to human embryo research are to be found in documents and legislation of both the CoE and EU.

The Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, also known as the Oviedo Convention or the Convention on Human Rights and Biomedicine, was drafted to prevent misuses of biotechnology that endanger human dignity.

It is the first international document which recognised in Article 1 the embryo as a human being. It prohibits the use of methods of medically assisted procreation for the purpose of choosing a future child's sex, except where serious hereditary sex-related disease is to be avoided (Article 14).

The convention is binding only on the states which have ratified it. Malta has neither signed, nor ratified this convention, in spite of the national Bioethics Consultative Committee's recommendations to the government to sign and ratify it, and the local Church's support, provided that reservations with respect to some particular provisions of the convention are made.

The Oviedo Convention establishes that it is up to each country to decide whether or not to authorise human embryo research. In Article 18, it states that each country - if research on embryos is allowed - is only obliged to respect two conditions: "to ensure adequate protection of the embryo", that is to say, to adopt legislation fixing the conditions and limits of such research. Paragraph 2 of Article 18 clarifies that the convention prohibits "the creation of human embryos for research purposes".

This is a very important provision and one of the reasons the UK - which allows so-called therapeutic cloning - the production of human embryos by somatic cell nuclear transfer for the production of embryonic stem cells - has not signed the convention.

To be continued.

Rev. Prof. Agius is dean of the Faculty of Theology at the University of Malta, member of the Malta's national Bioethics Consultative Committee and of the European Group of Ethics (EGE).

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