The enticing invitation to a specialist in international business law to talk about “Law, Ethics and Medical Research” inevitably brings a challenging question concerning the eventual identity of values and moral standards prevalent in both areas. With respect to the system of Multilateral trade I must repeat the words of an important European representative with respect to the agenda for a possible Millennium Round of the World Trade Organisation: “One cannot expect ethical negotiations in the ambit of international trade “. With respect to the former GATT, the General Agreement on Tariffs and Trade, Aristóteles Onassis once said “In international trade there is only one law: there are no laws.”

As a direct result of such a state of play and on the eve of the third Millennium, humanity has fully achieved, and with a singular efficiency, the infamous globalisation of misery and the individualisation of prosperity. The lords are few and the servants numerous; the lords swimming in a sea of prosperity and affluence; the servants begging for scraps; the lords haughty and arrogant; the servants prostrate and striving. The question that arises is to what extent can genetic research contribute to the minimisation of such a state of human misery and to what extent could it turn into a hateful instrument of evil, aggravating human exploitation and accentuating the heights of cruelty; to relive the nightmare of the Holocaust?

Already, 400 years before Christ, Plato analysed the ethical repercussions of genetics raising important problems yet without managing to resolve them satisfactorily. In fact Plato dealt with selective reproduction, of “ante natal education” the eugenic society; the use of abortion and infanticide as a means of eugenic control. Aristótoles immediately distanced himself from his master Plato in order to demonstrate that mans ultimate goal is happiness, the result of the harmonious development of reason guided by virtue. This is the conquest of liberty over irrational appetites, the submission of practical activity to dictates of reason, the custom of selecting in everything the exact measure, avoiding any extremes of quality which are just as negative as the defect itself.

Probably, under the influence of Aristotolism, Mishná, the first part of Talmud,from approximately 1800 years ago and which codifies the oral law of the Old Testament declared; “he who studies with the aim of teaching, may he be given the gift of learning and teaching; and he who studies with practical aims, may he be given the gift of learning, teaching observing and practising.”[1] This teaching of fundamental importance, transported to our present day and age, brings, in my opinion, two consequences: the first, in the sense that ethical and social responsibility of the researcher transcends the frontiers of science; and the second, in the sense that science is a subsidiary value, instrumental to the advance of supreme values such as truth, justice and peace.

Ever since Plato discussed eugenics in The Republic, the science in general and genetics in particular, have developed a great deal. Ethics on the other hand, in the best of hypotheses gives a strong impression of remaining stuck in 400 BC. The almost absolute mercantilisation of medical activities nowadays has contributed to profit coming before ethics as pivotal in science; and so that arrogance substitutes moral conscience as the scientists´ advisor. Such a combination of factors allows that genetic therapy research for example is guaranteed under the almost exclusive eye of pharmaceutical laboratories instead of wide social interest. In October this year, for example, the United States authorities suspended the enrolment of patients in genetic therapy tests for cancer carried out by Schering-Plough Corp. The criterion for the evaluation of such experiments is normally the success or failure of the therapeutic process, such as the recent case of Jesse Gelsinger, which will be under review in the National Institute of Health in the United States on 8 December 1999[2], without having any ethical orientation for the activity, and even more so without knowing how to create one.

The ethical deficit in this area could be derived from the praiseworthy initiative of the Universal Declaration on Family and Human Rights of UNESCO in 1997, in order to establish its main essential heartfelt and potentially antonomiac values, such as “human dignity, freedom of research and human solidarity.” According to Bobbio “antonomia means the meeting of two incompatible propositions which cannot both be true…”[3] In fact, as Dr Mengele amply demonstrated to the satisfaction within a monstrous page of history, freedom of research is far from being an absolute value or an autonomous right.

The 1988 Brazilian Constitution, a rushed and hasty juridical construction, with the undeniable merit of restoring the legal state of Brazil, established the right of free scientific expression, in Article 5, IX, together with individual and collective rights and obligations. As yet it does not deal with autonomous and self-executable rights . It consequently deals with a norm subject to the limitations and restrictions that exist within the ordinary legal system. There are those with their head in the clouds who, considered it relevant that every human activity, be forseen in a Greater Law, envisage the base for genetic research in Article 225, 1? , II of the federal constitution, which considers the right to an ecologically balanced environment. Nothing is more false or contemptuous. In reality the unfortunate provision determines the duty of the public power to intervene in the “genetic heritage of the country” and to supervise research in this area. If public supervision of genetic research is important the national “genetic heritage” clearly could do without the intervention of the state.

The Iberian-Latin American Declaration about Ethics and Genetics, known as the Manzanillo Declaration, revised on the 7 November 1998, confirms the fundamental importance of respect for human rights declared in international judicial documents, such as respect for human dignity, identity and integrity. This document draws special attention to the economic and social differences between developing and developed countries. The Manzanillo declaration establishes the following principals of bioethics:

i. autonomy: on the basis of well informed consent;

ii. beneficial: it is necessary that the practice brings benefits;

iii) no maliciousness: apart from bringing benefits, the practice of this science should not cause harm;

iv) justice.

In Brazil, the Guidelines and Rules of Research on Human Beings regulated the ethical aspects relevant to the activities of research involving human beings, through Resolution 196/96 of the National Health Council. Resolution 251/97 from the same body regulates aspects of the former in respect to pharmaceuticals, medicines, vaccines and diagnostic tests. Amongst us, the genetic manipulation of human reproductive cells is still prohibited, under the terms of Article 8? , paragraph II, law n. 8974/95. The sanction of such a provision, implies merely administrative punishment of pecuniary fines and the paralysis and suspension of the laboratory or institute responsible, under the terms of Article 12? , paragraph II.

Within Brazilian judicial circles, the absence of rules prevalent in this area of new discovery in the field of genetics has been denounced, such as by Prof. Sérgio Ferraz, in the following terms “it is impossible to leave that wealth of knowledge, to be maintained at the will of its´ creators without any regulation”[4] However, some worthy legislative initiatives have been presented to congress, notably Bill n. 4900, with the presence of Congressmen Eduardo Jorge and Fábio Feldman, who comment on protection versus discrimination on account of genetic information and other measures. Still in force is Bill n. 1953/99 of congressman Silas Brasileiro who comments on the Convention on Biological Diversity, access to traditional genetic heritage and the sharing of its´ benefits.

In conclusion, I must say that an enormous ethical deficit of a compromising nature today threatens the human race on a level without precedence in history. The great scientific advances remain out of reach to the majority of the human race. The scientist, before being a privileged professional, must be a human being and as such must cultivate the highest moral values. In the words of Ghandi “anybody can listen to the voice of their own conscience; it is within us” As part of his community responsibility, the scientist should, better than anybody, to project the social risks and consequences of the fruits of his labour and is duty bound to subject his thoughts to national and international public opinion, in the sense that his work could be instrumental in the advance of supreme values of truth, justice and peace and in this way, contribute decisively to the general well being of the people.