Kati Myllymäki
M.D. specialist in family medicine
President of World Medical Association
www.wma.net
kati.myllymaki@stm.vn.fi

The World Medical Association (WMA) is an independent confederation of free medical associations representing physicians all over the world. WMA was founded in 1947 when physicians gathered together to discuss human rights violations conducted by physicians during the Second World War. WMA has nearly 80 member associations representing more than 8 million physicians around the world.
The aim of the WMA is to serve humanity and to achieve the highest international standards in medical education, medical science, medical art and medical ethics and health care for all people of the world. The best known WMA document is the Declaration of Helsinki on ethical principles for medical research involving human subjects.

We thank for the opportunity to comment on the Revised Outline of the International Declaration on Human Genetic Data. As we have not had our own decision-making meetings (Medical Ethics Committee), my comments are based on our earlier decisions: declarations, resolutions and statements.
Applicable WMA documents are Declaration of Helsinki (1964,2002), Statement on Genetic Counselling and Genetic Engineering (1987), Declaration on the Human Genome Project (1992), Declaration of Lisbon on the Rights of the Patient (1981,1995), Resolution on Cloning (1997) and the most recent ones: Declaration on Medical Ethics and Advanced Medical Technology (2002) and Declaration on Ethical Considerations Regarding Health Databases (2002). These documents are available on our website (www.wma.net).

The Declaration of Helsinki is about ethical principles for medical research involving human subjects
- not only about randomised clinical pharmaceutical trials. The last revision of Helsinki (2000) defined the scope of the Declaration as "medical research involving human subjects includes research on identifiable human material or identifiable data". It was acknowledged that medicine and medical research have changed rapidly and the important issues of informed consent, confidentiality and risks and burdens have a new importance to our patients as well as healthy volunteers in research. We congratulate IBC for addressing these problems in the new version of the document.

WMA decided upon a statement on Genetic counselling and genetic engineering in Madrid in 1987 which addressed the possibilities of modern technology to screen and evaluate prospective parents for genetic disease before conception and in utero. The basic difficulty about abortion is described. "Physicians engaged in genetic counselling are ethically obligated to provide prospective parents with the basis for an informed decision for childbearing. Where a genetic defect is found in the foetus, the prospective parents may, or may not, request an abortion. Physicians, for personal moral reasons may, or may not, oppose the provision of contraception, sterilization or abortion as part of the genetic counselling services. Whether they advocate or oppose providing such services, physicians should avoid the imposition of their personal moral values and the substitution of their own moral judgment for that of the prospective parents.

Physicians who consider contraception, sterilization and abortion to be in conflict with their moral values and conscience may choose not to provide genetic services. However, in appropriate circumstances, the physician is nevertheless obligated to alert prospective parents that a potential genetic problem does exist, and that the patient should seek medical genetic counselling from a qualified specialist.
About genetic engineering research this document refers to the Declaration of Helsinki especially about informed, voluntary and written consent. WMA states that appropriate guidance must be provided by the scientific community, medicine, industry, government and the public to regulate research in genetic engineering.

WMA Declaration on Human Genome Project was adopted in Marbella in 1992. This Declaration deals with evaluation of risk versus advantage. It emphasizes strongly respect for a person as a human being, respect for autonomy and respect for privacy. This document clearly states that information should not be passed on to a third party without consent. "Even if family members of the patient may be at risk, medical secrecy has to be kept unless there is a serious harm and this harm could be avoided by disclosing the information."

The Declaration of Lisbon on the Rights of the Patient (1981, amended 1995) is one of the key documents of WMA. It states that "the patient has right to be fully informed about his/her health status including the medical facts about his/her condition The patient has the right not to be informed on his/her explicit request, unless required for the protection of another person's life. All identifiable data must be protected. Human substances from which identifiable data can be derived must be likewise protected. The patient's dignity and right to privacy shall be respected at all times in medical care and teaching, as shall his/her culture and values."

In Paris in 1997 WMA adopted a resolution on cloning : "WMA calls on doctors engaged in research and other researchers to abstain voluntarily from participating in the cloning of human beings until the scientific, ethical and legal issues have been fully considered by doctors and scientists, and any necessary controls put in place."

Last year in Washington, Medical Ethics and Advanced Medical Technology was discussed. In the adopted Declaration, it is said that "efforts must be made to ensure the provision of comprehensive medical education as a way to deepen the understanding that at the heart of medicine is a love for all humanity".

In 2002 also, a Declaration on Ethical Considerations Regarding Health Databases was adopted. The background to this declaration was the so-called Icelandic Database which aroused great concern about confidentiality of patient records combined with genealogic data. As this document is the latest one by WMA and it addresses the very same problems as the IBC document, the full text is added:

Full text