On 19 November 1996 something happened in Strasbourg, France, which could fundamentally remove many of the rights of patients. It had no public airing beforehand and has been little reported on since.
After marathon discussions, the Committee of Ministers of 39 European Union member states adopted the Convention On Human Rights And Biomedicine. Although the ostensible purpose of the convention was protection of human rights, what is little understood is that it paves the way for sweeping relaxation of informed consent to medical treatment.
It allows future drug and other medical trials to be carried out on potentially huge numbers of people, possibly without their consent. Those particularly at risk would be the mentally ill, who are deemed not to be able to give their consent; those with diseases for which there is no known effective treatment; people who are in a coma; those needing emergency treatment; and, perhaps most worrying, children.
The convention also provides for research on embryos in vitro and for organ removal from living donors for transplants.
Although the convention applies only to EU member countries, the US Food and Drug Administration (FDA) simultaneously changed its rules on drug trials. These new rules also mean that some groups of people may be involved in medical research programs without their consent. The FDA's new rules are strikingly similar to those of the Strasbourg Convention.
These momentous developments to date have received almost no publicity in the UK. Even the FDA rule changes were introduced very quietly.
In the 49-page Strasbourg document, general rules are set out applying to intervention in the health field. Although this is normally done with the individual's free and informed consent, "protection" is also extended to those unable to give such consent, either because they are too young, too ill, or mentally incapacitated. In these cases, treatment may be given so long as it is authorized by his or her representative or an authority or person provided for by law. With mental disorders, treatment may be given in an emergency, or if without the treatment the individual's health would be seriously harmed.
Patients will be given the chance to consent to taking part in scientific research subject to several conditions. This means that a patient doesn't necessarily need to be told they are part of an experiment:
if no alternative treatment of comparable effectiveness exists;
if the risk isn't disproportionate to the potential benefits of the research;
where research has the to produce results which are of direct benefit to the person's health (such as contributing to medicine's understanding of the condition, and possibly bringing benefit to them or other sufferers, and otherwise if the risk is minimal (presumably as defined by medicine).
The final document was signed by 20 countries on 4 April, 1997, and is only binding in those countries. However, it has to be formally ratified by each country before passing into law in that state. In Britain, this hasn't happened yet because of the general election.
Despite safeguards stipulated in the Strasbourg Convention, this and changed FDA rules appear to annul fundamental human rights laid down in the Code of Medical Ethics, which was drawn up after World War II. This stated that no one should ever be forced to participate in a trial again. Voluntary consent became the cornerstone of medical researchers' principles. The new convention and new FDA rules imply that such consent will not always be needed.
BESIDES THE FAR-REACHING IMPLICATIONS FOR LAWYERS, RESEARCHERS AND ETHICISTS THE MOST WORRYING ASPECT OF THE DOCUMENT IS THAT IT SEEMS TO GIVE MEDICINE AN OPEN-ENDED TICKET TO DO WHAT IT LIKES. UNDER THE GUISE OF INDIVIDUAL "PROTECTION", THE CONVENTION SAYS THAT IN CERTAIN SITUATIONS "GENERAL INTERESTS" WILL TAKE PRIORITY OVER THOSE OF THE INDIVIDUAL.
There is even the provision for organ removal from a living person without consent for transplant purposes in "exceptional circumstances" (such as where there is no compatible donor), or for saving the recipient's life.
At present, many cases of vaccine damage remain unsettled, as do countless other drug-pesticide and chemical-injury cases. Under the convention's rules, there will be virtually no chance to prove negligence or misdemeanors in cases involving the mentally ill, those suffering from certain diseases, coma patients or accident victims.
As a German paper (Stuttgarter Nachrichten-Medizin Aktuell, 27 November, 1996) commented: the Strasbourg convention creates a Europe with two things: "Less Morality, but more Commerce."
Doris Jones is an independent medical researcher.
"WHAT DOCTORS DON'T TELL YOU" - December 1997
(British Monthly Newsletter - Dist: Agora Publishing 800-433-1528)