A decision by a chain of pharmacies to sell an over-the-counter DNA paternity test has provoked serious ethical concerns.This content was published on March 10, 2002 - 10:42
Sun Store, which operates mainly in French-speaking Switzerland, has decided to sell the PATERtest in its larger stores. Although such do-it-yourself tests are available on the Internet, it is believed to be the first time such a service has been offered over the counter. The test is expected to go on sale at the end of April.
Sun Store spokesman Francis Rossier says a whole range of safeguards will be put in place. The kit will only be sold by the head pharmacist, the client will have to sign a form with a disclaimer, and a list of psychologists and other specialists is made available when the results come back, he says.
The price has been set at around SFr1,400 to dissuade all but the most serious clients.
The test has been developed by the Swiss biotech start-up, EAtech, which is based in Sion and Geneva.
The PATERtest kit consists of three cotton swabs with which to collect samples from the inside of the mouth, and a box in which to put them. These are then returned to the pharmacy, given a number to ensure anonymity and sent off to be tested. A few days later the results come back.
This simple procedure, however, opens up a can of ethical worms.
"The biggest problem with this kind of test is that the origins of the samples cannot be guaranteed," says Dominique Sprumont of the Neuchatel-based Institute of Health Law.
Meanwhile, an "indignant" Swiss Pharmacists' Society accused Sun Store of failing to carry out the necessary basic checks before putting the product on the market. Sun Store is not a member of the society.
Like any company that sells anonymous genetic tests, EAtech and Sun Store are venturing into a legal minefield. They are quick to emphasise that the PATERtest cannot be used as proof in a court of law.
While the test itself is not illegal, it is forbidden to carry out tests on another person's genetic material without their authorisation.
"As soon as you work on a person's genetic samples without their knowledge, you infringe their privacy and the federal law on data protection comes into play," says Kosmas Tsiraktsopoulos, spokesman for the Federal Data Protection Commissioner.
In such a case, he told swissinfo, the mother of a child whose samples have been tested without her consent, would be within her rights to take legal action against the company concerned.
EAtech director Vincent Pellissier says this should not happen, since, although it is not scientifically necessary, his company will insist that three swabs are returned - one from the father, another from the mother and a third from the child: "The consent of the mother is an absolute necessity," he told swissinfo.
"This is not intended for those fathers who want to go behind the mother's back," he says. These men who do not want to alert their partner to their doubts will have to obtain their tests via the Internet or mail order, where fewer questions are asked.
If there are only two samples, or if it is found that the mother's does not correspond genetically to the child's, the results will not be returned, Pellissier explains. The only exception will be if the mother has died or if her whereabouts are unknown, and in these cases it is up to the pharmacist to decide whether or not they should accept the samples.
"We are taking all the necessary measures to guarantee that the test is carried out within the law," Rossier says. He points out that all those concerned must sign a consent form. In certain cases, as an additional security measure, the pharmacist will ask for the mother to give her consent in person.
"There will be the odd case that slips through the net. People will try to forge signatures. But if you pay SFr1,400 to know the truth, why would you cheat?" says Francis Rossier.
EAtech is producing other tests that it would ultimately like to put on the market. One will detect whether a woman is at an increased risk of developing breast cancer.
It raises the possibility of a wide range of over-the-counter genetic tests. In all these cases, the DNA samples would have to be destroyed once the test is completed, just as EAtech intends to do with the PATERtest.
"Genetic testing without consent can entail big changes for the life of the person concerned. Here we are talking about whom a child belongs to. But you can also find out about genetic predisposition to illnesses, and that's why in most countries genetic testing without consent is forbidden," Tsiraktsopoulos says.
by Roy Probert
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