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September 21, 1999
Bern, Switzerland

Swiss Lower House Eases Restriction on Animal-Human Transplants

The Swiss Parliament's lower house has overturned a ban on transplanting animal organs into humans, paving the way for a less-restrictive policy on the procedure, known as xenotransplantation, in Switzerland.

Almost 90 percent of Swiss citizens participating in a referendum last February supported a government-sponsored constitutional amendment that would put a temporary ban on transplants of animal organs into people as a medical practice, while continuing to allow medical research in the field. A government-sponsored Technology Assessment study issued last year also recommended a temporary ban.

But the upper house of Swiss parliament narrowly voted in March against recommending the ban. The reversal means that the transplantation of animal tissues, cells and whole organs for clinical trials and standard medical treatment could be permitted in some cases for at least the next few years, Swiss Television reported. The government plans to implement a permanent law governing transplants in 2002.

Novartis AG, the world's No. 2 drugmaker, is likely to benefit if the xenotransplant market grows. Its drugs Sandimunn and Neoral, which limit a patient's immune-system reaction to an organ transplant, generated sales of 1.8 billion Swiss francs ($1.2 billion) last year, making them the company's biggest selling drugs. Still, even with the reversal, restrictions still apply to xenotransplantation in Switzerland.

Xenotransplantation will now be allowed in Switzerland - for clinical experiments, under the condition that

i) the risk of infection of the population can be excluded very probably, and
ii) a therapeutic benefit can be expected.
- for therapeutic treatments, under the condition that
i) the risk of infection of the population can be excluded by "state of the art" science and technology, and
ii) a therapeutic benefit has been demonstrated by clinical experiments.

Any treatments using xenografts will require permission from the federal office of public health.

This regulation will be valid until the new law on transplantation medicine becomes effective (probably in the year 2002 or 2003).

France is the only country in Europe that currently allows xenotransplants for therapeutic purposes. The U.K. government last year set guidelines to license clinical tests.

The value of the market for transplants of animal organs into humans could reach $6 billion by 2010, according to Salomon Smith Barney estimates.

Sources:
Bloomberg News:
aol://4344:30.BLOOMBRG.5288278.602602747

Dr. Adrian Rüegsegger
Technology Assessment
Schweizerischer Wissenschaftsrat
Inselgasse 1
CH 3003 Bern
e-mail adrian.rueegsegger@swr.admin.ch