Research on humans needs comprehensive law

A federal law on research on humans is still a dream Keystone

Plans for a law regulating research on humans are currently being discussed in Switzerland but it is a vast and complex issue, a symposium in Bern has heard.

More than 200 people, mainly health experts, heard that a situation similar to one in London, where six men were hospitalised when a drug trial went wrong, could also happen in Switzerland.

Earlier this year the Swiss government published a draft law on such research, which is now the subject of nationwide consultation.

“We want to have clear rules for people taking part in medical experimentation in Switzerland and make it clear for researchers about what is allowed and what is not, where they need an approval and where not,” Thomas Zeltner, director of the Federal Health Office, told swissinfo.

He warned that despite strict laws in the pharmaceutical area, a London scenario could also happen here.

“Unfortunately I have to say yes. In that case something happened which can always happen – that is a pharmaceutical product that didn’t seem to be dangerous in animals… has side-effects [on humans] that nobody expected.

“That’s the reason why you have to start these experiments in a first step with very few people,” he said.

Scientific advance

There is little doubt that research on humans is necessary for the advance of science. But a number of issues have been raised, ranging from an ethical, medical and legal nature to those of a social and economic dimension.

These include protection of the individual, how decisions are made for permission of research studies, research promotion, protection from abuse and the accessibility of research results.

A citizens’ panel brought together by TA-SWISS, the Centre for Technology Assessment, said in January that protection of the individual was in general secured in Switzerland.

However, it found that certain aspects could be improved, in particular those affecting vulnerable people including children, disabled people, mentally disturbed people, those not competent to give consent and the unborn.

Risk of abuse

It is this aspect that is turning a new law into a balancing act: if you do not have adequate legislation there is a risk of abuse, if there is over-regulation, research may go elsewhere.

Zeltner explained that while current Swiss legislation is considered strict regarding the pharma industry, other areas were unclear, for example with experiments in surgery, psychology and data exchange.

“There’s a whole set of questions that are not regulated in Switzerland and give a fuzzy situation,” he said.

He is also aware of the risk of over-regulation. “The law should be such that it attracts research to Switzerland and not make researchers go to other countries.”

Consent

Zeltner made it clear that abuse can never be totally prevented. He said research on humans always had to have the consent of the individuals concerned.

“If that approval is not there, the researcher will be prosecuted by law and have to pay a fine. We try to prevent that by clear laws and law enforcement,” he said.

As Switzerland’s cantons provide 26 different health systems and opinions, a new law on research on humans will not come into force in the near future.

“I hope we will have it in this decade but obviously it takes a long time in Switzerland,” Zeltner said. “We hope that in 2009, 2010 or 2011 it will come into effect.”

swissinfo, Robert Brookes

Key facts

In March 2006 six men in London suffered convulsions and organ failure after being given trial doses of TGN1412, a drug being tested for treatment of leukaemia and autoimmune and inflammatory diseases.
It was the first time the drug had been tested on humans, but the trial was preceded by animal testing, including on other primates.
Each of the volunteers had been paid £2,000 (SFr4,500).

In brief

Research on humans is only partially covered by legislation at the federal level.

The main areas include clinical testing of drugs, transplantations, professional secrecy in medicine and public health, the handling of data, gene technology and stem cell research.

In other areas, Switzerland’s 26 cantons are responsible for legislation on research on humans.

The Federal Health Office notes that regulations differ from canton to canton.