By CRG Staff

Rosario Isasi, J.D., MPH, is an attorney specializing in human rights and genetic technologies and a Postdoctoral Fellow for the Centre de Recherche en Droit Public at the University of Montreal. She is a member of the advisory board of Global Lawyers and Physicians.

There is often a trans-Atlantic divide in how genetic technologies are regulated. Is this true of U.S. and European approaches to regulating stem cell research?

In a way, the U.S. position, with the disparities between states, is similar to the European situation - you have legislation at each end of the policy spectrum. So in the U.S. you have some very conservative and restrictive approaches that ban all embryo research and hold that an embryo should be treated like a human being; and then you have states that are more liberal, the California approach, which allows more research using stem cells from embryonic sources as well as adult sources, and also research of what they call therapeutic cloning. Then you have all of the policy in between, allowing research on stem cell lines from embryos providing that the embryos are those no longer needed for reproductive treatments.

That same spectrum appears at the European level in terms of how they classify their policy approaches. It goes from very restrictive in Italy, where the embryo is given a full personhood moral status, to the UK, Sweden, and others that allow cloning for a variety of research initiatives, including stem cell research - but with strict government oversight.

That is the main distinction, I would say: in the U.S. there is a vacuum, which the NIH is starting to fill now, on considering stem cell research at a national level through some federal approach or regulation. However, the scope of this federated approach is limited to NIH funding. The U.S. has more of a free market approach, whereas in Europe there is more strict government oversight - not only of obtaining embryos for research purposes but of the research methods, to ensure that it is not only scientifically sound but ethically sound. That is an important distinction.

Meanwhile, Canada adopts a moderate approach: stem cell research is allowed and is publicly funded, and research is only allowed on surplus embryos no longer needed for reproductive projects. What is interesting is that only Europe has an international and regional binding treaty on human reproductive cloning.

How has the U.N. addressed reproductive cloning?

George Annas and I wrote a series of articles calling for a legally binding document to ban human reproductive cloning, but the U.N. process ended in a declaration. Everybody in the world so far has agreed that human reproductive cloning should be prohibited, but on research cloning there are different positions. So the U.N. adopted a non-binding declaration. They used some of the language of the European treaty regarding preservation of human dignity, sanctity of human life, et cetera - but it doesn't have teeth, it doesn't have any force. And in a way it's repetitive, because UNESCO in 1998 already had condemned reproductive cloning. So it was expected that when the U.N. took it up there would be a legally binding instrument, a mandate to all countries - a ban. But it didn't happen. This is what UNESCO was subsequently trying to do, but they have also backtracked.

What was UNESCO doing before they backtracked?

In 2007, UNESCO asked the U.N. to do a sort of exercise to see how human reproductive cloning could be addressed internationally. They found that all of the countries involved accepted that human reproductive cloning is impermissible and a violation of human rights and human dignity. It has been only one year since UNESCO put this topic into their agenda, and they have had some arguments back and forth over whether it was the right time to address it. And there has been a lot of wrestling going on in terms of setting a definition from a legal standpoint: what is an embryo, what is stem cell research, what is cloning? And that prevented UNESCO from really taking a strong hand in this issue. So the last position by the UNESCO bioethics committee was to say, "We're not ready to move into the adoption of a legally binding instrument, but we will continue monitoring development in the area."

And they still think that it's premature for the international community to engage in this effort. It's a shame - I think that the time is right. There are researchers in enough different countries working on fast approaching scientific advances that will someday lead to the technology for reproductive cloning of human beings. There are not enough checks and balances, mechanisms for governance or oversight of this kind of research ... so we should take action now. There are reasons to be concerned. I don't want to be apocalyptic, but looking at the worst case scenario, I think it is the time now to take a brave approach - to say, "We're not against science; we're not against stem cell research, we're not against a number of interventions; but this particular one, which we all agree is unacceptable, should finally have some meaningful regulation to put on the brakes."

Do you think that a legally binding U.N. resolution is the best way to address that?

Well, what I think is that we need some authoritative international body, independent - as much as it can be - that will monitor and sanction violations, or at least that will have enough authority to compel countries to take action at an international level. I think the United Nations would be the best place to start this. So far we have nothing else suitable.

If human reproductive cloning was to ever happen - or some attempt at it - where do you think it could happen?

To be clear, I don't think that human reproductive cloning is right around the corner. But most likely, this would be in developing countries, in a context where there's not enough national oversight for this type of research. I think those countries would provide a safe haven for this kind of rogue scientist. And reproductive cloning is the best example of technologies that eventually will have eugenic purposes.

Some people find it very inflammatory and apocalyptic to talk about eugenics and cloning, but it seems to have some sense. I'm talking about, certain technologies, like germline genetic engineering, used for enhancement purposes - things you do at the embryo level which have nothing to do with improving human health or medical purposes, but are done for some sort of genetic enhancement. Transhumanists will say this is creating a 'better human.'

So how do you suppose, in a regulatory sense, you can distinguish between researchers' intentions?

That is something that is hard to regulate, but I think that the most important thing is to establish what type of research is allowed and to have a proper governance mechanism that regulates and monitors the research. If you have a comprehensive governance system that tracks, for example, the research, you can monitor and control what end results are permissible and which are not. And of course there will always be a slippery slope, and intentions are very hard to prove.

On an international level, where do you find this conversation is taking place?

I think that ever since the United Nations' efforts, there was kind of a vacuum of discussions. We were kind of distracted by the hype of a lot of scientific discoveries - and for many of them, much praise - but we forgot about seriously looking at the implications. But now the discussion is again taking place, in academic circles and at the policy level as well.

What kind of international movements exist regarding adult (induced pluripotent) stem cell research?

The ISSCR is, I would say, so far the most legitimate organization encouraging researchers to operate within a sound ethical framework. They have adopted some guidelines (in 2006) on the ethics of conducting embryonic stem cell research, and in 2008 on the so-called stem cell therapies. Now they are looking not only at embryonic stem cell research but at the big picture, of moving into other sources. So they are no longer distinguishing as much about where the stem cells come from, but rather about how you conduct the research, what constitutes sound scientific, ethical, responsible research. And they have adopted a lot of criteria and guidelines on this.

On the other hand, I think that induced pluripotent stem cells (iPS) are the new Pandora's box for us. I think the ethical and legal implications, the old rules, changed with the idea that you can take, in theory, a cell line from your body and one day maybe create gametes. So we saw that the Dolly technique was troublesome, and that's why having an international discussion on these issues and having a consensus on the technologies is important. People sometimes say "this is pathetic, forget about it, you're mixing apples and oranges" - but it makes sense. We're talking about technologies that could have significant implications on our very humanness, our human rights.

And not all of these technologies are the same. I work with stem cells - I'm a big supporter of stem cells from all sources. But I always call for careful analysis, for appropriate balancing of the pros and cons, and not forgetting the big picture.

Are there any issues receiving international attention that aren't coming up in the Americas?

In both the U.S. and Canada, what I see is that we are overwhelmed by the hype of what stem cell research can promise, and there's a lack of information about where the technologies are now. We are only hearing "success stories" about so-called stem cell treatment, when these are really trickery or fraud. And I see that the media is not taking a responsible approach, taking a more balanced and educated approach to these issues.

Every day we see a new story about someone with a horrible condition traveling to the Caribbean, China, India or Germany for stem cell treatments. But the way that the media is reporting it - they are not telling people that this is not a proven stem cell treatment. And there are great scientific and ethical implications. We aren't telling these places, "You have to inform the patient that this is unproven intervention, that this is an experiment."

And it would seem that when someone says they're going to the Caribbean for stem cell treatment, it would raise a red flag.

It does, but we sometimes get into the hype of the new technology and the progress. We celebrate iPS because now we won't have to use embryos - but we forget what is happening every day. Desperate people are making uninformed decisions and being exploited. We concentrate on personalized medicine, we talk about epigenetics here and there, and all these concerns are valid; but I think the way that our actions can be more meaningful and have a greater impact now is to care more about patients and informing them.

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