The science of east versus west

China is poised to become the world's next superpower, leading the way in science and technology. So why is the west so worried?

The US may have dominated the world's economy for the past 60 years, but now another country is emerging to claim the role of chief driver of global wealth. A recent study of 33 countries shows that China will soon pass the US in its ability to develop basic science and technology, turning these into economically important goods and services.

The High Tech Indicators study, prepared every third year by the Georgia Institute of Technology in Atlanta, shows China rushing ahead of the competition over the past 12 years towards a position of technological leadership. The data points towards a revolution in China's capacity to do science and commercialise its discoveries.

While economies wax and wane over the decades, some in the West fear burgeoning Chinese capabilities in research and development, and not just in a competitive sense.

Concerns are being expressed about differences in how science is conducted in the East. There are claims of ethical slackness: greater freedoms to pursue research, particularly life sciences research, without the restrictions imposed by ethics committees, legal frameworks and even basic human rights.

Those raising concerns point to major gaps in the regulatory controls and oversight restrictions in the East compared to those in the West.

However, there is a strong whiff of colonialism associated with some of the claims, as if China and the Asian Tiger economies have no right to make scientific discoveries faster than the West.

There is also the claim that China enjoys a strong competitive advantage in life science research, given a less restrictive approach to the use of embryonic stem cells, transplanted tissues and human trials. There is a sense that the ethics controls applied in the West are much tougher than those applied in the East.

While the claims are certainly circulating among the Western scientific community, there is usually a paucity of direct evidence for such arguments, due to the cultural differences and difficulty of direct comparisons. Yet the issue is being discussed openly, and the concerns are being debated in forums that involve both Western and Eastern scientists.

Two years ago, a world forum on bioethics was held in Beijing, where the issues were thrashed out by scientists and policy-makers, says the scientific director of the Irish Council for Bioethics, Dr Siobhan O'Sullivan.

"We discussed stem cells, organ transplants and how they were going to deal with avian influenza," she says. "What was clear was, it is potentially more complex than we imagined. In some areas, they are stricter than some European countries; in others, they are not."

A more formal initiative is also under way in the form of Bionet, a co-operative venture involving China and the EU and aimed at co-ordinating ethical governance of research in the life sciences and biomedicine.

Established in October 2006 with funding under the EU's Framework Programme 6, Bionet now has an expert group involving 21 partners who are putting together recommendations on how ethical governance of research can be achieved. The body is co-ordinated by the London School of Economics.

"We developed the idea that we should systematically initiate a project like this. It is for sustainable and good governance of Chinese-European research activity," explains Dr Ole Doering, who was one of the originators of the project. He is an academic and a philosopher who has spent 12 years studying bioethics as applied in China.

The goal of Bionet is not to attempt to change everything or to impose European systems on China, he stresses.

"Our basic aim is how to improve the governance situation in Europe and China for research collaborations. China wants to be an equal player in international research," he adds. "The only way they can achieve this is by having good governance."

He says the problems are not all just in China. "We also have problems inside Europe, with differences in the checks and balances."

"Are Chinese ethics compatible with European ethics? This is not the right question. There is no real conflict about the basic norms between the Europeans and Chinese, but there are problems that are bound to come up," he says.

Undoubtedly, untested and unsafe technologies are being applied in China. For example, it is illegal to use genetic technologies to pre-select the sex of a foetus, yet practitioners are offering this service because of the demand spurred by population-control laws restricting couples to only one child per family.

He also cites a surgeon working in Beijing who was offering unproven stem cell treatments to "cure" spinal injuries. He was exposed as a fraudster and prosecuted.

"These things are happening in China, as they are in other countries. It is not because of evil intentions, but people taking advantage of weak regulatory controls," Dr Doering says.

Merging two quite different research norms is a challenge, however. Dr Doering says the Chinese system lacks transparency and there is too little institutional review to maintain standards.

"These are middle-level questions. These are the questions we would like to emphasise. We are also identifying the real ethical issues."

For example, there are major differences in how the medical professions operate in the two regions. "In China, they are entrepreneurs. They have to run their surgeries like businesses. They have never had to play a role, as in Europe, as a fundamental pillar of society."

China will face difficulties if it attempts to alter this well-established system, so it throws up problems for the Bionet expert committee, including who it needs to talk to about the issue.

"Who is the real partner here, who do we need to monitor? Is it the doctors or the oversight body?" he asks.

The weakness of oversight is a problem for China, as opposed to the West, where there is considerable oversight to control research. "China's oversight bodies are not properly educated or trained. They just don't see any problem, but accept it because of medical opinion or advice."

This creates difficulties, say, for the monitoring of research carried out on human subjects. "We cannot be sure whether informed consent is being taken very seriously," he says.

The doctors and researchers may offer an experimental treatment that might work, but without giving proper warnings about the risks, he says. And people may volunteer for trials - if only to benefit from getting free, good-quality food and a clean bed during the period of the trial. "They will just go for it. This is systematic coercion you can't place on people," Dr Doering says.

This demonstrates a powerful cultural difference between East and West, suggests Dr O'Sullivan. The Chinese stressed two important considerations at the Beijing meeting two years ago, she says. "They are a country of about one billion-and-a-half people. We don't have to deal with population in these terms. The second is the cultural context."

The West highlights the rights of the individual, but the Chinese approach to human research is informed by its dominant philosophy, Confucianism.

"It has to be seen in this context. The way that they regulate their research is not along the lines of consent and the primacy of the individual. If it is in the common good, it is worth doing."

The size of the country and its population make regulation difficult, she adds, pointing to the foetus sex-selection issue.

"It is not allowed, but the service is being provided. It is such a vast country it is difficult to know if the regulations are being enforced or not. The regulations are there. It's like any country - are they being enforced?"

One of Ireland's top stem cell researchers is well aware of the claims being made about Chinese life-science research. Dr Frank Barry, scientific director of NUI Galway's Regenerative Medicine Institute (Remedi), sees the research papers and understands the rapid advances being made in China in this field.

"Clearly China has forged ahead in the publication of stem cell research over the past few years," he says. "It gives the impression that there is a vast army of scientists to work on these questions."

He raises the possibility that it is a numbers game only, and questions whether significant advances are actually being made, but his belief is that it is easier to do research in China than in the EU. "There would be a widely-held view that the threshold in China is lower, and there is a great deal more freedom to do things in an unregulated fashion," Dr Barry adds.

"It is not as tightly regulated and not as controlled as under the EU or FDA [US Food and Drug Administration] systems would be. Look at the procurement of embryonic cells for research. The perception is it is easier to do this in China than in other countries," he adds. "A number of maverick centres are offering dubious stem cell treatments for those who can pay."

For this reason, he is strongly in favour of the Bionet initiative.

"There is an absolute need for harmonisation of approaches between researchers," Dr Barry believes. Without it, some of the work coming out of China may be sidelined: for example, data from a stem cell human trial could be rendered useless if it couldn't be matched with procedures for similar trials in the West.

Another Irish expert believes that failure to operate to higher research standards will work against the Chinese in the long term. There is a balance, suggests Prof Martin Clynes, director of Dublin City University's National Institute for Cellular Biotechnology. "They may be able to move faster, but they may have safety issues, so I don't think this makes a substantial difference," he says.

"You might make some breakthroughs, but the downside will probably outweigh the advantages."

Without good governance of the research, discoveries may never really have any impact.

"In the long term, countries like China will want to come into the more ethical framework too," Prof Clynes suggests.

"What we want out of a research framework is safety and ethical controls. What we want are cures in an ethical framework that protect human rights and guarantee safety."

Any competitive advantage China may hold becomes somewhat irrelevant given that the market also serves as a way to control research activity, suggests the Government's chief scientific adviser, Prof Patrick Cunningham.

"The US and Europe would be the two markets anybody would be headed for with research discoveries. There are gateway bodies controlling access to these markets. There is a kind of filter there," he says.

The EU has a large body of regulations and bodies overseeing access for any drug or medical treatment to its marketplace. The FDA provides a similar service in the US.

"They [the Chinese] have to work to the regulatory regime established by the great markets of the world. Any new entrant must get through this before they have any access to these markets," Prof Cunningham says. "It is not just efficacy and safety: it is also ethical controls.

"We essentially have to rely on our own gatekeepers in the FDA and the EU. In years to come, the Chinese will undoubtedly have the same regulations."

Ireland is not in a position to point the finger at the regulatory framework, say, for embryonic stem cell research, given our own lack of controls, says Dr Deirdre Madden, senior lecturer in law at University College Cork.

Different European countries have responded differently to the question, she says.

"Some would be permissive, and others less so. Some, like the UK, allow embryo research, while Italy and Austria ban it. There is variability in the use of IVF [in vitro fertilisation], leftover embryos, and limits to when they can be used," she says.

"I guess we would fall in the permissive category, given that we have no legislation to prevent embryo research," she adds.

Dr Madden pointed to a recent court decision that afforded no protection to the embryo, ascribing it to the fact that there are no laws and that the people haven't voted on it. "I am not sure the Irish people have made up their minds."

A similar view is held by Asim Sheikh, barrister and lecturer in forensic and legal medicine in University College Dublin's School of Medicine and Medical Science. Legislation was recommended in the May 2005 report by the Commission on Assisted Human Reproduction, he says.

"Specifically, in terms of doing research on stem cells, things haven't changed. We don't have anything like the UK's regulatory controls," he says. "Other guidelines are following, but nothing has been done in a legislative sense.

"It relates to the legal problems on the status of the embryo. We haven't taken the bold step to regulate the issue at all, and I don't foresee us getting legislation any time soon."

Bionet's remit only lasts through September 2009 and before then it will have produced a list of recommendations on how to regulate governance of research, says the chair of the body's expert panel, Prof Christoph Rehmann-Sutter, professor of bioethics at the University of Basel, and president of the Swiss National Advisory Commission on Biomedical Ethics.

Prof Rehmann-Sutter stresses that Bionet has no powers to enforce or demand - it is a co-operative venture only. Ultimately, he would like to see the establishment of a permanent body to oversee joint research ventures, a body that also has the capacity to police standards.

Yet he already views Bionet as a success, given the level of exchange already taking place.

"All the contacts taking place didn't exist before," he says. "I think what will continue after Bionet is the network of contacts which will last until we can build an institution."