PURSUIT OF SHORVON BIOMEDICAL ETHICS CASE

PURSUIT OF SHORVON BIOMEDICAL ETHICS CASE:

(Rationale): 8.

Dr Fatimah Lateef asked the Minister for Health what is the rationale behind the Singapore Medical Council’s pursuit of the Shorvon biomedical ethics case to the British courts and whether this case will have any long-term effects on Singapore’s standing and reputation as a regional/international centre for biomedical research.

The Minister for Health (Mr Khaw Boon Wan): The Singapore Medical Council ("SMC") has a practice of notifying its foreign counterparts when foreign doctors practising in Singapore are convicted for professional misconduct. In return, SMC also receives notifications from regulators in the UK, Canada, Australia, New Zealand and the US, just to name a few.

The case involving Professor Simon Shorvon was referred by the SMC to the General Medical Council (“GMC") of UK under this reciprocal arrangement. As Members may recall, Professor Shorvon, then Head of the National Neuroscience Institute ("NNI") was in charge of a major research project involving a number of patients with Parkinson disease. The research project was found to involve serious ethical breaches. Three separate inquiries conducted by the Ministry, the NNI and the SMC established these facts: Professor Shorvon breached medical confidentiality by accessing patient records without their permission. He got Parkinson’s patients to omit or change their medication, without getting their consent or telling them about the risks. Their reaction was then filmed. The doctors treating these patients were unaware that all this was being done. In fact, some patients were misled into thinking that their doctors had given approval. It turned out that Professor Shorvon did not seek ethics approval to do any of this testing. All of this put the safety and well-being of patients at risk. What is worse, many were elderly and mentally frail.

Many of you may remember this when then Health Minister, Minister Lim Hng Kiang, first described to this House what had taken place during the NNI research project. That was in April 2003 in response to a Question in this House by Mdm Halimah. After a thorough inquiry, the SMC Disciplinary Committee found Professor Shorvon guilty of professional misconduct in February 2004.

In March 2004, the SMC brought this matter before the GMC, as Professor Shorvon was registered in the UK. It provided the GMC with its findings and all the evidence that it had obtained. In September 2004, the GMC decided that a public inquiry should be held in the UK. It took the view that what Professor Shorvon had done in Singapore would amount to serious professional misconduct if proved.

Then unexpectedly, in September 2005 - this is one year later - the GMC reversed its earlier decision, cancelled the public inquiry and closed the case against Professor Shorvon. Two reasons were given. First, the GMC felt that logistical difficulties would make it hard for them to prove the case. Second, it had obtained an expert report that said that what Professor Shorvon had done in Singapore was not wrong according to British standards.

The SMC was totally surprised by this sudden change of position. Both reasons given by the GMC were unconvincing. First, teleconferencing could easily solve any "logistical difficulty". Second, the SMC found the expert report substantially flawed. Besides containing serious factual mistakes, it did not explain why Professor Shorvon’s conduct, which clearly violated the GMC’s own guidelines, was not a breach of ethics.

The GMC's decision had undermined the integrity of SMC’s findings and cast doubt on the fairness of the SMC’s procedures. It also risked harming Singapore’s reputation as a centre where internationally-established standards of ethical practice are upheld. After consulting legal counsel, the SMC decided to challenge the GMC’s decision before the British courts.

Needless to say, the SMC was disappointed to learn that the British courts had ruled in favour of the GMC. I too am disappointed that the substance of the SMC’s grievance was not fully addressed by the British courts. There are established international rules governing the conduct of research on human subjects, based on the Helsinki Declaration. Under these rules, the welfare of the human subjects is paramount. The research procedure must also be approved by independent Ethics Committees of Hospitals where the research is to be conducted. In the NNI project, Professor Shorvon and his assistant deliberately subverted these rules. I am baffled why the British professional community should choose to condone such a practice.

Will the outcome of this case affect Singapore’s reputation as a biomedical research hub? Over the past two years, internationally-renowned researchers and scientists have come to Singapore to lead and conduct key research in their respective areas of expertise. Many of them are settling down here for at least a good stint.

Our ongoing success in attracting research talent speaks volumes. If anything, this case has clearly reaffirmed our unwavering commitment to upholding international standards of bio-ethical practice, even as we promote biomedical research. Singapore will sacrifice neither patients nor ethical principles in the name of research.

Dr Fatimah Lateef (Marine Parade): Sir, I have three supplementary questions. Firstly, I would like to ask the Minister with regard to the intellectual debate that is on-going now on the future directions of research. What would be the future on biomedical research as this would really have a bearing for the research fraternity as well as the influx of foreign talent and research into Singapore? Secondly, can he please elaborate on the fund allocation for research, say, in the next five to 10 years? Thirdly, I would like to know whether there would be plans for a ratio or a quota of foreign versus local researchers or research grants and projects.

Mr Khaw Boon Wan: Mr Speaker, Sir, all public hospitals claim to do three things - service to patients, teaching/training students, nurses, trainees, and clinical research. In practice, of course, all public hospitals definitely do the first two. In fact, we are extremely busy doing all these two. As for clinical research, it varies between hospitals. Some are a lot more active than the others. But on an overall basis, I will be the first one to admit that we do not do substantial clinical research as we would hope to do, and there are good reasons for that. There are two. First, we are really very busy just on treating patients and teaching, and there is very little time left to do clinical research. The second reason is related to the first. The amount of money set aside by the Ministry of Health and the public hospitals in clinical research is quite limited, very modest.

If I recall correctly, say, a few years ago, we only set aside something like $10 million per year for the whole Ministry of Health. So this is a very modest sum. And because of that, the ability to have enough doctors whose patient-load can be reduced so that they have time to spend on doing serious research, is very hard to achieve. At the beginning of last year, we decided to take a good hard look at this, particularly because of the recent years of emphasis on biomedical research. We sat down with the National Research Foundation as well as A STAR, and there were many man-months spent discussing this. We were pleasantly surprised to find a coincidence of objectives because A STAR and MTI have been pushing life sciences for several years. Quite correctly, their initial plan was to do basic sciences at the Biopolis, at the bench level. But having now attracted so many world-class researchers and doing very good bench work, they wanted to go to the natural next stage which, in our trade, we call it "translational and clinical research". So Biopolis and A*STAR look at the Ministry of Health and say, "Let's work together." Of course, the Ministry of Health is ever-ready for more research money so that we can do a lot more clinical research than we have traditionally done. So very quickly, there was a consensus of opinion that for the next stage of life sciences development, we should put serious money into translational and clinical research. Because without serious money, the rest is just words and that only frustrates the doctors because if you do not give them money and resources and you ask them to do research, it is just humanly impossible. The end result of it all was a series of very serious papers, after extensive discussions among the scientists, researchers and experts, both local and foreign, who are familiar with this subject. The series of papers culminated in several recommendations that went up to the Life Sciences Steering Committee, chaired by Dr Tony Tan, and of which I am a member.

Some time in the middle of last year, we then took a strategic decision that for the next stage of development of biomedical sciences, we should emphasise translational and clinical research. We went to Cabinet for endorsement and approval of this strategic direction and I also went to Cabinet to ask for an inclusion of a mandate in the Ministry of Health's charter that clinical research is also one of the mandates. Together with that, there is a commitment of sums of money, not huge sums like in the US because we cannot afford it, but based on what we can afford, something like $1.55 billion new money to be spent on clinical research over the next five years. And Dr Tony Tan quite wisely noted that for this to succeed, you need all the stakeholders to be committed to it because it is a long-term mission and therefore he insisted that this project should be co-funded by the key players. For Ministry of Health, we are the poorer cousin, so we contributed $350 million over the next five years, which is still a lot to me because we were spending only $10 million a year, now we will be spending $70 million a year, a seven-fold increase. The National Research Foundation would chip in $550 million and A*STAR, the biggest chunk, $650 million. $1.55 billion to be spent over the next five years. But of course, it is not something that you can create overnight because you need to build up capacities and capabilities and we need expertise from outside.

In the last few months, we had been engaged in this whole exercise on what to do and to set up the infrastructure. The first thing we did was to rehash the National Medical Research Council which was responsible for allocation of funds and we brought in Prof. Ed Holmes, a very distinguished clinician and scientist internationally, to chair this Committee. The last few months, they have been discussing. Obviously we need to focus because $1.55 billion is not unlimited. So they have also decided, after consultation with the medical and scientific community, on the five key areas, ie, heart, cancer, infectious diseases, ophthalmology and neurosciences. These are the five key areas as they affect most patients in Singapore and also where we have some expertise. But they were also quite clear that, having identified these five areas, when bids are submitted from researchers for grants, it has to be based on competitive bidding, peer review, internationally reviewed. In that way, we do not waste taxpayers' money. That is how I see clinical research going forward under the Ministry of Health, together with our partners, over the next five years and, if necessary, I can elaborate further during next month's COS.