SLIMMING PILLS (Regulation of importation and sale)

[Mr Speaker in the Chair]

Mr Tan Soo Khoon asked the Minister for Health what are the steps taken by the Health Sciences Authority to regulate the importation and sale of slimming pills and to ensure that such drugs are safe for consumption.

The Minister for Health (Mr Lim Hng Kiang): Mr Speaker, Sir, synthetic pharmaceuticals for treatment of obesity, for which safety, quality and efficacy can be scientifically assessed, are regulated as Prescription-Only Medicines in Singapore. Currently, we have approved five Western synthetic drugs for treatment of obesity in Singapore. Due to the presence of generics, these five approved drugs come in eight brands. These medicines are effective but can only be prescribed by doctors as they may sometimes have serious side-effects. Such medicines are used in the short-term treatment of obese individuals in conjunction with an overall weight-loss programme under medical supervision.

All synthetic medicines, commonly known as Western medicines, are stringently evaluated by HSA for their quality, safety and efficacy before marketing approval is granted. After marketing approval has been granted, these products are subjected to post-marketing surveillance that includes quality compliance testing and Adverse Drug Reaction monitoring.

Besides these synthetic pharmaceuticals, there are a number of other products, ranging from Chinese proprietary medicines (CPM) and health supplements to other complementary or traditional medicines, which are promoted as being useful for weight reduction. These claims cannot be evaluated by HSA since rigorous scientific data to validate efficacy and benefits are generally not available. Instead, such products are regulated on the basis of safety and quality of the product. This is a risk-based approach that is in line with the systems adopted by regulatory agencies in developed countries like the US, UK and Australia.

Compared to synthetic pharmaceuticals, traditional and complementary medicines are generally considered to be relatively less toxic, because they usually comprise herbs in low individual concentrations and, in the case of traditional medicines, because of long historical usage. However, the manufacturing processes may result in contamination of the products with toxic heavy metals and micro-organisms, or the products may be adulterated with Western medicines. In view of this, for CPM, the main group of complementary medicine remedies used in Singapore, HSA's system is more stringent than that of the US and UK which do not have pre-market assessment of CPM products.

In Singapore, control measures to ensure that CPM meet appropriate quality and safety standards comprise the following:

One, the licensing of CPM dealers - importers, wholesalers, manufacturers and re-packers - to ensure accountability for the safety and quality of their products.

Two, pre-market product assessment to ensure that products are from licensed manufacturers, sold freely in country of origin, do not contain Western medicines or naturally occurring toxic substances, and that heavy toxic metals, such as mercury, arsenic, lead and copper, and microbial counts are within permissible limits.

Three, submission of test reports and written declaration of the absence of any synthetic drugs or poisons as defined in the Poisons Act by the licensed importers for every consignment imported.

Four, approved product labelling in English to clearly specify the ingredients, indications for use, dosages, batch number, expiry date and the identity of the importers and manufacturers. Labels and packages must not stipulate any of the 19 diseases or conditions specified in the First Schedule of the Medicines Act, such as cancer, diabetes and hypertension.

Where there is any doubt on the documents submitted by the applicants, product samples are tested by HSA's laboratories to exclude suspected adulterants, and analyse toxic heavy metals and microbial contents.

There are currently no licensing requirements for the import, manufacture and sale of health supplements and other traditional remedies like Jamu and Ayurvedic preparations, but dealers are required to ensure that the products do not contain any prohibited substances and the toxic heavy metal content does not exceed legally permissible limits.

HSA also carries out regular post-marketing surveillance and runs a quality-testing programme on products sold in the market to ensure compliance with legal requirements. HSA also has an Adverse Drug Reaction (ADR) Monitoring System to detect any adverse reactions of products used in Singapore, and this is tied to international ADR networks to pick up early signals and intelligence on any problems with health products. Health care professionals are requested to report suspected adverse drug reactions encountered to HSA so that unsafe products can be removed from the market as and when they surface.

Mr Speaker, Sir, synthetic pharmaceuticals for weight loss can only be used under a doctor's supervision. Where consumers are considering self-medication with other products that claim to cause weight loss, they have to be cautious and discerning and exercise care in the selection and use of these products.

HSA will look into how the labelling of complementary and alternative medicines can help the public to make better informed choices as to whether to use a health product or not. HSA will also review and refine regulations and guidelines governing slimming products to ensure safety for users. HSA is developing a regulatory framework for health supplements, targeted for implementation in phases from 2003.

Mr Tan Soo Khoon (East Coast): Mr Speaker, Sir, in the case of the Slim 10 product, I understand that the routine laboratory tests discovered the presence of two controlled substances, nicotinamide and fenfluramine, after the product had been put on the market. My question to the Minister is why can the tests not be conducted before the product is put on sale and, in the case of Slim 10, why was it allowed to be sold for five months before any action was taken by HSA?

Mr Lim Hng Kiang: Mr Speaker, Sir, let me go through the process of how Slim 10 came in. Slim 10 was imported from China, and for the ingredients declared by the company, they claimed that the product contained five common Chinese herbs, with dosages within those recommended in the official Chinese pharmacy literature. So this product was, therefore, classified as Chinese proprietary medicine. HSA had these products tested and found that they were indeed based on the tea leaves and the Chinese herbs.

On that basis, they were allowed to come in. Each time a consignment comes in, the importer has to declare that the consignment does not include any of the items in the Poisons Act and that the product does not have any toxic metals or microbial contents exceeding the legal requirements. Based on those declarations, they were allowed to be sold. Then, as I have explained earlier, HSA runs the Adverse Drug Reaction Monitoring System and, based on that system, in early April, HSA received reports from doctors about patients with serious adverse drug reactions. So HSA went to test the product from the shelf and discovered that there were indeed these adulterants in these batches. So HSA took action to withdraw these samples. That is how the issue became public.

What I want to say is that for Chinese proprietary medicine, the procedure is, first, anybody who wants to import a Chinese proprietary medicine submits the application to HSA and tells HSA what the product contains. HSA will test the product and make sure that the product is as declared. On that basis, HSA will allow it in. On every consignment, the importer will then have a declaration to say that the consignment of the product coming in does not have any of the items in the Poisons Act, does not have any heavy metals or any microbial contents above the legal limits.

It is not possible for HSA itself to test the items because, as you can appreciate, the CPM is a very wide range and, therefore, we use the regulatory regime of making the importer declare that whatever they bring in is in accordance with what they indicate as ingredients, and that they do not have any of the poisons in the Poisons Act and any of the other toxic heavy metals.

Mr Tan Soo Khoon: Sir, why can the laboratory tests not be taken when the importer submits the declaration at the same time?

Mr Lim Hng Kiang: As I have explained, this is not a synthetic pharmaceutical. For the Chinese medicine, they claimed that these are the ingredients in it. HSA can test that indeed these ingredients are there, but it is not possible for HSA to test what else is not there. We will be testing for a lot of things. We can test for the poisons, we can test for a few toxic metals, but they could be putting in a lot of other things, eg, steroids, all kinds of adulterants in it. So it is not possible for HSA to put upon itself the responsibility of testing what is not declared by the importer, because you do not know what to look for.

Let me give another analogy. When I was in charge of the Ministry of National Development and we imported vegetables from Malaysia and we had this problem of pesticide residue. We could impose a very strict regime because the number of known pesticides used is limited and we can test for the 10 or 15 pesticides and make sure that the residue does not exceed the level that we set. Therefore, we can have a very tough system in testing every consignment for those 10 or 15 pesticides and make sure that it does not exceed the residue level.

But when we come to Chinese medicine, we do not have a similar list of things we can say that you cannot put these in the Chinese medicine. We can have a list of the poisons, but they will be put in steroids and all kinds of stuff, and they may put in things which are above the safe dosage. So it will be very difficult for us to do tests on every consignment and to test for what is not declared as ingredients in Chinese medicine. That is why in 1999, when we were looking at how to regulate Chinese medicine, we decided that it is not possible for the HSA to license every product and every consignment. Therefore, we put the responsibility on the importer, the wholesaler, to make sure that whatever they bring in they must declare that the product they bring in does not have the items in the Poisons Act, do not have heavy metals, and the ingredients of the product are clearly labelled.

Dr Teo Ho Pin (Holland-Bukit Panjang): Sir, may I ask the Minister whether the Ministry has any plans to control other slimming treatments, such as the use of equipment for slimming, the use of slimming oil and body wraps, and also whether the Ministry will help CASE to investigate into all those complaints on slimming treatment?

Mr Lim Hng Kiang: The whole issue of medical devices is currently not regulated, and we intend to regulate medical devices when we put up legislation towards the end of this year or next year. So, medical devices and devices which claim to have health benefits, these we intend to put under regulation.

As for the rest, slimming oil, body wrap, these cannot be regulated. If you want to wrap plastic or elastic around your waist and claim that you will be slim, there is no way we can tell you not to do so.

In helping CASE to look after the products, I am sure we can work together. But as I have said, health products cover a wide range and when it relates to pharmaceutical products, the so-called Western medicine, because these are synthetic, and chemicals, they pose higher risks. The HSA's stand is to regulate this stringently.

At the other end of the spectrum, when it is Chinese medicine, because these are herbs and plants, and these are traditional medicine which have been in use for hundreds of years and proven to be reasonably safe, we have to take a different approach. Unfortunately, the problem now is that many people bring in Chinese medicine but actually they adulterate it with Western medicine, and they come in under the guise of pure Chinese medicine. This is the middle area that we have to review and make sure that even though we cannot regulate the efficacy, we must regulate for safety, and that is the intention that we set out.

Mr Tan Soo Khoon: Sir, I was a bit surprised by the Minister's answer. I thought it was the job of HSA to safeguard public confidence in the quality safety and efficacy of healthcare products. Is he not aware that last year, there were 561 cases of people suffering from side effects from approved medicine which were reported to HSA? Does that not say something about the way HSA goes about doing its work?

Mr Lim Hng Kiang: Mr Speaker, Sir, even for Western medicine, the synthetic pharmaceuticals which are manufactured by the big pharmaceutical companies with very stringent quality control, which have certificates for good manufacturing practice and a series of clinical tests and approved by the home regulatory body, whether it is FDA in the US, etc, even for such drugs, you cannot test for the full range of adverse drug reactions. Sometimes, even after such a stringent process, you do come across unexpected adverse drug reactions. Even for synthetic pharmaceuticals, you get products being withdrawn because some of these after-effects were not encountered during the clinical trials.

What I am saying is that even at this end of the spectrum, where we have such a strict regime, together with the western countries, we also have unexpected drug reactions, and through this Adverse Drug Reaction Monitoring System, we have to pull products out. When you look at Chinese medicine at the other end of the spectrum, generally, we do not face this problem because these are low concentrations which have been used for a long time, through historical and traditional use, the adverse reaction is minimal. When we come to the middle area, this is where the problem arises.

As I explained just now, we cannot adopt wholesale the Western medicine approach of regulating it, in line with what other countries do. In the US, for example, when they come to traditional medicine or complementary medicine, the approach is that you take it at your own risk. FDA does not regulate. If you take traditional medicine or Chinese medicine, it is entirely at your own risk. In Singapore, we realise we cannot adopt that hands-off approach because traditional medicine or Chinese medicine has a wide following in Singapore. Since 1994 and then in 1999, we have put in place a system which tries to address the unique characteristics of Chinese proprietary medicine and, at the same time, put in some safeguards. One of the safeguards, as explained earlier, is when somebody wants to bring in a product, HSA tests the product and makes sure that it is qualified under Chinese medicine, and not Western medicine disguising as Chinese medicine. Having allowed the importer to bring it in, we make sure that for each consignment, the importer declares that whatever he brings in has the minimum safety standards of not having poisons or heavy metals in it. What happens in some of these cases is that the quality control in the manufacturing of these products in China is not tight and sometimes, it gets adulterated. The laboratories that test these products are not stringent enough, so it gets through the net. We are reviewing the system. One of the things that we may consider is to only accredit qualified laboratories to make sure that the testing is done by certified laboratories, and not just laboratories from different parts of China. This is one of the measures that we are considering.

Our objective is to ensure safety but if it is prescription-only medicine, we have a higher level of safety because there are more checks, the doctor is in charge of prescribing it, we ensure that the pharmaceutical companies which manufacture them have good manufacturing certificates, so there are more stringent checks. When it comes to traditional medicine, I am afraid that the regulatory regime is quite different, as practised everywhere else. There are a lot of grey areas, whether it is medical devices, health supplements or food products, they are now coming in with different claims. It is very difficult for us to say that a food product cannot be adulterated. If somebody puts adulterants into food products and thinks he can get away with it, unless you go round checking every item and every consignment, there is no way we can prevent that from happening.

Mr Leong Horn Kee (Bishan-Toa Payoh): Sir, it seems that the present procedure does not seem to have worked because Slim 10 has got in and has caused harm to the people. May I ask three questions? Firstly, could I ask the Minister to review the procedure whereby in the first instance, although an importer may declare certain substances, he will not be so stupid as to declare disallowed items, so he probably declares all the allowed items. Could the Ministry consider asking the HSA to conduct limited testing of other disallowed products because if the product, for example, is for slimming, they can test the limited range of products that are used for such effects, but maybe not allowed for health reasons? At least, that will help to give better protection to the people.

Secondly, after the products are allowed to come in, when the products are being sent in by batches, to do batch testing of the products. At least, they are being tested and monitored regularly by batch testing through the HSA getting samples from each batch being imported.

The third question is: if deterrence is the way the Ministry wants to go about doing it, then what is the level of deterrence we are having now? For example, what kind of penalty do we impose on these defaulter importers, and whether this can be reviewed as a procedure?

Mr Lim Hng Kiang: Mr Speaker, Sir, I agree with the sentiments of some of the Members here that even though our procedures are stricter than in UK or US and about the same as Australia, because of the widespread use of Chinese proprietary medicine in Singapore, we ought to re-look at the procedures and see how we can tighten this up. We are, in fact, doing this review.

On the other hand, I do not want to give the House the wrong impression that whatever we come up, it is going to ensure 100% safety. I think we can improve, but it is the nature of such products. I have many meetings with Health Ministers from the region. When I meet the Health Minister from Taiwan or Hong Kong and we discuss the problems we face, this is quite a widespread problem in Taiwan and Hong Kong, where they bring in Chinese proprietary medicine. So, we are all grappling with this.

Specifically, with regard to Mr Leong Horn Kee's suggestion, we will take this up. We do conduct random testing. HSA does not have the resources to test every batch and everything that comes in. But HSA will do random testing, and we indeed do that as part of our post-marketing surveillance mechanism. Mr Leong also suggests that we do batch testing. We will review that but it means we are going to slow down and, in fact, it will affect the trade and it will raise costs.

For the bulk of the Chinese medicine that comes in, the herbs and grasses are fairly innocuous. They have been used for hundreds of years and they are reasonably safe. But if an importer wants to adulterate such stuff, then it is very hard for us to prevent them from doing so. We must have a regime that does not penalise the bona fide importer. We cannot treat every importer as a possible crook. But I agree with Mr Leong that we must have in place a regime that deters and which can ferret out those who are unscrupulous. As far as deterrence is concerned, our present Act allows for a two-year jail sentence for those who bring in items which are adulterated.

Mr Tan Soo Khoon: Sir, I have three questions. First, if HSA does not have the resources to test everything that is imported, can this work be done by private laboratories? Second, in the case of Slim 10, I understand that the decision by HSA to ban Slim 10 was made on 15th April. Why was the public informed of the ban through press release only on 30th April? Why was there a wait of two weeks? My last question: is there a way for HSA to inform the public as soon as it is possible of dangerous drugs, instead of having to wait, as in this case, for two weeks?

Mr Lim Hng Kiang: Mr Speaker, Sir, in fact, this is the current regime. We try to use the private laboratories. This importer came with the declaration from a private laboratory. We accepted the report of the private laboratory. Now, we are saying that maybe not all private laboratories can be trusted, and therefore, we ought to have a shorter list of accredited laboratories. This is one of the things that we are thinking of doing.

As to the time difference, according to the report given to me, when HSA first received the report of adverse drug reaction, they went out to the market and picked up samples from different batches to test. They found nicotinamide, which is a B3 vitamin. This is not banned, but the dosage that was found in this Slim 10 was beyond safe levels. It is not a banned item, but it is above the safe dosage. HSA told the importer to withdraw the item and the product was withdrawn from retail. HSA also sent out an advisory to all the doctors to say that they have received these adverse drug reactions and asked for other confirmation from the doctors. It is after HSA sent out this advisory that other doctors also sent in reports and HSA then suspected that what is adulterated is beyond B3. From the kind of reports that they get from the doctors, they came to the conclusion that excessive dosage of Vitamin B3 could not have caused some of these reactions. These reactions were not just hyper-thyroidism but also, in some cases, hepatitis. So they investigated further, and this is where they found traces of fenfluramine, and this is where they put up the press release and took action. HSA took action according to the investigations, because when you bring in these products and send them to the laboratories for testing, the test results do not come in immediately. They take about a few days to a week for the test results to come in. So I have examined the report and the procedures. I do not think HSA was laggard in their reaction. I think what they put out was commensurate with the test results, and when they found this banned item, then I think they make it very clear, not only to withdraw the product, but also to warn the public.

Mr Leong Horn Kee: I want to pick up the point from the Minister about the penalty. It seems that the two-year jail penalty is a bit light for a case when the medicine brought in can be very poisonous. Could the Minister reveal whether this needs to be reviewed because if the importer brought in substances that can cause not only permanent damage to a person, but even death to several people, I think the penalty should be even more deterrent than just a 2-year jail sentence.

Mr Lim Hng Kiang: HSA is still in the process of investigating and the 2-year jail deterrent is under the Act, for the violation of the Poisons Act. If the consequences are more serious, HSA will consult AG's Chambers to see under what other Act we can pursue the importer, which will carry a heavier penalty.

Dr Lily Neo: May I ask the Minister whether there is any watchdog body that scrutinises the efficacy claims by drug distributors on over-the-counter drugs and Chinese medicine?

Mr Lim Hng Kiang: The answer is "No". To be able to evaluate the efficacy claims, if you want to do so scientifically, then you must have the whole process of evidence-based medicine, you must have proper trials. Unfortunately, for some of these products, whether it is supplements, or natural products, or herbs, they do not have this kind of records. So there is no way we can evaluate such items for efficacy claims. That is why we state very clearly that for such products, our primary objective is safety. And, where the rules for safety are not tight enough, I can assure the House that we will tighten them. But there is no way we can evaluate, or justify to the public, the evaluation of efficacy claims.