HEALTH PRODUCTS BILL

HEALTH PRODUCTS BILL: Order for Second Reading read.

3.30 pm

The Minister for Health (Mr Khaw Boon Wan): Mr Speaker, Sir, I beg to move, "That the Bill be now read a Second time."

Our current legislative framework regulates western medicines and, to some extent, traditional Chinese medicines, but it does not cover the other health products, such as medical devices, leaving them largely unregulated. Meanwhile, as medical science continues to advance, new varieties of health products are being added to the market, both in diversity and complexity. These new products are no longer limited to external applications but include devices to be implanted in the human body, often for long term or even for life. Examples include cardiac pacemakers and coronary stents. Rapid developments in biotechnology have also produced a new category of health products called biologicals, such as cultured chondrocytes for repairing joint cartilage injuries.

There is a need to regulate some of these new products to protect public safety. First, we need to prohibit such products from containing harmful substances, at the very least. Second, we need to evaluate the more complicated health products for their quality and effectiveness. Third, we need an effective post-marketing surveillance programme to detect any problems early. But we need to regulate them in a practical manner given the wide diversity and different risk profile.

Review of legislation

One way is to extend the existing legislation on medicines to cover the other health products as and when we decide that they should be regulated. But we do not find this option satisfactory as the existing medicines laws were crafted with orthodox pharmaceutical-type medicines in mind, and their provisions are not entirely suitable for the regulation of other types of health products. For example, we think that we should regulate medical devices or biotechnology products differently from the way we regulate medicines.

Another way is to introduce separate legislation for the different health products, say, one for medicines, one for medical devices, another one for biologicals, etc. However, this is also unsatisfactory as some health products are combination products, eg, a drug-coated stent is both a medicine and a medical device.

At the same time, my Ministry and the Health Sciences Authority (HSA) would like to consolidate and streamline the existing medicines control laws. This is because having separate, and sometimes overlapping, pieces of legislation makes it cumbersome for the industry to understand and comply with the controls. There are currently four different pieces of legislation on medicines.

Given these considerations, we think the most practical approach is to draw up a single law to cover the regulation of different types of health products but structure it in a way which can allow different categories of products to be regulated to different degree based on their risk profile. The idea to have a single encompassing law for a range of health products is not new. This approach has already been adopted in other countries, including Australia and the US.

Based on this approach, we have drafted the Health Products Bill which is now before this House.

The Minister for Health (Mr Khaw Boon Wan): 3.35 pm

Regulatory approach

In drafting the Bill, we adopted two principles. First, we will preserve the control elements in our existing medicines laws, which have served us well. They are fundamentally sound and will still be applicable in the future. We have therefore included the provisions for such controls in the Bill.

Second, we will build flexibility into the Bill. This will allow us to apply different levels of control for different types of products, taking into account their different risk profiles. Given the wide spectrum of health products, we cannot use a "one-size-fits-all" regulatory solution. We have instead structured the Bill such that the controls could be tailored according to the special regulatory requirements of each particular group of health product.

Main features of Bill

Let me now go through the main features of this Bill. First, in Part I, clause 2(1) defines "health product" and "health-related purpose". We have defined it widely so as to describe the potential scope of this Bill. However, we are not committing to regulate all these health products. Clause 4 makes it clear that, after the Bill is passed, the Health Products Act will only apply to those categories of health products that are specified in the First Schedule.

In other words, not all health products will come under the immediate control of the Health Products Act when it is enacted. In fact, we will start with only medical devices in the First Schedule. Over time, we will, as required, add other categories of health products that need to be regulated under this law into the First Schedule. In the meantime, existing laws will apply to the other categories of health products.

Part II of the Bill describes the various parties involved in administering and enforcing the controls under this piece of legislation. The main party is the Health Sciences Authority which is the regulator of health products in Singapore and they will be responsible for its administration and enforcement.

Parts III and IV of the Bill contain clauses that impose controls on the three key activities of manufacture, import and supply. The controls are similar to the existing controls in the medicines laws. But we have updated the penalties where appropriate. Here, I would like to highlight the prohibitions against dealing in adulterated or counterfeit products, in clauses 12(5), 13(5) and 16(1). Anyone doing so would be committing an offence and, if convicted, would be liable to a fine of up to $100,000 or imprisonment for up to three years or both, for each offence. Items like counterfeit medicines, which might not contain the essential life-saving drugs they are supposed to contain, or traditional medicines that have been adulterated with potent drugs, are especially dangerous. They threaten public health, and we have singled them out to make clear that we take such offences seriously.

Part V of the Bill covers controls on the advertising and promotion of health products. Again, these controls are similar to those in the medicines laws. This aspect of regulation is important because accurate and truthful information about a product is essential in helping consumers, as well as healthcare professionals, make sensible and well-informed decisions in choosing which health products to use. We have also included, in clause 23, the power for Health Sciences Authority to direct an advertiser to publish a "corrective advertisement" if he is found to have published a misleading or offending advertisement.

Parts VI and VII of the Bill contain provisions that describe the general steps in the licensing and registration processes. They are also similar to the provisions in the medicines laws. Under clause 34, there will be a "Register of Health Products" for all categories of products that have to be registered. This Register, which will be made available to the public, can then be used by consumers to check whether a particular product has been registered, as well as find out certain basic information about the product, for example, the declared ingredients or the product manufacturer.

Part VIII of the Bill specifies the key duties and obligations of parties who deal in health products: manufacturers, importers, suppliers and registrants. Here, I would like to highlight the important role expected of the industry. Companies and dealers should not only introduce safe, effective and good quality products into the market, but they also have the continuing responsibility to ensure that the products they have introduced into the market remain safe, effective and of good quality. For these reasons, there are provisions, such as clause 40, which require dealers to maintain records of the products they deal with, and clause 42, which makes it mandatory for dealers to inform HSA of any information they receive about adverse effects or defects concerning their products.

Part IX of the Bill allows HSA to impose controls, by way of subsidiary legislation, on specified raw materials, or "active ingredients", used in the manufacture of health products.

Parts X, XI, XII and XIII of the Bill contain clauses relating to various administrative aspects, such as enforcement and legal procedures. For example, clause 49 describes the rights of enforcement officers when performing their duties. These are fairly standard and in line with those accorded to officers of other regulatory agencies that also enforce public health and safety laws. Another example is clause 66, relating to the protection of "confidential information", which bars anyone who has obtained commercially-sensitive information in the course of administering or enforcing this legislation from disclosing that information except for an official purpose, or else with the consent of the 'owner' of the information.

Clause 72 of the Bill allows HSA, with the approval of the Minister for Health, to make subsidiary legislation for the purposes of the Health Products Act. These are needed to flesh out the technical matters and details relating to various aspects of the regulatory framework. The Second Schedule gives an indication of some of those aspects. The intent is for the different categories of products to each have their respective sets of subsidiary legislation catering to their specific regulatory requirements, appropriate to the risks and benefits of each category.

We have also included, under Part XIV of the Bill, clauses that will allow the Ministry of National Development and the Agri-Food and Veterinary Authority (AVA) to use the controls in this Bill and to make subsidiary legislation to regulate the health products used for veterinary purposes. These have been put in because some products, like human medicines, are sometimes also used by veterinarians on animals, and AVA may need to regulate them.

Phased implementation

Let me now touch on implementation. As I said just now, after the Bill is passed, the first category of health products that we plan to bring under the control of the Act will be medical devices. We have therefore included the definition of "medical devices" in the First Schedule.

Regulating medical devices

Currently, there are no laws to specially regulate medical devices. We have mostly left it to the industry to self-regulate on a voluntary basis, and also depended on healthcare professionals to act as 'gatekeepers' in deciding which medical devices are suitable to use. The current approach is inadequate. First, we now have more new and advanced medical devices coming into the market. Second, many medical devices are increasingly being designed for use by lay persons, instead of just healthcare professionals, and it is important for the presentation and advertisement of these medical devices to be properly controlled.

Other countries, such as the US, Australia, Japan and the European Union (EU), have had laws for medical devices for some time now. For example, in Australia, medical devices are regulated under their Therapeutic Goods Act, which requires that medical devices be registered with the authorities and must meet certain technical standards.

Medical devices cover a wide range of products, from syringes to artificial hearts. Not all medical devices need to be regulated to the same degree of stringency. Internationally, there is a task force called Global Harmonisation Task Force (GHTF) for the regulation of medical devices. We work closely on a bilateral basis with the Task Force members

and also through an Asian Harmonisation Working Party. The GHTF has endorsed a set of principles based on the concept of risk management and recommends that the level of regulation should be proportional to the degree of risk involved. Our proposed regulatory framework for medical devices is based on these GHTF principles, which we find sensible, with just some modifications to suit our local needs. There is no need for us to reinvent the wheel.

In particular, we have applied the concept of risk management in designing the proposed regulatory framework for medical devices. For example, for product registration, higher-risk devices, such as those to be implanted in the body or with an active power source attached, will be required to show more evidence and scrutinised more closely, while lower-risk devices like syringes can be registered through a simple notification process.

The Health Sciences Authority (HSA) is currently conducting a public consultation on the proposed regulation of medical devices, using a draft Health Products (Medical Devices) Regulations. I hope all stakeholders – industry, healthcare professionals and consumers – will contribute their inputs and let us have their views. This will help us refine the regulatory framework before we formalise it for implementation.

Other categories of health products

Meanwhile, pharmaceutical medicines will continue to be regulated under the current medicines laws and not yet brought under the Bill. This is to enable HSA to conduct a thorough review of the existing medicines laws to see if we need to refine or update any provisions. This may take a couple of years. When pharmaceutical medicines are eventually brought under the Bill, we will repeal the Medicines Act, Poisons Act and Sale of Drugs Act.

Chinese Proprietary Medicines (CPM) are currently regulated under the Medicines Act, though using a slightly modified regulatory regime from Western medicines. Similarly, we will see if CPM should be regulated under the new Bill as a separate category of health products or together with other types of traditional and complementary medicines.

Beyond these health products, we will study other categories of health products, such as biologicals and health supplements. We do not intend to rush this but will actively monitor and learn from the experience in other countries.

Cost of compliance and consultation

We are mindful there is a cost to regulation and we should not impose unnecessary cost on businesses. Furthermore, even the most stringent controls will not be able to eliminate all accidents or stop irresponsible behaviour. So, it is important that we find a suitable balance of how much regulation and controls there should be.

To achieve this, we consider it important to consult with the stakeholders, both industry and consumers, to understand their concerns and desires, and we will continue to do so before adding new categories of products into the First Schedule under the future Health Products Act. Furthermore, whenever we need to consider adding a major new category of health product into the First Schedule, we will bring the proposed amendment before this House, to explain why and how we intend to regulate that category of product.

Our current legislation has not caught up with advances in new health products and, in particular, medical devices. The Health Products Bill will provide greater clarity for the health products industry with a single law as the reference point. More importantly, the Bill will permit customisation of legal requirements and controls for the different categories of health products through the more flexible rule-making process written into the Bill.

I ask all Members of this House to support this Bill.

Sir, I beg to move.

Question proposed.

3.49 pm

Mdm Halimah Yacob (Jurong): Mdm Deputy Speaker, I rise in support of this Bill.

This Bill is timely and necessary, considering the vast advancements that have been made in medical technology today and the proliferation of so many health products in the market. Consumers, not being trained medically nor very well informed, are often very much reliant on the advice of those who sell health products or use such products during medical procedures. They can become confused and are vulnerable to all kinds of representations and commercial practices that sometimes put profits above public health and safety.

The dangers that an unregulated market presents are indeed real. In 2005, six heart patients in Singapore were affected by the American Food and Drug Administration’s worldwide recall of 50,000 Guidant-made defibrillators because of an electrical fault that caused it to short-circuit. At least one patient here had the pacemaker replaced. And in December last year, a major health products manufacturer, Boston Scientific, had to recall its guide catheters distributed in the United States. The company had discovered a batch that had excess resin, which could dislodge and obstruct a blood vessel, leading to serious complications, such as stroke, heart attack or kidney problems. In the US, the use of medical devices are regulated by the US Federal Food, Drug and Cosmetic Act, which allows the US authorities to order a recall of such defective medical devices if the manufacturers themselves fail to do so. If the two cases were to occur in Singapore and we do not have equivalent legislation, then the Health Sciences Authority may not have the powers to order a recall or to take other action against the manufacturers or distributors of defective or harmful health products. Hence, this Bill is important to vest such powers in the Government to order that the manufacturing, retailing, importing or exporting of such products cease or to order a recall of such defective products.

There are also other compelling reasons why this Bill is important. The Health Products Bill will bring our legislation in line with the legislation already found in many developed countries, such as Canada, Australia and the US. As we aim to position ourselves as the regional if not the global medical hub through Singapore Medicine, and as we try to expand and gain recognition for our life sciences activities, this legislation is important as it will send a strong signal that Singapore will take effective measures to ensure that health products manufactured, sold or used here are of the highest standards. This will give a tremendous boost to our efforts in promoting Singapore Medicine and the Life Sciences hub, and will go a long way in instilling confidence in the integrity of our health care system.

Mdm Deputy Speaker, the approach taken under this Bill is to provide for a comprehensive framework that will cover many products but at the same time ensure sufficient flexibility for the authorities to decide when to extend coverage to specific products and to what extent, depending on the risk profile. I agree with this approach, as it is better to focus on the most important product that has the potential to cause the greatest harm if unregulated, rather than to try and cover all health products at the same time, thus putting a tremendous strain on finite resources but not achieving much. The first product to be regulated will be medical devices. Today there are hundreds of thousands of Singaporeans with some sort of medical devices implanted in them. With rapid improvements in medical science, the number will rise even further. Even a minor flaw in these devices can have disastrous consequences, and it is therefore absolutely essential that this is the first health product that should be regulated.

Mdm Deputy Speaker, small businesses have aired their concerns on the need to guard against over regulation which will add to their costs as they do not have the same resources as bigger players. I think that this is a valid concern, which should be addressed. One way of doing so is to ensure that the licensing and registration requirements are kept simple and the fees are not excessive. In this way, the compliance costs will not be prohibitive for the small businesses. Much as we want to regulate the market to ensure public safety, we also do not want to kill initiative and keep out the small players from entering the market, as this will lead to the market being dominated by a few big players who could dictate the price and other terms which are also not in the long-term interest of the public. There is another reason why the Government should keep the licensing and registration regime simple and inexpensive. This is to ensure that we do not inadvertently push some of these businesses underground, which is worse for the public as dangerous health products can still flood the market. I would like to suggest that the HSA work closely with the medical technology industry to help them understand the requirements of the Act before it comes into effect. The HSA could also consider extending some financial assistance to the small businesses to help them set up the system to comply with the registration and licensing requirements. This is a win-win strategy, as the real objective of the Bill must be to ensure that businesses uphold high standards and with penalties kicking in only if there are violations. Hence, it is better to try and assist businesses to comply in the first place, rather than to rely on penalties alone to keep them in line.

Mdm Deputy Speaker, since 2002, we have had a voluntary registration system in place for medical devices. I would like to ask the Minister to enlighten this House on the number of companies that had registered with the HSA voluntarily. I would also like to ask the Minister if he could provide this House with information on how many companies had been prosecuted for violations of the various legislation, such as the Medicines Act, the Poisons Act and the Sale of Drugs Act, and whether violations are increasing.

Mdm Deputy Speaker, unlike the US Federal Food, Drug and Cosmetic Act, our Act does not cover food products. Increasingly, this can become an area of concern. One example is milk or food products for infants, which can make all kinds of claims that it is good for health. Or for that matter, dietary supplements used for convalescing patients or generally as a replacement in some cases for normal meals. I know the difficulty of trying to cover so many areas but, other than this reason, I would like to ask the Minister what is the rationale for excluding food products that are promoted as health-related products from the ambit of this Bill.

Mdm Deputy Speaker, the Bill provides the Government with great flexibility to cover the other health products when the Ministry deems it appropriate by listing those products in the First Schedule. However, I think that one area, which the Ministry could consider with greater urgency, would be medicines as these contain potent substances that can cause great harm, if not effectively regulated. I know that there exist laws covering medicines, such as the Medicines Act, but the Health Products Bill provides a more comprehensive framework. So, I would like to know when the Ministry of Health intends to bring medicines under the ambit of this Act.

Finally, Mdm Deputy Speaker, clause 61 of the Bill penalises agents and employees of health products companies that commit any violations. Clause 61 is very broad as it covers “an … employee of another person, or being otherwise subject to the supervision or instruction of another person for the purposes of any employment in the course of which the offence was committed, that person shall … be liable.” I am concerned about this clause because the ambit seems to be very wide. It seems to cover even a production operator working in a health products manufacturing company or a clerk doing documentation work, who knows nothing about what he is doing as he is merely a cog in the machine. If indeed this interpretation were correct, then it would impose very onerous obligations on employees, which is way beyond their capacity. I would appreciate it if the Minister could clarify on the scope of this clause.

In conclusion, Mdm Deputy Speaker, this Bill is a forward-looking and progressive piece of legislation that is needed to raise the safety standards of health products manufactured, imported, exported or supplied in Singapore. However, having the law alone to regulate the market is not sufficient. What is equally important is the commitment on the part of those who manufacture, import or sell health products to act responsibly by maintaining the highest safety standards and by placing the public interest above profit making. I hope that businesses dealing with health products will uphold high ethical standards that go beyond the requirements of this Act as the potential for inflicting harm arising from dangerous, defective or tampered health products are really great.

On that note, Mdm Deputy Speaker, I support this Bill.

4.00 pm

Dr Lam Pin Min (Ang Mo Kio): Mdm Deputy Speaker, I rise to speak in support of the Health Products Bill that was first read on 22nd January this year. I applaud the system of regulatory control implemented by the Ministry and the Health Sciences Authority (HSA) to ensure that health products, particularly, the medical devices, available in Singapore are of high quality, safety and efficacy.

Many health products are currently unregulated and are left to the consumers' discretion in deciding what is safe and what is best for his or her own health and well-being. Many seemingly "harmless" health products and food supplements can have serious adverse effects on the individual's health if taken inappropriately. It is well-known that certain vitamin supplements when taken in excessive amounts can be toxic to the human body. Garlic, another naturally occurring food product, for example, has blood thinning properties that can result in bleeding problems during surgery.

The Health Products Bill serves to protect public safety and is essential to weed out "snake oil merchants" making outrageous health claims about their products. The proposed new Health Products Bill, in its first initial stage, applies to medical devices only, as depicted in the First Schedule. There are currently no regulations to ensure that such medical devices are reliable, safe and perform to their claims. Regulation is therefore necessary because an increasing number of medical devices are being implanted into the human body and left there for a long time. It is also imperative to note that minor flaws in these intricate devices can have disastrous consequences, resulting in severe morbidity or even mortality. The new Bill also covers products which do not fit the sole description of either medicine or device, such as the drug-eluting stent.

With the present climate of increasing globalisation, where goods and services are expected to move freely with minimal barriers between markets, it is important that we maintain the appropriate levels of regulation, control measures, and vigilance in order to prevent the entrance of unsafe medical devices and other health products into our Singapore market.

In addition, the Health Products Bill also proposes to bring the four existing legislation on medicines, namely, the Medicines Act, the Poisons Act, the Sale of Drugs Act and the Medicines (Advertisement & Sale) Act under one framework, as the general feedback of having the current regulatory controls fragmented and spread out in the different Acts makes them rather confusing and difficult to understand.

The new Health Products Bill provides a detailed list of pre-market administration control measures that entails a series of control measures of manufacturing, importing, supplying and advertising health products in Singapore. It also illustrates the registration, licensing, enforcements and offences related to the dealings of health products. While the Bill already covers a relatively broad area of control measures, I believe it can be fine-tuned further to greater enhance the regulatory system of the health products in Singapore.

Apart from the pre-market administration of the health products and the devices in Singapore, we need also to recognise the importance of the post-market surveillance. Post-market surveillance is a critical form of control measure to ensure that manufacturers, importers, suppliers and other health professionals continue to adhere to the regulations of the Act even after registering or attaining the licence to the health products.

An example of an agency that places relatively high regard to post-market surveillance on medical devices is Australia's Therapeutic Goods and Administration (TGA). To place some flavours on the post-market activities implemented by TGA, its three major components include:

(i) the manufacturer's post-market surveillance system;

(ii) post-market monitoring of market compliance by TGA; and

(iii) vigilance programmes.

In future reviews of the Act, the Authority may consider advocating greater emphasis on such post-market surveillance of the health products.

With the implementation of the new Health Products Bill, it could be a good time to also relook into some of the current auxiliary plans that help to maintain the high quality, safety and efficacy of the medical products and devices in Singapore.

A good example of such a plan is the Memorandum of Intention of Cooperation (MOI) signed between our HSA and its Australian counterpart, TGA, in May 2002. The MOI was signed to jointly collaborate and cooperate in the regulatory framework for pharmaceuticals, medical devices and complementary health products of the two bodies. The scope of the MOI covers the exchange of information relating to the authenticity, quality, safety and efficacy of complementary medicines, medical devices, human and tissue products, the development of professional competencies and other scientific collaborations.

As we can see, these areas are critical and significant components of the Health Products Bill and such MOIs with our regional or distant neighbours would certainly help to reinforce the effectiveness of the new Health Products Bill.

To increase the efficiency and competencies in medical science technologies of our nation, I suggest that we could look into the possibility of establishing similar MOIs with countries like Japan and the United States where medical science technologies are advancing rapidly. Besides collaboration with agencies from the technologically advancing nations, we may also like to consider working with countries that are facing increasing cases of counterfeit or adulterated health products. Cooperation and exchange of information with regulatory agencies from countries, where most of such products originate, could help to increase the quality, safety and efficacy of their health products, which would in turn reduce the possible entrance of counterfeit products into Singapore.

Mdm Deputy Speaker, I would like to caution that the new Health Products Bill be introduced gradually and judiciously. A 'one-size-fits-all' regulatory regime will not be in the best interest of consumers and it should allow for modular application of the different controls to different types of health products. This will help to minimise over-regulation as well as under-regulation of certain types of health products.

For example, there are currently many different types of medical devices in the market, ranging from the simplest to the most complex; the non-invasive to the invasive. It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available. A graduated system of control is more appropriate. In such a system, the level of control is commensurate with the level of potential hazard inherent in the type of medical device concerned. A medical device classification system is therefore needed in order to channel medical devices into the appropriate degree of regulation and control.

It is also important to note that should the regulation on health products, such as health supplements, be made too stringent in the future, it may require a very high level of scientific substantiation, including human clinical trials to license their use. The imposition of such an inappropriate pharmaceutical model for low-risk natural health products would inevitably raise the cost of natural health products and reduce consumer choice.

Interestingly, while many countries are pushing for some form of regulation of natural health products, the Canadians are moving in the opposite direction. They have debated on the Bill C-420 - one which attempts to move natural health products from under a repressive 'drug style' directorate to a 'food style' directorate for natural health products with a long history of safe use in Canada.

Even FDA allows certain health claims for food high in nutrients proven to support health, eg, FDA allows food high in potassium to claim that 'diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke'. Such permission is given based on sufficient medical evidence and strong authoritative recommendation.

I would, therefore, like to propose to the Ministry that the principle based on the concept of risk management endorsed by the Global Harmonisation Task Force for the regulation of medical devices be applied to other health products as well.

A medical device classification system is needed in order to channel medical devices into the appropriate degree of regulation and control. Health products can also be classified into the following in decreasing order of regulation and control:

(a) pharmaceutical drugs, requiring the most stringent regulation for obvious reasons;

(b) biologicals, such as stem cells and vaccines;

(c) nutriceuticals or functional foods and other active ingredients known to result in possible but uncommon adverse effects when consumed inappropriately; and

(d) dietary supplements, with good track records and have no reported adverse effects reported in the literature.

In conclusion, I wish to reiterate that the Health Products Bill is a proper framework that embodies the critical regulations, control measures and proceedings required to ensure safe and effective entrance and availability of health products in Singapore.

With fine-tuning over time and as the Act expands to include other health products in future gazettes, I am confident that we will be able to strike a good balance between the expeditions of wide availability and access of health products, including new medical device technologies and the assurance of high quality, safety and efficacy of such health products in Singapore.

On that note, I support the Bill.

Mr Sam Tan Chin Siong (Tanjong Pagar): Thank you, Mdm Deputy Speaker, for allowing me to join in the debate today. I would like to speak in Mandarin first and followed by English.

( In Mandarin ): [For vernacular speech, please refer to Appendix A.] I support the Health Products Bill submitted by the Minister for Health. When we open the newspapers, magazines or other publications, one can hardly miss advertisements or reports on healthcare products and medical devices. In this regard, one can find more of such medicines, tonics and healthcare products in pharmacy stores of shopping centres. Such products include drugs, ointments, medicines for external application, as well as drugs to be taken orally. There is a great variety in the selection, from head to toe, from being applied on the body to implants into the internal organs. As such, consumers are confused. There are certainly plenty of choices and the consumers may not know how to select the right type which would meet the safety standards and whether, after taking or using it, it would cause any harm to the body.

As these products are not subject to control, we do not have a comprehensive system to ensure that these medical and health products can meet the safety standards to safeguard the interest of the consumers. Due to plenty of choices, consumers rely on word of mouth and recommendations from their relatives and friends and even advertisements in order to make decisions about purchasing such products. Among these products, they include health equipment or devices that must be implanted into the internal organs through operational procedures. These devices, for example, the heart stent, valves and pacemaker, have a high degree of risk. Even if they are effective, they will be very risky for the consumers.

In view of the increasing affluence of Singaporeans, increasing purchasing power and ageing population, more and more people are in need of these medical devices. Therefore, the control over these medical devices and medicines has become more and more critical. However, the current Bill only covers the regulation of medical devices.

As pointed out by the Minister earlier, other medicines and supplements are not subject to control. So it is not really that ideal because there are different varieties of health supplements. And there are numerous consumers consuming this kind of health supplements. If we do not control these supplements, we cannot protect the interest of the consumers.

To evaluate and to study all kinds of health supplements available in the market is rather difficult. And to classify them appropriately is also a very difficult process. In this regard, I hope that the Ministry of Health will set a timeline and target and gradually, for those health supplements which are widely consumed, to be subject to control.

I hope that the Ministry of Health will also formulate some advertising guidelines for health supplements so that the promoters, advertising companies and mass media, in promoting these supplements and medicines, can be more careful. Indirectly, it can also reduce the chances of false and misleading advertising. The Ministry of Health can also step up public education to ensure that the consumers select and take these medicines and supplements wisely.

Last but not least, with this three-pronged approach and policy, I do believe that it will bring us closer to our goal of becoming a leading medical hub in the world.

( In English ): As part of my research for this speech, I wandered into several health stores in a few shopping centres. There, I found supplements to wake you up, put you to sleep; to slim you down or fatten you up; to make you younger, to help you age slower. There was even one medicine called Mega-man, whose function, I guess, is self-explanatory.

Mdm Deputy Speaker, as Singapore moves towards making itself a medical hub, there will be more health products and medicines brought in for the consumers, for both the foreign and local patients. I therefore support the Government's move in stepping up regulatory framework and powers to ensure that only credible products are made available for public consumption.

However, I understand that the preoccupation of the current Bill is with the regulation of medical devices. It does not cover health supplements. The Minister has said that he will study other categories of health products, such as biologicals and health supplements in future. He also said that "we do not intend to rush this", and do more work before including additional products under the Health Products Act.

Mdm Deputy Speaker, the current laws do not cover products that hold themselves out to be mere supplements which do not make medical claims. Importers can bring in many health products, both Western medicines and Chinese proprietary medicines. As the public has high confidence in the Government, they will tend to believe that all the health products available in medical outlets or through the multi-tiered sales networks are safe to consume, as the Government surely must have tested and approved them. This is a misplaced confidence.

We remember well the severe cost in the Slim 10 case, where at least one woman lost her life and another had to have an organ transplant. There could be other cases too. I appreciate the need to be circumspect and resist over-legislation. Hence, I urge the Government to consider other measures, such as stricter advertising guidelines for health supplements, in ensuring that no superlative, unfounded claims are made. The Government can also step up public education on the dos and don'ts of taking health supplements, through the already very active Health Promotion Board.

I must stress that I urge this not because I want fewer supplements in the market - indeed, going by my trips to the health stores, I would welcome more choices for all. I am also not suggesting to over-regulate the control of health supplements, as this will result in lengthy testing of health products as well as pushing up their costs which will eventually be passed on to the consumers. Madam, what I am looking for is for the Ministry of Health to keep one eyeball on the regulation of health devices now and the other eyeball on health supplements in the near future.

Mdm Deputy Speaker, with that, I support the Bill.

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• Cols. 1335-1338.

4.17 pm

Dr Fatimah Lateef: Mdm Deputy Speaker, I rise in support of the Health Products Bill. I will speak in English first, followed by Malay.

This Bill will create an omnibus to regulate all health products eventually. The common legislative provision is indeed a welcome move to make it easier for understanding and practice. Starting off with only the medical devices listed in the First Schedule, this legislative Act will eventually become the vehicle regulating all types of health products for human use and consumption. The review of the Medicines Act is going to be carried out for future incorporation into this Bill. I would like to put forth the following two recommendations: firstly, the provision of bio-equivalent data to be provided by generic manufacturers. This is also already a requirement by the US Food and Drug Administration (FDA) and it is time for Singapore to follow suit. Secondly, with respect to identification of medicines, it would be safe as well as useful to have the drug name, composition, batch number or expiry date printed on every segment of the blister package of medication. Currently, this information is shared by several segments at a time, and when patients, especially the elderly, cut these segments into individual pieces, which they very often do, the crucial information is missing and lost.

Pertaining to the regulation of health supplements, I agree with the Health Minister that we should not be rushing into this. A detailed assessment by the Health Services Authority will be required. Currently, health supplements are not regulated, even in the United States. And if we do decide to regulate, it would indeed be a very bold and complex step indeed. However, one area which I would like to see regulation would be over the claims and advertisements of health supplements.

One other consideration would be whether the Ministry of Health, HSA and the Ministry of National Development, in particular the Agri-Food Veterinary Authority, have any plans to regulate food with therapeutic claims, for example, ginseng drinks with claims of lowering blood pressure, under this Health Products Bill.

Medical technology has indeed expanded by leaps and bounds in the last decade and major open surgery is now being overtaken by less invasive laparoscopic procedures with highly sophisticated equipment. With all these developments, we have to remain vigilant. Let me illustrate with an example. Several years ago, a well-known medical device company was redesigning its 60-degree heart valve to open to 70 degrees. This was with the aim of reducing the chance of clog formation and therefore the risk of strokes. The FDA reviewers did not approve the application because it lacked the engineering metal stress analysis and also clinical data. The valve was however approved for marketing and use in Europe. After use in several thousand patients, it was found to break six times as often as the old valve. Another example - a company designed a new stent that was smaller and more flexible than existing ones so that it could be used in convoluted as well as narrow heart arteries. The device was approved for marketing in Europe. When the FDA reviewed the device, engineers discovered a design feature which caused metal fatigue and breakage, and the company had to redesign the stent before the clinical trials could start.

The point I am trying to make here is that post-market surveillance of already marketed devices is a very vital complement to the pre-market review. This is because no system of pre-market review, no matter how thorough, can prevent all potential safety problems once a device is in widespread use. A post-marketing reporting system is essential to monitor adverse events, interactions, falsifications, malfunction, operational and technical defects. In some countries, consultants or safety officers for medical devices are appointed and, thus, I fully support the stipulations in clauses 23 to 28 and the essential principles of safety and performance of medical devices under the Second Schedule.

The penalty provisions in this Bill have also been updated and this is certainly necessary. For example, the maximum court fine for the offence of providing false information in the process of applying for a licence under the Medicines Act is only $5,000. The maximum fine for a corresponding offence in the proposed Health Products Act has been adjusted to $20,000. This will serve to act as a deterrent and will certainly stress the seriousness with which such penalties are being viewed. The prohibitions against dealing with adulterated or counterfeit products in clauses 12(5), 13(5) and 16(1) will help to act as a checking mechanism and to reduce chances of another Slim 10 incident.

Finally, the modular application of different controls to the different types of health products, which is a new feature, will assist with the customisation of the regulatory regime with the appropriate levels of control.

Let me now just say a few words in Malay.

( In Malay ): [For vernacular speech, please refer to Appendix A.] Many developments have been taking place in the medical world which is becoming more advanced. Every year, various medicines and new devices are being introduced. Therefore, it is very important to have this Health Products Bill which incorporates various types of medicine and medical devices so that the safety of consumers is ensured. For example, among the Malay community, the usage of jamu or herbal medicine and traditional medicine is still going on actively. Every year, this industry develops by 25% to 30%. This makes the regulation process very complex. Therefore, from what aspect can control be put in place? Certainly, from the advertising point of view. As consumers, we have to be conscious especially with information which is not so correct or wrongly featured in advertisements as well as promotions. Not everything that they say or promise is true. That is why I strongly support the Bill, especially clause 23, where HSA, which handles issues on health products, may order the person who has advertised unsuitably to withdraw all the information which is not true, wrong and inaccurate. This is known as corrective advertisement. It is also hoped that it will make the industry more responsible.

I am also very relieved to note that under this Bill, there will be a register of health products. This can be referred to by anyone to ensure that the medicine or device can be used and also be informed of the ingredients. Cooperation between Singapore and members of the Asian Harmonisation Working Party can be further enhanced through participation in courses in this industry and also the regulation sector. Singapore’s specialists who attend these courses can gain benefits and study the available systems in countries like America and Europe. Singapore will also study and share the experiences of these countries.

With that, I support this Bill.

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• Cols. 1339-1340.

Mr Khaw Boon Wan: Mdm Deputy Speaker, I thank the Members who have spoken in support of the Bill, and in particular the approach of regulating the different categories of health products in phases.

As Members have noted, this will provide flexibility in customising the regulations to suit the different risk profiles of the products. The key objective is to be able to balance the need to protect the safety of consumers and the need of the industry to remain innovative and financially viable.

Let me touch on the specific issues raised. First, let me discuss medical devices. This will be the first health product category which we intend to regulate under the proposed Act. I thank Members for their support of our proposals to regulate medical devices. Mdm Halimah cautioned against over-regulation, and indeed several other Members mentioned that too - to keep registration requirements simple and fees at an appropriate level. I fully agree. We should not over-regulate, not only medical devices but also for other health product categories that may eventually be added. There is a cost to regulation, whether in terms of licence fees or other costs in compliance with regulatory requirements. We must strike an appropriate balance between consumer protection and business viability. That is why we are taking a risk management approach to regulating health products - doing the minimum for low-risk products and applying stringent regulations only on the high-risk products.

Mdm Halimah wondered if clause 61 of the Bill may be too broad and onerous on employees, like factory operators, as they may be held liable despite not knowing what the production process is all about. Let me assure the House that this is not the intention. Clause 61 holds a principal or an employer responsible under certain circumstances for offences committed by his agent or employee. For example, if an employer has encouraged or allowed his employee to commit the offence, then he will also be held accountable. Whether employees, like factory operators, will be held liable for offences will depend on how culpable they are. The Attorney-General will have to assess each case individually but the Act will be enforced sensibly and judiciously.

Mdm Halimah suggested that HSA work closely with the medical technology industry to help them understand the requirements of the Act before it comes into effect. I agree. HSA has been engaging the medical devices industry in dialogue over the past many months and will continue to do so. Once the current public consultation phase is concluded, HSA will have further dialogue to communicate impending controls to the industry before those controls are implemented. As far as possible, HSA will try to guide those who are not familiar with the controls to understand the regulatory framework and requirements when this is finalised. However, we are not in a position to provide financial assistance to companies to help them comply with regulations as compliance cost is part and parcel of the cost of doing business.

Mdm Halimah asked about HSA's voluntary product registration scheme. This was introduced in 2002. So far, more than 4,000 products have been registered by over 250 companies.

Dr Lam spoke in support of a classification system for medical devices. I agree. The proposed regulatory framework envisages a

risk-based classification system. This is in line with the Global Harmonisation Task Force's regulatory principles and is practised in many other countries. Having a risk-based classification system for medical devices, we allow HSA to better calibrate the extent of controls that need to be imposed, ie, the higher the degree of risks, the tighter the control.

Let me now discuss regulating other categories of health products. Dr Lam suggested using the Global Harmonisation Task Force's regulatory principles for medical devices in regulating other categories of health products. As it stands, the basic principle of risk management is already applied in regulating those health products that come under existing laws and will continue to be applied in future and certainly the experiences learned from regulating medical devices will be reviewed and applied, where appropriate, in shaping the regulatory framework for other categories of products as and when they may be added in future. There are likely to be specific issues in each group of products that will require some degree of customisation, and this is what the future Health Products Act will allow. For example, the regulatory controls currently in place for pharmaceutical-type medicines are not necessarily suitable for regulating other categories of health products which may have different risk profile.

I have noted Dr Lam's suggestion to rank the degree of regulation for the different types of health products. But I prefer not to commit myself or to predetermine their risk classification now and their ranking at this point in time.

Let me now touch on pharmaceuticals. Mdm Halimah asked when we would include medicines under the new Act. We would do so as soon as possible after we have completed the regulation of medical devices. There is less urgency as medicines are already regulated under the current legislation but we certainly want to subsume the existing medicine legislation under the new Act. We will do so not in a mechanical way but take the opportunity to review the existing provisions to see if we should not update the provisions. This would require some time for public consultations. But I hope to be able to do so within two years from now.

In the process, we have taken note of Dr Fatimah's two suggestions on how to refine the registration requirements for medicines. Let me now touch on the subject of health supplements, whether we should regulate health supplements and, if so, how to regulate them, a complex issue. This afternoon, we heard two different views from Mr Sam Tan and Dr Fatimah on whether we should indeed rush to do the regulation of health supplements. We should carefully discuss the pros and cons and, in particular, study the experience in other countries. It is not a straightforward subject. We do note the comments by Dr Fatimah and Mr Sam Tan about the need to look into such products, especially with respect to claims and advertisements, and we will bear that in mind.

As I said earlier, we have not made a decision on this yet and we certainly should not rush to do so. In the meantime, aside from legal controls and prohibitions, Mr Sam Tan's idea of having more consumer education is certainly something we can look into. Increasingly, we should try to educate people to be more savvy and discerning in making choices about the products they use and consume. As a rule, consumers should always be wary of wild claims.

Mdm Halimah noted that this Bill does not cover food products. This is because there are already a set of well established laws for regulating food in Singapore, for example, the Sale of Food Act which is administered by AVA under the Ministry of National Development. The controls on food do include certain restrictions and requirements on the claims made about the food products. HSA does work with AVA, especially where it involves products that fall into the grey area between medicines and food.

Let me now address some broader aspects of a regulatory system starting with post-marketing surveillance. I agree fully with the points made by Dr Fatimah and Dr Lam on the vital need for post-marketing surveillance. There is a continuance in regulation that extends from what is done in the pre-marketing stage to what continues to be done after a product enters the market. No matter how stringent the assessment is before a product is granted approval to be marketed, effective regulation is never complete without a robust post-marketing surveillance system. HSA's health product regulatory programme currently comprises the two key elements of risk assessment before the products enter the market and ongoing management of any evolving risks for as long as the products continue to be marketed and distributed. This approach will continue to be applied for other categories under the Health Products Act.

Mdm Halimah asked about violations under existing medicine controls laws, such as the Poisons Act and Medicines Act. If I recall correctly, there are about 100 such violations every year, a very stable number. Last year, there was a significant increase mainly because of Subutex abuses which we assume will be one-off.

Finally, Dr Lam highlighted HSA's collaboration with the Australian counterpart and how we can learn from the experience there as well as other countries which he mentioned, Japan, US, in particular, how they manage counterfeit medicines and counterfeit products. In addition, HSA has also signed a memorandum of understanding with US Food and Drug Administration and Health Canada. Over the years, it has also played an active part in various international regulatory forums, such as those organised by La Leche and ASEAN. HSA will continue to explore deepening and formalising its professional links with other key regulatory partners overseas. Today, we live in a globalised world and regulatory issues and solutions are no longer self-contained in local jurisdictions, as highlighted by Dr Lam. Strong international involvement is important to ensure that HSA is engaged in strategic networks that enhance our regulatory framework and continues to be an active partner with major regulators around the world. In this respect, the Health Products Bill will help ensure that Singapore's regulatory system for health products not only fulfils the essential aim of safeguarding public health but also continues to meet our future regulatory requirements in line with international best practices.

Mdm Deputy Speaker, I thank once again the Members for their support for this Bill and I invite them to continue to give us their suggestions and feedback on the regulation of medical devices.

Question put, and agreed to.

Bill accordingly read a Second time and committed to a Committee of the whole House.

The House immediately resolved itself into a Committee on the Bill. - [Mr Khaw Boon Wan]

Bill considered in Committee; reported without amendment; read a Third time and passed.