Parliamentary Speech for Second Reading on 12 February 2007 - Health Product Bill

12 Feb 2007

By Mr Khaw Boon Wan, Minister for Health

Venue: Parliament

Mr Speaker, Sir, I beg to move, "That the Bill be now read a second time."

Background

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 legislations 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 legislations 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, e.g. 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 legislations makes it cumbersome for the industry to understand and comply with the controls.  There are currently 4 different pieces of legislations 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.

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 this 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 mean time, existing laws will apply to the other categories.

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 HSA 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 3 year 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 HSA 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 requires dealers to maintain records on 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 this Bill is passed, the first category of products that we plan to bring under the control of the Health Products 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 laypersons, 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.  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 Global Harmonisation Task Force (GHTF) for the regulation of medical devices. We work closely on a bilateral basis with the Task Force members (US, Australia, EU, Japan and Canada), 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 the 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 notification process.

HSA is currently conducting a public consultation on the proposed regulation of medical devices, using a draft of the 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 medical devices 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 product 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 to 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. 

Conclusion

Our current legislations have 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.