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     FrontPage Edition: Tue 13 February 2007

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Health Products Bill passed

Source: www.moh.gov.sg

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

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.
More.....

Source: www.moh.gov.sg News Release 12 Feb 2007

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