|
 |
|
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 |
|
 |
|
Important
Notice |
|
Our FrontPage
Editions are a historical record of our Web site and reflect
the changing of the times, and also of our Web site through
time. We do not and will not update the links and stories on
these FrontPages even if they have become obsolete. |
|
FrontPage Edition: Tue 13 February 2007
All rights reserved
