|
Continued from
FrontPage of Article
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.
Source:
www.moh.gov.sg News Release 12
Feb 2007
|
Health Products Bill passed
All rights reserved
