Closing Speech by Mr Khaw Boon Wan, Minister For Health, in Parliament on 12 February - Health Product Bill

12 Feb 2007

By Mr Khaw Boon Wan, Minister for Health

Mr Speaker, Sir, I thank the Members who have spoken in support of this Bill, and in particular, its 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 health 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 respond to the specific issues raised. 

Medical Devices

First, let me touch on medical devices.  This will be the first health product category which we intend to regulate under the proposed Health Products Act. I thank Members for their support of our proposal to regulate medical devices.

Mdm Halimah cautioned against over-regulation and to keep registration requirements simple and fees at an appropriate level.  I agree.  We should not over-regulate, not only medical devices but also for other heath product categories that may eventually be added.  There is a cost to regulation, whether in terms of licence fees or other costs in complying 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 had 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 few years and will continue to do so.  Once the current public consultation 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 the 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 (GHTF) regulatory principles, and is practised in other countries that have formal regulations on medical devices (e.g. US, Australia, EU countries).  Having a risk-based classification system for medical devices will allow HSA to better calibrate the extent of controls that need to be imposed - the higher the degree of risk, the tighter the control. 

Other Product Categories

Let me now touch on regulating other categories of health products.    

Dr Lam suggested using the GHTF 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.  Certainly, the experiences learnt from regulating medical devices will be reviewed and applied where appropriate in shaping the regulatory framework for other categories of products, as and when these 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 profiles.   

I have noted Dr Lam's proposal to rank the degree of regulation for the different types of products.  But I prefer not to predetermine their risk classification and ranking at this point of time.   

Pharmaceuticals

Let me now touch on pharmaceuticals.  Mdm Halimah asked when we would include medicines under the new Act.  We will 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 legislations but we certainly want to subsume the existing medicines legislations 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 will require some time for public consultations.  But I hope to be able to do so within 2 years from now.   

In the process, we will take note of Dr Fatimah's recommendations to refine the registration requirements for medicines. 

Health Supplements 

Let me now touch on the subject of health supplements.  Whether we should regulate health supplements and if so, how to regulate them are complex issues.  We should carefully discuss the pros and cons and in particular study the experience in other countries.  It is not a straight-forward subject. 

We note the comments by Dr Fatimah and Mr Sam Tan about the need to look into such products, especially with respect to the claims and advertisements. We will bear them 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 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.  

Food Products

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 (e.g. Sale of Food Act), which are administered by the Agri-Food and Veterinary Authority (AVA) under the Ministry of National Development. The controls on food do include certain restrictions and requirements on the claims made about a food product.  HSA does work with AVA, especially where it involves products that fall into the grey area between medicines and food. 

Post-Market Surveillance

Let me now address some broader aspects of the regulatory system, starting with post-market surveillance. 

I agree with the points made by Dr Fatimah and Dr Lam on the need for post-marketing surveillance.  There is a continuum 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 products regulatory programme currently comprises the two key elements of risk assessment before products enter the market, and ongoing management of any evolving risk for as long as a product continues to be marketed and distributed.  This approach will continue to be applied for categories under the Health Products Act.  

Violations under Existing Legislation 

Mdm Halimah asked about violations under existing medicine control laws such as the Poisons Act and Medicines Act.  If I recall correctly, there are about 100 such violations annually.   

International Collaboration  

Finally, Dr Lam highlighted HSA's collaboration with their Australian counterpart.  In addition, HSA has also signed memoranda of understanding with the US Food and Drug Administration and Health Canada.  Over the years, it has also played an active part in various international regulatory fora such as those organised by the WHO 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.  Strong international involvement is important to ensure that HSA is engaged in strategic networks that enhance Singapore's regulatory framework, and continues to be an active partner with major regulators around the world. 

Conclusion

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.     

Sir, 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 on medical devices.