Conclusion to the Public Consultation on the Proposed Health Products Bill
The Public Consultation for the proposed Health Products Bill is now closed.
The Public Consultation was held over a 6-week period from 15 June to 31 July 2005. The Health Sciences Authority (HSA) received a total of ten responses from various sources, including industry associations (2), companies dealing in health products (4), healthcare professionals (2) and members of the public (2).
HSA thanks all respondents for their valuable feedback on the draft Bill.
We are pleased to provide a summary of the feedback received and our responses.
There was general support from the respondents for having a consolidated legislation to regulate health products, with most of them recognising the potential benefits from the consolidation.
The majority of the respondents also made specific recommendations and requests concerning certain aspects of control. These were mostly related to technical requirements specific to a particular type of product (e.g. medical devices, health supplements) rather than to the overall regulatory controls covered in the main Bill. HSA has noted these points and will take them up subsequently as part of the public consultation process when drafting the subsidiary legislation for each respective product type.
Application of International Standards for Product Assessment
Some respondents expressed concern as to whether, with a consolidated legislation for all health products, the controls to be applied to their respective types of health products would still be in line with international standards and requirements.
HSA fully appreciates that the different segments of the health products industry generally adhere to different sets of international standards specific to their respective types of product. The flexibility built into the proposed Health Products Bill allows for different standards of assessment to be applied to different types of products and will help ensure that appropriate degrees of control are accorded to each product type.
Controls on Claims in Product Labels and Advertisements
Some respondents, from the viewpoint of consumers, expressed the desire for tighter controls on product claims and suggested having mandatory disclosure of more product information so as to empower consumers in making informed decisions when buying health products. Other respondents, particularly those from the industry, were concerned that the future controls on advertisements might be too restrictive and would affect their advertising and promotional activities.
HSA recognises that these two positions represent the different perspectives of consumers and industry, and both raise valid issues. The underlying aim of regulating product information and claims is not to restrict the advertising and promotion of health products per se, but rather to ensure that the information disseminated is accurate and truthful, and can help consumers, together with healthcare providers, make sensible and well-informed decisions when selecting health products. In this respect, HSA will pay particular attention to the regulation of product information and advertising when working out the detailed controls for each type of product, and will take into account the prevailing standards of practice for that particular segment of the industry, as well as the degree of preparedness of consumers to assess related information and claims.
Regulation of Related ´Quasi-Medicinal´ Products
One respondent called for regulatory controls not only for the more commonly-recognisable therapeutics and supplementary health products, but also for products that play a ´supporting role´ in healthcare, such as nutritional preparations for the ill and aged.
In principle, HSA believes that such products have their role and place in the overall healthcare system, and agrees that some degree of regulation would be justified. However, the timing and extent of the regulatory controls to be implemented for such products need to be examined in greater detail. These products will be among those considered when HSA looks into the regulation of supplementary health products.
Some respondents requested further information or clarification on certain legal terms used in the draft Bill, and HSA would be reverting to these respondents directly on their queries.
There were also some suggestions for improvements in the current regulatory controls. HSA has assessed that these could be addressed without waiting for the enactment of the proposed Health Products Act legislation, for example, revising the ´Poison´ warning label that appears on medicines. These suggestions will therefore be taken up as part of HSA's ongoing review of its rules and regulation.
HSA would like to thank all respondents for their valuable feedback in this public consultation.