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Therapeutic Goods Amendment Bill (No. 4) 2000 [2001]

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1998-1999-2000

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

 

SENATE

 

 

 

 

 

 

 

 

 

 

 

 

 

THERAPEUTIC GOODS AMENDMENT BILL (NO. 4) 2000

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Parliamentary Secretary to the Minister for

Health and Aged Care, Senator the Hon Grant Tambling)

 

 

 



 

 

THERAPEUTIC GOODS AMENDMENT BILL (NO. 4) 2000

 

OUTLINE

 

 

The Bill makes a number of changes to allow the introduction of a redeveloped system for electronically entering listable medicines on the Australian Register of Therapeutic Goods (the Register).  This new refined listing system seeks to assure the safety and quality of and consumer confidence in listable medicines whilst facilitating quicker market access by applicants (sponsors).  Listable, or listed, medicines are considered to be of low risk based on their ingredients and therapeutic indications and claims.  Most complementary medicines (eg herbal, vitamin and mineral products) and sunscreens fall into this category, and also some over-the-counter medicines.

 

Under the changes introduced by the Bill sponsors of listable medicines will have greater responsibilities in relation to pre-market assessment of the medicines they wish to list on the Register and the Therapeutic Goods Administration (TGA) will assume greater post-market monitoring responsibilities in relation to these medicines.  This shift in responsibilities emphasises the accountability of sponsors to provide correct information in applications to list medicines. There will be a corresponding increase in penalties for sponsors that provide false or misleading information in any documentation, including applications to list medicines.  The changes will expand the Secretary’s power to take action to cancel the listing of a medicine that does not comply with the listing requirements or where the sponsor fails to comply with a request to supply information.

 

Financial Impact Statement

 

The amendments to the Therapeutic Goods Act 1989 have no significant financial impact.

 



NOTES ON CLAUSES

 

 

Clause 1: states that the short title of the legislation is the Therapeutic Goods Amendment Act (No.4) 2000.

 

Clause 2: sets out the commencement date for the changes set out in Schedule 1. Schedule 1 will come into effect on a day to be fixed by Proclamation or, at the latest, 6 months from the day the Bill receives Royal Assent.

 

Clause 3: has the effect of stating that the Therapeutic Goods Act 1989 (the Act) will be amended in the manner specified in the Schedule.

 

SCHEDULE 1 - Electronic Lodgement Facility for listing medicines

 

Item 1:  inserts a definition of "export only medicine".  An "export only medicine" is one that is manufactured in Australia or imported into Australia for export only and is required, under the regulations, to be included in the part of the Register relating to listed goods only because it has been manufactured or imported solely for that purpose. Where a medicine that is manufactured or imported for export only can also be caught under another Item under Schedule 4 of the Regulations (which lists what goods are listable), then it is not an “export only medicine”, and will be eligible for listing under section 26A of the Act using the new electronic lodgement facility, whereas an "export only medicine" will only be eligible for listing under section 26 of the Act.

 

Items 2 and 3:  insert definitions of "listable goods" (those required to be included in the part of the Register for listed goods) and "working day".

 

Items 4 and 5:  amend subsection 16(1) of the Act to provide for a new description of what constitutes separate and distinct listable medicines.  This description does not apply to export only medicines. There are to be three features that will define what makes listable medicines separate and distinct from other therapeutic goods. These are different active ingredients, different quantities of active ingredients or different dosage form.  Other different characteristics may be set out in the regulations.

 

Item 6:  inserts a new offence in subsection 22(2A) for the making of false or misleading statements in relation to certification of matters for the listing of medicines under section 26A. The certification includes statements regarding the safety of the medicine for the purposes for which it is to be used, conformity with applicable standards, compliance with prescribed quality or safety criteria and correctness of the information provided with the application.

 

The electronic listing of medicines under section 26A relies heavily on information provided by applicants and is predicated on self-assessment, rather than the TGA checking every detail to establish whether the medicine meets statutory requirements for listing in the listing process. An applicant could, on the basis of false or misleading information, successfully list a medicine and place it on the market.  This would create potential risks to public health by the supply of potentially dangerous medicines. 

 

The penalty of 400 penalty units is designed to discourage the provision of inaccurate information that could have serious public health consequences.  It also reflects the higher risk of false or misleading information resulting in a successful listing under a fully electronic lodgement process.  A lesser penalty for provision of false or misleading information is currently provided in subsection 22(2) of the Act where listing is achieved through a combination of an electronic lodgement process followed by an immediate review of the application by the TGA.  This is because, under current arrangements attracting the lower penalty, the TGA has a much greater opportunity to assess the information upon which the application is based at the time of the application.

 

Item 7:  clarifies the operation of paragraph 26(1)(j) of the Act which, in its previous form, was unclear in its intent.  This paragraph deals with the situation where the Secretary refuses to list therapeutic goods that are manufactured or imported solely for export because an importing country has not agreed to accept the goods. The goods may not havebeen accepted for listing or registration for supply in Australia or the Secretary may have required this agreement from the importing country for some other reason.

 

Item 8:  replaces the words "therapeutic goods" in paragraph 26A(1)(a) with the word "medicine" to reflect the fact that listing under section 26A is now to be restricted to medicines that are listable goods.  Listing of other therapeutic goods not covered by section 26A will take place under section 26.

 

Item 9:  repeals paragraph 26A(1)(b).  That paragraph required compliance with requests by the Secretary for information in relation to therapeutic goods prior to listing of the goods on the Register.  This paragraph is redundant because entry onto the Register will be largely automatic once an application has been submitted by an applicant using the electronic lodgement facility and any requests for information about the goods will be made after entry of the goods on the Register, as part of the post-market monitoring.

 

Item 10:   provides for the exclusion of export only medicine from listing under section 26A.

 

Item 11:  makes it clear that the Secretary must list a medicine where the medicine meets the requirements of subsection 26A(1).

 

Item 12:  replaces subsection 26A(2) with a new certification requirement for applicants seeking listing of a medicine.  Paragraphs (h), (i), and (j) are matters which were not previously required to be certified.  These require the applicant to certify that the application contains the names of all manufacturers of the medicine, that written agreements are in place with prescribed manufacturers and that information or evidence is held to support any claim made relating to the medicine.  These additional certifications emphasise the accountability of the applicant at the time of listing of a medicine.  The other certification requirements reflect those previously contained in the repealed subsection 26A(2).

 

Items 13 to 17:  make a number of changes to section 26A to restrict its operation to the listing of medicines that are listable goods.

 

Item 18:  inserts a new matter to be taken into account under paragraph 26A(4)(c) where the Secretary is certifying the manufacturing and quality control procedures in respect of medicines manufactured overseas.  The Secretary may consider whether the applicant has complied with any request for information that is made under section 31 of the Act relating to the manufacture or preparation of the medicine.  This amendment recognises that, whilst the power to require information under section 31 will no longer be required for the purpose of making a decision on the application for listing of the medicine, it will be required for the purpose of certification of the acceptability of manufacturing facilities of overseas manufacturers under subsection 26A(3).  This certification takes place prior to an application for listing being made.

 

Items 19 to 26, and Item 28:  make a number of further changes to section 26A to restrict its operation to the listing of medicines that are listable goods.

 

Item 27:  removes the requirement under subsection 26A to notify an applicant of a decision on the application.  This requirement is redundant as listing will be automatic providing the requirements of section 26A are met.

 

Item 29: inserts a new condition of listing for medicines listed under section 26A that the sponsor deliver samples requested by the Secretary within the period specified (which must be at least 10 working days) and in accordance with any other requirements specified by the Secretary.   Subsection 23(2) gives the Secretary the power to require samples to be delivered to the TGA before an application is treated as effective.  For goods that are automatically listed under the electronic lodgement facility following self-assessment by the applicant this power will be redundant.  A key aspect of post-market monitoring of listed medicines will be laboratory testing to determine the composition and quality of medicines. This amendment will strengthen the post-market monitoring system for listed medicines.

 

Item 30: This amendment makes it clear that the grounds for cancelling goods under paragraph 30(1)(e) of the Act applies to listed medicines that have been listed under section 26A of the Act.

 

Item 31:  inserts two new grounds in section 30 (subsections (1A) and (1C)) for the cancellation of the listing of medicines that are listed under section 26A.  Firstly, where the medicine is not eligible for listing, is exempt, or there is a serious breach of the advertising requirements which results in the presentation of the medicine (except a medicine that is manufactured or imported for export only) being misleading to a significant extent, the listing may be cancelled by notice in writing.  Secondly, the listing may be cancelled by notice in writing where the sponsor fails to comply within 20 working days with a request for information, made for the purpose of determining whether the medicine should have been listed, for information or documents relating to the medicine.

 

Listed medicines are required to meet certain eligibility criteria for listing including that they may only contain certain substances (considered to be low risk) and they may not make claims in relation to serious diseases.  A medicine that contains a non-listable substance or makes a claim in relation to a serious disease, for which it has not been evaluated, represents a risk to public health and safety and should not be supplied without pre-market evaluation.  Medicines that are exempt from the operation of Part 3 of the Act should not be listed on the Register.

 

A serious breach of the advertising requirements that results in the presentation of the medicine being misleading to a serious extent may pose a risk to public health.  Misleading information may arouse unwarranted and unrealistic expectations of the safety and effectiveness of the medicine.  It may lead to consumers self-diagnosing or inappropriately treating potentially serious diseases without seeking appropriate medical advice.  It may also encourage inappropriate consumption of a medicine.

 

Post-market monitoring of listed medicines will rely in part on the ability of the TGA to obtain information from the applicant in order to determine whether the medicine meets the criteria for listing.  If an applicant fails to supply such information the TGA will be unable to determine whether the medicine should have been listed.   If the medicine does not meet the criteria for listing there is a risk that a potentially dangerous medicine will continue to be available for public consumption.

 

Item 32:  clarifies that the ground for cancellation under paragraph 30(2(ba) of the Act applies to listed medicines that have been listed under section 26A of the Act.

 

Item 33:  provides for the cancellation by notice in writing of medicines listed under section 26A where certifications under paragraph 26A(2)(h), (i), (j) or (k) are incorrect.  This expands the cancellation power to incorporate the new certification requirements described in Item 12.

 

Item 34:  provides for the application of the provision specifying the date of effect of cancellation to cancellations of listings under new subsections 30(1A) and (1C).

 

Item 35:  inserts a new offence provision into section 31 in respect of medicines listed under section 26A, where false or misleading information is provided in purported compliance with a request for information relating to the medicine. A maximum penalty of 400 penalty units is provided. This provision complements the new offence provision described in Item 6. To undertake surveillance of medicines listed under section 26A information about the medicine may be requested under section 31.  The content of this information may determine whether or not a medicine is to remain listed on the Register and therefore available for public consumption.  If this information is false or misleading in a material particular there is a risk that a potentially dangerous medicine will continue to be available for public consumption. The high penalty is meant to be a deterrent to sponsors of medicines for similar reasons to those described in Item 6.

 

Item 36:  provides for the application of the amendments contained in this Bill to pre-existing applications or therapeutic goods that are listed on the Register.  Applications for listing made prior to commencement of this Bill will continue to be dealt with under the Act as in force immediately before commencement.  However, new subsection 16(1A) will apply to all medicines listed before commencement of the Bill and new subsections 30(1A-C) will apply to medicines listed under section 26A before commencement of this Bill.