Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1997 NO. 399

STATUTORY RULES 1997 No. 399

Issued by Authority of the Minister for Health and Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1999 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. The Therapeutic Goods Administration (the TGA) has the responsibility of administering the Act.

Section 63 of the Act provides that the Governor-General may make Regulations prescribing, amongst other things, matters necessary or convenient for carrying out or giving effect to the Act.

Paragraph 63(3)(b) of the Act provides for the refund, reduction or waiving of fees or charges in cases identified in the Regulations.

Paragraphs 17 (4)(a) and (b), and subsections 18(1) and (3) of the Act prescribe the classes of therapeutic goods which are to be included in each part of the Australian Register of Therapeutic Goods (ARTG), transferred from one part to the other, exempted from inclusion or included by revocation of an exemption.

The Regulations:

(a)        Provide for an orphan drugs program by waiving fees in relation to the designation, evaluation and registration of orphan drugs, Orphan drugs are drugs used in the treatment, prevention or diagnosis of rare diseases, and are often not commercially viable because of their small market potential. The amendments provide an opportunity for sponsors to market orphan drugs in Australia at a reduced cost through the waiving of application and evaluation fees (Regs 3.2, 4, 5, 6, 7, 8).

(b)        Remove the exemption from Schedule 5 for drugs used for gene therapy. Schedule 5 lists therapeutic goods exempt from the provisions of Part 3 of the Act (those dealing with the Australian Register of Therapeutic Goods (ARTG)). Drugs that are "dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person" are exempt (Item 6). Gene therapy products come within the definition of "drug" for the purposes of the Act, and would therefore be covered by this exemption. Item 6 was provided in order to allow pharmacists to prepare special mixtures or ointments for individual patients, when safety was not an issue. The amendments remove the exemption in relation to gene therapy because of individual and public safety concerns. The preparation and use of gene therapy products can result in serious adverse effects on the recipient if unacceptable standards of preparation and design are used. They can also pose a risk to the population at large if the virus vector acquires the ability to reproduce in the patient for whom the gene therapy products were made (Regs 3.1, 9).

(c)        Provide an exemption from Part 3 of the Act for visiting military personnel. Schedule 5A currently provides for exemptions for therapeutic goods from part 3 of the Act (provisions dealing with the ARTG), subject to conditions. Item 4 provides for such an exemption for members of visiting sporting teams who are in Australia to participate in national or international sporting events. The amendments provide a similar exemption to military personnel visiting Australia to participate in official training exercises. This will allow them to bring with them (ie import into Australia) unregistered therapeutic goods for use by their own military personnel. The exemption also allows them to provide the therapeutic goods to members of the Australian defence forces, if necessary, during the training exercise (Reg 10).

Further details of the Regulations are set out in the Attachment.

The Regulations commence on 1 January 1998 except for subregulation 3.1 and regulations 9 and 10 which commence on the date of Gazettal.

ATTACHMENT

DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Regulation 1 provides that these Regulations, other than subregulation 3.1 and regulations 9 and 10, commence on 1 January 1998. Subregulation 3.1 and regulations 9 and 10 commence on gazettal.

Regulation 2 states that the Therapeutic Goods Regulations are amended as set out in these amending Regulations.

Regulation 2 (Interpretation)

Subregulation 3.1 inserts a definition of "gene therapy".

Subregulation 3.2 inserts a number of definitions in relation to orphan drugs. These include definitions of "orphan drug" and "designated orphan drug".

New Part 3B

Regulation 4 inserts a new Part 3B entitled "Orphan Drug" consisting of the following proposed clauses:

Orphan drug

Clause 16H sets out the criteria which determine whether a drug is an orphan drug for the purposes of the regulations, and also sets out criteria which preclude a drug from being an orphan drug.

Application for orphan drug designation

Clause 161 sets out the requirements in relation to an application for orphan drug designation.

Orphan drug designation

Clause 16J sets out the steps the Secretary must take in designating the drug as an orphan drug. If the Secretary is satisfied that the statements made in the application are correct then he or she must designate the drug, in writing, as an orphan drug. Conversely, if the Secretary is not satisfied that the statements made in the application are correct then he or she must refuse to so designate the drug. The decision of the Secretary is to be communicated in writing to the applicant as soon as practicable and details of designations granted must be published by notice in the Gazette, as soon as practicable after the decision to designate has been made.

Regulation 45 (Waiver or reduction of fees)

Regulation 5 provides that the Secretary must waive any fees which would have been payable for the application for designation, the decision concerning the designation (ie the evaluation of the application) and the registration of a designated orphan drug.

Regulation 46 (Release of information)

Regulation 6 adds the category of information about whether goods are designated orphan drugs to the list of types of therapeutic goods information which can be released by the Secretary under subregulation 46(2).

Regulation 48 (Review of decisions)

Regulation 7 expands the definition of "initial decision" to include decisions made under subregulation 16J (3) - namely a decision of the Secretary to refuse to designate a drug as an orphan drug. This allows an applicant to seek internal review of a decision by the Secretary not to designate a drug as an orphan drug.

Schedule 3 (Therapeutic goods required to be included in the part of the Register for registered goods)

Subregulations 8.1 and 8.2 provide that orphan drugs must be included in the part of the Register for registered goods. A new Part 3 of Schedule 3 is created, for designated orphan drugs, entitled "Therapeutic goods attracting no fee under Divisions 1 or 2 of Part 3". This is because fees for applications made under subsection 32(5) of the Act (which is in Division 3 of Part 3) for the variation of information on the Register concerning designated orphan drugs will be charged.

Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)

Regulation 9 makes it clear that drugs used for gene therapy are not exempt from the operation of Part 3 of the Act.

Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions)

Regulation 10 adds new item 8 to Schedule 5A. This provides that members of military forces of another country, visiting Australia for military training, are exempt from the operation of Part 3 of the Act subject to conditions, which are listed.