Explanatory Memorandum
(Circulated by authority of the Hon Mark Vaile MP, Minister for Trade)Schedule 7 - Therapeutic Goods
210. Item 1 replaces the existing provision that requires the Secretary to inform an applicant about whether or not its application to register therapeutic goods has been approved, and if not to provide reasons for not approving the application, or where approval is granted, to register the goods in the Australian Register of Therapeutic Goods (the Register). The new provision takes into account changes made by new Item 6, which requires an applicant seeking to include therapeutic goods (other than therapeutic devices) in the Register to provide a certificate in certain circumstances. The new certification requirements specifically exclude applications for the registration of therapeutic devices under section 23 of the Act.
211. The new provisions insert new subsections 25(3), (4) and (4A) into the Therapeutic Goods Act 1989 (the Act). New Subsection 25(3) provides that after the Secretary has completed an evaluation of therapeutic devices under s.25 of the Act, the Secretary is required to give written notification to the applicant informing the applicant whether or not the devices may be included in the Register. The decision to approve or refuse to approve an application must be given in writing within 28 days of making the decision, and if the decision is to refuse registration, the Secretary must provide reasons for that decision. If the decision is to approve registration of the device, the Secretary must include the device in the Register and give the applicant a certificate of registration for the goods. The arrangements in relation to therapeutic devices are not changed by these amendments.
212. New subsection 25(4) covers registrable therapeutic goods that are not therapeutic devices. These are goods in relation to which the new certification requirements apply. Where an evaluation of these goods has been completed, again the Secretary is required to give written notification to the applicant informing the applicant whether or not the goods may be included in the Register. The decision to approve or refuse to approve an application must be given in writing within 28 days of making the decision, and if the decision is to refuse registration, the Secretary must provide reasons for that decision. Where the Secretary decides to approve the application to register therapeutic goods in the Register, the Secretary must give written notification to the applicant that the goods will be included in the Register if the applicant gives the Secretary the certificate required under new subsection 26B(1), inserted by Item 6.
213. Where the applicant has provided to the Secretary the certificate required under new subsection 26B(1), the Secretary must include the goods in the Register without inquiring into the correctness of the certificate, and to give the applicant a certificate of registration for the goods.
214. New subsection 25(4A) provides that civil proceedings will not lie against the Secretary, or his/her delegate, where the Secretary includes therapeutic goods in the Register in reliance upon the certificate given by an applicant to the Secretary under subsection 26B(1), and another party has or claims to have suffered loss, damage or injury of any kind as a result of the inclusion of the goods in the Register.
215. Items 2 and 3 make changes to the process for including in the Register export-only medicines. Again, these changes have been inserted to accommodate new requirements for a certificate to be lodged under new subsection 26B(1) in connection with the inclusion of export-only medicines in the Register.
216. Item 2 provides that where an application is lodged under section 23 for the purposes of subsection 26(1) of the Act to include listable medicines not intended for supply in Australia and intended only for export from Australia, it must be accompanied by the certificate referred to in new subsections 26B(1).
217. Item 3 inserts new subsections 26(1A) and (1B). New subsection 26(1A) provides that where an application is made to include export-only medicines and the requirements of subsection 26(1) have been met and the application is also accompanied by the certificate required under subsections 26B(1), the Secretary must include the export-only medicines in the Register without inquiring into the correctness of those certificates. New subsection 26(1B) provides that civil proceedings will not lie against the Secretary, or his/her delegate, where the Secretary lists the goods under section 26 in reliance upon the certificate given by an applicant to the Secretary under subsection 26B(1), and another party has or claims to have suffered loss, damage or injury of any kind as a result of the listing of the goods.
218. Items 4 and 5 make changes to the approval process for including listable medicines in the Register under s.26A of the Act. "Listable" medicines are, in the main, low risk therapeutic goods that require a different assessment process for the purposes of being granted marketing approval, than higher risk "registrable" therapeutic goods, such as prescription medicines that are intended for use in the treatment of serious medical conditions. Under s.26A applicants electronically lodge their applications to include their goods in the Register, and all applications are electronically processed. Under this process therapeutic goods are directly entered onto the Register electronically on the basis of the certifications made by the sponsor under subsection 26A(2)(a)-(k).
219. Item 4 makes it clear that an application for listing of a medicine lodged under section 23 for the purposes of section 26A must also be accompanied by the certificate required under new subsection 26B(1).
220. Item 5 inserts new subsections 26A(1A) and (1B). New subsection 26A(1A) provides that if an application is made to list medicines of a kind described under subsection 26A(1) and the requirements of subsection 26A(2) and where applicable (3) are met and the application is also accompanied by the certificate required under new subsection 26B(1), then the Secretary must list the goods in the Register without inquiring into the correctness of the s.26B(1) certificate. New subsection 26A(1B) provides that civil proceedings will not lie against the Secretary, or his/her delegate, where the Secretary includes the goods in the Register under section 26A in reliance upon the certificate given by an applicant to the Secretary under subsection 26B(1), and another party has or claims to have suffered loss, damage or injury of any kind as a result of the inclusion of the goods in the Register.
221. Item 6 inserts new section 26B which provides for what certificate is required to be provided by an applicant in accordance with sections 25, 26 and 26A of the Act.
222. New subsection 26B(1)(a) provides that where an applicant is seeking to have therapeutic goods included on the Register, the applicant must provide a certificate to the effect that they are not marketing, and do not propose to market, those therapeutic goods in a way or in circumstances that would infringe a patent that has been granted in relation to the therapeutic goods.
223. New subsection 26B(1)(b) provides where an applicant is seeking to have therapeutic goods included on the Register, the applicant must provide a certificate to the effect that a patent has been granted in relation to the therapeutic goods and that the applicant proposes to market the therapeutic goods before the expiry of the patent for such goods and the applicant has notified the patent owner of its application to include goods in the Register.
224. New subsection 26B(2) provides that the certificate required under subsection 26B(1) is required to be signed by, or on behalf of, the applicant and in a form approved by the Secretary.
225. New subsection 26B(3) creates an offence for an applicant to lodge a certificate that is required under subsection 26B(1) and the certificate is false or misleading in a material particular. The maximum penalty for this offence is 1,000 penalty units. The Criminal Code Act 1995 (the Criminal Code) provides that 'recklessness' is the necessary mental element which would apply to the false or misleading nature of the certificate provided by the applicant. Subsection 5.6(2) of the Criminal Code provides that if the law creating the offence does not specify a fault element for a physical element that consists of a circumstance or a result, recklessness is the fault element for that physical element. Recklessness can be established by proving intention, knowledge or recklessness (see subsection 5.4(4) of the Criminal Code).
226. New subsection 26B(4) provides that for the purposes of section 26B, a patent is taken to have been granted in relation to the therapeutic goods, if marketing of the therapeutic goods without the authority of the patentee would constitute an infringement of that patent. The term patent granted in relation to the therapeutic goods is intended to cover a patent on the therapeutic good, a component of the therapeutic good, or a product for an approved use, where the approved use is claimed in a patent.
227. New subsection 26B(5) inserts a definition for 'patent' to ensure that the word has the same meaning as 'patent' under the Patents Act 1990.
228. Item 7 states that the changes made to the Act by this Schedule apply to new applications that are lodged under section 23 of the Act on or after the day this Schedule comes into force.