THERAPEUTIC GOODS AMENDMENT (2020 MEASURES NO. 1) BILL 2020

The bill amends the Therapeutic Goods Act 1989 to align certain device-related definitions with the equivalent definitions in the European Union; to enable the secretary to provide early scientific advice to a sponsor developing new medicine before they apply for marketing approval; to remove certain offences for persons claiming to be able to arrange supply of therapeutic goods; to specify the circumstances in which a sponsor may apply for the provisional registration of a medicine, without having to first obtain a provisional determination; to introduce a targeted data protection regime for assessed listed medicines; and to make minor amendments and corrections to reduce regulatory burden.

Amendments:

• The bill reduces the definition of “medical devices” by including only instrument, apparatus, appliance, software, implant, reagent, material or other article if it is used:
  1. for the 'prediction' or 'prognosis' of disease
  2. for human beings for the investigation, replacement or modification of a 'physiological or pathological process or state';
  3. for human beings for the support of conception
  4. for human beings for the in vitro examination of a specimen derived from the human body for a specific medical purpose
• The bill establishes a process for potential applicants to request the Secretary for advice about whether, if the person were to make an application for the registration of a medicine, a prescribed aspect of the medicine’s quality, safety or efficacy has been satisfactorily established for the intended use of the medicine. Each such request must relate only to one aspect of safety, quality or efficacy (though nothing would preclude a person from making more than one such request).
• The bill repeals subsection 22(6) of the Act, which provides that it is an offence if a person claims, by any means, that they or another person can arrange the supply of unapproved therapeutic goods. Concerns have arisen that the criminal offence in subsection 22(6) of the Act may be a disincentive for sponsors of potential alternative products to a medicine affected by a shortage from identifying if they are able to arrange for the supply of their products to help alleviate the effects of the shortage. Despite the repeal of subsection 22(6), it continues to apply on and after that commencement in relation to claims made before that commencement.
• The bill inserts new subsection 23AA(2) in section 23AA of the Act, which would set out a new set of circumstances in which an application will be taken to be an application for provisional registration in the Register. Principally, these circumstances are where:
  1. there is a medicine that is provisionally registered in the Register because of an application that, under subsection 23AA(1), was taken to be an application for provisional registration - this is the original medicine on which the new medicine is based;
  2. another medicine - the new medicine - is separate and distinct from the original medicine, under subsection 16(1) of the Act (this lists matters which make registrable medicines separate and distinct from one another, e.g. if they have different directions for use);
  3. the sponsor applies under section 23 of the Act for the registration of the new medicine, before the end of the original medicine's provisional registration period;
  4. the sponsor specifies in the application that they are seeking the provisional registration of the new medicine;
  5. at the time of that application, the active ingredients, and indications of the new medicine and the original medicine are the same.
• The bill introduces a data protection regime of 5 years in relation to assessed listed medicines. The criteria for information to be 'restricted information' in this context are set out in new subsection 26AF(2):
  1. the information was given to the Secretary in relation to an application made under section 23 of the Act for the listing of a medicine under section 26AE of the Act (i.e. the new data protection regime will only apply in relation to listed assessed medicines, and not in relation to other listed medicines);
  2. the information is derived from a clinical trial that relates to an indication of the medicine (and where the indication is not a permissible indication covered by a determination made by the Minister under paragraph 26BF(1)(b) of the Act);
  3. the information is not available to the public;
  4. at the time the application to list the medicine in the Register under section 26AE of the Act was made, there was no other medicine with the same indication in the Register, and no other medicine with the same indication had been included in the Register at any time before then;
  5. the medicine is listed in the Register under section 26AE of the Act;
  6. five years have not passed since the commencement of the medicine's listing in the Register (i.e. this is the period for which a listed medicine sponsor's restricted information will be protected under the new data protection regime); and
  7. the sponsor of the medicine has not given the Secretary their permission in writing for the Secretary to use the information (i.e. in connection with another medicine application).
• The bill includes a number of minor amendments to the Act in order to:
  1. remove spent and redundant references in the Act to therapeutic devices to reflect that this is a superseded category of therapeutic goods, and remove a small number of other spent and redundant provisions;
  2. amend a small number of headings to make it clear that the provisions to which they relate set out approvals or authorities in relation to the supply of unapproved therapeutic goods, rather than exemptions;
  3. clarify the Secretary’s power to specify classes of registrable or assessed listable therapeutic goods for the purposes of the preliminary assessment requirements for applications for marketing approval for such products; and
  4. include a reference to the Agreement on Mutual Recognition in Relating to Conformity Assessment, Certificates and Markings between the Government of the United Kingdom of Great Britain and Northern Ireland (the UK) and the Government of Australia in the definition of ‘therapeutic goods information’ in subsection 61(1) of the Act, to ensure that the Secretary will be able to disclose information relating to the performance of the Department’s functions under that Agreement once it enters into force.

Analysis:

• The closer alignment of the Australian medical devices regulatory framework with the EU regulatory framework minimised differences between the two frameworks, and in so doing reduces the delay for Australian consumers in accessing new medical devices.
• The introduction of a pathway for sponsors to request the Secretary for early scientific advice reduces the risk for medicine sponsors who invest time and resources into developing supporting evidence that is not required, or omitting data that is needed. Moreover, it reduces the delay for Australian consumers in accessing new medical devices.
• The repeal of the criminal offence in subsection 22(6) of the Act removes a disincentive to sponsors of potential alternative products from addressing shortages of unapproved therapeutic goods.
• The new provisional registration pathway for medicine sponsors removes the barrier of re-applying for a provisional determination before they could apply for provisional registration, and thereby reduces considerable delay for both sponsors and consumers in being able to access promising new medicines for very serious conditions.
• The new data protection regime provides incentive for the complementary medicines sector to innovate and invest in research to improve the efficacy of their products.
• More minor amendments introduced to the Act reduce regulatory burden and improve consistency.

Conclusion:

The Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020 ensures that Australians have access to medicines and therapeutic devices in a timely, affordable and safe manner.