In March 2017, the TGA invited responses to the public consultation paper, ‘Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)’. The TGA responded on 9 October 2017 with a number of changes that will assist medical practitioners, patients, the Human Research Ethics Committee (HREC) and specialist colleges.

The TGA considered a total of 37 submissions from respondents including from pharmaceutical companies, health professionals and their representative organisations, consumer groups, individuals, the Medical Technology Association of Australia and Medicines Australia.

Overall there was broad support from respondents for using a criterion of ‘established history of use’ to identify unapproved therapeutic goods that could be notified to TGA and extending the AP approval period to 3 years (devices) or 5 years (medicines and biologicals) (subject to delegate decisions).

Category B patients are those who require the use of unapproved therapeutic goods and do not have a life-threatening condition or illness.

Changes include:

  • Creating a list of certain unapproved goods that have been deemed to have an established history of use;
  • Eligible prescribers may supply their goods immediately to their patient and submit a notification to the TGA within 28 calendar days which will improve access to unapproved goods with an established history of use;
  • New and revised guidance documentation has been prepared for users of the SAS;
  • New smart forms for all pathways of the scheme will be produced;
  • Implementing a new monitoring and compliance framework which will assist the TGA to identify inappropriate use of the SAS; and
  • New and revised guidance documentation has been prepared, including a decision pathway to assist prescribers decide which access pathway is the most appropriate for the circumstances.

These changes are aimed at reducing administrative and regulatory burden and will assist prescribers in the compliance of requirements of the SAS.

Authorised Prescriber Scheme

Instead of medical practitioners having to provide a clinical justification to a HREC or specialist college to become an AP and thereafter having to resubmit their clinical justification and documentation in support of the justification to the TGA for evaluation and approval, the TGA will rely on a HREC or specialist college to evaluate the clinical justification of the medical practitioner, thereby removing duplication of work.

Other changes include:

  • Implementing a new monitoring and compliance framework;
  • Increasing the approval for goods with an established history to 5 years for medicines and biologicals, and 3 years for devices;
  • New and revised guidance documentation has been prepared including a decision pathway to assist prescribers decide which access pathway is most appropriate for their circumstances; and
  • New smart forms for all pathways of the scheme will be produced.

These changes are aimed at decreasing the time taken to assess AP applications (since the TGA will not evaluate a medical practitioner’s clinical justification), reducing the regulatory burden on medical practitioners, HRECs and specialist colleges, and assisting them with the compliance of the requirements of AP.

The TGA will undertake activities to address a number of issues raised by respondents in their submissions, including:

  • Further targeted stakeholder consultation will be undertaken on the online system for unapproved goods; and
  • The monitoring and compliance framework for unapproved goods is being reviewed and strengthened by the TGA to ensure that the various pathways are used appropriately and that unapproved goods are supplied only when registered goods are not available or suitable.

TGA’s revised guidance on the SAS can be accessed here.

TGA’s revised and improved guidance and educational material to assist HRECs and specialist colleges can be accessed here.