Submissions received and TGA response: Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)

9 October 2017

The TGA would like to thank respondents who provided submissions in response to the public consultation paper, Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS).

A total of 37 public submissions were received from the pharmaceutical industry and their representative organisations, health professionals and their representative organisations, consumer groups and individuals.

The submissions that gave permission to be published on the TGA website are now available below in PDF format. However, submissions that contained sensitive personal information and/or did not address the initiatives being consulted on have not been published, even where the respondent gave their permission to do so.

Submissions received

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TGA response

Broad support was received for the changes proposed to the Special Access and Authorised Prescriber Schemes. This includes support from the majority of respondents for:

  • Using a criterion of 'established history of use' to identify unapproved therapeutic goods that could be notified to TGA.
  • Extending the AP approval period to 3 years (devices) or 5 years (medicines) subject to delegate decisions.

TGA will undertake the following activities to address a number of issues respondents raised in their submissions:

  • Further targeted stakeholder consultation will be undertaken on the online system for unapproved goods.
  • Revised and improved guidance and educational material has been published by the TGA to assist Human Research Ethics Committees (HRECs) and Specialist Colleges to better understand their roles in the Authorised Prescriber Scheme.
  • 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.
  • In communications about the new SAS notification pathway TGA will reiterate approved goods should be used in the first instance, where clinically appropriate, as they have been assessed for safety and efficacy by TGA; and only where clinically appropriate should unapproved goods be accessed through the relevant SAS application, SAS notification or AP pathway. Revised guidance on the SAS is available on the TGA website.

Outcome summary

Scheme Situation Changes Benefits
Special Access Scheme - Category B

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

An eligible prescriber must submit an application to TGA; and only once approved they may supply the good to their patient.

A list of certain unapproved goods that have been deemed to have an established history of use has been created.

Eligible prescribers will not be required to submit an application for goods on this list and may supply the good immediately to their patient and submit a notification to the TGA within 28 calendar days of the supply.

New and revised guidance documentation has been prepared for users of the SAS including eligible prescribers and sponsors of unapproved therapeutic goods. This includes a decision pathway to assist prescribers decide which access pathway is most appropriate for their circumstances.

New smart forms for all pathways of the scheme will also be produced.

A new monitoring and compliance framework will be implemented.

The new notification pathway will reduce regulatory burden and improve access to unapproved goods with an established history of use.

The guidance documentation and decision pathway will help prescribers comply with the requirements of the SAS.

The online smart forms and prefilled information fields will reduce administrative burden.

The new monitoring and compliance framework will assist TGA to identify inappropriate use of the SAS.

Authorised Prescriber Scheme

Medical practitioners currently provide a clinical justification to become an Authorised Prescriber (AP) to a Human Research Ethics Committee (HREC) for approval or a specialist college for endorsement. The medical practitioner then had to resubmit their clinical justification and documentation in support of the justification to the TGA for evaluation and approval.

The TGA could approve an applicant as an AP for up to three years for medicines and biologicals and one year for medical devices.

The TGA will not evaluate the clinical justification of the medical practitioner as this a duplication of work. We will rely on the expertise of a HREC or specialist college.

The maximum duration of approval for goods with an established history of use will increase to five years for medicines and biologicals, and three years for devices.

New and revised guidance documentation has been prepared for users of the AP Scheme including medical practitioners, sponsors of unapproved therapeutic goods, HRECs and specialist colleges. This includes a decision pathway to assist prescribers decide which access pathway is most appropriate for their circumstances.

New smart forms for all pathways of the scheme will also be produced.

A new monitoring and compliance framework will be implemented.

Since the TGA will not evaluate a medical practitioner's clinical justification, the time taken to assess the AP application will decrease.

Increasing the duration of an AP approval will decrease the regulatory burden on medical practitioners, HRECs and specialist colleges who will not need to participate in renewals of AP status as often./p>

The guidance documentation and decision pathway will help practitioners, HRECS and specialist colleges comply with the requirements of AP./p>

The online smart forms and prefilled information fields will reduce administrative burden./p>

The new monitoring and compliance framework will assist TGA to identify inappropriate use of AP.