APS Ethics Applications for Medicinal Cannabis Schedule Approvals

Contents

WHAT IS THE ROLE OF ETHICS IN THE TGA’S AUTHORISED PRESCRIBER SCHEME?

The TGA offers multiple ways for medical practitioners to secure for their patients medicinal goods which are otherwise unauthorised for use in Australia. One of these is the Authorised Prescriber Scheme (APS). Under the APS, a practitioner becomes authorised to prescribe unauthorised goods for a fixed period of time, subject to various conditions.

When a medical practitioner wishes to become an Authorised Prescriber (AP), the practitioner must obtain ethical approval/approval from an ethics body and supply this to the TGA as part of their AP application.

Obtaining an ethics approval from the NIIM HREC does not make you an AP – it is a step in the process. Once granted ethical approval, you need to take your ethics approval to the TGA to apply to become an AP for each specific product you wish to prescribe.

HOW DO THE NIIM HREC’S NEW, AMENDMENT, AND RENEWAL APPLICATIONS WORK?

It is important to understand the distinction between product-focussed and prescriber-focussed approvals.

  • When you apply to the TGA to become an AP, you apply for specific products and the TGA, being the Therapeutic Goods Association, will be particularly concerned with the suitability of those specific unauthorised therapeutic goods for the use you wish.
  • When you apply to the NIIM HREC for AP ethics approval, the HREC, as a Human Research Ethics Committee, is particularly concerned with your ethical suitability as a practitioner to prescribe unauthorised goods of the nature you wish for the use you wish.

Although both the TGA and the NIIM HREC are interested in both the prescriber and the product, each body has a distinct focus. This may mean you are required to submit similar but different information in your HREC ethics application to what you submit in your TGA AP application.

The NIIM HREC grants three kinds of ethics approvals: New, Amendment, and Renewal approvals.

  • If you have never applied for AP ethics approval from the NIIM HREC before, you must submit a New application.
  • If you have previously received AP ethics approval from the NIIM HREC but you wish to modify the details of your approval, you must submit an Amendment application.
  • If you have previously received AP ethics approval from the NIIM HREC and that approval is within six months of expiry, you need to submit a Renewal application to ensure continuity of approval.

Important: because the NIIM HREC takes a practitioner-focussed approach to AP ethics approvals, you should never submit multiple different applications in the same meeting round. You, as the practitioner, should always know what you have applied for / are applying for.

  • If in a new application you want to apply for numerous products or product categories, include all of them on your application form. Do not submit multiple New applications.
  • If in an amendment application you want numerous changes made to your approval, all desired changes should go into a single application form. Do not submit multiple Amendment applications.

Note that your own AP ethics approval relies on your current Original or Renewal approval, not the date of any Amendment approval. (See below.)

RENEWAL APPLICATIONS

Renewal applications warrant a section of their own, as these have been seriously misunderstood in the past.

Because the NIIM HREC’s AP ethics approvals are prescriber-focussed, not product-focussed (although they do include attention to products), their Renewal requirements are prescriber renewals, not product renewals.

Important: The approval duration granted in your Original approval letter is your approval duration for all products, including products subsequently added to your approval by amendment. Amendment approvals do not carry their own duration or extend your AP ethics approval. The approval is your approval, not your products’ approval.

When it comes time to Renew your AP ethics approval, you should Renew all your products once onlyYou should not submit multiple Renewal applications for different products or product categories.

This allows you to bring all your original approval items and your subsequent amendment items and combine them in a single Renewal application, bringing them together and unifying your entire approval.

Your Renewal letter then replaces your Original approval letter and grants a renewed approval duration. Any Amendments made after this fall under the conditions and duration of your current Renewal approval.

This process allows the NIIM HREC to fulfil its responsibilities and provide ongoing ethical monitoring through six-monthly reporting and confirmation of your continuing professional development in the prescribing of the unauthorised good. Amendment applications do not require this extra evidence because they come under your current approval duration, where your ethical suitability has already been established.

CHANGES TO THE TGA AUTHORISED PRESCRIBER SCHEME ETHICS REQUIREMENTS

In mid-2021, the TGA announced changes to its Authorised Prescriber Scheme (APS) ethics requirements which will significantly ease the administrative load of ethics approval for Authorised Prescribers (APs). In a nutshell, the changes were as follows:

  1. The TGA would accept ethics approvals for more than 1 year – up to 5 years at the HREC’s discretion – and would align its AP approval with the ethics approval duration to bring the two distinct approvals into alignment.
  2. The TGA would accept ethics approvals for medicinal cannabis products according to the TGA Schedule of the products, rather than each product’s trade name.

These changes simplify the APS process considerably from how it was previously. After extensive deliberation, the NIIM HREC has been able to resolve how it will adjust its processes to serve practitioners under the updated TGA requirements.

NIIM HREC’S RESPONSE TO THE TGA’S CHANGES

Changes to the NIIM HREC APS ethics process may be ongoing as the long-term impacts of the TGA’s changes are encountered. The immediate changes are as follows:

  1. The NIIM HREC’s APS ethics approval durations will be 26 months.
    The HREC discussed approval durations early in 2021 and chose to extend its approval duration from 12 months to 26 months. The HREC is unwilling to grant approvals of longer than 26 months until the monitoring effectiveness of this already-more-than-doubled approval duration is seen. Approval durations may be reviewed again from mid-2022.
  2. The NIIM HREC will accept schedule-based APS ethics applications.
    The HREC will continue to accept product-based applications in its October 2021 meeting; however, after this it is expected that all applications will be schedule-based applications, as schedule-based approvals grant practitioners greater professional autonomy and secure for patients more reliable access to medicinal cannabis goods.

If a practitioner has specific reason to require a product-based approval after the October 2021 meeting, they may contact the HREC directly to justify such an application.

THE UPDATED NIIM HREC APS APPLICATION PROCESS

The updated ethics application process has been simplified significantly from earlier application processes. It is still necessary for each practitioner to apply for their Authorised Prescriber (AP) ethics approval with an application form and supporting documentation.

The process of obtaining a schedule-based ethics approval differs for current APs compared to new AP applicants.

Practitioners who hold current NIIM HREC APS ethics approvals

Current APs can use the APS MC Schedule Amendment Form to apply for Schedule-Based AP approval. Applicants will be required to send in their current Approval letter to demonstrate their AP standing. Other supporting evidence may be required as specified in the form.

A Schedule Amendment carries the same fee as any other Amendment application.

Take care to include all desired product categories and indications on your Transition application so that you do not need to submit further amendments in the near future.

Practitioners who do not yet hold current NIIM HREC APS ethics approvals

New AP applicants can use the APS MC Schedule Application Form to apply for Schedule-Based AP approval. Applicants will be required to demonstrate their previous experience with and education in medicinal cannabis, as well as their patient care and informed consent processes. Other supporting evidence may be required as specified in the form.

A Schedule Application carries the same fee as any other New application.

RENEWING YOUR NIIM HREC APS ETHICS APPROVAL

If your Current ethics approval does not include a validity date range, it may expire after twelve months. If it does include a validity date range it will expire after the specified period. Your Amendment letters do not extend your approval duration. Only New approvals and Renewal approvals grant approval duration.

You should renew your APS ethics approval a few months before it is due to expire. Do not Renew your approval more than six months before it is due to expire.

If you need to Renew your APS ethics approval, you should use the APS Renewal Form (to renew product-based approval) or the APS MC Schedule Renewal Form (to renew or transition to schedule-based approval).

Renewal applications no longer include Amendment options, as these have frequently complicated the application process. If your approval is due for Renewal you can either Renew it as-is on the Renewal Form or transition to schedule-based approval by renewing using the Schedule Renewal Form. Other than this, any amendments desired must be made using the Amendment process.

If your approval is not due for Renewal, do not use the Renewal form to transition to schedule-based approvals; use the Schedule Amendment form.

SIX-MONTH REPORTS

The NIIM HREC requires six-month reports from APs for the January-June and July-December reporting periods. This requirement is distinct from and additional to the TGA’s reporting requirements, and helps the NIIM HREC to fulfil its ethical monitoring obligations.

Please do complete the NIIM HREC’s six-month report form and send it to the HREC for each six-month period. Sending TGA report documents to the HREC is insufficient, as the HREC’s report form covers different information.

You only need to complete one HREC six-month form; all your approved products and prescribing activity should be added and summarised in the one form.

FEES

As of 18 August 2021, the APS ethics application fees will be raised. These higher fees provide for the growing administrative needs of the HREC in processing applications, monitoring approvals, and building and maintaining a developing database and online application portal.

However, the higher fees should not equate to greater costs for practitioners in the long term. This is for two reasons:

Firstly, the HREC’s APS approval durations were more than doubled in early 2021. The raised application fees are less than equal to the increased approval duration, meaning practitioners now receive longer approvals compared to their application fee.

Secondly, under the schedule-based approval system, amendment applications should become almost redundant. Where many practitioners have previously submitted regular amendment applications to keep up with ever-changing product availability, a single comprehensive schedule-based approval will now suffice, saving practitioners frequent amendment fees.

APPLICATION SUBMISSION

Until the release of the NIIM HREC online submission portal, submit applications via email to aps@niim.com.au. Allow two weeks for confirmation of receipt.

Please do not send .zip folders or links to online file systems unless absolutely necessary; these foul the file-handling system.

Please do use logical, intuitive naming conventions for all files – including your name and the type of the file. You could write your surname, a comma, your first name, an underscore, and then the file type, such as ‘Application Form’ or ‘CPE’ or ‘SAS-B1’ or ‘Consent Form.’

Please do thoroughly check every required item for your application—that it is there, that it is complete, and that it meets the HREC’s requirements. The biggest reason applications are held up is because a file was missing or incomplete or did not meet the requirements. When this happens, not only is your application delayed, but so are others’ because we spend time re-sending you our submission checklists instead of moving on to help the next person.

A good patient informed consent form will be easy to read, clear, and to the point. Avoid long, text-heavy consent forms, as these can actually hinder a patient’s degree of being informed rather than helping it. Be thorough without being overwhelming.

It is essential that a medicinal cannabis informed consent form includes a warning that driving with THC in the system is ILLEGAL in most Australia states and territories and may be detected at random roadside testing, as well as that a legally issued medical prescription does not provide protection from prosecution under these laws.

The NIIM HREC has prepared an informed consent form template to assist you in meeting these requirements. Note that the template is a template, not a complete form. You may use the template as the basis for your form, but you must edit the template to create your own form which aligns with your practice and prescribing needs. Please pay attention to this. Forms that are returned to us with our own guidance notes still on them do not inspire confidence.

DOCUMENTS

NIIM HREC APS MC Schedule Application Form 1.2

NIIM HREC APS MC Schedule Amendment Form 1.2

NIIM HREC APS MC Schedule Renewal Form 1.2

NIIM HREC APS MC Informed Consent Form Template

NIIM HREC APS Six-Month Report Form 1.3

NIIM HREC Application Fees – From August 2021

The NIIM HREC is privileged to serve an ever-growing community of Authorised Prescribers and, by extension, their patients around Australia. We are always delighted to help as much as we can. Please help us by educating yourself to thoroughly understand the elements and requirements of AP authorisation in Australia, as well as the uses and mis-uses of medicinal cannabis, and together we can continue to improve the lives of many Australians through your prudent medical care.