TGA Category Approval & What It Means For Patients

Important: The information in this article is not legal advice and is not being provided by lawyers. If you have questions about the law, please consult a legal practitioner. 

In November 2021, the Therapeutics Goods Administration (TGA) changed the medicinal cannabis access framework to help streamline the process. The changes mean that as of late November ‘21, prescribers of medicinal cannabis apply for approval to prescribe patients based on product categories, not individual products.

In this article, we’ll explain the old and new frameworks and the implications of these changes on everyone involved in the medicinal cannabis framework. If you’re interested in learning about the confusion created by these framework changes, we recommend you read our Generic or Open Script Article. 

The only patient-facing change that the category scripts creates is that when a product goes out of stock, the pharmacist may contact the doctor and determine with the prescriber which alternative product is suitable for the patient without another patient consultation. Here’s what the article covers:

• How do the current application and prescribing system work?
  • Before changes and current process
• Implications for prescribers, pharmacists and patients
• Conclusion (includes specific FAQs)

How do the current application and prescribing systems work?

To answer this question fully, we’ll give you an overview of how the application and approval system worked before the changes and how the current system works. We’ll cover the Special Access Scheme (SAS) and Authorised Prescriber (AP) Schemes so you get the complete picture.

It’s important to note that these changes to the TGA guidelines are about the application to authorise prescribing a product for a patient and how the approval works. The TGA is not specifically guiding the scriptwriting and dispensing process. So, while some of the articles you may read make it seem like the TGA is making rules around State prescriber and dispensing guidelines, the TGA has always stated that local rules apply. 

Please also note that the application processes are more complicated than outlined in the section below. Therefore, we’ve chosen to leave out the details so you understand the concepts rather than the detailed framework.

Old application process

Old Special Access Scheme (SAS) Guidelines

Under the old rules, health professionals could apply via the SAS to get approval to prescribe medicinal cannabis. The old application was for the authority to prescribe:

• A single patient with a
• Specific product for a 
• Specific condition

This meant that, upon approval, the health professional could prescribe the approved product to that patient using a single script. If the prescriber wanted to change or add a new medication, the prescriber would need to apply for each product or new product. Repeats did not need a new script, and TGA approvals were generally valid for 24 months.

Old Authorised Prescriber (AP) Guidelines

For a prescriber to become an AP, they needed to apply for Human Research Ethics Committee (HREC) or endorsement from a specialist college and then apply to the TGA for the AP approval. AP applications to the TGA were submitted for authorisation to prescribe:

• A specific product for a
• Specific condition(s) to
• Unlimited patients with that condition

This meant that, upon approval, the health professional could prescribe a specific product for the conditions they were approved for to any patient with those conditions. The AP did not need to apply for every script they wrote but needed to provide reporting to the TGA once every six months. They could always use the SAS pathway if the AP wanted to prescribe outside of their AP authorisation.

Current application process 

New Special Access Scheme (SAS) Guidelines

Under the new SAS pathway guidelines, prescribers now apply to the TGA for the authorisation to prescribe:

• A category of products for a
• Specific condition to 
• A single patient

If approved, a prescriber may write a script for any product within the approved category. The new rules also mean that if the prescriber wants to add or change medications within that category, they do not have to re-apply. This is particularly important when products go out of stock.

New Authorised Prescriber (AP) Guidelines

Under the new AP framework, the TGA created two main pathways. One requires an HREC or specialist college endorsement and approval by the TGA, and the other, called the Established History of Use pathway (EHOU), only requires TGA approval. Similar to the SAS pathway changes, the approvals are now for:

• A category of products for a
• Specified condition(s) to
• Unlimited patients with that condition

Again, we’ve left several details on these changes out of the description to make it easier to understand; however, the key takeaway is that prescribers are applying for approval to prescribe a category of products rather than a single product. 

NOTE: The EHOU pathway only applies to Category 1, 2 & 3 oils or capsules and is limited to 

• Chronic Pain (Cat 1, 2 & 3) and 
• Anxiety (Cat 1 & 2) and 
• only applies to Adult patients. 

We’ve focussed on the category change because people have interpreted the category approval as “A prescriber can now write a blank category script which entitles the patient and pharmacist to choose the product.”

Implications for prescribers, pharmacists and patients

For prescribers and health professionals, the TGA made these changes for various reasons.

The changes that moved away from product-specific TGA approvals to category approvals were to reduce the admin and workload for prescribers, pharmacists and the TGA when products go out of stock and for scenarios where the prescriber wants to change the product to a similar product for clinical reasons (where the products are within the same category).  

The changes to the AP Framework with the addition of the EHOU pathway were to allow prescribers who have experience with medicinal cannabis to reduce their admin burden and to streamline access to medicinal cannabis products that the TGA deems to be less risky than dose formats like flower.

As a result, more prescribers have taken the steps to become Authorised Prescribers, and we’ve seen SAS B approval numbers decrease as a percentage.

The implication is that when patients are eligible for medicinal cannabis, they’re likely to get access to their medication more quickly because their prescriber is more likely to be an AP. When products go out of stock Australia-wide, patients don’t need to wait for weeks to see their prescriber to access a new script for a product in stock. Pharmacists may now substitute products that are out of stock Australia-wide and don’t need to deal with upset patients because of the red tape and resulting lag in approvals.

Conclusion

In making these updates to the framework, the TGA has streamlined parts of the process to improve access to medicinal cannabis for patients. The reduction in admin from category approvals has been a factor in getting more health professionals to try prescribing medicinal cannabis. More prescribers have become APs, which means less wait time for products, and patients have better access to medication when products go out of stock Australia-wide, which is unfortunately still happening regularly. 

While these outcomes seem positive for all parties involved, not everyone has received the changes as positive. The TGA category changes have raised questions and, at times, conflict around whether Generic/Open Scripts are valid prescriptions and if pharmacies should dispense these scripts. 

While the TGA has provided clear guidance around the implications of the category changes, the TGA does not regulate prescribers and pharmacists. Some health professionals around the country argue that the Generic/Open Script is a valid prescription. To learn more about this ‘new’ prescription format, read our Generic or Open Script Article.

FAQs