Accessing Medicines through the Special Access Scheme

Please note: This article details an out of date procedure for accessing medicines through the special access scheme. Please visit TGA for the current procedure for accessing medicines through the special access scheme.

Introduction

Medicines and medical devices are generically termed ‘therapeutic goods’ in Australia. The Therapeutic Goods Administration (TGA) website broadly defines therapeutic goods as products for use in humans, in connection with:

• Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
• Influencing, inhibiting or modifying a physiological process
• Testing the susceptibility of persons to a disease or ailment
• Influencing, controlling or preventing conception, or
• Testing for pregnancy.

Examples of therapeutic goods include bandages, medicines and complementary therapies.

Most therapeutic goods are evaluated for quality, safety and efficacy by the TGA, before they are be included on the Australian Register of Therapeutic Goods (ARTG), and supplied in Australia. The major legislation dealing with the regulation of therapeutic goods in Australia are the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations).

Situations sometimes arise where a medicine, or a medical device, is required that has not been approved. In these instances, the therapeutic goods may be exempt under the Act, and do not require listing on the ARTG prior to supply. However, in such cases, the TGA is unable to guarantee the quality, safety and efficacy of the unapproved product and its use is therefore regarded as experimental.

Access to these exempt therapeutic goods is managed by the TGA through various mechanisms, including:

• The Special Access Scheme (SAS), categories A and B
• Clinical trials (CTN and CTX Schemes)
• Authorised prescribers, and
• Importation for personal use.

In order to access unapproved therapeutic goods under the SAS, medical practitioners must follow a specified application process.

Application Process

The SAS refers to an arrangement which allows for the importation and/or supply of unapproved therapeutic goods, on a case-by-case basis. The TGA does not make distinctions between different medicines or therapeutic classes, therefore, there is no list maintained by the TGA of SAS medicines or medical devices. With the exception of drugs of abuse where the manufacture, possession, sale or use is prohibited by State or Territory law, any unapproved therapeutic good can potentially be supplied via the SAS. For drugs of abuse, the supplier must also ensure they hold all the relevant permits and licences relating to the specific type of product. It is important for the supplier to also confirm whether the therapeutic product is controlled under the Customs (Prohibited Import) Regulations 1956.

Applications under the SAS are made to the TGA by medical practitioners, usually the treating doctor, who should have a thorough understanding of all the relevant and available information about the product prior to its use. They should also discuss treatment using an unapproved product with the patient and obtain their informed consent.

Specifically, the patient should be informed of the following:

• The product is not approved in Australia
• The possible benefits of treatment, including any risks and side effects, and
• Any alternative treatments using approved products which are available.

Patients are grouped into two categories under the scheme, with the determination of classification lying with the prescribing medical practitioner. The application process varies, depending on which category the treating medical practitioner deems to be more appropriate for the patient.

• Category A patients are defined as ‘persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment’.
• Category B patients are all other patients that do not fit the Category A definition.

Category A Patients

Medical practitioners may initiate supply to seriously ill patients without TGA approval, provided the TGA is notified within 28 days, using the Category A form.

After completing the Category A form, copies are sent to the supplier of the product and to the TGA. Generally, the supplier will be the dispensing pharmacist, regardless of whether they are based in a community pharmacy or a hospital pharmacy. The SAS Category A form gives the supplier the legal authority to supply the unapproved therapeutic good for that patient only.

In order to provide urgent treatment of very unwell patients, suppliers may stock these items in anticipation of receiving a completed Category A form. However, supply may only occur after the Category A form has been received.

Unlike Category B, the Category A application process only requires notification of the TGA. Letters of approval or acknowledgement are not issued, as such is not required prior to supply, partly due to the risks of adverse effects being less than the potential for benefit in this group of patients.

Category B Patients

Applications for Category B patients require approval from a delegate who represents the TGA. All approvals are given on a case-by-case basis to reflect the needs of different patients. Whilst medical practitioners are not restricted to using the Category B form, the application should be made in writing, where possible, and must include the same information as stipulated on the form. Table 1 shows the specific information required by the TGA for Category B patient applications.

Table 1. Information Required by the TGA for Category B Patient Applications.

Once approved, the TGA will send a letter of advice to the medical practitioner. Generally, medical practitioners can expect the TGA to prepare and post the response for commonly requested products approximately two business days after receipt of the application. However, the turnaround time for products not previously requested under the SAS may take longer.

Should there be an urgent clinical need for access to the product via the SAS, then applications should be notated with “Urgent: Fax Response ASAP” and faxed to the TGA directly. In a limited number of cases, phone approvals may be granted if the clinical need is extremely urgent.