DRW Monthly
November 2008
Issue No. 24

Regulatory Paths to Access Unapproved Medicines and Medical Devices in Australia

The Australian Register of Therapeutic Goods (ARTG), which was established under the Therapeutic Goods Act 1989, divides therapeutic goods into two broad categories: medicines and medical devices. All approved medicines, unless exempt, must be entered into the ARTG computer database as either 'registered' or 'listed', if medicines, and 'included', if devices, prior to being manufactured, supplied, imported into, or exported from Australia. Unapproved therapeutic goods are classified as exempt if they meet specific criteria within the Therapeutic Goods Administration (TGA) regulatory framework.

Exemption provisions outlined in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations permit unapproved medicinal and medical device products to be supplied through four channels:

• Personal Importation;
  
• Clinical Trials;
  
• Authorised Prescribers; and
  
• Special Access Schemes.
  
  

Although the exemption process is generally the same for unapproved medicines and medical devices, the laws governing medicines are located in the Therapeutic Goods Regulation 1990 while those governing devices are based on the Therapeutic Goods (Medical Devices) Regulations 2002.

The Personal Importation procedure is employed when "an individual either brings a therapeutic good into Australia on their person or arranges from within Australia for a therapeutic good to be sent to them from an overseas supplier; and, the goods are to be used by that individual or a member of his/her immediate family and are not sold or supplied to any other person."(1) The total supply requirements limit a personal importer to a three month supply per importation and the total quantity per year cannot exceed 15 months supply at the manufacturer's recommended maximum dosage. In addition, the importer is also responsible for ensuring they have complied with all relevant Commonwealth and State/or Territory laws. Products that require additional import permits for personal importation include:

• Substances that are prohibited imports under the Customs legislation;
  
• Products which are injections;
  
• Products which contain material of biological origins; and,
  
• Products that contain substances derived from endangered species(2)
  

Sponsors who choose to apply for access to unapproved therapeutic goods through the clinical trial path, may use either the TGA regulated clinical trial notification (CTN) or clinical trial exemption (CTS) scheme. The majority of clinical trials conducted in Australia are carried out under the CTN scheme. The Human Research Ethics Committees (HRECs) have the primary responsibility for monitoring the conduct of these trials and approving the trial protocols. Ongoing HREC monitoring and supervision is guided by the principles and practices outlined in the National Health and Medical Research Council's National Statement on Ethical Conduct in Research Involving Humans. The TGA is not required to review any data relating to the clinical trial.

The CTS scheme, by comparison, must be approved by the TGA's Secretary of the Department of Health and Ageing. Sponsors must submit a seven-part application covering risk analysis, serious adverse events, administrative and scientific aspects of the trial, product design and manufacturing information, preclinical and clinical data, and information for ethics committees. The CTX application provides sponsors with a TGA review of relevant, but limited, scientific data prior to beginning a clinical trial. This feedback can be very helpful in the development of therapeutic goods that are in the early developmental phases. Several trial protocols may be conducted under a single CTX application as long as they are all consistent with the TGA's approved Usage Guidelines.(3)

The Authorised Prescriber route to accessing unapproved therapeutic goods is available to medical practitioners who may apply for the designation to provide immediate care to a patient with a life-threatening or serious illness or condition. The TGA is able to grant certain physicians this authority based on the practitioner's training and expertise appropriate for the condition being treated and the proposed product use. Moreover, it is presumed that the Authorised Prescriber is best able to determine the patient's needs and to monitor the outcome of the therapy. The Authorised Prescriber may only use the product on his/her own specified patients and may not give other practitioners access to this product. Applications must include information on the indication, clinical justification, product details, prescriber details, safety and performance data, informed patient consent, an ethics committee endorsement, and a signed "Agreement to Treatment Directions" form.(4)

The Special Access Scheme (SAS) is the final avenue that may be used to access unapproved therapeutic products. This mechanism refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis, through his/her medical practitioner. Patients classified as Category A are defined as those persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which a premature death is reasonably likely to occur in the absence of early treatment(5). For these patients, physicians are permitted to supply unapproved medicines and devices without the approval of the TGA, but the TGA must be notified. Patients classified within Category B include all other patients. For this category, approval is given by a TGA delegate or an external delegate outside of the TGA. It is the medical practitioner's responsibility to classify a patient as Category A or B. The practitioner must write an SAS application and be able to justify on medical grounds why his/her patient requires the unapproved product. The treating doctor is in the best position to determine the patient's needs, including whether or not treatment with a particular unapproved product is required. It is expected that, in accordance with good medical practice, a medical practitioner will educate him/herself with all relevant and available information about an unapproved product before using it.(6)

More recently, the TGA has focused on developing its consolidated publication, the Australian Regulatory Guidelines for Medical Devices. The most current document issued as part of this project is the new draft guideline providing clarification on accessing unapproved medical devices. This web-based reference will replace all existing guidance documents and information sheets for medical devices. The TGA anticipates that the project will be completed by the end of the year.

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