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NHMRC Draft Statement and Resource for Consumers: Direct-to-Consumer Genetic Testing submission

ID: 
9
This submission reflects the views of
Organisation Name: 
Therapeutic Goods Administration
Please identify the best term to describe the Organisation: 
Government department – Federal
Personal Details
Questions
Q1. Is the draft Statement presented and written in a manner that is easy to understand?: 

Yes.

Comment: The Therapeutic Goods Administration (TGA) is supportive of the development of information and education material in relation to DTC genetic testing and raising the awareness of some of the risks associated with the use of these tests, particularly where testing is performed outside Australia and is not subject to TGA regulation.

Q2. Is the draft Statement comprehensive and does it cover all of the key issues?: 

Yes, see comments below on the current regulatory status of DTC genetic tests in Australia

Current Regulatory Status of DTC Genetic Tests Supplied Within Australia

The TGA is part of the Australian Government Department of Health, and is responsible for administering the Therapeutic Goods Act 1989 (the Act). Through this Act and associated Regulations the TGA regulates therapeutic goods including medicines, medical devices, blood and blood products. This legislation provides a framework for a risk management approach that allows the Australian community to have timely access to therapeutic goods which are consistently safe, effective and of high quality.

In 2010 a new regulatory framework was introduced for in vitro diagnostic medical devices (IVDs) and has been designed to ensure that all IVDs are subject to a level of regulatory scrutiny that is commensurate with the risks associated with their use. The framework encompasses both commercially supplied IVDs as well as those that have been developed by providers for use in their own laboratories. Genetic tests that are being supplied in Australia to carry out testing on human samples, the results of which are intended to assist in clinical diagnosis and patient management, are regulated as IVDs and are required to comply with the new requirements by 1 July 2014.  

 Under these Regulations, DTC genetic tests intended to be used by a lay person, cannot be included in the Australian Register of Therapeutic Goods (ARTG) or legally supplied in Australia (unless imported for personal use).  This includes devices for self-collection of samples of saliva or blood which are then sent to a laboratory for testing where the results are then returned directly to the patient.

While members of the public are able to purchase and import DTC genetic tests for personal use only, the quality and performance of these products have not been assessed by the TGA, and the results of such tests should be interpreted with caution. As previously stated, the TGA has no jurisdiction over testing services provided by overseas laboratories. The TGA strongly recommends that anyone who is concerned about the risk of inherited diseases or disorders should talk to their doctor.

Proposed Amendments to the IVD Regulatory Framework

The regulatory status of genetic tests to determine predisposition or susceptibility to disease or condition is currently anomalous. Although these tests fall within the definition of therapeutic goods in the Act, the definition of a medical device does not fully capture all IVDs, particularly those intended to diagnose susceptibility to disease. The TGA is proposing to amend the definition of a medical device to ensure all genetic tests, including those to determine predisposition or susceptibility to a disease or condition, are subject to the IVD regulatory requirements. The proviso would still apply that a genetic test could not be included in the ARTG or legally supplied in Australia if it is intended for use by a layperson and the results are returned directly to the patient (ie, DTC genetic testing).

Q3. Is there any further advice that should be included in the draft Statement on the accuracy of DTC genetic testing?: 

No further comment.

Q4. Is more advice needed in the draft Statement on legal risks, risk rated insurance or privacy issues?: 

No further comment.

Q5. Is more advice needed in the draft Statement on the usefulness of DTC genetic testing?: 

Comment: The TGA does not regulate clinical practice nor is it responsible for making recommendations or decisions on the clinical utility and cost-effectiveness of a product for the purpose of obtaining a listing in the Medicare Benefits Schedule or Pharmaceutical Benefits Schedule.

Q1. Is the draft Resource for Consumers presented and written in a manner that is easy to understand?: 

Yes.

Comment: The TGA is supportive of the development of information and education material in relation to DTC genetic testing and raising the awareness of some of the risks associated with the use of these tests.

Q2. Is the draft Resource for Consumers comprehensive and cover all of the key issues?: 

Yes.

Comment: DTC genetic tests that do not have a therapeutic purpose, such as kinship testing, are not regulated by the TGA.

Q3. Is there any further advice that should be included in the draft Resource for Consumers on the accuracy of DTC genetic testing?: 

No further comment.

Q4. Is more advice needed in the draft Resource for Consumers on legal risks, risk rated insurance or privacy issues?: 

No further comment.

Q5. Is more advice needed in the draft Resource for Consumers on the usefulness of DTC genetic testing?: 

No further comment (comment provided at Q5 for draft statement)

Page reviewed: 9 December, 2014