Regulating access to offshore testing

11.85 DP 66 noted that individuals in Australia can access overseas genetic testing services with relative ease using the Internet and the postal service. The problems involved with regulating such access were referred to in a number of submissions.[117]

11.86 While it may be possible to regulate the supply and advertising of genetic testing products directly to the Australian public through the Therapeutic Goods Act and regulations, effective regulation of genetic testing services provided overseas by foreign companies and advertised through the Internet is more difficult. Moreover, ensuring accreditation of all genetic testing performed in Australia will not necessarily overcome concerns about access by individuals to non-accredited genetic testing conducted overseas.

11.87 DP 66 noted that federal legislation has been enacted to restrict access to certain forms of Internet content such as offensive material and interactive gambling.[118] These laws and associated industry codes could serve as models for regulating the advertising on the Internet of genetic testing services.[119] For example, the online content scheme provides that any person may complain to the Australian Broadcasting Authority (ABA) if they believe Australians can access prohibited or potentially prohibited online content using the Internet.[120] If the content is hosted overseas the ABA notifies the content to the suppliers of filter software in accordance with procedures outlined in the Internet Industry Association Codes of Practice.[121]

11.88 The Interactive Gambling Act 2001 (Cth) reflects a similar attempt to regulate Internet content hosted overseas. Complaints about interactive gambling content hosted outside Australia are investigated by the ABA and, if the content is found to be prohibited, the ABA will notify the content to the makers of Internet content filter software.[122]

11.89 There are major technical difficulties in preventing access in Australia to Internet material hosted overseas because no blocking technique is completely effective.[123] Nevertheless, in relation to online offensive material, the government has concluded that, where it is technically and commercially feasible to prevent access in Australia, this should be done. The fact that such regulation may not be completely effective was considered ‘no reason not to try to align online content regulation with regulation applying to conventional media’.[124]

11.90 Although the regulation of offensive material and interactive gambling on the Internet provide some comparisons, the Inquiry has concluded that it would be premature to implement a similar regime intended to restrict Internet advertising of products or services used in direct to the public genetic testing.

11.91 The advertising of genetic IVDs is already subject to the restrictions contained in the Therapeutic Goods Act, the Therapeutic Goods Regulations and the Therapeutic Goods Advertising Code. These restrictions also apply to Internet advertising. For example, it is an offence to advertise a genetic IVD on the Internet[125] unless the device is listed.[126] However, while advertising of therapeutic goods on the Internet is regulated when the Internet service provider is based in Australia, the TGA is unable to regulate advertisements of any nature when the Internet service provider is based overseas.[127]

11.92 There has been some recognition that advertising therapeutic goods (and medicines in particular) on the Internet may need specific regulation. For example, in 2001, the final report of the National Competition Review of Drugs, Poisons and Controlled Substances Legislation stated:

A number of stakeholders raised the issue of advertising [medicines] via the Internet. The Review noted that the current advertising restrictions apply to all forms of advertising, including the Internet. However, the capacity of the Commonwealth, State and Territory governments to regulate Internet advertising originating from overseas sources is limited. This is an international problem and one which the Commonwealth government and the governments of other countries are attempting to resolve. The Review was also concerned about the potential dangers facing consumers who purchase medicines from Internet suppliers.[128]

11.93 The public health and safety implications of Internet advertising of medicines can be expected to be even more significant than those relating to the Internet advertising of direct to the public genetic testing. To date, no regime has been implemented specifically to prevent access to Internet material that is hosted overseas and advertises therapeutic goods.

11.94 The Queensland Government noted that federal, state and territory trade practices legislation may already regulate Internet advertising sufficiently to address concerns relating to direct to the public genetic testing and submitted that:

Other methods of safeguarding the interests of consumers may be more effective than imposing a legislative regime that requires surveillance and enforcement. Other methods may include an education campaign through doctors’ surgeries, legal offices, schools and hospitals to assist consumers to make informed decisions and permitting accredited laboratories to advertise their NATA accreditation.[129]

11.95 With these considerations in mind, the Inquiry has concluded that any consideration of options for regulating advertising on the Internet of genetic testing provided directly to the public should take place as part of addressing concerns about the Internet advertising of therapeutic goods generally, rather than in the context of the present Inquiry.

[117] Commonwealth Department of Health and Ageing, Submission G150, 15 April 2002; Medical Practitioners Board of Victoria, Submission G155, 10 April 2002; Confidential Submission G022CON, 3 December 2001; Office of the Federal Privacy Commissioner, Submission G143, 22 March 2002; Genetic Technologies Corporation Pty Ltd, Submission G245, 19 December 2002; Department of Human Services South Australia, Submission G288, 23 December 2002; Association of Genetic Support of Australasia, Submission G284, 25 December 2002; Queensland Government, Submission G274, 18 December 2002.

[118] See Australian Law Reform Commission and Australian Health Ethics Committee, Protection of Human Genetic Information, DP 66 (2002), ALRC, Sydney [5.66]–[5.69].

[119] See Broadcasting Services Act 1992 (Cth) s 216B; Sch 5; Internet Industry Association, Internet Industry Codes of Practice for Industry Self Regulation in Areas of Internet Content Pursuant to the Requirements of the Broadcasting Services Act 1992 as amended (9 May 2002), Australian Broadcasting Authority, <>, 20 February 2003; Interactive Gambling Act 2001 (Cth); Internet Industry Association, Internet Industry Interactive Gambling Industry Code: A Code for Industry Co-Regulation in the Area of Internet Gambling Pursuant to the Requirements of the Interactive Gambling Act 2001 (9 May 2002), Australian Broadcasting Authority, <>, 20 February 2003.

[120] Under the legislation, prohibited material is defined on the basis of the current national Classification Code, as RC and X-rated material, and R-rated material hosted in Australia that is not protected by adult verification procedures.

[121] Department of Communications Information Technology and the Arts, Broadcasting and Online Regu­lation — Online Content, DCITA, <,,0_1-2_10-3_481-4_106158,00.html>, 20 February 2003. A number of filter products are listed in the IIA Codes (scheduled filters). One of the criteria for inclusion of filters on the schedule is ability to be updated to reflect notifications from the ABA. Internet service providers are required to provide, on a cost-recovery basis, one or more of the scheduled filters for the use of their subscribers.

[122] Ibid.

[123] See eg P Greenfield, P Rickwood and H Tran, Effectiveness of Internet Filtering Software Products (2001) CSIRO.

[124] Department of Communications Information Technology and the Arts, Frequently Asked Questions, DCITA, <,,0_1-2_10-3_481-4_13871,00.html#Filtering>, 11 October 2002.

[125] Under the Act, an ‘advertisement’ in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods: Therapeutic Goods Act 1989 (Cth) s 3(1).

[126]Therapeutic Goods Regulations 1990 (Cth) r 6(1)(f). Unless the advertisement is directed exclusively to health professionals: Therapeutic Goods Regulations 1990 (Cth) r 4.

[127] The TGA may liaise with consumer affairs bodies in the relevant country regarding inappropriate advertising material which is either mailed to Australian addresses or is placed onto the Internet: Commonwealth Department of Health and Ageing, Submission G313, 6 February 2003.

[128] R Galbally, Review of Drugs, Poisons and Controlled Substances Legislation Final Report, Commonwealth of Australia, <>, 20 February 2003.

[129] Queensland Government, Submission G274, 18 December 2002.