Helen Polley (Tasmania, Australian Labor Party, Shadow Assistant Minister to the Leader (Tasmania)) Share this | Hansard source

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017 primarily implement reforms flowing from the expert panel review of medicines and medical devices, also known as the Sansom review. This is the second tranche of legislation following the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, which was passed in the middle of last year. These bills were referred to the Senate Community Affairs Legislation Committee on 30 November and the committee handed down its report on 2 February.

I turn now to the detail of the legislation. Schedule 1 of this legislation provides a pathway for the provisional registration of promising new medicines. These will be included in a new class of therapeutic goods, which will be known as provisionally registered goods. Sponsors will be able to apply for this provisional registration subject to the Therapeutic Goods Administration reviewing and accepting early clinical data on the efficacy and safety of the medicine. That registration will be limited to a two-year period, although they may apply for up to two extensions. Sponsors will also be required to comply with additional conditions relating to the efficacy and safety of these medicines after it is available on the market.

Whether we are talking about medicines, medical devices or procedures, there are always risks. In many cases those risks may be very low, but they are there and patients often do not fully appreciate this until after something has gone wrong. The potential risks must, however, be weighed against the potential benefits. In many situations it is the patients themselves who must weigh up these risks and benefits, hopefully with the guidance of health professionals. Patients who are presented with the same risks and benefits may well reach different conclusions about what is right for them. Even with medicines that have been in use widely and for a long time, new information may become available. That new information may improve our understanding and change either side of the risk-benefit ratio.

Recognising that these medicines are based on early clinical data, it's important that doctors, health professionals and, most importantly, patients fully understand and appreciate the risks involved. With access to a medicine being given without the level of clinical data that would normally be provided, it is foreseeable that new information will show some of these medicines to be less effective than first thought, and there may be greater or new risks that weren't known at the time. Of course, the opposite could also occur. There will be strict conditions under which a medicine will be available through the provisional approval pathway. It will be for patients with unmet clinical needs for serious health conditions.

These bills also reform the regulatory framework for complementary medicines. These reforms include: establishing a list of permitted indications for listed complementary medicines by the minister through a legislative instrument; creation of a new assessment pathway for listed complementary medicines; and allowing sponsors to claim evidence of efficacy. Complementary medicines fit into two categories: they are listed or registered. Listed medicines are assessed for quality and safety by the TGA. However, they are not assessed for efficacy. Registered medicines are assessed by the TGA for efficacy in addition to quality and safety.

Schedule 2 of the bill allows the establishment of the permitted indications list, which removes the option of a free-text field for sponsors and allows only pre-approved low-level claims to be made. The National Boards and the Australian Health Practitioner Regulation Agency stated in their submission to the Senate inquiry that the current system:

… will be greatly strengthened by the removal of the free text field for indications and replaced by a more controlled approach to permitted indications.

This was an area where stakeholders' views diverged greatly. Many stakeholders made submissions to the inquiry suggesting that there should be a disclaimer in relation to indications based on traditional evidence, stating that there is no scientific evidence of efficiency.

Schedule 3 of the bill creates a new assessment pathway for listed complementary medicines and provides an option for sponsors who want to use indications that are not on the permitted indications list. In this case, the TGA would assess the evidence of the efficiency, and the sponsor would certify the quality and safety. Sponsors would then be able to indicate in their promotional material that medicine had been assessed.

Schedule 4 amends the act to provide classification so that it more accurately reflects existing administrative practices. For example, an application must meet primary requirements before it can further proceed. It makes little sense to waste resources further processing an application if that application is clearly deficient.

Schedule 5 provides changes to the act in relation to Australia's conformity assessment body. This was a major part of the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 and ensures that the TGA has the power to obtain documents relating to certification activity from these bodies and the manufacturers whom they have certified. It also enables the greater use of assessment by overseas regulators for medical devices.

Schedule 6 makes changes concerning the advertising of therapeutic goods. It allows for the TGA to be the single body responsible for management of complaints about advertising of therapeutic goods. It also broadens the sanctions and penalties available in relation to misleading advertising.

Part 2 of schedule 6 reviews existing requirements for pre-approval of certain advertisements. Presently, there are inconsistencies in which therapeutic goods require pre-approval before they are advertised to the public. For example, medical devices do not. The inconsistency also extends to the media in which goods are advertised, with over-the-counter medicine advertisements being subject to pre-approval on television, on radio and in print; however, those same goods don't need pre-approval when advertised on the internet.

The removal of the pre-approval process appeared to be the primary concern that arose from the Senate inquiry, with many civil society groups expressing alarm. CHOICE in its submission stated:

The responsibility for pre-vetting advertisements is currently split between two bodies; Australian Self Medication Industry (ASMI) and Complementary Medicines Australia. The Advertising Standards Manager at ASMI reported that in 2014/15, ASMI reviewed over 1,400 advertisements with an average turnaround time of 7 days. She noted that during this period, the majority of new advertisements assessed required changes to avoid breaching the Therapeutic Goods Advertising Code, sometimes wholesale revisions. Considering this, it is evident that this process is essential in protecting consumers against false and misleading advertising. Ceasing pre-vetting opens a floodgate of issues – advertisers can say anything they want and, while the TGA has enforcement powers, once an advertisement has been aired or published, the damage has been done and consumers are unwittingly misled.

Before any changes to this process are made, we strongly support a formal independent review of the system. Sufficient evidence should be collected that demonstrates that there is no need for pre-approval of adverts before such a decision is made.

The Public Health Association of Australia also expressed those same concerns in its submission:

The PHAA is concerned about abandoning pre-approval of advertisements without a formal review of the effectiveness of the proposed reform package. We note that the majority of published submissions to the TGA consultation on advertising reforms did not support removal of pre-approval in favour of self-regulation; with all those supporting the changes coming from industry or media organisations.

Although there is room for improvement, the current pre-approval process is largely efficient and effective. It reviews over 2,000 advertisements per year with an average turnaround time of 7 days, and identifies changes required in most advertisements it reviews to bring them in alignment with the Code. Prevention is better than cure, and the current Bill replaces a co-regulatory scheme of known effectiveness with a self-regulatory scheme of unknown effectiveness. This is particularly important for media advertisements, which may persist even once found to be in breach of the Code (for example, remaining in print media indefinitely).

Those reviews were echoed by many others. The core issue is that, if the pre-approval system is abolished, any protection can only be applied after the damage is done. Labor accepts that this legislation does provide positive measures including the improvement to post market surveillance, stronger penalties for a regulatory violation and a new complaints handling system. However, what we don't know is whether those measures will be sufficient to remove the pre-approval system without risking the increased harm that comes from misleading advertising.

This legislation implements many complex reforms. A further concern is whether implementing all of these changes in a very short time frame will overload the capacity of the TGA. Schedule 7 will allow for powers of search and entry to monitor compliance with the act. It will also allow for more graduated penalties to contraventions of the act so that the response to breaches of the act can be more appropriate to the severity of the breach. Schedule 8 makes amendments to ensure that the record keeping and reporting requirements of biologicals are consistent with other medicines. Schedule 9 makes some minor amendments to the act including improving consistency with different types of therapeutical goods.

Finally, the Therapeutic Goods (Charges) Amendment Bill 2017 primarily allows for regulations to be made to prescribe an annual charge for a conformity assessment body determination and to ensure that annual charges will also apply to provisionally registered goods entered in the Australian Register of Therapeutic Goods.

Schedules 4, 5, 8 and 9 were not controversial, and the committee heard no evidence of any concerns about the measures in those schedules. The charges bill was not of great concern, with little discussion of this bill in the inquiry submissions.

I now return to the main issue Labor had with this legislation, the removal of pre-approval process for advertisements. Labor drafted an amendment to retain the pre-approval system; however, we welcome Minister Hunt's willingness to negotiate on this matter. The government has agreed to retain the mandatory pre-approval system for two years subject to an evaluation at 18 months. We understand that the government will therefore now be moving its own amendment. Whilst we accept that some concerns remain, on balance, Labor believes that these bills are an improvement over what exists. The government's amendment and other non-legislative commitments made by the minister in his letter to Labor's shadow minister for health on 4 February this year addressed the most serious concerns we had. Labor will therefore support the government's amendments and the bill without further amendment. This will allow for swift passage of the legislation, and the provisional approval pathway for promising new medicines will be very important for patients awaiting treatment.