Wednesday, 25 October 2017
Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, Therapeutic Goods (Charges) Amendment Bill 2017; Second Reading
The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017 further implement reforms stemming from the 58 recommendations of the expert panel review of medicines and medical devices, which reported to the government in 2015 via two separate reports. My understanding is that the government accepted in full, in part or in principle all but two of those 58 recommendations.
The Therapeutic Goods Amendment (2016 Measures No. 1) Bill began this process, recommending eight key recommendations from the review. That bill passed with Labor's support, albeit with some reservations which we held about the use of Australian notified bodies to carry out conformity assessments for medical devices. This is the second tranche of the legislation. It further supports three of the eight recommendations that were dealt with in the first bill and an additional 11 recommendations from the review. Again, Labor supports this legislation, as do, I understand, most of the stakeholders who made representations with respect to it during the consultation and, indeed, who made representations and submissions to the Senate inquiry that was held prior to the bills being debated in this House.
Specifically, these bills do a number of things that I will go to in a moment, as did the minister in his second reading speech. But for anybody who is listening to this broadcast or who is not familiar with the proposals, I will outline the intent of the bills. The bills allow for provisional registration of promising new prescription medicines by creating a new class of therapeutic goods that will be known as provisionally registered goods. This will allow sponsors to apply for a time-limited provisional registration of certain prescription medicines using early clinical data. Sponsors will also be required to meet post-market conditions relating to the efficacy and safety of those medicines.
The bills also form the regulatory framework for complementary medicines by, firstly, establishing an additional pathway for intermediate risk complementary medicines. Presently, complementary medicines are either listed on the ARTG, based on self-certification, or registered after evaluation by the Therapeutic Goods Administration. The additional new pathway will consist of a new application and assessment process for sponsors of listed complementary medicines seeking to use indications that are not on the Permitted Indications List. This will allow these medicines to be included on the register following certification by the sponsor about the safety and quality of the product, and assessment by the TGA of the evidence of the efficacy for the proposed indications; secondly, supporting the implementation of the recommendation that sponsors of relevant products be able to indicate on promotional materials and on the product label that the efficacy of the product has been independently assessed for approved indications; and, thirdly, providing the minister with the power to make a legislative instrument, specifying permitted indications for use with listed medicines.
When applying to list their medicines, sponsors will need to certify that each indication for their medicine is permitted under the new instrument. If certification was incorrect, or becomes incorrect, the listing can be cancelled from the register. This is to ensure that listed medicines, which are not assessed, only make pre-approved, low-level claims for the conditions that the medicine can treat.
The bill strengthens the postmarket monitoring powers in relation to biologicals by, firstly, adding compliance with record-keeping requirements to the standard conditions of registration; secondly, enabling the inspection of premises where documents are kept; and, thirdly, allowing record-keeping requirements for biologicals to be prescribed in the regulations.
The bill also implements stronger compliance and enforcement powers to protect the public and provide for graduated penalties that allow the TGA to respond appropriately to the full range of non-compliant behaviours. Powers from the Regulatory Powers (Standard Provisions) Act 2014 will be incorporated with some modifications, providing similar powers to other regulators in the health portfolio. The changes will remove the current requirement to prove harm, or the likelihood of harm, from strict liability offences in the act and reduce the maximum penalties for these offences. Aggravated criminal offences in the act will be strengthened by including the likelihood of harm or injury to better address culpable behaviour. Strict liability offence provisions will complement, where appropriate, existing standalone criminal offences throughout the act for matters such as breaches of conditions, licences or permits.
Existing offences in relation to advertising of therapeutic goods will be strengthened and clarified to deter inappropriate or misleading advertising of therapeutic goods. With respect to advertising, the review recommended that a single agency be responsible for handling complaints about the advertising of therapeutic goods but that the government should consider whether this should be a national regulatory authority—that is, the TGA—or another Commonwealth agency or put this function out to tender. The bill changes the advertising requirements for therapeutic goods by, firstly, repealing the requirement for certain advertisements to be pre-approved, shifting to a more self-regulatory approach; and, secondly, by providing provisions to support the TGA as the single body responsible for implementing the complaints management process about advertising of therapeutic goods and by broadening sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods.
The bill also makes changes to properly recognise Australian conformity assessment bodies. Most of the legislative changes required to enable the TGA to authorise Australian companies to undertake conformity assessments were made in the first tranche of legislation. Additional changes will enable the TGA to publish information in relation to Australian conformity assessment bodies and will ensure that it has the same powers in relation to conformity assessment certificates issued by Australian conformity assessment bodies as it does for assessment certificates that it issues.
Finally, these reforms will enable greater use of assessments of comparable overseas regulators when the TGA makes its own assessments of medical devices. Medical devices were not included in the first tranche of legislation. For the inclusion of a kind of medical device in the register, applicants will be required to certify that an appropriate conformity assessment procedure, or an equivalent procedure carried out by a comparable overseas regulator, has been carried out in relation to medical devices of that kind. I understand that the overseas regulators would be specified in a notifiable instrument. The use of overseas reports in evaluating medicines is already allowed by the act. If we trust the use of overseas agencies in our assessment process for medicines, it seems reasonable that the same should apply for medical devices.
Notwithstanding the changes, there have been several issues with medical devices in recent years, as there have been with medicines. In speaking on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, I highlighted some high-profile cases where medical devices had failed in some way. Those cases included hip and breast implants. In many cases those failures had disastrous consequences for patients. Furthermore, the Senate Community Affairs References Committee is currently inquiring into transvaginal mesh implants and related matters. I understand that many women who have received the mesh implants have experienced severe and life-changing pain and complications. I have no doubt that the TGA will closely follow the progress of the Senate inquiry, which is due to report on 30 November, and I will also have a close look at that report when it is presented.
Labor appreciates the complexity and difficulty in the regulation of therapeutic goods, but there is a need to balance the desire to ensure patients have timely access to new treatments with ensuring safety. This is more difficult when it comes to medical device regulation, which has a shorter history than regulation of medicines. Again, I have met with both patients and manufacturers of both medical devices and medicines who would like to see products on the market sooner rather than later. If you're a patient who is in a very serious medical state, any hope that is brought by a new device or a new medicine is something that you would want to see the government allow you access to. Indeed, I understand that sometimes people travel overseas to get such devices or such medicines because in overseas countries they have been approved. Therefore, if we can in any way safely fast-track access to those products, we should do so.
But there are obviously qualifications in the way we should do that, because, as we have seen with devices and medicines, in some cases problems have arisen. We never know with certainty until, sometimes, many years down the track whether those devices or medicines have side effects that were not known or not listed. Indeed, when it comes to medical devices, there is the added complexity of determining whether the device itself is at fault when an adverse event occurs or whether it was not implanted correctly. It could be either, and I suspect that in some cases it may be that it was the procedure that went wrong rather than the device itself. So all of those matters need to be taken into account.
But the important thing, and the main focus, is to provide patients with earlier access to medicines and medical devices. That's even more the case when we know that, almost on a daily basis, new products and new medicines are being brought onto the market or are being researched and developed, and it's happening at a faster rate than perhaps ever before. For the manufacturers, understandably, with the costs that go into the research and development phase of any new product, it's important from a financial point of view to have the products on the market as soon as possible in order to recoup the expenses that they have incurred when they have researched and developed the product.
For many people with a serious condition, as I said earlier, every day counts, and earlier treatment should not be unnecessarily delayed. That said, however, Labor again sounds a word of caution: great care is required when dealing with the regulation of therapeutic goods, particularly in making use of assessments of medical devices by overseas regulators over whom we have no control and on whom we rely for their integrity, or allowing bodies in Australia, for that matter, to conduct the conformity assessments. In that respect, I will quote from a letter submitted by the Royal Australasian College of Physicians in respect of the cautious advice that needs to be taken. The letter, dated 2 March 2017, which was submitted to the Senate inquiry, says:
Faster access to medicines and medical devices comes with significant implications, and a considered and at times slower approach can have advantages as it allows for more rigorous evaluation of medicines and medical devices in a real-world setting, as opposed to the homogenous setting of the clinical trial.
I believe that statement quite responsibly sums up the situation that exists and the position that we should try and adopt.
Labor support these bills, as I said at the outset, and we do so because we believe that on balance—and it is a case of having to make a judgement whether, on balance, it is in the public interest to do so—it is in the public interest. We do so with some provisos. These include that we will again look carefully at the regulations that the government draws up that will be associated with this legislation, because much of the detail and the matters that were also contained in the recommendations of the Sansom review will be contained in the regulations. Of course the regulations will not be debated in this House, although they will lie before the parliament and can be rejected. Nevertheless, the point I strongly make is that many of the changes will be made by regulation, and we will have a close look at that at that time.
The other matter I want to reinforce is a matter that I talked about when I spoke the first time with regard to the first tranche of changes that were made to the TGA process—that is, the TGA has a very sound track record on ensuring that medicines and medical devices not only comply with the claims made by manufacturers but are also products that can safely be used, based on all the evidence presented to the TGA. Indeed, it has been the TGA that at times has been a leader in identifying problems or unreported risks of products and, in turn, has then asked for those products to be removed from the market. It is an authority that I believe Australians can have a great deal of confidence in. The outsourcing of some of the responsibilities to private bodies may lead to a downsizing of the TGA. That is a concern that we have, because if the TGA is downsized then its ability to continue to carry out its functions and its responsibilities may also be compromised. It is a matter that we will also watch over with close interest, because we don't want to see the TGA in any way diminished in its ability to carry out the role that it has done so well for so many years and in which the public have a high degree of confidence.
In closing my remarks, I say that this has been a long process. It is a process that started in 2014, when the inquiry was established, and then continued with the report in 2015 and finally the legislation that was brought before this parliament in 2016. It is now 2017. It just highlights the cautious approach that is required when we're dealing with medicines and medical devices. That caution will continue, and it's my view that, with all of the changes that have been proposed both in the first tranche of legislation and in this legislation, there ought to be a consistent, close monitoring by both the TGA and the government of the changes and how well they are working out there in the community. We will watch with interest not only how well these changes are received but also what impacts they have on the community. With those comments, I repeat: Labor will be supporting this legislation.