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Community Affairs Legislation Committee
Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

ALEXANDER, Ms Susan, Chair, Regulatory Affairs Working Group, Medicines Australia

de SOMER, Ms Elizabeth, Director, Policy and Research, Medicines Australia

KARPISH, Ms Larissa, Manager, Industry and Regulatory Policy, Medicines Australia


CHAIR: Welcome. Is there anything you wish to add about the capacity in which you appear today?

Ms Alexander : I am also the Director of Regulatory Affairs for Roche, one of the member companies of Medicines Australia.

CHAIR: Excellent. I would like to confirm that you have all received the information on parliamentary privilege?

Ms de Somer : Yes.

CHAIR: If any or all of you would like to make an opening statement, you may, and then we will proceed to questions.

Ms de Somer : We have prepared a written statement. I would just like to read from that.

CHAIR: Yes; excellent. We have a copy here.

Ms de Somer : Great. Thank you for the invitation to appear today. Medicines Australia is the peak body representing the research based pharmaceutical industry, who provide up to 86 per cent of the prescription medicines currently available to patients on the Pharmaceutical Benefits Scheme. Medicines Australia and its members strongly support the Therapeutic Goods Administration in its role as the independent regulator of medicines, and, firstly, we would like to say that the TGA is a first-class regulator of prescription medicines and is highly respected internationally. Australia has globally recognised standards for approval of medicines through the TGA, which is something we should be proud of and should preserve. It is also very well regarded for its consultation with healthcare professionals, the industry and the community at large.

In this context, Medicines Australia has welcomed the proposed reforms enabled by this bill. These reforms will further strengthen the role of the TGA in its ability to provide more efficient, streamlined and expedited availability to medicines through multiple regulatory pathways. The reforms enacted in the bill will be underpinned by a robust postapproval monitoring framework—to the senator's earlier heads-up: thank you!—which will ensure ongoing safety and quality of medicines in the community.

The proposed reforms are the result of a thorough and considered review of the TGA and its statutory and administrative functions. This review—the medicines and medical devices review—was led by a panel of independent and eminent experts and began in 2017. So, it has been going for a while. The stated principle underpinning the review—that the role of regulation is to protect public health and safety—is upheld in the proposed reforms. During the medicines and medical devices review, over 100 submissions were received and the review panel met with more than 60 organisations during the consultation process. Medicines Australia welcomed the government's adoption of 56 of the 58 recommendations of this independent and expert review.

The extensive consultation during the review resulted in consensus between the industry and the broader community in many important areas, including reducing unnecessary regulation, harmonising to international best practice, eliminating duplication and using resources appropriately, and ultimately ensuring that the system in Australia is fit for purpose for the Australian public. The bill contains reforms that can be implemented only through legislation and that are the most impactful for medicine's availability to patients in the near term.

We would like to highlight some key areas that will significantly benefit Australian patients. These are earlier and more efficient medicines access, improvements to postapproval monitoring processes and improvements to the management of variations to the register. With regard to earlier and more efficient medicines access, in 2015 the Community Affairs Reference Committee's inquiry into access to cancer medicines highlighted significant inefficiencies in the processes for approving medicines, and this concurred with many of the concerns that were raised by the community, patients and clinicians during the course of the medicines and medical devices review that Australia's regulatory system is not delivering medicines to patients quickly enough. These inefficiencies were further confirmed.

Consultations across the sector and the community uncovered a range of alternative assessment pathways that would and could provide a flexible and fit-for-purpose approach to assessing, evaluating and ultimately approving new medicines, the goal being to harness efficiency, reduce waste of resources, eliminate duplication and enable patients to get the best medicines they need at the earliest opportunity. This bill will ensure that the new expedited pathways are available for certain new treatments to enter into our health system in a more timely and efficient way, ultimately for patients. This is consistent with regulatory systems in Europe and the US—for example, priority review, which is one of the reforms. Medicines that offer substantial benefits over existing therapies or which address an area of really high unmet clinical need could be available to those patients in half the current time, not from less evaluation and assessment and not from inefficient assessment but from more efficient and flexible ways of receiving, reviewing, evaluating and assessing the quality, safety and efficacy of these medicines and weighing up the risks and benefits for patients.

With regard to improvements in postapproval monitoring, the bill enables the TGA to introduce further enhancements to the existing postmarket monitoring surveillance scheme for medicines. For example, some of the enhancements to postmarket monitoring will identify very clearly to health professionals and consumers that a new medicine has been improved under an expedited pathway and therefore will be subject to specific monitoring by the TGA.

With regard to improvements in the management of variations, under the reforms notification of variations to a medicine's registration details will be streamlined. This will apply only to variations that do not impact on the quality or safety of a medicine but will help to ensure that minor administrative functions do not delay or disrupt continuity of supply for some important medicines. This notification system is available in the EU, and the TGA can benefit from adapting a harmonised approach.

In closing, the proposed reforms enabled by this bill will preserve the TGA as the sovereign decision-maker on medicines regulation, with public health and safety at the core of all decisions. To be clear, there will be no diminution of the role of the TGA but, rather, a strengthening of its functions and its ability to adapt to international best practice, respond to public health issues and ensure quality use of medicines. Thank you, and we welcome your questions.

CHAIR: Thank you for your submission and for that comprehensive opening statement. We will go to questions.

Senator WATT: Thank you, everyone, for coming along today. In an overall sense, you are pretty happy with the bill. I think everyone has an interest in seeing effective medical treatments, whether they be drugs, devices or anything else, come onto the market as quickly as possible with the proviso around patient safety, obviously. In your written submission you point out that the Sansom review made 58 recommendations and the government accepted 56. I understand this bill implements eight of those recommendations. Do you know what has happened to the other 48?

Ms de Somer : I will answer initially and then I might refer to my colleagues if they have any additional information. The bill was to enable the most important and most impactful parts of the reforms to be introduced, and we understand that a lot of the other reform measures will be enacted by regulations and changes to business practice and later legislative reforms will come through. The details of that are probably better put to the TGA who will know what their program of legislative change is and what the drafting requirements might be, but we understand that it was on the most impactful for patients at the earliest.

Senator WATT: You say 'the most impactful'. In whose view? Is that in industry's view or was there some kind of broader consultation?

Ms de Somer : We certainly did not select which measures would be put to the bill in any way, so this is obviously a question that might be better put to the TGA, but, looking at it from our perspective, we would expect that the major benefits are for the patients.

Senator WATT: Did anyone want to add to that?

Ms Alexander : No.

Senator WATT: But you were obviously supportive of these eight in particular being moved along, at least as a first stage?

Ms de Somer : We are supportive of all of the reforms that have been accepted and adopted by the government. We believe that there is probably some low-hanging fruit that would be of benefit to the consumers more quickly and also of some benefit to industry as well.

Senator WATT: Are there other recommendations from the Sansom review that you consider urgent and quite easily achievable that have not, as yet, been picked up in this bill?

Ms de Somer : I will ask my colleague, Ms Alexandra, if there are any that we think should be expedited.

Ms Alexander : In the consultations and discussions that I was party to, it was clear that there was a frustration in the fact that expedited pathways were not available for evaluations of some of our medicines. There are a lot of things that come into what might get something to patients faster, but the fact was that it did not seem that it was reasonable that some medicines can be available to patients in Europe and the US and they are not available here. I would say that, picking up on that one thing, that was the most obvious thing to deliver first.

The other thing that probably benefits the industry and the TGA potentially more than patients is the simplification to the variation process. Essentially, up until now we have been unable to do anything, even if it is quite simple like changing your address, without making an application to the TGA. So, if you would think in that context, it is just obvious that we would roll up some of those things which would just take away an administrative process and make it easier. But of the remaining, no, I do not see that there has been anything left for later that should be done now.

Senator WATT: What do you consider will be the particular benefits to your members in approving and getting these eight recommendations through?

Ms de Somer : The important thing that my members see with the reforms as they sit is that there is a more flexible and fit-for-purpose system being proposed that will enable industry applicants to register medicines in Australia in a more timely and efficient way and seek greater parity with the time that medicines become available to patients in overseas jurisdictions. Previously, there has been criticism in the media of delays in access to medicines or availability of medicines to patients in Australia. This is seen as a tool that would be useful for the regulator to enable access to and availability of medicines for patients in a more timely and efficient way. So the benefit for our members obviously is some of that efficiency in the time for the evaluation to take place.

Senator WATT: You and other witnesses have talked about the improvements in terms of time frames for approvals. Do you also think that making these amendments will potentially allow certain medicines or devices to actually get onto the market at all, when the current system effectively prevents that from happening, or is it really just a matter of time frames?

Ms de Somer : I don't think you could make that assumption, because that would imply there were some diminution of the powers and ability of the TGA to make very robust decisions. I certainly will not be speaking on behalf of devices, but from prescription medicines there is nothing in the bill or in the reform measures that would reduce the TGA's powers and abilities to make full assessment of medicines.

Senator WATT: You have mentioned that the TGA has commenced consultation on regulations that will follow this bill. I think that was in your written submission. Can you tell us a little bit about what consultations occurred, and your involvement so far?

Ms de Somer : I will refer to the chair of the Regulatory Affairs Working Group for Medicines Australia, who has been party to those consultations.

Ms Alexander : I don't want you to mistake that a draft set of regulations has been constructed by the industry and the TGA. But if I could put it in the context that we have been looking at regulatory reform for a long time. All of you may be aware that we were going to have a joint regulatory authority, and it was on and off the table for many years. In preparation for that joint authority there were many consultation sessions between the regulators and the industry and other stakeholders as to what might be in and what might be out and what would be preferable. I think it has allowed us over a long period of time to really assess what the TGA should be doing, what the TGA is capable of, how we can best marshal resources, both by TGA and industry people, and ensure that we have a framework where we feel that we can do what is intended here, which is to basically have well-understood processes that allow for a product to go through the appropriate pathway and be done as soon as possible. So I would say that the extended consultation we have had is not specific to this bill, but it rolls over a long period of time over successive frameworks where we have been looking at regulatory reform and I think we are all very well aware of the capabilities of the industry and the regulator to do what needs to be done.

Senator WATT: I hear what you are saying—that it is not as if there are draft regulations that people are looking at.

Ms Alexander : We aren't.

Senator WATT: Are you aware of any regulations that are in the pipeline that are even being talked about in the genetic sense, as opposed to 'here they are' as a draft?

Ms de Somer : I think that the consultation process is more about what will be required in order to enable the bill—the legislation and the regulations—and the information that has been gathered across multiple consultations will inform the TGA when they do start to draft regulations. We are not aware of any regulations that are drafted.

Senator WATT: Do you have a view on the kinds of things that will need to be done by regulation to operationalise the bill?

Ms de Somer : The devil is in the detail, I think, with every regulation, so it will be important that the regulations do cover every aspect of the requirements on both the industry and the regulator in making sure that they are able to implement the reforms in the way that they are intended.

Senator WATT: Can you give us a couple of examples of topics that are likely to be the subject of regulations?

Ms de Somer : The criteria that would enable a product to be submitted for a priority review. Our understanding of a priority review is that they are to be specifically for products of high unmet clinical need or for urgent or immediate emergency access, and there will obviously need to be some criteria developed to enable the distinction between products that will be evaluated through a priority review rather than a normal other process review, for example.

Senator WATT: You would have heard the evidence from the Consumers Health Forum. They made the point about the risks associated with third-party review of what they call high-risk—I think there were more talking about devices—

Ms de Somer : Devices, yes.

Senator WATT: But it is conceivable that they might be a situation where a similar concern would arise around a drug. Do you have a view about whether third-party review should apply to all drugs or should there be a threshold?

Ms de Somer : Can I ask you what you mean by a third-party review, in the context of prescription medicines? Do you mean looking at overseas regulatory—

Senator WATT: Yes.

Ms de Somer : There is nothing in the bill and my understanding of the bill that would suggest that the TGA will accept carte blanche a decision from overseas regulator. The purpose of having access to overseas regulators' decisions is to inform the TGA's own sovereign decision-making, but the decision will still rest with the Australian regulator. So I think that the risk of a decision from overseas regulator just being adopted is not a real risk. The TGA does retain all of its powers and functions to make the decision and will be making the decision. If they felt that the Australian context of that overseas regulators decision-making did not fit Australia then they could go down a number of pathways: either completely review the medicine themselves or choose not to approve the medicine, if they felt that was appropriate. Again, that is probably a question best put to the TGA, but that is our understanding of how it would work.

Senator WATT: You have made very clear that you think the bill will also enhance patient safety. What aspects in particular within the bill do you think will do that?

Ms de Somer : Consumers—and we heard from Consumers Health Forum—have high expectations of the health care they received today and are wanting to know as much as possible about medicines. The post-market surveillance mechanisms that the TGA has proposed to ensure really robust monitoring of medicines once they are in the community will give clinicians, doctors and patients very clear visibility of new medicines. There will be, I believe, enhancements to encourage and enable patients and doctors to better report any adverse or side-effects that they may feel are related to medicines, and very close monitoring of the impact of new medicines on patients in the real world. In terms of safety it would enable early pickup of any potential signals that might suggest there is more information that needed to be gathered. There are already quite robust mandatory requirements for manufacturers to provide ongoing safety and quality data. That will be strengthened in many ways and linked to very visible labelling for patients and for doctors around new medicines, so that they are well aware of where they are in the market.

Senator WATT: Regarding post-market assessment and monitoring, you point out in your submission that the bill does implement recommendation 27 of the Sansom review, which I think related to post-market assessment, and particularly some issues around transparency of information that should be provided. I see that that recommendation has five very specific sub-recommendations, which I can take you to if necessary. Do you have a view on whether the bill does effectively implement each of those specific sub-recommendations in this area?

Ms de Somer : I am just reading recommendation 27 to refresh my memory.

Senator WATT: Perhaps I should read them out for the record:

1. Better integration and timely analysis of available datasets, including analysis of matched de-identified data from the Pharmaceutical Benefits Scheme, Medical Benefits Scheme, eHealth records, hospital records, private health insurance records and device and other relevant registries and datasets;

2. Establishment and maintenance of registries for all high-risk implantable devices;

3. Implementation of a scheme to alert practitioners and consumers that a drug is newly registered and to encourage reporting of any adverse events;

4. Provision for electronic reporting of adverse events; and

5. Enhanced collaboration with overseas NRAs to share information relating to safety or efficacy.

It is one thing for the recommendation, in an overall sense, to be implemented, but are you confident that the bill adequately deals with those five sub-recommendations?

Ms de Somer : I think that the bill adequately enables the TGA to introduce these enhanced postmarket monitoring mechanisms. How that is done and where it will be pinpointed will be in the regulations. It is important, in my view, for the legislative bill not to overly constrain those mechanisms just to those five, and to enable evolution if more enhancements are required over time. The bill enables that flexibility to even go beyond those five over time if required. We are all holding our breath and hoping for better integration time, analysis and management of available datasets, and I would say the industry broadly is very hopeful that that will be enacted and enabled. There definitely appears to be an intention and a willingness to do so.

Senator WATT: I am taking a step back and thinking about what we have been hearing so far today. It does feel that, generally speaking, people are quite comfortable with the architecture that is being proposed in this bill, but a lot of trust is being placed in regulations, and the way the department and the TGA carry out their functions, to ensure that the objectives around patient safety and access are actually delivered. Would you agree it is a little bit difficult for any of us to really draw conclusions about whether access and patient safety are assured when there are a whole range of other matters such as regulations that have yet to be drafted and presented? We are placing a lot of trust in what comes next.

Ms de Somer : I cannot say I am an expert in how the legislative processes work. I would imagine that the legislation has to be considered first before the regulations are drafted and therefore I think with any legislative amendment the regulations would come next. I am confident that there will be quite extensive consultation over the regulations and opportunity to ensure that those regulations meet the intention of the bill. That is my expectation, and that of the industry, the broader community and the clinicians.

CHAIR: And regulations are disallowable instruments in the parliament.

Senator WATT: Yes, I was just thinking that.

Ms de Somer : I take the senator's point that the devil will be in the detail of the regulations, and I would absolutely anticipate and expect there to be sufficient time for robust and thorough examination of those regulations before they came into being.

Senator WATT: Perhaps our friends in the department can take that on board and leave sufficient time to allow scrutiny.

Ms Alexander : Do you mind if I add to that? I want to allay people's fears that what is being put here is for everything that would go before the TGA to suddenly get on some rapid fast train to somewhere. What we are talking about is business as usual to a certain extent. We have a legislative time frame and we put in an understood body of evidence of safety, efficacy and quality, and we have that evaluated. That is not proposed to change under this bill. What is proposed to change is that there is the opportunity to do a couple of different things. One is that, if it would suit a company and their resourcing for whatever reason, instead of putting in an application to the TGA at the same time as to Europe and the US, they might wait until one of those jurisdictions has done something and use an evaluation report from overseas to facilitate. It still leaves with the TGA the same sovereign decision-making about risk and benefit. The third one is that, for a small subset of medicines which may be perceived to be about to meet an urgent and unmet medical need, there is the opportunity for an accelerated pathway.

Under one of those pathways, you are going to have the same amount of data that you already were going to have under the first pathway. When you put it forward, what is going to happen under the regulations is that the TGA will evaluate that more quickly. How will they do that? Hopefully it will be by taking resources from some of these are areas where there is a duplication of effort and actually putting more people onto looking at these more important medicines faster. That is one accelerated pathway, and the other one is actually what we are going to call a provisional licence. And that is really saying that you have early data but it is very promising. At the moment, we do not have the opportunity to have a provisional licence, so one of the consequences can be that the TGA might feel that they cannot, even though they would like to, approve this medicine for what it is intended for, because it is too early. But having a provisional licence allows it to be clearly stated that some patients can have the benefits of a medicine which is early, while we still build more data to continue.

I personally feel that the bill actually does not take away from anything we already have. It still applies for most medicines, and it actually provides a more certain framework for the TGA to either apply resources to get important things done faster or to have some certainty around some decisions made a bit early and to know that they have the legislative framework to keep building the information that is needed to convert to a full licence.

CHAIR: Thank you very much to Medicines Australia.