Division Description Changes — Bills — Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020; Second Reading — 3rd Feb 2021

Change	Division
representatives vote 2021-02-03#1 Edited by mackay staff on 2021-02-12 17:13:40	Title Bills — Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020; Second Reading Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 - Second Reading - Keep text unchanged Description ~~<p class="speaker">Katie Allen</p>~~ <p>Mr Speaker, it would be no surprise to you that the Morrison government is committed to keeping Australians healthy and safe. The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 builds on this objective by introducing to the Therapeutic Goods Act 1989 a suite of amendments that are fundamentally centred on promoting efficiency and flexibility in our healthcare system. This will be particularly critical as we turn attention to the swift and successful rollout of the COVID-19 vaccine over coming months.</p> <p>This bill comprises five principal measures designed to ensure we continue to keep Australians healthy and safe. First, this bill helps guarantee the availability of prescription medicine. Throughout the COVID pandemic there have been major concerns about the availability of prescription medicines, and I take note of the hard work of the Minister for Health and Aged Care, Greg Hunt, with regard to supply of prescription medicines during what has been quite a difficult period in 2020. This is a reality that few Australians have ever faced or even contemplated. Many will recall that in March 2020 India, the world's main supplier of generic drugs, restricted the export of pharmaceutical ingredients and medicines, including paracetamol. This created a significant sovereign supply issue for many countries, including Australia.</p> The majority voted in favour of a motion to keep the usual [second reading motion](https://peo.gov.au/understand-our-parliament/how-parliament-works/bills-and-laws/making-a-law-in-the-australian-parliament/) unchanged. The usual second reading motion is "that the bill be read a second time," which is parliamentary jargon for agreeing with the main idea of the bill. This vote was put after the MP for Hindmarsh [Mark Butler](https://theyvoteforyou.org.au/people/representatives/hindmarsh/mark_butler) (Labor) proposed an amendment. ### Proposed amendment text** > That all words after 'that' be omitted with a view to substituting the following words: > *> 'whilst not declining to give the Bill a second reading, the House condemns the ongoing campaign by some government members against the independent and expert Therap*eutic Goods Administration, and urges the Prime Minister to finally censure those members.' <p>In the case of a serious shortage of a prescribed medicine, this bill will allow pharmacists to substitute a different medicine from the one that has been prescribed for a person. This would not require the approval of the prescribing doctor, but could only occur when a safe alternative is available. This will be particularly helpful in regional and remote areas of Australia. Importantly, it would only be permitted under the act when the minister is satisfied there is a serious scarcity of a specified medicine. This will help improve the availability of prescription medication during medicine shortages, giving Australian families peace of mind that their loved ones will always have access to critical medicine. These legislative changes are very practical measures and are welcomed by patients and providers in the sector. Importantly, they build on legislative changes introduced in 2018. In 2018, our government introduced legislation to ensure medicine companies report shortages of important medicines as soon as they occur. In addition, if a critical drug is to be removed from the market, the Department of Health must be notified by the manufacturer at least 12 months in advance. This measure has been a really important step in giving comfort to patients who have life-saving drugs but can have their health put at risk at the whim of overseas manufacturers and suppliers.</p> <p>The 2018 legislation followed on from a serious event that arose earlier that year when there was a critical shortage of medicines. Australia was one of several countries hit by a shortage of EpiPens, which provide life-saving adrenaline for people who've had an acute allergic response. As an allergist, I cannot tell you the chaos that was created in the lives of families whose children depend on the provision of EpiPens to keep their children safe from anaphylaxis. The phones were running hot across the country as literally thousands of families were concerned that, if their child were to eat a food that could be potentially life threatening, their child might die because they didn't have an EpiPen available. In this and a number of other cases the shortages were not reported in advance to the TGA within the Department of Health. Prior to 2018, medicine shortages had become an increasing problem, as medicine companies, manufacturers and importers had failed to comply with the previous voluntary reporting scheme. Mr Speaker, you'll be pleased to know that tough penalties, including fines of up to $210,000 for each infringement and the possibility of further court action, are now in place for companies that do not comply with these new laws.</p> <p>The 2018 law protects patients who rely on vital medicines. It also gives the community, medicine companies and patients opportunities to take action to mitigate a medicine shortage. Responses to a shortage can include redirecting the available supplies to patients who need them most, nominating alternative treatments and providing PBS coverage for the alternatives. What the legislative amendments being debated today do is ensure that the alternatives, including formulation and dosage changes, can be provided by pharmacists if there is a serious shortage. For instance, a pharmacist can provide two 10 milligram tablets instead of a 20 milligram tablet, if that is not available. I have to say that a frequent occurrence in daily practice is a pharmacist having to resend a script because they have a short-term shortage of 20 milligram tablets instead of 10 milligram tablets. A pharmacist can now provide a capsule rather than a tablet, or a topical cream rather than a skin patch, if there is indeed a serious shortage of a vital medicine. These are practical and safe alternatives that help ensure vital medicines are supplied to patients in serious need.</p> <p>Second, this bill will improve the traceability and monitoring of medical devices. Australians have become keenly aware of the importance and utility of accurate and up-to-date health data over the past year. This bill will provide a pathway to establishing a unique device identification, or UDI, database to improve the traceability and monitoring of medical devices post market. The current inability to trace medical devices once implanted or supplied has been a costly and timely constraint on clinical action on patient safety issues. Recent unfortunate examples include defective mesh devices and breast implants. The bill consolidates the work of many public and private hospitals that are in the process of making changes to their systems to enable the recording of devices implanted and supplied. As a previous member of the board of our local hospital, Cabrini, I know how important this change in process is in ensuring safety for our important patients. Establishing a UDI system also brings us into line with our international counterparts, including the European Union, the United States and Japan, who are undergoing various stages of implementation of the UDI system. These measures will also help prevent counterfeiting, helping keep Australian IP safe. This bill will enable faster responses to safety issues and more rapid and targeted recalls of defective devices, again, keeping Australians healthy and safe. This sort of market responsiveness to safety issues is something all Australians want and indeed deserve.</p> <p>Third, this bill will provide protection to our TGA investigators so they can successfully fulfil their duties. In this place, we recognise the vital work of our TGA investigators and their role in keeping Australians healthy and safe. It is important we give our TGA investigators the scope and flexibility to carry out their duties effectively. This bill will allow TGA investigators to obtain illicit therapeutic goods to determine whether the act and regulations have been complied with. For example, a TGA investigator may order a test purchase of such products to examine the goods and determine whether they are being supplied legally or contain other potentially dangerous substances not declared to purchasers. This type of practice is becoming rampant online. For example, selective androgen receptor modulators, which have been used to assist in the gym and with bodybuilding, can now be more formally assessed. This will protect TGA investigators from being found criminally responsible under state or territory law for unlawfully obtaining and possessing these goods for the purpose of investigating their safety. By protecting the important work of TGA investigators, the Morrison government is helping protect Australians. These types of investigative powers enable our world-class TGA to be on the front foot to ensure the public is protected from potentially unsafe products making their way to our shores.</p> <p>Fourth, this bill will protect Australians from internationally prohibited therapeutic goods. Just as we are committed to keeping Australians healthy and safe, the Morrison government is also committed to being a good global citizen. That is why the bill will allow for the making of regulations that prohibit the import, export, supply or manufacture of therapeutic goods that are prohibited under international agreements that Australia has ratified. For illustration, it is anticipated that the Minamata Convention on Mercury may potentially be ratified this year. This pertains to mercury-containing products which, in relation to therapeutic goods, would affect mercury-containing thermometers and sphygmomanometers as well as topical antiseptic, with the phasing out of mercury dental amalgams. This bill will allow regulators to give effect to Australian obligations under the Minamata Convention on Mercury. It is at the core of improving the safety—and, therefore, the safe health of Australians—of dangerous therapeutic goods.</p> <p>Finally, and most importantly, this bill streamlines the rollout of COVID-19 vaccines. One of the most important aspects of the bill is enabling the secretary of Health to consent to the importation and supply of registered or listed therapeutic goods that do not have their registration or listing number on their label. This may seem like a small detail, but it's actually quite an important practical detail. This is primarily designed to address the potential impediment to the timely availability of COVID-19 vaccines, because, as we all know, some of these COVID vaccines, particularly the Pfizer one, have to be stored at very low temperatures. In the case of the Pfizer vaccine, this is minus 70 degrees. As a medical researcher myself, I know how difficult it is to store these minus-70 products, and it may not be possible to have the registration number affixed to the label. So this is a very pragmatic change that, in other circumstances, may result in the failure to have the registration or listing number on the label of the therapeutic good, and that could incur a maximum potential civil penalty of $440,000. This could be a major roadblock to the prompt and seamless rollout of the COVID-19 vaccine. I know it seems like a small change, but it's an incredibly important one. What it shows is a government that is very, very carefully thinking through all of the potential roadblocks so that we have a seamless rollout of the COVID-19 vaccine. It's a massive undertaking. It's an important undertaking—and it's one that I know Australians are waiting very carefully for—to make sure that all of the regulations, all of the policy and all of the potential practices that are going to be taking place do so for the safety of all Australians.</p> <p>At the risk of sounding like a broken record, we are committed to keeping Australians healthy and safe. This bill supports the delivery of the highest quality health care for Australians, particularly as we look to the future rollout of the COVID-19 vaccine. Australians need to understand that the government has their back. This vaccine will be safe and it will be voluntary and, most importantly, we look forward to an effective rollout. The measures contained in the bill will provide efficiency and flexibility, meaning Australians can rest assured that our healthcare system will continue to deliver in these unprecedented times.</p> ~~<p class='motion-notice motion-notice-truncated'>Long debate text truncated.</p>~~

~~Katie Allen~~
Mr Speaker, it would be no surprise to you that the Morrison government is committed to keeping Australians healthy and safe. The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 builds on this objective by introducing to the Therapeutic Goods Act 1989 a suite of amendments that are fundamentally centred on promoting efficiency and flexibility in our healthcare system. This will be particularly critical as we turn attention to the swift and successful rollout of the COVID-19 vaccine over coming months.
This bill comprises five principal measures designed to ensure we continue to keep Australians healthy and safe. First, this bill helps guarantee the availability of prescription medicine. Throughout the COVID pandemic there have been major concerns about the availability of prescription medicines, and I take note of the hard work of the Minister for Health and Aged Care, Greg Hunt, with regard to supply of prescription medicines during what has been quite a difficult period in 2020. This is a reality that few Australians have ever faced or even contemplated. Many will recall that in March 2020 India, the world's main supplier of generic drugs, restricted the export of pharmaceutical ingredients and medicines, including paracetamol. This created a significant sovereign supply issue for many countries, including Australia.
The majority voted in favour of a motion to keep the usual [second reading motion](https://peo.gov.au/understand-our-parliament/how-parliament-works/bills-and-laws/making-a-law-in-the-australian-parliament/) unchanged. The usual second reading motion is "*that the bill be read a second time,*" which is parliamentary jargon for agreeing with the main idea of the bill. This vote was put after the MP for Hindmarsh [Mark Butler](https://theyvoteforyou.org.au/people/representatives/hindmarsh/mark_butler) (Labor) proposed an amendment.
### Proposed amendment text
> *That all words after 'that' be omitted with a view to substituting the following words:*
>
> *'whilst not declining to give the Bill a second reading, the House condemns the ongoing campaign by some government members against the independent and expert Therapeutic Goods Administration, and urges the Prime Minister to finally censure those members.'*
In the case of a serious shortage of a prescribed medicine, this bill will allow pharmacists to substitute a different medicine from the one that has been prescribed for a person. This would not require the approval of the prescribing doctor, but could only occur when a safe alternative is available. This will be particularly helpful in regional and remote areas of Australia. Importantly, it would only be permitted under the act when the minister is satisfied there is a serious scarcity of a specified medicine. This will help improve the availability of prescription medication during medicine shortages, giving Australian families peace of mind that their loved ones will always have access to critical medicine. These legislative changes are very practical measures and are welcomed by patients and providers in the sector. Importantly, they build on legislative changes introduced in 2018. In 2018, our government introduced legislation to ensure medicine companies report shortages of important medicines as soon as they occur. In addition, if a critical drug is to be removed from the market, the Department of Health must be notified by the manufacturer at least 12 months in advance. This measure has been a really important step in giving comfort to patients who have life-saving drugs but can have their health put at risk at the whim of overseas manufacturers and suppliers.
The 2018 legislation followed on from a serious event that arose earlier that year when there was a critical shortage of medicines. Australia was one of several countries hit by a shortage of EpiPens, which provide life-saving adrenaline for people who've had an acute allergic response. As an allergist, I cannot tell you the chaos that was created in the lives of families whose children depend on the provision of EpiPens to keep their children safe from anaphylaxis. The phones were running hot across the country as literally thousands of families were concerned that, if their child were to eat a food that could be potentially life threatening, their child might die because they didn't have an EpiPen available. In this and a number of other cases the shortages were not reported in advance to the TGA within the Department of Health. Prior to 2018, medicine shortages had become an increasing problem, as medicine companies, manufacturers and importers had failed to comply with the previous voluntary reporting scheme. Mr Speaker, you'll be pleased to know that tough penalties, including fines of up to $210,000 for each infringement and the possibility of further court action, are now in place for companies that do not comply with these new laws.
The 2018 law protects patients who rely on vital medicines. It also gives the community, medicine companies and patients opportunities to take action to mitigate a medicine shortage. Responses to a shortage can include redirecting the available supplies to patients who need them most, nominating alternative treatments and providing PBS coverage for the alternatives. What the legislative amendments being debated today do is ensure that the alternatives, including formulation and dosage changes, can be provided by pharmacists if there is a serious shortage. For instance, a pharmacist can provide two 10 milligram tablets instead of a 20 milligram tablet, if that is not available. I have to say that a frequent occurrence in daily practice is a pharmacist having to resend a script because they have a short-term shortage of 20 milligram tablets instead of 10 milligram tablets. A pharmacist can now provide a capsule rather than a tablet, or a topical cream rather than a skin patch, if there is indeed a serious shortage of a vital medicine. These are practical and safe alternatives that help ensure vital medicines are supplied to patients in serious need.
Second, this bill will improve the traceability and monitoring of medical devices. Australians have become keenly aware of the importance and utility of accurate and up-to-date health data over the past year. This bill will provide a pathway to establishing a unique device identification, or UDI, database to improve the traceability and monitoring of medical devices post market. The current inability to trace medical devices once implanted or supplied has been a costly and timely constraint on clinical action on patient safety issues. Recent unfortunate examples include defective mesh devices and breast implants. The bill consolidates the work of many public and private hospitals that are in the process of making changes to their systems to enable the recording of devices implanted and supplied. As a previous member of the board of our local hospital, Cabrini, I know how important this change in process is in ensuring safety for our important patients. Establishing a UDI system also brings us into line with our international counterparts, including the European Union, the United States and Japan, who are undergoing various stages of implementation of the UDI system. These measures will also help prevent counterfeiting, helping keep Australian IP safe. This bill will enable faster responses to safety issues and more rapid and targeted recalls of defective devices, again, keeping Australians healthy and safe. This sort of market responsiveness to safety issues is something all Australians want and indeed deserve.
Third, this bill will provide protection to our TGA investigators so they can successfully fulfil their duties. In this place, we recognise the vital work of our TGA investigators and their role in keeping Australians healthy and safe. It is important we give our TGA investigators the scope and flexibility to carry out their duties effectively. This bill will allow TGA investigators to obtain illicit therapeutic goods to determine whether the act and regulations have been complied with. For example, a TGA investigator may order a test purchase of such products to examine the goods and determine whether they are being supplied legally or contain other potentially dangerous substances not declared to purchasers. This type of practice is becoming rampant online. For example, selective androgen receptor modulators, which have been used to assist in the gym and with bodybuilding, can now be more formally assessed. This will protect TGA investigators from being found criminally responsible under state or territory law for unlawfully obtaining and possessing these goods for the purpose of investigating their safety. By protecting the important work of TGA investigators, the Morrison government is helping protect Australians. These types of investigative powers enable our world-class TGA to be on the front foot to ensure the public is protected from potentially unsafe products making their way to our shores.
Fourth, this bill will protect Australians from internationally prohibited therapeutic goods. Just as we are committed to keeping Australians healthy and safe, the Morrison government is also committed to being a good global citizen. That is why the bill will allow for the making of regulations that prohibit the import, export, supply or manufacture of therapeutic goods that are prohibited under international agreements that Australia has ratified. For illustration, it is anticipated that the Minamata Convention on Mercury may potentially be ratified this year. This pertains to mercury-containing products which, in relation to therapeutic goods, would affect mercury-containing thermometers and sphygmomanometers as well as topical antiseptic, with the phasing out of mercury dental amalgams. This bill will allow regulators to give effect to Australian obligations under the Minamata Convention on Mercury. It is at the core of improving the safety—and, therefore, the safe health of Australians—of dangerous therapeutic goods.
Finally, and most importantly, this bill streamlines the rollout of COVID-19 vaccines. One of the most important aspects of the bill is enabling the secretary of Health to consent to the importation and supply of registered or listed therapeutic goods that do not have their registration or listing number on their label. This may seem like a small detail, but it's actually quite an important practical detail. This is primarily designed to address the potential impediment to the timely availability of COVID-19 vaccines, because, as we all know, some of these COVID vaccines, particularly the Pfizer one, have to be stored at very low temperatures. In the case of the Pfizer vaccine, this is minus 70 degrees. As a medical researcher myself, I know how difficult it is to store these minus-70 products, and it may not be possible to have the registration number affixed to the label. So this is a very pragmatic change that, in other circumstances, may result in the failure to have the registration or listing number on the label of the therapeutic good, and that could incur a maximum potential civil penalty of $440,000. This could be a major roadblock to the prompt and seamless rollout of the COVID-19 vaccine. I know it seems like a small change, but it's an incredibly important one. What it shows is a government that is very, very carefully thinking through all of the potential roadblocks so that we have a seamless rollout of the COVID-19 vaccine. It's a massive undertaking. It's an important undertaking—and it's one that I know Australians are waiting very carefully for—to make sure that all of the regulations, all of the policy and all of the potential practices that are going to be taking place do so for the safety of all Australians.
At the risk of sounding like a broken record, we are committed to keeping Australians healthy and safe. This bill supports the delivery of the highest quality health care for Australians, particularly as we look to the future rollout of the COVID-19 vaccine. Australians need to understand that the government has their back. This vaccine will be safe and it will be voluntary and, most importantly, we look forward to an effective rollout. The measures contained in the bill will provide efficiency and flexibility, meaning Australians can rest assured that our healthcare system will continue to deliver in these unprecedented times.
~~Long debate text truncated.~~