Division Description Changes — Bills — Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019; Second Reading — 1st Dec 2021

Change	Division
senate vote 2021-12-01#1 Edited by mackay staff on 2022-05-13 14:21:24	Title Bills — Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019; Second Reading Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 - Second Reading - Agree with bill's main idea Description ~~<p class="speaker">Sam McMahon</p>~~ <p>As I was saying last night when I opened my contribution on the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019, the importance of agricultural and veterinary chemicals and their regulation can't be overemphasised. How has this come before us? It's not something we thought up yesterday; it has been a long process. It was part of the 2015 <i>Agricultura</i><i>l competitiveness white paper</i>. The government committed to streamline access to agvet chemicals and better manage the risks they pose whilst at the same time retaining protection for the health, welfare and safety of humans, animals, plants and the environment. The Morrison-Joyce government recognises the need to better balance regulatory effort with risk and improve veterinary surgeons', farmers' and other users' access to newer and better agricultural and veterinary chemicals, including many medications. This government also recognises the need to ensure that our regulatory agencies have effective governance arrangements, with clear accountability and transparency.</p> <p>The department consulted on potential agvet chemical reforms between 2015 and 2018. Stakeholder feedback indicated widespread interest in reform and support for a more efficient and effective regulatory system. I can personally report that people in industry that I have been speaking to recently—as you're well aware, I'm very close to this industry, being a veterinary surgeon—have talked about how they have seen improvements in the way that the APVMA works, in the way that it approves medications and chemicals and in the time that it takes to get approvals through. That was a big thing that industry has had for many, many years. This is quite a small agency and it's often dealing with hundreds of applications at any one time. Industry has been concerned for many years about the time taken to get things approved. I am very pleased to report that under the previous ag minister, Senator McKenzie, and under the current ag minister, Mr Littleproud, there have been incremental improvements. Industry is still looking for more improvements to be made, but they are quite impressed with the steps that have been taken to improve these areas.</p> <p>The APVMA is probably an agency that a lot of people haven't really heard of and don't really pay a lot of attention to, but, as I've stated, it is a vital agency. It approves and regulates all of the chemicals that are used in agriculture. It's absolutely vital for our agricultural industries. We have a very strong agricultural industry in Australia. We have a proud history of our agriculture and the food and fibre that we produce. For all of this to be efficient, effective and safe relies on the efficient regulation of the chemicals that are used in it.</p> <p>Although many Australians would not have heard of this agency, the vast majority of Australians have animals, or have at some stage owned animals. They've owned either farm animals or companion animals, pets or performance animals, such as racing horses and greyhounds, or horses that are used in competition. The veterinary side of it is very vital for production animals. Veterinarians and the medications that we have access to are vital for animal health and welfare in our production systems. These range from intensive production systems, such as chicken and pigs, to quite extensive systems, such as beef cattle. The treatment, the maintenance of not only the health but, as I said, the welfare is absolutely vital. It's vital we get the medications that are used in doing that approved in a timely manner. It's vital that they are regulated in a way that, as I said, is safe, efficient and effective.</p> <p>We also have companion pets. Most people in Australia will be well aware of pet cats, dogs and birds, and these days reptiles, fish. Veterinary medications that are regulated by this agency are absolutely vital for all of these companion animals. Modern veterinary medicine is increasingly coming into line with human medicine, and people are increasingly demanding improved treatments and outcomes for their pets. In fact, these days it is quite common for pets to undergo chemotherapy for cancer, to have complex surgeries—including complex orthopaedic surgeries and complex soft-tissue surgeries—and to take medications for many emerging and existing diseases and conditions. The regulation and approval of these medications is vital to pets and their owners.</p> <p>We're a very small country, in terms of population and in terms of our pets and our veterinary industry, compared to countries such as the US and the UK, so we don't have a lot of medications that are developed in this country. We rely heavily on both human medications and medications that are developed overseas. These have to be approved in Australia to be used, and that is where this agency comes in. It is absolutely critical in getting timely approval for these medications and in making sure that the testing and regulation that have been done overseas are appropriate for Australian conditions and for Australian pets and production systems.</p> <p>This bill will improve the APVMA's governance, reduce the regulatory burden on industry, support the APVMA's operations, strengthen the integrity of the regulation system and enhance the way the regulation operates. I've already spoken about how this agency operates and the fact that it's important to increase efficiency and the time in which various medications and chemicals are approved. One example of this is minor use permits. These are permits that are granted by the agency for chemicals and medications that generally don't have widespread use or are needed in a very urgent situation. They're generally used in small amounts, with small production systems, and there may not have been the time or it may not have been worthwhile to the company to go through the full registration process, which is quite expensive and quite onerous.</p> <p>An example of where these are used in veterinary medicine is autogenous vaccines, where you have an outbreak of a disease on a particular property. We're trying to get away from the widespread use of antimicrobials, and that's where these vaccines are important. There will be a veterinary investigation on a property where a disease is occurring. Identified bacteria—the cause of the disease outbreak—will be found and a vaccine will be developed for the specific bacteria on that specific property. You're not going to go through a whole regulation process to get a vaccine to market for use on one or two individual properties. That's where the minor use permits come in.</p> <p>One of the issues that has come about is that, while the APVMA has five months in which to approve one of these minor use permits, the agency can go back to the proponent with a question about the information that's contained in the permit application and that then triggers another five months. So you can have almost a year between a disease being identified on a property and a permit being issued for the vaccine to combat that disease. Anyone would acknowledge that that's not desirable. We need to speed this process up. We still need to maintain safety and efficacy, but we need to speed this process up. That is where this will come into effect, so that we're continually improving the governance of the APVMA and we're continually improving its efficiency and effectiveness.</p> <p>As someone who is intimately involved in the agricultural and veterinary industries, I thank the ministers involved. As I said, Minister McKenzie has been instrumental in this, and I thank her for the work that she's done on it. Industry certainly strongly welcomes and recommends this bill and the improvements in effectiveness and efficiency that it will bring about.</p> ~~<p class='motion-notice motion-notice-truncated'>Long debate text truncated.</p>~~ The majority voted in favour of a [motion](https://www.openaustralia.org.au/senate/?gid=2021-12-01.23.18) to agree with the main idea of the bill. In parliamentary jargon, they voted to read the bill a [second time](https://peo.gov.au/understand-our-parliament/how-parliament-works/bills-and-laws/making-a-law-in-the-australian-parliament/). This means they can now discuss the bill in more detail. ### What does this bill do? According to the [bills digest](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd1920a/20bd063), the bill was introduced to: * to amend various statutes to improve the effectiveness and efficiency of the national system for regulating agricultural and veterinary (agvet) chemical* products and* * to establish a governance Board for the Australian Pesticides and Veterinary Medicines Authority Board (APVMA) and formally cease* the existing APVMA Advisory Board.*

~~Sam McMahon~~
As I was saying last night when I opened my contribution on the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019, the importance of agricultural and veterinary chemicals and their regulation can't be overemphasised. How has this come before us? It's not something we thought up yesterday; it has been a long process. It was part of the 2015 Agricultural competitiveness white paper. The government committed to streamline access to agvet chemicals and better manage the risks they pose whilst at the same time retaining protection for the health, welfare and safety of humans, animals, plants and the environment. The Morrison-Joyce government recognises the need to better balance regulatory effort with risk and improve veterinary surgeons', farmers' and other users' access to newer and better agricultural and veterinary chemicals, including many medications. This government also recognises the need to ensure that our regulatory agencies have effective governance arrangements, with clear accountability and transparency.
The department consulted on potential agvet chemical reforms between 2015 and 2018. Stakeholder feedback indicated widespread interest in reform and support for a more efficient and effective regulatory system. I can personally report that people in industry that I have been speaking to recently—as you're well aware, I'm very close to this industry, being a veterinary surgeon—have talked about how they have seen improvements in the way that the APVMA works, in the way that it approves medications and chemicals and in the time that it takes to get approvals through. That was a big thing that industry has had for many, many years. This is quite a small agency and it's often dealing with hundreds of applications at any one time. Industry has been concerned for many years about the time taken to get things approved. I am very pleased to report that under the previous ag minister, Senator McKenzie, and under the current ag minister, Mr Littleproud, there have been incremental improvements. Industry is still looking for more improvements to be made, but they are quite impressed with the steps that have been taken to improve these areas.
The APVMA is probably an agency that a lot of people haven't really heard of and don't really pay a lot of attention to, but, as I've stated, it is a vital agency. It approves and regulates all of the chemicals that are used in agriculture. It's absolutely vital for our agricultural industries. We have a very strong agricultural industry in Australia. We have a proud history of our agriculture and the food and fibre that we produce. For all of this to be efficient, effective and safe relies on the efficient regulation of the chemicals that are used in it.
Although many Australians would not have heard of this agency, the vast majority of Australians have animals, or have at some stage owned animals. They've owned either farm animals or companion animals, pets or performance animals, such as racing horses and greyhounds, or horses that are used in competition. The veterinary side of it is very vital for production animals. Veterinarians and the medications that we have access to are vital for animal health and welfare in our production systems. These range from intensive production systems, such as chicken and pigs, to quite extensive systems, such as beef cattle. The treatment, the maintenance of not only the health but, as I said, the welfare is absolutely vital. It's vital we get the medications that are used in doing that approved in a timely manner. It's vital that they are regulated in a way that, as I said, is safe, efficient and effective.
We also have companion pets. Most people in Australia will be well aware of pet cats, dogs and birds, and these days reptiles, fish. Veterinary medications that are regulated by this agency are absolutely vital for all of these companion animals. Modern veterinary medicine is increasingly coming into line with human medicine, and people are increasingly demanding improved treatments and outcomes for their pets. In fact, these days it is quite common for pets to undergo chemotherapy for cancer, to have complex surgeries—including complex orthopaedic surgeries and complex soft-tissue surgeries—and to take medications for many emerging and existing diseases and conditions. The regulation and approval of these medications is vital to pets and their owners.
We're a very small country, in terms of population and in terms of our pets and our veterinary industry, compared to countries such as the US and the UK, so we don't have a lot of medications that are developed in this country. We rely heavily on both human medications and medications that are developed overseas. These have to be approved in Australia to be used, and that is where this agency comes in. It is absolutely critical in getting timely approval for these medications and in making sure that the testing and regulation that have been done overseas are appropriate for Australian conditions and for Australian pets and production systems.
This bill will improve the APVMA's governance, reduce the regulatory burden on industry, support the APVMA's operations, strengthen the integrity of the regulation system and enhance the way the regulation operates. I've already spoken about how this agency operates and the fact that it's important to increase efficiency and the time in which various medications and chemicals are approved. One example of this is minor use permits. These are permits that are granted by the agency for chemicals and medications that generally don't have widespread use or are needed in a very urgent situation. They're generally used in small amounts, with small production systems, and there may not have been the time or it may not have been worthwhile to the company to go through the full registration process, which is quite expensive and quite onerous.
An example of where these are used in veterinary medicine is autogenous vaccines, where you have an outbreak of a disease on a particular property. We're trying to get away from the widespread use of antimicrobials, and that's where these vaccines are important. There will be a veterinary investigation on a property where a disease is occurring. Identified bacteria—the cause of the disease outbreak—will be found and a vaccine will be developed for the specific bacteria on that specific property. You're not going to go through a whole regulation process to get a vaccine to market for use on one or two individual properties. That's where the minor use permits come in.
One of the issues that has come about is that, while the APVMA has five months in which to approve one of these minor use permits, the agency can go back to the proponent with a question about the information that's contained in the permit application and that then triggers another five months. So you can have almost a year between a disease being identified on a property and a permit being issued for the vaccine to combat that disease. Anyone would acknowledge that that's not desirable. We need to speed this process up. We still need to maintain safety and efficacy, but we need to speed this process up. That is where this will come into effect, so that we're continually improving the governance of the APVMA and we're continually improving its efficiency and effectiveness.
As someone who is intimately involved in the agricultural and veterinary industries, I thank the ministers involved. As I said, Minister McKenzie has been instrumental in this, and I thank her for the work that she's done on it. Industry certainly strongly welcomes and recommends this bill and the improvements in effectiveness and efficiency that it will bring about.
~~Long debate text truncated.~~
The majority voted in favour of a [motion](https://www.openaustralia.org.au/senate/?gid=2021-12-01.23.18) to agree with the main idea of the bill. In parliamentary jargon, they voted to read the bill a [second time](https://peo.gov.au/understand-our-parliament/how-parliament-works/bills-and-laws/making-a-law-in-the-australian-parliament/). This means they can now discuss the bill in more detail.
### What does this bill do?
According to the [bills digest](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd1920a/20bd063), the bill was introduced to:
* *to amend various statutes to improve the effectiveness and efficiency of the national system for regulating agricultural and veterinary (agvet) chemical products and*
* *to establish a governance Board for the Australian Pesticides and Veterinary Medicines Authority Board (APVMA) and formally cease the existing APVMA Advisory Board.*