I welcome the Minister for Agriculture, Food and the Marine, Deputy McConalogue, to the House.
Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Bill 2023: Committee and Remaining Stages
Section 1 agreed to.
SECTION 2
Government amendment No. 1:
In page 8, between lines 2 and 3, to insert the following:
“(3) The Animal Health and Welfare (Animal Remedies Veterinary Practice and Veterinary Medicine) Regulations 2017 (S. I. No. 558 of 2017) are revoked.”.
The amendment revokes the Animal Health and Welfare (Animal Remedies Veterinary Practice and Veterinary Medicine) Regulations 2017. This statutory instrument governed certain matters relating to the prescribing of veterinary medicinal products that are now dealt with in this Bill.
Amendment agreed to.
Section 2, as amended, agreed to.
Section 3 agreed to.
SECTION 4
Amendments Nos. 2 to 4 inclusive, No. 6, and Nos. 8 to 15 inclusive, are related and may be discussed together.
Government amendment No. 2:
In page 8, to delete lines 21 to 24 and substitute the following:
“ “companion animal” means—
(a) a dog or cat kept for domestic purposes only,(b) a rabbit not kept for human consumption, small rodent, cage bird or homingpigeon kept for domestic purposes, or(c) a terrarium animal or an aquarium fish kept for domestic purposes;”.
The amendment is necessary to alter the definition of companion animals. It sets out that the animals concerned are to be kept for domestic purposes only. This is to ensure, by way of an example, that when the Bill applies to companion animals we are not putting dogs that are used in racing or breeding or animals kept in a zoo into that category.
I will speak to the rest of the grouping now, if I may. Amendments No. 3 is necessary to allow me to make regulations about a specific category of animals, such as companion animals, as well as animals generally. The purpose of amendment No. 4 is to add clarity to the subsection. Amendment No. 6 is necessary to clarify that this subsection refers to a pharmacist operating from a retail pharmacy business. Amendments Nos. 8 and 9 are necessary to align and dovetail section 4(5)(b) and section 4(6)(e) regarding registration on the database. They are ambiguous as they currently stand and these amendments will bring clarity to the wording of the subsections. Amendment No. 10 is necessary to provide additional clarity for people not familiar with veterinary medicinal legislation such as users of companion animal medicines. Amendment No. 11 is necessary to clarify that products that may be permitted under Article 110 on the use of immunological veterinary medicinal products or Article 116 on the use of veterinary medicinal products not authorised in a member state but where the marketing of such products is authorised in another member state, will require a derogation from Article 106 (1) of EU regulation 2019/6 to require that they are veterinary medicinal products only and are not human medicinal products used to treat animals which is permitted elsewhere. Amendment No.12 deals with a grammatical issue, while amendment No. 13 is a technical amendment that removes the need to declare penal provisions in any draft regulations made under section 32 as required under section 4(3). Amendment No. 14 is necessary to set out the sections under which a fixed-payment notice may issue. Amendment No. 15 is necessary to remove unnecessary wording without changing the function of the text.
Amendment agreed to.
Section 4, as amended, agreed to.
Section 5 agreed to.
SECTION 6
Government amendment No. 3:
In page 10, line 7, after “animal” to insert “or a class of animal”.
Amendment agreed to.
Government amendment No. 4:
In page 10, lines 14 and 15, to delete “specifying a category or categories of product” and substitute “specifying a category of product or a category of product listed on the nationaldatabase”.
Amendment agreed to.
Amendments Nos. 5 and 7 are related and may be discussed together.
Government amendment No.5:
In page 10, between lines 17 and 18, to insert the following:
“(e) dispensing of a veterinary medicinal product prescribed for an animal to which the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (S. I. No. 543 of 2012) applies by a veterinarian where the prescription for the product has been prescribed by another veterinarian;”.
The amendment inserts a provision whereby the "dispensing of a veterinary medicinal product prescribed for an animal to which the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (S. I. No. 543 of 2012) applies by a veterinarian where the prescription for the product has been prescribed by another veterinarian".
This amendment is necessary to allow the Minister to make regulations for the dispensing of veterinary medicinal products in a research environment.
Amendment No. 7 is necessary as the matter is deemed substantive. This provision continues the current practice of allowing a veterinarian not to provide a veterinary prescription for a companion animal if the owner of the animal agrees. The owner of such an animal may, of course, request a prescription and a prescription must be issued in such circumstances.
Amendment agreed to.
I thank the Minister. Before we move on to the next stage I welcome the New Ross Swimming Club to Seanad Éireann. They are very welcome. I hope they are enjoying their trip today.
Government amendment No. 6:
In page 10, line 27, to delete “by” and substitute “by a pharmacist from”.
Amendment agreed to.
Government amendment No. 7:
In page 10, between lines 35 and 36, to insert the following:
“(3) (a) Subject to regulations made by the Minister under paragraph (c), a veterinarian need not write a veterinary prescription in respect of a medicinal product prescribed or dispensed for, or administered to, a companion animal, if he or she offers a veterinary prescription to the owner or person in charge of the animal at the time and the offer is declined.
(b) For the purposes of paragraph (a), the person in charge of a veterinary premises (within the meaning of section 105 of the Act of 2005) shall display, prominently, at the premises, signage which makes clear that a client is entitled to receive a veterinary prescription in respect of a prescription issued in respect of an animal under the care or control of the client.
(c) The Minister may by regulations make requirements or provide exemptions for the purposes of paragraph (a).
(d) A veterinarian who fails to comply with paragraph (a) or regulations made under paragraph (c) or a person who fails to display signage in accordance with paragraph (b) commits an offence and is liable on summary conviction to a class A fine.”.
Amendment agreed to.
Section 6, as amended, agreed to.
SECTION 7
Government amendment No. 8:
In page 11, to delete lines 31 and 32 and substitute the following:
“(b) may be accessed and used by the Minister and, subject to being required to be registered on it in accordance with regulations made under subsection (6) for the purpose of paragraph (e), the following persons:”.
Amendment agreed to.
Government amendment No. 9:
In page 12, to delete lines 19 and 20 and substitute the following:
“(e) providing for the registration on the national database of a person referred to in subparagraph (i)*, (ii)*, (iii)* or (iv)* of paragraph (b) of subsection (5) to access and use it, and”.
Amendment agreed to.
Section 7, as amended, agreed to.
Sections 8 to 19, inclusive, agreed to.
SECTION 20
Question proposed: "That section 20 stand part of the Bill."
This section just deals with training. The Minister will be familiar with it. This is the kernel of this important Bill. We do need training and I will loosely speak on the issue. We do need upskilling. We have ICOS Skillnet from the Irish Co-operative Organisation Society, we have the Irish Farmers Association, IFA and the Irish Creamery Milk Suppliers Association, ICMSA, and all the agricultural bodies. There are green certs and other education and we incentivise farmers in compliance with EU regulations. This is about healthy soils, healthy animals, animal welfare, traceability, transparency, and compliance. These are all the issues the Minister has covered in great detail.
I do not want to keep interrupting because we are running at a good pace here today, but I do believe that we need to be mindful of the need for upskilling and education around many aspects of this. Farmers want to be on the right side of it. Veterinarians want to be on the right side of all of this legislation when it is passed. The focus needs to be on training through agricultural colleges, from our environmental schemes and from the users on the land. It is about animal welfare and animal health. It is also about the health of our soil and ultimately it is about the viability and sustainability of our farms and our farm incomes. I ask the Minister to consider, in the broader context of this legislation, how we can use opportunities for training to assist people to carry out all of the aspects of this legislation.
Question put and agreed to.
SECTION 21
Government amendment No. 10:
In page 21, line 7, after “products” to insert “for companion animals”.
Amendment agreed to.
Section 21, as amended, agreed to.
Sections 22 to 24, inclusive, agreed
SECTION 25
Government amendment No. 11:
In page 24, line 36, to delete “medicinal product for the purposes of Article 110, 111, 112, 113,114 or 116” and substitute the following:
“veterinary medicinal product for the purposes of Article 110 or 116, or a medicinal product for the purposes of Article 111, 112, 113 or 114,”.
Amendment agreed to.
Section 25, as amended, agreed to.
Sections 26 to 31, inclusive, agreed to.
SECTION 32
Government amendment No. 12:
In page 29, line 16, to delete “products,” and substitute “products, or”.
Amendment agreed to.
Government amendment No. 13:
In page 29, to delete lines 34 to 39, and in page 30, to delete line 1 and substitute the following:
“(3) A person who contravenes or fails to comply with a provision of a regulation made under—
(a) this section (other than under subsection (1)(h), (j) or (k) or subsection (2) (d))commits an offence and is liable on summary conviction to a class A fine, or
(b) subsection (1) (h), (j) or (k) or subsection (2) (d) commits an offence and is liable—
(i) on summary conviction, to a class A fine, or
(ii )on conviction on indictment, to a fine not exceeding €100,000.”.
Amendment agreed to.
Section 32, as amended, agreed to.
Sections 33 to 54, inclusive, agreed to.
SECTION 55
Government amendment No. 14:
In page 46, lines 3 and 4, to delete “this Part which may only be prosecuted summarily” and substitute the following:
“section 6(2) or (3)(d)*, 7(8), 8(3), 13(3), 14(2), 16(2), 17(3), 18(5)(b), 19(2), 21(5)(b), 22(2), 26(2)(a), 28(4), 29(2), 30(3) or 32(3)(a)”.
Amendment agreed to.
Section 55, as amended, agreed to.
Sections 56 to 60, inclusive, agreed to.
SECTION 61
Government amendment No. 15:
In page 53, line 17, to delete “of fertiliser products undertaken by the person” .
Amendment agreed to.
Section 61, as amended, agreed to.
Sections 62 to 64, inclusive, agreed to.
Schedule agreed to.
Title agreed to.
Bill reported with amendments.
When is it proposed to take Report Stage?
Now.
Is that agreed? Agreed.
Bill, as amended, received for final consideration.
When is it proposed to take Fifth Stage?
Now.
Is that agreed? Agreed.
Question proposed: "That the Bill do now pass".
I thank all Members of the Seanad for their time and attention to this Bill, and their further detailed consideration of it. I thank the staff here also for their work in facilitating its effective and efficient passage. I thank all of those in the Oireachtas Select Committee on Agriculture, Food and the Marine in relation to the earlier aspects of the Bill, and I thank all of the Deputies in Dail Éireann.
I also thank the staff who worked so hard to bring legislation from the design stage, through the drafting aspects and then through Committee Stage and both Houses of the Oireachtas. Extensive work, time and attention were required as part of this endeavour. I thank June Fanning, Conor O'Mahony and Paul Vickers, the latter two of whom are here with us today. They put huge work into this throughout the process. I thank them both. Other members of the team have also worked closely with them and put a great amount of time into this process as well. I mention Melanie Hall, Sheila Nolan, Finbarr O'Regan and Jack Hazlitt. I thank all the team for bringing this Bill through to passage today.
It is significant legislation on two fronts. One is the introduction of a fertiliser register, which makes a great deal of sense. It means we can have full line-of-sight awareness of fertiliser use nationally, ensure it is used appropriately and proportionally, ensure we are stepping-out our sustainability agenda and ascertain that everybody uses fertiliser in the way it should be used. This is an important step forward and this was acknowledged by both Houses of the Oireachtas.
The legislation is also important in respect of the challenge facing all of us that is crucial not only to our food production but also to human health. This is the aspect of antimicrobial resistance and antiparasitic resistance. I refer to putting in place a system whereby the prescribing and management of these substances and the regime around this process will change significantly, ensuring there will be prescription and veterinary oversight of how this happens for all these products, while at the same time ensuring there is availability in the marketplace. We have much work to do, though, in addressing the significant challenges for animal and human health that have emerged in recent years and decades concerning resistance issues. That is what this legislation is aimed at. This will not be something just for this Bill to address but something that must be addressed at all policy and practice levels. We will also have to put significant effort into this area in research and education. It is crucial that these products are used effectively and that they remain effective for years and generations to come to ensure the protection of human and animal health on a one-health basis.
I thank everyone for their work and engagement. It is very much appreciated.
I wish to be associated with the Minister's comments. I thank him personally. This Bill has been mooted since the European regulation came in more than two years ago. There have been many discussions on it. As the Minister said, the Oireachtas Joint Committee on Agriculture, Food and the Marine had many meetings concerned with this issue, even prior to the pre-legislative scrutiny process. There was much engagement with all the stakeholders. Senator Boyhan is also a member of that committee. During all that time, I do not think the focus was ever taken off, by the committee or any member, the importance of the issue of antimicrobial and antiparasitic resistance, as the Minister said, and the one-health policy.
Regarding the veterinary medicine and fertiliser aspects of this legislation, one issue that was very prominent was having an all-island policy. With the UK no longer in the EU, we could have created potential difficulties if we did not get this Bill right. I welcome, however, the legislation as passed today. I assume the Government amendments we have passed today will also pass through the Dáil.
I also wish to be associated with the Minister's extension of thanks to his officials in the Department who have worked so hard on this legislation and also to all the stakeholders who engaged on this issue. The Bill as presented now is an amicable solution to a problem. The issue of the availability of medicines is equally important as getting the prescribing right and the control of the resistance issues, as the Minister again said. This was an issue for many people.
The end of this saga will be the Minister's issuing of the statutory instrument. We will be keeping our eyes firmly fixed on the Minister until that has been written and released. I suppose we can then move on to our next challenge. I again thank the Minister for his personal engagement with me and his engagement with the committee and the stakeholders during this process. I again thank his officials and all the stakeholders. Many compromises were made by everybody. We are a long way from what was being suggested when this measure was first mooted two years ago. Everybody involved has moved a long way. This in itself is compromise and good compromise will always result in good legislation. I again thank everybody and welcome the passing of the Bill.
I too join in thanking the Minister. I have time and time again said that when a Minister works with parliamentarians it makes everything easier. I again acknowledge his hands-on engagement and discussions at our joint committee, which are always very meaningful, fruitful and respectful and that is important. As Senator Paul Daly said, and he is a member of the joint committee like myself, we have engaged extensively with stakeholders. Initially, people were not happy but they have travelled on a journey. At the end of the day, we have signed up and bought into the EU and there are many benefits in respect of the Common Agricultural Policy, CAP, environmental schemes and new schemes. Yes, sometimes we must push people along, but this measure was undertaken in compliance with a requirement. It was not something we necessarily wanted. It makes sense, though, and it is right that we should pursue it. We had to do a bit of convincing along the way.
I thank the Minister and his officials for their engagement with the Seanad and the Oireachtas Joint Committee on Agriculture, Food and the Marine. I finish on the point that farmers do not need lectures about ecosystems, compliance or biodiversity. They do not need lectures about animal welfare. Their livelihoods are crucially linked to the sustainability of agriculture, their animals and their land. This is about food, health, traceability and accountability. We should use every opportunity available through our education models and training to assist them. This is going to take time to bed down.
There may be some more work to do in terms of the IT systems and that whole area. There is also anxiety and concern when registration is being undertaken and when what is being used by farmers will be registered, but this makes sense and is the right thing to do. This ties in with the compliance aspect. Many people have difficulties in respect of compliance, but the benefits outweigh the anxieties and concerns. I think we will have teething problems initially, so we must support farmers. We must support the end users of fertiliser because this goes into the amenity horticultural sector as well. I refer to how they can embrace this legislation and make it meaningful.
I again thank the Minister. It makes it easy when a Minister is prepared to listen, negotiate and, more importantly, set out the background, principles and rationale of legislation. I thank the Minister very much.
I also congratulate the Minister on this legislation. It is important for all the agricultural community. Health and well-being, from our land right up to our animals, are very important. This is an important step towards ensuring those aspects and the longevity of our very fine agricultural community. I call Senator Ahearn.
I will not repeat what everyone else said. I thank the Minister and his officials for their work on this legislation. As he knows, my colleague, Senator Lombard, did much work on this legislation as well through the joint committee and this House. He wanted to be here today but could not be. I just wanted to pass on his gratitude to the Minister and his officials for getting this over the line. As always, we are happy to work with the Minister. He is a very engaging Minister. We have always found this from our perspective and we wish him well going back to the Dáil with this legislation. I am delighted it got through the House.
I thank the Senator for his work today. I also recognise the role of the chief veterinarian, Martin Blake. I should have mentioned the role he played throughout this process as well. It was important and appreciated.
Question put and agreed to.
Cuireadh an Seanad ar fionraí ar 4.28 p.m. agus cuireadh tús leis arís ar 5.00 p.m.
Sitting suspended at 4.28 p.m. and resumed at 5.00 p.m.