Paul Daly (Fianna Fail) | Oireachtas source

I welcome the Minister and thank him for all the work he has put into the Bill up to this Stage. Without going over what he said, we are here today in the context of EU Regulations 2019/6 and 2019/4 in respect of the manufacture of medicated feed. The regulations were agreed in 2018 and came into effect in January 2022. The regulations set out rules for the manufacture, import, export, sale, supply, distribution, advertisement, control and use of veterinary medicinal products and medicated feed, aiming to modernise legislation, stimulate innovation and increase the availability of VMPs and strengthen the EU's campaign against AMR. These regulations have direct effect, leaving some details for member states to provide for in national law.Part of the Bill relates to fertiliser regulation and the establishment of a fertiliser database.

I thank the Minister and his officials and all the stakeholders involved for their work on the legislation to date. It has been a long-drawn-out process in many regards. These regulations were introduced in 2018 and the national debate has been happening since. As the Minister mentioned, the Bill received a lot of scrutiny in the Oireachtas committee. We had hearings prior to the pre-legislative scrutiny, PLS, and then the PLS. The Minister has brought in some amendments and made changes along the way, and that is to be appreciated. It is important legislation for animal health and welfare and it is vital that farmers are equipped to deal with the challenge of both AMR and antiparasitic resistance. The majority of the Minister's contribution placed an emphasis on AMR, as has been the case through all our debates. Everybody who has been involved - all stakeholders and everybody we met at the agriculture committee - has had no issue with the regulation when it comes to antimicrobial resistance. That relates to the prescription and sale of antibiotics. I do not think anybody along the way mooted any change on where we were on that. From an animal and, indeed, human health point of view, it is vital that we get the prescription and distribution of antibiotics right to limit AMR going forward. The biggest part of our debate, which I will come to it later, was about the making of all antiparasitic products prescription medicines only.

It is important that the Bill and future regulations made under it reflect the aims of the overarching European legislation in ensuring that the regulatory framework for veterinary medicines should be adapted to scientific progress, current market conditions and economic reality, while continuing to ensure a high level of protection of animal health, animal welfare, environment and safeguarding of public health. I again thank the Minister and his officials, and all stakeholders who engaged with the Oireachtas joint committee both through our hearings and the PLS. I also very much welcome the amendments the Minister has tabled to the Bill on the back of those during the Bill's passage through the Dáil. I would like him to ensure that the necessary statutory instruments to be made under the Bill are implemented in practical, fair and even manner to ensure that everyone across the supply chain of veterinary medicines can continue to work together in improving animal health and welfare and supporting rural businesses throughout Ireland.

The introduction of the NVPS and the national fertiliser database during our deliberations received a lot of discussion with regard to the whole area of data storage and data sharing. I know the Minister has been in contact with the regulator and is happy that all the information that will be gathered on both the fertiliser database and the NVPS will be handled in the correct manner. This, however, was an issue the farmers in particular were very concerned about as to who would have their information and with whom that information may be shared. I for one appreciate the value of all that information, as the Minister said, and it will be vital information for the Department to have at its disposal, particularly from the fertiliser end of things, when it comes to getting things right in controlling our water quality, the application of our environmental schemes and our nitrates regulations. I welcome the fact that the Minister is happy and I take it at face value that he is after his consultation with the regulator because it was an issue for the farming community as to who would have access to their information, where that information would go and by whom it would be used.

There were ongoing issues from both perspectives from the aspect of the technology that was going to be used for both the NVPS and the recording of the fertilisers and how usable it would be for the people who would need to be inputting the information to that and, therefore, I hope the Department can keep an eye on the evolution of both systems. As I said earlier, the biggest point of discussion during our deliberations was probably on making antiparasitic treatments become prescription-only medicines and how they would then be dispensed. At the moment, before the changes, a person can go to a merchant, pharmacist or co-operative and, in collaboration with a responsible person, get those treatments. The Minister stated that one of the themes of the regulation was to stimulate innovation in and increase the availability of veterinary medicinal products. There was a fear from the word go that, depending on how this was regulated, we could end up with a monopoly on the market and seriously affect the supply chain and the competitiveness from the perspective of farmers when they go to acquire medicines.

The committee looked at the different potential solutions that are in use throughout Europe. One of these involves a complete decoupling whereby only vets could prescribe while somebody else dispensed, in a way similar to the doctor-pharmacist relationship here. However, we found that would limit the role of vets and their ability to enhance their practices. While it has proven to be one of the most effective ways of controlling antimicrobial and antiparasitic resistance on a European level where it has been introduced, we did not see it as the solution.

I welcome the amendment and look forward to the statutory instrument. Other members of the committee are in the House and they may have other opinions. Following all our deliberations, however, I believe that the Bill now satisfies all the stakeholders. I thank the stakeholders who engaged with the committee on an ongoing basis during the entire process. It is important to say at this juncture that, while there were people who had opinions based on the competitiveness and the sale of the products, everybody who was involved was genuinely interested in and concerned with addressing the antimicrobial and antiparasitic resistance aspects of the regulations.