Charlie McConalogue (Donegal, Fianna Fail) | Oireachtas source

I move: "That the Bill be now read a Second Time."

The Bill, which I am pleased to bring forward, legislates for two areas. The first part seeks to modernise the area of veterinary medicines and medicated feed. As Deputies may be aware, at EU level last year, we saw the implementation of two new regulations in this area. The Bill will reinforce those regulations in Irish legislation in a once-in-a-generation change.

It shows our commitment to key objectives in the regulations, namely addressing antimicrobial resistance and protecting the supply of veterinary medicines and medicated feeds while supporting Irish farmers and businesses through this unique period of change.

The second Part of the Bill provides through the amendment of the Fertilisers, Feeding Stuffs and Mineral Mixtures Act 1955 for the creation of a national fertiliser database which will collect data on import, sale, supply and use of fertilisers and allow for analysis of this data to assist in the administration of other departmental schemes.

I take this opportunity to thank the stakeholders who have engaged with my Department during the past three years on the issues at the core of this Bill. I also thank the members of the Joint Committee on Agriculture, Food and the Marine for their valuable work both through meetings with my Department and in particular their work on the pre-legislative scrutiny report. I believe the report’s recommendations that have been incorporated into the Bill, where possible, have helped to strengthen the Bill I put before the House today. I also wish to recognise the work of my own officials and the Attorney General and his office in the preparation of the Bill and in the very significant work and engagement to bring it to this stage.

As we all know, Ireland’s agrifood sector plays a critical role not only for the economy but also for hundreds of communities. It is our largest indigenous sector and is truly the lifeblood of rural Ireland. Total exports of agrifood products last year were estimated by my Department at €18.7 billion. This phenomenal success is driven by the farm families and fishing communities of Ireland who are the bedrock of the sector, which is the envy of the world.

This Bill and the matters provided for within it will play a key role in the success of our agrifood sector going forward. In January 2022, I enacted SI 36 of 2022, the European Union veterinary medicinal products and medicated feed regulations, to give effect to EU Regulation 2019/4 on medicated feed and EU Regulation 2019/6 on veterinary medicinal products. This Bill provides for powers to make regulations on areas that these recent EU regulations left to be determined by national law such as the retailing of veterinary medicines.

The Bill will repeal the Animal Remedies Act 1993. It will provide for the introduction of a national veterinary prescription system, NVPS. This system, which is being developed by my Department, will position Ireland as a leader within the EU in terms of regulatory oversight on the use of veterinary medicinal products in food-producing animals. Ultimately, this will help us to protect human and animal health and our shared environment, provide us with the best opportunity to access new trade markets and increase the viability of our food-producing sector, thus protecting and supporting jobs in our economy and in rural Ireland in particular.

Tackling antimicrobial resistance, AMR, is accepted as being critically important to achieving the best public, animal and environmental health outcomes, achieving economic, environmental and socially sustainable development and ensuring food security. AMR is now a leading cause of deaths worldwide. It is incumbent on us all to address this problem. The European regulation is now a cornerstone to support the achievement of the objectives set in the European one health action plan and in the farm to fork strategy against antimicrobial resistance. The regulation recognises the important role of the animal health sector in addressing the one health challenge of antimicrobial resistance, which has been referred to as the silent pandemic. This Bill strengthens Ireland’s position in the global fight against AMR and supports a sustainable agrifood sector. Actions taken to improve animal health and prevent disease are key to reducing the use of antibiotics and effectively tackling antimicrobial resistance. These actions align well with Ireland’s national farmed animal health strategy, with one of the key enabling principles being prevention is better than cure. This Bill provides a wide range of measures to fight AMR and promote a more prudent and responsible use of antimicrobials in animals. These measures serve to protect public health, as well as animal health, by working to keep antibiotics as effective disease treatments into the future. Vets as the prescribers and, indeed, gatekeepers of antibiotics have a key role to play to promote their responsible use. The farming sectors have a responsibility to work collaboratively with their vet and other farm advisory professionals to ensure the best possible health outcomes for their animals, and to use antibiotics only when absolutely necessary. The growing understanding of the risks of AMR is among the key drivers for recent EU veterinary medicinal regulation change. AMR is a global health threat, posing significant challenges to human and animal health, and to the Irish farming sector.

The Bill also provides for the introduction of the new national veterinary prescription system, NVPS, and the collection and effective use of the data collected therein. This has the potential to provide local, national and international benefits across the sector to multiples of stakeholders. The system itself is a free-to-use digital online platform which is accessible from any desktop or mobile device which allows veterinary practitioners to record and issue veterinary prescriptions to their clients for veterinary medicinal products including medicated feed. The introduction of the NVPS will meet the Government's commitment under its digital strategy to introduce greater digital services to its citizens. It will assist with Ireland's national one health-one welfare, antimicrobial resistance and antiparasitic resistance programmes by identifying where and when particular medicines are being used and why, to what levels and in which animal species, information which was never previously available to the policy makers addressing these international disease issues. It will assist with the development and provision of farmer education policies on the effective and good use of veterinary medicinal products. With this education, it is expected that vets and farmers alike will prescribe and use less medication over time, ultimately resulting in huge financial savings to farming communities. It will also provide greater choice and control to the individual farmer on where they purchase their medications. It will help to develop the sustainability of the food producing farming community. The data will assist policy makers in identifying alternative medicinal options and practices from a farming perspective through detailing good farming and prescribing practices. Its introduction will simplify and reduce administrative burdens by digitalising cumbersome and labour-intensive manual prescription and dispensing processes. It will provide assurances to international trading partners that Ireland is at the forefront of safe food production with the highest level of regulation on the supply and use of medications in its food-producing animal population. It will aid Ireland with its EU regulatory veterinary medicinal products usage data submission commitments under the EU regulation and will also help with efficiently directing limited Department and other national resources when scheduling inspections or introducing national programmes.

I am committed to ensuring a competitive marketplace for the supply of all veterinary medicines and a continuation of the current routes of supply into the future. The importance of competition in the marketplace and protecting the choice of the farmer in where he purchases antiparasitic veterinary medicines is central to the work of my Department.

The Bill, when enacted, will also enable the collection and processing of information on the import, manufacture, sale, supply and use of fertiliser in the State. It will enable data related to fertilisers and lime to be collected from the point of import into the State, or manufacture for sale, to an end user. The climate action plan 2023, Food Vision 2030 and the EU farm to fork strategy have all set ambitious targets to reduce fertiliser use including reducing emissions associated with chemical fertiliser use by more than 50% by the end of this decade. There is also a need to improve water quality, especially in specific catchment areas.

This Bill is divided into three Parts. Part 1 of the Bill provides for standard provisions in relation to the Title and commencement of the Bill, including a commencement order for section 7, which relates to the establishment of a national database for the prescribing and dispensing of veterinary medicinal products and medicated feed, and also for the repeal of the Animal Remedies Act 1993 and certain provisions of other Acts.

Part 2 details the regulation of veterinary medicinal products and medicated feed with section 4 providing the definitions for Part 2 of the Bill.

Sections 5 and 6 provide for restrictions on those who may issue a veterinary prescription to ensure only registered veterinary practitioners do so. The recent advice received from the Attorney General’s office brings clarity to certain issues regarding prescriptions raised in the pre-legislative scrutiny report. The Bill provides for persons permitted to dispense a veterinary medicinal product subject to a prescription. It also provides for the making of regulations in relation to the prescription and dispensing of veterinary medicinal products or medicated feed, including such areas as setting the maximum validity period of a veterinary prescription other than an antimicrobial, specifying the contents of a veterinary prescription, the emergency dispensing of veterinary medicinal products by pharmacists and, as recommended in the pre-legislative scrutiny report, producing a list of antiparasitic veterinary medicinal products that can be dispensed in lieu of the product on the veterinary prescription.

Section 7 provides for the establishment, maintenance and operation of a database, called the “national database” in the Bill, on which veterinary prescriptions and dispensing of veterinary prescriptions shall be recorded. This will be known as the NVPS. This section deals with the information held on the database, who it may be accessed by and shared with and the reasons for the processing of the data.

The explanatory memorandum that was published with the Bill contained an error in detailing section 5 where it stated “that all veterinary prescriptions shall be issued electronically and dispensed and recorded on or transmitted to the national database”. This detail should have been included in the explanatory memorandum at section 7. This section is necessary to give legal effect to the NVPS, to permit the collection of the data needed to operate such a system and to comply with the general data protection regulation, GDPR. The NVPS will also be utilised to assist in complying with Ireland’s obligations under Article 57 of EU 2019/6 on the collection of data on the usage of antimicrobials. I have provided for the introduction of the NVPS on commencement order, which will allow the necessary time to further develop the NVPS as necessary to facilitate the continuation of existing retail and supply chains of antiparasitic products. The use of the NVPS by prescribers and dispensers of veterinary medicinal products is a key tool in ensuring a competitive market for the supply of such products.

Sections 9 to 26 provide for the rules on retail. The recent EU regulation states that retail of veterinary medicinal products is a matter for national law. The rules being introduced cover areas including the routes of retail of veterinary medicinal products to ensure they are retailed in an appropriate manner. The routes are detailed in the Schedule to this Bill. The labelling requirements of veterinary medicinal products that are subject to a prescription, or those that are retailed out of their original packaging, are detailed to ensure the correct information in relation to the supply and use of the product is clearly displayed. An application process is provided for the granting of a retailer’s licence to enable someone to retail veterinary medicinal products. The obligations that attach to such a licence, including training of retail responsible persons, are outlined. Rules on retailing on the Internet are provided for, along with powers to make further regulations in that area. Record-keeping provisions for those who are retailers, as well as a provision that retailing must only take place from a fixed premises, are detailed. The procedures around the special import licences that vets and wholesalers may avail of in certain circumstances are also covered in this section.

Sections 27 to 30 provide for the making of regulations on the possession, administration, advertising and storage of veterinary medicinal products and medicated feed.

Sections 31 to 34 provide for the making of regulations on the licensing of the importation of certain veterinary medicinal products and medicated feed in circumstances permitted under EU law, other matters that EU regulations left to national law and general provisions on licences and regulations made under the Bill.

Sections 35 to 56 are enforcement matters. The provisions of these sections are adapted from the Animal Remedies Act 1993.

Turning to Part 3 of the Bill, which contains eight sections, the proposed legislation will amend the Fertilisers, Feeding Stuffs and Mineral Mixtures Act 1955 to provide for a register of fertiliser economic operators, a register of professional fertiliser end users and the establishment of a national fertiliser database and associated provisions.

Sections 57 and 58 provide definitions for Part 3 of the Bill, while section 59 provides a means for substances not considered fertilisers or feeding stuffs to be excluded from the legislation.

Section 60 provides for the application of a licence and the right to appeal if a licence is not granted.

Section 61 provides for the establishment of a fertiliser economic operator's register and a fertiliser end user register. It also provides for a national fertiliser database, which will encompass the registration of fertiliser economic operators and end users. Information on the manufacturing, import, placing on the market, making available on the market or sale, whether wholesale or retail, of fertiliser products will be included in the database.

Section 62 provides for the appointing in writing of such persons or class of persons as the Minister considers appropriate to be authorised officers for the exercise of the functions conferred on an authorised officer under this Part. This section also provides the powers for an authorised officer and details the specific circumstances in which an authorised officer can use their powers. It also provides the procedures for properly processing the information collected.

Section 63 provides for the prosecution of offences under this Part of the Bill and Section 64 provides for penalties for offences under the Bill.

The national fertiliser database will provide for accurate tracking of fertiliser sales along the supply chain. The recording of fertiliser sales data at farm level will facilitate traceability and monitoring of quantities and types of fertiliser used over time. Additionally, farmers can use this data to demonstrate compliance with any future voluntary industry sustainability or quality assurance initiatives. The data captured in the database will provide a solid basis for future policy interventions to support our environment and climate ambitions. It will assist farmers in improving nutrient use efficiency on their farms, thereby contributing to the key targets on fertiliser use under the climate action plan, and will facilitate improved compliance with nitrogen and phosphorous limits. Data from the database will also facilitate regulatory controls by my Department under Ireland’s nitrates action programme, nitrates derogation and the eco-scheme liming and reduced fertiliser options under Ireland’s Common Agricultural Policy, CAP, strategic plan.

In time, checks that previously involved examining paper records supplied by farmers will be completed using information from the database. This will significantly reduce the administrative burden that would otherwise be placed on farmers. Establishing the database will also meet a commitment that Ireland made during negotiations with the European Commission to secure the current extension to Ireland’s nitrates derogation.At this stage all EU member states availing of a nitrates derogation have set up, or are in the process of setting up, a national fertiliser database.

Under the Bill, anyone wishing to purchase fertiliser for professional use will have to register as a professional fertiliser end user, the vast majority of which will be farmers.Farmers or agents acting on their behalf will be able to register using the Department’s online portal, www.agfood.ie.

In response to recommendations made during pre-legislative scrutiny, I reiterate that this will be a simple process and will only be required once. Non-farmer professional fertiliser end users will have to apply to my Department for registration. Once registered, they will be assigned a unique identification number. Professional fertiliser end users will have to submit stocks of fertiliser on their farms or premises on dates to be agreed as part of the consultation process.

The pre-legislative scrutiny process raised the issue of purchase of fertiliser by sports clubs and organisations. The purchase and use of fertiliser in quantities sufficient for use on football fields and their environs is considered as a commercial use and sports clubs will be required to register as professional fertiliser end users. Beyond registration, it is not anticipated that there will be any burden placed on clubs, particularly if they do not hold stocks on site. The sale of fertiliser to sports clubs and organisations will be recorded by fertiliser merchants.

Non-professional users of fertiliser, such as gardeners producing for their own use, will not be impacted by this legislative proposal. Businesses or individuals selling fertiliser must also register with my Department as fertiliser economic operators and will be required to submit information to the national fertiliser database as set out in the Bill.

The Department has been engaging with fertiliser stakeholders over many months to ensure this process is as straightforward as possible. In this regard, retailers of fertilisers will have two options to supply their sales data. This information can be submitted through an application programme interface, API, which will allow sales data to be sent directly to my Department’s IT systems.

Alternatively, the information can be submitted manually through the Department’s online portal, agfood.ie.

The robust data sharing provisions in the legislation will allow the potential specific sharing of data with other bodies to achieve environmental and sustainability targets and will be fully in line with general data protection regulation, GDPR, and other data.

In conclusion, I look forward to support for this important legislation that will provide many far-reaching benefits for farmers, public and animal health and welfare and the environment. I also look forward to the debate on Second Stage and other Stages of the Bill as it progresses through the Dáil.

I thank all who have contributed so far and officials in my Department for their work in bringing this legislation together. It is heavy and complex legislation, but it is important we progress it given its significance. Both elements of the legislation involve the daily lives of farm families and, therefore, it is important that we continue to offer as much clarity as possible.

See this speech in context