Relevant Matter
Legislation
Public Policy Area
Agriculture
Period
1 Sep, 2022 to 31 Dec, 2022
Specific Details
Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Bill 2022
Intended results
IFA requires that the Bill must facilitate prescribing for antiparasitic products by Qualified Persons. This can be achieved by recognising the procedures currently in place where Responsible Persons have fulfilled this function in National Law since 2007 under accreditation from the Department of Agriculture which meets the criteria set out in the EU Veterinary Medicines Regulation.
- As there will be a two-tier system created by this Bill in its current format on the island of Ireland in relation to sourcing antiparasitic products, placing Irish farmers at a competitive disadvantage while creating strong incentives for illegal trade in these products.
- The proposal for all veterinary medicine prescriptions to be issued on line through the National Veterinary Prescription Services (NVPS) raises significant farmer concerns in relation to the level and type of data that will be stored relating to each individual farm and the accessibility of that data by the Department of Agriculture, Food and the Marine (DAFM) and others.
- That the sanctions for non-compliance with measures in this Bill must be proportionate and farmers cannot be accountable for or sanctioned where prescribers or suppliers of veterinary medicines have failed to comply with their obligations in this area. Farmers are end users and dependant on prescribers and suppliers to meet their obligations.
As farmers we do not have oversight of these service providers, this is the responsibility of the Department of Agriculture, Food and the Marine (DAFM) and therefore we cannot be liable for their failures to comply with their legal obligations.
- That the power provided to those charged with implementing this Bill must not extend to farmers. Farmers can only access veterinary medicines when they are prescribed by a qualified person and supplied by a Department of Agriculture, Food and the Marine ( DAFM) approved outlet.
Entry by force onto farms is not acceptable and must be removed from the Bill. Entry to farms under this Bill must require a warrant and be by arrangement with the herdowner. Farms are also family homes.
- The IFA recommends that the Authority of the Health Products Regulatory Authority (HPRA) carefully consider the available scientific evidence showing that antiparasitic veterinary medicines that are intended for use in food-producing species do not comply with the criteria for derogation from veterinary prescription specified in Regulation 2019/6.
A consequence of this determination is that any such products that are supplied without veterinary prescription would need to be regulated to supply under veterinary prescription.
- IFA recommends that a multi-actor stakeholder approach be taken to elaborate national guidelines for sustainable parasite control, including the development of consistent scientifically-based advice on targeted selective treatments.
- IFA recommends that those involved in the prescribing and dispensing of antiparasitic veterinary medicinal products are provided with access to training/CPD on sustainable parasite control.
- IFA recommended that the Department of Agriculture, Food and the Marine (DAFM) carefully considers the merits of various options as a number of policy options have been identified in this report regarding the development of an appropriate regulatory framework for the supply of antiparasitic veterinary medicinal products that are designated veterinary prescription control
- It is recommended that the Department of Agriculture, Food and the Marine (DAFM) consider elaborating the system for veterinary prescription of antiparasitic medicines which support evidence-based prescribing given the expression of interest by certain stakeholders in providing parasitological diagnostic services to farmers
- There is a need for Marketing Authorisation Holders (MAHs) and other stakeholders to consider how best to disseminate the specific information on dose banding and instructions for use of antiparasitic veterinary medicinal products to the end-users, given the known rationalisation of the text of the labelling and outer packaging of veterinary medicinal products that will take place from January 2022 as a consequence of Regulation 2019/6.
- In the event that the Authority accepts the conclusions of this report, there will be a need for existing stakeholders to adapt to the requirement for a veterinary prescription for antiparasitic veterinary medicinal products. It is recommended that the Health Products Regulatory Authority (HPRA) provides the maximum flexibility and allows a period until 1 January 2022 to comply with this report.
It is also recommended that stakeholders, including veterinarians, other health care professionals and licensed merchants be informed of this report in order to be able to engage with the Department of Agriculture, Food and the Marine (DAFM) in relation to the elaboration and implementation of any new regulatory framework.
- Given the status of the honey bee and its importance in pollination, it is recommended that special status be given to antiparasitic veterinary medicinal products that are indicated for bees (in line with that applying to centrally authorised products for bees).
The IFA recommends that a multi-actor stakeholder approach be taken to elaborate national guidelines for sustainable parasite control, including the development of consistent scientifically-based advice on targeted selective treatments.
- The IFA recommends that those involved in the prescribing and dispensing of antiparasitic veterinary medicinal products are provided with access to training/CPD on sustainable parasite control.
-That given a number of policy options have been identified in this report regarding the development of an appropriate regulatory framework for the supply of antiparasitic veterinary medicinal products that are designated veterinary prescription control, it is recommended that the Department of Agriculture, Food and the Marine(DAFM) carefully considers the merits of the various options.
- Given the expression of interest by certain stakeholders in providing parasitological diagnostic services to farmers, it is recommended that the Department of Agriculture, Food and the Marine (DAFM) consider elaborating the system for veterinary prescription of antiparasitic medicines which support evidence-based prescribing.
Regulations - Prescriptions and Dispensing
The validity period of the prescription for all products with the exception of antibiotics must be 12 months to align with standard herd health planning on the farm and minimise costs and bureaucracy associated with short validity periods for these products while also maximising farmers opportunity to competitively source their on farm medicine needs.
National Database This section proposes the establishment of a National database for all veterinary medicine prescriptions and sets out the information that will be held, its format and those who will have access to it.
- IFA have consistently raised concerns with this proposal and the access it provides for DAFM and others to individual farm and animal specific information. This information is and should remain private to the herdowner and the decision must rest with each individual herdowner as to who can access
- IFA proposes that in the first instance farmers who are purchasing products from more than one supplier must have the opportunity to identify that product on the prescription to the supplier, having all products on the prescription visible to the dispenser would severely limit farmers ability to source their various medicines from the most competitive outlets.
- IFA proposes that the Bill must ensure the National database is developed in a way that does not provide the Department of Agriculture, Food and the Marine (DAFM) or any outside agencies with access to individual farmer data at a level or in a format than what is currently available.
Enforcement
IFA proposes that the Bill must require a warrant and arranged entry with the farmer concerned. Farms are also family homes and this approach, while adopted in the past by Department of Agriculture, Food and the Marine (DAFM) officials, must be prohibited by the Bill.
As farmers cannot source veterinary medicines, unless they are prescribed by a Qualified person and supplied by a person approved by the Department of Agriculture, Food and the Marine (DAFM),it is not acceptable or appropriate the Bill seeks to provide the right of entry (if necessary, by force) to authorised officers or others to farmland, farms or homes of farmers.
Sanctions - In the event prescribers or suppliers have failed to meet their obligations in the Bill farmers cannot be held accountable. The current Veterinary Medicines Regulation incorrectly sanctions farmers where others have not met their obligations, this is not acceptable and must be addressed in the Bill.
Amendment of Fertiliser Feeding Stuffs and Mineral Mixtures Act 1955 - IFA recommends;
1) An exact definition of a fertiliser product must be provided in the Bill.
2) A definition of fertiliser product manufacturing must also be provided
3) IFA firmly believes that it is unfair and unreasonable to consider farmers who source or pay for fertiliser in Northern Ireland or the United Kingdom as fertiliser importers and therefore liable for inclusion or categorisation under both the Fertiliser Economic Operators Register and the Professional Fertiliser End Users Register.
There must be flexibility and ease of use in the database for fertiliser economic operators in Northern Ireland to sell and transfer fertiliser products to to professional users in the ROI. Farmers who choose to purchase fertiliser from suppliers in Northern Ireland must not be unfairly disadvantaged for doing so.
4) Throughout the Bill there are references to fines and sanctions, in the event fertiliser economic operators fail to meet their obligations in the Bill, farmers cannot be held accountable.
National Fertiliser Database - Returns of details of fertiliser products held on a premises -
The submission of fertiliser product details and quantities owned or held on a premises by end users at regular intervals of time or even in real time has potential to be onerous and overly demanding for farmers. IFA have concerns over the ability of older and less technologically literate farmers to comply with these requirements.
To this extent, many farmers now employ agents and consultants for any submissions that require online completion on agfood.ie and IFA believe this trend would likely extend to the national fertiliser database. This will increase administrative costs for farmers with no direct economic return.
Taking this into account, IFA believes submission of fertiliser information or statistical returns should be kept to a minimum and take place within the closed spreading period and away from the major farm payment scheme deadlines.
Further clarifications are needed on what additional details could be required for submission to the database by professional fertiliser end users.
Processing of Information -
(1) The use of the information compiled under a national fertiliser database to inform policy and control programmes and to reduce inorganic fertiliser usage is clearly stated. IFA are concerned that 2023 would be used as a baseline or reference year to inform this decision making.
Given the unprecedented increase in fertiliser prices in 2022 and widespread predictions for more restricted fertiliser availability and demand in 2023, IFA believe this must be considered by the Minister and his officials.
(4) Clarification must be provided on which third parties anonymised data from the National Fertiliser Database could be shared with.
Service of Notice and Notifications -
Should an inspection of a premises be required, sufficient notice must be provided by officials and entry must be strictly by arrangement only.
Name of person primarily responsible for lobbying on this activity
Tim Cullinan IFA President, TJ Maher IFA Animal Health Chair, Tomas Bourke IFA Senior Policy Executive, Anna Daly IFA Policy Executive, James Walsh IFA Policy Executive
Did any Designated Public Official(DPO) or former Designated Public Official(DPO) carry out lobbying activities on your behalf in relation to this return? You must include yourself, and answer Yes, if you are a current DPO or a DPO at any time in the past. (What is a Designated Public Official?)
No
Did you manage or direct a grassroots campaign?
No
Was this lobbying done on behalf of a client?
No
Lobbying activity
The following activities occurred for this specific Subject Matter Area.
Designated public officials lobbied
The following DPOs were lobbied during this return period on this specific Subject Matter Area. These DPOs were involved in at least one of the Lobbying Activities listed above, but not necessarily all of them.
As returns are specific to a Subject Matter Area the above Lobbying Activities may be associated with multiple returns.
Martin Browne
TD (Dáil Éireann, the Oireachtas)
Jackie Cahill
TD (Dáil Éireann, the Oireachtas)
Matt Carthy
TD (Dáil Éireann, the Oireachtas)
Michael Collins
TD (Dáil Éireann, the Oireachtas)
Michael Fitzmaurice
TD (Dáil Éireann, the Oireachtas)
Joe Flaherty
TD (Dáil Éireann, the Oireachtas)
Paul Kehoe
TD (Dáil Éireann, the Oireachtas)
Brian Leddin
TD (Dáil Éireann, the Oireachtas)
Michael Ring
TD (Dáil Éireann, the Oireachtas)
Victor Boyhan
Senator (Seanad)
Lynn Boylan
Senator (Seanad)
Paul Daly
Senator (Seanad)
Tim Lombard
Senator (Seanad)
Denis O'Donovan
Senator (Seanad)
Danny Healy-Rae
TD (Dáil Éireann, the Oireachtas)