Oireachtas Joint and Select Committees
Wednesday, 5 October 2022
Joint Oireachtas Committee on Agriculture, Food and the Marine
General Scheme of the Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Bill 2022: Discussion (Resumed)
Jackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I remind members, witnesses and persons in the Public Gallery to turn off their mobile phones. The purpose of today's meeting is to continue the pre-legislative scrutiny of the general scheme of the veterinary medicinal products, medicated feed and fertilisers regulation Bill 2022 in the first session and to receive a briefing on the EU nature restoration target in the second session. The committee will hear from representatives of the Independent Licensed Merchants Association, ILMA, and the Irish Pharmacy Union, IPU, in the first session. It will hear virtually from Mr. Niall Curley, policy adviser on biodiversity, soil and water at Copa-Cogeca, in the second session.
All of those present in the committee room are asked to exercise personal responsibility in protecting themselves and others from the risk of contracting Covid-19.
Witnesses giving evidence from within the parliamentary precincts are protected by absolute privilege in respect of the evidence they give to the committee. This means that witnesses have a full defence in any defamation action for anything said at a committee meeting. However, witnesses are expected not to abuse this privilege and may be directed to cease giving evidence on an issue at the Chair's direction. Witnesses should follow the direction of the Chair in this regard and are reminded of the long-standing parliamentary practice to the effect that, as is reasonable, no adverse commentary should be made against an identifiable third person or entity. Witnesses who are giving evidence from a location outside the parliamentary precincts are asked to note they may not benefit from the same level of immunity from legal proceedings as witnesses giving evidence from within the parliamentary precincts, and they may consider it appropriate to take legal advice on this matter. Privilege against defamation does not apply to the publication by witnesses, outside the proceedings held by the committee, of any matter arising from the proceedings.
Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against any person outside the Houses or an official, either by name or in such a way as to make him or her identifiable. Parliamentary privilege is considered to apply to utterances of members participating online in this committee meeting when their participation is from within the parliamentary precincts. There can be no assurances in the context of participation online from outside the parliamentary precincts. Members should be mindful of this when they are contributing.
I welcome from Mr. Ollie Ryan, Mr. Terence O'Shea and Mr. Barry Larkin from the ILMA; and Mr. Daragh Quinn, Ms Clare Fitzell, Ms Lara Marin and Ms Nicola Cantwell, who is joining us remotely, from the IPU. I invite Mr. Ryan to give his opening statement.
Mr. Ollie Ryan:
The ILMA welcomes EU Regulation 2019/6 for veterinary medicinal products and has no issue with the stated objectives aimed at reducing the administrative burden, enhancing the internal market and increasing the availability of veterinary medicinal products while guaranteeing the highest level of public and animal health and environmental protection. Furthermore, the Health Products Regulatory Authority, HPRA, task force report into antiparasitic resistance has highlighted the need to address effectively antiparasitic-resistance measures for cattle, sheep and horses using a multi-stakeholder approach.
The ILMA also welcomed the support for responsible persons, RPs, we employ at all licensed merchants' outlets from the Chief Veterinary Officer, CVO. In his letter to the EU in June 2020, he not only affirmed that the existing route of supply and distribution were not associated with increased resistance and environmental damage but also that the RPs undertake a professional, internationally recognised qualification and training regime.
The committee is acutely aware of the consequences of failing to include the RP in the prescribing of antiparasitic medicines and has worked tirelessly with Ministers and stakeholders to find the solution. The stark reality of these warnings was underlined by the Irish Co-operative Organisation Society, ICOS, last week, with the collapse and loss of more than 90% of intermammary sales to private vet practices and virtually no vet prescriptions given to farmers to use at co-operative stores, effectively creating a monopoly in this market. This windfall of new businesses will multiply at least tenfold if antiparasitic medicines are allowed to go down the same vet-only prescribing channel. Recognition of anti-competitiveness and accessibility was also noted in the CVO’s letter to the EU. He stated that if sales of these products were undertaken largely by veterinarians, the current competitive environment for these products would be significantly weakened.
The ILMA, as a stakeholder, has agreed that antiparasitic medicine prescriptions will be entered onto the national veterinary prescription system, NVPS, once the technology is available and working and that licensed merchants and RPs will invest time and money into systems compatible with the programme. To this end, NVPS-prescribing terminals should be installed at all licensed merchants’ premises and the required technology training undertaken. Continuing professional development programmes will also be introduced to ensure the best and most up-to-date advice is given to farmers on antiparasitic-resistance methods.
Close examination of the RP professional qualification, introduced in 2012, emphatically proves that the RP was meeting all EU-required criteria to avail of the derogation Article 105(4) at the time of its entry into force. The qualification consists of an intensive, 100-hour course, with four hours of practical and written exams, and is accredited to an internationally recognised standard and approved by the Department of Agriculture, Food and the Marine. As part of the course, a comprehensive prescribing protocol was introduced to help guard against the rising number of reports and trials showing anthelmintic resistance in cattle and sheep and environmental issues that needed urgent addressing. The Department moved swiftly to include in the qualification many prescribing responsibilities on the dispenser, including record-keeping and all other information relevant to the sale and use of the appropriate products. To this end, it is clear the Department accepts that the RPs are professionals.
In summary, the Department must retain a level playing field in the prescribing and dispensing of antiparasitic medicines and ensure they adhere to the expressed wishes of Irish MEPs, the recommendation of the HPRA report and the advice of the CVO, coupled with the unified support of all the stakeholders.
Compliance with the directive to enhance the internal market and increase the availability of veterinary medicinal products will thus met in full. The RP must remain able to advise and deliver a consistent message on antiparasitic resistance measures, help preserve the life of the existing groups of available wormers and introduce responsible use measures across entrenched farming practises. A holistic multi-pronged approach is nothing short of imperative if Ireland is to effectively address antiparasitic resistance. A fresh solution has been offered to the Department that stakeholders believe has no legal impediment to its implementation and this is the only route of travel to resolve this outstanding issue.
Jackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I invite Ms Fitzell to make her opening statement.
Ms Clare Fitzell:
I thank the committee for the kind invitation to contribute to this discussion. We look forward to highlighting the concerns of our members. The IPU is the representative and professional organisation for more than 1,900 community pharmacies and more than 2,300 individual pharmacists. Our vision is to be the authoritative voice of community pharmacy and a driving force in the evolution of accessible, equitable primary healthcare. The sector employs 31,000 people directly and indirectly. Of our members, in excess of 300 pharmacies operate dedicated professional services to animal owners through the supply of veterinary medicinal products, advice on their correct use and associated recording keeping and legislative requirements.
Pharmacists are trained healthcare professionals and are fully committed to the Government's one health strategy. We are acutely aware of the serious global public health challenge presented by antimicrobial resistance, AMR, that we are facing not only from the perspective of medicines used in human health, animal health and welfare but also from our shared environment. We are actively supporting initiatives such as the Pharmacy Antimicrobial Stewardship Network, which promotes the responsible and rational use of antimicrobials, including antiparasitics from the animal welfare perspective.
The committee will be well aware of the current situation and, therefore, I will focus on our concerns and potential solutions. Implementation of the regulation in its proposed format will have a myriad of unintended consequences. The impact on antiparasitic veterinary medicinal products, VMPs, will be quite the opposite of that intended as stated in objective 5 of EU Regulation 2019/6, which states: "This Regulation aims to reduce the administrative burden, enhance the internal market, and increase the availability of veterinary medicinal products, whilst guaranteeing the highest level of public and animal health and environmental protection." With regard to antiparasitic VMPs, we anticipate an increased administrative burden for all stakeholders, reduced competition in the sector, reduced availability of products, increased costs for animal owners, adverse impact on animal welfare, increased cross-Border trade due to different regulatory stances, reduced accountability of use, diminished food quality assurance, loss of services and jobs, reduced viability of essential small rural pharmacies that have a sizeable veterinary business and reduced compliance with the one health approach.
The experience since the implementation of Regulation EU 2019/6 came into effect on 28 January 2019 regarding VMPs other than antiparasitic medicines, which took effect in Ireland on 28 January 2022, has resulted in what can only be described as a seismic downturn in the dispensing of some prescription-only VMPs by pharmacists. Intramammary antibiotic tubes have seen a downturn of between 80% and 90%, which is similar to that reported by ICOS last week. Some prescription-only veterinary vaccines, dispensing and supplies from pharmacies have decreased by 50% to 60% over the same period. We understand that veterinary pharmaceutical manufacturers and suppliers have not reported any differential in the Irish market. It is our assumption that pharmacists, licensed merchants and co-operatives have all experienced a significant downturn in their business and this business has migrated elsewhere. The critical factor is the absence of veterinary prescriptions for the aforementioned products.
The IPU along with other stakeholders was assured that the NVPS would achieve the objectives of reduced administrative burden, enhanced market and increased availability of VMP prescriptions and VMP choices for animal owners. Despite the best intentions and efforts, the NVPS has been beset by challenges, one of the most significant hurdles to date being the lack of engagement by veterinarians. Other challenges that we have encountered with the current NVPS solution are an initial lack of engagement with pharmacists and other end users to gather essential user requirements before design; no integration with prescribing or dispensing systems in pharmacies; the need for double administrative activities when dispensing to comply with legal requirements; no facility to amend a record, which is essential before this solution comes into place; no facility for generic substitution; no engagement by veterinarians; slow response time to queries raised regarding the solution; no facility to print a pharmacy information label to attach to the VMP to meet pharmacy legal requirements; the fact that no pharmacies have been registered to use this system despite submitting registration forms for access; and the fact that the system is set to pharmacist level, not pharmacy level, which is highly problematic when it comes to our record-keeping requirements.
Regarding our recommended solutions, resolution of the impasse regarding prescribing antiparasitic VMPs can be achieved by retrospectively amending SI 786/2007 European Communities (Animal Remedies) (No. 2) Regulations 2007. Precedent exists throughout the Statute Book of such retrospective amendments. Article 105(4) of EU Regulation 2019/6 provides a derogation designed for precisely this purpose. It is intended to facilitate professionals other than veterinarians to issue veterinary prescriptions, where such individuals will qualify to do so at the time the regulation entered into force. The availability and potential application of the derogation were confirmed in September 2020 by Ms Stella Kyriakides on behalf of the EU Commission in response to letters from Chris McManus, MEP and Martin Blake, Chief Veterinary Officer. In summary, this means that Ireland can confirm by means of submission that the terms of the derogation have been met by virtue of the retrospective amendment of SI 786/2007.
The IPU call on the committee to delay further implementation of the regulation and the associated Bill until the NVPS is fit for purpose; ensure the completion or sharing of the HPRA task force recommended impact assessment as we are not sure whether it has been completed; design and implement an education programme for the animal owners to address this serious issue, as highlighted by at last week's meeting of this committee and as proven by UK studies, this measure was the most successful; consult pharmacists on a multi-actor stakeholder approach to be taken to elaborate national guidelines for sustainable parasite control, including the development of consistent scientifically-based advice on targeted selective treatments; and ensure that involve all stakeholders involved in the prescribing and dispensing of antiparasitic VMPs are provided with access to training-continuous professional development on sustainable parasite control as recommended by the HPRA task force.
Removing pharmacists and responsible persons from their prescribing roles in the supply of antiparasitics will result in the loss of the holistic approach previously favoured by the Department of Agriculture, Food and the Marine and required as part of the one health strategy. Collaboration is the key to ensuring that the focus on compliance and patient-animal safety is maintained as part of the safe and responsible use of antiparasitics. To this end, the status quoin the supply route should be maintained and we respectfully suggest that the committee plays a significant role in ensuring this equity. I thank members for your time. We are happy to answer any questions from committee members.
Paul Daly (Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I welcome the representatives from the ILMA and the IPU. I will be brief because as I said last week, we have been over a lot of this and are at the stage where we want to be solution-focused. There is a lot of correlation between what we heard from both groups and what we heard from ICOS last week. What are the ILMA's issues with the Bill?
Mr. Terence O'Shea:
The major issue is the failure of the current proposal to include the responsible person as a prescriber of antiparasitic veterinary medicines. That is the crux of the issue. The solution is to include them as prescribers of such medicines.
If we are included as prescribers, that will free a route for the current proposals to be carried through.
Paul Daly (Fianna Fail)
Link to this: Individually | In context | Oireachtas source
Based on the figures from the witnesses about the drop-off in antimicrobials and what we heard last week, what are the ultimate consequences for them if those changes are not made?
Mr. Ollie Ryan:
One of the stark realities was outlined by ICOS last week. There has been a 90% drop in sales of intramammary tubes since last January. The proof of the pie is in the eating. This will happen next year if the Bill continues in its current format. We are all in great danger of becoming extinct in our current format if this is followed through on.
Paul Daly (Fianna Fail)
Link to this: Individually | In context | Oireachtas source
Is it down to the responsible person? How can these issues be addressed?
Mr. Ollie Ryan:
Most people here are farmers. Over the past 20 years, the RP has played a huge role in the distribution of veterinary medicines and has done a good job. The Department will recognise that. It has to recognise that this Bill will totally wipe out our industry if we are not allowed to prescribe our own medicines.
Paul Daly (Fianna Fail)
Link to this: Individually | In context | Oireachtas source
Has the ILMA engaged with the Department on this?
Paul Daly (Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I have a final question for the association. I am conscious that we do not want to fully concentrate on the veterinary medicine issue. The Bill also includes the fertiliser register. Many of ILMA's members sell fertiliser too. How are they fixed with regard to the implementation of technology and related training that will be required?
Mr. Barry Larkin:
I can answer that. I have a statement that I can read out, if that is okay.
Merchants' co-operatives and agri-retailers around the country have aligned their businesses in a way that best serves Irish farmers. The resulting landscape of the agri-retail trade in Ireland means that there are businesses of varying size across the country, but the core principles of these businesses remains similar across the board, with sales of fertiliser and animal health products playing a fundamental role in the economic survival of their businesses. Merchants and co-operatives around the country are acutely aware of the sustainability requirements set on the agricultural industry as a whole and they are willing to put their shoulder to the wheel. These businesses employ a significant number of suitably qualified people across the industry that they service, including nutritionists, agronomists, RPs for animal health, specialists for human-consumable foods, and so on. Many are qualified to a reasonable level, including to level 8, level 9, and even to PhD level. Farmers rely on these people for expertise and advice to maximise efficiency on their farms.
It is imperative for the industry that all of these businesses are kept economically viable so that the trade can continue to provide its far-reaching service to farmers. These businesses and the people who work there will be crucial to providing services, expertise, advice and knowledge to farmers as we all embark on the journey to reduce emissions from the sector without compromising output.
The implementation of the veterinary medicinal products medicated feed and fertilisers regulation Bill 2022 in its current form threatens the viability of many agri-retail businesses around the country and, in turn, also threatens the jobs of the many people with specific qualifications whom I have outlined. If the sale of animal health products is taken away from many of the smaller merchants around the country, then those businesses will become unviable and close their doors, leaving farmers with no option but to look further afield for the services and advice that they require.
I will note some issues with the Bill in its current form. With regard to the North of Ireland and the Border, there is free trade and movement of goods on the island of Ireland under historic agreements. While the Department of Agriculture, Food and the Marine correctly maintains that it cannot impose legislation on the North of Ireland, it makes it quite difficult to successfully implement legislation on one side of the Border. Fertiliser has been traded across the Border for many years by both farmers and agri-retailers. Until recently, this has tended to happen in just the Border counties. However, this has extended much farther with commercialisation. If farmers in County Cork want a load of fertiliser from a retailer in the North of Ireland, all they have to do is make a phone call and the fertiliser will land in their yard within days. It would be incredibly naive for anyone to think that farmers who are pushing boundaries will not use this angle to avoid recording some of their fertiliser purchases.
While we have been involved and engaged with the Department through stakeholder meetings, it seems that the current route of travel regarding the IT requirements of agri-retailers is overly comprehensive. There are currently two proposed ways by which the Department will accept sales information. In one, merchants have a responsibility to input fertiliser sales data into the agfood.ieportal, transaction by transaction. This is a laborious and tedious process.
The second option is for the Department's IT system to link with agri-retail systems through the use of an API, which will cost a significant amount for agri-retailers that have meticulous and secure IT systems. It would potentially force smaller merchants away from fertiliser sales, since they may not have the IT systems or resources to implement this Bill in their businesses. Some of these smaller businesses still use pen and paper to record sales. The API to link IT systems has yet to be disclosed to the trade, leaving very tight timeframes for it to be ready and successful. The requirement for the Department's IT system to link with the IT systems of agri-retailers for the purposes of the legislation seems to be overly comprehensive. A simple monthly reporting mechanism, where data can be exported to a .csv file and sent to the Department, which can use its IT system to seamlessly extract the required data, is a far more feasible solution that would not incur the huge costs and potential security problems that can arise from IT systems linking together.
In summary, agri-retailers around the country have many concerns about the Bill in its entirety. However, the availability of goods from the North of Ireland puts most aspects of the Bill in question. An all-Ireland approach would be better, if possible, or at least we could have the same processes in place on both sides of the Border, with RPs on both sides.
Merchants throughout the country have a full understanding of why the Bill is being introduced. It will address water quality and emissions from fertiliser and antiparasitic resistance, which is an animal health issue. All businesses are willing to achieve what is required to make our island a better place. However, an increasing financial burden is being placed on agri-retailer businesses across the country, including administrative, IT system, and staff training costs. The Department of Agriculture, Food and the Marine can take pathways to successfully implement this Bill. It seems that we are going down an overly comprehensive route for both the anti-parasitic medication and fertiliser issues.
Paul Daly (Fianna Fail)
Link to this: Individually | In context | Oireachtas source
That was a comprehensive answer.
I have questions for the IPU. There has been much talk about the RP. When people train to become pharmacists in college, how much is orientated towards veterinary issues? The IPU is best placed to answer that question. Is there a substantial element of veterinary issues in training to be a pharmacist? The union mentioned the HPRA task force recommended an impact assessment. Has it had communication with the Department about whether that has been done? If so, where is it now?
Mr. Daragh Quinn:
I thank the Senator for the opportunity to address his questions. All pharmacists spend at least four years in university, with one year of postgraduate study. Their training is essentially about pharmaceuticals. All pharmaceuticals are common for both humans and animals. Many pharmaceuticals at the core of this discussion, mainly antiparasitics, are routinely supplied by pharmacists in community pharmacies in their everyday jobs. That is done in a competent manner because those pharmacists have done five years of study. A human is a different species from a cow or sheep but the drugs and medicines are the same. There are different dose rates for each species but the same principle applies to each species. Some pharmacists have undertaken postgraduate masters' degrees in veterinary pharmacy. All pharmacists undertake continuing professional development and continuing education annually, which is regulated and monitored in Ireland. As a component of that, I as a veterinary pharmacist undertake veterinary pharmacy as part of my continuing professional development.
Pharmacists have a considerable knowledge in that regard and that builds upon their core education as pharmacists. In discussion of medicines, the pharmacist really should be the top of the tree because they are the experts on medicines. We work in primary healthcare with our doctors, nurses and physiotherapists in a collaborative practise so that everybody works as part of that team for the optimum outcome for the healthcare of the patient. It would be nice to apply the same principle to veterinary medicine and that there would be a collaborative effort involving the veterinarians, the veterinarian nurses, the pharmacists, the responsible persons and the farmer - the animal owner at the end of the day. We all have a responsibility to sustain these medicines so that we get the best outcome from them and animal welfare is primary to our input.
To address the Senator's second question, the Health Products Regulatory Authority, HPRA, established a task force back in 2019 to review these medicines. It became apparent subsequent to its review that there were issues with regard to the antiparasitic medicines. There were issues of resistance, within the different parasites, to the particular medicines, that had become apparent since the previous review occasion. That meant that the exemption Ireland had availed of when SI 785/2007 - Infectious Diseases Maintenance Allowance (Increased Payment) Regulations, 2007 was implemented, an exemption for prescription status for these medicines recommended by Europe because Ireland had no evidence at that stage of any resistance, had changed.
Come the review by the HPRA expert task force, a group of seven experts from different backgrounds including the Department of agriculture, University College Dublin, Teagasc and various other sources, decreed that because there was evidence of resistance in that incidence, the antiparasitics had to be upgraded to a prescription-only medicine. As pharmacists, I referred earlier to the fact that we counter prescribe antiparasitic medicines for our human patients on a regular basis. To extend that, as a veterinary pharmacist, I have counter prescribed, or de facto prescribed, these same medicines in my practice for over 30 years, as have many of my colleagues and the responsible persons who are suitably trained in that regard.
In essence, what we have been doing is prescribing these medicines in response to the symptoms presented by the animal owner or the animal keeper whereby we use a protocol and ask a routine series of questions. As pharmacists, we ask who the patient is; what the background is; whether there have been any other medication supplied; the cohort species; the weight; and the background details that are required. We establish a picture and are not making a diagnoses but respond to the symptoms and use the data that is available. Nowadays, this data is routinely available be it a fecal egg count test, a bulk milk sample test or post mortem results. We can use this data as can my colleagues who are responsible persons, to make a judicious decision or recommendation and on the back of that, we direct a course of treatment.
The word "prescribe" is derived from Latin. It is a long time since I did Latin under the auspices of Father Flannan and I was not his top scholar but scribereis to write and pre scribereis "direct to write". When we put that in context in modern English, we are actually writing a direction and that is what we have been doing. We have been giving a direction. Even though it was not written into the statute in 2007, we have been doing that in practice as far back as the last 20 years. I would like that to be taken into consideration by this committee and hopefully we will progress on. I apologise if I have exceeded the time.
Jackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
We got a few very comprehensive answers there which have given a serious background to the situation.
Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source
I apologise in advance to our guest that I have another engagement I need to go to. The opening statements and the subsequent answers we have heard have been very comprehensive. I have two brief questions. The first is in respect of the evidence we have now heard from the co-op sector, the licensed merchants sector and the pharmacy sector in that the sales of veterinary medical products that fall under the regulations currently implemented across all three sectors, have essentially reduced from somewhere in the region of 60% to 90%.
If I am correct, and this can be clarified, the evidence from the Irish Pharmacy Union is that overall sales have not actually reduced. Essentially there were four sectors, including the witnesses' own three and the vets that dealt with these products. In three of the four sectors, sales have reduced dramatically and in one they have increased dramatically. The question I have is whether the various organisations have raised that issue with the Competition and Consumer Protection Commission, or whether they have any intention of doing so because it appears to me that legislation and regulation is actually distorting the market, On the evidence that the witness groups have now, can the representatives say with authority that the new regulations, if implemented in their current guise, would have the same proportional impact in terms of sales across the other products that would be included?
Mr. Terence O'Shea:
One of the figures that has not been mentioned is the 300 prescription-only medicines a licensed merchant can currently stock. The majority of licensed merchants do not stock any of those products because they failed to secure prescriptions from veterinary practitioners. The national sales trend on that range of prescription-only medicines is that less than half of 1% are sold by licensed merchants premises. In reality, the figures provided by the Irish Co-Operative Organisation Society, ICOS, applied to licensed merchants but a long time ago. We have been squeezed out of a substantial part of the retail industry already. The majority of licensed merchants focus on the sale of antiparasitics, be they for the treatment for internal or external parasites. Some 80% of my turnover is antiparasitics.
One of the things we have looked at over a long period of time is to try to get a financial or regulatory impact assessment of how this will impact the licensed merchant industry. The bottom line is that the majority of licensed merchants, people like me who focus strictly on antiparasitics, would close. My estimation is that my own business would be closed within a period of six to 12 months. My turnover would collapse, it would be no longer profitable and I would have to close my door and walk away. Other merchants who may be involved in the sale of agrichemicals, fertilisers or feeds would obviously exit the veterinary medicines industry and focus on other aspects of their business.
The important thing in all of this is that every business closure and every job loss is a blow to rural Ireland. I live in rural Ireland. I service part of west Cork and south Kerry: the Iveragh Peninsula, the Beara Peninsula, the Sheep's Head Peninsula and the Mizen Head Peninsula which is as rural as you can get. We do see tourists in the summer but there is a lot of winter there. Every single job in important. My business is important to me and it is our only source of income, our only livelihood.
In regard to the financial impact assessment, the IMA carried out such an assessment on our members and I will give an example of the results that came back from two counties. One of the counties had 12 licensed merchants in total. Some 11 of those engaged in the survey. Four of these businesses would close in their entirety, seven would exit the sales of veterinary medicines, and no business would continue to trade. In another county with 11 merchants, there would be two business closures, seven would exit the industry to focus on other aspects of their business, and one of the businesses would survive. In two counties then, where there are 22 licensed merchants premises, there would be one remaining. If this was replicated in the farming and the co-op industry, all of a sudden where there was competition with maybe two licensed merchants-----
Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source
I will cut across Mr. O'Shea because I am going to end up not getting an answer to an important question. Can I ask the IPU, in terms of the Competition and Consumer Protection Commission, whether that is something it has considered?
Mr. Daragh Quinn:
If I could jump in there again, it is something that has been discussed. Obviously it is very pertinent when we see the level of businesses that have encountered a downturn. However, we have been assured that the national veterinary prescription scheme when up and running through the Department of agriculture is intended to create a level playing field. The vet would create a prescription that would be accessible to the farmer on an electronic basis, which would then allow the farmer the choice to purchase the product wherever he or she wished.
That aspiration is based on the previous statutory instrument in 2007 which stated that where a veterinarian prescribes veterinary medicine, he or she has an obligation to issue that prescription at the time of prescribing to the animal owner or keeper. Where they do not do so, it is deemed a statutory offence. I do not know whether that aspect of the regulations has ever been applied. We have encountered a dearth or shortfall of prescriptions and it has been particularly significant since the regulations came into play on 29 January 2022.
Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source
I want to refer to an aspect of the ILMA’s opening statement which spoke about a fresh approach and a new legal opinion that may resolve the problem and that has been submitted to the Department for consideration. Could its representatives briefly outline how that would work in practice and how it would differentiate from the current heads of the Bill that we have seen?
Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source
It is in terms of what the Department has provided to us in respect of its legal advice, which of course we have not seen, which essentially states that responsible persons cannot be provided for in the way that they have been to date. I take it that the ILMA’s advice is saying something different. I am asking how it would work if the IPU’s advice was adopted by the Department?
Mr. Ollie Ryan:
The original advice from the Attorney General was that on its entering into force, the only one who could write a prescription was a vet . When we look at back at the role the responsible person has played in this regard over the past 20 years, we believe we have been prescribing all along and that we have a huge role to play in the future of prescribing anti-parasitic medicines. We took a fresh approach. It is with the Department at the minute and we are awaiting an outcome from that.
Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source
To clarify, essentially the ILMA is saying it has advice that would allow responsible persons to act as they heretofore have been acting.
Matt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source
That is okay. I thank the Chair.
Jackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I call Deputy Fitzmaurice.
Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source
I think anyone would be delusional to think that if a vet is to give out a prescription, people would be running down the road to somewhere else because a farmer would nearly be embarrassed into getting the stuff. That needs to be called straight.
It is my understanding at the moment, and the witnesses may or may not comment on this, is that it is in double-digit figures. The Chair, in fairness to him, is bringing forward a Bill on the number of veterinary practices that are being scouted, sold to or are in the process of it, by companies from other countries. It is my understanding that when those businesses are being sold for the medicine side of it being looked into, which gives you more money to be quite frank about it. It makes it more valuable. Have the witnesses looked at an angle whereby part of a business is taken away to make a fair living? Has either group looked at anything like that?
Mr. Daragh Quinn:
I will comment on the move into the Irish market of what we will refer to as the corporates. Corporates are active in buying veterinary practices throughout Ireland. There is no doubt about that. Like anybody who buys a business, if you invest a substantial amount of money in buying a business, you are looking for a return. You get a return from your business by doing two things, namely, by increasing sales and by increasing margin. If the current proposal was carried through as it is proposed at the moment, that would move the emphasis of the sales to veterinary practices. That would be the way they would increase their volume of business. If you end up in a situation whereby only one stakeholder group is involved in the supply of any product, it would be anti-competitive. That would be the word to describe it. You can dominate the market and you can create whichever price you wish. Remember that if a corporate owns it, it does not take over one veterinary practice, but a group of veterinary practices that are geographically near to one another so that it can dominate a certain sector of the industry in the county or the county in its entirety. It then has the ability. Everybody becomes a customer of that veterinary practice and the veterinary practice becomes the only entity that can issue a prescription. It will then hold all the key cards in its hand to issue the prescription. It will carry out the diagnosis, it will prescribe the product and it will also supply it. The world really is its oyster. As the Deputy can appreciate, when a customer is standing at the counter, he or she is getting a product that cannot be supplied anywhere else. Then, obviously, the ability of the retailer to get an increased margin is presenting itself. Anybody who is commercially driven will take the margin. Does that pick up on the point?
Ms Nicola Cantwell:
I want to go back the question that was asked about the legal advice that was given on the fact that responsible persons could not dispense prescriptions. It is quite difficult because we do not have all of the information. We have not seen the advice but we also do not know exactly what was the question that was asked at the particular time.
The licensed merchants, co-operatives and ourselves all want to know if the derogation will apply to us because we were prescribing. When you go back to 2007, the way the tradition of veterinary medicines, including the anti-parasitics, have been supplied was by us dispensing or de facto prescribing or whatever way one would like to describe it. The general consensus seems to be that we need a solution to the situation that we are in at the moment. The only way to get a solution and to have everything in place for the projected date, which is 1 December, is to have a strong regime in place to protect anthelmintics. This is only going to be achieved with a collaborative approach. There are four main stakeholders in the situation we are in at the moment. Three of these four are suffering and we need to look at how the four groups can work together.
The UK was able to halve the sales of antibiotics for food-producing animals just by collaboration between the Government and the stakeholders. This is what we need to do. I would like to see, if it is possible, either the Minister or this committee contacting the Attorney General to specifically ask how this derogation comes into play for licensed merchants, responsible persons and pharmacists. The three main stakeholders need to be considered in this approach. The only way we can do that is if the Attorney General gives specific guidance to these stakeholders. We all have our legal advice that tells us that we were prescribing, that this derogation should be continued and that the situation as it is at the moment should be allowed to continue. I wonder if that would be possible.
Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source
Ms Cantwell spoke about the derogation. It was my understanding that there was something on the table between Britain and Ireland a few years ago and Ireland did not sign up to that. Ms Cantwell might enlighten me on that. Is it not a dangerous road to go down to speak about derogations? In my opinion, if you are a licensed prescriber or responsible person where there are grandfather rights or whatever, you are either capable or you are not, to put it very bluntly. Why would you be going down a road of a derogation? I know personally from a different field that the EU does not keep giving derogations.
I will put a few questions together so that the witnesses can address them. I believe Mr. Larkin is dealing with the question of fertilisers. Has any analysis been done? Earlier today, some of us met representatives of the company that makes stents and different things here in Ireland. It is the pharma crowd. New regulation is coming in from them. A CE mark at one time cost €35,000 but it now costs €235,000, along with three or four years of a wait. The same thing seems to be coming with more paperwork for fertiliser. There is this EU paperwork trail that seems to be coming the whole time. Have the witnesses done an analysis on this? I am thinking of the local fellow down the road from me in the local shop who sells bread, butter and a bit of meat, and when you go out the back, you can get stakes, wire and fertiliser.
This business is not a co-op as it is not big enough. Is there data to show that these people are being pushed out of business because of the introduction of IT systems and keeping track of this, that and the other? It started with diesel a few years ago. They have to keep track of that and report to Revenue. Has analysis been done on that and how much it will cost each of them? It might be fine for a person selling 10,000 or 20,000 tonnes, but it could be problematic for a person in a local area selling 1,000 tonnes. Has the cross-Border market been assessed and what could happen?
On the veterinary issue, what engagement have both groups had with the Department of late? It was said that the Department is looking at legal opinion. You can look at legal opinion all you like, but you have to give a decision. When will these decisions be made? When will the two or three guys, if and when the groups have met them, make a decision on what has been provided to them?
Jackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I ask witnesses to keep their answers as concise as possible because a number of other members have questions.
Ms Nicola Cantwell:
In response to the comment about whether we can or cannot prescribe, the Bill currently indicates that we cannot prescribe. We could decide to prescribe now and as soon as the legislation comes into play, we will not be able to prescribe. If the Bill comes in as it stands, qualified persons in the North will be able to prescribe while qualified persons in Ireland, south of the Border, will not. That is what is important. It is not about grandfathering anything into place. It is about continuing what we are doing, giving us the opportunity to provide a collaborative approach with everybody across the country to ensure we put a strong system in place to protect our agricultural industry and antiparasitic medicines, and to make sure we reduce the risks of antimicrobials. To be clear, we are well capable of doing what we are doing. We are all educated to the level we need to be to do it. There is no question of grandfathering or anything like that.
Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source
I beg to differ in that a piece could be included to allow another section to do this, rather than a derogation. I am fearful of derogations.
Mr. Ollie Ryan:
I refer to our interaction with the Department on the roll-out of the national veterinary prescription system, NVPS. The responsible persons and merchants have widely engaged with and are embracing the roll-out of the new NVPS. It is a great leap forward in technology. On the regulation side, we have had many meetings with them and they recognise the problems with the regulation going forward. They are working towards a solution on that with us. I cannot give a timeframe on that, but we are working with them on this at the moment.
Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source
Will it be two, three or six months?
Mr. Barry Larkin:
On the question of fertilisers, there are two parts to that. To answer the Deputy's question on whether we have done an analysis of costs, the simple answer is "No." However, there are reasons for that and we have tried. The Deputy gave an example of going to his local store that sells milk, bread and butter as well as fertiliser, a few stakes and a bit of wire in the back. As I said earlier, if any one of those things are taken out, such as animal health, fertiliser or hardware, the business may become unviable. The costs incurred will have a greater impact on that type of business, as the Deputy said, rather than on a business that sells 10,000 or 20,000 tonnes.
There are reasons we have not done a cost analysis. While we might try, we are unsure about the application programming interface, API, system that links the Department's IT system with the agri-retailers' IT system. We have been given no direction on that as of yet. In my view, it is overly comprehensive and incurs costs on these businesses. I have spoken to a couple of IT people who maintain that there are ways in which a report can be generated by my IT system that would be sufficient for the Department's IT system to withdraw the data. It is impossible to do a cost analysis when we do not know what the link between the API systems entails. By way of an example, the multi-species sward scheme was introduced this year. While it worked well, and we are all happy to be a part of it, the administrative burden was put on the trade rather than taken up by the Department, which has caused huge problems. The benefit of the scheme was given out on the day of purchase, yet there are still merchants throughout the country waiting for payment four months later. It is those types of problems that will arise. There are administrative, training, and IT costs, but it is hard to quantify what is required in that regard.
In terms of the cross-Border market, not much different from animal health legislation, there is free movement of goods across the Border. If I were a farmer in Cork who wants a load of fertiliser, all I have to do is pick up the phone and there will be a load of fertiliser in my yard within days, but that fertiliser does not have to be recorded. That has been happening over recent years with cross-Border trade in the Border counties. As I said, it is happening more frequently in commercialisation. However, where guys are pushing boundaries there will be a shortfall in data. Essentially, the guys pushing boundaries may be the ones who are causing the problems with water quality and they are the ones who will continue to purchase fertiliser from across the Border. If we could have an all-Ireland approach, while it may be difficult, it would be better, or we could put the onus back on the farmer to declare his fertiliser purchases on an ongoing basis rather than having the merchant do it.
Tim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source
The fertiliser issue was discussed in detail at the last committee meeting. Does Mr. Larkin have any idea how much tonnage comes across the Border and what the current capacity figures are?
Tim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source
Who has that information?
Mr. Barry Larkin:
The primary manufacturer may have a better idea. I only deal with merchants in the south of the country. A number of primary manufacturers based in Northern Ireland have lines with agri-retailers up there. No doubt, there is a commercial incentive for that to happen more. It is creating more of a black market. It is a bit like the smokey coal or bale wrap situations whereby there is a levy here but not across the Border.
Tim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source
Mr. Larkin mentioned the free movement of goods that is required under EU law, and there have been changes in that regard over the past few years. If one were in derogation, the fertiliser coming from the North would still have to be included when returns are being made. However, if one were not in derogation, as I understand it, such recording is not required. Would that be true?
Mr. Barry Larkin:
Currently, that is right but in the new scheme, everyone will have to record every tonne of fertiliser purchased. It would be naive to think that the guys sailing close to the edge will record all the data.
There is also another aspect to this. If merchants are to record fertiliser sales and submit the information to the Department, agri-retail traders could be accused of telling tales on and compromising their customers. It seems as though that has not been thought about nor has it been on anyone's radar, but it is the truth of it.
Tim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source
Mr. O'Shea is from Glengarriff and is based in west Cork.
What would be the geographical implication if this directive went through in its current form? Mr. O'Shea might explain the implications for his farming community and some of his clients who do not have a veterinarian on their farms on a yearly basis. There is pressure on veterinarians in that particular part of the world. Mr. O'Shea might give us an indication of the geographical issues and the implications for a sheep farm, in particular, that never has a veterinarian on the farm. How would this derogation work if it remains unchanged?
Mr. Terence O'Shea:
As has been reported by veterinary representative bodies and the various groups which speak on behalf of veterinarians, there is a shortage of veterinarians in rural Ireland. The majority of the veterinarians in our part of the world on the western seaboard are in single-veterinarian practices. It might be ageist of me to say this but the majority of those veterinarians are not getting any younger. In most cases, no young veterinarians are interested in getting into large-animal practices on the western seaboard. That is one matter.
In respect of sheep farmers who do not keep bovine, there is no reason for a veterinary practitioner to visit the farm unless he or she is invited to do so. Many sheep farmers would not engage with a veterinary practitioner from one end of the year to the other. Sheep farmers' trusted source for medicinal supplies and up-to-date advice around practice, especially in respect of anti-parasitic resistance, has always been their supplier. That supplier may be a veterinary practice, if the farmer is involved with veterinary medicine. It may be the local co-operative, merchant or pharmacist. The success of any business is not based on how cheaply you can sell something but is based on the soundness of the advice you can offer your customers. Repeat custom is based on advice and best practice. As I said earlier, if the licensed merchants, pharmacists and co-operatives exit the industry, there will be nobody left to take up the slack in large parts of rural Ireland because people are not there, are not interested and are not involved. Veterinarians in a one-veterinarian practice are involved in all aspect of their practice. They are not at the coalface. They are not at the counter when a customer comes into the practice because they are out on farms. Veterinary pharmacists or pharmacists are required to be on the premises for the pharmacy to operate. A licensed merchant's premises does not operate unless the responsible person is on the premises. As long as the door is open, the person who can provide the sound and solid advice is available for a discussion and interaction, or to offer any advice that the farmer needs. We are considering promoting prudent and appropriate usage of anti-parasitic medicines. That is a constant engagement between the customer and the supplier. It happens on a weekly and daily basis. There are cases where someone will come in and buy a product before ringing back a week later. We are there and available to the customer. We are qualified to give the service and capable of doing so. We need to continue giving that service.
Tim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source
There is a shortage of veterinary practices, particularly in the part of the world we are talking about, and in County Kerry. The distances involved are enormous. A veterinarian might be called to a sheep farm to deliver a prescription. It would be considered nothing for that veterinarian to travel 30 or 40 miles. My understanding is that such a veterinarian would have to call to the farm to deliver the prescription. There must be due regard in making that call to provide a prescription. Logic would dictate that unless that changes, there may be animal health or cruelty issues.
Mr. Terence O'Shea:
I agree with the Senator with regard to the animal health issue. If there is no veterinary practice, or a veterinary practice is very busy, a veterinarian cannot make an on-farm call to every one of the people considered his or her clients, whether they are owners of a dairy herd, a suckler herd or sheep. That is the first and most important thing. Consider a location such as the Iveragh Peninsula in south Kerry. In the 120 miles from Kenmare to Killorglin, there is one veterinary practice, one co-operative store and two licensed merchants. If the current proposal is carried out, both licensed merchants will exit the industry, as will the co-operative. The co-operative will continue to provide other supplies but will exit the industry. All of a sudden, the whole of south Kerry would be serviced by one veterinary practice based in the general area. That veterinary practice provides a fantastic service as it is. It is brilliant and provides a great service. However, to expect a veterinary practice to provide the extra service of going onto farms to provide animal health plans and prescriptions for part-time farmers with nine suckler cows, 43 sheep and a donkey would not work. It would be not be cost effective. It would not be effective in any way. A part-time farmer such as the one I described can now go into his local pharmacy, co-operative or merchant to get advice. Those outlets have provided that advice for more than 20 years. It is a generational thing. Customers do not return unless sound advice is being provided. At the stroke of a pen, that sound advice can be put in the bin. It does not make sense.
Carol Nolan (Laois-Offaly, Independent)
Link to this: Individually | In context | Oireachtas source
I thank the representatives of the IPU and the ILMA for their comprehensive presentations. I will pick up on what Mr. O'Shea said earlier about economic impacts. It is a concerning situation and there will be a wider impact on the local economy of rural communities. If 90% of the anti-parasitic business is transferred to veterinarians, as the antibiotic sales were, would Mr. Ryan envisage the same impact as Mr. O'Shea outlined in his presentation?
Some of the medicines that have been referred to are available without prescription in the North. What problems will that cause?
Mr. Ollie Ryan:
I am a merchant in the midlands. I have listened to different people, including Deputy Fitzmaurice, speak about small merchants. If the rural merchant is taken out of places such as Roscomroe, which is near us, and Rosemount in County Westmeath, nothing and no one will be left. Those merchants are the hub of the community. They are an integral part of that particular area. They are all over the place. Mr. Willie Gibson is a merchant in Donegal. People like him are at a crossroads. They provide a service and interaction for the many farmers who never see anybody. If this segment of the business is taken away, the farmer at home in his yard will say to himself that if the merchant does not have everything, there is no point in visiting him or her. The farmer will go wherever he or she can get everything. A farmer will take a Tesco approach to the matter. He or she will go to the biggest place which supplies everything. It would mean a wipeout of all rural merchants in such places, including on the western seaboard, across the midlands and everywhere else. Small merchants play a significant part in local communities in small villages all over the country. If those merchants are taken out of the picture, those communities will be gone. Veterinary medicine is an enormous part of the business. If one segment of a business is taken away, the rest will ebb away until it is all gone.
I would not like to be a merchant near the Border. Such a merchant would be wiped out. Why would a farmer go to a veterinarian, pay for a prescription and go to his merchant to buy anti-parasitic medicines when he or she could go across the road into the North and buy them over the counter without any hassle? Any merchant in that area would be totally wiped out. That effect would trickle down the country if those medicines are easily accessed in the North. Farmers are no different to anyone else and will go wherever there is easiest access.
Michael Ring (Mayo, Fine Gael)
Link to this: Individually | In context | Oireachtas source
I will be brief. I have not previously had the opportunity to say the following to the IPU, which I ask its representatives to take back to its members. I congratulate the pharmacies in this country for the job they did during the pandemic when other professions were not available. They did an excellent job. Many people were unable to get professional people when they wanted them. They went into the professional people in the pharmacies and dealt with them. Human beings are important. It was important they were there and I want to put that on the record. I have not previously had the opportunity to do that publicly. Pharmacists did a fantastic job during the pandemic. I previously named in the Dáil a profession, the members of which went on holiday and could not be found. People were very sick. I am sure the case was the same for animals. It is sometimes not easy to get a veterinarian because they are busy people. The arrangement we have at present is working very well in Northern Ireland and other parts of Europe. Why can we not have the same arrangement here? There are issues in this country in respect of EU and national regulations.
I will give an example. I recently went to buy a small bit of sterling because someone was going to a wedding in England. It would be easier to go in and rob the bank than get the sterling. That is the truth. I had to sign my name and give the details of what I wanted it for and where I wanted it for. We are over-regulated in this country. The time has come to say "Stop". At the moment, the pharmacies and merchants are all doing a fairly good job. They understand rural people and rural life and the needs of rural people and rural life. We have a crowd of people in Dublin and Europe and every Monday morning they must get up and ask themselves what they can do this week to upset rural people. They are getting paid, of course, so they do not care. They are bringing in rules and regulations and we are over-regulated. We will not have enough offices for all the paperwork that will be required in the future.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
It is challenging.
Michael Ring (Mayo, Fine Gael)
Link to this: Individually | In context | Oireachtas source
That is the truth. All these services are behind. People cannot get a driving licence or an appointment in a hospital. I cannot get a civil servant or anyone on the phone anymore. Now they want to bring more regulation in. They want to put people in rural Ireland out of business. They want to put these merchants out of business. The witnesses are right. There should be no changes made here until any changes are made in Northern Ireland. Why should we always be having people losing their jobs for us? Why should we always be over-regulated? It is always a case of attacking the small man and woman. It is the same with Revenue. It will not go asking the big people. It will go after the small people. That is what it does all the time. Why can we not have an Irish solution for an Irish problem? I would like a comment on that.
Jackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I ask the witnesses to be brief as there are two more members to get in.
Mr. Terence O'Shea:
I thank Deputy Ring for his comments in support of the merchant and pharmacy industry. I agree with him 100%. The merchant industry provides a valuable service in Ireland and we have done for a long number of years. Osmonds was one of the original companies in Ireland and was there since 1932. It has now exited the business after 85 or 88 years. That was a huge loss. We have taken up the mantra that antiparasitic resistance, APR, is the big issue here. We believe that as merchants, and I am sure the pharmacists and those who represent the co-ops will agree, we are best placed to deliver a response to antiparasitic resistance. We are suitably trained. We are quite happy to have continuous professional development and embrace all the modern technologies. We can deliver if we are included. There is a simple solution to this issue. If the Department recognised the role a responsible person can play as a prescriber of antiparasitics, that would solve the problem. That can be done with the stroke of a pen or one line. It rests with the Minister and his officials. I ask the committee to ensure the message is delivered to the Minister and his officials that this needs to be done. This will secure our future. There are 160,000 farming families in Ireland who will be directly affected by this.
Mr. Daragh Quinn:
I appreciate Deputy Ring's comments and his recognition of my pharmacy colleagues. As Mr. O'Shea said, the responsible persons were open right through Covid. It was a challenging time for this country but pharmacists, responsible persons, and all those professions stood up and were counted. They were available when this country needed them. Sometimes in life, one just has to stand up and be counted. The EU has implemented this regulation. There is an onus on us as a country to provide data back to Europe about the use of antimicrobial and antiparasitic medicines. There is a responsibility there. However, sometimes we feel we go above and beyond the requirements in implementing these regulations in Ireland. Many other European countries have taken different approaches to implementing the regulation, such as in Northern Ireland and the Scandinavian countries, and it has been seamless. There are other models that can be applied that will work. It has been well discussed already.
Barry Cowen (Laois-Offaly, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I thank the Chair for the opportunity to come in on this issue. I am only a part-time visitor to this committee. There was a time when I thought I would be here much more regularly. The issue here is antiparasitics. The issue of fertiliser usage and the registration of fertiliser usage is understandable in the context of water quality and so forth. We will have to live with that. I was at this committee about a year ago and I do not think we are much further on than we were then. The initial departmental interpretation of this directive is not workable. That is widely acknowledged by all concerned. I think they have come to that realisation now. Its impact on licensed merchants and pharmacists and, by association, farmers, is not one that will be accepted, quite simply. They have all been very quiet, understanding and patient to this point. We cannot guarantee that will continue if the legislation that is brought to bear to give effect to this directive does not meet with the approval of all concerned.
Last year we spoke about the potential of veterinarians carrying out annual audits on herds based on the historical needs of that herd, in relation to the expectation and provisions there would be in a given year. That would be forthcoming initially and used thereafter the same way it has been in recent years. That does not appear to have gathered any momentum and does not appear to be in the mind of the Department with regard to the proposals it may eventually come up with. As Deputy Ring says, in the meantime, the status quoremains the same in the North. That is at variance with the interpretation of this by our Department of Agriculture, Food and the Marine, despite the fact that we need an all-island economy for agriculture and animal healthcare. We cannot have that while this continues. Deputy Ring is quite right. It may well be that the meeting in the middle is done around the duty, the responsibility, the qualification and the ongoing review of the capacity of the responsible person to maintain their role into the future. There is nothing to suggest that these people have broken any trust in years past but there may be some merit in an agreement for them to continue to augment their own qualifications, capacity and ability to do their job into the future. That could be reviewed on a regular basis and proof could be provided for those who initiated this rule in Europe around the capacity or capability of the State to manage its affairs adequately, properly and effectively. That comes from the best intentions to maintain our standards in the delivery of our products in the agriculture sector.
I appreciate the witnesses being here again and the efforts I am sure they have made in the meantime to discuss this with relevant departmental officials. Our party will continue to talk to those in office and in government with a view to the legislation giving effect to this directive meeting with the approval of all concerned. This has gone on too long. It needs to come to a conclusion. People's livelihoods cannot continue to be threatened in the way they are by the fear about what is contained in the initial interpretation by the Department over 12 months ago. I ask this committee to do what it has been doing, and I am sure will do again, and ensure the officials who are charged with responsibility for this legislation reach agreement with the parties and stakeholders concerned. That is our direction and that is the direction of members of all parties and none on this committee, which is representative of the Dáil itself. There is a majority within the Dáil that wishes to see this resolved forthwith, to allow these people to get on with their business and allow us to get on with what we do best in producing the sort of quality that is renowned throughout the world.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
On the EU directive, is the proscription on selling antiparasitic medicines without a prescription or on buying them? Which will be banned - buying them or selling them?
Mr. Terence O'Shea:
I will take that question. Both of them will be banned, in the sense that the farmer customer cannot purchase the product without having a valid veterinary prescription, and the retailer cannot sell the product without being presented with a valid veterinary prescription. That is the way it is at the moment for quite a number of products. We touched on it earlier. Almost 300 products already come under that category. As I said, the licensed merchant has been squeezed out of that business for a long number of years in that they do not receive the prescriptions. I will give the Deputy the figure again. The percentage of national sales of those 300 products dispensed by licensed merchants is 0.04%, which is less than half of 1% of the entire sales. Therefore, both the farmer and the supplier would be in breach of the regulation if the product was supplied without a valid veterinary prescription.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
Okay, but it is perfectly lawful for a merchant in Northern Ireland to sell that product. Obviously, it is a different jurisdiction so it is perfectly lawful to sell that, put it in a courier's van and have it at any farm in Ireland the next day.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
There is, therefore, no enforcement. We are trying to keep it that there is no enforcement at the Border.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
I would respectfully suggest it is much more. The purpose of this directive at an EU level is to reduce the unnecessary use of medicines and to be able to keep account of what is used.
Mr. Terence O'Shea:
Yes. Basically, there are two parts to the proposal. Number one is that there would be more prudent and appropriate use of the products, and there would also be a national veterinary prescribing system that would record the usage of the products. That would record both who the retailer was and who the end user of the product was. If the product is moved in from Northern Ireland, it is an unrecorded movement of the product across the Border. Then, we have unrecorded usage. The image of Irish food internationally is that we are clean and green. However, we are clean and green because of our record keeping. The hard work farmers put into keeping records is exemplary.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
If a system were to be introduced whereby people had to get a prescription and then go to a pharmacist with that prescription, it is quite obvious that there would be a huge increase in people going online or picking up the telephone and ordering from Northern Ireland for it to arrive in the courier's van the next day. The merchants in Northern Ireland would be committing absolutely no offence by doing that. If it were to be-----
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
Yes, of course.
Mr. Daragh Quinn:
The products are sometimes dual-licensed in that some of the products are licensed by the Health Products Regulatory Authority in the Republic of Ireland and also in Northern Ireland and the UK. However, Northern Ireland pharmacists or merchants are entitled to supply or prescribe to clients who are based in Northern Ireland. Clients coming from Southern Ireland, technically, according to the Department of Agriculture, Food and the Marine, should not be sourcing their products in Northern Ireland because-----
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
According to the Northern Irish Department?
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
Should it have as much to say about what happens in Northern Ireland as - I do not know; take your pick - Vladimir Putin?
Mr. Daragh Quinn:
Absolutely. We are all aware that cross-Border trade has existed in Ireland for 100 years and will probably continue to do so. However, it does so undercover and it is undocumented. There is a lack of transparency then as regards residues whereby the safety of Irish food and the quality assurance we like to believe stands over all our food products is then diminished.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
This is the question I am asking. If the current system whereby a person can go to a merchant for antiparasitics or an antibiotic, etc. is removed, does anyone on the panel think we are not going to see a huge increase in people ordering from Northern Ireland, thereby completely defeating the purpose of the regulation?
Mr. Barry Larkin:
I will come in on that. Currently, a farmer can go to Northern Ireland and purchase whatever antiparasitic product he or she wants and there is no problem. He or she can bring that product back across the Border and there will be no regulations there. Potentially, a farmer may be in breach of his or her Bord Bia obligations or some other schemes by using that product, but if he or she does not record the use of that product, there is no problem.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
Is that phenomenon going to increase dramatically?
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
Because of a different interpretation across the Border.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
It will, therefore, be self-defeating. Implementing it will defeat the purpose of the EU legislation in the first place.
Michael McNamara (Clare, Independent)
Link to this: Individually | In context | Oireachtas source
That is all I wanted to clarify.
Jackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
Okay. I thank both sets of witnesses this evening. They gave a very comprehensive representation of the issues this legislation presents. The IPU has been very clear about the important role it plays, especially in rural areas, in the dispensing of antiparasitics.
I wish to put on record as Chairman of the committee that we can summarise the current position as follows: the ILMA, together with the ICOS, put a recent proposal to the Department, which is supported by legal opinion, regarding the role a responsible person can play with regard to the prudent prescribing of antiparasitics, which the Department is considering. We all welcome this and hope it can bring a resolution to a situation we all recognise is critical to this Bill and needs to be resolved.
The witnesses have made it clear that unless we get a common-sense solution here, the whole purpose of the Bill will be defeated. The representative groups have put their points tonight very comprehensively. As Deputy Cowen said, it is now up to this committee to go back to the people in charge and see that we get a common-sense resolution to this. I can very clearly see the common sense both sets of witnesses have presented this evening. I thank them very much. We will now suspend the meeting to allow the witnesses for the second session to enter via Microsoft Teams.