Joint Committee on Agriculture and the Marine debate -
Tuesday, 9 Feb 2021

EU Regulation on Veterinary Medicinal Products: Irish Co-operative Organisation Society

Chairman

I welcome to the meeting the representatives from the Irish Co-operative Organisation Society, ICOS, Mr. T.J. Flanagan, CEO, Mr. John O'Gorman, chairman of the dairy committee, and Mr. Ray Doyle of the livestock executive, who join us remotely. The witnesses are very welcome to the meeting.

I will give some context to our discussion today. The committee held a meeting with stakeholder groups in November 2020 on the topic of the regulation of veterinary medicines. ICOS was not included at that time. In organising this follow-up meeting the committee agreed to give ICOS an opportunity to present its view on the matter. Unfortunately, due to Covid-19 restrictions our time is limited. There will not be enough time for a full question and answer session. The ICOS briefing will inform the committee's engagement with the Department officials in the next session today.

Before we begin, I must draw attention to the fact that witnesses are protected by absolute privilege in respect of their evidence to the joint committee. However, if they are directed by it to cease giving evidence on a particular matter and continue to do so, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against a person, persons or an entity by name or in such a way as to make him, her or it identifiable. Participants at the committee meeting from a location outside the parliamentary precincts are asked to note that the constitutional protections afforded to those participating within the parliamentary precincts do not extend to them. No clear guidance can be given on whether or the extent to which their participation is covered by absolute privilege of a statutory nature.

I now ask the ICOS representatives to brief the committee on the matter. I apologise for the time restrictions. Unfortunately, Covid is our governing body in that regard. I ask ICOS to give its view on the proposed change in legislation.

Mr. T.J. Flanagan

I thank the Chairman. I am joined today by Mr. John O'Gorman, ICOS dairy committee, and Mr. Ray Doyle, ICOS livestock services executive. Mr. O'Gorman is a dairy farmer from south Tipperary and also the chairman of the Dairygold Co-operative Society. Mr. Doyle leads our policy efforts in animal health and animal welfare. I will defer to my colleagues in a moment but I will first make some brief opening comments on the matters at hand.

ICOS has long been involved in the development of the regulatory regime for animal remedies in Ireland. From the 1999 report of the Irish Medicines Board, which is a predecessor to the Health Products Regulatory Authority, HPRA, recommending that access to intramammary antibiotics "should be on the basis of informed choice such as that available from a properly established and audited mastitis control programme or herd health programme."

The European Communities (Animal Remedies) Regulation SI 786/2007, schedule 8, formally recognises the status of a co-op mastitis control programme as a recognised structure within which a vet is in a position to make an appropriate assessment on the treatment needs of dairy cows with regard to intramammary remedies. The same regulation provides the exemption for antiparasitic remedies to allow them to stay prescription free on the basis that there was, at the time, no evidence of the development of resistance in cattle.

We are now faced with a new challenge with the HPRA recently recommending that antiparasitic products can no longer avail of the aforementioned exemption due to the proven evidence of anthelmintic resistance in cattle, which was first demonstrated on Teagasc farms. This will result in those medicines becoming prescription only. The members should be in no doubt that shifting this group of medicines from the current merchant and co-op route of supply, or responsible persons in licensed merchants, LM, to prescription only, will result in a significant shift in sales from co-ops and merchants.

This will result in economic loss and the undermining of the economic basis for the stores network, as well as a substantial increase in the cost for end users. Co-ops want to reduce rather than to increase the sales of medicines, but they do want to be able to sell medicines to their members. Footfall generated in small rural branches by the sale of animal health products is an important part of their activities and if it were to be lost branches would undoubtedly close. It is the view of ICOS that the simplest solution to this change would be to investigate the potential to extend the right to prescribe those medicines to the responsible persons who now work in co-ops and merchants, as provided for in the directive. We will, however, need to substantially enhance the data gathering and controls associated with that activity so we can reduce usage, halt the development of resistance and protect those valuable medicines. The Department of Agriculture, Food and the Marine and the European Commission have rejected this proposition. Pending a definitive view from the Office of the Attorney General, and being conscious that time is very tight, we must prepare contingency strategies. Mr. Doyle will go over those in a moment.

In parallel, the world has changed regarding the use of antibiotics, and the co-ops have shown great leadership in driving down the usage of dry cow tubes especially. Using the mastitis control programme, as set out in schedule 8 of the 2007 regulations, we have seen substantial reductions of sales in dry cow tubes, a move towards selective dry cow therapy and many co-ops banning the use of critically important antibiotics. We accept that substantial changes will need to occur in the mechanics of prescribing dry cow tubes, with the likely necessity of moving to 100% milk recording to get a dry cow prescription.

The concept of a specialist or consultant vet working out of a co-op laboratory, with access to the data on milk recording, bulk milk, sensitivity and detailed reports on dairy hygiene and other audits, continues to be robust and scientifically sound. Unfortunately, one stakeholder, the Veterinary Council of Ireland, has taken what we see as being a view more appropriate to a representative body than a regulator and has thus far rejected the concept of a co-op specialist vet. We call on the Department to do what it did in 2007 and to recognise the strategic importance of the co-ops, large and small, in animal health and to ensure that the Veterinary Council of Ireland does not exceed its remit in this regard. I will hand over to my colleague, Mr. O'Gorman, now.

Mr. John O'Gorman

I thank the Chair for the opportunity to address the committee this afternoon. The committee members will be aware that the Irish dairy industry exports more than €5 billion worth of dairy products and ingredients to over 120 countries. It is Ireland's largest indigenous sector. The sector is extremely focused on food safety, the consumer and its reputation as a trusted supplier of safe and traceable foods.

As a responsible and trusted stakeholder, the Irish dairy industry has identified the need to provide antimicrobial and antiparasitic resistance as a key priority for our farmer members. In the past decade, the Irish dairy industry has invested more than €1 billion in processing capacity, routes to markets and in people and systems to ensure compliance and food safety. The co-operative structure of the Irish dairy industry has ensured that it has developed a significant degree of vertical integration with its farmer members and it surrounds and supports them with systems and expertise to deliver on safe and sustainable milk production.

Included in this support is major investment in milk quality, built on animal health including lowering somatic cell count, SCC, levels and reducing antibiotic usage. The current position of the Irish dairy co-ops in the supply chain for appropriate medicines allows them to control and influence the delivery of key priorities. This includes reducing the use of critically important antibiotics which are also used in human medicines, moving towards selective dry cow therapy and protecting and maintaining valuable antibiotics from the development of resistance. For example, my co-op, Dairygold, has destocked critically important antibiotics. In addition, we provide sensitivity testing as a service to our farmers to allow them to identify the most effective drug to treat their animals.

Co-ops have led the national effort in improving milk quality and mammary health through individual co-op mastitis control programmes provided for under Schedule 8 of the current legislation. This has resulted in substantial reductions in somatic cell counts and a reduction in antibiotic use, particularly critically important antibiotics, CIA. It is essential that the Department of Agriculture, Food and the Marine legislates for the continuation of the co-op mastitis control programme.

We fully accept and understand that we will need to evolve to address new challenges such as selective dry cow therapy. The current routes of supply for veterinary medicines are strategically important to co-ops as a way of ensuring the competitive and safe availability of necessary medicines to our farming members. While co-ops are committed to substantial reductions in the use of animal medicines, in line with their prudent use, the ability to retail them in branch networks is vitally important to that network as it maintains competitiveness in the marketplace.

ICOS is calling on the Department of Agriculture, Food and the Marine to ensure an appropriate balance in this regard. It is essential for the Department to recognise the positive role that the co-ops can play in delivering on shared objectives, such as antimicrobial resistance, AMR, when finalising the new legislation for veterinary medicines. Key to this is ensuring a proper definition for any other assessment under Article 105 that allows a holistic approach to herd health planning, supported by data-assisted prescribing for inter-mammary tubes and co-op herd health plans for other veterinary medicines.

As food processors the dairy co-op sector has a vested interest in ensuring that animal medicines are used in a responsible manner in full compliance with legal requirements and best practice. Co-operatives are trusted and reliable partners in the process and are extremely well-placed to help our farmer members to address and prevent the challenge of antimicrobial and climatic resistance. I thank the Chairman and welcome questions from the committee.

Chairman

We are under severe time pressure. Mr. Flanagan and Mr. O'Gorman have outlined clearly ICOS's position and that of the Irish co-ops on what they are doing about herd health. They are taking a very constructive approach to the different sections.

Senator Paul Daly

I thank the witnesses for their submission. I am delighted that it appears everybody is singing off the one hymn sheet from a supply point of view in rural Ireland. I would like to hear ICOS's opinion on part of the Department's submission. The Department was very cognisant of the problem of antiparasitic resistance and in recognition of that it set up the antiparasitic resistance stakeholder group. ICOS is a member along with the Independent Licensed Merchants Association, ILMA, Veterinary Ireland, the HPRA, Teagasc and others. The Department submission listed what this stakeholder forum has been dealing with and the sixth item mentioned was to "facilitate an efficient, competitive supply chain through effective regulation and innovation". My interpretation of that, and they are the Department's words, is the status quo. What negotiations, dealings or discussions have the witnesses had on the regulation within that stakeholder group?

Mr. Ray Doyle

I will respond to Senator Daly's questions through a small address. I will then answer his questions directly.

The issue of a responsible person's right to issue prescriptions for products that did not require a prescription in the past is not the only issue at stake here. The Irish dairy, beef and sheep industry depends heavily on having a suite of antiparasitic products that are effective and continue to allow Ireland to capitalise on its natural advantage of growing grass and turning it into valuable protein sources for an estimated 60 million people worldwide, whilst generating an income for more than 120,000 Irish farm families and over €14 billion in exports for Ireland's GDP.

The committee needs to be made aware that the Department of Agriculture, Food and the Marine has delegated the design of the new prescription-only medicine prescribing regime to the Veterinary Council of Ireland, VCI. In our discussions directly with the Department, it insisted that ICOS meet directly with the VCI to air our concerns on creating a practical, transparent, fair and internationally defendable prescribing regime for prescription-only medicine products for food producing animals. At a recent meeting between the VCI and ICOS, the VCI publicly expressed its view that the current legal method via Schedule 8 of the Animal Remedies Regulation 2007 of using data to assist veterinary prescriptions, cannot be allowed in the absence of a costly clinical visit which cannot on its own diagnose clinical and sub-clinical disease of certain mastitis and parasite conditions but data assisted diagnosis can in isolation detect these infections even before they affect animal productivity, let alone welfare.

Increasingly, data is now being used in all aspects of human and veterinary diagnosis. Even on farms the use of robotic milking has empowered farmers, in consultation with the veterinary profession, to intervene early in treating animals and drive down the overall use of valuable antibiotics in Irish agriculture. For example, Catherine McAloon stated at a recent Animal Health Ireland, AHI, sow check meeting that usage of antimicrobials, through the current mastitis control programmes as administered by the co-ops via the Schedule 8 remote prescribing legislation, has resulted in a dramatic 43% reduction in antibiotic usage over the 2015-2019 period.

However, during this time our overall national usage of antibiotics has increased which must have been as a direct result of antibiotics being prescribed and supplied via the vet-only channel, which relies almost entirely on costly clinical visits as per the VCI guidance. This clearly has not worked in driving down antibiotic usage but the VCI is adamant it should be the only route prescriptions are generated on. Preventative medicines such as vaccines, many of which are prescription-only medicines, must be increased in their use and availability to Irish farming if we are serious in driving down antimicrobial resistance and antiparasitic resistance. Yet many of these products are currently not available through the co-op network and remain a veterinary only channel of supply.

Dairygold, one of Ireland's largest co-ops, has reduced its sales of antibiotic dry cow tubes by 35% in the last ten years, even within the context of an increase of 40% in cow numbers, and increased its sales of a simple teat sealer in the same timeframe by 64%. It is not in the co-ops' interest to increase sales of antibiotics, anthelmintics and antiparasitics. However, it is in the co-ops' and farmers' interest that they can deliver them in a timely and cost-effective manner to all farmers when required. The use of multiple data sources through laboratory, on-farm dairy advisers and co-operative vets has delivered for Ireland and must be allowed to continue.

There are currently three possible options available to Ireland to resolve this issue, and, in the absence of doing nothing between now and next January 2022 when the European regulation must be transposed into Irish law, we are faced with three options: status quo regarding the point of sale of anthelmintics, inter-mammaries and antiparasitic drugs via co-op branches, independent merchants and pharmacies where responsible persons are allowed to generate prescriptions for all antiparasitic products, but the Irish Government is going to need to seek changes directly to the EU regulation in this regard if this is to become a reality; prescriptions generated via co-operative vets to farmers when they are part of an overall herd health plan and prescriptions generated on accurate data decisions for select drug types and ruminant species remotely with a clinical visit; or break the dispensing and prescribing links completely and align it with current best human practice. Indeed, several other competing EU countries such as Denmark, Sweden and Italy have done so with their farmed animal prescriptions for maximum transparency and the least market disruption.

We are running out of time on this issue. The Department of Agriculture, Food and the Marine needs to decide the policy that is best for Ireland and not delegate its responsibility in this regard to other stakeholders who can create a legal framework that will only enrich one profession and damage the competitiveness and sustainability of the entire food production chain.

Chairman

ICOS has clearly outlined its stance. I want to move on to the Department officials but if members have specific questions for ICOS, I will take one or two more.

Otherwise, I have a distinct preference for moving on to the Department officials who are waiting in the lobby. However, if anyone wants to ask a specific question, I will allow it.

Senator Paul Daly

I asked a question and I would like some feedback from the Irish Co-operative Organisation Society, ICOS, on what is going on in that stakeholder group that the Department is giving such kudos to.

Mr. Ray Doyle

I will answer that. On 31 January 2020, we made a detailed submission to the Department of Agriculture, Food and the Marine on this. On 28 February, we did so with the Health Products Regulatory Authority, HPRA, which was discussing the upregulation of anthelmintics to prescription-only medicines. We have had detailed discussions on this. Our primary objective all along, as outlined by my CEO and my chairman, was to maintain the distribution network we have in the co-operative stores, and licensed merchants and pharmacies as being the widest possible distribution base for this.

We are where we are, almost where the Oireachtas committee is. We are still no further on with what will happen in little over 12 months time. As I have said in my submission, time is running out. At the moment, we are being pushed to the Veterinary Council of Ireland, VCI, to try to agree a prescribing regime. We have put forward a very practical, transparent, robust, internationally defendable model to it, which was rejected. Until the Department of Agriculture, Food and the Marine adjudicates on this matter, or takes it by the scruff of the neck, we are where we are.

Chairman

Deputy Flaherty, Senator Boyhan and Deputy Browne have indicated. We are going to take those questions together. We will run out of time with the Department officials because we have to stick to our two hours with Covid-19.

Deputy Joe Flaherty

I am fine. I will let the others in.

Chairman

Senator Boyhan does not seem to be there. I call Deputy Browne.

Deputy Martin Browne

The witnesses said that the UK allows its suitably qualified persons to issue prescriptions for a limited range of the prescription-only medicine products. However, Ireland did not choose this route in 2007 when the current directive became law. Instead, it relied on derogation to Article 34(3) relating to the evidence of the restrictions. Could the witnesses expand on that? Are they saying the Department is reluctant to put national legislation in place which would have helped deal with this issue? What is their opinion on the action the Department took?

Chairman

Could the ICOS representatives hear that? The sound quality was not superb.

Mr. T.J. Flanagan

We were able to hear.

The Department availed of the exemption that existed in 2007. It did not go down the suitably qualified person, SQP, route. To be fair, it probably suited us for 13 or 14 years. That route, according to the Department, has been withdrawn from us. As Senator Daly suggested, it would be by far the simplest route if the SQP route were available to us now. However, we are conscious the Department has pushed back strongly against this, as has the Commission.

We still think it would be the simplest route, but we have less than 12 months to get this sorted. Our members have big and complex businesses to run. They need time to make changes, so we are considering contingencies which include the option of putting a co-operative vet in place, a consultant vet who could issues prescriptions. We await the legal advice the Department has said it will get from the Attorney General, which will be definitive in this regard.

Deputy Matt Carthy

Could the representatives from the Irish Co-operative Organisation Society, ICOS, briefly give an overview of the implications of the fact that Britain and the North of our country will potentially be operating under a different system? What challenges and difficulties might this present?

Mr. T.J. Flanagan

There is no question whatsoever but that the SQP route which exists in the North will be quite attractive for people. We already see sophisticated supply chains for smoky coal and silage wrap, available cheaper in the North, making its way down as far as south Kerry.

It would be extremely naïve of us to think that, with the best will in the world, somehow we can keep these products from coming into the market because the access will be substantially cheaper and simpler. It will have implications for the merchant and co-operative movement here and it will have huge implications for food safety if medicines that are not being regulated are coming in. It would be naïve of us to think that just because it is illegal, they will not come in.

Chairman

I thank the ICOS representatives for coming in today. They will know from the questions from the committee members that we want to get a satisfactory resolution to this. We have had a lot of different representations from stakeholders and our guests from ICOS have been clear and concise in what they have said to us. I thank them for that and if they want to contact the committee about this issue again they should do so.

Sitting suspended at 5.06 p.m. and resumed at 5.08 p.m.