Oireachtas Joint and Select Committees

Tuesday, 9 February 2021

Joint Oireachtas Committee on Agriculture, Food and the Marine

EU Regulation on Veterinary Medicinal Products (Resumed): Department of Agriculture, Food and the Marine

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I would like to welcome to the meeting the following officials from the Department of Agriculture, Food and the Marine: Ms Paula Barry Walsh, deputy chief veterinary officer; Mr. Colm Forde, head of endoplasmic reticulum-associated protein degradation, ERAD, and veterinary medicines division; and Ms Caroline Garvan, superintending veterinary inspector, who are all appearing remotely. We received their opening statement, which has been circulated to members. We are limited in our time due to Covid-19 safety restrictions. The committee has agreed that the opening statement will be taken as read so that we can use the full session for questions and answers.

Before we begin, I draw attention to the fact that witnesses are protected by absolute privilege in respect of their evidence to the 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 invite questions from the members. I call Senator Paul Daly.

I welcome the officials to our meeting and thank the Chair and the secretariat for facilitating it. I will be very brief because many members will have questions for the officials on this issue.

As the officials may be aware, we had a presentation from the Irish Co-operative Organisation Society, ICOS, prior to this engagement. I want a statement from the officials on an interaction I had with ICOS on the antiparasitic resistance stakeholder groups. The officials said in their submission that it had been set up and was attended by the licensed merchants, ICOS, Veterinary Ireland, the Health Products Regulatory Authority, HPRA and Teagasc. There may have been others.

I asked ICOS about the progress of this stakeholder group. In their submission, the officials said there were 30 actions but with six over-arching objectives. No. 6 is to facilitate an efficient, competitive supply chain through effective regulation and innovation. When I asked ICOS about the progress on that objective, the answer I was given was that it had been told to discuss the prescribing regime going forward with the Veterinary Council Ireland, VCI, and that no progress had been made. I have to take its word on that. I ask for a response from the Department of Agriculture, Food and the Marine.

I ask for feedback from the Department as to why our system of trained responsible persons not defended at drafting stage in the EU? Who were the Department representatives on the expert vet committee? Why did we not put up a fight for our system when this was being drafted? Why was it not defended?

I will leave it at that but I reserve the right to get in again at the end, if time allows.

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Which of the officials wants to take that question?

Ms Paula Barry Walsh:

Good afternoon, Chair, Deputies and Senators. Could I make a brief statement which will give clarification on many of these things and some context on progress made in the last while? I would be grateful if I could go ahead with that.

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Okay.

Ms Paula Barry Walsh:

I thank the Chairman, Deputies and Senators for inviting the Department here. I am joined by Mr. Colm Forde, head of division, with responsibility for the Veterinary Practice Act, and Ms Caroline Garvan, superintending veterinary inspector, both of whom are engaged in the policy and proposed implementation of the veterinary medicines regulation. We welcome the opportunity to appear before the joint Oireachtas committee to contribute to the discussions it has been having on the new EU Regulation on Veterinary Medicinal Products EU 2019/6 which comes into force next January.

Regulation 2019/6 legislates for the authorisation, use and monitoring of veterinary medicinal products in the European Union. It came into effect on 28 January 2019 and will apply in all EU member states on 28 January 2022, so there is a three year implementation phase. The regulation followed the adoption of a proposal in 2014-----

Photo of Paul DalyPaul Daly (Fianna Fail)
Link to this: Individually | In context | Oireachtas source

May I interject through the Chair?

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Senator Daly may interject.

Photo of Paul DalyPaul Daly (Fianna Fail)
Link to this: Individually | In context | Oireachtas source

This is the submission which we have all received and were mandated to have read before the meeting in the interest of time saving for questioning of the Department officials. The submission is being read verbatim, which is going to eat up much time for interaction. We have all read the submission, as instructed, before the meeting.

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

We have all received and read Ms Barry Walsh's opening statement. When she made the request, I thought she had something fresh to say that was not in her opening statement. With Covid-19, we take the opening statements as read and we have all read her statement. Unless it is something that is not in her opening statement, I ask her to answer Senator Daly's opening question.

Ms Paula Barry Walsh:

I thank the Chairman for his patience. I had hoped it would help clarify some of the matters. I will defer to my colleague, Mr. Colm Forde, on the question relating to the Irish Co-Operative Organisation Society, ICOS, interaction on action point No. 6 in the antiparasitic stakeholder group.

I will mention the draft at EU level and why the responsible persons, RPs, were not defended. Ireland was an active member in the negotiations with Brussels. Various different members from the Department, who I will not name, drew up the policies through consultation, not only in-house but also at a wider level with industry, even at that time. The regulation has been largely transposed. In other words, like what was put in during 2007, when responsible persons were introduced to dispense antiparasitics, that could continue under the current situation. However, even the older regulation had a caveat on it, that is, that it complied with a specific part of the derogation regarding antiparasitic resistance. When the negotiations were finished, RPs were still doing the job they had always done.

However, it was around that time that the HPRA, through its task force, did an examination of data and of various research that was available. Through that research, it determined that there was no longer compliance with the directive. It was on that basis that the antiparasitics moved into the sphere of requiring a prescription. There was no question that the responsible persons were not defended. The other point about it is that the responsible persons do more than give out antiparasitics. They are also involved in another interaction with their clients on a professional level in dispensing and retailing other products. In the future, it would be envisaged that where a prescription for an antiparasitic would go to a licensed merchant, which is the situation we are striving to maintain in the Department, the responsible person would have a role in the dispensing of the prescriptions that would be issued on foot of antiparasitics. That deals with the second part of the question. I will defer to my colleague for the first part.

Mr. Colm Forde:

The Department's approach to policymaking, particularly now, is to facilitate extensive consultation with stakeholders in developing any policies. That is part and parcel of what we do. One of the consequences of that is that policymaking can take time because we need to take account of everyone's viewpoints. I appreciate that Senator Paul Daly asked Ray Doyle that question during the earlier session and the answer that came back to him may not have gotten across the breadth of consultation that we have had. I am sure Mr. Doyle will confirm this subsequently if asked but I have met with him countless times on these regulations, be it bilaterally with ICOS or though the different stakeholder groups we have.

The antiparasitic stakeholder group was set up in the middle of last year to address all of the various concerns that have been brought forward by stakeholders. As the Senator rightly pointed out, one of the key objectives of the group is to look at an efficient and competitive supply chain through effective regulation and innovation. The major concerns we have with this regulation are that there are certain entities which fear that they may suffer a loss in business as a result of the new prescribing regime. There are two different aspects involved. We want to make sure that the prescribing of these products is done prudently and effectively so that we can protect their efficacy. ICOS relayed that point well. It is so important that we protect the efficacy of these products to support the pasture-based farming model, which we are all so proud of. If these products fail to work, however, then we cannot help support that type of farming and that will ultimately impact on the ability of farms to cut costs.

I will go back to objective 6 which concerns facilitating an efficient and competitive supply chain. We would like to have a system whereby all suppliers in the market can continue to supply farmers and that, ultimately, farmers will have that choice on where they want to buy their medicines from. Farmers are savvy business people and if we allow them to have that choice it is up to them to decide where they buy their product.

There are five or six different actions within that strategic objective and maybe the most important one of those is the development of a secure electronic prescribing system. As outlined in our opening statement, our ambition is to have all prescriptions available online and that a farmer, in theory, could get a prescription sent to him or her by text message on his or her mobile phone. He or she would then be able to buy that wherever he or she may choose. We hope that would open up the market to a competitive level so that farmers can buy from their vet, pharmacist, or licensed merchant, whichever one they choose.

One of the issues we have been asked to consider, and I think ICOS is supportive of this, is to look at the decoupling of prescribing and sale of medicines. Some member states in Europe have gone down the route of not allowing vets to sell veterinary medicines. They only allow them to prescribe. We have committed to doing a piece of research on that and will present the pros and cons associated with that approach to the antiparasitic stakeholder group. It is important to say that there is no silver bullet answer to this. Obviously, if one stops vets from selling then that has other potential consequences.

We also outlined that we made representations to the Commission about the continued role of responsible persons. We received that response and it clearly indicated to us that we are not able to avail of the derogation in Article 105(4). As ICOS outlined, we separately sent a request for legal opinion on that to the Attorney General, which we are awaiting a response to. ICOS referred to the role we have given to the Veterinary Council. It is important to highlight that the Veterinary Council is an independent statutory body tasked with overseeing the practice of veterinary medicine in Ireland in the public interest. I think it was suggested that the Veterinary Council may be aligned with the views of particular stakeholders. It is important to outline that it is an independent regulatory body and is under the Department's remit.

One of the key articles in the regulation states that a veterinary prescription can only be issued following a clinical examination or any other proper assessment. The question from many of our stakeholders is, what exactly does that mean and what is a proper assessment? We tasked the Veterinary Council with meeting all stakeholders, including experts in the field, farming organisations, ICOS, Teagasc, and Animal Health Ireland, to benefit from the best practice that is out there and to determine what is a proper assessment. ICOS referred to the kind of data one should be aware of when determining the kind of prescription that should be used and for how long that prescription should last. If I get a prescription for some dosing products perhaps that could last for several months at a time, again this would give a farmer the choice as to where he or she could buy that product over a period of time. The council engaged extensively with stakeholders throughout the end of last year and early this year, and will be presenting its views on what constitutes a proper assessment to the antiparasitic stakeholder group in March. I hope I have given members an overview of where we are at with those consultations.

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Mr. Forde has given a comprehensive answer but I think he has generated many questions as well. There will be a barrage of questions. Deputy Fitzmaurice is next.

Mr. Colm Forde:

That is what we are here for. That is fine.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

I welcome the Department staff. I will direct a few quick fire questions at Mr. Forde. He said farmers can buy medicine wherever they want. Who is going to be texting or emailing them or giving the prescription?

Mr. Colm Forde:

I mentioned in our statement that we hired a number of IT specialists and business support officials to look at the development of how the secure electronic prescribing system will work. We will be talking to all stakeholders over the coming months to develop the requirements.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

Who will be issuing it?

Mr. Colm Forde:

By European legislation the only person who can issue a veterinary prescription is a veterinary practitioner.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

Will that cost money?

Mr. Colm Forde:

There are already a number of occasions when vets visit farms during the year, for example, during the annual TB test. We envisage that as part of these regular visits, it may be possible for the vet to engage with the farmer and to develop a herd health plan or whatever else may be required to provide an antiparasitic prescription. All of that is to be developed through consultation with stakeholders.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

I asked a straight question. Will it cost money?

Mr. Colm Forde:

That will be a commercial decision for the person who is prescribing the prescription and the person gaining the prescription.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

Will we get them for nothing, as farmers?

Ms Paula Barry Walsh:

Whether it will cost money is a very difficult question for us to answer here.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

The regulation is coming down on top of the farming communities.

Ms Paula Barry Walsh:

Yes.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

I am asking a very simple question. If one wants a prescription under the new regulation the witnesses are talking about, will it cost money to get it or will it be free?

Ms Paula Barry Walsh:

The regulation is changing business models in many respects, and we recognise that. Licensed merchants, LMs, have expressed concern around whether a prescription will shift the buying, selling and dispensing directly between the farmer and the vet who will prescribe it. I understand that fear but in the context of the overall change of business models, it is impossible for us to determine today whether things will cost money. I am at pains to say that when one looks at the overall context of the antiparasitic resistance stakeholder group and the objective behind it, less antiparasitic medicines will be sold. ICOS actually identified it very well. It recognised that and we recognised that. However, what is not at stake and what we seek to maintain is the animal health and welfare status of the country's herds and flocks. Within that, there is a need to safeguard the €14 billion trade, which was referenced earlier.

There will be and can be decreased costs for farmers in the context of less antiparasitics. In a changed business model, what can happen is that veterinarians and their expertise will be needed in the context of animal herd health. Their expertise will be a necessary prerequisite to ensure any lessening of antiparasitic sales will be met by increased herd health management programmes and increased awareness. It is not that farmers are unaware or that they are not well-educated but we hope to increase education and awareness across the whole system.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

I am trying to ask a few quick fire questions. I do not need essays, if that is possible. Do the witnesses think the people in co-ops who are qualified to give out antiparasitic medicine at the moment will be made redundant due to this regulation? Do the witnesses fear that there may be a clause in EU law that one cannot take a living from someone? There is also something called a "grandfather right".

On top of that, do the witnesses think the Department is fully responsible for what we are facing at the moment? Looking at what the Brits have done, they were ahead of the posse. My understanding is that the industry asked the Department going back years to allow not only vets but others to prescribe. However, the Department said no. One can look at what the UK has done, especially in the context of the Brexit situation. Whether one likes it or not, a suitably qualified person, SQP, can operate in the North. There are two different rules from Monaghan to Enniskillen and there are going to be major problems.

Can we also get the reply the EU sent the witnesses? Can that and the letter or email that was sent by the Department looking for a relaxation of this be given to the committee?

Ms Paula Barry Walsh:

I will deal with the first part of that question about the responsible people. We recognise the qualifications of responsible people. These are the persons who are currently giving out veterinary medicines and antiparasitics. Due to the fact that we were involved in the drawing up of the course, we are well aware that they are trained not only to sell antiparasitics but they are required to retail other categories of veterinary medicines that can be supplied to date other than the antiparasitics.

They continue to be dispensed. I do not want to repeat myself with regard to prescription-only medicines. When one goes into a pharmacist with one's own health prescription, that does not mean one does not have some questions for a knowledgeable person at the point of sale. We always consider that they have an important role to play. There are other veterinary medicines that are retailed from licensed merchants. Rather than saying whether people will be let go, which is something I cannot reply to, I can say the Department is very focused on ensuring the licensed merchants remain viable and active. It is in that context we see a suite of arrangements such as those laid out by my colleague. Those arrangements are focused on ensuing that licensed merchants as an entirety will remain viable and, within that, will have the employees they need.

A question was asked about the UK and SQPs. What we find now is that Ireland is aligned with member states. We are in the European Union and we are aligned with member states. That is not a surprise to us. It was not necessarily something that we set out to do as a particular policy. I would point out that the UK has often been an outlier. Of course now it is outside of the European Union with Brexit. We are aligned with our member states in the context that other member states also use veterinary prescription for the issue of antiparasitic products.

May I pass over to my colleagues regarding opinions and letters to the EU and from the EU?

Mr. Colm Forde:

To follow up on the points made by my colleague, Ms Barry Walsh, the negotiating position of departmental officials at the time of the regulation was to retain the status quoso that antiparasitic medicines could still be made available without a veterinary prescription. We were successful in that regard. What has changed since then is that we now know there is extensive evidence of resistance so we no longer meet the derogation criteria that allows those products to be made available without prescription. Our UK counterparts also sought to retain the status quowhereby they had people other than vets who could issue prescriptions. Both countries got to retain the status quothat they already had in existence.

Photo of Michael FitzmauriceMichael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

Would we be okay if we had SQPs?

Mr. Colm Forde:

This goes back to the Deputy's question about our correspondence with the Commission. We are more than happy to share the correspondence that we have had with the Commission. It is quite similar to the response we got in the answer to a question posed by Mr. Chris MacManus MEP at the European Parliament, which basically said that if people other than vets were allowed to issue veterinary prescriptions before January 2019, that can remain in place. Under our 2007 statutory instrument, the only people in Ireland who were allowed to issue veterinary prescriptions were vets. Therefore, we do not qualify for that derogation. As I have said, we have submitted that query to the Attorney General to seek final clarity because of the range of views expressed. I think I have addressed the questions raised.

Photo of Michael CollinsMichael Collins (Cork South West, Independent)
Link to this: Individually | In context | Oireachtas source

The Independent Licensed Merchants Association submitted substantive evidence that Ireland can meet the terms of the derogation of Article 105(4) in its legal opinion, which was immediately made available to the Department. To date, the Department refutes that, defending the fact that it has legal advice to the contrary. Why has the legal advice and the brief to the Council never been shown to stakeholders, their legal representatives or the committee?

The Department has taken three months to study the legal opinion requested by its Minister with no response forthcoming. Do we take that silence as an acceptance or is the Department now prepared to create a prescription category that focuses on the resistance for vets, pharmacists and RPTUs for non-antimicrobial medicines?

Mr. Colm Forde:

We met with the Independent Licensed Merchants Association after our last meeting with the committee and it was quite a constructive meeting.

I assure the committee we are not sitting on any advices. In the advice we received from the licensed merchants, there are some arguments in it that may have merit and others which we are not in agreement on. For example, the legal advice did not refer to the definition of a veterinary prescription in place in this jurisdiction. As I said previously, the clear derogation in the European regulations is that unless one allowed someone other than a vet to prescribe prior to 2019, one cannot allow that now. Maybe that was a gap in the legal advice.

However, we have forwarded the legal opinion from the licensed merchants on to the Attorney General's office. We have asked it to fully consider that in the detailed advice it gives back to us. I assure the committee we liaised with the Attorney General's office both last week and today to see if there has been any move because we wanted that advice before today's meeting. We were advised that due to resource and other work pressures, it has not been in a position to finalise those advices yet.

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I thank the witnesses for their attendance. The position of the European Commission has been referenced a number of times in response to questions. The correspondence directly between the Department has been mentioned and a parliamentary question by Mr. Chris MacManus, MEP. Mr. MacManus, MEP, received a response that did not say what the Department is saying now. It set out the position but said it was up to the member state to confirm whether the conditions of the derogation of Article 105(4) of the regulation are met. It is an important distinction.

I have experience of dealing with the European Union and the institutions. There is a method of ensuring arrangements can be put in place legally or procedurally. The first instance is that a government has to want them to change.

Do the officials agree the prevailing situation whereby licensed merchants are able to prescribe and supply these products should continue?

Ms Paula Barry Walsh:

I am happy to answer that. I will try to be as succinct as possible and my colleague can provide extra detail. We seek to have licensed merchants distribute and dispense it, but it will be on foot of a prescription. I refer to the MEP's question where the Commission pointed out was up to the member states to say if they have met the criteria. That is correct. We agree with that. In considering the regulation, one can only allow for the dispensing of a prescription if it had been done by somebody other than a veterinarian prior to the 2019 point of legislation being brought forward rather than the 2022 point-----

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Where is the blockage? If we take it as a given for now that the Department's legal position is correct, is the blockage within Irish legislation or European legislation?

Ms Paula Barry Walsh:

There is probably some history behind it. I again refer to the Irish Co-operative Organisation Society. When one considers the directive and legislation in 2007, one also had an option of having antiparisitics prescribed by a non-veterinarian. Ireland chose that option. As the Irish Co-Operative Organisation Society, ICOS, said, it was happy with that. We all thought it was a good idea. It was the way we went forward, in a considered manner.

On the basis of the study done by the HPRA, which demonstrated evidence of antiparasitic resistance, we were no longer in a position not to have prescriptions used. However, we did not have a methodology under which a prescription could be given except by a veterinary surgeon. As I said, that is aligned with the whole of Europe. Mr. Forde probably has more details.

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Before Mr. Forde comes in on that-----

Mr. Colm Forde:

I can succinctly answer Deputy Carthy's question if he likes.

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Okay.

Mr. Colm Forde:

Deputy Carthy's point was on whether the blockage was at European or Irish level. Our view on this has been consistent. There is no discretion under national legislation to provide for anybody other than a vet to issue prescriptions, therefore the blockage is at European level. European legislation makes it very clear to us that the only people allowed to issue prescriptions are vets.

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

Okay. If I can go back to Senator Daly's original point, was that something the Department was aware of? Did it brief the Minister responsible at the time that this was a potential difficulty, which could come down the line? As a committee, we have substantial documentation in the form of submissions from several groups that have highlighted huge challenges in terms of both financial costs and practical difficulties that are going to be met by the people who we have a primary concern for, those being our own primary producers. Did this come out of nowhere or did the Department have any sense of the difficulties that would be presented by that particular formula with respect to the derogation? The derogation was put in place for a reason. The derogation was there to be availed of by some member states. I know the British Government appears to have used the derogation in a more practical way, if I can put it that way, compared to the Irish Government. I want to know where the difficulty was in that regard. European legislation is the same as Irish legislation, in that it can be changed. The second issue I want to explore is whether or not there is a willingness to change European legislation.

Mr. Colm Forde:

I am happy to take on the first part of that question. In our opening statement, we outlined the legislative developments. I think I referred to this earlier but when the Department of Agriculture, Food and the Marine officials were negotiating this particular regulation - if members have the opening statement in front of them, it comes under the heading of EU and domestic legislative position of AVMPs - and when the 2019 regulation was finalised, it would have allowed for antiparasitics to still be sold by licensed merchants without requiring a prescription. One of the issues that has not been touched on too much is Article 33 of the regulation. It states all veterinary medicinal products for food producing animals must require a prescription but there are certain exemptions to that. Certain products can be made available without a prescription if there is no evidence of resistance, no harm to humans or no environmental damage, in addition to a number of other criteria. It was on the basis that we met those criteria historically that antiparasitics could be sold without using a veterinary prescription.

Since the regulation was finalised, the Health Products Regulatory Authority has become the competent authority for analysing medicines. It determines whether medicines are working and doing exactly what they should be doing, and what route of sale they should have. It analyses-----

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I appreciate other members are looking to come in. I am going to ask my question for the third time. Assuming the Department's legal advice is correct, that means a change in legislation is required. Mr. Forde stated any change in legislation needs to take place at European level.

Mr. Colm Forde:

Yes.

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

We know European law will not change unless, at the very least, a government asks for it to change. I am trying to get a sense of whether the Department accepts there is a problem and that the law needs to change so that we can begin the process of seeking that change. I will leave it at that. I would appreciate if I could get a response to that question.

Mr. Colm Forde:

The point that has been consistently made is that there is concern from licensed merchants and others that they may lose business share and, as a result, that may damage their ability to earn a living. We have outlined extensively how we are trying to mitigate that. We have an action plan, as I have mentioned, that involves a secure electronic prescribing system and other elements, which we hope will mean that they will still be able to retain a sizeable market share and support their own businesses.

I would take issue with the assumption that this will automatically damage their livelihoods and the income that they can generate.

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

"No" would be a sufficient answer. I think we have got to the root of the problem.

Mr. Colm Forde:

As we have said, we await the opinion of the Attorney General on that issue and at that point we can consider it.

Photo of Tim LombardTim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source

Mr. Forde referred in his statement to the issue of how we will license these prescriptions going forward. He mentioned that with the new action plan, hopefully there will be an opportunity for them to be done by electronic means, for example by text message or email. He also said that some European models would have veterinary surgeons prescribing but not actually dispensing. Am I clear about what has been stated?

Mr. Colm Forde:

Yes. There are different models in different member states. One of the issues that some of our stakeholders have highlighted is that if all of these medicines are now going to require a prescription, the best way of ensuring a competitive supply chain is to break the link between prescribing and dispensing. We committed to examining that as part of the antiparasitic stakeholder group. Some countries do not allow vets to sell medicines and allow them to prescribe only. We said we would examine that as an option.

Photo of Tim LombardTim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source

What is involved in examining the proposal? Will the Department engage with the Veterinary Council of Ireland and stakeholders? Will there be a public consultation process? Has the Minister been involved in the decision? Has he made a public statement on what is involved in taking away the dispensing of medical products from vets? Where will the protocol go? What is the timeline for the consultation to produce a result?

Mr. Colm Forde:

I guess, as part of our antiparasitic stakeholder group action plan, there are 46 different actions of which this is only one. We committed to our stakeholders that we would examine this. We invited them all to send us in any information or views that they felt would be useful in this analysis. We committed to presenting an overview of it to the March antiparasitic stakeholder group where we would outline the pros and cons associated with such an option. We can only probably work from there at that point. It is part of this broader stakeholder consultation, which we are committed to as part of the regulations.

Photo of Tim LombardTim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source

Will there be an indication by next March?

Mr. Colm Forde:

Next month.

Photo of Tim LombardTim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source

In a few weeks' time the Department will have an indication on whether it will push ahead with, and make more progress with, breaking the link between vets and the dispensing of drugs. If I believe what has been said, the scenario will be the same as what exists in medical circles where one goes to a doctor and gets a prescription and then a pharmacy dispenses the product. Do I take that to be one of the options that will be considered at the forum?

Mr. Colm Forde:

I would not want to oversell this as a developed policy that could be rolled out quite quickly. We said we would look at it for stakeholders to outline the potential pros and cons that would be associated with it. Basically, what the Senator has said is correct. One of the options available will be that vets would not be permitted to sell the products and would be permitted to prescribe only. My colleague, Ms Barry Walsh, may want to add something further.

Ms Paula Barry Walsh:

All of the options will be looked at in the context of the analysis. Then they will be discussed at the antiparasitic resistance group, keeping in mind that every option that is exercised has its own intended or unintended consequences. That aspect will have to be taken account of when the stakeholder group looks at the options.

Photo of Tim LombardTim Lombard (Fine Gael)
Link to this: Individually | In context | Oireachtas source

My final question is on the report that showed we have an issue. What is the long-term plan? We hope this issue will be resolved by getting practitioners to prescribe the appropriate medication. Have we looked at what happens if that does not work? What happens if we do not receive the resistance? Where is this project going to go in the next five or ten years? Is the golden bullet going to be to have a vet prescribe for this issue or is there a plan B?

Ms Paula Barry Walsh:

I will give an overarching view of that and my colleagues can come in with more detail, as appropriate. As we mentioned, the antiparasitic stakeholder group was put together last year.

Every one of those stakeholders has a vested interest in and a particular perspective on antiparasitic resistance. Together, chaired by the Department and provided with secretarial assistance by the Department, they drew up 30 different actions under the six different headings. I will go through them briefly.

First, we want to improve the knowledge and awareness of antiparasitic resistance. That is an important message. What we know that not every farmer or licensed merchant, LM, in the country knows. It is a growing problem. On improving knowledge and awareness, the stakeholders have websites, training and personnel who are interested. We need to reach out, with our stakeholders, to those people and improve our own knowledge and awareness all round.

Second, we are enhancing the surveillance of antiparasitic resistance and usage. We believe electronic prescription gives a real opportunity for the stability of the LMs. It also gives us much data so that we can watch these things and can try to determine what is happening. We can see where the trends are going, what is being prescribed and, as mentioned, whether it is less or more.

We also want to reduce the spread of infection-----

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I have four other members who want to ask questions and I want to let them in. I will take two together. I will take Deputy Browne and Senator Boylan together because we are going to be-----

Photo of Victor BoyhanVictor Boyhan (Independent)
Link to this: Individually | In context | Oireachtas source

There is a Senator Boyhan and a Senator Boylan. Which one is the Chairman calling? Is he calling Senator Boyhan or Senator Boylan?

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I am calling Senator Boyhan. Sorry Senator, it was my mistake.

Photo of Martin BrowneMartin Browne (Tipperary, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I will ask the same question I asked earlier but I asked it at the wrong time. The claim is that Regulation (EU) 2019/6 precludes availing of the derogation that has been in place here for years. I take issue with that based on legal advice with which we have been issued. Is it not the case that an offer was made in 2011, years before Regulation (EU) 2019/6 existed, to further upskill the recognised persons and the Department turned it down at that stage? Is it not true that the UK approached the Department about replacing the derogation with proper legislation and that was also turned down? That regulation came into effect on 28 January 2019.

Why was there no consultation with the stakeholders ahead of the regulation coming into effect in 2019 because any real public engagement happened afterwards, more or less after the horse had bolted. Is it not true that the Department was intent on relying on the derogation rather than addressing the fundamental reasons the derogation was needed which was that necessary legislation was not in place? This was despite the fact that a significant number of jobs and livelihoods relied upon it. Why was that and why now that the regulation has been signed is the Department suddenly reluctant to use the derogation? Is it because the Department is concerned it will be found that it messed the whole thing up?

In 2005 an identical situation arose that was referred to the Competition Authority, which is now called the Competition and Consumer Protection Commission, CCPC, for its view. Its opinion was that creating a situation where vets could be the only prescribers of veterinary medicines would restrict competition, raise transaction costs and restrict consumer choice. Will the Minister for Agriculture, Food and the Marine, Deputy Charlie McConalogue, now instruct the Department to respect that opinion and seek a solution with the stakeholders to avoid the need to re-engage with the CCPC?

Photo of Victor BoyhanVictor Boyhan (Independent)
Link to this: Individually | In context | Oireachtas source

I thank Ms Barry Walsh, Mr. Forde and Ms Garvan for coming in and for what, quite frankly, are their robust responses. To be fair, it is a robust system of questioning. I acknowledge that and thank them for making themselves available. It is important to say that. We welcome engagement with anybody at this committee, so I thank them for making themselves available.

Given the shortage of time, I will not dwell too much on things other than ask two or three questions. The officials might indicate when they contacted the Attorney General for his advice. Hopefully, they might come back to the committee when they have that advice. Would the chief veterinary officer of the Department be able, and agree, to make available all correspondence with the Commission? I presume the chief veterinary officer is part of Irish veterinary union. There is a conflict between the Irish veterinary union and the merchants on the issue of competition.

We have to be very careful we have open transaction and transparency in this area. This is an area of great concern for me.

In terms of the commitment to an economic impact statement in addition to the regulatory impact assessment, that was an issue the last time and the responses we got vexed many people. Could the witnesses commit to an independent economic impact statement on the ramifications of this directive?

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

There are some very precise questions for the officials. I ask that they give brief answers. I want to bring in two more members before the meeting concludes.

Ms Paula Barry Walsh:

I thank the Senator for his comments. They are very much appreciated. I refer to the chief veterinary officer, CVO, who is not here to speak for himself. I know nothing about his joining the Irish veterinary union. To be clear, the Veterinary Council of Ireland is the organisation we mentioned earlier. It is a statutory body under the aegis of this Department. I am on the Veterinary Council of Ireland, and for transparency, I am glad to be able to make that point. As was said earlier, it is a body that deals with the regulation of veterinary personnel registrants - vets and nurses. My work on that is not related to Department work; it is more to do with its work.

My colleagues have said we can make any letters related to EU Regulation 2019/6 available. I will let my colleague deal with the regulatory impact assessment and other queries raised.

Mr. Colm Forde:

I refer to the initial questions from Deputy Browne about the derogation. Our view on that is simple. We do not think it is a legal option to us. It would be breaching European law if we allowed people other than vets to issue prescriptions. We are awaiting the Attorney General's opinion on that point.

I refer to Ms Barry Walsh's point on competition concerns. Other than Northern Ireland, no country in the European Union allows people other than vets to issue veterinary prescriptions. In terms of competition concerns, European law has precedence, so I do not think there is an issue. As Ms Barry Walsh said, we are in line with other member states. We are in line with international best practice, which is important when we export 90% of our agrifood produce.

In terms of any potential conflicts of interest, first and foremost, we are all public servants. We all take that incredibly seriously. We are fully transparent and objective in our analysis. I can assure Senator Boyhan that is not an issue that causes any conflict with us.

We have discussed a regulatory impact assessment at length with our stakeholders, including the licensed merchants association. We said we were not refusing to do an economic impact assessment. However, what one is seeking from an economic impact assessment is captured under a regulatory impact assessment, which we are doing as part of the transposition of this regulation. We have asked our stakeholders, including the licensed merchants association, to provide us with any information which can feed into the developing of that regulatory impact assessment. We cannot complete a regulatory impact assessment until we have confirmed and clarified all the various regulations. As I said earlier, this takes time because we are committed to extensive stakeholder consultation with all of our stakeholders.

In terms of the advices from the Attorney General's office, we have our own internal legal team. We wanted to make sure we provided a request to the Attorney General's office which was substantive, clearly laid out the issues and provided all the correspondence from our stakeholders, including the legal advices from the licensed merchants association. It was submitted to the Office of the Attorney General. We got confirmation it had received it on 16 December. We are still awaiting a response. I will keep asking the Attorney General to provide us with those advices. We can then provide the committee with a synopsis of what is in the Attorney General's advice when we receive it.

Many of my questions have been asked. Mr. Forde mentioned the derogation. Is he sure that no European country other than the UK had used the derogation or is doing so now? He spoke of vets issuing prescriptions. It would be similar to when the doctors set up pharmacy practices beside their business. It will have an awful negative effect. The issue really comes down to a way of life for farmers and merchants who had businesses in this country since the foundation of the State and now some of them will be put out of business because of this new regulation coming in from Europe. I am not being disrespectful - I have a lot of time and respect for officials, they have a job to do and so do we - but this does not seem to have been fought very hard at European level by the Department or anyone else. They were quite prepared to go along with the professional view that the merchants were not really capable of issuing these prescriptions. I do not agree with that. As others have said, maybe it boils down to a decision that has to be taken not in Europe or the Parliament, but in the courts.

Photo of Carol NolanCarol Nolan (Laois-Offally, Independent)
Link to this: Individually | In context | Oireachtas source

I will make some points and ask some questions. I ask that the officials please send me written answers if they are unable to answer them today.

The officials referred to a secure electronic prescribing system and mentioned farmer choice. Did the farmers look for the system to be changed? It is very disingenuous to suggest they did. I raised this directly with the Taoiseach in the Dáil and his view was that we do not want a cliff-edge scenario where thousands of jobs in rural Ireland are lost unnecessarily. I do not remember any farmer or group of farmers seeking change in the current system.

The regulation was passed by the 27 permanent representatives to iron out any major difficulties and obstacles. At that stage the derogation clause was drafted, scrutinised and agreed with Ireland, joining others to support the inclusion of the derogation. This action proves that Ireland needed to avail of the derogation to enshrine the responsible persons in future prescribing. Why is the Department of Agriculture, Food and the Marine reneging on all that work and adopting the opposite view in light of the fact that the chief veterinary officer and the HPRA recommended a multi-stakeholder approach to address resistance?

The Department will be aware that in 2010 a new class of wormer was launched as vet prescription-only for sheep with nil resistance. Within four years of vet control the first case of resistance was recorded in New Zealand, and in 2018 in the UK. Despite this, the Department of Agriculture, Food and Marine wants to make vets the only prescribers of wormers in Ireland. The officials mentioned the other system, about which I also have questions. I would like a response on that.

On the secure electronic prescribing system, it is outrageous to recommend such an approach and not be able to give any cost. Did no cost-benefit analysis take place? Is the Department not concerned about wasting money unnecessarily?

This looks as though it is simply about putting all control in vets' hands. No matter how it is dressed up, farmers did not look for a change to the system.

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

We are over time so I ask that the officials respond as briefly as they can, please.

Ms Paula Barry Walsh:

We will commit to looking at those questions to give written answers to Deputy Nolan, as she asked a few different questions.

To respond to Deputy Ring, the stakeholder group which was set up by the Department recognised that real issues were emerging from anti-parasitic resistance. That is the driver around this. We have tried to address people being put out of business today. We are continuing our consultations on that end.

We have given an idea of the various issues, which involve not just the electronic prescribing system but also looking at the validity of a certificate. A farmer will not be under any pressure to exercise that certificate on the spot if he is in a veterinary premises. He will have time to think about where he wants to go. They are the types of options we seek to have.

That is some of it, but my colleague might wish to respond to some of the points.

Mr. Colm Forde:

Do I have time to respond, Chairman?

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Yes. I am getting cross looks so be as brief as you can, Mr. Forde.

Mr. Colm Forde:

Deputy Ring asked if I was sure that no other member state is availing of it. I am not aware of any other member state aside from the UK that is availing of the derogation, but I will look into it for the Deputy. As far as I am aware, we are in tune with every other member state.

We have tried to get the point across a number of times in terms of the negotiation of the regulation. When the negotiations were finalised, anti-parasitics in Ireland under the regime that was negotiated could still be supplied without a prescription, so nothing would have changed. The only thing that has changed is that extensive research and analysis have now been done, which is in the HPRA task force report and shows there is evidence of resistance. That means we no longer meet the derogation criteria allowing those products to be sold without a prescription. At the time the regulation was finalised the status quowas still provided for.

To respond to Deputy Nolan, I did not mean to suggest that farmers looked for this regime to be changed. We were merely highlighting the potential benefits of the secure electronic prescribing system for farmers. I apologise if we made that suggestion.

As my colleague said, we will respond in writing to the other questions.

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I thank Ms Barry Walsh, Mr. Forde and Ms Garvan for their contributions today. We have had a robust exchange of views. It is clear that the committee is very unhappy with these proposed changes and seriously worried about the impact they will have on people who are involved in the business and on the primary producer. This is an issue we will return to again. We are waiting for the advice of the Attorney General. When you get that advice and pass it to the committee, I believe we will meet again and put forward the committee's views. Thank you for the exchanges. You answered our questions comprehensively and we appreciate that.

Ms Paula Barry Walsh:

I wish to make a final clarification in case anybody refers to the legislation. It is Article 34 that gives the derogation, not Article 33. That was just a misquote. We are happy to be here and I thank the members of the committee for listening to us.

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

Thank you.

I will deal with some items of business before we conclude. I propose we hold a private virtual meeting on Wednesday, 17 February, at a time to be confirmed closer to the date, in which we will try to finalise our forestry report. Is that agreed? Agreed.

That concludes today's proceedings. The committee is adjourned until 4 p.m. on Tuesday, 16 February, when we will discuss issues relating to peat and the availability of peat for various industries.

I am sorry for rushing people near the end of the meeting, but I wanted to have a comprehensive discussion on the legal advice at the start of the meeting because it was key to the formulation of our thoughts. I knew it would lead to time difficulties at the end of the meeting, but thank you for your forbearance.

The joint committee adjourned at 6.09 p.m. until 4 p.m. on Tuesday, 16 February 2021.