Mr. Colm Forde:

I am happy to take those questions. We have been talking extensively, and continue to talk, to our stakeholders about how this regulation will be implemented. Our door is always open and we have spoken to Mr. Quinn on several occasions. He is a part of the antiparasitic stakeholder group that has been established in the Department and is chaired by the Chief Veterinary Officer.

The first time I heard of a claim to the effect that we refused to undertake an economic impact assessment was in that statement today. We have committed to carrying out a regulatory impact assessment, which is effectively the same thing, on how each regulation affects different elements of society, in this case the supply chain, so I do not understand where that claim came from. I am happy to follow up with Mr. Quinn on that.

The point we would make is that the previous legislation relating to veterinary medicines has been a directive. A directive in European law allows a certain level of national discretion as to how one seeks to comply with the provisions of that directive, whereas a regulation has direct effect on a member state and there is far less discretion as to what can be done at a national level. The law is basically written down here already and we know what it is. There is far less room for us at a national level and we explained that at length to our stakeholders. The regulatory impact assessment was going to focus on the areas where Ireland has national discretion. One could argue that the value of carrying out an impact in respect of on areas where we have no discretion is potentially limited. I hope that addresses that point.

We have met extensively with representatives from the ILMA but did not previously meet with Mr. Scott or are not aware of his views so they are news to us. Mr. Scott mentioned that it submitted legal opinions to the Department yesterday, which I received before 7 a.m today. I sent these on to our legal advisers. We are working with all of our stakeholders, our internal legal advisers and the Office of the Attorney General to get legal clarity on the elements of the regulation. With regard to the views expressed today, there are differences of opinion of different legal interpretations so we must make sure what we are doing is legally robust.

Regarding the charges raised by Mr. Scott about departmental officials acting against stakeholder concerns, I think Senator Boylan mentioned commenting on third parties and not having a chance to respond. None of the officials here were involved in negotiating the regulation at EU level. We have been all involved in the medicines aspect in the past couple of years by which point the regulation had already been negotiated at EU level so I am not in a position to comment on the particular points made by Mr. Scott. My view is that this would be unusual.