Billy Kelleher (Cork North Central, Fianna Fail) | Oireachtas source

I welcome the witnesses. Some of the technical issues have been covered by other Deputies and Senators. My questions relate to the Bill and the Health Products Regulatory Authority's recommendation on the access programme.

When the Department of Health was asked for its views on the Bill did the Chief Medical Officer have any input in that regard? Did that office express any particular views on this Bill as proposed and on the broader issue of the HPRA's recommendations on the access programme or were its views sought?

With regard to the European Medicines Agency and its recommendations, does it follow suit that if a medicine is recommended by the European Medicines Agency the Health Products Regulatory Authority is obliged to licence use of the product in this State or does the European Medicines Agency supersede the Health Products Regulatory Authority? What is the relationship between the two agencies in terms of authorisation for the use of any drug or medicine?

Mr. Lennon mentioned in his opening remarks on the Bill that the Department is of the view that it is not necessary and is not in the public interest. Is the Bill not in public interest because it proposes to establish parallel regulatory authorities or because of concern about health implications? Perhaps Mr. Lennon would elaborate on that issue.

On the access programme, is there sufficient architecture in place in terms of regulation to allow for the dissemination of cannabis for medicinal purposes through the pharmacies or is additional regulation or legislation required to fulfil the HPRA access programme recommendations?

The report states that there is evidence to suggest that this product could be beneficial in the treatment of pain, although some of that evidence is not supported by broad clinical trials. Does the HPRA continually analyse the clinical evidence produced on a regular basis in regard to all products and medicines and does it have the capacity to monitor the international evidence in that regard, be it in favour or otherwise of a health product currently being authorised in the State through an access programme or the pharmacies?