Jonathan O'Brien (Cork North Central, Sinn Fein) | Oireachtas source

The HPRA is now saying that we should look at establishing an access programme for three specified medical conditions. An outline was given of what the potential access programme could look like. It was said that the programme would be monitored, that it would be for five years and that there would be a centralised data collection point. It was also said that a new legal framework would be needed in order to establish the access programme. On page 32 of the report there is reference to the 1961 UN convention on narcotic drugs, to which Ireland is a party. It says that under the convention the production and distribution of controlled substances must be licensed and supervised and the rationale for that is outlined. In terms of the legal framework, do the witnesses from the HPRA expect the changes will have to be made in primary legislation or if they can be made in secondary legislation? Did they make any recommendations to the Minister or was that left to the Department?

The witnesses from the Department stated that the Minister has accepted the establishment of a new access programme and that it will take time to implement. We heard that the Department is looking at options in terms of legislation. Will the legislative changes be made in primary legislation or by means of statutory instrument? It was also outlined that in the absence of an access programme it remains open to the Minister to grant a licence under certain circumstances. Could the witnesses outline what those circumstances are because there seems to be much confusion in terms of how someone can get a licence from the Minister before the access programme is established? Could they indicate exactly what are the criteria? What conditions does someone have to fulfil in order to be granted a licence? Only one licence has been granted to date.

It is important to put on the record exactly how someone achieves the criteria to get that licence while we are awaiting the establishment of the access programme. In regard to the access programme, it is important that the witnesses give us some knowledge of their consideration of the type of legislation that will be required.