Mr. Eugene Lennon:

Statutory instruments. We reckon we will need at least three in respect of the access programme.

Returning to some of the other points that were made, my colleague will deal with the question about the European Medicines Agency, EMA. Outside of the access programme, it will still be open to people to apply for a licence where their consultant endorses the treatment and feels it appropriate. If somebody has another condition outside of the three that are in the access programme initially, it is open for a consultant to apply for a licence for treatment with cannabis. It was suggested that we would be overwhelmed with licence applications. That will obviously not be the case. We have not had very many to date. The access programme itself will not require a licence as that is not how it is being set up. Patients will be on a register for treatment under it.

As reference has been made to the Barnes report, it is worth noting that the Minister initiated his review of policy on medicinal cannabis last November and now we are working on the guidelines for an access programme. Professor Barnes published his report in the UK well over a year ago and there is no progress there. There is no access programme or any change in anything. We are making a lot of progress very quickly in Ireland, partly because the HPRA programme set out how something could work in a practical health care setting.

Reference has been made to other European countries. The numbers receiving cannabis are not as high as one might think. Our understanding is that in the Netherlands, a country with a population of 16 million people where there has been access to cannabis for medical purposes for over a decade, we are talking about 2,000 patients in total. The idea that 40% of 800,000 Irish patients will end up on cannabis is not realistic. The numbers in other European countries are quite small. In some of them, the access programmes are only getting going at the moment. Denmark's population is greater than Ireland's by about 1 million. They reckon that after four years they might have up to 1,500 people on their access programme. The HPRA said that there are three countries in Europe with more liberal regimes and about eight countries with access programmes. Ireland is joining those eight countries. The majority of EU countries still do not even have an access programme for cannabis.

There is a lot of talk about the risk from benzodiazepines and other products. That does not pertain to the substance of this Bill. We have set out what we believe are issues around this Bill. The benzodiazepine question is a different issue not covered by the proposed legislation. Some of the issues in that regard have to do with the illegal sale of benzos rather than those prescribed by doctors and dispensed by pharmacists. Yes, benzos cause problems for people and they are misused. However, if used appropriately, they are of benefit to patients and there is a positive benefit-risk ratio when those products are used appropriately. That is a different argument from what is proposed here in respect of cannabis.