Dr. Lorraine Nolan:

I want to reassure Deputy Boyd Barrett that we had intended answering his questions; I just happened to answer Senator Burke's questions first. The Deputy asked why we would choose to align ourselves with those nine countries that have a restrictive access programme versus those three countries in Europe that have a wider access programme. We need to be clear that we have not aligned ourselves with any particular country or position taken by a European country with regard to this. What we have done is review the available scientific evidence on this issue. We have also reviewed the position in other countries but what we have ended up with, in terms of the proposals for the access programme, is based upon a review of the available science. However, it is also taking into account the Irish context, the Irish health care system and the view of those clinicians who are practising within the Irish health care system because whatever comes from this has to be implementable in the Irish context. That is an important point to make at the outset.

The position, and it is not a question of alignment, is that none of those three countries in Europe changed to a very wide access programme in one move. No country has moved from a position where it had very strong prohibition to a position where it has a wide programme of access in one change. Those three countries have all moved through this process of having a restricted form of access programme in which they can gather and generate information on their needs. They know their needs and requirements before they move to a wider access programme and they also know, coming back to the International Narcotics Control Board, INCB, issue I spoke of earlier, their consumption needs in that context, which is an important point in this regard.

The Deputy mentioned pain. I want to say at the outset that in the course of conducting our review we had a number of discussions with Professor David Finn. He has contacted us since the Irish Pain Society's statement has come out and we are in the process of discussing it with him.

With regard to pain, the Deputy is right. One in five or 800,000 people suffers from chronic pain, so we acknowledge the number of people who are impacted by pain. In that context, we can understand that people suffering from pain are looking for alternative approaches to treatment. However, when we reviewed the data on that, and the Deputy mentioned the Barnes review, including the Corcoran review, the national academy's report and those of the Journal of the American Medical Association and others, we saw that they all look at pain. Twenty-eight pain studies have been conducted in this area and when we look at those pain studies we see that pain is a symptom associated with many conditions. It is not ring-fenced in the way epilepsy or spasticity associated with multiple sclerosis can be. It is an outcome of very many diseases and conditions. Those studies are looking at pain across a variety of contexts. They are also looking at a wide range of products including some of the medicines that are authorised that we spoke about such as Nabilone and Dronabinol. The nabiximols, which would be Satifex, would be one of those also. They are also looking at cannabis, which is smoked and inhaled. We are looking at no standardisation in terms of the type and the form of the product used or investigated in those pain trials and no standardisation of the conditions. It is incredibly difficult, therefore, to draw objective evidence from that.

Coming back to objective evidence, the outcomes for patients in those trials is very different when we look at the detail, depending on whether it is the doctor who is reporting on those outcomes versus the patient. That is because pain is subjective. If I experience pain I may say mine is ten on a scale of one to ten whereas the Deputy's might be five. That is very much down to the individual. That is the problem in looking at all of those pain studies. All of the reviews we have looked at clearly cite the need for more research in pain.

The Deputy mentioned the context of other alternatives in addition to opiates. He is saying that, potentially, opiates may offer-----