Dr. Lorraine Nolan:

In terms of their inclusion within the trials, one has to remember that what we are saying is that there should be an access programme that provides access to small groups of patients. The problem is the risks have not been appropriately qualified. If one wants to have a system under which one potentially expose 800,000 people to risks, that is a huge jump in moving forward. What we are saying is that in order to ensure the correct levels of patient protection it is more important to look at the issue in a different way. We are certainly not closing the door on use for pain relief. We are simply saying the evidence is currently not strong enough to move forward because their use cannot be ring-fenced in the way that it can be for other patients.

I would like to come back to the point Dr. Elaine Breslin made about end points, namely, that for all of the conditions chosen under the access programme there are measurable end points that can be determined. A doctor can look at how a patient's spasticity is responding to the treatment and make a decision on whether the treatment is working and if it is not, it is not acceptable or appropriate to expose him or her to an unqualified risk. It is the same issue in the treatment of nausea associated with chemotherapy. It is obvious whether the use of cannabis is working in the treatment. Similarly, in the treatment of epilepsy. There are measurable end points, but there are no end points in the treatment of pain which fundamentally is one of the problems.

The point on opiates to which I would like to come back concerns the idea of whether they provide a less addictive alternative. I am not saying it does not have validity, but it simply has not been studied. Nobody has looked at the effects in switching patients from opiates to cannabis and determined whether it is less addictive. Nobody knows what dose of cannabis one could try for a patient. The evidence is simply not available. It needs to be studied and the evidence brought forward. The access programme can give a lot more information and confidence in how the system could be worked. Nobody is saying clinical research should not be encouraged alongside it. In this country, much of it due to Professor David Finn's efforts, a huge range of preclinical research has been conducted. We really need to harness, work with and back it from a policy perspective and carry out more properly conducted trials on pain subjects. Including within the programme pain patients will not generate data in the way needed to bring them forward because it is not a formal clinical trial programme. That is an important distinction in this respect.