Health and Sport Committee

Meeting date: Tuesday, June 12, 2012

Official Report 293KB pdf

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Petitions

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Orphan Diseases (Access to Therapy) (PE1398)

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Pompe Disease (Access to Therapy) (PE1399)

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Paroxysmal Nocturnal Haemoglobinuria (Access to Therapy) (PE1401)

Item 4 is consideration of petitions. Members will recall that after we heard evidence from the petitioners we agreed to write to the Scottish Government, the Scottish Medicines Consortium and NHS National Services Scotland. We have replies to our letters and further submissions from two of the petitioners.

I remind members that we have agreed to hold an evidence session in September on access to newly licensed medicines. The committee will confirm its plans for that session when we consider our work programme under the next item. I invite members to comment on the action so far and the correspondence that we have received.

The correspondence, particularly from the SMC, was helpful. When we previously discussed the petitions, I remember that one or two committee members thought that we did not have the expertise to enable us to map out the process effectively. As a result of the correspondence, as well as a number of helpful events at the Parliament, which Nanette Milne has been involved in sponsoring, I feel that I am in a stronger position to be able to take forward the petitions. I very much hope that we will return to the issue when we consider our work programme.

I agree with Bob Doris. Our evidence session in September will be interesting in that it will provide us with the detail about SMC procedures. I was a member of the Public Petitions Committee when the petitions were considered prior to their referral to this committee, and I am pleased that the matter is being taken further forward than the PPC was able to take it. I welcome the information that is before us.

The correspondence is helpful because it begins to define some of the central questions, including, for example, whether the SMC’s modifiers are entirely appropriate, particularly with regard to the major issue of palliative care, and whether the new individual patient treatment request system is working well in two respects, the first of which is the criterion for acceptance under IPTR, which is that the patient’s characteristics should be significantly different from those of the general population of patients covered by the medicine’s licence or the population of patients included in the clinical trials. That almost creates a catch-22 situation for rare and orphan drugs, because the numbers are so small that it becomes very difficult to differentiate one patient from a group.

The second question that has been raised, particularly in the petitioner’s correspondence, is whether there is enough expertise in the 14 IPTR panels and each health board to examine these issues in a fair, equitable, transparent and even way across all health boards with regard to particularly rare conditions that only one or two experts in Europe, never mind the UK, might know about. Certain issues are emerging and I am looking forward to the evidence session later in the year, because it will allow us to define things further.

I also ask our support staff to provide us with a list of medicines that have been approved by the National Institute for Health and Clinical Excellence or the new advisory group on national specialist services but have not been approved in Scotland. After all, there will be concerns—at least, as long as we remain in the UK—that patients in Scotland are being treated differently from those in different parts of the UK and it will be helpful to have a list of the drugs that have highlighted discrepancies in approval systems.

Finally, the English NHS has decided to set up a cancer drugs fund. We in Scotland have generally agreed not to do the same, particularly because of the view that it discriminates against other conditions, but that decision has led to a discrepancy that might not be fully addressed under the IPTR system and we need to review the matter at our evidence session.

If we are to consider differences between Scottish and English operations, we will need a corresponding list of the drugs that are used in Scotland but not in England. We need to find out the rationale for such decisions and why there are positive and negative outcomes north and south of the border.

If no one else wishes to speak, I will bring Bob Doris back in and then we will move on.

I will make a very brief point, because I hope that we will examine the issue in more detail in the very near future. Richard Simpson has made a number of important and fair points but, for the sake of completeness, I note that in its written correspondence the SMC states that the AGNSS process itself might have some shortcomings. We cannot state that, just because England has another process, it is necessarily better; what we are looking for is the best process for Scotland.

The SMC also makes the point that England has three different systems running in parallel. One might suggest that such an approach simply fragments the situation and does not provide consistency of judgment; in fact, you might argue that with the cancer drugs fund England has four different systems. I think that we have to approach the issue with an open mind, examine the strengths of the English and Scottish processes and recommend changes if we need to. I know that Dr Simpson was not doing this, but we should not simply assume that just because England has something different it is necessarily better. There might be issues with that system that we should scrutinise before we make any recommendations.

I entirely agree, convener.

It was useful to get those comments on the record, as they will help in our preparations for the evidence session. Do members agree to note the additional correspondence that has been received and to consider the petitions again following the evidence session in September?

Members indicated agreement.