My Lords, Clause 98 concerns a duty of co-operation with the Health Research Authority. That is of course absolutely supported. My Amendments 58B and 58C would insert into the list of organisations,
“Medical Royal Colleges … the General Medical Council, the General Dental Council and the Nursing and Midwifery Council”.
I have no doubt that the noble Earl will warn me of the dangers of this, but in a sense his own department has provoked it by putting a list into the Bill. Inevitably, we looked at that and wondered why some organisations were missing. I realise that Clause 98(1)(i) allows flexibility by regulations to add to the list and I am sure that that flexibility is welcome, but we should get this right in the first place. I find it difficult to understand why, for instance, the medical royal colleges are not listed. They have a vital role to play in this area.
Similarly, I support the noble Baroness, Lady Emerton, in her Amendment 59. I am sure she will speak to that in a moment. If the Chief Medical Officer is named, why is the Chief Nursing Officer not? I know there has been concern over the years about the position of the Chief Nursing Officer. The last Government as well as this one have debated this issue. Given that we wish to see an extension of research into nursing and clinical areas because of the absolute importance of enhancing the quality of nursing, it is disappointing that the Chief Nursing Officer is not listed.
I also support Amendment 61 from the noble Lord, Lord Willis, which takes the responsibility in Clause 98(7) of local authorities and NHS trusts to have regard to guidance from the HRA on good practice in research and extends it to other providers, including the private sector. These are important amendments as a whole. It is important that the Bill is informed and improved.
On my Amendment 61A, I am puzzled that in Clause 98(7) the requirement is only to have regard to HRA guidance. Surely that should be strengthened, as in my amendment, which says that guidance “must” be followed,
“unless there is good reason not to do so”.
I have taken advice on this matter. The noble Earl will know that there has been a problem over the years in getting approval for multicentre trial research. I understand that the research ethics committees have improved their performance in recent years, and that is to be welcomed, but we now apparently have the problem with some NHS trusts and foundation trusts. Of course, as this is the start of another Committee day, I ought to declare my interests as the chair of a foundation trust and as a consultant and trainer with Cumberlege Connections. It is disappointing if individual NHS organisations are holding up multicentre research, for all the reasons that we know about: UK plc and the need for us to ensure that there is greater investment in research in the UK. I want some assurance that if there is undue delay, the HRA will be able to intervene and ensure that NHS organisations get on with giving the necessary approval.
On Amendment 60A, health research capacity in the UK is of course one of our strongest assets. It includes pharmaceuticals and medical devices, and takes place in our medical schools and hospitals. World-class research is undertaken here, frequently with outstanding results, yet we consistently fail to exploit that research when it comes to its translation into practice. How many other countries have exploited research undertaken in this country? I very much welcome the establishment of academic health science networks, which are responsible for encouraging much closer links between research and health service practice.
However, there is much more to be done. I would like the HRA’s objectives to include encouraging innovation and practice. It is important that the HRA is in a position to advise the department on potential policies that might have an impact on the scale of research and development in the UK. One such example is the present intention to move away from the current pharmaceutical price regulation scheme method of reimbursing pharmaceuticals. I know that the Government are committed to the introduction of value-based pricing. I always try to tempt the noble Earl to debate in your Lordships’ House the introduction of value-based pricing, principally because very few people understand what it involves. Even having been the Minister who received the original report on it, I must say that I am still in the dark as to exactly how it will unfold.
My key question is this. I know that the PPRS approach is not perfect and that at regular intervals Governments negotiate it downwards, but it has always given flexibility to the industry to price new-licence medicines as it wishes within a profit cap. The advantage
of that flexibility is that many new drugs are launched in the UK rather than in other countries. I would like to hear from the noble Earl that the introduction of value-based pricing will not have an impact on the willingness and ability of pharmaceutical companies to continue launching products in the UK. I believe there is a link between the launch of products and investment in R&D in this country.
I may strain the patience of the House, but while I am talking about pharmaceuticals it is tempting to ask the noble Earl about the implications for the cancer drug fund. He knows that the intention was for that fund to become obsolete with the introduction of value-based pricing. However, cancer charities that I have met believe that value-based pricing will apply primarily to new active substance licences from 2014, and will therefore have limited impact on treatments made available through the fund. Will the noble Earl comment, or perhaps write to me, with an assurance that, before firm proposals are made on this issue, full consideration will be given to the impact of value-based pricing on the cancer drug fund, its continuation or potential substitution? I beg to move.
4.45 pm