The amendment seeks to ensure that NICE cannot impose blanket charges for advice currently offered free to users. The amendment is necessary because the clause provides that NICE can charge for advice on anything connected with health care, public health or social care. Although we understand that that is to be further defined in much-awaited regulations, it is not clear. We are concerned that the definition of health care in subsection (4) is broad and seems to relate to a wide range of conditions. We seek clarification from the Minister.
I can be very clear that the clause is not about enabling NICE to charge end users or drug companies for its main guidance, advice or information products such as technology appraisals. NICE does not charge for those, and there is no intention that it should. However, NICE can already charge for some services, subject to direction from Ministers. I believe that it is right and necessary that it should continue to do so in specific cases, subject to regulation.
The clause provides that regulations may permit NICE to provide advisory services in relation to health care, public health or social care to any body or organisation within or outside the United Kingdom. In its existing form, NICE offers two such advisory services that may come under the scope of the clause. They are the scientific advisory service and NICE International.
NICE officers a scientific advice service to companies with drugs or technologies in development who want to ensure that information requirements for health technology assessment are addressed through the research that the company undertakes as part of the drug development. That is an entirely optional service, which was introduced in response to demand from pharmaceutical companies. It is widely accepted that it is reasonable for NICE to charge those companies that decide to take advantage of the service. NICE’s advice may be useful to companies in meeting the needs of health technology assessment systems internationally, not just in this country.
Through NICE International, NICE in its existing form also shares its extensive experience of evidence-based decision making with foreign Governments and other bodies operating outside the UK. It has been active as far afield as Asia and south America. Again, NICE currently charges for such activity, as it is not right that such costs should be covered by the UK taxpayer.
Will the Minister clarify a point that he raised in the debates on some of the earlier clauses? The Minister has said that European competition law will apply only to services, but what the Minister has just said clearly demonstrates that NICE’s sphere of operation is in the provision of services. So NICE could be subject to European competition law in the particular areas that the Minister has just identified.
That was a good try and a demonstration of how to weave a point that has nothing to do with this part of the Bill into this part of the Bill. I am afraid that, despite his use of a crowbar, the hon. Gentleman will not get me to go down that path and dally with him on competition yet again.
Subsections (2) and (3) make provision for NICE to charge for such work on the basis it sees fit, whether that be on a cost recovery or commercial basis. NICE does not directly charge end users for most of the services it provides, such as technology appraisals and quality standards. We have no intention that it should begin to do so, and regulations made under clause 224 would not in any event be able to make provision for charging on functions that NICE is given under other clauses, including clause 221.
Any provision for NICE to charge will be set out in regulations, which, before the hon. Member for Halton asks, will be subject to the negative procedure. That is a more robust process than the current arrangements, which rely only on ministerial directions. Ministerial directions do not even require the signature of a Minister, let alone any form of parliamentary scrutiny.
I do not understand why Opposition Members are so keen to remove subsection (4), because it merely gives a definition of “health care”. Elsewhere in this part there are definitions of “social care” and “public health”. A definition of “health care” is needed to give meaning to the provisions in this clause. I note that the amendment proposes no alternative definition, so I confess to being puzzled by its intention.
I believe that NICE, as re-established, should be able to continue to provide advice of the kind I have set out. There is no justification for the Department of Health or the NHS commissioning board meeting the cost of advice provided by NICE to third parties, so to continue with such work NICE needs to be able to charge for it.
The amendment would address a potential conflict of interest. If NICE was privately advising drug manufacturing companies and separately making recommendations on their products, such as whether purchasing them was in the public interest, surely that would be a clear conflict of interest. Why do it? Why should the Department not meet the cost?
Let me deal first with the conflict of interest allegation. There is no conflict of interest. The service does not offer guidance on securing a positive recommendation. It ensures that drug companies can consider the requirements of NICE’s appraisal process at every stage of drug development and may design clinical trials accordingly. It is comparable to the service offered by the Medicines and Healthcare Products Regulatory Agency to pharmaceutical companies on seeking a market authorisation. So the hon. Gentleman is trying to suggest something that is not the case, has never been the case and certainly will not be the case when the Bill is enacted.
To address the hon. Gentleman’s obsession with competition law, I should say that Monitor has a role only on services. Monitor does not have a role on drugs, so, as I have said several times today, it does not apply in this situation.
I disagree with the Minister’s interpretation of the amendment, but one of the reasons for moving it was to get more information on the record, which will be examined both on Report and elsewhere later during the Bill’s passage. We will examine in detail what the Minister has said, because, as my hon. Friend the Member for Easington has said, there are some serious concerns about the implications. As I understand it, the Minister said that there will be no extension of the ability of NICE to charge.
Paul Burstow indicated assent.
In the debate that we have just had on the amendment, I indicated that the regulations could cover whether the basis would be commercial or cost recovery. That is the case at the moment. I can supply the hon. Lady with the details of what currently happens and of what will happen as a result of the Bill. She will see that there is no difference, but she will also have some information about the level of income currently generated by NICE’s activities.