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Fifth Standing Committee
on Delegated Legislation
The Committee consisted of the following Members:
Chairman:
Mr. Greg Pope
†Campbell, Mr. Ronnie (Blyth Valley) (Lab)
†Challen, Colin (Morley and Rothwell) (Lab)
†Dobbin, Jim (Heywood and Middleton) (Lab/Co-op)
Doran, Mr. Frank (Aberdeen, North) (Lab)
†Dunne, Mr. Philip (Ludlow) (Con)
Goldsworthy, Julia (Falmouth and Camborne) (LD)
†Hands, Mr. Greg (Hammersmith and Fulham) (Con)
†Kennedy, Jane (Minister of State, Department of Health)
†McCabe, Steve (Birmingham, Hall Green) (Lab)
†Merron, Gillian (Lord Commissioner of Her Majesty’s Treasury)
Milton, Anne (Guildford) (Con)
†Murrison, Dr. Andrew (Westbury) (Con)
†Owen, Albert (Ynys Môn) (Lab)
†Randall, Mr. John (Uxbridge) (Con)
†Webb, Steve (Northavon) (LD)
†Wright, Mr. Iain (Hartlepool) (Lab)
Fiona McLean, Committee Clerk
†attended the Committee
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Tuesday 19 July 2005
[Mr. Greg Pope in the Chair]
Draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2005
4.30 pm
The Minister of State, Department of Health (Jane Kennedy): I beg to move,
That the Committee has considered the draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2005.
It is a pleasure to serve under your chairmanship, Mr. Pope. Between us, we have probably clocked up many hours of service to the House on many statutory instrument and Bill Committees, although none as important as the order that we are considering today.
I shall make some opening comments and then draw the Committee’s attention to the report on the consultation. The order is a technical and enabling amendment to the Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003. It extends the remit of the fund to include the Secretary of State’s functions as the UK competent authority for the safety and quality of blood and blood components. It also removes the Device Evaluation Service from the remit of the fund in preparation for its transfer to the NHS Purchasing and Supply Agency—PASA.
I hope that the report on the consultation will deal with any concerns that hon. Members might have. A letter was sent to 619 representative organisations and other interested parties, as hon. Members will see from the report to the Committee. Five responses were received, and all those who replied supported, had no objections to or had no comments to make on the amendment to the trading fund. I take that as an encouraging starting point.
The Blood Safety and Quality Regulations 2005, which were introduced in January, transposed into UK law European blood safety directives that set standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. The UK must apply those requirements from 8 November 2005. Health Ministers have agreed to the MHRA taking on responsibility for those functions.
The other aim of the order is to facilitate the transfer of the Device Evaluation Service to PASA. That is in response to the recommendation of the Healthcare Industries Task Force, jointly chaired by my predecessor, Lord Warner, and by Sir Christopher O’Donnell of Smith & Nephew. I shall not go into further detail on the measure, as it is quite straightforward, but Committee members might have questions about the process.
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4.33 pm
Dr. Andrew Murrison (Westbury) (Con): I shall be brief. As the Minister said, the consultation exercise appears to have been fairly extensive, yet very few consultees responded or, more importantly, raised any serious objection to the order, so it would be churlish of me to detain the Committee for long. I will say, however, that devices have been something of a poor relation in terms of items expended by the NHS. Traditionally, there have been concerns, for example, about kit used in the battle against MRSA and the rapidity with which things are brought on stream.
Interestingly, I recently met representatives of a company that makes something called Sterilox and they expressed concern about the introduction of a consumable that is used to clean endoscope kit as a substitute for glutaraldehyde. Their concern was that the product was not being rolled out sufficiently quickly in the NHS, so there is an issue to do with the introduction of kit as opposed to drugs into the NHS and the consumables related to that. It would be interesting to hear from the Minister how the rather “techie”—if I can put it that way—changes referred to in the measure will help that process. In other words, how will patients benefit from the changes?
The literature refers to stakeholders in the context of others who might use the services of the Device Evaluation Service. I am not sure who the non-NHS stakeholders might be and whether customers from outside the NHS were in the habit of paying for products to be evaluated by the DES. That is the implication. I should be grateful if the Minister could say whether that is the case. If it is, how will the measure affect that? It would be interesting to know whether there are other customer stakeholders, how much revenue they produce and how that might be affected by the proposed changes.
Reading through the measure, it struck me that some of the work that the Device Evaluation Service might do might also be done by National Institute for Health and Clinical Excellence. It would be interesting to know from the Minister how NICE and its work might be affected by the changes that are heralded by the order.
That is all that I should like to ask the Minister, and I should be grateful if she could address those questions. If she cannot do so today, perhaps she might write to me.
4.36 pm
Steve Webb (Northavon) (LD): It is a pleasure to serve under your chairmanship, Mr. Pope, for, I think, the first time.
I have a couple of brief questions for the Minister. She says that the Blood Safety and Quality Regulations 2005 implement European directives into UK law. I always want to know why Europe is involved at all in such matters, and although one can see in the context of a single market of tradeable products a case for pan-European regulation, what is it about blood that we are talking about? Is it, for example, that within the European Union, we import
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blood for use in the NHS, and there needs to be Europe-wide standards of regulation? Is it that the blood transfusion service is exporting blood? What is the European dimension to the measure? Why do we not just do it ourselves, as it were, as opposed to harmonising or standardising across Europe? Can she clarify that?
On the issue of the Device Evaluation Service, I am aware from previous debates with the Minister on the NHS Logistics Authority a few weeks ago that we have discussed the position of arm’s length bodies within the Department of Health. I must admit that, coming relatively new to the topic, there are several bodies in the regulations that are new to me. I am sure that I should have known about the Medicines and Healthcare products Regulatory Agency, but I did not. Now I know that it has a trading fund. However, it is going to hand over one of its functions, device evaluation, to what appears to be—though I may be wrong—a new body, a national Device Evaluation Service. In the context of the Government apparently wanting drastically to cut down on the number of arm’s length public bodies, are they creating one here or are they giving new functions to one that already exists?
The Minister was admirably brief, but perhaps brief to the point of excess, and I am still slightly hazy. I accept the hon. Gentleman’s question about what we gain by transferring device evaluation from one quango of sorts to another. It says that the financial flow associated with device evaluation comes out of the MHRA trading fund and will be met by central Government—the taxpayer. I suspect that it is also the taxpayer in the other case, but a different bit of the taxpayer. However, when device evaluation was in the trading fund, it might have been offset by other sources of income, as it cannot be when it is outside the trading fund. Can the Minister give us a feel for orders of magnitude? How much money are we talking about here? The notes that have been circulated say:
“Without such a change, the cost of DES activity would continue to be met from the MHRA’s Trading Fund. We therefore propose that the Order be amended”
so that
“DES expenditure would then be met centrally by the Department of Health.”
Are we talking about £10,000, £100,000 or £1 million? I have no sense of the magnitude of what we are talking about here. Can the Minister flesh that out so that we can consider the regulations? Given that the overwhelming response to the consultation was a massive show of indifference, it is hard to get too worked up, but it would be helpful to understand.
4.39 pm
Jane Kennedy: I do not necessarily take the view that the lack of response to the consultation represents indifference, but more contentment and an acceptance that the measure is a sensible step.
Those were two useful contributions, containing questions that were worth asking. The hon. Member for Westbury (Dr. Murrison) asked about the Device Evaluation Service. If I answer his question in a particular way, it will answer a number of questions
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that have been asked. The Healthcare Industries Task Force considered the arm’s length body review, which was completed and which I inherited in my new portfolio. The taskforce included the private companies that work in partnership with the health service to produce devices that will move treatment on and improve patient experience and treatment.
The hon. Gentleman referred to the speed with which innovative ideas and new devices were taken up by NHS. The recommendations of the taskforce took into account the industry’s concerns and it clearly indicated that moving the Device Evaluation Service from its current home in the MHRA closer to the procurement organisation of the health service would enable the faster take-up of the devices. That has nothing to do with their licensing or regulation; it is about procurement and uptake. It fits in with the objective of the arm’s length body review, which is designed to streamline and reduce the number of bodies. We are merely moving the DES to a more appropriate body, and we have taken the opportunity of the review to do so.
The budget for the DES has recently been increased from £4.2 million to £6.4 million. The initial £2.2 million additional funding will ensure a healthy start for the new enhanced service to the NHS. DES’s customers are any organisations involved in the procurement and use of health care technology, devices or procedures. The hon. Gentleman gave some examples of customers; they include the NHS breast-screening programme, and PASA’s collaborative procurement hubs in the health service, which streamline the process of procurement.
The transfer of the DES to PASA was one of the key outputs of the Healthcare Industries Task Force. With industry, we focused on developing ways of increasing people’s access to innovative medical technologies and products, a move which was roundly endorsed, which is why the consultation has been so quiet. The enhanced service will inform procurement decisions and encourage and support the uptake of useful, safe, innovative products and procedures and by doing so develop a new DES. It will develop the good service that we already provide in order to integrate and strengthen what we call “horizon scanning”—in other words, to look at products that are coming down the track to the NHS. That will aid in the assessment of value, the effective performance of new and enhanced health care technologies, devices and related procedures and develop nationally accepted methodologies and tool kits for device evaluation that can be used locally.
One reason for taking DES to PASA is to allow it to work closer to the primary care trusts who do the commissioning and authorise the purchase through the hubs that I mentioned earlier. I firmly believe that the proposal is a sensible step to take.
On the blood and blood components issues raised by the hon. Member for Northavon (Steve Webb), it is not really about exporting or importing blood products. However, the market— if that is what one wants to call it—in blood products gets ever more detailed. The products now being produced are very
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specialised and there will be much more international exchange than there has been. I would not expect large amounts to be involved, but small amounts of specific blood products are necessarily transferred internationally. The European directive, which was considered by the House in the previous Parliament, builds on the existing good practice of the UK blood service and harmonises standards across all member states. It recognises that the UK set the standards and it raises standards elsewhere to those of the UK. Today, we are not debating the directive itself and its transposition into law but an amendment to the MHRA fund to enable us to do that.
I think that I have covered all the points raised. If not, I will read Hansard after the debate and pick up on anything that I may have missed. The order
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provides the final step in completing the transfer of the DES to PASA, and also marks a necessary step in implementing the EU blood directive. It enables the MHRA to discharge, within the terms of its trading fund, its new responsibilities to perform the functions of the competent authority under that directive. I trust that the Committee will agree to the order.
Question put and agreed to.
Resolved,
That the Committee has considered the draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2005.
The Committee rose at fourteen minutes to Five o’clock.
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