Draft Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003

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Dr. Evan Harris (Oxford, West and Abingdon): I welcome you to the Chair, Mr. Conway. Generally speaking, it seems to be sensible to merge the two organisations—at least it is not reckless, which is an allegation that could be levelled against some of the reorganisations that have taken place in health care over the past few years. I was particularly pleased to hear that the chairman of the new body will be Professor Breckenridge, if only because that will give me an opportunity to have more contact with him. He was my boss in my house job in medicine in Liverpool and he certainly made an impression on me, although I fear that I did not make an impression on him, because I was doing a lot of political work even then. He is a remarkable man and has achieved a great deal of recognition for his work on the Committee on Safety of Medicines. I wish him well in his new job.

Clearly, the biggest change will be for the MDA, because the MCA will be carrying on within the new body much as it did before. One of the key questions will be whether the MDA will be able to meet its new challenges better in the new body, in which it will be sharing some of its expertise with people from the MCA.

As the Minister said, some of the issues relate to joint technologies. He alluded to drug-eluting stents,

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which is an exciting technology whereby a medical device is inserted into the coronary arteries and over time releases drugs that keep them open, combating the problems of re-stenosis and the need for re-operation. It is an important technology, which is more expensive up front but better in the long run. There is a great deal of concern in the health service about whether there are the funds up front to ensure that that sort of technology is rolled out as quickly as possible. Those fears would be compounded if there were to be hold-ups because of the need for technology to go down regulatory pathways controlled by both the MCA and the MDA. I hope that the Minister will give an undertaking that one of the outcomes of a successful merger will be that the time taken for the important and necessary regulatory process for drugs and medical devices will not grow longer and that in the case of combination technologies, as part of the aim of evaluation, someone will monitor the average time taken for approval following the submission of an appropriate device.

Another challenge for the MDA is the issue of patient safety and medical error—the Government should be congratulated on giving a new focus to that. Will the Minister tell us how he proposes the new body to relate formally, as well as informally, to the National Patient Safety Agency? We know that a huge amount of mortality and morbidity arises from errors. Tragically, the use of medical devices involves some errors. I fear that some of those errors are unavoidable because they are system errors, but some are design faults. There must be a more powerful way for the regulatory body—in this case, the MDA—to learn from the experience of adverse incidents gathered by the National Patient Safety Agency. That would add value to the development of medical devices and flag up improvements and concerns relating to new technology.

I draw the Minister's attention to some of the points made during the consultation. I am happy to endorse, and not repeat, the questions about charging asked by the hon. Member for Epsom and Ewell (Chris Grayling) on behalf of the Conservatives. It is worth adding to the concerns raised about the possible grey area surrounding potential new charging. I refer the Minister to point 3 of appendix 2 of the summary of the points made during the consultation, which states:

    ''Increased funding for the MDA's contracted Evaluation Centres should be made available to individual evaluation centres according to workload and productivity, and further funding could be sought directly from the manufacturers.''

The response continues:

    ''There are no plans at present to seek direct funding from manufacturers of devices for evaluations.''

Normally, when the Government say that “there are no plans” I expect something akin to tuition fees or top-up fees to follow shortly afterwards, so that is no reassurance, particularly when the words “at present” are used, which seems to be an additional qualification. The response continues:

    ''However, under the Trading Fund, it would be possible to expand the range of services offered by the evaluation service and the range of customers, possibly generating increased income.''

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That implies that the Minister is seeking to use the trading fund as a way of generating increased income by increasing the range of customers and services from a service that is already able to charge. I understand that, but will the Minister confirm that one of the benefits of a trading fund is that the business side of the agency will be given a new lease of life? I am not sure whether that will be reassuring, but it should be made clearer.

Point 6 of appendix 2 stated that the respondents

    ''want an assurance that implementation of the new agency will not result in an increase in fees charged to Notified Bodies for medical devices work.''

The Government said:

    ''The Trading Fund Order is not in itself a power to charge or to increase charges for any activity. Charges to Notified Bodies will be based, as now, on the costs of providing services to them.''

Again—I echo the points made by the Conservative spokesman—the intentions should be made clear as soon as possible. I hope that the merger of the two organisations is not an isolated incident, but part of a coherent strategy to improve regulation of medicines and medical devices in this country, and to improve public health. It is only fair to say that there have been widespread reports that public health has taken a back seat under this Government because of increased structural change and—as the Government sees it—a need to make targets and pledges regarding acute care, rather than some of the preventative work. I hope that that is not the be-all and end-all of new Government thinking in the area of public health and improved regulation.

My final point is to ask whether the MDA is to take a leaf out of the book of the Medicines Control Agency and Committee on Safety of Medicines. The current system of yellow cards is restricted to clinicians. The Government have brought in a system whereby patients will be able, through a system using NHS Direct, to report adverse events relating to medicine. I am wondering whether the Government have something similar in mind regarding an analogous mechanism for medicines devices.

The yellow card system runs through the CSM, which mainly deals with pharmaceuticals rather than devices. Many patients have devices in their homes at the moment, not simply in a clinical or hospital setting. It would be reassuring if the Government would confirm whether they have any plans to ensure that the power of individual consumers and patients will be increased to draw the attention of national authorities, rather than simply manufacturers and suppliers, to errors or problems with devices. We are in agreement with the narrow terms of the order.

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Sir Teddy Taylor (Rochford and Southend, East): Some people seem to be quite happy with the order. I do not want to go on unduly, but I was quite horrified when I read it. That is probably because I feel that the Government throughout all their activities are becoming far more right wing in their attitudes than Mrs. Thatcher would ever have dreamed.

In my constituency, we are experiencing the privatisation of the Defence Evaluation and

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Research Agency. There is also the privatisation of air traffic control, which we would not have thought about. We now have the proposal that two departments in the Department of Health are to be made into a trading fund. The impression that I got from the Minister was that it would be so successful that we might be encouraged to buy shares in it.

I want to ask three questions that I think are relevant. First, how will it be possible to control the size of the new organisation? The Financial Services Authority is a perfect example of a privatised organisation, in that it is wildly out of control. It seems to have the most expensive offices in the world and is constantly expanding its staff.

Secondly, how will the Minister control the size of the organisation under the new legislation? Is the intention basically to transfer responsibility for funding from the health service to the industry, as happened with the FSA? There are plenty of clues. The order says, clearly and precisely, that

    ''the revenue of the fund would consist principally of receipts in respect of goods or services'',

so receipts will not come from Government funding. We can see that the Government will not have control over the agency's work because the new organisation will be responsible for all the legislation coming from the European Union, so how will it be controlled? Is it the intention, now or in future, simply to pass over responsibility for raising funds from the Government to the service? I know that it can be argued that only one of the two organisations has the ability to make charges. The Medical Devices Agency has no such power.

My third question is how will the charges be controlled, because the legislation refers to charges for the sale of goods and other items, as well as for providing services. The legislation introduces a significant change, and I find it strange that such fundamental issues have slipped through without anyone apparently noticing. No one seems to question them, but we should. I know that the Minister is an honourable person, so will he say how the size of the organisation will be controlled and whether he will be able to prevent it from becoming enormous? Will the funding go to the industry, as I think that it inevitably will, and how will charges be controlled? Although, as a Conservative, I am in favour of private enterprise, I fear that this is not the good side of private enterprise, because it relates to legislation and funding that we will not control. I am scared that the agency will end up as a horrendous burden on the Financial Services Agency, over which the Government have no control whatever. It could be a very bad thing.

I am sorry to raise these points when, obviously, I am in a minority of one in the Committee, but they should be put on record because they are genuine and the Minister should consider them. I know from experience that the Minister takes life seriously and I know that we can depend on him to tell the truth, so I should be grateful for his advice.

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