HC Deb 10 April 1989 vol 150 cc707-13 12.33 am
The Parliamentary Under-Secretary of State for Health (Mr. Roger Freeman)

I beg to move, That the draft Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989, which was laid before this House on 20th March, be approved. The order is made under section 102 of the Finance (No. 2) Act 1987. Its purpose is to provide the legal basis for making regulations to enable the full costs of the licensing agency to be charged out to the industry through licence and other fees.

To that end the order lists in schedule 1 the functions of Ministers to be taken into account in fixing fees. The schedule refers to the relevant parts of the Medicines Act 1968 that set out the powers and duties in question. Broadly speaking, they cover the licensing functions, including pre-licensing clinical trials, and also post-marketing surveillance, inspection, enforcement, the regulation of advertising and labelling, and the classification of medicines—that is, whether a drug is available only on prescription.

Schedule 2 to the order sets out the matters which can be taken into account in setting fees. The objective is to secure that all the costs of discharging the functions in schedule I can be taken into account in fixing fees. This includes the power to take account of deficits in fee income against expenditure so that a deficit in one year can be recouped in a subsequent year. It is intended that Ministers should also be able to take into account surpluses, so that any excess income can be offset by lower fee income in a subsequent period.

The fees regulations—the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Regulations 1989—were laid before the House on 10 March 1989, and are not the subject of debate tonight. They set out the definitions of the various types of licence applications and inspections and the levels of fees which are prescribed. The new fee structure is considerably more complex than the one it replaces. The new range of fees is very wide, from £40,000 for a major new drug application through to £50 for administrative modifications to licences involving no professional assessment. Some new fees have been introduced and some existing fees have been split so as to reflect the different workloads involved in assessing the different types of application.

One major change in the new structure is the abolition of the requirement on companies to pay an annual fee related to turnover. The annual fees have in recent years amounted to about 85 per cent. of the total fee income. We argue that their abolition is necessary because of the Government's view that self-funding public bodies should charge fees that broadly reflect the costs of the services or other activities for which the fee is charged. In the case of annual fees related to turnover, any correlation is regarded as insufficient in a timely sense. That is because the fees are paid over a number of years.

Abolition of the annual fees necessarily means that there has to be a very considerable increase in the application fees to make up the shortfall as well as provide the extra resources necessary to cover the whole rather than two thirds of the costs of the agency. The fee levels proposed are intended also to strengthen the staffing of the agency to enable it better to tackle the heavy workload, including the very considerable backlog in the handling of product licence applications that has built up. The total costs of the agency in 1989–90 are expected to be about £11.5 million.

The new fees set out in the regulations have been the subject of statutory consultations with the industry. The increases in fees proposed are not welcome to some parts of the industry and particularly to the smaller firms. I recognise fully their concerns and understand them. However, I ask them to remember that the increase in application fees is partly the result of the abolition of the annual turnover fees. Looking to the longer term, I believe that the decision that the funding of medicines control should be met by the industry through fees will prove to be strategically the right choice. It provides a basis on which this work can be resourced separately from the rest of the work of the Department.

Mr. Roger Gale (Thanet, North)

Can my hon. Friend give the House an assurance that the increase in fees will be met by a commensurate reduction in the waiting time for the processing of applications?

Mr. Freeman

I cannot give that assurance in as direct a form as my hon. Friend would want, simply because there was a substantial increase in the number of applications before the end of the last financial year by companies seeking to take advantage of the lower fees that then prevailed. It will take some time to work through that case load. However, because those applications were being brought forward from this financial year, we anticipate that the level of applications this year will be slightly lower than anticipated, so we shall clear the backlog fast.

I can assure my hon. Friend that the principle of increasing fees to cover the costs involved and increasing fees to cover the costs of a 10 per cent. increase in staff in the Medicines Control Agency should eat into the backlog, about which I am as concerned as he is.

Achieving real improvements in the time taken to deal with licence applications will represent a good investment for the industry. While it inevitably has to put the money up front before better performance can be attained, the new arrangements certainly hold out better prospects than hitherto for delivering improvements. I commend the order to the House.

12.39 am
Ms. Harriet Harman (Peckham)

I should like to ask the Minister six questions and the first is about the openness in practice. Obviously we welcome the fact that the scale of payments will be made public. Will the accounts of such payments be made available every year in sufficient detail to allow public and parliamentary scrutiny? That would give us the assurance that the new scheme is effective and that the funding is sufficient to allow the proper implementation of the appropriate regulations.

My second question is about what will happen in 1992. If payments fall drastically in that year, following the introduction of unified EEC drug licensing arrangements, and payments go to Brussels rather than to the Medicines Control Agency, will money still be directed to the agency so that it can carry out the essential policing duties that the Minister has mentioned?

Thirdly, it is clearly the intention that the phamaceutical industry will pay for the order and that the changes will save public money. How much does the Minister anticipate will be saved and to what ends will the savings be put? Will they be used for research or will they simply drift back to the Treasury?

Fourthly, it has been said that, because the regulatory agency will be directly financed by the pharmaceutical industry, he who pays the piper will be able to call the tune. Is the Minister satisfied that the agency will be sufficiently independent even though it will be entirely financed by the industry that it is regulating?

Fifthly, will the industry be able to set against profits the payments that it makes to the agency for the purposes of the industry's returns under the pharmaceutical price regulations scheme? The Government are asking the industry to give money to the agency and if they then subsidise the industry for that payment through the mechanism of the pharmaceutical price regulation scheme, I am not sure where that leaves us in terms of saving public money.

My sixth question is about the pharmaceutical price regulation scheme and the savings that the Government intend to make under the indicative drugs budget. As the House will know, there has been much concern among GPs about the savings that the Government intend to make in the indicative drugs budget. Will not whatever marginal savings are made by GPs by paring at the edges of their drugs budget be clawed back by the drug companies through the pharmaceutical price regulation scheme and will not the companies be able to show that their guaranteed level of profit has not been met? Will the Minister say how much he expects to save in the indicative drugs budget? Will there be a net saving or will the saving be clawed back under the pharmaceutical price regulation scheme?

12.43 am
Mr. Peter Rost (Erewash)

I speak on behalf of the manufacturers of herbal medicines represented by the Natural Medicines Group to which I am a consultant. I also speak as joint chairman of the parliamentary group for alternative and complementary medicine. My hon. Friend the Member for Stafford (Mr. Cash) apologises for not being present for the debate. He is in Europe on parliamentary business and has asked me to say that he supports what I shall say.

The manufacturers of herbal medicines are mostly small companies. They each have many thousands of licensed products which they bring to market, but most of them have a modest turnover. Even the largest herbal manufacturer in the United Kingdom, Weleda (UK) Ltd., employs about 200 people even though it has been growing very fast. Again I declare an interest because that company is in my constituency. Nevertheless, it markets some 5,000 different medical products. It says that the proposed fees are intolerable, and unfair to the smaller manufacturers.

The regulations, as proposed, are not opposed by any responsible manufacturer of herbal products. Such manufacturers support regulation on safety and all other grounds: that is not at stake. They say, however, that the basis of the fixing of fees must be fairer than is at present proposed. One manufacturer says that MLX 175—the proposed scale of fees—represents an increase of between five and eight times the present fee. That is completely unacceptable.

Let me quote from a desperate letter sent by Potter's (Herbal Supplies) Ltd. of Wigan to my hon. Friend the Minister, dated 31 March. It is not the first letter that that company has sent to him. your Department has placed before Parliament two vital documents, S.I. 418 and Fees and Charges, both of which will undoubtedly have unprecedented and detrimental effects on smaller pharmaceutical firms—a rise in fees of between five and eight times those paid today proposed in MLX 175 will destroy small businesses … It would seem then that as a company that has made safe herbal medicines for over 176 years, the most serious threat to our existence comes from the Department of Health. The effect of these fees on top of the hugely exaggerated requirements of review to new E.C. standards will result in job losses and lack of competitiveness —leaving the U.K. market place for 'green' natural medicines to our European partners. We hope that as Minister responsible, you will make time to understand our problems by seeing members of our trade organisations before enacting these statutory instruments. I expressed concern to my hon. Friend on 25 February. He replied most courteously, confirming that a joint consultative group had been set up to administer the proposals. The members of the manufacturing group of the Natural Medicines Group, however, say that they have not been consulted, although the Minister has confirmed that their pleas have been taken into account—or so we are told. If "taking their pleas into account" means imposing increased fees of between five and eight times their existing fees, that is a form of consultation that they do not regard as entirely satisfactory, and I think that the House will agree with them.

The chairman of the largest manufacturer of herbal products in my constituency, Weleda, also wrote to my hon. Friend, on 30 March. The letter reads: Whilst I note that in your letter you state that 'the Agency has no wish to close down small companies', I am gravely concerned that the implementation of Statutory Instrument No. 418 will indeed have that effect on Weleda (UK) Ltd. This is because we, as a small company, will be required to pay a greatly increased level of fees for the specialised products we manufacture, which do not have large turnovers. Closure of Weleda (UK) Ltd. would not only mean the loss of over 100 jobs in a area which has suffered high unemployment, but also, because Weleda is the sole manufacturer in the U.K. of anthroposophical medicines, it would mean that there would no longer be any source of supply of these medicines for doctors, hospitals, clinics, pharmacies and the general public. I therefore write to ask for your assurance that the regulations as laid down in Statutory Instrument No. 418 are not implemented until there has been further consultation with small, specialised pharmaceutical manufacturing companies such as Weleda (UK) Ltd. My hon. Friend the Minister has yet to reply to that letter. That is understandable—it is dated 30 March.

The proposed structure of fees is unacceptably unfair. We hope that the quango that has been set up to administer the fees will be properly regulated by my hon. Friend the Minister. I was not re-elected to the House to support a radical Government, whose policies have, on the whole, been aimed at reducing red tape and encouraging enterprise and small business, to find now that we are moving in a reverse direction with these smaller entrepreneurial companies. They appear to be setting up a bureaucratic structure, which perhaps my hon. Friend has not had the time to investigate fully to assure himself that we are doing this the right way. I urge him to have another look at this to make sure that there is not a better way to organise this that would be fairer to the small manufacturers. They should be consulted and I hope that my hon. Friend will allow me to help with those consultations.

It is easy enough for the larger pharmaceutical groups to face these fees. Proportionately, the fees are much smaller for them, so they are quite happy. No doubt they were consulted. They have huge resources, huge profits, far bigger sales and fewer products. The scale of fees is not being based on turnover, as we were originally assured that they would be, so the larger pharmaceutical groups will come out better off than they were. Smaller manufacturers —I am speaking only of the herbal manufacturers, as I do not know about the others—are coming out far worse.

I have a final quote from the Natural Medicines Group, which represents the herbal manufacturers. This letter asks me to make representations on the group's behalf. It says: we need to modify this S.I., failure to do so will cause more harm to the herbal industry than almost any other requirement so far. It is of course even more dramatic because many small companies now being asked to increase their payments have also had their most expensive last couple of years, trying to satisfy the unrealistic requirements of review. As you know, the Natural Medicines Group and its members are dedicated to a sensible licence structure and the public protection that this gives. The result of this 'last straw' in increased fees will result in many products being taken out of licensing and what then for consumer protection?!! I urge my hon. Friend to allow further time for consultation, particularly on the way that the fees are to be implemented and their allocations, so that we can devise a fairer system that will allow the smaller manufacturers of pharmaceutical products—again I speak only about those I know—to survive without being so unfairly penalised.

12.53 am
Mr. Ronnie Fearn (Southport)

The order relates to the Fixing of Fees Relating the Medicinal Products for Human Uses". Following the questions asked by the hon. Member for Peckham (Ms. Harman), I have several questions. What human reaction has there been from manufacturers and from the Pharmaceutical Society of Great Britain? It seems that this is a cost-efficiency exercise, which shows that fees have increased greatly above the rate of inflation. How can that be justified?

I realise that there was some sort of ploy in producing first a licence fee for a new product of £50,000, which was then reduced to £40,000. Was there a reason for taking that course, which was a doubling of the present rate? Surely that is inflationary and something that will add to the drugs budget of the National Health Service.

Perhaps the Minister will explain what is meant by a "variation of licence", which will cost much more than hitherto. I believe that he talked of £50. Will the alteration of a label be classed as a variation? What is meant by a "complex variation licence", which will now cost £1,250? If a product's colour is changed, is that classed as a complex variation? The parent Act and the order are far from clear on these matters and perhaps there should be clarification now.

Is the order not a restraint on innovation? Will a producer stop marketing or not bother to market a product which has only a relatively small sale? I shall be grateful if the Minister will give assurances to meet the issues which I have raised.

Finally, can the Minister not envisage that in the end the losers must again be consumers, to whom the increased licence fee costs will undoubtedly be passed by the manufacturers?

12.56 am
Mr. Freeman

This has been a brief but well-informed debate. The hon. Member for Peckham (Ms. Harman) asked me six questions and I shall try to answer them as briefly as I can. The hon. Lady asked whether reports and accounts would be published. The answer is that they will be published annually. They will cover the fees, costs and performance of the Medicines Control Agency.

The hon. Lady asked what will happen in 1992. Additional responsibilities have been placed on the licensing authority through our membership of the European Community. Under Community rules, there is now provision for companies to apply for product licences under the so-called multi-state procedure. In essence, it requires the member states of the Community to reach a common view on licence applications, though, as yet, any such consensus is not binding on member states which remain sovereign in licensing matters. Participation in European Community work is a growing aspect of the work of the licensing authority and will continue to be so, especially as 1992 approaches. The EEC Commission has not yet published its proposals for the completion of internal markets and medicinal products. Proposals could involve national authorities continuing some licensing activities, and these would continue to be financed by fees. If the EEC proposes taking over licensing on a supranational basis, the Commission will have to include some method of financing. Possibly companies would have to pay fees to new supranational agencies for EEC licences as well as some payment to national authorities.

The hon. Member for Peckham asked me about savings being ploughed back. Income in the past financial year went to the Treasury, and the Department of Health bore on its own votes the expenses of the licensing authority. In this financial year the revenue will come to the Department of Health and offset the expenses of the agency. We expect these sums broadly to match each other. As the fees being charged will be greater than hitherto, because we are increasing the charges to reflect more accurately the costs involved, additional fees will be raised from the pharmaceutical industry. These will amount to about £5 million per annum. This sum will go back into the NHS and improve services for patients and, more broadly, for all those who are provided with some form of service by the NHS.

The hon. Member for Peckham asked me whether the piper would call the tune. The new agency, whose new director—Dr. Keith Jones—was appointed today, will be answerable ultimately to Ministers in the Department of Health and in the Ministry of Agriculture, Fisheries and Food. It is Ministers who determine levels of fees and control the agency.

The hon. Lady asked me whether the licence payments could be set against the profits for pharmaceutical price regulation scheme purposes. The answer is yes; it is a perfectly appropriate revenue expense.

The hon. Lady also asked me about indicative drug budgets. The purpose of our White Paper proposal for indicative drug budgets, which will apply to all general practitioners, is to bring downward pressure to bear on prescribing. It is undoubtedly true that some doctors overprescribe, measured simply against the average rates of prescription for patients. I cannot give the hon. Lady an estimate because we have made none. We aim to eliminate wasteful prescribing; the objective is not to save a specific sum of money.

I appreciate the role that my hon. Friend the Member for Erewash (Mr. Rost) plays in the Natural Medicines Group in his constituency. He raised points about consultation. The order that we are debating is different from the one that sets the fees, and my hon. Friend will have noted that that order was laid before Parliament on 10 March. In December, the Department of Health wrote to every licence holder and we received a substantial number of representations. The fees are being set for one year only and I give my hon. Friend the assurance that we will take into account the experience in the first year. I am not sure that I agree with his estimate of the fees being some five to eight times more than would have applied under the old regime. We are abolishing the annual fee related to turnover and collapsing that fee into the initial up-front fee. In looking at an increase in fees, one must compare apples with apples. There is certainly not a five to eight times increase. There is a joint consultative group which will take representations into account.

I listened to my hon. Friend the Member for Erewash with great interest and care. I am prepared at a time convenient to him to meet him and representatives of the Natural Medicines Group to take into account their concerns and fears. I shall get in touch promptly with my hon. Friend to arrange such a meeting, which I hope will be timely.

The hon. Member for Southport (Mr. Fearn) asked me about representations received from the industry. We have received 78 replies to our letters which were sent out last December, making 121 apparently representative points. We took them into account in setting the fees laid down in the draft order.

The hon. Gentleman asked me about the increases in the rates. Last year and in previous years we were charging or recovering two thirds of the costs of the licensing agency. We now propose to increase that to 100 per cent. and to include in the costs to be recovered a much broader category of costs. We think that that is economic. We shall provide also for recovery of an increase in staff of about 10 per cent. to deal with more applications. The hon. Gentleman asked me a number of other detailed points. I shall read them tomorrow in the Official Report and write to him.

I commend the order to the House.

Question put and agreed to.

Resolved, That the draft Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989, which was laid before this House on 20th March, be approved.