HL Deb 31 January 2002 vol 631 cc442-50

9.22 p.m.

Earl Howe rose to move, That an humble Address be presented to Her Majesty praying that the order, laid before the House on 12th December, be annulled (S.I. 2001/3968).

The noble Earl said: My Lords, I beg to move the Motion standing in my name on the Order Paper. In common with most if not all noble Lords who had the privilege of debating the Care Standards Act 2000 during its passage through your Lordships' House, I have been and remain now a firm supporter of the Government's proposals to strengthen the regulation and oversight of independent hospitals. In tabling my Motions for debate this evening, I do not seek in any way to criticise the primary purpose for which the statutory instruments listed on the Order Paper were drafted. My reason for laying these prayers is very specific. It is to voice a strong protest on behalf of a single category of establishment which these regulations will affect. I refer to clinics and beauty salons that operate a particular type of equipment designed to remove unwanted body hair.

There is a type of machine that removes body hair using a technology called intense pulsed light. Intense light is not the same thing as a laser. An IPL machine operates on a principle of administering light to the growing hair, thereby conducting heat to the hair follicle and destroying the cells responsible for the growth of new hair. The technique is painless, noninvasive and extremely safe. It is also, I understand, very effective. While the operator of an IPL system requires training, such training is simple and straightforward. Intense pulsed light hair removal systems were introduced on to the market some two or three years ago and the market for them has grown. There are currently around 1,000 locations around the country that use it, mainly leisure establishments such as hotels, spas and beauty salons.

Although hair removal using this technique is a cosmetic procedure, not a medical one, those establishments that offer it fall within the licensing and inspection regime applicable to full-blown private hospitals. A clinic offering IPL hair removal has no beds, no nurses. no doctors. Typically it is just a small room in which clients are treated with a machine little bigger than a hairdryer. The absurdity of equating such a facility with a private hospital has not, I think, been appreciated in the Department of Health. All the more absurd is it when one considers that other types of hair removal systems such as electrolysis, an invasive procedure, will not be affected by the regulations.

The way in which the IPL sector was brought within the scope of these regulations does not do much credit to the Department of Health. The first consultation paper relating to the National Care Standards Commission was published in July 1999 and was followed by a further document in December 1999 outlining the result of the consultation. At that stage there was no mention of extending healthcare regulations to the intense pulsed light technique. The Care Standards Bill was silent on the issue.

After the Care Standards Bill received Royal Assent in 2000, there was a further period of consultation with the industry on the proposed standards but there was still no consultation with the main intense light manufacturers or users. Thus in two years, and after several major consultation papers, there was no public mention of the intention to regulate intense light—none, that is, until the eleventh hour when in July 2001 the draft statutory instrument was issued. All of a sudden, establishments using intense light equipment were included within the scope of the regulations. The manufacturers, therefore, had no opportunity to discuss the merits or otherwise of these regulations as they might affect them. Only after the formal consultation process had ended did officials belatedly attempt to consult the sector. Several months ago the noble Lord, Lord Haskins, intervened at ministerial level, but no Minister has to date replied to this approach.

I do not lay Prayers lightly but I have done so in this case because it appears to be the only way of bringing the Minister's attention to a situation that should never remotely have been allowed to arise. I shall not be irresponsible over the order, and there is no question of my calling a Division on it. Nevertheless, I have three concerns which I should be grateful if the Minister would respond to, and of which I have given him prior notice.

The first relates to the need for transitional arrangements to ensure that establishments using intense light machines may continue to do so after the day on which these regulations commence. The commencement order provides for phasing-in arrangements whereby applications submitted prior to 1st April for registration under the Act will be treated as being in compliance with the regulations until the commission has processed the application and made a decision. However, crucially, that concession will not apply to applications submitted after 1st April.

The reason that is important is that in April the single largest trade fair takes place in which IPL machines are sold. The four weeks after 1st April, therefore, will see registration applications reach their peak for the year. If those individuals and businesses who purchase IPL machines at the April trade fair are obliged to wait for six, nine or even 12 months while the National Care Standards Commission gets through the backlog of applications for registering all private hospitals, then I really do not think that that is reasonable or equitable. It may even amount to an unfair restraint of trade. No small business is going to buy such a machine for the first time if it will be prevented from using it for several months. Again, had the sector been consulted at the appropriate time, it could have advised the department of the damaging effect that the regulations, as drafted, are likely to have on their business.

Therefore, I should like an assurance from the Minister that he will give very sympathetic consideration to extending the transitional arrangements so as to enable those who apply to register IPL machines after 1st April to operate them normally until such time as their applications are processed by the commission.

My second concern relates to dual registration. During our debates on the Care Standards Act we established that one of the benefits of having a National Care Standards Commission would be that private hospitals would no longer have to register twice—once with the local authority and once with the health authority. Unfortunately, the belated inclusion of leisure facilities within the Care Standards Act regulations looks set to create a new system of dual registration because many facilities within beauty salons and health clubs already have to be registered with the local authority and will continue to have to be so. Nowhere is that issue addressed in the statutory instrument. I should be grateful if the Minister would give sympathetic consideration to this problem which, again, might well not have arisen had there been proper consultation.

My third main concern relates to fees. There will be three registration fees for IPL establishments: £1,100 for the owner of the establishment where the machine is used; £300 for the registration of the day-to-day manager; and £750 for annual registration of the room in which the machine is located. This adds up to a regulatory bill in the first year of £2,150. Added to these explicit costs will be the implicit costs of complying with both the paperwork and the annual inspection process. It is perhaps one thing for a full-blown private hospital to carry costs of this size. For a small beauty salon providing an intense light machine, often as a marginal service, it will be a considerable and, in my view, disproportionate burden.

But the matter does not end there. The consultation document indicated that the National Care Standards Commission intends to move, in time, towards full cost recovery. This means that within perhaps five years the fees may have doubled from the levels that I have just read out. I am not aware of any clarification by the department or the commission as to whether this kind of uprating of fees will be carried through. There was no published response to this particular aspect of the consultation. Can the Minister give an assurance that the burden of the registration fees on smaller providers will be closely monitored? Can he say whether the NCSC does indeed intend to proceed to "full cost recovery", whatever that means in the context of these very small IPL establishments?

I end by reiterating what I said at the beginning of my remarks. In the context of intense light machines, these regulations have been particularly poorly thought out. Indeed, they seem to me, knowing what I do about the cosmetic treatment concerned—not, I hasten to say, from personal experience—wholly anomalous. Although these regulations will be brought into force as drafted, it is not too late for the Government to look again at the inclusion of intense light technology under the same heading as private hospitals. I hope that the Minister can give me an assurance that he will carry out such a review at an early opportunity. I beg to move.

Moved, That an humble Address be presented to Her Majesty praying that the order laid before the House on 12th December be annulled (SI. 2001/ 3968).—(Earl Howe.)

Lord Clement-Jones

My Lords, I congratulate the noble Earl, Lord Howe, on introducing this Prayer to annul. As the Minister will know, I wrote to him on 16th January in a tenor very similar to the points made by the noble Earl. Obviously this is the best way to get a ministerial assurance; I am still waiting for a reply to my letter. Meanwhile the clock ticks on on a negative instrument.

I shall not repeat the points made by the noble Earl. Suffice it to say that there are real issues here in terms of, first, the lack of consultation with the industry; secondly, the burden of regulation in terms of fees and costs; thirdly, the classification of these businesses as independent hospitals—it is a nonsense that they are so classified in view of the establishments that use these intense light machines—and, fourthly, the whole question of transitional arrangements.

One of the problems for the Minister in replying to the fourth point is that, effectively, the regulation that determines the transitional arrangements, as I understand it, falls under a different order—that is, the Care Standards Act 2000 (Commencement No. 9 ( England) and Transitional Savings and Provisions Order) 2001, the date of which has passed. If the Minister can say anything to mitigate that, the industry would be extremely grateful, despite the passing of the regulation.

Two further points were raised by my honourable friend Dr Evan Harris in the Commons debate on this subject, the Hansard for which is not available but the Minister probably has a note of these issues. First, under the regulations—Part III deals with the conduct of healthcare establishments—there appears to be no criterion in terms of inspection for inspectors to observe whether or not the EU Working Time Directive has been complied with. That is not yet in force, as I understand it, but it will be important. It will certainly be extremely important in the NHS, so it will have considerable importance in the independent healthcare sector as well.

Secondly, the Minister will have noticed some of the press coverage surrounding anaesthetists' fees. Because these are not paid for directly by independent hospitals, as I understand it, regulation 7(1)(b) will not cover anaesthetists' fees. The Minister is no doubt aware of the activities of the OFT in looking at possible cartels in terms of consultants' fees. That is very welcome, although I have mixed views about whether or not there should be a schedule of fees. Certainly that is a course adopted by some independent hospitals, but not by others.

I do not want to bowl the Minister too fast a ball. If he cares to write to me, I shall be happy to accept that. Those are the points I wish to make on the regulations.

Lord Hunt of Kings Heath

My Lords, I thank the noble Earl, Lord Howe, for allowing us to debate these important regulations and for his general support for the process of regulations and the work of the National Care Standards Commission. We heard about the work of the commission earlier this evening from the noble Baroness, Lady Howarth. We all have a great deal of confidence in the work that it undertakes.

Intense pulsed lights have the power of class 4 lasers, but are not technically lasers. Both types of machine are used to remove unwanted hair or thread veins and both have the same potential dangers if misused, including burns to the skin or eyes and scarring. They were not developed until after the Registered Homes Act 1984 was passed and the department was not originally aware of their existence. However, in 1996 medical practitioners, radiation experts and laser providers and manufacturers began to ask the department to get rid of the anomaly whereby only class 4 lasers were regulated.

Under the Registered Homes Act 1984, which operates until 31st March, health authorities have no powers to inspect or assess the quality of the treatment provided by medical practitioners of services provided. Inspections focus on the state of the premises and facilities and on staff qualifications and numbers. At present, the managers and owners of establishments are not held to account for the treatment provided in their establishments. They merely facilitate the provision of treatment by medical practitioners, to whom they grant practising privileges. It is the medical practitioner alone who contracts with the patient.

The new system brings a radical change, in that the managers and owners of the establishments will be held responsible for the quality of the treatment provided. They will also have to have in place policies and procedures for clinical audit.

In the USA, before an IPL or any new technology that is designed for application to the human body can be sold and used, the manufacturer is required to apply for it to be licensed. Thereafter, regulation is enforced through legislation by individual states rather than nationally. A common feature of US legislation is that the use of IPLs is restricted to medical practitioners. Those availing themselves of their services are referred to as patients rather than clients. It is interesting to reflect on US experience. The system proposed here would be applied nationally and therefore consistently, but we have already made one concession so that providers of IPL treatment and class 4 lasers for beauty purposes will not have to be medical practitioners, or have to work under the direction of medical practitioners, which, in the case of class 4 lasers, is currently required.

I take this opportunity to clarify that we are not seeking to regulate providers of intense pulsed light treatment on a par with private hospitals. Classifying them as independent hospitals is merely a device to bring them under the Care Standards Act 2000. For the purpose of regulation, the term "independent hospital" is as defined in that Act, in the same way as countless other terms have particular interpretations in particular Acts. They will be registered as independent hospitals, but they will not be regulated as hospitals. They will not be hospitals in any other sense of the word. Providers will not be able to advertise themselves as being hospitals, they will not have to incorporate the word "hospital" into the name of the establishment and they will not have to meet the acute hospital national minimum standards. They will have their own unique set of service-specific standards.

For example, independent hospitals are currently registered as nursing homes, because of the context of the 1984 Act. We have introduced new legislation because the 1984 Act and the way in which it is applied have not kept pace with developments in healthcare and modern policies on consumer protection, safety and rights.

The noble Earl, Lord Howe, paid particular attention to consultation. We received more correspondence about IPLs than any other independent healthcare issue. In November 2000 the department wished to approach the IPL industry concerning the proposal to bring it into regulation. However, some difficulty was experienced: precisely because IPLs were not regulated, there was a limited contact with the industry and, therefore, limited knowledge of who and where the manufacturers were to be found.

As one would expect, officials wrote to a number of trade associations representing those in the beauty industry, and to other organisations that might have connections with lasers or IPLs. The organisations that we approached included, the Hairdressing & Beauty Industry Authority, four other cosmetic or beauty-related organisations, as well as associations of electrolysists, dermatologists and ophthalmologists. Out of these we received only a handful of replies, saying that either they agreed with the proposal or that they would consult their members and respond to us. However, very few contacted the department with the views of their members.

When the formal consultation was carried out at the beginning of July 2001 we had a very good response; for example, from individuals including consultant physicists, health authority inspectors, laser protection advisers and laser service providers. Among the bodies that welcomed the proposals were laser and IPL manufacturers or distributors, the Hairdressing & Beauty Industry Authority and the Institute of Physics and Engineering in Medicine. The latter had set up a working group on the private use of lasers and intense light sources where these applied to the human body. The group is an independent, professional body and comprises experts in laser technology, medical physics, photobiology, imaging and radiation.

I was asked about the position concerning IPLs after 1st April as regards the question of pre registration. I can tell the House that the existing unregistered providers who must apply for registration by 31st March this year may continue to operate until finally registered. After 1st April, in common with providers in all other services under the 2000 Act, new providers cannot operate before registration. I am afraid that we cannot make an exception for one group when many others are in the same situation. However, as long as existing unregistered providers apply for registration by 31st March they may then continue to operate until finally registered.

I turn to the issue of the trade fair in April where it is claimed by one of the companies involved that the bulk of business selling or hiring out of intense pulsed light machines takes place. I understand the situation, but I have to say that we have received information that contradicts that view. We know of clinic owners who have had contact with a number of laser and light companies, including ESC Sharplan, which I understand has some connection with Aculight (one of the companies involved). They say that when they have hired machines from Sharplan, and other manufacturers, they have routinely been given a four-month or six-month moratorium on payment in which to build up a client base. That might be one way to approach this particular issue.

The noble Earl was quite right to raise the issue of dual registration. Under the London local authorities legislation of 1991 establishments for special treatment are required to be licensed by the local authority. Special treatment includes the use of any treatment using lights. In Section 4 of that legislation, premises registered as "nursing homes" under Part II of the Registered Homes Act 1984 are exempted from the requirement to be licensed by the local authority. When the Care Standards Act was passed, that part of Section 4 of the London local authorities legislation should have been amended to except premises registered under the Care Standards Act. However, due to an oversight, I regret that it was not excepted. Consequently, establishments using class 4 lasers and IPLs in London will be required to be registered with the NCSC, and licensed by their local authority. Obviously, the cost of licence fees varies through the capital, as does the methodology involved.

After consultation with manufacturers and providers, we agreed to waive the requirement for medical direction and to introduce a protocol drawn up by a medical practitioner. This means that providers will be required to register with both the NCSC and their local authority in London. I accept that that is an issue, and I can tell the noble Earl that we are considering options for amending the London local authority legislation.

As for fees, we understand that most intense pulsed light practitioners are new to registration. They will have to pay a registration fee of £.1,100 in April 2002, and then an annual fee of £750 on 1st April 2003. They will therefore have a full 12 months between paying their registration fee and the first annual fee.

We are introducing a robust regulatory system. One has to accept that there will he a thorough inspection for intense pulsed light practitioners, and that the cost of regulating them will therefore be significant. We proposed an annual fee of £1,000, but after the consultation exercise we reduced that to £750 in response to concerns. As I said, we are also allowing them a full 12 months, until 1st April 2003, before they have to pay their first annual fee. These fee levels still represent a subsidisation of the true cost of regulation.

Our policy is therefore to move towards full cost recovery for all regulated services subject to review after two years. I think that, having made some of the concessions that I have mentioned, we have tried to achieve a balance.

The noble Lord, Lord Clement-Jones, raised the issue of junior doctors. As I understand it, no junior doctors are practising in private hospitals and consultants with practising privileges are not employed there. The issue of hours worked therefore does not arise in that context. Junior doctors are employed and work longer hours only in NHS hospitals. I should also be grateful if the noble Lord would allow me to write to him on the important issue of fees for anaesthetists which he raised.

Earl Howe

My Lords, I am grateful to the Minister for his reply. I shall very briefly cover some of the points he made.

The Minister said that IPL machines run the risk of inflicting the same damage to the skin as lasers, but that is not my understanding. I have been advised very firmly that the risks from the use of a laser are very much greater and that the risk of an accident with an IPL machine is very slim indeed, providing that the operator is suitably trained.

The Minister mentioned the experience of the United States. I know that the industry was grateful that the department was able to make the concession that a medical practitioner need not supervise the operation of these machines. However, the fact that that concession has been made makes me wonder why the Minister drew the United States analogy at all, as officials were clearly satisfied that no medical expertise was necessary in operating the machines.

The Minister rightly said that, under the 1984 legislation, acute hospitals have been classified as nursing homes. I have personally viewed that as a quirk of history more than anything else. I am not sure whether it is a sufficiently good reason to classify IPL establishments as hospitals ab initio under these regulations, but I accept that it has been done for reasons of expediency and convenience.

I am a little surprised that, as I understood the Minister to be saying, because it did not know who to approach in the consultation exercise the department rather ran out of steam in trying to contact the companies involved. I should not have thought that the department was absolved of the need to conduct thorough and rigorous consultation when proposing to regulate, and I wonder what sort of precedent that sets for other sectors.

Lord Hunt of Kings Heath

My Lords, I am grateful to the noble Earl for allowing me to intervene, which I am not sure I am allowed to do when we are discussing regulations. What I was trying to say is that for the department this was very much a new territory and a new field. Of course, the department made every effort to consult the organisations that it considered represented the trade. Inevitably, in that situation some organisations may have been missed out. I did not seek to say that the department had not taken the matter seriously.

Earl Howe

My Lords, I am grateful for those comments. I understand the point the Minister has made. He suggested that someone who wished to hire or operate a machine for the first time after 1st April might find a way through one of the problems that I raised by means of a rent free period. I am not sure how much that would help someone who wanted to operate a machine for the first time after 1st April because, as I understand it, such operation would be illegal unless the application for the licence had been submitted prior to 1st April. Therefore, I am not quite sure what is—

Lord Hunt of Kings Heath

My Lords, what I was suggesting was that in the industry it is quite normal for a newcomer in the field to be given a moratorium before he or she has to start paying for equipment. That provides one way through the difficulty of a trade fair that is held in April. Given the financial arrangements I have mentioned, newcomers can still enter into agreements and apply for the relevant licence.

Earl Howe

My Lords, I, and, no doubt, the sector too, will take careful note of that suggestion. No doubt it will be followed through. I am grateful for the fact that the Minister and the department have given thought to the matter.

I am also grateful for the Minister's reply on the issue of dual registration. It is helpful that the department is looking at the issue of amending the London local authorities legislation. I also thank the Minister for clarifying, as far as he is able. the issue of full cost recovery and the department's intentions in that regard.

I have no doubt that the industry is prepared to accept the case for regulation in this context but I still feel that the lack of consultation initially—although the department has since entered into useful discussions with the sector—has created a system that is unclear and, in my view, anomalous. I hope that, despite the fact that these regulations will be put in place, the department will not close its mind to looking at these issues afresh. With that I beg leave to withdraw the Motion.

Motion, by leave, withdrawn.