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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 or 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

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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

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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 be a thorough inspection for intense pulsed light practitioners, and that the cost

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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.


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