Select Committee on Science and Technology Sixth Report


CHAPTER 5: REGULATION

Regulatory Options

Voluntary Self-Regulation

5.16 The regulatory information pack produced by Budd and Mills outlined the features of a good voluntary self-regulatory body. These are also set out in Box 5.

5.17 There was general consensus among our witnesses that a good voluntary regulatory structure is needed for each CAM therapy before statutory regulation would be further considered. However, voluntary self-regulation, when administered by a single, professional body, is often thought to be enough to protect the patients and organise the practitioners of some therapies. We have heard a substantial amount of evidence suggesting that, in many circumstances, voluntary self-regulation may, when administered by a single professional body, be as effective as statutory regulation. Mr Michael McIntyre, speaking as a trustee of FIM, in response to a question, observed: "I think your point about it not being absolutely necessary to have statutory state regulation for risk of harm to be reduced, or to be monitored, is a good one. Provided the profession has all the self-regulatory mechanisms in place, there is no reason why it should do harm" (QQ 104 & 105).


Box 5
  
Features of an Effective Voluntary Self-Regulatory Body
  
An effective voluntary self-regulating professional body:
  
—  maintains a register of individual members or member organisations;
  
—  sets educational standards and runs an accreditation system for training establishments;
  
—  maintains professional competence among its members with an adequate programme of Continuing Professional Development;
  
—  provides codes of conduct, ethics and practice;
  
—  has in place a complaints mechanism for members of the public;
  
—  has in place a disciplinary procedure that is accessible to the public;
  
—  requires members to have adequate professional indemnity insurance;
  
—  has the capacity to represent the whole profession;
  
—  includes external representation on executive councils to represent patients or clients and the wider public interest.
  
Source: Budd, S. & Mills, S. (2000) (Op.cit.).


5.18 Some of the evidence we have received has made the point that, on the other hand, statutory regulation does offer greater power of control than voluntary regulation. Mr Michael McIntyre qualified his praise of good voluntary regulation with the point that "…there are certain benefits accruing out of statutory self-regulation for some professions which would not come otherwise." These would include, for example, prescription of certain restricted herbs and protection of title (QQ 104 & 105). Protection of title is particularly important, as it ensures that practitioners who have been struck off a register for misconduct cannot continue to practise under the title of a particular therapy.

5.19 Ms Julie Stone has written and lectured extensively on the subject of the regulation of CAM therapies. She provided evidence against the need for further statutory regulation of any CAM therapy. She suggested that statutory regulation was not needed to minimise risk to the public: "Whilst such risks as do exist are a matter of concern, the therapies which are most likely to give rise to harm are already the most effectively regulated, either by statute (in the case of osteopathy and chiropractic) or by effective voluntary self-regulation mechanisms (in the cases of acupuncture, homeopathy and herbalism). The only reason for expecting the statutory regulation of herbalists is because of the anomalies in the Medicines Act 1968 which currently permit unregulated practitioners to supply the public with potentially harmful medicinal products" (PP 286 & 287).

5.20 Ms Stone also argued that many of the risks of CAM are not inherent, but only exist if practitioners are not properly trained, and that a good voluntary self-regulatory structure could ensure practitioners were properly trained: "It is also important to separate the risks which are inherent in the therapy from risks which are far more likely to materialise if the practitioners are insufficiently trained…ensuring that practitioners are properly trained is certainly one aspect of effective regulation. The vital question is whether statutory regulation is the only way in which high standards can be assured. My opinion is that it is not" (P 287). She went on to cite the work of the British Acupuncture Accreditation Board as an example of the high standards which can be achieved within a voluntary self- regulatory context, adding that public awareness of voluntary regulatory bodies was important in order to marginalise practitioners outside such schemes (P 287).

5.21 Where there is no lead professional body, and where the various associations representing the therapy are disparate in the views that they hold regarding educational and training standards, there is a problem. We have, for example, been disturbed to read in evidence from the British Complementary Medicine Association (p 145) that some organisations are offering home study training courses which, on the basis of advertising material, seem seriously inadequate. In a situation where a therapy is represented by various disparate professional bodies it is very hard for the public to know where to look to find a 'competent' therapist. Therefore the voluntary regulatory system might be inadequate. Ms Julie Stone acknowledged this but suggested there would be less merit in forcing statutory regulation on such therapies than there would be in aiding the development of a better voluntary regulatory structure: "I would support any moves which encourage the development of a single professional register for each therapy, although I would challenge whether this should imply a move towards statutory regulation for therapies where the risk of harm to the public is less acute. There are various ways in which the Government could support such initiatives, including introducing education and training grants and/or fees for those studying on an accredited professional course (as is the case in medicine and nursing)" (P 287).

5.22 Ms Julie Stone concluded her evidence by saying: "The current professionalisation taking place within CAM is to be encouraged. Effective voluntary regulation and the existence of single professional registers can provide many of the safeguards of statutory regulation. Voluntary self-regulation is less expensive to administer and for that reason alone carries the support of many practitioners. Since incidence of serious harm appears to be low, and is equally capable of arising in a statutory context, there would seem to be no justification at the present time for introducing mandatory licensing or statutory regulation for all practitioners. Nonetheless, there may be an argument for requiring, as a minimum safety precaution, that all practitioners carry professional indemnity insurance, so that a patient who sues a practitioner can seek damages through the courts" (P 287).

5.23 For the therapies in our Groups 2 and 3 we are in agreement with Julie Stone's argument. A good voluntary regulatory structure is needed before a profession can seek statutory regulatory status. None of the therapies in Groups 2 and 3 has yet united under one professional body, and so statutory regulation is not a viable option for them at the present time. Indeed, for the disciplines we have listed in Group 3, such a prospect seems to us remote. For therapies in Group 2 the inherent risks of the therapies are minimal, and most are used as a complement to conventional medicine and not as an alternative, but to ensure that the public are protected from rogue practitioners, and have clear reliable information on these therapies, a good voluntary regulatory structure would be of benefit. Therefore, we recommend that practitioners of each of the therapies in Group 2 should organise themselves under a single professional body for each therapy. These bodies should be well-promoted so that the public who access these therapies are aware of them. Each should comply with core professional principles, and relevant information about each body should be made known to medical practitioners and other healthcare professionals. Patients could then have a single, reliable point of reference for standards, and would be protected against the risk of poorly-trained practitioners and have redress for poor service.

Statutory Regulation

5.24 Statutory regulation has the same aims and functions as good quality voluntary regulation; the desirable features of statutory regulation are therefore very similar to those achieved under voluntary self-regulation. The difference is that statutory regulation has the force of the law to ensure that its aims are met.

5.25 There are three routes to achieving statutory regulation. The first is for a profession or therapy to pursue its own Act of Parliament which establishes a statutory regulating body. The second and third are to pursue statutory regulation through the provisions of the Health Act 1999, which provides two separate options for achieving statutory regulation. Option one allows new regulatory bodies to be set up by order, subject to affirmative resolution in both Houses of Parliament. Option two allows professions to take advantage of the new Health Professions Council which will replace the Council for Professions Supplementary to Medicine. The Health Act allows new professions to join the previously closed group of professions within the Council. (These routes are reviewed below).

5.26 There are several advantages of statutory regulation, all of which derive from the legal backing afforded and the respect of the rest of the healthcare professions, which derive from having achieved statutory recognition. The advantage most often articulated to us was protection of title, so that only practitioners who are registered with the relevant statutory regulatory body can legally use a particular title. This provision makes it very easy for the public to determine who is, and who is not, a properly qualified practitioner, and gives the relevant professional body the power to determine who can claim to practise the therapy in question. The Consumers' Association explained the importance of this: "…unless you have protection of title you have little control over the practitioner who has no training, or has training and has been taken off the register" (Q 841).

5.27 The second main advantage of statutory regulation is the legal establishment of a single register of practitioners. This makes it easy for the public to find out who is, and who is not, qualified and trained properly and also makes tracking of practitioners easier. This could be done by voluntary regulatory bodies which provide a register of practitioners, but without protection of title there is little opportunity to ensure that those not on the register do not mislead the public into thinking they are adequately qualified and trained therapists. The Consumers' Association also articulated the importance of the public having a single reference point that covers all practitioners in a field, saying: "Consumers should be able to contact a body to establish if the practitioner they are going to see is indeed registered" (Q 840).

5.28 The third advantage of statutory regulation is the legal underpinning of a body's disciplinary procedures so that a practitioner struck off a list due to misconduct has nowhere else to register and can no longer use the title the list had bestowed upon him.

5.29 All these features could probably be achieved by well-publicised voluntary regulation. However, for therapies with high inherent risk it is probably desirable to have legal underpinning of these provisions.

5.30 FIM added another advantage of statutory regulation to this list. Mr Michael McIntyre, a Trustee of FIM, told us: "…there are certain benefits accruing out of statutory self-regulation for some professions which would not come otherwise. For example, there may be actual medicines...which the regulatory authorities would not want on the market generally and those would only be available to those who were actually in some way state registered, as doctors are" (Q 104).

5.31 However, one of the main advantages of statutory regulation, protection of title, is not as clear-cut as it may seem. Although statutory regulation does provide protection of title, the common law right to practise medicine means that anyone can use the techniques of a therapy, even if it is statutory regulated, as long as they do not identify themselves by using the title which is protected. The GOsC explained that there is "…a difference between a restriction of title and a functional closure. We have, under the Osteopaths Act, a protection of title only, so it is possible for members of the medical profession or physiotherapists to use osteopathic techniques provided they do not hold themselves to be an osteopathic practitioner…it was felt at the time of the Act going through Parliament that it would be inappropriate and, indeed, impossible to produce a functional closure" (QQ 421 & 422). We have learned that some former osteopathic practitioners, refused registration under the Act, continue to practise, for example, as osteomyologists or cranio-sacral practitioners.

5.32 There are also some disadvantages to statutory regulation. These come in two forms: difficulties that arise from the process of achieving statutory regulation; and the potential effects of statutory regulation itself. The main concern about the effects of regulation is that regulation of a therapy may restrict consumer choice. Statutory regulation is expensive to set up and its very nature restricts the number of practitioners. If a therapy does not have appropriate numbers of therapists and resources for statutory regulation then the process may cause the professional bodies to lose money and make it impossible for some individuals to register as practitioners. The Consumers' Association explained that: "To over-regulate may make particular therapies inaccessible to people, and we do not feel that would be appropriate either" (Q 832). The British Complementary Medicine Association also articulated this view, stating: "perhaps to use statutory regulation for complementary therapies is like using a sledge hammer to crack a nut" (Q 610).

5.33 However, the idea that statutory regulation may restrict consumer choice is not necessarily true. Statutory regulation could even have the opposite effect by giving consumers the confidence to consult practitioners whom they might not otherwise consult due to concerns about regulation. And it is not necessarily true that statutory regulation, by its very nature, restricts the number of practitioners of a therapy. It is true that, in the short term, statutory regulation might prevent a few practitioners from using a particular professional title on the basis that they were not judged to be sufficiently well qualified or competent. In the medium term, a profession regulated by statute is far more likely to attract students to its accredited colleges, partly because career advisers are much more likely to recommend such professions to their students.

Routes To Statutory Regulation

OWN ACT

5.34 Until the provisions of the Health Act 1999 came into force, healthcare professions seeking statutory regulation have had to seek it through primary legislation (except for the Professions Supplementary to Medicine).

5.35 The two CAM professions that have followed this route are the osteopaths, who achieved statutory recognition through the Osteopaths Act 1993, and the chiropractors who achieved statutory recognition through the Chiropractors Act 1994[38]. The features of the GOsC and the GCC, which were set up under the two Acts, can be seen in Appendix 2.

5.36 We talked to both the GOsC and the GCC about their experience of statutory regulation.

5.37 The GOsC told us that they could not think of any disadvantages, from the patients' perspective, of statutory regulation (Q 465). They did say that from the profession's point of view some would argue that the process of achieving statutory regulation has been "complicated and difficult" (Q 465). However, they qualified this statement by saying: "In the final analysis the profession will be stronger and patients will benefit more from the process" (Q 465). The GOsC explained that the cost in terms of what each practitioner has to pay each year is similar to what most of them were paying under the voluntary system (Q 466). However, they did raise a note of caution for smaller therapies which may not have as many practitioners to spread the costs: "…there is a certain limit, a certain sum of money, which a statutory body…does require…and therefore, professions which are small in number would have to think very seriously about whether they could actually afford to have a system of statutory regulation in place" (Q 466). The GOsC stated that the cost per annum of their body is likely to reach £1.8 million, with at present about 2,000 registered osteopaths.

5.38 The GCC were more outspoken about the problems they had faced in achieving their Act. Mrs Norma Morris, Chairman of the GCC, told us that it is "…a very onerous system" (Q 470). She added: "…I doubt whether it would be suitable for all the professions that may seek that status. I hope that it would be possible to find some sort of half way house for such practitioners…One problem is that despite the very best intentions of all the civil servants with whom we have worked, there is a difficulty in getting business done through the Department of Health…and also there is the question of start-up funds for new bodies" (Q 470). However she did say that statutory regulation was "a very desirable system and one that has benefits for the public" (Q 470). It is clearly important that the Department of Health should deploy sufficient staff and resources to deal with future regulatory applications.

5.39 Each Act has tended to make provisions which could in the past only be amended through primary legislation which can take a very long time. With the passage of the Health Act, amendments can be made by Order in Council.

5.40 Neither the GOsC nor the GCC highlighted any problems with the status of being regulated by statute. They felt it increased public safety and public confidence, as well as professional respect and the standard of organisation within the profession itself. The negative feelings they did articulate were all concerned with the time, cost and complications of the process of getting their Act drafted and through Parliament. The Health Act provides for the same level of statutory regulation, but through a less onerous system (discussed below). Therefore the process of achieving an individual professional Act is no longer necessary, but the advantages of statutory regulation remain, and the lessons learnt by the GOsC and the GCC will be very valuable to other professions. It is also worth noting that many of the problems experienced by the osteopaths arose from the fact that they were setting up from scratch, with no State funding, a new and innovative statutory regulatory mechanism, with no precedent in healthcare legislation for the previous 40 years. Professions in the future seeking statutory regulation will have a wealth of knowledge and experience upon which to draw.

HEALTH ACT 1999

5.41 The Health Act 1999 provides two main opportunities for healthcare professions aspiring to achieve statutory regulation; the first of these is the opportunity for a single body representing the entire profession to apply for statutory regulation by Order in the Privy Council, in contrast to pursuing its own Act of Parliament. The second opportunity is by virtue of the abolition of the Council of Professions Supplementary to Medicine (CPSM) which is being replaced by the Health Professions Council, furnished with new provisions and wider powers.

5.42 In their evidence the Department of Health said that they envisaged the provisions laid out in the Health Act as being advantageous to professions with a good voluntary structure: "To help all healthcare professionals improve the current levels of self-regulation, the Government took powers in the Health Act 1999 to enable existing professions to modernise their legislative provisions and to provide a statutory self-regulatory framework for those professions whose members supported such a system" (P 106). With specific reference to the opportunities afforded to CAM bodies by the Health Act, FIM referred to a speech by Tessa Jowell MP, the then Minister for Health, who told them in May 1999 how it would be possible for aspiring CAM professions to attain statutory self-regulation using the provisions of the Health Act, provided they met certain conditions. The Department of Health made it clear to us that they saw the Health Act 1999 as being advantageous, in that it will "enable existing statutory schemes to be strengthened and statutory schemes for other professions to be introduced" (Q 5).

5.43 The Department of Health are not yet clear as to how the practicalities of the Health Act will work. Yvette Cooper MP, Parliamentary Under Secretary of State for Public Health, said she was unable, as yet, to clarify the advantages and disadvantages of each route to regulation offered by the Act, nor how it would be decided which route a therapy should take. When we asked her what advantages a therapy would gain from coming under the Health Professions Council, as opposed to achieving statutory status in its own right, she told us: "I think it is probably too early to give a definite answer to that question. There is clearly, in all these regulatory issues, a trade-off between, on the one hand, having an individual regulatory organisation for individual professions that have sufficient expertise to regulate themselves…and, at the same time, having critical mass within the organisations and having proper co-ordination between them where regulatory issues are in common or overlap…I think we do not have closed minds on this at all" (Q 1876). Professor Liam Donaldson, Chief Medical Officer, told us that the Department of Health have recently published a consultation document on the Health Professions Council and are awaiting responses on that (due in early November) before moving ahead (Q 1876). Despite these uncertainties there is a generally positive view amongst the CAM world towards the provisions of the Health Act.

5.44 FIM sees the Health Act as lifting some of the burden which therapies previously faced when pursuing their own Act: "…the NHS Bill…now gives much greater flexibility in terms of approaching statutory self-regulation. The path which the chiropractors and osteopaths had to go down was through a Private Member's Bill, which was terribly long and drawn out and does not give the sort of flexibility which the new arrangements potentially do" (Q 102). Yvette Cooper MP expanded on the flexibility of the Health Act: "I think that the Health Act provides several advantages in that it allows us to become more responsive to the needs of the health profession and to the Health Service. That has been a problem with the previous situation where any amendment or changes, whether it be new professions coming aboard or changes in the nature of the profession…requires primary legislation that has been a very cumbersome and slow process and has resulted, over a long period of time, in changes that might otherwise have happened not being able to take place for that reason. I think that the Health Act provides advantages in terms of responsiveness. Where there is widespread support, and a proper consultation has been gone through, I think it would allow us to put an effective statutory regulation framework in place much more smoothly and rapidly than we might otherwise be able to do" (Q 1878).

5.45 The GOsC, which has had the experience of the single Act route, also thought that the provisions of the Health Act offered a good opportunity for other CAM professions. "Recent changes in the powers given to the Secretary of State and proposed legislation to supersede the current Professions Supplementary to Medicine Act 1960 could help to facilitate the process of statutory regulation for some of the professions which have reached the appropriate stage of development" (p 102). Mr Simon Fielding, Chairman of the GOsC, elaborated: "I think those provisions [envisaged under the Health Act] do offer a very useful method for complementary medical practitioners and groups to consider, and certainly would obviate the need for going for a single parliamentary Bill…So in a sense, those provisions certainly facilitate those professions that are ready to make that transition" (Q 414).

5.46 To understand the option of coming under the Health Professions Council, provided by the Health Act, it is necessary to understand the old CPSM. The Council was set up under the Professions Supplementary to Medicine Act 1960 and has supervised the activity of specialist boards representing twelve professions: art, music and drama therapy; chiropody; clinical scientists in health; dietetics; medical laboratory science; occupational therapy; orthoptics; paramedics; physiotherapy; prosthetics and orthotics; radiography; and speech and language therapists. Each of the boards maintained a register of practitioners, had a role in regulating and overseeing training which led to State registration, and also sifted applications for state registration and cancelled registration in cases of misconduct. The Council's role was that it financed each of the boards, arranged and monitored elections for each board's membership and supervised and co-ordinated each board's work. However there were deficiencies in the Council's ability to monitor practitioners as it was not illegal for an unregistered practitioner to use the title of one of the professions in the Council for Professions Supplementary to Medicine's remit as long as the term 'state registered' was not used[39].

5.47 Another limitation of the Council was that it could not register any further groups as they have reached the limit of twelve professional boards set out in the Professions Supplementary to Medicine Act 1960 (P 72).

5.48 Clause 47 of the Health Act 1999 addresses the problems faced by the CPSM by replacing it with a new regulatory body called the Health Professions Council. The main differences between the new Health Professions Council and the CPSM are as follows:

  • Protection of title: this will mean that no-one can use the title of any of the professions within the Council's remit unless they are on the Council's register. This should remove public confusion and increase public protection.

  • Increased accountability: there will be new disciplinary powers which will include reprimands, suspension pending retraining, and fines.

  • A new health committee: to deal with registrants who put the public at risk because they themselves are ill, with the power to suspend registration until registrants have recovered.

  • Lay representation: and a shift of power from the CPSM's boards to a central council.

5.49 The Health Professions Council will also have the ability to register new groups (P 72). The provisions which a profession will need to meet to be eligible to come under the new Health Professions Council will be the same as the criteria were to join the CPSM and are reviewed in Box 6 below. Any CAM profession wishing to come under the Health Professions Council will need to meet these criteria.


Box 6
  
Criteria for Petitioning to come under the Council for Professions Supplementary to Medicine or its Successor
  
1. Is there a need for the public to be protected from the activities of the group in that their work involves invasive procedures or clinical intervention with the potential for harm or can the exercise of judgement by the unsupervised professional significantly impact on patient health or welfare where such procedures or judgement are not already regulated by other means such as through supervision or other legislation?
  
2. Does the group naturally fall within the family of health professions and conventional medicine?
  
3. Can the group be considered to be a mature profession? The nine definitions given by the late Lord Benson in a House of Lords debate on 8 July 1992 are used as a general test (see Box 7).
  
4. Has the group a single, defined professional voice which can speak for it and does it work to a common level of threshold competency?
  
5. Is there a common education system at an appropriate level which would allow a unified approach to the approval of course programmes and the establishments providing them?
  
6. Is the group large enough to provide the additional body of unpaid volunteers to fill the necessary offices at the CPSM or its successor in turn and to undertake the considerable work inherent in the statutory regulation of a profession?
  
7. Can the group statutorily fall within the Professions Supplementary to Medicine Act or its successor? This is a requirement as it could, on investigation, be found that the activities of a group could partly fall within or significantly impinge upon a group or groups being regulated under other Acts.
  
Source: Council for Professions Supplementary to Medicine.




Box 7
  
Criteria for a Group to be Considered a Profession
  
1. The profession must be controlled by a governing body which in professional matters directs the behaviour of its members. For their part the members have a responsibility to subordinate their selfish private interests in favour of support for the governing body.
  
2. The governing body must set adequate standards of education as a condition of entry and thereafter ensure that students obtain an acceptable standard of professional competence. Training and education do not stop at qualification. They must continue throughout the member's professional life.
  
3. The governing body must set the ethical rules and professional standards which are to be observed by the members. They should be higher than those established by the general law.
  
4. The rules and standards enforced by the governing body should be designed for the benefit of the public and not for the private advantage of the members.
  
5. The governing body must take disciplinary action including, if necessary, expulsion from membership should the rules and standards it lays down not be observed or should a member be guilty of bad professional work.
  
6. Work is often reserved to a profession by statute - not for the advantage of the members but because, for the protection of the public, it should be carried out only by persons with the requisite training, standards and disciplines.
  
7. The governing body must satisfy itself that there is fair and open competition in the practice of the profession so that the public are not at risk of being exploited. It follows that members in practice must give information to the public about their experience, competence, capacity to do the work and the fees payable.
  
8. The members of the profession, whether in practice or in employment, must be independent in thought and outlook. They must be willing to speak their minds without fear or favour. They must not allow themselves to be put under the control or dominance of any person or organisation which could impair that independence.
  
9. In its specific field of learning a profession must give leadership to the public it serves.
  
Source: Council for Professions Supplementary to Medicine.


5.50 The provisions of the Health Act are a step forward in easing the path of health professions that wish to achieve statutory status. How much easier this route will be remains to be seen. Our discussions with the Department of Health indicate some uncertainty over how they will decide which route, under the Health Act, a therapy should follow to achieve statutory status, even though it will be the Department of Health itself that will decide which route is most appropriate for each therapy, after discussion with that body. We believe there are some therapies that would benefit from statutory regulation and should use the opportunities provided by the Health Act. These are reviewed below.


38   Both Acts were taken through the House of Lords by Lord Walton of Detchant, who chaired the Sub-Committee which prepared this Report. Back

39   Budd, S. & Mills, S. (2000) (Op.cit.). Back


 
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