This response has been prepared by the Alliance of UK Health and Social Care Regulators on Europe (AURE). The Alliance has been working closely with UK consumer organisations in developing its response to the proposed Directive. Those organisations share many of our concerns and have also been active in raising the issues with their colleagues in Europe.

As regulators we are responsible for the protection of patients and are required to register for practice only those with the appropriate training and qualifications and who are able to communicate effectively with their patients. As our comments on this consultation paper illustrate, the Alliance has serious concerns regarding the Directive and its drive toward free movement at the expense of patient safety and proposes amendments that would remedy the main shortcomings in the draft.

Although the Alliance supports facilitating the freedom of movement of health and social care professionals, we believe that the proposal, as drafted, does this at the expense of patient protection. The draft disregards Article 152 of the Treaty of Rome, which provides that a high level of human health protection shall be enshrined in all Community policies. We suggest that a reference to Article 152 of the Treaty of Rome is included in the first paragraph of the preamble of the proposed Directive and further reflected throughout the proposal.

We would urge the UK government to press for the amendments to the Directive described in this paper in order properly to protect the health and welfare of UK citizens.

We are aware of a number of UK laws which would require amendment as a consequence of this provision:

Section 18 of the Medical Act 1983 makes provision for the temporary registration of visiting EEA doctors. It describes the circumstances in which such registration may be granted and the documentation which shall be provided to the GMC by the visiting doctor for this purpose. This section also describes the scope of the medical services which may be provided. Section 18 has its origin in Article 17 of Council Directive 93/16/EEC.

Articles 5-9 of the proposed new Directive would remove the requirement for visiting EEA doctors to register with the GMC and would allow medical practice for up to 16 weeks each year without registration. As such, these articles would require an amendment of section 18 of the Medical Act.

Further comments on the proposals contained in articles 5-9 are set out in our response to question 3 of the consultation paper.

The specialist medical order will require amendment as a consequence of the Commission’s proposal to move 35 medical specialties from the sectoral to the general systems.

Schedule 4 of the Dentists Act 1984 places a duty on the General Dental Council to maintain a List of Visiting EEA Practitioners. This schedule includes disciplinary provisions affecting practitioners who render services while visiting the UK. The introduction of articles 5-9 of the proposed Directive would make these provisions in the Dentists Act redundant.

Under section 32 of the Osteopaths Act a person ‘who (whether expressly or by implication) describes himself as an osteopath, osteopathic practitioner, osteopathic physician, osteopathist, osteotherapist, or any kind of osteopath, is guilty of an offence unless he is a registered osteopath’. However, article 5 of the proposed Directive would enable osteopaths to practise in the UK without registration. The current Act would therefore require amendment.

Under section 32(1) of the Chiropractors Act a person ‘who (whether expressly or by implication) describes himself as a chiropractor, chiropractic practitioner, chiropractitioner, chiropractic physician, or any other kind of chiropractor, is guilty of an offence unless he is a registered chiropractor’. As a consequence of article 5 of the Directive, this section of the Act would require amendment.

The Opticians Act restricts the testing of sight, the use of certain drugs, the fitting of contact lenses and the dispensing of spectacles to persons registered with the General Optical Council (GOC). The Act also restricts the use of titles to persons registered with the GOC. Articles 5-9 of the Directive would necessitate changes both to the Act and to supporting regulations which apply to NHS practice.

Section 61 of the Act gives protection of title to a person registered as a social worker in England and Wales. Whilst this section of the Act is yet to be commenced, the Act would need amendment. Parallel legislation exists in Scotland and Northern Ireland.

Under section 5(d) of the Pharmacy (Northern Ireland) Order 1976, the Pharmaceutical Society of Northern Ireland has the power to make regulations setting out the conditions on which persons who are members of the Pharmaceutical societies outside Northern Ireland may be registered as Pharmaceutical chemists under the Order.

As an example, the Pharmaceutical Qualifications (EEC Recognition) Regulations (Northern Ireland) 1987 were made so that the Pharmaceutical Society of Northern Ireland could recognise the qualifications of and therefore register pharmacists from other EC countries.

Regulations under the Pharmacy Order would be needed to implement any change in provision.

Question 2a: Do you know of any regulated profession in England, Wales, Scotland or Northern Ireland, which may lend itself to the fragmentation of autonomous activities, as envisaged in Article 4(3)?

Question 2c: Would changes be required to UK legislation as a consequence?

We are concerned that the proposed fragmentation of autonomous activities envisaged in article 4(3) could have adverse consequences for patient care in some healthcare professions.

The core activities of optometrists are refraction, determination of the health of the eye, the management of certain conditions, contact lens fitting and dispensing. UK law prescribes that refraction and the examination of the eye have to be carried out on every patient as part of a ‘sight test’. Dispensing, although part of an optometrist’s work is also the responsibility of the independent profession of dispensing opticians. Dispensing opticians may also fit contact lenses after further training and qualification.

Because of the wide variation in training and scope of practice amongst European optometrists, there may be significant differences in a migrant’s training which cannot be made up by compensation measures, but where the migrant’s qualifications would allow practice as a dispensing optician with or without compensation measures.

If optometrists/opticians were allowed merely to refract, this would create a further level of qualification leading to a public health risk. This is because optometry is the primary referral profession in the UK for ocular disease. The UK government has previously considered and rejected a proposal for a two tier eye examination.

Question 3: Is the 16 week threshold proposed in Article 5 for the provision of services under home state registration, an acceptable and workable criterion?

This provision represents a serious threat to the interests of patients throughout the EEA.

The proposal, in its current form, would allow individuals who are established in one Member State to practise in another Member State for up to 16 weeks per year without being registered in the host State (or even informing the host State of their activities). As a result, not only would patients in the host Member State be unable to recognise the professional status of the service provider, they would also be unable to pursue any complaint in their home State concerning the conduct or competence of the service provider. There would also be no means of preventing a professional found guilty of misconduct or poor performance in one Member State from practising in other Member States since, as the proposal is currently drafted, the host State regulatory body would be unaware of the service provider’s intentions within its jurisdiction.

There are also particular concerns for professions such as chiropractic and osteopathy which are not recognised or regulated in many EEA countries. Where the profession is regulated in the host State, but not in the service provider’s state of establishment, it will not be possible for the host competent authority to be assured that the service provider is competent and fit to practise. More importantly, nor could the public have any such assurance.

The effect of this specific provision of the proposed Directive is that regulators would not be able to ensure sufficient patient protection at all times. This is unacceptable. We would therefore wish a clause to be included in Title II: Free movement of services, to exempt health and social care professionals from this provision. We propose the following wording for an additional article.

"Article x

Question 4b: How will their introduction impact on regulated professions in the United Kingdom?

It is not clear from the proposal how common platforms would operate in practice. Although they may facilitate freedom of movement for those who are subject to the platform, the Alliance has the following concerns.

As drafted, article 15 provides for the establishment of common platforms by professional associations. In relation to health and social care in the UK, the setting of standards and the recognition of qualifications are matters for the competent authorities and not the professional associations. It is also inconceivable that platforms could be agreed without appropriate input from government.

We understand that the Commission would be able formally to recognise common platforms agreed between individual states. We also understand that the effect of the Commission’s recognition of a such a platform would be the automatic recognition of those qualifications across the EU and not simply confined to those states which are part of the original platform. We are concerned that the implementation of platforms across the EU in this way could result in the lowering of standards in some states. This risk would be compounded if the formal recognition of platforms by the Commission can be achieved by qualified majority voting.

Further, without agreed minimum standards to underpin common platforms, the ability of individual States to maintain standards of practice would only be as strong as the weakest member.

Question 5: What is your view of the amendments proposed for specific professions (architects, doctors, general care nurses, medical and dental specialisations and pharmacists) on the basis of co-ordination of minimum training conditions (Articles 20-45)?

The members of AURE affected by these proposals have commented separately in the submissions on the draft Directive made by their individual organisations. In particular, see the responses to the consultation submitted by the General Medical Council, General Dental Council, Nursing and Midwifery Council, Royal Pharmaceutical Society and the Pharmaceutical Society of Northern Ireland.

The sectoral Directives have, in the past, been supported by Advisory Committees on Training (ACTs) – one for each profession. The remit of the ACTs has been:

• To help ensure throughout the Community a comparably high standard of training, through exchange of comprehensive information as to training methods and the content, level and structure of courses provided in Member States.

• Discussion and consultation with the object of developing common approaches; keeping under review the adaptation of the training to developments in practice.

The Commission has also received regular advice from a group of national officials known as the Committee of Senior Officials on Public Health (CSOPH). The current Commission proposal seeks to abolish the ACTs and CSOPH and instead establish a single Committee on the recognition of professional qualifications. The proposed role of the new Committee will apparently include monitoring the implementation, as well as regular updating, of the Directive in relation to individual study programmes of all the professions covered by the Directive. A single Committee of this kind cannot possibly incorporate the professional expertise and range of knowledge necessary to oversee and manage issues relating to practise across the full range of health and other professions.

The alliance requires a guarantee of a clearly established mechanism, with legal status, to ensure appropriate and updated programmes of training for entry to a health profession’s register. That mechanism must ensure appropriate input from each of the practising professions, the regulators and the universities, and this must be reflected in the text of the Directive. Without such a guarantee it would be essential for the regulators to have the power to make an assessment of each migrant’s capability for practice at the point of registration so that they may properly fulfil their role of public protection.

Further, in view of the Commission’s history of disregarding the recommendations of its Advisory Committees, the Directive should be amended to make the Commission accountable where it does not adopt the recommendations of the professional bodies it has consulted.

The current proposal for a single committee is unacceptable. As indicated above, there must be clear arrangements guaranteeing the involvement of the relevant health and social care regulators in issues affecting their professions.

Article 10 states that general systems will apply to all cases in which the applicant does not satisfy the conditions laid down in the relevant provisions of the sectoral system.

Applying general systems as the default position in cases where applicants fail to meet the minimum training requirements of the sectoral system will undermine the integrity of sectoral system. It will lead to a two-tier system in which the public cannot have confidence that all healthcare professionals have attained the minimum standards specified in Chapter III of the Directive.

Article 13 states that attestations of competence or evidence of formal training shall attest a level of professional qualification at least equivalent to the level immediately below that which is required in the host Member State, which means that the duration of the training would be at least one year shorter than that required by the host Member State.

Health professionals in the UK currently covered by the general directive usually have qualifications at level 5 (four years) and the fourth year of training typically has the heaviest concentration on development of clinical competence. A three year period of training would provide insufficient time for the necessary academic and clinical components of training to be covered to the depth and level required to ensure patient safety.

Article 14 states that if the training is at least one year shorter than that required by the host Member State the applicant can be required to complete an adaptation period or take an aptitude test, with the applicant having the choice between the two. An adaptation period for health professionals employed outside the NHS is no substitute for the acquisition and demonstration of the requisite knowledge, skills and understanding within a formal programme of training. Patient safety would be best protected by the host Member State having the right to determine whether the applicant should be required to take an aptitude test.

Article 49 of the Commission’s proposal provides: "The Member States shall ensure that, where appropriate, the beneficiaries acquire the language knowledge necessary for performing their professional activity in the host member state". It is unclear whether the article enables regulators to test the language proficiency of migrants at the point of registration. The Alliance believes that, in order to guarantee patient safety, the ability to communicate effectively in the language(s) of the host state must be a pre-requisite to the registration of health and social care professionals.

We seek clarification of the intentions of this article, and recommend including the following wording: