Mary Harney (Dublin Mid West, Progressive Democrats)

The Medical Practitioners Bill 2007 updates and modernises the regulation of medical practitioners by the Medical Council. It is acknowledged the current legislative framework, which is almost 30 years old, needs to be revised. The Health and Social Care Professionals Act 2005 provided for the appointment of the new Health and Social Care Professionals Council, which recently held its first meeting. The Pharmacy Bill 2007 will modernise the regulation of pharmacists and I am ensuring that further legislation governing nurses and midwives will be on the legislative agenda in the near future.

The Medical Practitioners Bill is part of a set of legislation aimed at enhancing patient safety, which is at the heart of the health reform agenda, and the accountability of health professionals. The Bill has been the subject of extensive consultation and consideration. When I published the draft heads in 2006, I was pleased many organisations and individuals responded with comments on the proposals. A total of 58 submissions were received from members of the public, patient groups, individual doctors and their representative organisations, the third level sector, medical specialist training bodies, Departments, State agencies and other interests. In addition to that consultation process, the Medical Council and other bodies organised seminars to allow the public to debate and identify the key issues which were to be addressed.

Following a constructive and useful debate in the Dail, I am pleased to bring this long-awaited and much-needed legislation to the Seanad. The need to act decisively is more evident than ever following the publication of the reports of various health care inquiries, including the inquiry into events at Our Lady of Lourdes Hospital in Drogheda. The Bill is consistent with the Government's commitment, as outlined in the health strategy, to strengthen and expand the provisions for the statutory registration of health professionals, including doctors. If we are to maintain the trust of patients in the doctors who treat them, we need to demonstrate and maintain quality at all levels. Patients want to know the service they receive from doctors is based on the evidence of best practice and meets the highest standards. Improving quality involves implementing internationally recognised evidence-based guidelines and protocols and ensuring professionals commit to and engage in ongoing education and updating of skills. The maintenance of trust requires that deficiencies in practice are identified at the earliest possible stage, corrective actions are taken and future progress is monitored. If we are to put people first, we should ensure patients are given more influence and responsibility.

One of the priorities of this legislation is to strengthen and clarify accountability. In April 2006 the Department of Health and Children issued a Framework for Corporate and Financial Governance to all statutory bodies, including regulatory bodies, which operate under its aegis. The provisions of the legislation are in line with the Department's framework. The governance procedures and arrangements outlined in the Bill are accepted as normal by public bodies across the wider public sector. The laying before the Oireachtas of statements of strategy, business plans and annual reports will give the public an opportunity to see how the Medical Council is fulfilling its statutory delegated functions. Some argue these provisions increase the potential for ministerial or political interference in the workings of the council, but that is most certainly not the case. The provisions are about openness, accountability and responsibility which should be embraced by any statutory body undertaking public functions in a modern and democratic society.

I do not doubt doctors are working in a much more demanding environment than they previously did. While evidence-based guidelines, tighter professional standards and increased patient rights and expectations are welcome and necessary, they add to the demands faced by doctors. Such forms of accountability will be strengthened by these legislative proposals.

This legislation will ensure members of the public are guided, protected and informed in order that they can be confident that doctors are properly qualified, competent and fit to practise on an ongoing basis. Importantly, it will support doctors by allowing them to demonstrate the high standards they strive to maintain on an ongoing basis. It will increase the trust doctors have in their own profession and their continuing personal and professional competence.

I am conscious that in the modern world, the regulation of doctors, as with other professions, cannot be solely the remit of the profession itself with minimal input from patients and other professionals. There are many interested parties and stakeholders who have an important role to play in the regulation of the medical profession, including patients, employers and other caring professionals.

Education is key to quality medical practice, as is research. I have endeavoured to ensure the third level sector, as well as those representing the broader science and humanities areas, are represented. I have also included a representative from the Health Information and Quality Authority. The Medical Council's functions under the legislation will be significant in setting and monitoring standards and quality and this new membership will serve only to enhance that role. The council exists to regulate the medical profession, not to represent the interests of that profession or any constituent group within it. The public interest comes first and everything in the Bill, including the membership of the council, is designed with that in mind.

For the first time the legislation imposes a clear requirement on all medical practitioners to register with the Medical Council before engaging in the practice of medicine. The Bill provides for the designation of titles for the sole use of registered medical practitioners or particular classes of registered medical practitioners on the basis of specific criteria. This will help to guide members of the public as to the level of competence of the medical practitioner responsible for their care.

A strong feature of this legislation is the new system of registration, with procedures which will be more streamlined for all. It includes a new, appropriately divided register. Temporary registration for doctors from outside the European Union will be discontinued, in order to allow for those doctors who have given such significant support to our health service to enjoy the same benefits of registration as their Irish and EU-qualified colleagues and peers. For the first time, doctors with suitable non-EU specialist qualifications will be able to gain direct access to specialist registration. Legal registration confers a professional privilege which demands the adoption of a consistent and ongoing high standard of professional conduct for each registered medical practitioner. We are all aware, however, that sometimes things go wrong. Therefore, a comprehensive fitness to practise structure which can act quickly and appropriately in such circumstances is required.

A central feature of the Bill is the adoption of a contemporary approach to fitness to practise issues, which provides for alternatives to the existing complex legal process of a fitness to practise inquiry. A mediation process for less serious complaints by agreement of the parties concerned is provided for. The Bill also includes a means for a complaint to be referred to the statutory complaints process established under the Health Act 2004, or to another body or authority, or for the referral of a matter to competence assurance procedures.

During the years it has been of significant concern that fitness to practise procedures are conducted behind closed doors and that the Medical Council is precluded by the existing legislation from disclosing any details regarding the conduct of inquiries. Arising from these concerns, I have decided that fitness to practise inquiries will be generally held in public. To allow for individual situations where this may not be appropriate, provision is included for the fitness to practise committee to decide to hold in private all or part of an inquiry, depending on the circumstances. In addition, the Bill now specifically provides that the council may, if it is in the public interest, publish the transcript of an inquiry. However, I am also concerned that we should demonstrate our commitment to support medical practitioners. With that in mind, I have ensured that a new health committee is provided to assist individual doctors with health issues.

The support of doctors and the protection of patients also require the modernisation of medical education and training processes. The overall approach is consistent with the broad thrust of the recommendations of the Fottrell and Buttimer reports on medical education and training at basic and specialist level. The Health Service Executive will assume a significant role in the development and co-ordination of medical education and training, in co-operation with the Medical Council and the medical specialist training bodies. However, I consider it important that the Medical Council's role in education and training has been significantly redrafted to provide more clarity on the requirement to set standards and develop guidelines to assist all. It should be clear to all parties that the Medical Council's role is about standards, guidelines and quality in education and training, while the HSE will have a more facilitative, co-ordinating role.

This country has bitter experience of what can happen when appropriate systems and supports for the maintenance of ongoing competence and high standards in medical practice are absent. Isolation of medical practitioners, even when working in a hospital setting, can lead to outmoded and outdated practice being perpetuated. The Lourdes Hospital Inquiry brought such matters into sharp focus. I am determined that we will learn and move on from these matters and as a result Judge Harding-Clarke's recommendations have had a strong influence on the drafting of this legislation. Her recommendations for the reform of education and training and ongoing competence assurance structures have been studied and will be implemented in a number of ways. While we can never guarantee that mistakes will not happen again, this legislation provides an important opportunity to learn from the past and put in place necessary elements to limit the impact of mistakes in the future. I consider it significant and imperative that all employers of medical practitioners, not least the HSE, have been given responsibilities with regard to the maintenance of the professional competence of medical practitioners.

The Medical Council will have a leadership role in ensuring doctors comply with what is a new legal statutory requirement for them to maintain their professional competence on an ongoing basis. This will require much commitment from all parties, individual doctors and the teams within which they work, their employers, the medical specialist training bodies and the Medical Council as the regulating competent authority of the profession.

I have ensured the Bill contains provisions which will allow funding for the administration of competence assurance structures and other matters to be provided for the Medical Council. While the Council will continue to be funded in the main by the medical profession through the payment of registration fees, I recognise that the State must also share the burden of the costs involved in such issues. I consider that these costs will be offset in this case by the benefits of the quality assurance of the competence of medical practitioners.

Given the importance of this legislation, I take this opportunity to highlight some key elements of the new system of regulation. In Part 2, section 6 sets out, for the first time, a statutory objective of the Medical Council, which is "to protect the public by promoting and better ensuring high standards of professional conduct and professional education, training and competence among registered medical practitioners".

Section 7 outlines in clear terms the functions of the council which relate to the registration of medical practitioners, the regulation of their education and training at all levels and matters relating to the recognition of qualifications of medical practitioners. The council's functions also include the setting of standards of practice, including advertising, and all matters of ethical guidance for medical practitioners, the handling of complaints and inquiries relating to the conduct of medical practitioners and proactively advising the public on all matters of general interest relating to the functions of the council, its area of expertise and the practice of medicine.

Section 9 provides for the Minister to give general policy directions to the council concerning its functions but it is important to emphasise this standard common provision specifically excludes matters relating to ethical guidance, complaints, inquiries and sanctions. In addition, the provisions of this section make it clear that any policy directions cannot prevent the council from, or limit the council in, performing its functions.

The Medical Council, as a statutory body established in 1978, cannot and does not operate in a completely independent or autonomous way despite the views expressed by some. It is important that it has regard to public policy, particularly in regard to areas such as medical education and training, in which it plays such an important role, along with a range of other stakeholders. Section 11 outlines the council's power to make rules. Rules will be subject to publication in draft form for public comment and all rules of the council must be laid before the Houses of the Oireachtas.

Part 3 provides for the council to prepare a statement of strategy, an annual business plan and an annual report on its activities. A modern public body with powers and responsibilities delegated to it must demonstrate how it plans to undertake its statutory functions and account for its progress and achievements in this regard.

Part 4 includes provisions for the membership, committees and staff of the Medical Council. Section 17 outlines the membership of the Medical Council, which shall continue to consist of 25 members. As I have consistently stated, it is my belief that public confidence in the Medical Council requires that a majority of its members should not be doctors. These members will represent a wide variety of interests and experience. However, I have made it clear that although all members of the Medical Council will receive an appointment order from the Minister in order that they are all appointed on an equal basis, the Minister may not refuse to appoint an individual nominated or elected to serve.

Section 20 outlines the council's power to establish committees to perform any of its functions and provides that persons who are not members of the council may be included in the membership of any of the council's committees. This will allow all committees of the council to co-opt additional expertise, both medical and non-medical, as required. The various sections in Part 5 deal with the accounts and finances of the Medical Council.

Part 6 is concerned with a new modern system of registration of medical practitioners. Medical practitioners who wish to practise medicine in the State must be registered unless acting lawfully in another professional capacity. Sections 39 and 40 provide for the designation of titles which are reserved for use by certain medical practitioners. Offences and significant penalties for breaches of registration requirements are included in this Part of the Bill. Section 43 establishes the register of medical practitioners to consist of four divisions, namely, the general division, the specialist division, the trainee specialist division and the visiting EEA practitioners division. Provisions are included to allow doctors who hold refugee status and who have had difficulties in the past providing the necessary documentation to prove they are in good standing to become registered and to work as doctors in this country. I am pleased medical practitioners with suitable non-EU specialist qualifications will, for the first time, be able to gain direct access to specialist registration.

Section 50 concerns the transposition of relevant articles of Directive 2005/36/EC and relates to temporary and occasional provision of medical services by medical practitioners who are already lawfully registered or legally established in another member state.

Part 7 relates to complaints regarding medical practitioners and the procedures for the handling of complaints. The sections outline the expanded grounds for complaint, what actions the new preliminary procedings committee can and must take and includes new and innovative provisions governing mediation, referral to other authorities and keeping the complainant informed.

Part 8 relates to procedures to be followed by the fitness to practise committee in conducting inquiries, once a prima facie case has been established. The fitness to practise committee must have a majority of persons who are not medical practitioners. It covers the conduct of the hearing which generally will be in public. Part 9 relates to the imposition of sanctions by the Medical Council following a finding against a medical practitioner. The role of the High Court in the confirmation of sanctions imposed is maintained and provision is made for rights of appeal.

Part 10 provides for the roles of the Medical Council and the Health Service Executive with regard to the education and training of medical students, interns and medical practitioners undertaking specialist medical training. The provisions of this Part are influenced by the recommendations of the Fottrell and Buttimer reports on medical education and training. It is clear that medical education and training must be undertaken in partnership by the various stakeholders and this Part emphasises that requirement for co-operation and consultation.

Following the dissolution of the postgraduate medical and dental board under Part 12, the HSE will now be responsible for the co-ordination and development, including funding matters, of medical and dental specialist education and training.

The education and training role of the Medical Council was outlined in a minimalist fashion under the Medical Practitioners Act 1978. Sections 87 and 88 now outline in clear terms the role of the council in setting standards and guidelines on medical education and training and monitoring adherence to those guidelines. The council will continue to be the body which inspects and approves medical training programmes and institutions at basic, intern and specialist level and to approve medical qualifications. The Medical Council will also continue to act as the competent authority for the recognition of EU medical qualifications.

Part 11 is new to the system of regulation of medical practitioners as it outlines new requirements for the maintenance of professional competence of registered medical practitioners. The Medical Council, the HSE and other employers and individual medical practitioners are given statutory responsibilities by this part. An appropriate link to fitness to practise procedures is also included.

Part 13 provides for a number of miscellaneous matters, including a power for the Medical Council to investigate unregistered persons and new provisions regarding licensing for the practice of anatomy.

As I said at the outset, the Bill marks a further significant step in the process of strengthening and expanding provisions for the statutory registration of health professionals as set out in the health strategy. It is further confirmation of the Government's commitment to the delivery of a reformed health service which has as its core objective the maximisation of the level and quality of care provided to patients in the years ahead. Protecting patients and supporting doctors is at the heart of the policy behind this legislation and I urge Members to support the principles it outlines.

I commend the Bill to the House.