I move: "That the Bill be now read a Second Time."
This Bill seeks to modernise the Opticians Act 1956, as there have been no substantive amendments to it since its provisions came into force in 1959. There is now a pressing need to bring the current legislation up to date with the modern practice of optometry while advancing the interests of the consumer and ensuring that effective precautions are taken to safeguard public health. I hope it will therefore receive the full support of the House.
It is important that we remind ourselves of the context of the regulation of the practice of optometry in Ireland. The primary purpose of the 1956 Act was to protect the public by a number of legal mechanisms. Those qualified to practise or those who, at the Bill's introduction, were deemed to be experienced enough to practise, now had to be registered. There was a commitment to fostering continual improvement in the education and training of entrants to the professions. A set of rules was devised under the Act to control the activities of registered opticians and sanctions were put in place to enable the Opticians Board to discipline those persons who breached the provisions of the Act or the rules of the board as approved by the Minister for Health.
The development of legislation to regulate the practice of optometry was given impetus by the creation of the National Health Service in the United Kingdom in the 1940s. When the NHS was established, central professional committees were set up simultaneously to assess the applications of those who wished to be approved as service providers under the new system. In the case of the profession of optometry, some of those who applied had no formal training or qualification. They were therefore deemed by the central professional committees to have inadequate competence to act either as ophthalmic opticians or dispensing opticians in the United Kingdom. Consequently, an influx of persons who claimed to be ophthalmic opticians and who had been excluded from the National Health Service arrived in Ireland, where there were no barriers to their activities at that time. As evidence of those matters built up, the then Minister for Health and his officials accepted the need for legislation to ensure adequate standards of training and education for those entering the professions and controls on their activities and behaviour. The Opticians Bill was subsequently introduced in July 1955 and passed in 1956. Following the appointment of the first Opticians Board and the approval of the Minister for Health of the rules made under the Act, the provisions came into force in 1959.
I will examine the Bill's main provisions in detail. First, the title "optometrist" will be used in place of "ophthalmic optician". There is no issue of principle involved in the change of title. The amendment's purpose is to give a legislative basis to the use of the more modern title of "optometrist". During the Bill's passage through the Seanad, there was some confusion as to use of the titles "optician", "ophthalmic optician" and "optometrist". I would like to clarify that the term "optometrist" will replace any occurrence of the title "ophthalmic optician" or "registered ophthalmic optician" in the principal Act, while the term "optician" or "registered optician" will remain unchanged.
Sections 24, 25, 33 and 34 of the principal Act will be amended to provide that being of good character and not having been declared bankrupt are requirements for the registration of optometrists and dispensing opticians trained within and outside the EU. In addition, not having been prohibited or suspended from practice because of conviction for a criminal offence or serious misconduct in connection with the carrying out of professional duties will also be a requirement for registration for both professions.
Sections 24, 25, 33 and 34 are also being adjusted to provide for the registration of optometrists and dispensing opticians in different categories – those trained in the EU and those trained outside the EU. Those provisions will correlate with the terms of the EU directives on the mutual recognition of professional education and training, which were transposed into Irish law by SI 1 of 1991 and SI 135 of 1996.
One of the Bill's main provisions will be to deregulate the sale of ready-made reading glasses and provide for their wider and cheaper distribution. Under current legislation, only a registered medical practitioner or a registered optician may prescribe and/or dispense spectacles. In 1993, the Opticians Board adopted rules under which a registered optician could sell spectacles without prescription where the spectacles are intended to correct, remedy or relieve the condition known as presbyopia.
The Office of the Attorney General had previously advised that legislation to deregulate the sale of ready-made reading glasses was urgently required to avoid a potential liability in damages, should proceedings be instigated by the European Commission – as was proposed – and prove successful. My Department was subsequently advised, through the Department of Enterprise, Trade and Employment, that the Commission had decided to close the case. It is assumed that the Commission took that decision on the basis of our proposal to deregulate. However, under the current legislation, the potential for action to be taken by private citizens in the Irish courts remains. A case was heard by the High Court in December 2002 and a judgment is awaited.
With regard to the Bill, the specific details of how the sale of ready-made reading glasses will be deregulated are as follows. While section 49(1) of the principal Act, which regulates the sale of spectacles, will remain unchanged, its provisions will no longer apply to the sale of ready-made reading spectacles by unregistered persons. The Bill redefines "spectacles" to exclude ready readers, afocal sunglasses and afocal goggles and defines "ready-made reading glasses" separately. The separation of ready readers from the definition of "spectacles" in the Act has the effect of excluding them from the provisions of section 49(1). Contact lenses, with or without focal power, are included in the definition of "spectacles" and their sale will remain regulated.
Originally it was proposed that the sale of ready-made reading glasses should be subject to an age restriction and accompanied by the stipulation that clients must be advised that ready readers are not a substitute for normal eye examinations. However, after consultation and detailed consideration, it was decided that the above proposals would not be included because: it was realised there would be practical difficulties with enforcement among sellers not registered with the Opticians Board; the stipulations are not enforced in other EU jurisdictions; imposing a labelling requirement would place an unfair burden on the industry; and, while worthy, the proposals are not medically necessary.
The liberalisation of the sale of ready-made glasses already applies in the majority of member states of the European Union and should find favour with the general public. I note that the recent report carried out by Indecon International Economic Consultants for the Competition Authority welcomed my Department's proposals and stated that deregulation would lead to an improvement in competition and consumer welfare.
Since 1993, the Opticians Board has expressed concern over the lack of disciplinary powers to deal with allegations of professional misconduct or unfitness to practise against registered opticians. The current legislation provides two categories of fines reflecting the fact that certain offences under the Act are more serious than others. The amounts payable in the two categories are derisory by modern standards: for first offences fines are £20 and £10, and for second and subsequent offences the fines are £100 and £50, respectively.
It is proposed to provide for fines which range between €500 and €3,000. That will enable the board to apply reasonable discipline in an effort to ensure that those registered under the Act, as well as those commercial interests which may employ them, are obliged to behave in a manner which will contribute to the protection of the public by ensuring proper standards of practice and behaviour.
The amendments to section 48(1) concern the administration of drugs. Section 48(1)(b) of the current legislation places an absolute prohibition on the prescription and administration of drugs by a registered optometrist who is not also a registered medical practitioner. However, in modern optometry practice it is not possible to conduct a proper examination of the eye without dilation of the pupil, which requires the use of mydriatic drugs. One effect of such drugs is to freeze the accommodation of the eye, that is, to reduce the eye's ability to change focus. In practice, optometrists are interpreting the 1956 Act to mean that the use of such drugs is lawful, since the principal Act refers to the administration of drugs whose purpose is to paralyse the accommodation of the eye. Optometrists contend that paralysing the eye is not the purpose but the effect of their professional activities, an application, perhaps, of the old moral principle of direct and indirect effect.
It is now proposed to remove the absolute prohibition on administering drugs. Rather than permitting unrestricted access to drugs, the following additional changes are being made in conjunction with the deletion of subsections 48(1)(a) and (b) to allow optometrists to carry out their professional function while stopping short of facilitating their medical treatment of an injury or disease of the eye. Article 14 of the Medicinal Products (Prescription and Control of Supply) Regulations 1996 will be amended simultaneously with the Bill's enactment to ensure that opticians will have limited access to just three diagnostic drugs. The drugs in question are for topical application only, and they cannot be injected or taken orally. Optometrists will not have the authority to prescribe or supply those drugs. In other words, they will not be for resale and they may not be given to the patient. The regulations will also stipulate that optometrists may only use those drugs in the course of their professional practice.
Optometrists will therefore be unable to carry out therapeutic treatment, as they will not be permitted access to therapeutic drugs. Control of the use of certain medicines by opticians will be put clearly within the remit of the Minister for Health and Children and will safeguard against future use of potentially dangerous drugs.
Furthermore, in the revised section 48(1)(c), there will be a continued prohibition on diagnosing diseases. It is proposed to introduce an amendment to that subsection which will state that, if an optometrist suspects the presence of a condition or a disease which requires medical attention, he or she will be obliged to inform the patient and recommend that the patient consult a registered medical practitioner.
I would like to emphasise that there is now a statutory obligation to refer under current legislation. The new requirement for the referral of patients to medical practitioners where injury or disease is suspected will be indicative of best practice.
The question of striking a balance has not been easy to resolve, and there have been extensive consultations with the opticians board and the College of Ophthalmologists. At a meeting with the college in February, the President outlined the difficulties which many ophthalmologists had with the use of the word "treatment " which was originally in section 12(b)(4) of the Bill. I subsequently gave an undertaking to have my Department re-examine this area. Having examined the subsection in question and having consulted with the Office of the Chief Parliamentary Counsel to the Government, I proposed an amendment on Committee Stage of the Bill in the Seanad to delete the words “or treatment of the eye” from section 12(b)(4), which was accepted.
The decision to proceed with the provisions allowing optometrists to use certain drugs in the course of their professional practice was influenced in part by the fact that the UK General Optical Council permits the use of drugs by optometrists for diagnostic purposes and is proposing to extend their provisions to allow optometrists to use drugs for therapeutic purposes also. The UK College of Ophthalmologists has accepted the General Optical Council's decision on diagnostic drugs.
This Bill is intended to open up competition in terms of the deregulation of the sale of ready-made reading glasses, but it also has a strong element of health and safety built into it, which is indicative of best practice. I have recognised from the start that unanimity on the issue of the use of drugs by optometrists would be very difficult to secure. There are those who would wish to see a more restrictive approach and those who would wish to see a more liberal approach. However, I hope that the Department's previous concessions will enable a level of compromise, if not consensus, to be reached. I am pleased to introduce this short Bill in the Dáil. I commend it to the House and look forward to hearing the views of Deputies.
