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Dáil Éireann debate -
Wednesday, 18 Jun 2003

Vol. 568 No. 6

Opticians (Amendment) Bill 2002 [ Seanad ] : Report and Final Stages.

Amendments Nos. 1, 5, 6 and 8 are related and are taken together by agreement.

I move amendment No. 1:

In page 3, line 31, after "spectacles." to insert the following:

"and

(c) by the insertion of the following subsection:

‘(2) Reference in section 21(1)(b), 25(1)(b), 33(1)(b) or 34(1)(b) of this Act, or in or by virtue of the regulations referred to in section 24A(b) or 33A(b) of this Act, to a person who has not been declared bankrupt shall be construed as a reference to a person who is not for the time being an undischarged bankrupt.”

I know the Minister of State, Deputy Brian Lenihan, was not dealing with this issue before, so it is important to remind him that there is a difficulty with regard to the registration of opticians. Standards are obviously set so that unsuitable people would not be given registration. With regard to the requirement that a person who has not been declared bankrupt qualifies but somebody who has been declared bankrupt does not, there are problems with this requirement.

For example, if the Minister of State decided when he was young and foolish to set up a business, but it failed with the result he went bankrupt, then when he matured, as he has done, this error of judgment and youthful experiment would come back to haunt him if he wished to be a registered optician. This does not make any sense at all. If one is an undischarged bankrupt, it is a different matter entirely. The Bill, however, is not stating that, but instead it is stating if one "has been declared bankrupt". That is an important distinction.

I was advised by the Minister for Health and Children on Committee Stage that this was a requirement under EU regulations. My legal adviser has informed me that this amendment would resolve that difficulty, and would ensure fairness and level the playing field. Without this amendment, a grave injustice could be done in the future. This is an important amendment that would deal with an issue that has not been thought out sufficiently by the parliamentary counsel.

I support Deputy McManus's list of amendments. The logic of the presentation she has made sustains the argument. I disagree with her point on the Minister of State having not dealt with this issue before on Second Stage. Was it not the Minister of State who had an interesting exchange with me on dependants?

No, it was not on Committee Stage, but on Second Stage.

Yes, on Second Stage.

So, the Minister of State is familiar with the issue. The arguments presented by Deputy McManus with regard to people who have had an experience with bankruptcy is a fair and just view. Such a designation and experience does not warrant a life sentence, curtailing later ambition or self-improvement. I support the Deputy's call for the amendment to be accepted.

I support the amendment.

I also support Deputy McManus's amendment.

There are eminent advisers, but the Government has to proceed on the advice of the office of the parliamentary counsel. We sought the advice of the office since Committee Stage on this specific matter. Our legal advice is that the phrase "has not been declared bankrupt" mirrors the wording used in the EU Directive on Mutual Recognition on Professional Education and Training. We are obliged to mirror that wording in our legislation. I note that the amendment tabled by Deputy McManus seeks to clarify the meaning of "declared bankrupt". It is not necessarily the case that that is not implicit in the phrase "has not been declared bankrupt". There may be an issue of interpretation on that, but I am advised we still have to comply with the EU provisions.

If we accepted the amendment, it would create a different regime for optometrists and dispensing opticians whose qualifications had been obtained in the State or outside the European Union on the one hand and those qualified in other member states on the other. In the view of the advice of the parliamentary counsel that would raise a difficulty in terms of our compliance with EU obligations. We would be introducing a requirement or a refinement into the definition of "bankruptcy" which does not exist in the other member states. In those circumstances, we could leave ourselves open to an issue of discrimination between different members states.

The Department of Education and Science advised that the Commission is looking at a process where it is consolidating the sectoral and general systems directives into one. We are advised that it is inappropriate to depart from the terminology used in the EU Directives. Under EU law there can be no differentiation in treatment or access to the profession between Irish nationals and EU nationals unless there are compelling grounds for same. If the requirement of Community Law includes disqualification based on the declaration of bankruptcy, then we have to maintain it as the consistent standard in this State as in other member states. Of course, the question of how that falls to be interpreted is not concluded by our enactment of the legislation in this form because its interpretation is a matter of EU law and, as I understand it, has not yet been determined by the EU law courts.

This is very unsatisfactory and the ground is shifting all the time. Either the Minister of State is saying that if one is ever declared bankrupt one can never become a registered optometrist or he is not. I would have thought that we have the power to interpret what is being presented to us by way of EU directives or regulations. The Minister of State tells us that this would be in conflict with all the other EU member states but is that true and has he checked with all the other countries? Can he honestly tell me that someone who was declared bankrupt in their youth will still be prevented from being registered as an optician in any EU member state 20 years later? Is that correct? Is the Minister of State saying that where we have an opportunity to interpret in a reasonable way, we should not do so? The Minister of State knows well that in relation to any court decision, it is not what the Minister says that matters but what is actually enshrined in law. We have an obligation to address this matter now. Surely we are still a sovereign State?

The Minister of State can interpret this in a reasonable manner to ensure that unfair restrictions are not being put on people who were unable to avoid bankruptcy in an earlier period. It is wrong that this matter is not being addressed now. What is the Minister of State waiting for? Is he waiting for somebody to go to court? He is a barrister and obviously he has great faith in the courts but that is not really a solution for many people. It would be much better if we did it. The parliamentary counsel is always brought out of the cupboard whenever there is a difficulty. I am not even sure who the parliamentary counsel is but I know that the Bill could be improved by this simple change. It is within the power of the Minister of State to do so and he is taking advice from the parliamentary counsel, which, in my view, is plainly silly.

The terms of the directive are clear and our obligation as a sovereign State that has entered into international arrangements is to implement directives according to their terms. The terms of the directive require us to insert this particular qualification. To ensure uniformity and consistency of practice on this matter throughout the European Union, we must transpose into our domestic legislation that phrase, in the same way as it has been transposed into the domestic legislation of other member states.

We can interpret it, though.

Our advice is to the contrary because the interpretation of that phrase is ultimately a question of EU law, not Irish law. It is an EU law requirement that we have this disqualification for optometrists. The question of whether the phrase captures only an undischarged bankrupt or extends beyond that is a matter that has to be left open. Were we, as legislators, to insert this additional and very specific clarification we would be departing from the uniformity of EU law, which the directive requires us to implement. As I understand it, that is the argument of the parliamentary counsel. We took advice from the parliamentary counsel on this issue in relation to the implementation – I prefer that word to "transposition"– of this directive into domestic law. Were I to accept Deputy McManus's amendment, in the context of EU member states, Ireland would have inserted an additional requirement into the directive. The legal advice is that it is not open to us to do that.

The law of the land.

Amendment put and declared lost.

Amendment No. 2 in the name of Deputy Ó Caoláin is out of order as it does not arise from committee proceedings.

May I ask a question on that? I am not a member of the Committee on Health and Children, although I am my party's spokesperson for that area. Not having the gift of bilocation, I raised this matter on Second Stage, the only other opportunity open for me to do so. It is on the record of the House that I referred specifically to the report of the consultants, Indecon, who had recommended that the opticians' board should have a patient representative. Indeed, the Minister of State, Deputy Brian Lenihan, was the Minister attending the debate at that point. I followed through by the only other mechanism open to me from that contribution and I wished to press the issue of a patients' representative.

You have made your point, Deputy.

It is with great disappointment that I note the decision that my amendment cannot now be moved.

The Chair has no control over that matter because in accordance with Standing Orders, once the issue does not arise out of committee proceedings, the amendment is judged inadmissible for Report Stage.

The Minister of State is seeking to contribute.

We will move on to amendment No. 3 in the name of Deputy Cowley, which arises out of committee proceedings. Amendment No. 4 is related so both amendments may be discussed together by agreement.

On a point of order, I have no objection to dealing with the issue on Final Stage, if that is permissible under Standing Orders, but I am in your hands, a Cheann Comhairle.

Do you wish to recommit the Bill to Committee Stage to take the amendment?

I will not press the Minister of State. I respect the fact that he made an intervention to accommodate the opportunity of dealing with the matter on Final Stage. If the Standing Orders thwart us further, then I understand the situation. However, I am highlighting an anomaly in that I cannot be at all these committees. I serve on the Committee on Finance and the Public Service but I have neither the facilitation nor the numbers to deputise on every committee that I would wish.

I do not have the facilitation to go back to Committee Stage so we will proceed.

The Minister of State may actually have that facility but I will not press him.

Amendment No. 2 not moved.

I move amendment No. 3:

In page 3, after line 31, to insert the following:

"3.–The packaging of ‘ready-made reading spectacles' and any printed material attached to or accompanying such spectacles shall bear a warning in the following form:

"Government Health Warning: "ready-readers" are recommended only as a temporary substitute for prescription spectacles. A sight test by a registered optometrist is advised.".

I am glad of the opportunity to move this amendment. People require ready-readers, which is what they claim to be – ready-readers for people in a contingency. The trouble is, however, that people will use these ready-readers as an excuse not to have an eye test. There is a natural instinct to choose a stronger lens, like people taking extra paracetamol, so their eyes have to work harder. The public will be at risk because they do not know what they are getting. They do not understand that each eye has different defects. A product such as ready-readers, which is supposed to be ready for all, is not ready for anybody because it does not take into account the sight variation in our eyes, which have different requirements when there are sight defects.

The natural instinct is for people to pick a stronger lens just as people take extra paracetamol for a headache, frequently exceeding the recommended dose. It is human nature, but by getting a stronger lens their optical lens must work harder. They are getting a stronger prescription than they need. The lens's only function is to magnify but if people are getting something that makes an image larger, they think they have got a better product, which is not the case. That is the rock upon which people can perish. There is a wide range of lenses available, from 0.5 to six. I know the Bill does deal with a size six lens, but eye strain can and will result from such a lens, causing chronic headaches. One man's meat is another man's poison. People are getting headaches from something which could have been prevented. There is an onus on the Government in that regard.

The iris must accommodate, therefore it must work harder. I know the Cheann Comhairle is aware of the condition called astigmatism. Ready readers are not suitable for people with that condition. There are different vertical and horizontal measurements in the eye and the measurement is not the same around the cornea or the transparent covering of the eye. The lens may also be uneven. If there is more than one unit of difference between the vertical and the horizontal, the ready reader will not solve the problem. It is wrong and inappropriate to use the ready reader in that case. It might solve the vertical problem, but not the horizontal problem. It is difficult for someone with astigmatism to use contact lenses because of the different contours of the eye. People with good distance vision who do not have astigmatism or myopia find that their lens must work harder. That increases the need for stronger spectacles and the eyes must adapt to the stronger lens. The eyes, therefore, become more dependent on the glasses which must be used more often. It is like someone, who does not need spectacles, using them.

There is something we can do about this. We must issue a warning so that people are aware of the dangers. There is more chance of eye strain or chronic headaches across the forehead and eyebrows that could be prevented if people knew the reason for it. There is an onus on the Government to highlight that.

It should also be pointed out that ready readers are not suitable for children. Children under seven years of age should not use ready readers because there is a danger of permanently damaging their sight. It is not appropriate for children to use them. However, if they are readily available, people, who are financially compromised, will use them. Many people who are on the bread line might use these glasses when their own break. However, it can result in amblyopia of disuse. In other words, the brain gets two different images, like someone with a turn in their eye or a strabismus, which is commonly called a squint. The brain ignores one image and that eye becomes useless. The same thing happens if one uses ready readers because they do not address the sight problems. It is possible the child could end up with amblyopia of disuse, in other words, a useless blind eye. Children under seven years of age must not use ready readers. However, they will not know that unless parents are warned about it. It is dangerous for children under seven years of age to use ready readers because they could permanently damage their sight. That is why I tabled these amendments.

I support Deputy Cowley's amendments Nos. 3 and 4. I commend him not only for tabling them but for the informed case he presented. While I welcome the wider availability of ready made reading spectacles, there must be a balancing arrangement in terms of cautioning people about the consequences of long-term dependency and non-prescriptive use. The second amendment reflects on the issue of child dependency, although I note that Deputy Cowley mentioned children under seven years of age. I said on Second Stage that young people today, particularly young girls, regard spectacles as a fashion accessory. That is contrary to the way it was when I was growing up. Many of them wear spectacles with clear glass inserts rather than with lenses which correct eye problems. There is a need to signpost caution and to bring to the purchaser's attention, particularly to young people's attention, that this is not the panacea for all their concerns about disimproving eyesight. I support both of the amendments. The arguments presented are a credit to Deputy Cowley.

As regards the proposed amendment, I appreciate the spirit with which it was tabled. However, it is not legally necessary to go down that route because the Medical Services Directive, 93/42/EEC, which was implemented into Irish law by Statutory Instrument 254 of 1994, deals with the issue of labelling. Under that directive, ready readers are classed as Class I medical devices. In practice, that means that ready readers must be CE marked by their manufacturers. The CE marking is the European wide recognised symbol for the safety, quality and per formance of medical devices. This marking indicates the safety of a device and a product carrying the CE marking may be placed on the European Union market without further restrictions. Under the directive, manufacturers of ready readers are obliged to supply information regarding the safe use of their product, taking account of the training and knowledge of potential users. The label must include any warnings and-or precautions to take. That is an existing legal requirement. Under the directive, it is the manufacturer's responsibility to provide this information.

In Ireland a small number of outlets are currently selling ready readers. The Opticians Board has not taken action against them because deregulation is pending. In those pharmacies which sell ready readers, warning notices can be seen advising of the need for eye examinations. Such warnings must be given as a matter of professional regulation under the existing EU provisions. In the circumstances, an amendment to the effect that ready readers are not a substitute for eye examination is not required.

It was originally proposed that the sale of ready readers should be subject to an age restriction. However, in June 1999 the Department was advised that the Opticians Board did not favour an age restriction as it would be unenforceable. The Department's chief medical officer advised that an age restriction was unnecessary. The decision to drop the age restriction related to the position in other European countries. A survey carried out in 1994 by the European Council of Optometry and Optics among the European Union member states, together with Norway and Switzerland, identified only three countries with restrictions on persons to whom ready readers can be sold. These were France, the United Kingdom and Ireland. In the United Kingdom the sale of ready readers is restricted to persons over the age of 16 where the sale is wholly for the purpose of correcting, remedying or alleviating presbyopia. The United Kingdom Department of Health advised that when the relevant legislation was drafted, it was not intended that an age restriction would apply, but one was included when the Bill went to the House of Lords. The UK General Optical Council has advised that this provision is not policed by the council because there are so many outlets selling the glasses it would be impossible to prove whether the sale is wholly for the purpose of correcting, remedying or alleviating presbyopia.

Deputies should be aware that any amendment imposing a labelling requirement would render the Bill notifiable to the European Council under the directive on technical standards. This is because such a regulation would be considered a potential barrier to trade.

I thank the Minister of State for his reply. I take the point about the directive. However, it states that CE marking is a symbol for the safety, quality and performance of a medical device. That is a contradiction. Given the reasons for the amendment, how can it be a recognised symbol for safety, quality and performance? Just because something is done in one country in Europe does not make it right. I made the point that this country adopted the euro, but the United Kingdom did not. Who is wrong or right? What about the right to bodily integrity, which is a right under our Constitution? We have an obligation to protect the right of our citizens to bodily integrity. Surely that is the case here? What happens if someone gets the ready readers and a warning is not visible? There is an onus on the Government in that regard. We live in a litigious society. If an individual crashes his or her car, will the Government be subject to a law suit? Just because it is difficult to enforce does not mean it should not be done. This issue is about making the information available. While there is a legal obligation on the manufacturer to provide warnings and so on, the Government also has an important role.

I agree with the Deputy that we live in a litigious country, but opticians and vested interests are also aware of that. That is the reason, as a matter of professional obligation, they display warning notices. The existing EU legislation together with professional practice based on it is sufficient. The relevant regulation states: "The label must bear certain particulars, including any warnings or precautions to take." The matter is covered by EU law and for that reason I cannot accept the amendment.

Does the regulation cover children? I have never seen a warning that states that such spectacles are unsuitable for children. Perhaps the Minister will provide information on that.

Amendment put and declared lost.

I move amendment No. 4:

In page 3, after line 31, to insert the following:

"3.–The packaging of ‘ready-made reading spectacles' and any printed material attached to or accompanying such spectacles shall bear a warning in the following form:

‘Government Health Warning: Sustained use of "ready-readers" by children under seven years of age can result in permanent visual defect.'.".

Amendment put and declared lost.
Amendments Nos. 5 to 8, inclusive, not moved.
Bill received for final consideration and passed.
Sitting suspended at 6.35 p.m. and resumed at 6.45 p.m.
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