SELECT COMMITTEE ON HEALTH AND CHILDREN debate -
Wednesday, 11 Jun 2003

Vol. 1 No. 3

Opticians (Amendment) Bill 2002 [Seanad]: Committee Stage.

Section 1 agreed to.

SECTION 2.

Ms McManus

I move amendment No. 1:

In page 3, paragraph (a), line 19, after “presbyopia” to insert “and which are labelled at the point of sale or accompanied by a written notice to the effect that they are not a substitute for spectacles and recommending consultation with a registered optometrist”.

This is fairly obvious. When we are opening up the opportunity for people to buy glasses without having to go through any kind of process of examination, it is important that we indicate to the consumer the limitations of such glasses. We are always talking about giving information to the public on good health practice and health promotion and in this instance I do not accept the Minister's view that it is unreasonable or impractical to do so. I ask him to take this amendment on board.

Minister for Health and Children (Mr. Martin)

I will explain the background. The Deputy's amendment may not be required because the medical devices directive - 9342/EEC - as transposed into Irish law by Statutory Instrument 254 of 1994, deals with the issue of labelling. Under this directive, ready readers are classed as class 1 medical devices. In practice, this means ready readers must be CE marked by their manufacturers. The CE marking is the European-wide recognised symbol for the safety, quality and performance of medical devices. This marking indicates the safety of a device. 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. Under the directive, it is the manufacturer's responsibility to provide this information. In the circumstances, an amendment to the effect that ready readers are not a substitute for eye examination is not required.

Ms McManus

What happens if manufacturers do not comply with the directive and do not provide the information?

Mr. Martin

They would be in breach of the directive.

Ms McManus

The directive is not contained in national legislation.

Mr. Martin

It is. It was transposed into Irish law.

Ms McManus

Would it be by that route that they would be pursued?

Mr. Martin

I will check the enforcement procedure. I do not have details with me but can forward them to the Deputy.

Amendment, by leave, withdrawn.

Mr. Martin

I move amendment No. 2:

In page 3, paragraph (b), line 24, to delete “containing”.

The Opticians Board recently drew my attention to the description of contact lenses in section 2 (b) which currently states: “contact lenses whether containing afocal or focal lenses”. The board’s view is that the word “containing” should be omitted. I agree with its view and therefore propose an amendment to this effect. It is a change in terminology.

Amendment agreed to.

Ms O. Mitchell

I move amendment No. 3:

In page 3, paragraph (b), line 31, after “spectacles” to insert the following:

", or

(iv) ready-made reading spectacles which are also sun glasses".

I appreciate that it is not necessary to exclude sun glasses, but the reality is that the Bill, in page 3, line 30, specifically excludes ordinary sun glasses from the definition of spectacles. Therefore, to avoid all confusion, it is necessary to specifically exclude ready readers which are also sun glasses. It may be that nobody will ever contest this, but the likelihood is that somebody will find a reason to contest it. It is an oversight.

Mr. Martin

The definition of spectacles in the Bill is in a form which includes and excludes certain items, but it is not exhaustive. Ready-made reading glasses are excluded from the definition. By extension, from a practical reading and interpretation of the objective of the amendment, it would follow that the mere tinting of ready-made reading glasses would not include them in the definition of spectacles. My Department has consulted both the parliamentary counsel and the Association of Optometrists on the matter and they agree the tinting of ready-made reading glasses would not make any difference to their function. The parliamentary counsel therefore advised that the amendment proposed by the Deputy is unnecessary. I tend to agree with that view.

Ms O. Mitchell

I do not agree with the Minister. I accept that it does not make any difference to their function, but it may make a difference to the law. Does the Minister understand the point I am making? If we are making a new law, its meaning should be absolutely clear. Sunglasses and ready-made spectacles are being excluded.

Mr. Martin

I took legal advice.

Ms O. Mitchell

Does the Minister believe it is certainly included?

Mr. Martin

Yes.

Ms O. Mitchell

In that case I will withdraw the amendment.

Amendment, by leave, withdrawn.

Section 2, as amended, agreed to.

NEW SECTION.

Chairman

Amendment No. 4 is in the name of Deputy Cowley. It has already been discussed with amendment No. 1.

Dr. Cowley

I move amendment No. 4:

In page 4, before section 3, to insert the following new section:

"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.'.".

People will use ready readers as an excuse not to have an eye test. My information is that people will pick a stronger lens, like taking more paracetamol than is required. The function of the lens is to magnify. People think if it magnifies it more, they are getting a better quality set of spectacles but that is not true. There is a wide range of lenses and eye strain can be caused. The iris will have to work harder. An eye problem such as astigmatism means the parameters of the eye are different, the vertical and horizontal measurements are different in the eye. The use of a standard lens will only correct part of the eye, if at all. This condition could be due to a congenitally uneven cornea or the covering of the eye or even the lens may be uneven. A ready reader will not solve this problem. If there is more than one unit of difference between the vertical and the horizontal measurement, the ready reader will not solve the problem and should not be used. That is the reason it is so difficult to treat astigmatism by the use of contact lenses. Even for those with good distance vision who do not have astigmatism or myopia, their lens has to work harder which will increase the need for stronger spectacles. The eye will adapt but what will happen is the eyes will become more dependent on the glasses. It is like giving glasses to someone who does not need them. It will accelerate the demise of their eye as regards ageing. There is more chance of eye strain or headache which could become chronic.

I raise the issue of the danger to children of the use of ready readers and will raise it on Report Stage also. There is a danger to the eyesight of children, particularly those under seven years.

Mr. Martin

I have answered in my reply to amendment No. 1. In 1999 the Opticians Board advised that it was not necessary to advise that ready readers should not be used for extended periods as users would simply stop wearing them if they became uncomfortable. It is also worthwhile looking at the situation in the United Kingdom where there are no specific labelling requirements such as the specific one advanced by the Deputy. EU regulations state there must be safety warnings according to the European directive which has been transposed into Irish law.

Dr. Cowley

Must they be advised by the retailer?

Mr. Martin

We have decided not to put in such a specific labelling advice.

Dr. Cowley

Just because it is not done in England does not mean that is the correct action. They do not have the euro, for example.

Mr. Martin

I accept that. This is a very modest step towards the regulation of ready readers. This Bill is 13 or 14 years in gestation with conflict on both sides - or from different perspectives. We are trying to achieve a balance in our approach and safety is central.

Dr. Cowley

I agree with the safety aspect. What worries me is the risk to somebody with normal sight. If the ready readers are only correcting half their sight - for instance if they have astigmatism - it means they will be half-blind. I wonder what would happen if a person crashed the car while using ready readers with no warning labelling. We have a very litigious population. Where would the Government stand in that instance?

Mr. Martin

Ready readers are class one medical devices. They are covered by Statutory Instrument 254 of 1994 which our predecessors introduced to transpose a medical devices European directive which deals with placing an obligation on manufacturers. This would deal with issues pertaining to the safe use of the product, taking account of training and knowledge of potential users. The label must include any warnings or any precautions to be taken. That is a legal obligation on the manufacturers of ready readers.

Dr. Cowley

Does the Minister mean it is up to the manufacturers to include that warning?

Mr. Martin

In law, yes.

Dr. Cowley

I suggest there should be a warning about the need for an eye test and the danger to children. I will return with the amendment on Report Stage.

Amendment, by leave, withdrawn.

Sections 3 and 4 agreed to.

SECTION 5.

Chairman

Amendments Nos. 5 to 8, inclusive, are related and may be discussed together.

Ms McManus

I move amendment No. 5:

In page 4, lines 36 and 37, to delete "has not been declared" and substitute "is not an undischarged".

I did not raise this point on Second Stage because I was not aware of the difficulty. Having read the Seanad debate and taken legal advice I am concerned about the definition of what would exclude somebody from the register of optometrists. In principle, the points such as training and being of good character are acceptable. Paragraph (b) states the person must be of good character and repute and not have been declared bankrupt. I propose that a person can only be prevented from registering if he or she is an undischarged bankrupt at the time of registration. I believe in redemption. If somebody has been declared bankrupt in the past and then puts his or her life in order, that bankruptcy should not be hung around his or her neck for the rest of his or her life. When the Bill was under consideration in the Seanad, the Minister did not believe that was the implication of the wording but my advice is that that is the interpretation and regardless of what the Minister believes, the Supreme Court has decided that the words written down in an Act are what will be taken into account and it will not take a view of the Minister into account. It is very important that this is put right.

Under paragraph (c) another exclusion is if one is prohibited or suspended from practising by reason of a conviction for an offence or serious misconduct in connection with the carrying out of professional duties. This may be a far-fetched proposition but if, for instance, somebody murders his wife, as long as it was not a patient, technically speaking, he would not be covered by these requirements. However, a person who is or has been a bankrupt would be covered and be prevented from registering. There is a requirement on Members of the Oireachtas not to be bankrupt but even Oireachtas Members have a second chance. If a Member loses a seat because of bankruptcy, there is nothing to stop him or her coming back having sorted out his or her affairs, presenting himself or herself to the electorate, and coming back into the Oireachtas if re-elected. It is not a life sentence. The interpretation of these words in the Bill leads me to believe - I trust my legal advice - that it is a life sentence. It is important that we are very specific in terms of what we are saying about somebody. One can be guilty of worse things than bankruptcy.

Mr. Martin

I have some sympathy with the Deputy's views. Senator Ryan raised this point in the Seanad. Historically, bankruptcy has been a standard feature of legislation.

Ms McManus

As an issue, yes.

Mr. Martin

If I am not mistaken - I have been a Member of the House for about ten years - it has always been so, if a Member is declared bankrupt.

Some of the general points the Deputy has made are quite valid, to a certain extent, including her point on redemption. Giving people a chance to sort out their lives and get on with it again is meritorious. On the other hand, the issue needs to be examined by the Oireachtas. I will communicate with the Attorney General on the issue because I am interested in it - not just the bankruptcy issue but how one can declare people not to be fit for any particular discipline or career. That being said, I undertook to seek the opinion of the parliamentary counsel on the issue. The parliamentary counsel has informed us that the phrase "has not been declared bankrupt" mirrors the wording used in the EU directives on mutual recognition of professional education and training, transposed into Irish law by Statutory Instrument 1 of 1991 and Statutory Instrument 135 of 1996.

The Bill, as drafted, amends sections 24, 25, 33 and 34 of the principal Act to bring their provisions clearly into line with EU directives. The amendments would have the effect of creating a different regime for optometrists and dispensing opticians whose qualifications have been obtained either in this State or outside the European Union, on the one hand, and those qualified in other member states, on the other. That would not be ideal.

The Department of Education and Science has lead responsibility for transposition of the relevant EU directives. It has advised us that the European Commission is engaged in a process whereby it is consolidating all the sectoral and general systems directives into one directive. It is a matter that we can input into that process. We can ask that the matter be looked at in terms of the wider picture because we have signed up to the directive in terms of the mutual recognition of professional education and training. Therefore, at this stage I will not consider the amendment for this Bill. However, I hope we can sort out the matter in the context of the new directive.

Ms McManus

I do not want to labour the point but we accept that bankruptcy is an issue. That is the reason I tabled an amendment which would allow for the fact that if somebody was declared bankrupt, they could not register. That matter would be sorted within the amendment. However, I find it difficult to accept the idea that because it is EU law we have to follow it automatically and unquestioningly, even though it is clear there is a issue concerning it. We are creating our own legislation. We have our own Judiciary, and judges make judgments on the basis of the laws we pass. There is a responsibility on us therefore to make sure people are not unfairly penalised. We can discuss this in whatever format we like as regards making sure that there is a common playing field across Europe or even outside Europe. That work can continue but we are being asked to support legislation which has something unacceptable within it. There is nothing to stop us from putting it right in the way I am proposing. I do not understand the reason we cannot do so. It is like indexation - it is another idea that somehow we have to keep including in legislation matters which at some point in the future we can change. Let us do it now to ensure what we are including will be of the best clarity in terms of any future interpretation by the courts.

Mr. Martin

We cannot disregard what is happening in Europe. We work in concert with other European countries. It has always been difficult to obtain mutual recognition of professional qualifications in a European context in terms of mobility of professionals. If we sign up for legislation at European level, it clearly has an impact on our jurisdiction and we cannot simply discard it in that manner. It is better to seek to change in the European context when they are about to consolidate the directives. It is a matter that we can feed through, via the Department of Education and Science, in changing the EU directive. The wording in the directive is exactly the same as this wording. Therefore, that is what I am proposing.

Ms McManus

I wonder if the interpretation of an EU directive may be different.

Mr. Martin

It is the same wording.

Ms McManus

Is it the case that a person declared bankrupt in the past, but who got his or her act together, sorted out his or her life and now wants to register, is barred from doing so forever? Is that actually the case? It seems incredible that it is so penal.

Mr. Martin

My information is that the EU directive on the mutual recognition of professional and educational training was transposed into the Act in 1991. It goes back that far but I take the Deputy's point.

Ms McManus

I intend to return to it on Report Stage because it makes no sense.

Amendment, by leave, withdrawn.

Section 5 agreed to.

Section 6 agreed to.

Amendment No. 6 not moved.

Section 7 agreed to.

Amendment No. 7 not moved.

Section 8 agreed to.

Section 9 agreed to.

Amendment No. 8 not moved.

Section 10 agreed to.

SECTION 11.

Ms McManus

I move amendment No. 9:

In page 9, between lines 7 and 8, to insert the following subsections:

"(2) The Minister may by regulations vary the amounts referred to in subsection (1) having regard to changes in the value of money.

(3) Regulations under subsection (2) shall not be made unless a draft thereof has been approved by both Houses of the Oireachtas.”.

The Minister has made the point that the Bill has been 13 or 14 years in gestation. That is a very good argument for this amendment because 13 or 14 years from now the value of money will be very different, particularly if the Government is still in power, which I hope it will not. The rate of inflation for which it is responsible means money will have very little value in 13 or 14 years time. Will we end up in the same situation where fines are, relatively speaking, meaningless because their value has declined so much? I trust, given the powers we are proposing, a Minister would be able to index link fines in some way to ensure they would have real impact.

Mr. Martin

Originally, we had intended to include a provision for updating fines by ministerial order but this was dropped on legal advice. The advice from the office of the parliamentary counsel is that increasing fines for offences is a matter for primary legislation, and there is no precedent in legislation linking fines, as may be imposed by the courts, with the CPI. As I said on Second Stage, the Government has included in its legislative programme a Bill "to provide for the updating and indexation of fines and related matters". Publication of that Bill is scheduled for late 2003. In the circumstances, it would perhaps be wiser to wait for that overall, encompassing Bill to deal with the issue.

Ms McManus

I will withdraw the amendment.

Amendment, by leave, withdrawn.

Section 11 agreed to.

Sections 12 to 14, inclusive, agreed to.

Title agreed to.

Bill reported with amendment.