News

The law in practice

Richard Wilshin discusses aspects and questions of practice that frequently arise and cause concern or tend to affect the standard of the profession's service to the public (CET Module: C4685c)

The fact that optometrists and dispensing opticians are regulated health professionals is well established, but what in the real world does this regulation mean?
The statutory provisions of the Opticians Act 1989 and the regulations made under it are well known and the General Optical Council through its edicts and decisions in disciplinary cases seeks to meet its statutory obligation to promote 'high standards of professional conduct among opticians'.
At the same time, the College of Optometrists and the Association of British Dispensing Opticians indicate to their members what is required of them in the scope and standard of their practice as optometrists and dispensing opticians respectively. Add to that situation the occasional intervention of the Association of Optometrists and Federation of Ophthalmic and Dispensing Opticians on practice or standards issues in the proper exercise of their respective functions, and the scenario can become a little confusing.
Where there is confusion, the inevitable effect is a conflict between the law and what may be described as the professional regulation. At best, this conflict can result in a misunderstanding; and at worst, in dissatisfaction or harm in the professions' service to the public.
While it is for the GOC's disciplinary process, or ultimately the High Court, to determine issues arising from this conflict, the intention of this article is not to be contentious but only to demonstrate to practitioners examples of the effect of this conflict between the requirements of the law and professional guidance. Practitioners who disagree with anything that follows should consider whether their disagreement is a result of this conflict.

sale of optical appliances
The sale of optical appliances was first regulated by the Opticians Act 1958, which was the precursor to the current legislation in the Opticians Act 1989.
The 1989 Act consolidated the 1958 Act and its subsequent amendments; and Section 27 provides that 'subject to the following provisions of this section, a person shall not sell any optical appliance unless the sale is effected by or under the supervision of a registered medical practitioner or registered optician'.
As enacted in the 1958 Act, this was the basic principle and initially the 'following provisions' were of little consequence to that basic principle; but subsequent legislation now in the 1989 Act radically amended that principle in two respects. First, the Sale of Optical Appliances Order of Council 1984 was made by the Privy Council under new powers inserted into the (then) 1958 Act.
This Order regulates the circumstances in which a person other than a registered medical practitioner or registered optician may sell an optical appliance other than a contact lens or low vision aid. (For brevity, the word 'spectacles' will be used in further comment.)
There are a number of detailed and complex conditions in the Order, but the essential effect in law is to authorise anyone to sell spectacles, provided that the sale is not for a person who is under 16 years of age or registered blind or partially sighted.
A particular and important condition of a sale under the Order is that the spectacles must be in accordance with a written prescription that:

Is given by a registered medical practitioner or registered optometrist following a sight test by him or her
Is not more than two years old
Is presented at the time.

Registered opticians
Although optometrists and dispensing opticians need to be fully familiar with the provisions of the Order, it should be emphasised that the Order does not apply to registered opticians.
The legal power of a registered optician to sell an optical appliance derives (now) from Section 27 of the 1989 Act. The Order relates only to sales by unregistered persons, sales which are exempt from the regulation of Section 27, provided that the sale is in accordance with the Order's provisions.
Section 27 does not require a written prescription of any age to be presented. Therefore, other than for the practical purpose of ascertaining the lens(es) to be dispensed, a registered optician does not need a prescription.
If the required lens(es) can be deduced by use of a focimeter, or any other means, then it is perfectly legal for a registered optician to sell spectacles without a prescription. Also, as the Order does not apply to registered opticians, it is perfectly legal for a registered optician to dispense a prescription that is more than two years old.
An interesting question of law, as yet untested in the courts or otherwise resolved, is whether a registered dispensing optician, without a prescription, may legally refract before dispensing spectacles. This contentious proposition is based on the argument that a prescription follows the 'testing of sight', which expression is defined in Section 36 of the 1989 Act as: 'Étesting sight with the object of determining whether there is any and, if so, what defect of sight and of correcting, remedying or relieving any such defect of an anatomical or physiological nature by means of an optical appliance prescribed on the basis of the determination.'
The GOC has for many years accepted the interpretation that the testing of sight has three elements as indicated by the words italicised above. The argument is that a refraction comprises the 'determining' and 'correcting, remedying or relieving' and provided that the result of the refraction is not prescribed, then there has not been a testing of sight within the meaning of the statutory definition.
The validity of this argument must depend on the legal interpretation of 'prescribed', which word is defined by Section 36 as: 'prescribed' means 'prescribed by rules under this Act'.
The rules under the Act are the Sight Testing (Examination and Prescription) (No 2) Regulations 1989 and they provide for the requirements to be met by a registered medical practitioner or optometrist when testing sight. These requirements include the duty of the sight tester to perform the necessary examinations and tests for the purpose of detecting signs of injury, disease or abnormality of the eye or elsewhere.
There is, therefore, a strong argument to support the proposition that it is legal for a registered dispensing optician to refract, and dispense the result of that refraction. It would not be a testing of sight as defined, because the resulting optical appliance was not prescribed by the rules. The rules only apply to registered medical practitioners and optometrists when testing sight, a defined activity that refraction does not set out to complete.
To rely on this proposition in adopting the principle of refraction as a matter of course could be hazardous to say the least. It is emphasised that although what is described above complies with the law, as a registered health professional an optician must have proper regard to what is expected of him by his peers in the conduct of his professional activities. In acting in accordance with this proposition, the health of the patient is paramount; and if there is any reason to suppose that this can be prejudiced, then it would be improper to dispense on the basis of a refraction.
Although there would be certain commercial advantages in only undertaking refraction, which is the situation in most other countries in Europe, it would undoubtedly be contrary to the professional regulation contained in the guidance of the ABDO and the College of Optometrists. And, it would be likely to lead to disciplinary action before the GOC, which could result in erasure.
It is suggested that if proper steps are taken by a registered optician to be satisfied that the patient has had a sight test within such period as the circumstances of that patient indicate, and that there are otherwise no other contra-indications, he/she would not be guilty of professional misconduct. As a registered optician does not require a prescription to dispense, in view of the arguments expressed above, it would not be illegal or unprofessional to dispense on the basis of a refraction.

Ready-made reading spectacles
The second major amendment of the 1958 Act legalised the sale of ready-made reading spectacles, which were already widely sold other than in registered opticians' practices when the House of Lords introduced the amendment that is now incorporated in the 1989 Act.
Under current law, there is in reality no regulation of their sale, but see the remarks below.

Sales by unregistered persons
It is seen from the above that a sale of spectacles by a person other than a registered medical practitioner or registered optician is illegal unless it is made in accordance with Section 27 or the 1984 Order.
If a sale is illegal then it is a criminal offence under the 1989 Act and on conviction a heavy fine can be imposed in respect of each offence prosecuted.
It is frequently the case in opticians' practices that 'assistants' (of whatever job title) actually 'effect', or complete, the sale. A typical practice procedure would be the sight test (or refraction?), followed by the dispensing and then, in due course, the delivery of the spectacles to the patient.
On the basis that the sale is completed when the spectacles are delivered to the patient, such a procedure could well contravene the law, and in some circumstances the professional regulation, if an unregistered person completes the sale.
A sale of spectacles is only legal if either:

It is completed 'by or under the supervision of a registered medical practitioner or registered optician' [Section 27(1)]
Or it is an excluded sale, that is the spectacles are ready-mades [Section 27(4)]
Or it is strictly in accordance with the Sale of Optical Appliances Order of Council 1984.

To consider each of these points in turn, there is no statutory definition to determine precisely what is meant by 'supervision', but the courts in cases concerning the dispensing of medicines have given some help.
The relevant provision in the regulating legislation for pharmacists has identical wording. In short, 'under the supervision' must mean that in practice the supervisor must be present, aware of the transaction and be in a position to intervene.
As regards the sale of ready-mades, there is in reality absolutely no regulation of their sale. Section 27(2) expressly excludes them from the regulation of Section 27(1), so no supervision is required, and the only regulation is that the sale must be:

For a person not under the age of 16
Of spectacles with two single-vision lenses of the same positive spherical power not exceeding 4 dioptres
Where the sale is wholly for the purpose of correcting, remedying or relieving presbyopia.

Thus, a sale is only illegal if it is to a person aged under 16 or to someone who is not presbyopic. While the former may be a matter that an assistant in the chemists or 'corner shop' can check, the latter is likely to be quite beyond his or her competence.
As long as the provisions of the 1984 Order are complied with, then an unregistered person may sell spectacles. Although there are a number of unregistered spectacle sellers, it is frequently the case that the procedures within registered practices are such that the law is broken. As mentioned above, although the 1984 Order does not apply to registered opticians, it does apply to their unregistered staff.
Sales to persons under 16
An important point to note in practice is the wording of the exception contained in the 1984 Order, which relates to a sale to persons under the age of 16. It is emphasised that excluded from the scope of the Order is the sale of spectacles that are 'for' (not 'to') a person who is under 16 years of age. Thus, it would be a technical breach of the law for an unregistered assistant to sell to a parent the spectacles dispensed for his or her child.
Although this is a technical point, it is relevant in considering the proper management procedures within any practice; and it should be noted that the GOC has taken disciplinary action and erased from the list an enrolled body corporate that failed to comply with the law in this respect.

Sale of contact lenses
The 1958 Act did not contain any specific provisions regulating the sale or fitting of contact lenses and the current regulation in the 1989 Act was inserted by amending legislation. Section 25 of the 1989 Act provides that only registered medical practitioners and registered opticians may fit contact lenses, with specific exceptions for medical students and persons training as opticians.
The GOC has made rules under Section 31 regulating the qualifications required by registered opticians before they may fit contact lenses. It would seem that the regulation of the fitting of contact lenses is adequately provided for and observed.
In reality, the regulation of the sale of contact lenses is confused and ineffective. There is no specific regulatory reference in the 1989 Act to the sale of contact lenses and the Act does not include a definition of a contact lens.
Provided that the contact lens has a power, it falls within the definition of 'optical appliance' in Section 36(1) of the 1989 Act as 'an appliance designed to correct, remedy or relieve a defect of sight'. Therefore, the sale is regulated under section 27 as mentioned above and is expressly excluded from the provisions of the 1984 Order. The following points are important to note:

A contact lens with a power is an optical appliance which can only be sold by a registered medical practitioner or registered optician
A registered optician, even though not qualified to fit, may sell a contact lens
Currently, the law does not require a prescription or specification to be produced by the purchaser of a contact lens
A plano contact lens is not an optical appliance, because it is not designed to correct, remedy or relieve a defect of sight, and may therefore be sold by anybody.

Although the law may be clear on the question of who may legally sell contact lenses, it is well known that in fact there are two issues that are apparent in the public's ability and opportunity to purchase. These issues go to the root of the service that registered opticians provide to the public. First, there is now a wide opportunity for the public to purchase contact lenses through the internet or by mail order.
Currently, an internet search will reveal over 13,000 links to sites within the UK and more than 275,000 links on the web as a whole. Many of these links refer to sites managed by registered opticians who (it is hoped) operate their business in a manner that has proper regard for the customer's eye care; but others may not. Many suppliers operate through mail order.
Although the GOC has for nearly three years sought to introduce legislation to regulate the direct supply of contact lenses, to date nothing has been confirmed; and so there is no real control of the internet or mail order sale of contact lenses, other than the legislation applying to the sale of any goods.
The consumer legislation covering the public's rights when purchasing contact lenses are the Sale of Goods Act 1979 and the Supply of Goods and Services Act 1982 (as amended). The law requires contact lenses to be of 'satisfactory quality', namely free from defects; 'fit for their purpose', meaning the lenses are capable of performing their function; and they must be 'as described', that is the purchaser receives the lenses as specified and ordered.
In addition, the Consumer Protection (Distance Selling) Regulations 2000 apply to a 'distance contract', which means any contract for the supply of contact lenses between a supplier and a consumer under an organised distance sales or service provision scheme run by the supplier who, for the purpose of the contract, makes exclusive use of one or more means of distance communication up to and including the conclusion of the contract.
'Means of distance communication' is defined as any means that, without the simultaneous physical presence of the supplier and the consumer, may be used for the conclusion of a contract between those parties. In addition to these regulations are the Electronic Commerce (EC Directive) Regulations 2002, which transposes an EU E-Commerce Directive into UK law to clarify the rights and obligations of businesses and consumers.
The key features of the regulations are:

The consumer must be given clear information about the goods or services offered
After making a purchase the consumer must be sent confirmation
The consumer has a cooling-off period of seven working days
New powers for local Trading Standards departments and the Office of Fair Trading.

Where the purchase of contact lenses is made without any face-to-face contact between supplier and consumer, the seller must provide clear and comprehensible information to enable the consumer to decide whether to buy. This must include:

The seller's name and, if payment is required in advance, their postal address
A description of the goods or services
The price including all taxes
Delivery costs where they apply
Arrangements for payment
Arrangements and date for delivery
The right to cancel the order
How long the offer or price remains valid.

Enforcement authorities for these regulations include Trading Standards departments and the Office of Fair Trading.
Secondly, most registered opticians refuse to sell contact lenses to persons who are not their patients. Although a seller of any goods may refuse to sell to a customer, it is questioned whether the stance taken by most practices in refusing to supply any purchaser is justifiable. This refusal offends the public, who with some cause will accuse the profession of restrictive practice; and it is probably a main factor contributing to the growth of direct sales by suppliers that are not actually part of the profession. There is no legal obstacle to such a sale and there should not be a professional one, but the guidance given by the professional bodies seems to deter registered opticians from providing a perfectly legitimate commercial service to the public as a professional activity.
The sale of contact lenses is a simple commercial activity, which section 27 confines to registered medical practitioners and registered opticians. If a person seeks only to purchase contact lenses, then the contract between the seller and that person is simply that purchase. In law, the only responsibility of a registered optician making the sale is to comply with the consumer legislation referred to above; and he/she has no responsibility for the purchaser's eye care.
The position would, of course, be different if the purchaser was a patient, when there would be an additional responsibility for the patient's eye care and it would be a professional obligation to refuse to sell if there was a legitimate reason, eg because the patient had failed to attend for the last check-up appointment.
There is, therefore, no legal reason for a registered optician to refuse to sell contact lenses to anyone who seeks to purchase. It is the responsibility of a registered optician as a professional to take reasonable steps to be satisfied that the purchaser, or intended wearer, is not currently having problems with wear. This responsibility derives from what is expected as proper professional practice and not from any specific legal requirement.
Provided that there is no obvious sign that there is a problem with wear, and on enquiry the purchaser confirms that he/she, or the person for whom the lenses are intended, has no problem with wear, then there is no legitimate reason to refuse to sell.

Practice records
The keeping of suitable patient records is very important not only as necessary information of the patient's eye care and dispensing, but as a clear and comprehensive evidence in the event of any allegation of illegal or unprofessional practice.
Failure to keep adequate records is probably the most frequent criticism raised in disciplinary cases before the GOC; but there is another aspect in the management of records that requires particular attention in opticians' practices, namely the implications of the data protection legislation.
The Data Protection Act 1998 applies to health records in any form, ie any record that includes information relating to a person's mental or physical health and which has been made by or on behalf of a 'health professional' (which term includes a registered optician) in connection with the care of that person.
The Act provides that any processing of information within a record must comply with the following eight principles:

Fairly and lawfully processed
Processed for limited purposes
Adequate, relevant and not excessive
Accurate
Not kept longer than necessary
Processed in accordance with the data subject's rights
Secure
Not transferred to countries without adequate protection.

There is not space here to deal fully with the data protection legislation, but the following points are important to understand:

Patient records must be processed in accordance with the above eight principles
The consent of the data subject is required for the processing to be fair and lawful
A patient's prescription and/or contact lens specification is a part of his/her health record.

It follows, therefore, that it could contravene the Act to supply anyone other than the patient, such as another optician, with any information without the patient's consent. As it is often the case that other practices request prescriptions, and so on, it would be a wise precaution to have consent. Written consent is always preferable and the ideal would be to obtain a general signed consent from every patient authorising the supply of information to other registered medical practitioners and opticians.
If verbal consent is obtained then the records should be noted accordingly. It is also wise to ensure that any information such as a prescription is given or confirmed in writing, so that there can be no dispute over what was 'processed'.

Richard Wilshin is a former Registrar of the General Optical CouncilThe fact that optometrists and dispensing opticians are regulated health professionals is well established, but what in the real world does this regulation mean?
The statutory provisions of the Opticians Act 1989 and the regulations made under it are well known and the General Optical Council through its edicts and decisions in disciplinary cases seeks to meet its statutory obligation to promote 'high standards of professional conduct among opticians'.
At the same time, the College of Optometrists and the Association of British Dispensing Opticians indicate to their members what is required of them in the scope and standard of their practice as optometrists and dispensing opticians respectively. Add to that situation the occasional intervention of the Association of Optometrists and Federation of Ophthalmic and Dispensing Opticians on practice or standards issues in the proper exercise of their respective functions, and the scenario can become a little confusing.
Where there is confusion, the inevitable effect is a conflict between the law and what may be described as the professional regulation. At best, this conflict can result in a misunderstanding; and at worst, in dissatisfaction or harm in the professions' service to the public.
While it is for the GOC's disciplinary process, or ultimately the High Court, to determine issues arising from this conflict, the intention of this article is not to be contentious but only to demonstrate to practitioners examples of the effect of this conflict between the requirements of the law and professional guidance. Practitioners who disagree with anything that follows should consider whether their disagreement is a result of this conflict.

sale of optical appliances
The sale of optical appliances was first regulated by the Opticians Act 1958, which was the precursor to the current legislation in the Opticians Act 1989.
The 1989 Act consolidated the 1958 Act and its subsequent amendments; and Section 27 provides that 'subject to the following provisions of this section, a person shall not sell any optical appliance unless the sale is effected by or under the supervision of a registered medical practitioner or registered optician'.
As enacted in the 1958 Act, this was the basic principle and initially the 'following provisions' were of little consequence to that basic principle; but subsequent legislation now in the 1989 Act radically amended that principle in two respects. First, the Sale of Optical Appliances Order of Council 1984 was made by the Privy Council under new powers inserted into the (then) 1958 Act.
This Order regulates the circumstances in which a person other than a registered medical practitioner or registered optician may sell an optical appliance other than a contact lens or low vision aid. (For brevity, the word 'spectacles' will be used in further comment.)
There are a number of detailed and complex conditions in the Order, but the essential effect in law is to authorise anyone to sell spectacles, provided that the sale is not for a person who is under 16 years of age or registered blind or partially sighted.
A particular and important condition of a sale under the Order is that the spectacles must be in accordance with a written prescription that:

Is given by a registered medical practitioner or registered optometrist following a sight test by him or her
Is not more than two years old
Is presented at the time.

Registered opticians
Although optometrists and dispensing opticians need to be fully familiar with the provisions of the Order, it should be emphasised that the Order does not apply to registered opticians.
The legal power of a registered optician to sell an optical appliance derives (now) from Section 27 of the 1989 Act. The Order relates only to sales by unregistered persons, sales which are exempt from the regulation of Section 27, provided that the sale is in accordance with the Order's provisions.
Section 27 does not require a written prescription of any age to be presented. Therefore, other than for the practical purpose of ascertaining the lens(es) to be dispensed, a registered optician does not need a prescription.
If the required lens(es) can be deduced by use of a focimeter, or any other means, then it is perfectly legal for a registered optician to sell spectacles without a prescription. Also, as the Order does not apply to registered opticians, it is perfectly legal for a registered optician to dispense a prescription that is more than two years old.
An interesting question of law, as yet untested in the courts or otherwise resolved, is whether a registered dispensing optician, without a prescription, may legally refract before dispensing spectacles. This contentious proposition is based on the argument that a prescription follows the 'testing of sight', which expression is defined in Section 36 of the 1989 Act as: 'Étesting sight with the object of determining whether there is any and, if so, what defect of sight and of correcting, remedying or relieving any such defect of an anatomical or physiological nature by means of an optical appliance prescribed on the basis of the determination.'
The GOC has for many years accepted the interpretation that the testing of sight has three elements as indicated by the words italicised above. The argument is that a refraction comprises the 'determining' and 'correcting, remedying or relieving' and provided that the result of the refraction is not prescribed, then there has not been a testing of sight within the meaning of the statutory definition.
The validity of this argument must depend on the legal interpretation of 'prescribed', which word is defined by Section 36 as: 'prescribed' means 'prescribed by rules under this Act'.
The rules under the Act are the Sight Testing (Examination and Prescription) (No 2) Regulations 1989 and they provide for the requirements to be met by a registered medical practitioner or optometrist when testing sight. These requirements include the duty of the sight tester to perform the necessary examinations and tests for the purpose of detecting signs of injury, disease or abnormality of the eye or elsewhere.
There is, therefore, a strong argument to support the proposition that it is legal for a registered dispensing optician to refract, and dispense the result of that refraction. It would not be a testing of sight as defined, because the resulting optical appliance was not prescribed by the rules. The rules only apply to registered medical practitioners and optometrists when testing sight, a defined activity that refraction does not set out to complete.
To rely on this proposition in adopting the principle of refraction as a matter of course could be hazardous to say the least. It is emphasised that although what is described above complies with the law, as a registered health professional an optician must have proper regard to what is expected of him by his peers in the conduct of his professional activities. In acting in accordance with this proposition, the health of the patient is paramount; and if there is any reason to suppose that this can be prejudiced, then it would be improper to dispense on the basis of a refraction.
Although there would be certain commercial advantages in only undertaking refraction, which is the situation in most other countries in Europe, it would undoubtedly be contrary to the professional regulation contained in the guidance of the ABDO and the College of Optometrists. And, it would be likely to lead to disciplinary action before the GOC, which could result in erasure.
It is suggested that if proper steps are taken by a registered optician to be satisfied that the patient has had a sight test within such period as the circumstances of that patient indicate, and that there are otherwise no other contra-indications, he/she would not be guilty of professional misconduct. As a registered optician does not require a prescription to dispense, in view of the arguments expressed above, it would not be illegal or unprofessional to dispense on the basis of a refraction.

Ready-made reading spectacles
The second major amendment of the 1958 Act legalised the sale of ready-made reading spectacles, which were already widely sold other than in registered opticians' practices when the House of Lords introduced the amendment that is now incorporated in the 1989 Act.
Under current law, there is in reality no regulation of their sale, but see the remarks below.

Sales by unregistered persons
It is seen from the above that a sale of spectacles by a person other than a registered medical practitioner or registered optician is illegal unless it is made in accordance with Section 27 or the 1984 Order.
If a sale is illegal then it is a criminal offence under the 1989 Act and on conviction a heavy fine can be imposed in respect of each offence prosecuted.
It is frequently the case in opticians' practices that 'assistants' (of whatever job title) actually 'effect', or complete, the sale. A typical practice procedure would be the sight test (or refraction?), followed by the dispensing and then, in due course, the delivery of the spectacles to the patient.
On the basis that the sale is completed when the spectacles are delivered to the patient, such a procedure could well contravene the law, and in some circumstances the professional regulation, if an unregistered person completes the sale.
A sale of spectacles is only legal if either:

It is completed 'by or under the supervision of a registered medical practitioner or registered optician' [Section 27(1)]
Or it is an excluded sale, that is the spectacles are ready-mades [Section 27(4)]
Or it is strictly in accordance with the Sale of Optical Appliances Order of Council 1984.

To consider each of these points in turn, there is no statutory definition to determine precisely what is meant by 'supervision', but the courts in cases concerning the dispensing of medicines have given some help.
The relevant provision in the regulating legislation for pharmacists has identical wording. In short, 'under the supervision' must mean that in practice the supervisor must be present, aware of the transaction and be in a position to intervene.
As regards the sale of ready-mades, there is in reality absolutely no regulation of their sale. Section 27(2) expressly excludes them from the regulation of Section 27(1), so no supervision is required, and the only regulation is that the sale must be:

For a person not under the age of 16
Of spectacles with two single-vision lenses of the same positive spherical power not exceeding 4 dioptres
Where the sale is wholly for the purpose of correcting, remedying or relieving presbyopia.

Thus, a sale is only illegal if it is to a person aged under 16 or to someone who is not presbyopic. While the former may be a matter that an assistant in the chemists or 'corner shop' can check, the latter is likely to be quite beyond his or her competence.
As long as the provisions of the 1984 Order are complied with, then an unregistered person may sell spectacles. Although there are a number of unregistered spectacle sellers, it is frequently the case that the procedures within registered practices are such that the law is broken. As mentioned above, although the 1984 Order does not apply to registered opticians, it does apply to their unregistered staff.
Sales to persons under 16
An important point to note in practice is the wording of the exception contained in the 1984 Order, which relates to a sale to persons under the age of 16. It is emphasised that excluded from the scope of the Order is the sale of spectacles that are 'for' (not 'to') a person who is under 16 years of age. Thus, it would be a technical breach of the law for an unregistered assistant to sell to a parent the spectacles dispensed for his or her child.
Although this is a technical point, it is relevant in considering the proper management procedures within any practice; and it should be noted that the GOC has taken disciplinary action and erased from the list an enrolled body corporate that failed to comply with the law in this respect.

Sale of contact lenses
The 1958 Act did not contain any specific provisions regulating the sale or fitting of contact lenses and the current regulation in the 1989 Act was inserted by amending legislation. Section 25 of the 1989 Act provides that only registered medical practitioners and registered opticians may fit contact lenses, with specific exceptions for medical students and persons training as opticians.
The GOC has made rules under Section 31 regulating the qualifications required by registered opticians before they may fit contact lenses. It would seem that the regulation of the fitting of contact lenses is adequately provided for and observed.
In reality, the regulation of the sale of contact lenses is confused and ineffective. There is no specific regulatory reference in the 1989 Act to the sale of contact lenses and the Act does not include a definition of a contact lens.
Provided that the contact lens has a power, it falls within the definition of 'optical appliance' in Section 36(1) of the 1989 Act as 'an appliance designed to correct, remedy or relieve a defect of sight'. Therefore, the sale is regulated under section 27 as mentioned above and is expressly excluded from the provisions of the 1984 Order. The following points are important to note:

A contact lens with a power is an optical appliance which can only be sold by a registered medical practitioner or registered optician
A registered optician, even though not qualified to fit, may sell a contact lens
Currently, the law does not require a prescription or specification to be produced by the purchaser of a contact lens
A plano contact lens is not an optical appliance, because it is not designed to correct, remedy or relieve a defect of sight, and may therefore be sold by anybody.

Although the law may be clear on the question of who may legally sell contact lenses, it is well known that in fact there are two issues that are apparent in the public's ability and opportunity to purchase. These issues go to the root of the service that registered opticians provide to the public. First, there is now a wide opportunity for the public to purchase contact lenses through the internet or by mail order.
Currently, an internet search will reveal over 13,000 links to sites within the UK and more than 275,000 links on the web as a whole. Many of these links refer to sites managed by registered opticians who (it is hoped) operate their business in a manner that has proper regard for the customer's eye care; but others may not. Many suppliers operate through mail order.
Although the GOC has for nearly three years sought to introduce legislation to regulate the direct supply of contact lenses, to date nothing has been confirmed; and so there is no real control of the internet or mail order sale of contact lenses, other than the legislation applying to the sale of any goods.
The consumer legislation covering the public's rights when purchasing contact lenses are the Sale of Goods Act 1979 and the Supply of Goods and Services Act 1982 (as amended). The law requires contact lenses to be of 'satisfactory quality', namely free from defects; 'fit for their purpose', meaning the lenses are capable of performing their function; and they must be 'as described', that is the purchaser receives the lenses as specified and ordered.
In addition, the Consumer Protection (Distance Selling) Regulations 2000 apply to a 'distance contract', which means any contract for the supply of contact lenses between a supplier and a consumer under an organised distance sales or service provision scheme run by the supplier who, for the purpose of the contract, makes exclusive use of one or more means of distance communication up to and including the conclusion of the contract.
'Means of distance communication' is defined as any means that, without the simultaneous physical presence of the supplier and the consumer, may be used for the conclusion of a contract between those parties. In addition to these regulations are the Electronic Commerce (EC Directive) Regulations 2002, which transposes an EU E-Commerce Directive into UK law to clarify the rights and obligations of businesses and consumers.
The key features of the regulations are:

The consumer must be given clear information about the goods or services offered
After making a purchase the consumer must be sent confirmation
The consumer has a cooling-off period of seven working days
New powers for local Trading Standards departments and the Office of Fair Trading.

Where the purchase of contact lenses is made without any face-to-face contact between supplier and consumer, the seller must provide clear and comprehensible information to enable the consumer to decide whether to buy. This must include:

The seller's name and, if payment is required in advance, their postal address
A description of the goods or services
The price including all taxes
Delivery costs where they apply
Arrangements for payment
Arrangements and date for delivery
The right to cancel the order
How long the offer or price remains valid.

Enforcement authorities for these regulations include Trading Standards departments and the Office of Fair Trading.
Secondly, most registered opticians refuse to sell contact lenses to persons who are not their patients. Although a seller of any goods may refuse to sell to a customer, it is questioned whether the stance taken by most practices in refusing to supply any purchaser is justifiable. This refusal offends the public, who with some cause will accuse the profession of restrictive practice; and it is probably a main factor contributing to the growth of direct sales by suppliers that are not actually part of the profession. There is no legal obstacle to such a sale and there should not be a professional one, but the guidance given by the professional bodies seems to deter registered opticians from providing a perfectly legitimate commercial service to the public as a professional activity.
The sale of contact lenses is a simple commercial activity, which section 27 confines to registered medical practitioners and registered opticians. If a person seeks only to purchase contact lenses, then the contract between the seller and that person is simply that purchase. In law, the only responsibility of a registered optician making the sale is to comply with the consumer legislation referred to above; and he/she has no responsibility for the purchaser's eye care.
The position would, of course, be different if the purchaser was a patient, when there would be an additional responsibility for the patient's eye care and it would be a professional obligation to refuse to sell if there was a legitimate reason, eg because the patient had failed to attend for the last check-up appointment.
There is, therefore, no legal reason for a registered optician to refuse to sell contact lenses to anyone who seeks to purchase. It is the responsibility of a registered optician as a professional to take reasonable steps to be satisfied that the purchaser, or intended wearer, is not currently having problems with wear. This responsibility derives from what is expected as proper professional practice and not from any specific legal requirement.
Provided that there is no obvious sign that there is a problem with wear, and on enquiry the purchaser confirms that he/she, or the person for whom the lenses are intended, has no problem with wear, then there is no legitimate reason to refuse to sell.

Practice records
The keeping of suitable patient records is very important not only as necessary information of the patient's eye care and dispensing, but as a clear and comprehensive evidence in the event of any allegation of illegal or unprofessional practice.
Failure to keep adequate records is probably the most frequent criticism raised in disciplinary cases before the GOC; but there is another aspect in the management of records that requires particular attention in opticians' practices, namely the implications of the data protection legislation.
The Data Protection Act 1998 applies to health records in any form, ie any record that includes information relating to a person's mental or physical health and which has been made by or on behalf of a 'health professional' (which term includes a registered optician) in connection with the care of that person.
The Act provides that any processing of information within a record must comply with the following eight principles:

Fairly and lawfully processed
Processed for limited purposes
Adequate, relevant and not excessive
Accurate
Not kept longer than necessary
Processed in accordance with the data subject's rights
Secure
Not transferred to countries without adequate protection.

There is not space here to deal fully with the data protection legislation, but the following points are important to understand:

Patient records must be processed in accordance with the above eight principles
The consent of the data subject is required for the processing to be fair and lawful
A patient's prescription and/or contact lens specification is a part of his/her health record.

It follows, therefore, that it could contravene the Act to supply anyone other than the patient, such as another optician, with any information without the patient's consent. As it is often the case that other practices request prescriptions, and so on, it would be a wise precaution to have consent. Written consent is always preferable and the ideal would be to obtain a general signed consent from every patient authorising the supply of information to other registered medical practitioners and opticians.
If verbal consent is obtained then the records should be noted accordingly. It is also wise to ensure that any information such as a prescription is given or confirmed in writing, so that there can be no dispute over what was 'processed'.

Richard Wilshin is a former Registrar of the General Optical Council

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