Regulation of Laser Eye Surgery Bill

House of Commons

Session 2005 - 06
Internet Publications
Other Bills before Parliament

Regulation of Laser Eye Surgery Bill

Regulation of Laser Eye Surgery Bill
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and Qualifications) Order 2003 (S.I. 2003/1250) and in respect of whom
the register indicates his speciality to be ophthalmology; and
(c)
provides such other information as may be specified in guidance under
section 4(2)(e)(i).
(2)
The registered person in relation to a relevant establishment shall ensure that
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the patients’ guide in respect of that establishment—
(a)
states the types of laser eye surgery provided in the establishment;
(b)
provides information about the qualifications and experience of
persons carrying on laser eye surgery and activities relating to laser eye
surgery in the establishment;
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(c)
summarises the contractual requirements specified in section 9;
(d)
summarises the consent requirements specified in section 10;
(e)
provides a summary of information contained in annual returns for the
establishment prepared under section 11 for the prescribed period;
(f)
refers to the availability of the guidance prepared by the Royal College
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of Ophthalmologists under section 4(2)(a) for the time being in force;
and
(g)
provides such other information as may be specified in guidance under
section 4(2)(e)(ii).
(3)
The registered person in relation to a relevant establishment shall ensure that
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a copy of the guidance prepared by the Royal College of Ophthalmologists
under section 4(2)(a) for the time being in force is available to patients upon
request.
(4)
The registered person in relation to a relevant establishment shall send a copy
of—
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(a)
the statement of purpose, and
(b)
the patients’ guide,

in relation to the establishment to the Royal College of Ophthalmologists.
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Contractual requirements
(1)
The registered person in relation to a relevant establishment shall ensure that
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no laser eye surgery is provided within the establishment otherwise than
under a contract with a patient or a person authorised to act on the patient’s
behalf that complies with the requirements set out in subsections (2) and (3).
(2)
The requirement set out in this subsection is that the contract does not offer the
patient or other person entering into a contract a financial incentive to enter
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into the contract at a particular time or within a particular period.
(3)
The requirements set out in this subsection are that the contract specifies—
(a)
all direct costs expected to be incurred in relation to the laser eye
surgery, and
(b)
any other costs expected to be incurred in relation to the provision of
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follow-up services by optometrists or medical practitioners.
(4)
The registered person in relation to a relevant establishment shall ensure that
no staff of the establishment receive an undue financial incentive to encourage
potential patients or persons authorised to act on behalf of potential patients to
enter into a contract for the provision of laser eye surgery.
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Regulation of Laser Eye Surgery Bill
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Consent requirements
(1)
The registered person in relation to a relevant establishment shall ensure that
no laser eye surgery is provided except where properly informed consent has
been given by a patient or a person authorised to act on the patient’s behalf in
a manner that complies with the requirements set out in subsections (2) to (5).
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(2)
The requirement set out in this subsection is that consent is not sought by the
relevant establishment for laser eye surgery on a patient when that relevant
establishment has determined in accordance with guidance under section
4(2)(e)(iv) that the patient is unsuitable
(3)
The requirement set out in this subsection is that the person giving consent has
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been provided with a consent form that complies with the requirements of
guidance under section 4(2)(e)(v).
(4)
The requirement set out in this subsection is that appropriate counselling has
been made available to the person giving consent at least three days before the
day on which consent is to be given.
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(5)
The requirement set out in this subsection is that consent has been given at least
seven days before the day on which laser eye surgery is to be provided.
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Annual returns
(1)
The registered person in relation to a relevant establishment shall ensure that
an annual return is submitted to the registration authority within the
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prescribed period containing—
(a)
information of a prescribed kind about surgical outcomes and
complication rates,
(b)
information arising from post-surgery assessments of patients
undertaken in accordance with guidance under section 4(2)(e)(vi),
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(c)
such information as may be required to be included in the annual
return in accordance with guidance under section 4(2)(e)(vii), and
(d)
such other information as may be prescribed.
(2)
In this section “complication rates” and “surgical outcomes” have the
prescribed meaning.
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Advertising
(1)
This section applies to advertisements for the provision of laser eye surgery by
relevant establishments—
(a)
within the relevant establishment,
(b)
on the premises of any optometrist,
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(c)
in any electronic media, or
(d)
that are otherwise paid for.
(2)
Advertisements to which this section applies shall comply with the
requirements specified in regulations by the appropriate authority.
(3)
Regulations under subsection (2) shall, in particular, specify the form of a
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warning about the risks associated with laser eye surgery to be contained in
any advertisement to which this section applies.

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(4)
Before making regulations under subsection (2), the appropriate authority
shall consult—
(a)
the Royal College of Ophthalmologists, and
(b)
the registration authority.
(5)
For the purposes of subsection (1)(c), “electronic media” includes—
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(a)
radio and televisions services that are subject to the standards code of
the Office of Communications under section 319 of the
Communications Act 2003 (c. 21) (OFCOM’s standards code), and
(b)
the Internet.
Enforcement, etc.
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Additional powers of inspection
(1)
Section 31 of the 2000 Act (inspections by persons authorised by registration
authority) is amended as follows.
(2)
After subsection (1) insert—
“(1ZA)
The registration authority may at any time require a person who carries
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on or manages a relevant establishment to provide it with any
information relating to the establishment which the registration
authority considers necessary or expedient for the purposes of its
functions under the Regulation of Laser Eye Surgery Act 2005.”
(3)
In subsection (1A), after the words “under subsection (1)”, insert the words “or
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under subsection (1ZA)”.
(4)
In subsection (3), after paragraph (b), insert—
“(ba)
in relation to a relevant establishment, make any examination to
establish that equipment used in laser eye surgery is—
(i)
suitable for the purpose for which it is to be used,
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(ii)
properly maintained and, where appropriate,
calibrated, and
(iii)
in good working order.”
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Reporting duty of National Health Service bodies
(1)
This section applies where a National Health Service body provides treatment
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to a person which, in the opinion of a medical practitioner, arises in whole or
in part from laser eye surgery which that person has undergone as a patient in
a relevant establishment.
(2)
When this section applies, it shall be the duty of the National Health Service
body concerned to provide the prescribed information to the registration
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authority within such period as may be prescribed.
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Protection fund
(1)
It shall be the duty of the registration authority to establish and maintain a
protection fund in accordance with the provisions of this section.

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(2)
The registration authority may require a relevant establishment that is registered
under Part 2 of the 2000 Act to pay into the protection fund in respect of each financial
year such amount as the authority may determine.
(3)
Where the registration authority is satisfied on the basis of information
available to it arising from—
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(a)
the exercise of powers under sections 31 and 32 of the 2000 Act
(inspections) in relation to relevant establishments,
(b)
the making of returns by relevant establishments under section 11 of
this Act, and
(c)
the provision of information about relevant establishments by National
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Health Service bodies under section 14,

that the provision of laser eye surgery in the relevant establishment in a
financial year has not given rise to additional costs to the National Health
Service, the registration authority may take the step set out in subsection (4).
(4)
The step set out in this subsection is to make a payment to a relevant
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establishment from the protection fund which is equal to or less than the
payment made into the protection fund by that establishment in respect of that
financial year in accordance with subsection (2).
(5)
The registration authority shall prepare accounts for the protection fund for
each financial year in accordance with any directions given by the appropriate
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authority.
(6)
Accounts prepared under subsection (5) shall in particular specify—
(a)
the total amount paid into the protection fund in respect of that
financial year in accordance with the provisions of subsection (2),
(b)
the total amount paid out of the protection fund in respect of that
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financial year in accordance with the provisions of subsection (4), and
(c)
the difference between the amount specified in paragraph (a) and the
amount specified in paragraph (b).
(7)
The amount specified in subsection (6)(c) and any interest earned on the protection
fund shall be paid into the Consolidated Fund.
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(8)
In this section “financial year” means—
(a)
the period beginning with the date on which this section comes into
force and ending with the next 31st March, and
(b)
each subsequent period of twelve months ending with 31st March.
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Offences
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(1)
If a person registered in respect of a relevant establishment or as a person
seeking to carry on activities as an ophthalmologist in a relevant establishment
under Part 2 of the 2000 Act fails, without reasonable excuse, to comply with
any requirement for the time being in force under sections 7 to 12, he shall be
guilty of an offence and liable on summary conviction to a fine not exceeding
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level 4 on the standard scale.
(2)
The provisions of sections 29 and 30 (proceedings for offences and offences by
bodies corporate) of the 2000 Act apply to an offence under this section as they
apply to an offence under Part 2 of that Act or regulations made under it.