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
1

A
Bill
To
regulate laser eye surgery.
Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and
consent of the Lords Spiritual and Temporal, and Commons, in this present
Parliament assembled, and by the authority of the same, as follows:—
Registration requirements
1
Application of registration requirements of the 2000 Act to laser eye surgery
(1)
Part 1 of the 2000 Act (introductory provisions) is amended as follows.
(2)
In section 2 (independent hospitals, etc.), in subsection (7) (meaning of “listed
services”), after paragraph (e), insert—
5
“(ea)
laser eye surgery (within the meaning given by section 17 of the
Regulation of Laser Eye Surgery Act 2005);”.
2
Registration of relevant establishments and ophthalmologists
(1)
Part 2 of the 2000 Act (establishments and agencies) is amended as follows.
(2)
In section 11 (requirement to register)—
10
(a)
after subsection (1), insert—
“(1A)
Any person who carries on activities as an ophthalmologist in a
relevant establishment without being registered under this Part
in respect of those activities shall be guilty of an offence.”; and
(b)
after subsection (6), insert—
15
“(7)
In this Part ‘relevant establishment’ has the meaning given by
section 17 of the Regulation of Laser Eye Surgery Act 2005.”
(3)
In section 12 (applications for registration), in subsection (2), after paragraph
(a), insert—
“(aa)
in relation to a relevant establishment, must—
20
(i)
state the period to which the application relates, and

Bill 28 54/1

Regulation of Laser Eye Surgery Bill
2

(ii)
give such information as the registration authority
requires for the purposes of the Regulation of Laser Eye
Surgery Act 2005;
(ab)
in relation to a person seeking to carry on activities as an
ophthalmologist in a relevant establishment, must—
5
(i)
state the period to which the application relates, and
(ii)
confirm that the person is a medical practitioner whose
name is included in—
(a)
the register of specialists kept by the General
Medical Council under article 13 of the General
10
and Specialist Medical Practice (Education,
Training and Qualifications) Order 2003 (S.I.
2003/1250) and in respect of whom the register
indicates his speciality to be ophthalmology, or
(b)
the register established and maintained by the
15
Royal College of Ophthalmologists in
accordance with the provisions of section 5 of the
Regulation of Laser Eye Surgery Act 2005; and”.
(4)
In section 13 (grant or refusal of registration)—
(a)
in subsection (1), for the words “or agency”, substitute the words “,
20
agency or person”;
(b)
in subsection (2), for the word “and” after paragraph (a), substitute—
“(aa)
in relation to a relevant establishment, the requirements
of sections 7 to 12 and 15 of the Regulation of Laser Eye
Surgery Act 2005;
25
(ab)
in relation to a person seeking to carry on activities as an
ophthalmologist in a relevant establishment, the
requirement set out in subsection (2A); and”;
(c)
in that subsection, for the words “or agency”, substitute the words “,
agency or person”;
30
(d)
after subsection (2), insert—
“(2A)
The requirement set out in this subsection is the requirement for
the person seeking to carry on activities as an ophthalmologist
in a relevant establishment to be a medical practitioner whose
name is included in—
35
(a)
the register of specialists kept by the General Medical
Council under article 13 of the General and Specialist
Medical Practice (Education, Training and
Qualifications) Order 2003 (S.I. 2003/1250) and in
respect of whom the register indicates his speciality to
40
be ophthalmology, or
(b)
the register established and maintained by the Royal
College of Ophthalmologists in accordance with the
provisions of section 5 of the Regulation of Laser Eye
Surgery Act 2005.”
45
(e)
after subsection (3), insert—
“(3A)
Any application that is granted under subsection (3) in relation
to a relevant establishment or a person seeking to carry on
activities as an ophthalmologist in a relevant establishment may
only be granted for a period not exceeding twelve months.”;
50
and

Regulation of Laser Eye Surgery Bill
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(f)
in subsection (4), at the end, insert the words “which, in the case of a
relevant establishment or a person seeking to carry on activities as an
ophthalmologist in a relevant establishment, shall state the period for
which the application is granted”.
(5)
In section 14 (cancellation of registration)—
5
(a)
in subsection (1), after the first occurrence of the words “establishment
or agency”, insert the words “or as a person seeking to carry on
activities as an ophthalmologist in a relevant establishment”;
(b)
in that subsection, after paragraph (c), insert—
“(ca)
on the ground that a person seeking to carry on activities
10
as an ophthalmologist in a relevant establishment is
carrying on, or has at any time after the commencement
of section 13(2)(ab) carried on, activities in breach of the
requirement in section 13(2A);” and
(c)
in subsection (3), for the word “and” after paragraph (a), substitute—
15
“(aa)
in relation to a relevant establishment, the requirements
of sections 7 to 12 and 15 of the Regulation of Laser Eye
Surgery Act 2005; and”.
(6)
In section 16 (regulations about registration), in subsection (1), after the word
“agencies”, insert the words “or as persons seeking to carry on activities as an
20
ophthalmologist in a relevant establishment”.
(7)
In section 17 (notice of proposals)—
(a)
in subsection (1), at the end, insert the words “or as a person seeking to
carry on activities as an ophthalmologist in a relevant establishment”;
and
25
(b)
in subsection (4), after the word “agency”, insert the words “or as a
person seeking to carry on activities as an ophthalmologist in a relevant
establishment”.
(8)
In section 19 (notice of decisions), in subsection (1), after the word “agency”,
insert the words “or as a person seeking to carry on activities as an
30
ophthalmologist in a relevant establishment”.
(9)
In section 20 (urgent procedure for cancellation, etc.)—
(a)
in subsection (1)(a)(i), at the end, insert the words “or as a person
seeking to carry on activities as an ophthalmologist in a relevant
establishment”;
35
(b)
in subsection (3), after the word “section”, insert the words “in respect
of an establishment or agency”; and
(c)
in subsection (5), after the word “agency”, insert the words “or as a
person seeking to carry on activities as an ophthalmologist in a relevant
establishment”.
40
(10)
In section 24 (failure to comply with conditions), at the end, insert—
“(2)
If a person registered as a person seeking to carry on activities as an
ophthalmologist in a relevant establishment fails, without reasonable
excuse, to comply with any condition for the time being in force by
virtue of this Part in respect of the carrying on of those activities, he
45
shall be guilty of an offence and liable on summary conviction to a fine
not exceeding level 4 on the standard scale.”

Regulation of Laser Eye Surgery Bill
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Regulatory arrangements
3
Duties and functions of registration authorities
(1)
It shall be the general duty of the registration authority under this Act—
(a)
to promote and secure the maintenance of high standards in the
carrying out of laser eye surgery in relevant establishments, and
5
(b)
to protect the interests of patients undergoing laser eye surgery in
relevant establishments.
(2)
In pursuance of its general duty under subsection (1), the registration authority
shall, in particular—
(a)
exercise its functions under sections 13 to 20 of the 2000 Act
10
(registration) in relation to relevant establishments and persons seeking
to carry on activities as an ophthalmologist in a relevant establishment
having due regard to—
(i)
information available to the registration authority as a result of
the provisions of sections 11 and 14 of this Act,
15
(ii)
matters that have come to the attention of the registration
authority in the exercise of powers under sections 31 and 32 of
the 2000 Act (inspections);
(b)
ensure that its powers under sections 31 and 32 of the 2000 Act
(inspections) are appropriately exercised in relation to relevant
20
establishments,
(c)
exercise its functions under section 5 of this Act relating to the register
of ophthalmologists carrying on activities in relevant establishments,
(d)
exercise the function of monitoring and securing compliance with the
requirements of sections 7 to 12,
25
(e)
establish and maintain a protection fund in accordance with the
provisions of section 15, and
(f)
secure that persons acting on its behalf in exercising functions and
powers under paragraphs (a) to (e) of this subsection are suitably
trained for the exercise of those functions and powers.
30
4
Duties and functions of the Royal College of Ophthalmologists
(1)
It shall be the general duty of the Royal College of Ophthalmologists under this
Act—
(a)
to promote the maintenance of high standards in the carrying out of
laser eye surgery in relevant establishments, and
35
(b)
in particular, to promote the maintenance of high standards in the
carrying on by ophthalmologists of activities relating to laser eye
surgery in relevant establishments.
(2)
In pursuance of its general duty under subsection (1), the Royal College of
Ophthalmologists shall, in particular—
40
(a)
prepare guidance for potential patients in relevant establishments
about the matters specified in subsection (3),
(b)
prepare guidance for optometrists and general practitioners about the
matters specified in subsections (3) and (4),
(c)
under take functions relating to the provision of training for
45
ophthalmologists in accordance with the provisions of subsection (5);

Regulation of Laser Eye Surgery Bill
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(d)
undertake functions under section 5 in connection with the register of
ophthalmologists; and
(e)
prepare guidance for relevant establishments about—
(i)
information to be included in the statement of purpose of a
relevant establishment,
5
(ii)
information to be included in the patients’ guide of a relevant
establishment,
(iii)
the contractual requirements for laser eye surgery in relevant
establishments specified in section 9,
(iv)
the procedures to be followed for determining the suitability of
10
patients for the purposes of section 10(2),
(v)
the content of consent forms and other arrangements about
consent for the purposes of section 10,
(vi)
the procedures to be followed in undertaking post-surgery
assessments of patients,
15
(vii)
information to be included in annual returns under section 11,
and
(viii)
the advertising requirements under section 12.
(3)
The matters specified in this subsection are—
(a)
the different methods of laser eye surgery that are available,
20
(b)
the benefits and risks associated with each of the methods of laser eye
surgery referred to in paragraph (a), and
(c)
the particular benefits and risks associated with undergoing surgery on
both eyes at the same time.
(4)
The matters specified in this subsection are—
25
(a)
such information as the Royal College of Ophthalmologists considers it
appropriate to make available about the outcome of surgery generally
and in particular relevant establishments, and
(b)
such information as the Royal College of Ophthalmologists considers it
appropriate to make available about the qualifications and experience
30
of ophthalmologists in particular relevant establishments.
(5)
It shall be the duty of the Royal College of Ophthalmologists to promote
training arrangements in relation to laser eye surgery, including, in
particular—
(a)
training in the use of particular systems,
35
(b)
training provided in relevant establishments, and
(c)
arrangements for the approval and certification of training provision.
(6)
The Royal College of Ophthalmologists may from time to time revise guidance
prepared under subsection (2).
(7)
Guidance prepared under subsection (2) or revised under subsection (6) shall
40
be published in such form as the Royal College of Ophthalmologists considers
appropriate.
(8)
Before publishing guidance under this section, the Royal College of
Ophthalmologists shall consult—
(a)
the registration authorities,
45
(b)
the National Institute for Clinical Excellence,
(c)
the General Medical Council,
(d)
the General Optical Council,

Regulation of Laser Eye Surgery Bill
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(e)
the British College of Optometrists, and
(f)
such other persons as the Royal College of Ophthalmologists considers
appropriate.
5
Register of ophthalmologists
(1)
The Royal College of Ophthalmologists shall establish and maintain a register
5
of the names of ophthalmologists carrying on, or seeking to carry on, laser eye
surgery in relevant establishments.
(2)
The Royal College of Ophthalmologists shall prepare, and may from time to
time revise, guidance on—
(a)
the training and qualifications necessary for a person to have his name
10
entered on the register,
(b)
other criteria that will be used by the Royal College of
Ophthalmologists in reaching its decisions on whether the name of a
person should be entered on the register,
(c)
matters relating to administrative arrangements for the register,
15
including arrangements for the voluntary withdrawal of names from
the register.
(3)
Guidance prepared or revised under subsection (2) shall be published in such
form as the Royal College of Ophthalmologists considers appropriate.
(4)
Before publishing guidance under subsection (2), the Royal College of
20
Ophthalmologists shall consult—
(a)
the registration authorities,
(b)
the National Institute for Clinical Excellence,
(c)
the General Medical Council,
(d)
the General Optical Council,
25
(e)
the British College of Optometrists, and
(f)
such other persons as the Royal College of Ophthalmologists considers
appropriate.
(5)
The Royal College of Ophthalmologists shall make arrangements for the
register maintained under this section to be available for public inspection.
30
(6)
The registration authority may, if it thinks that a person whose name is entered
on the register is not a fit and proper person to be so entered, decide to exclude
that person from the register.
(7)
Where the registration authority reaches a decision under subsection (6), it
shall—
35
(a)
serve a notice on the person to whom the decision relates, and
(b)
inform the Royal College of Ophthalmologists of the decision.
(8)
A notice served under subsection (7)(a) shall inform the person to whom the
decision relates of his right of appeal under section 6.
(9)
Where—
40
(a)
the Royal College of Ophthalmologists has been informed under
subsection (7)(b) of a decision by the registration authority and the
period specified in section 6(2) has elapsed without an appeal being
made, or

Regulation of Laser Eye Surgery Bill
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(b)
the Royal College of Ophthalmologists has been informed under
section 6(4)(c) of a decision by the Tribunal to confirm a decision of the
registration authority,

the Royal College of Ophthalmologists shall remove the name of the person to
whom the decision relates from the register.
5
6
Appeals to the Tribunal
(1)
A person to whom a decision under section 5(6) relates may appeal against that
decision to the Tribunal.
(2)
No appeal against a decision may be brought by a person to whom a decision
under section 5(6) relates more than 28 days after service on him of the notice
10
of the decision.
(3)
On an appeal against a decision of the registration authority, the Tribunal may
confirm the decision or direct that it shall not have effect.
(4)
When the Tribunal has come to a decision under subsection (3), it shall
inform—
15
(a)
the person to whom the decision relates,
(b)
the registration authority, and
(c)
the Royal College of Ophthalmologists,

of that decision.
(5)
Section 9 of the Protection of Children Act 1999 (c. 14) (the Tribunal) is
20
amended as set out in subsection (6).
(6)
In subsection (2) of that section, omit the word “or” after paragraph (e) and,
after paragraph (f), insert “or
(g)
on an appeal under section 6 of the Regulation of Laser Eye
Surgery Act 2005.”
25
Additional regulatory requirements
7
Requirement for certain activities to be carried on by or under supervision of
an ophthalmologist
The registered person in relation to a relevant establishment shall ensure that
prescribed activities relating to laser eye surgery are only carried on in that
30
establishment by or under the supervision of an ophthalmologist who is
registered in accordance with the provisions of Part 2 of the 2000 Act.
8
Patient information
(1)
The registered person in relation to a relevant establishment shall ensure that
the statement of purpose in respect of that establishment—
35
(a)
states the qualifications of persons carrying on laser eye surgery and
activities relating to laser eye surgery in the establishment;
(b)
states in particular whether an ophthalmologist carrying on laser eye
surgery in the establishment is a person whose name appears in the
register of specialists kept by the General Medical Council under article
40
13 of the General and Specialist Medical Practice (Education, Training