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Make
provision about the evaluation of methods of testing the safety
of |
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medicines; and for connected
purposes. |
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Be
it enacted by the Queen’s most Excellent Majesty,
by and with the advice and |
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consent of the Lords Spiritual
and Temporal, and Commons, in this present |
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Parliament assembled, and
by the authority of the same, as follows:— |
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1 |
Medicines
Safety Evaluation Panel |
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(1) |
The Secretary of State must,
within six months of the date on which this Act is |
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passed, appoint a Medicines
Safety Evaluation Panel (“the Panel”). |
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(2) |
The members of the Panel
are to be appointed by the Secretary of State and |
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5 |
(a) |
no fewer than two statisticians
from the Office for National Statistics, |
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(b) |
no fewer than eight members
of the National Institute for Health |
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(3) |
The Secretary of State may
nominate one of the members of the Panel to act as |
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(4) |
The Secretary of State must,
in appointing members to the Panel, take steps to |
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ensure that no members appointed
have any commercial or other interests |
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which may conflict with their
duties on the Panel. |
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(5) |
The
Secretary of State may make payments to the chairman of the Panel
by way of |
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remuneration
and make payments to him and other members of the Panel in respect
of |
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expenses
incurred by them in the performance of their duties. |
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(6) |
The Panel shall cease to
exist after it has reported to the Secretary of State under |
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(1) |
The Panel must conduct a
review of methods of testing the safety of medicines |
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(2) |
The
review must comprise a comparison of the effectiveness of— |
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(a) |
human biology-based tests,
and |
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(3) |
The medicines or drugs considered
in the comparison of tests must include |
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(a) |
designed to treat a wide range
of disease types, and |
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(b) |
which have been licensed
by the Medicines and Healthcare products |
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Regulatory Agency (MHRA) or
Medicines Control Agency (MCA). |
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(4) |
Some of the products considered
in accordance with subsection (3) must have |
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been withdrawn from sale
or use on grounds of safety. |
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(5) |
The Panel must commission
bodies which it considers appropriate to conduct |
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those human biology-based
tests it regards necessary for the purposes of |
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(6) |
In determining the types
of test to be conducted for the purposes of subsection |
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(2)(a), the Panel shall have
regard to the desirability of using all available |
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(a) |
computer simulations, |
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(b) |
tests involving human cells,
tissues and DNA, and |
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(c) |
early clinical tests on volunteers.
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(7) |
The Panel must send the
Secretary of State a report on its review within two |
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years of the date of its
appointment. |
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(8) |
The Secretary of State must
publish the report, save that in doing so he may |
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take such steps as he considers
necessary to protect commercially confidential |
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“animal-based tests”
means those tests required by— |
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(a) |
the Medicines (Applications
for Product Licences - Products for |
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Human Use) Regulations
1993 (SI 1993/2538), |
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(b) |
the Medicines (Standard
Provisions for Licences and |
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Certificates) Amendment
(No. 2) Regulations 1993 (SI 1993/ |
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(c) |
the Medicines for Human
Use (Marketing Authorisations Etc.) |
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Regulations 1994 (SI
1994/3144); |
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“early clinical tests”
means tests involving minuscule levels of exposure to |
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“human biology-based
tests” means tests dependent on human biological |
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The MHRA must provide, on
request, all information it holds relating to the |
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testing of products which
the Panel requires in pursuance of its duty to conduct |
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a comparison of tests under
section 2(2). |
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There
shall be paid out of money provided by Parliament any expenses
of the Secretary |
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