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Safety of Medicines (Evaluation) Bill


 

Safety of Medicines (Evaluation) Bill

 

 
 

Contents

1   

Medicines Safety Evaluation Panel

2   

Duty of the Panel

3   

Duty of MHRA

4   

Expenses

5   

Short title and extent

 

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Safety of Medicines (Evaluation) Bill

1

 

A

Bill

To

Make provision about the evaluation of methods of testing the safety of

medicines; and for connected purposes. 

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:—

1       

Medicines Safety Evaluation Panel

(1)   

The Secretary of State must, within six months of the date on which this Act is

passed, appoint a Medicines Safety Evaluation Panel (“the Panel”).

(2)   

The members of the Panel are to be appointed by the Secretary of State and

must include—

5

(a)   

no fewer than two statisticians from the Office for National Statistics,

and

(b)   

no fewer than eight members of the National Institute for Health

Research.

(3)   

The Secretary of State may nominate one of the members of the Panel to act as

10

chairman.

(4)   

The Secretary of State must, in appointing members to the Panel, take steps to

ensure that no members appointed have any commercial or other interests

which may conflict with their duties on the Panel.

(5)   

The Secretary of State may make payments to the chairman of the Panel by way of

15

remuneration and make payments to him and other members of the Panel in respect of

expenses incurred by them in the performance of their duties.

(6)   

The Panel shall cease to exist after it has reported to the Secretary of State under

section 2(7).

2       

Duty of the Panel

20

(1)   

The Panel must conduct a review of methods of testing the safety of medicines

and drugs.

 

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Safety of Medicines (Evaluation) Bill

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(2)   

The review must comprise a comparison of the effectiveness of—

(a)   

human biology-based tests, and

(b)   

animal-based tests.

(3)   

The medicines or drugs considered in the comparison of tests must include

products—

5

(a)   

designed to treat a wide range of disease types, and

(b)   

which have been licensed by the Medicines and Healthcare products

Regulatory Agency (MHRA) or Medicines Control Agency (MCA).

(4)   

Some of the products considered in accordance with subsection (3) must have

been withdrawn from sale or use on grounds of safety.

10

(5)   

The Panel must commission bodies which it considers appropriate to conduct

those human biology-based tests it regards necessary for the purposes of

conducting the review.

(6)   

In determining the types of test to be conducted for the purposes of subsection

(2)(a), the Panel shall have regard to the desirability of using all available

15

technologies, including—

(a)   

computer simulations,

(b)   

tests involving human cells, tissues and DNA, and

(c)   

early clinical tests on volunteers.

(7)   

The Panel must send the Secretary of State a report on its review within two

20

years of the date of its appointment.

(8)   

The Secretary of State must publish the report, save that in doing so he may

take such steps as he considers necessary to protect commercially confidential

information.

(9)   

In this section—

25

“animal-based tests” means those tests required by Directives 2004/27/

EC and 2003/63/EC;

“early clinical tests” means tests involving minuscule levels of exposure to

the product;

“human biology-based tests” means tests dependent on human biological

30

material and data.

3       

Duty of MHRA

The MHRA must provide, on request, all information it holds relating to the

testing of products which the Panel requires in pursuance of its duty to conduct

a comparison of tests under section 2(2).

35

4       

Expenses

There shall be paid out of money provided by Parliament any expenses of the Secretary

of State under the Act.

5       

Short title and extent

(1)   

This Act may be cited as the Safety of Medicines (Evaluation) Act 2009.

40

(2)   

This Act extends to England and Wales, Scotland and Northern Ireland.

 
 

 
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