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Safety of Medicines Bill


 

Safety of Medicines Bill

 

 
 

Contents

1   

Medicines Safety Evaluation Panel

2   

Duty of the Panel

3   

Duty of Medicines and Healthcare products Regulatory Agency

4   

Financial provisions

5   

Short title and extent

 

Bill 59                                                                                                 

55/1

 
 

Safety of Medicines Bill

1

 

A

Bill

To

Make provision about 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 no fewer than six members of the National Institute for Health

5

Research.

(3)   

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

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

10

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

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

15

section 2(6).

2       

Duty of the Panel

(1)   

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

(2)   

The review must comprise a comparison of the effectiveness of—

(a)   

human biology-based tests, and

20

(b)   

animal-based tests.

 

Bill 59                                                                                                 

55/1

 
 

Safety of Medicines Bill

2

 

(3)   

The medicines to be tested in accordance with section 2(2) must have—

(a)   

been licensed for marketing by the appropriate regulatory authority or

have been authorised to enter clinical trials,

(b)   

been withdrawn from sale or never marketed on grounds of safety, and

(c)   

collectively caused a range of adverse reactions.

5

(4)   

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.

(5)   

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

10

technologies, including—

(a)   

computer simulations,

(b)   

tests involving human cells, tissues and DNA, and

(c)   

early clinical tests on volunteers.

(6)   

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

15

years of the date of its appointment.

(7)   

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.

(8)   

In this section—

20

“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

25

material and data.

3       

Duty of Medicines and Healthcare products Regulatory Agency

The Medicines and Healthcare products Regulatory Agency 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

30

section 2(2).

4       

Financial provisions

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

of State under this Act.

5       

Short title and extent

35

(1)   

This Act may be cited as the Safety of Medicines Act 2011.

(2)   

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

 
 

 

 
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Revised 13 October 2010