Overview

This bill establishes a Medicines Safety Evaluation Panel to review methods for testing medicine safety, comparing human-biology based tests with animal-based tests. The panel will report its findings to the Secretary of State, who will then publish the report.

Description

The bill creates a Medicines Safety Evaluation Panel (the Panel) appointed by the Secretary of State. The panel will consist of at least two statisticians from the Office for National Statistics and eight members of the National Institute for Health Research. The Secretary of State may appoint a chairperson. The Panel's duty is to review medicine safety testing methods, comparing the effectiveness of human-biology-based and animal-based tests across a range of medicines, including some withdrawn due to safety concerns. The Panel will commission necessary human biology-based tests, considering various technologies such as computer simulations, cell/tissue/DNA tests, and early clinical tests. The Medicines and Healthcare products Regulatory Agency (MHRA) must provide relevant information to the panel. The Panel will report its findings to the Secretary of State within two years, and the report will be published, with appropriate safeguards for commercially confidential information.

Government Spending

The bill mandates that the expenses of the Secretary of State in implementing this Act will be paid from public funds. The exact amount is not specified in the bill.

Groups Affected

Groups potentially affected include:

• The Medicines and Healthcare products Regulatory Agency (MHRA): Required to provide information to the Panel.
• The Office for National Statistics: At least two statisticians from this office will serve on the panel.
• The National Institute for Health Research: At least eight members from this institute will serve on the panel.
• Pharmaceutical Companies: Their testing methods and products will be under review, although confidential information will be protected.
• Animal Welfare Groups: The outcome of the review could influence the use of animals in medicine testing.

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