Overview

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

Description

The bill creates a Medicines Safety Evaluation Panel (the Panel) appointed by the Secretary of State. This panel will consist of at least two statisticians from the Office for National Statistics and eight members of the National Institute for Health Research, with the Secretary of State appointing a chair. The panel's duty is to conduct a comprehensive review comparing the effectiveness of human biology-based tests (e.g., computer simulations, tests using human cells, tissues and DNA, and early clinical tests) against animal-based tests, using medicines and drugs already licensed or withdrawn for safety reasons by the MHRA or MCA. The review must consider medicines designed to treat a wide range of diseases. The MHRA is mandated to provide the Panel with all relevant information upon request. The Panel will submit its report within two years of its establishment, which will then be published by the Secretary of State, with commercially sensitive information suitably protected.

Government Spending

The bill states that any expenses incurred by the Secretary of State in implementing the Act will be covered by Parliament. No specific figures are provided in the bill text.

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: Required to provide statisticians to the Panel.
• The National Institute for Health Research: Required to provide members to the Panel.
• Pharmaceutical companies: The outcome of the review could influence future testing methods and regulations, potentially impacting costs and research practices.
• Animal welfare groups: The findings may influence the use of animals in drug testing.

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