Overview

The Safety of Medicines Bill establishes a Medicines Safety Evaluation Panel to review methods for testing medicine safety, comparing human biology-based tests with animal-based tests. The aim is to improve the safety and efficacy of medicines testing procedures.

Description

This bill creates a Medicines Safety Evaluation Panel (the Panel), appointed by the Secretary of State, including at least six members from the National Institute for Health Research. The Panel's primary duty is to review medicine safety testing methods, comparing human biology-based tests (including computer simulations, tests on human cells, and early clinical trials) against animal-based tests (as defined in Directives 2004/27/EC and 2003/63/EC). The review will focus on medicines licensed for marketing, withdrawn due to safety concerns, or which have caused adverse reactions. The Panel will commission necessary human biology-based testing and will submit a report to the Secretary of State within two years. The Medicines and Healthcare products Regulatory Agency (MHRA) must provide the Panel with relevant information. The Secretary of State will publish the report, protecting commercially sensitive data.

Government Spending

The bill will require government spending to cover the expenses of the Secretary of State in establishing and running the Panel, including member remuneration and expenses. No specific figures are provided in the bill text.

Groups Affected

• The Medicines Safety Evaluation Panel members: Will receive remuneration and expenses.
• The Medicines and Healthcare products Regulatory Agency (MHRA): Will be required to provide information to the Panel.
• The pharmaceutical industry: The results of the Panel's review could impact testing methods and regulations, potentially affecting research and development costs and timelines.
• Animal welfare groups: The findings could influence the use of animals in medicine testing.
• The public: The outcome of the review could lead to safer and more effective medicines in the future.

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