Overview

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

Description

This bill creates a Medicines Safety Evaluation Panel (the Panel). The Secretary of State will appoint the Panel within six months, including at least six members from the National Institute for Health Research. The Panel will review medicine safety testing methods, specifically comparing human biology-based tests (including computer simulations, tests on human cells/tissues/DNA, and early clinical trials) and animal-based tests (as defined by Directives 2004/27/EC and 2003/63/EC). The review will consider medicines previously licensed, withdrawn, or never marketed due to safety concerns, and which collectively caused a range of adverse reactions. The Panel must commission appropriate bodies to conduct necessary human biology-based tests. The Panel will submit a report to the Secretary of State within two years, which will then be published (with commercially confidential information protected). The Medicines and Healthcare products Regulatory Agency (MHRA) will provide the Panel with relevant information upon request. The Panel will dissolve after submitting its report.

Government Spending

The bill mandates that the expenses incurred by the Secretary of State in implementing the Act will be covered by funds provided by Parliament. No specific figures are given.

Groups Affected

• The Medicines and Healthcare products Regulatory Agency (MHRA): Required to provide information to the Panel.
• National Institute for Health Research: At least six members must be appointed to the Panel.
• The Pharmaceutical Industry: Potentially affected by the findings and recommendations of the Panel's report, particularly concerning testing methods and the implications for research and development.
• Animal Welfare Groups: May be interested in the comparison of human and animal based testing methods.
• The Public: Ultimately benefits from improved medicine safety through better testing methods.

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