Overview

The Medical Innovation Bill aims to encourage responsible innovation in medical treatments while preventing reckless departures from established practices. It clarifies the legal position of doctors who choose to deviate from standard treatments, providing a framework for responsible innovation that balances patient safety with the advancement of medical care.

Description

The Bill defines "responsible innovation" as a decision to depart from standard medical practice based on a careful consideration of several factors. These factors include:

• Insufficient Evidence: Acknowledging why existing research is inadequate or unclear, particularly in cases of rare conditions.
• Risk Assessment: Weighing the risks and potential benefits of both the proposed innovative treatment and standard treatments.
• Success Rates: Evaluating the likely success of each treatment option.
• Consequences: Considering the potential outcomes of both applying and not applying the innovative treatment.
• Patient Input: Taking into account the patient's opinions and preferences.
• Other Relevant Factors: Considering any other factors deemed necessary for sound clinical judgement.

The decision-making process must be accountable, transparent, and involve careful consideration of all relevant aspects. This could involve multi-disciplinary team decisions, notification to a responsible officer (as defined in the Medical Act 1983), and explaining the reasons for deviating from standard practice to the patient, including discussing any dissenting opinions from colleagues.

Importantly, the Bill does not permit treatment without consent (where legally required) or treatment for research purposes outside the patient's best interests.

Government Spending

The Bill is not expected to have a direct impact on UK government spending. The costs associated with implementation would likely be absorbed within existing healthcare budgets.

Groups Affected

This bill directly affects:

• Doctors: The Bill provides them with clearer legal protection when responsibly innovating in patient treatment but also sets out the responsibilities of this innovation.
• Patients: The bill aims to protect patients by emphasizing responsible innovation processes, thus reducing risks of potentially harmful deviations from standard medical practices, while still allowing for innovation.
• Medical Regulatory Bodies: The bill will inform their guidance on responsible medical innovation.

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