Medical Negligence Determinations, the "Right to Try," and Expanded Access to Innovative Treatments

Area of Science:

• Medical Law and Ethics
• Pharmaceutical Policy
• Health Innovation

Background:

• Barriers to accessing innovative treatments are a significant concern in healthcare systems.
• Recent legislative initiatives in the UK and US have attempted to address these barriers.
• Existing legal frameworks, such as medical negligence and federal drug approval processes, are central to the debate.

Purpose of the Study:

• To analyze legislative proposals in the UK and US concerning expanded access to innovative treatments.
• To evaluate the effectiveness and rationale behind proposed changes to medical negligence law in the UK.
• To assess the impact and limitations of "Right to Try" laws in the United States.

Main Methods:

• Review of legislative initiatives in the United Kingdom and United States.
• Analysis of legal principles governing medical negligence and drug approval processes.
• Critical evaluation of the potential and actual outcomes of proposed and enacted laws.

Main Results:

• UK bills proposing a "responsible innovation" defense in medical negligence, based on a specified process, were not passed but highlighted a sound concept.
• US "Right to Try" laws permit access to investigational products without FDA approval but do not alter federal obligations, limiting their effectiveness.
• Both legislative approaches, despite differing outcomes, underscore the need for regulatory reform to facilitate access to novel therapies.

Conclusions:

• A process-based approach to managing innovation in medical negligence offers a potentially sound framework.
• US "Right to Try" laws, while well-intentioned, are unlikely to expand access due to their inability to override federal regulations.
• There is a clear need for rights-based reforms to federal regulations to genuinely enhance access to investigational treatments.