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

Abstract

This article considers the issue of expanded access to innovative treatments in the context of recent legislative initiatives in the United Kingdom and the United States. In the United Kingdom, the supporters of legislative change argued that the common law principles governing medical negligence are a barrier to innovation. In an attempt to remove this perceived impediment, two bills proposed that innovating doctors sued for negligence should be able to rely in their defence on the fact that their decision to innovate was "responsible." A decision to innovate would be regarded as responsible if it followed a specified process. Although these changes to the law of medical negligence were not passed, this article argues that the idea of a process-based approach was sound. In the United States, a number of states have passed "Right to Try" laws that permit doctors to prescribe and companies to provide investigational products without the need for FDA approval. These laws do not purport to and nor are they able to alter the obligations of individuals and companies under federal law. They are consequently unlikely to achieve their stated aim of expanding access to investigational products. This article argues that they nevertheless have a cogent rationale in so far as they highlight the need for rights-based reform to federal regulations governing access.

Whence and whither ‘modern medical law’?

“…The drive for innovation has brought campaigners for the 'right to try' into conflict with the pharmaceutical regulation that emerged in the 1960s to address the thalidomide scandal. 130 The rise of citizen science and bio-hacking challenge regulatory norms. 131 Scandal remains an important theme too in informing the development of law and regulation.…”

The ethical plausibility of the ‘Right To Try’ laws

“…Although RTT laws have emerged in the USA, the difficult issues they touch upon, and the complex area of end of life care in which they are situated, are relevant to other countries (13). Such issues include: the balance of therapeutic beneficence between medical research centred on the public and clinical practice centred on the individual patient; the potential conflict between individual medical autonomy and the interest of public health and medical research; the public understanding of (and trust in) the process and regulation of medical research.…”

Assessment of the Right-to-Try Law: The Pros and the Cons

“…The legislation does not contain incentives for insurance companies to cover experimental treatment costs and the potential outcomes of the treatment (2,9). Insurance companies in many states that passed Right-To-Try laws have denied hospice coverage, home health-care coverage, and even health-care coverage for at least 6 mo after treatment (2,9). This denial of coverage creates a financial burden left for the families, who often cannot pay.…”