Jessica Pace1, A/Prof Wendy Lipworth1
1University Of Sydney, Sydney Health Ethics , Sydney, Australia
The option to withdraw marketing approval or subsidy for medicines underpins a number of healthcare policies governing access to medicines. For example, a number of jurisdictions have introduced mechanisms that allow for the conditional approval and funding of medicines, whereby a medicine is granted marketing approval or subsidy on the condition that further data is collected to confirm its safety, effectiveness or cost-effectiveness once it has entered the market. This data is then used to decide if the medicine should remain on the market, if it should continue to be subsidised and, if so, whether a price adjustment is needed. There is also hope that the increased availability of biomedical real world and big data will allow for faster identification of low-value technologies, providing guidance on technologies to be targeted for withdrawal of regulatory approval or subsidy in order to make best use of scarce healthcare resources and deliver more effective, cost-effective and affordable care for both individual patients and society as a whole.
However, regulatory withdrawal and disinvestment of medicines also raises a range of important ethical and philosophical issues. These include questions related to clinical ethics (such as what responsibilities do physicians have to protect patients who have had a positive effect from medicines that are subject to disinvestment and withdrawal), epistemology (what is considered to be sufficient evidence of harm- either to individual patients or the broader community- that would justify a disinvestment or regulatory withdrawal initiative), distributive justice (how do we ensure that the benefits and burdens of any regulatory withdrawal and/or disinvestment initiative are distributed fairly) and procedural justice (what are considered to be “fair” processes for determining when market withdrawal and disinvestment are to take place). To date there has been minimal attention paid to these issues in either the empirical or theoretical ethics literature or policies in this area and these issues have not been subject to rigorous ethical analysis.
In this workshop, we aim to develop a more nuanced bioethical perspective of the ethics of market withdrawal of and disinvestment from medicines. We will begin with a series of short presentations outlining our research (both empirical and theoretical) in this area (40 minutes). We will then involve the audience in a series of group discussions utilising real and hypothetical disinvestment scenarios to examine the following questions:
- How might a bioethicist conceptualise the risks and benefits of disinvestment and communicate this to varied stakeholder groups (including patients and their families, physicians, members of the pharmaceutical industry and policy makers)? (25 minutes)
- What safeguards could we implement to minimise the risks of market withdrawal and disinvestment? Which (if any) of these should we implement? Is it feasible to do this or are other approaches needed? (25 minutes)
Jessica Pace is a PhD candidate at Sydney Health Ethics (SHE) at the University of Sydney, with undergraduate degrees in biochemistry, law, and pharmacy. She is pursuing research that examines stakeholder values and beliefs surrounding accelerated access to medicines, including initiatives that bypass or circumvent existing political processes in order to provide faster and/or broader access to new therapies.
Wendy Lipworth is a bioethicist and health social scientist at Sydney Health Ethics (SHE) at the University of Sydney. Her research, which is supported by an NHMRC Career Development Fellowship, focuses on the ethic and politics of health technology innovation.