Formulating an Ethics of Pharmaceutical Disinvestment.

There is growing interest among pharmaceutical policymakers in how to "disinvest" from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in order to identify ethical principles and concepts that might be relevant to pharmaceutical disinvestment decisions. This revealed a number of key ethical considerations-both procedural and substantive-that need to be considered when making pharmaceutical disinvestment decisions. These principles do not, however, provide practical guidance so we present a framework outlining how they might be applied to different types of disinvestment decisions. We also argue that, in this context, even the most rigorous ethical reasoning is likely to be overridden by moral intuitions and psychological biases and that disinvestment decisions will need to strike the right balance between respecting justifiable moral intuitions and overriding unjustifiable psychological impulses.

Additional peculiarities of medical devices that should be considered in their development process.

Medical devices are peculiar products: their definition varies from country to country, they are used to treat diseases and they are different from pharmaceuticals. In 2012, the authors began to describe the complex and demanding environment of the medical device industry. In this article, the authors' previous research is extended with additional peculiarities of medical devices such as recall, pricing and adoption factors.