Federal Right to Try: Where Is It Going?

Policy-makers, bioethicists, and patient advocates have been engaged in a fierce battle about the merits and potential harms of a federal right-to-try law. This debate about access to investigational medical products has raised profound questions about the limits of patient autonomy, appropriate government regulation, medical paternalism, and political rhetoric. For example, do patients have a right to access investigational therapies, as the right-to-try movement asserts? What is government's proper role in regulating and facilitating access to drugs that are still in development? In this review, we analyze the history of the right-to-try movement, review the arguments put forth by supporters and opponents of the legislation, and consider the movement's consequences. Two possible scenarios may emerge. One is that the right-to-try pathway may fail to meaningfully increase patient access to investigational products. Alternatively, certain companies may attempt to rely on the federal right-to-try legislation to sell investigational products, taking advantage of the provision that allows for direct costs, as there is currently no clear mechanism for enforcement or monitoring of cost calculations.

Assessment of decision-making capacity in patients requesting assisted suicide.

In this editorial, we argue that current attitudes toward terminally ill patients are generally too paternalistic, and that it is wrong to assume that patients suffering from mental health issues (including depression) cannot consent to assisted suicide.Declaration of interestNone.

When Doctors and Parents Don't Agree: The story of Charlie Gard.

This discussion follows a series of high profile cases involving a terminally ill child, Charlie Gard. These cases are significant as they trace the complexities that arise when parents and medical teams do not agree as well as addressing the question of whether there is a right to access experimental treatment.

Oregon's Death With Dignity Act: 20 Years of Experience to Inform the Debate.

Twenty years ago, Oregon voters approved the Death With Dignity Act, making Oregon the first state in the United States to allow physicians to prescribe medications to be self-administered by terminally ill patients to hasten their death. This report summarizes the experience in Oregon, including the numbers and types of participating patients and providers. These data should inform the ongoing policy debate as additional jurisdictions consider such legislation.

[New legal regulations for palliative care with implications for politics and practice]. / Neue gesetzliche Regelungen für die Palliativversorgung und ihre Implikationen für Politik und Praxis.

In December 2015 two different laws were adopted. Both are of importance for palliative care. One of the laws criminalizes commercial, "business-like" assisted suicide (§ 217 German Criminal Code), the other one aims to improve hospice and palliative care in Germany. Through the latter far-reaching changes in Social Code Books V and XI, as well as of the Hospital Finance Act have been made. This new Act to Improve Hospice and Palliative Care (HPG) focuses, amongst others, on: (a) Better funding of hospice services, by raising the minimum grant for patients in inpatient hospices paid per day by the health insurance funds by about 28.5%, and for outpatient hospice services by about 18%; (b) further development of general outpatient nursing and medical palliative care, and the networking of different service providers; (c) introduction of an arbitration procedure for service provider agreements to be concluded between the health insurance funds and the teams providing specialized home palliative care (SAPV); (d) the right to individual advice and support by the health insurance funds; (e) care homes may offer their residents advance care planning programs to be funded by the statutory health insurers; (f) palliative care units in hospitals can be remunerated outside the DRG system by per diem rates; (g) separate funding and criteria for multi-professional palliative care services within a hospital.While little concrete impact on hospice and palliative care can be expected following the new § 217 German Criminal Code, the HPG provides a good basis to improve care. For this purpose, however, which complementary and more concrete agreements are made to put the new legal regulations into practice will be crucial.

Ethical Analysis for Physicians Considering the Provision of Life-Ending Medication in Compliance with the California End of Life Option Act.

The End of Life Option Act in California, effective June 9, 2016, permits physicians to prescribe lethal medication to patients confirmed to be terminally ill and capable of independently making and carrying out a decision to ingest deadly medication. Medicine has traditionally excluded the provision of deadly medication from proper practice. Physicians reasonably may hold to that limit. However, honoring a repeated request from a capable, terminally ill patient to receive life-ending medication still can be considered to be a moral and permissible approach to relieve suffering. A physician choosing to expand his/her role within this narrowly defined context allows the patient to assume authority for a deeply personal decision that may belong to the patient more than to anyone else.

An Ethics of Permission: A Response to the California End of Life Option Act.

An ethics of permission can be helpful in framing a response to the ethical differences surrounding the California End of Life Option Act. Law does not define morality, and reaching a moral understanding demands thorough reflection. An ethics of permission examines the ethical demands of a permissive law for both clinician and patient. Serving the good of the patient, respecting professional conscience, and following the law are three ethical elements. Although developing an ethics of permission includes these three elements, these elements do not exhaust all the moral implications involved. An ethics of permission also includes the importance of exercising professional tolerance in the honoring of clinicians who choose to participate or refuse to participate. In addition, an ethics of permission also provides insight in implementing just and fair behavior among medical professionals.

Physician-assisted death with limited access to palliative care.

Even among advocates of legalising physician-assisted death, many argue that this should be done only once palliative care has become widely available. Meanwhile, according to them, physician-assisted death should be banned. Four arguments are often presented to support this claim, which we call the argument of lack of autonomy, the argument of existing alternatives, the argument of unfair inequalities and the argument of the antagonism between physician-assisted death and palliative care. We argue that although these arguments provide strong reasons to take appropriate measures to guarantee access to good quality palliative care to everyone who needs it, they do not justify a ban on physician-assisted death until we have achieved this goal.

QALYs, euthanasia and the puzzle of death.

This paper considers the problems that arise when death, which is a philosophically difficult concept, is incorporated into healthcare metrics, such as the quality-adjusted life year (QALY). These problems relate closely to the debate over euthanasia and assisted suicide because negative QALY scores can be taken to mean that patients would be 'better off dead'. There is confusion in the literature about the meaning of 0 QALY, which is supposed to act as an 'anchor' for the surveyed preferences on which QALYs are based. In the context of the debate over euthanasia, the QALY assumes an ability to make meaningful comparisons between life-states and death. Not only is this assumption questionable, but the ethical debate is much more broad than the question of whether death is preferable to a state of living. QALYs are derived from preferences about health states, so do not necessarily reflect preferences about events (eg, dying) or actions (eg, killing). This paper presents a new kind of problem for the QALY. As it stands, the QALY provides confused and unreliable information when it reports zero or negative values, and faces further problems when it appears to recommend death. This should preclude its use in the debate over euthanasia and assisted suicide. These problems only apply where the QALY involves or seems to involve a comparison between life-states and death, and are not relevant to the more general discussion of the use of QALYs as a tool for comparing the benefits derived from treatment options.

¿Podría ser aceptable la eutanasia infantil? / Could infant euthanasia be ever acceptable?

The recent enactment of a law that allows infant euthanasia in Belgium raises questions with varied answers. To contribute to a better understanding of the topic, euthanasia and legislation concepts are described. After a bioethical analysis, we propose as conclusion that children euthanasia could only be acceptable in very exceptional situations in which palliative measures have failed. The answer should be that it is not acceptable in our setting, not until we have public policies, protocols and palliative care services for terminally ill children.

La reciente promulgación de una ley que permite la eutanasia infantil en Bélgica plantea interrogantes que admiten respuestas diversas. Para contribuir a una mejor comprensión del tema se describen los conceptos de eutanasia y la legislación pertinente. Después de hacer un análisis bioético, se plantea como conclusión que la eutanasia de niños podría ser aceptable sólo de manera muy excepcional ante situaciones en las cuales hubiesen fracasado las medidas de cuidado paliativo. Para nuestro medio la respuesta debería ser que no es aceptable, al menos mientras no existan políticas públicas, protocolos y servicios de cuidados paliativos para niños con enfermedades terminales.

[Could infant euthanasia be ever acceptable?]. / ¿Podría ser aceptable la eutanasia infantil?

The recent enactment of a law that allows infant euthanasia in Belgium raises questions with varied answers. To contribute to a better understanding of the topic, euthanasia and legislation concepts are described. After a bioethical analysis, we propose as conclusion that children euthanasia could only be acceptable in very exceptional situations in which palliative measures have failed. The answer should be that it is not acceptable in our setting, not until we have public policies, protocols and palliative care services for terminally ill children.