This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products (...) in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)

In a recent paper, Charles Foster argued that the epistemic uncertainties surrounding prolonged disorders of consciousness make it impossible to prove that the withdrawal of life-sustaining treatment can be in a patient’s best interests and, therefore, the presumption in favour of the maintenance of life cannot be rebutted. In the present response, I argue that, from a legal perspective, Foster has reached the wrong conclusion because he is asking the wrong question. According to the reasoning in two leading cases —Bland (...) and James —the principle of respect for autonomy creates a persuasive presumption against treatment without consent. Therefore, it is the continuation of treatment that requires justification, rather than its withdrawal. This presumption also works as the tiebreaker determining that treatment should stop if there is no persuasive evidence that its continuation is in the best interests of the patient. The presumption in favour of the maintenance of life, on the other hand, should be understood as an evidential presumption on a factual issue that is assumed to be true if unchallenged. However, the uncertainties regarding PDOC actually give reasons for displacing this evidential presumption. Consequently, decision-makers will have to weigh up the pros and cons of treatment having the presumption against treatment without consent as the tiebreaker if the evidence is inconclusive. In conclusion, when the right question is asked, Foster’s argument can be turned on its head and uncertainties surrounding PDOC weigh in to justify the interruption of treatment in the absence of compelling contrary evidence. (shrink)

As health policy-makers around the world seek to make progress towards universal health coverage, they must navigate between two important ethical imperatives: to set national spending priorities fairly and efficiently; and to safeguard the right to health. These imperatives can conflict, leading some to conclude that rights-based approaches present a disruptive influence on health policy, hindering states’ efforts to set priorities fairly and efficiently. Here, we challenge this perception. We argue first that these points of tension stem largely from inadequate (...) interpretations of the aims of priority setting as well as the right to health. We then discuss various ways in which the right to health complements traditional concerns of priority setting and vice versa. Finally, we set out a three-step process by which policy-makers may navigate the ethical and legal considerations at play. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

Both developing and developed countries face an increasing mismatch between what patients expect to receive from healthcare and what the public healthcare systems can afford to provide. Where there has been a growing recognition of the entitlement to receive healthcare, the frustrated expectations with regards to the level of provision has led to lawsuits challenging the denial of funding for health treatments by public health systems. This book analyses the impact of courts and litigation on the way health systems set (...) priorities and make rationing decisions. In particular, it focuses on how the judicial protection of the right to healthcare can impact the institutionalization, functioning and centrality of Health Technology Assessment (HTA) for decisions about the funding of treatment. Based on the case study of three jurisdictions - Brazil, Colombia, and England - it shows that courts can be a key driver for the institutionalization of HTA. These case studies show the paradoxes of judicial control, which can promote accountability and impair it, demand administrative competence and undermine bureaucratic capacities. The case studies offer a nuanced and evidence-informed understanding of these paradoxes in the context of health care by showing how the judicial control of priority-setting decisions in health care can be used to require and control an explicit scheme for health technology assessment, but can also limit and circumvent it. (shrink)

In 2024, new legislation introduced significant changes to the rules, procedures and institutions governing research ethics in Brazil. One of its objectives was to limit sponsors’ post-trial access (PTA) obligations. However, a presidential veto weakened this reform. This veto maintained the sponsors’ indefinite duty to provide the tested intervention until it becomes available in the National Health System. In Brazil, where courts often order the public funding for treatments not included in the health system’s lists and protocols, a substantial reduction (...) in the sponsors’ PTA obligations would likely increase litigation seeking state-funded PTA. This dynamic adds an extra layer of complexity to the ethical analysis of the regulation of PTA in Brazil, as its distributive impact on the public health system must be considered. Therefore, any argument for reducing sponsors’ PTA obligations must go beyond simply demonstrating that sponsors do not owe participants an ethical obligation to provide them with indefinite access to the tested intervention or that such obligation discourages research. It must also make a compelling case for why the state, rather than sponsors, should bear the responsibility for funding PTA. (shrink)