Governments and financial institutions in several jurisdictions are planning or implementing nonmedical/'forced' switches by cutting drug coverage for reference biologics and funding only less expensive biosimilars. Switches raise numerous ethical and legal challenges, as the drugs are framed as not being identical and, despite strong evidence for noninferiority of some biosimilars, there is controversy over whether switching can sometimes lead to adverse events. Canadian law generally requires physicians to give precedence to their patients' best interests over social interests such as cost containment. The primacy of patients' interests is also clearly reflected in professional policies and codes of ethics. Moreover, physicians are obligated to disclose everything a reasonable person in the patient's position would want to know when obtaining informed consent for treatment, including addressing not only scientific information but also relevant social controversy about nonmedical switches. Under Canadian law, physicians may be obligated to tell patients about the ability to access unfunded biologics, even if patients lack the resources to obtain them. In sum, while there is no inherent right to funding for reference biologics in Canada, physicians in some circumstances may have a legal obligation as fiduciaries to advocate on behalf of patients to remain on a reference biologic. At a minimum, the controversy surrounding switching will necessitate, as part of the consent process, a robust and thorough disclosure of relevant risks, benefits and reasonable alternatives.
Article ; Cet article de revue examine les préoccupations éthiques lors de recherches menées chez les usagers potentiellement vulnérables de drogues injectables (PWID) dans un contexte canadien. L'Énoncé de politique des trois Conseils : Éthique de la recherche avec des êtres humains aborde un large éventail de principes traditionnels de l'éthique de la recherche concernant les personnes vulnérables mais le fait au détriment de la clarté et de la précision. La vulnérabilité est contextuelle plutôt qu'absolue. Dans le cadre de recherche auprès des personnes vulnérables, le consentement éclairé devrait être obtenu par une personne indépendante et la compréhension devrait être vérifiée à l'aide d'un questionnaire. Les participants peuvent être vulnérables en raison de nombreux facteurs, notamment la toxicomanie, les maladies chroniques, le statut socio-économique et ethnique et le faible niveau d'éducation. La capacité de PWID à donner un consentement éclairé peut être compromis par une influence indue ou une intoxication mais les recherches existantes montrent que ni le mode ni l'ampleur de l'indemnisation n'ont un effet significatif sur les nouveaux taux de consommation de drogues. L'indemnisation peut également contribuer à dissiper la méprise thérapeutique. L'intoxication plutôt que l'influence indue est la principale préoccupation lors de l'obtention du consentement éclairé des PWID. La stigmatisation des PWID comme incapables de consentir devrait être évitée. L'exclusion paternaliste de la recherche peut nuire aux PWID et exacerber leur vulnérabilité en réduisant notre connaissance et notre capacité à les traiter spécifiquement. En tant que tel, nous devons recueillir de meilleures données concernant les effets des politiques d'éthique de la recherche. Les études menées à ce sujet devraient être axées sur les expériences, les perspectives et les besoins des participants à la recherche qui sont potentiellement vulnérables. Les comités d'éthique de la recherche au Canada devraient adopter une approche fondée sur des preuves lors de l'application du pouvoir discrétionnaire pour les propositions en recherche clinique. ; This review article considers ethical concerns when doing research on potentially vulnerable people who inject drugs (PWID) in a Canadian context. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans broadly addresses many of the traditional ethical principles of research on vulnerable persons, but does so at the cost of clarity and precision. Vulnerability is contextual rather than absolute. When doing research with vulnerable persons, informed consent should be obtained from an independent person, and comprehension should be checked using questioning. Participants can be vulnerable due to many factors, including addiction, chronic disease, socioeconomic and racial status, and lack of education. The ability of PWID to give informed consent can be compromised by undue influence or intoxication, but existing research shows that neither the mode nor the magnitude of compensation has a significant effect on new rates of drug use. Compensation can also help dispel the therapeutic misconception. Intoxication rather than undue influence is the main concern when obtaining informed consent from PWID. The stigmatization of PWID as incapable of consent should be avoided. Paternalistic exclusion from research can harm PWID and exacerbate their vulnerability by reducing our knowledge of and ability to specifically treat them. As such, we must collect better data about the effects of research ethics policies. Studies to this effect should focus on experiences, perspectives and needs of potentially vulnerable research participants. Research ethics boards in Canada should adopt an evidence-based approach when applying discretionary power to proposals for clinical research.
The obligation to maintain the privacy of patients and research participants is foundational to biomedical research. But there is growing concern about the challenges of keeping participant information private and confidential. A number of recent studies have highlighted how emerging computational strategies can be used to identify or reidentify individuals in health data repositories managed by public or private institutions. Some commentators have suggested the entire concept of privacy and anonymity is "dead", and this raises legal and ethical questions about the consent process and safeguards relating to health privacy. Members of the public and research participants value privacy highly, and inability to ensure it could affect participation. Canadian common law and legislation require a full and comprehensive disclosure of risks during informed consent, including anything a reasonable person in the participant or patient's position would want to know. Research ethics policies require similar disclosures, as well as full descriptions of privacy related risks and mitigation strategies at the time of consent. In addition, the right to withdraw from research gives rise to a need for ongoing consent, and material information about changes in privacy risk must be disclosed. Given the research ethics concept of "non-identifiability" is increasingly questionable, policies based around it may be rendered untenable. Indeed, the potential inability to ensure anonymity could have significant ramifications for the research enterprise. ; L'obligation de préserver la vie privée des patients et des participants à la recherche est fondamentale en recherche biomédicale. Toutefois, les défis à relever pour maintenir la confidentialité des informations sur les participants suscitent une inquiétude croissante. Un certain nombre d'études récentes a mis en évidence les manières d'utiliser les nouvelles stratégies informatiques pour identifier ou réidentifier les personnes dans les banques de données de santé gérées par des institutions publiques ou privées. Certains commentateurs ont laissé entendre que les concepts de vie privée et d'anonymat sont "morts" dans leur ensemble, ce qui soulève des questions juridiques et éthiques sur le processus de consentement et sur les garanties relatives à la protection de la vie privée en matière de santé. Les membres du public et les participants à la recherche accordent une grande importance à la protection de la vie privée, et l'incapacité à garantir celle-ci pourrait avoir une incidence sur la participation. La common law et la législation canadienne exigent une divulgation complète et exhaustive des risques lors du consentement éclairé, y compris tout ce qu'une personne raisonnable dans la position du participant ou du patient voudrait savoir. Les politiques en matière d'éthique de la recherche exigent des divulgations similaires, ainsi que des descriptions complètes des risques liés à la vie privée et des stratégies d'atténuation lors du consentement. En outre, le droit de se retirer de la recherche entraîne la nécessité d'un consentement continu, et toute information sur l'évolution du risque pour la vie privée doit être divulguée. Étant donné que le concept de "non-identifiabilité" en matière d'éthique de la recherche est de plus en plus discutable, les politiques qui s'y rattachent pourraient devenir intenables. En effet, l'incapacité potentielle à garantir l'anonymat pourrait avoir des conséquences importantes sur l'activité de recherche.
BACKGROUND: Private umbilical cord blood banking is a for-profit industry in which parents pay to store blood for potential future use. Governments have noted the tendency for private banks to oversell the potential for cord blood use, especially in relation to speculative cell therapies not yet supported by clinical evidence. We assessed the regulatory landscape governing private cord bank marketing in Canada. MAIN BODY: Because the problematic marketing of private cord blood banking for future use often relates to speculative future cell therapies that do not exist and are not being advertised for current clinical use, most private blood bank marketing seems to fall outside Health Canada's regulatory scope. However, this problematic marketing is regulated by the Competition Bureau pursuant to the Competition Act. While representations relating to future hypothetical treatments may not always be subject to the legal requirement for claim substantiation, the law also prohibits individuals and companies from knowingly or recklessly making representations that are "false or misleading in a material respect." A representation is materially false or misleading when it could "influence a consumer's behavior or purchasing decisions," and consumers are likely to be considered to be "credulous and inexperienced" for the purposes of assessing an advertisement's general impression. Because all of the potential benefit of the banking is derived from the potential future use of the biological material for health interventions directed toward the customers and their relatives, and because we know the best available medical evidence indicates a very low probability of utility in this context, we can say with confidence that some private cord blood banking claims are materially misleading. Moreover, to the extent that medical professionals are involved in private bank interactions with customers or hold ownership stakes in private banks, they are subject to professional codes, standards of practice, and potentially fiduciary ...
