Legislation and Policy Recommendations on Organ and Tissue Donation and Transplantation From an International Consensus Forum.

There is a shared global commitment to improving baseline donation and transplantation performance metrics in a manner consistent with ethics and local cultural and social factors. The law is one tool that can help improve these metrics. Although legal systems vary across jurisdictions, our objective was to create expert, consensus guidance for law and policymakers on foundational issues underlying organ and tissue donation and transplantation (OTDT) systems around the world. Methods: Using the nominal group technique, a group composed of legal academics, a transplant coordinator/clinician, and a patient partner identified topic areas and recommendations on foundational legal issues. The recommendations were informed by narrative literature reviews conducted by group members based on their areas of expertise, which yielded a range of academic articles, policy documents, and sources of law. Best practices were identified from relevant sources in each subtopic, which formed the basis of the recommendations contained herein. Results: We reached consensus on 12 recommendations grouped into 5 subtopics: (i) legal definitions and legislative scope, (ii) consent requirements for donation' (iii) allocation of organs and tissue' (iv) operation of OTDT systems' and (v) travel for transplant and organ trafficking. We have differentiated between those foundational legal principles for which there is a firm basis of support with those requiring further consideration and resolution. Seven such areas of controversy are identified and discussed alongside relevant recommendations. Conclusions: Our recommendations encompass some principles staunchly enshrined in the OTDT landscape (eg, the dead donor rule), whereas others reflect more recent developments in practice (eg, mandatory referral). Although some principles are widely accepted, there is not always consensus as to how they ought to be implemented. As the OTDT landscape continues to evolve, recommendations must be reconsidered for the law to keep pace with developments in knowledge, technology, and practice.

Public Solicitation and The Canadian Media: Two Cases of Living Liver Donation, Two Different Stories.

BACKGROUND: . Two stories of public solicitation for living liver donors received substantial Canadian media attention in 2015: The Wagner family, with twin toddlers, each needing transplants, and Eugene Melnyk, wealthy owner of a professional hockey team. This study compared the print media coverage of these 2 stories to understand how public solicitation was portrayed and whether coverage differed depending on the individual making the plea. METHODS: We conducted a content analysis on 155 relevant Canadian newspaper articles published between January 1, 2015 and December 31, 2016. Articles were analyzed for their description of public solicitation, benefits and issues associated with public solicitation, and overall tone with respect to public solicitation. RESULTS: The foregrounding of public solicitation and associated ethical issues featured heavily in articles focused on Melnyk but were largely absent when discussing the Wagner family. The fairness of Melnyk's solicitation was the most prominent ethical issue raised. Laws and policies surrounding public solicitation also featured in the Melnyk story but not in articles focused on the Wagners. Public solicitation was portrayed more negatively in the Melnyk articles, but overall, was portrayed positively in relation to both Melnyk and the Wagner family. CONCLUSIONS: Public solicitation was generally portrayed as a positive phenomenon in Canadian print media, yet there were stark differences in how these cases were presented. The Wagner story was largely portrayed as a human-interest piece about a family in dire circumstances, whereas Melnyk's wealth, status, and influence raised questions of the fairness of his transplant.

Research on Human Embryos and Reproductive Materials: Revisiting Canadian Law and Policy.

Research involving human embryos and reproductive materials, including certain forms of stem cell and genetic research, is a fast-moving area of science with demonstrated clinical relevance. Canada's current governance framework for this field of research urgently requires review and reconsideration in view of emerging applications. Based on a workshop involving ethics, legal, policy, scientific and clinical experts, we present a series of recommendations with the goal of informing and supporting health policy and decision-making regarding the governance of the field. With a pragmatic and principled governance approach, Canada can continue its global leadership in this field, as well as advance the long-term health and well-being of Canadians.

Family veto in organ donation in Canada: framing within English-language newspaper articles.

BACKGROUND: Because organ transplantation relies on public support for donation, an analysis of public discourse around organ donation is essential. We investigated the portrayal of family veto - when a family overrides the deceased person's prior legally executed wishes to donate - in Canadian news media. METHODS: Using the Canadian Newsstream database, we identified articles published in English-language newspapers addressing family veto between 2000 and 2016. Guided by the theoretical perspectives of framing of media effects, we conducted a systematic content analysis of the articles to examine how the Canadian media framed family veto. An initial in-depth analysis of the data set in which themes and patterns were captured and recorded identified coding categories, including primary framing of family veto, prevalence, reasons, ethical or legal concerns and overall tone of the article. Two coders analyzed the data set to ensure intercoder reliability. RESULTS: A total of 133 relevant articles were identified. Family veto was framed predominantly as something that should not be allowed (81 articles [60.9%]) and as a reality that is little understood outside the transplantation community (45 [33.8%]). One-quarter of the articles (32 [24.1%]) highlighted ethical principles of autonomy and justice associated with family veto. Family veto was represented as a stumbling block in the present organ donation system, with most publications (107 [80.4%]) calling for change. There were differing interpretations of organ donation legislation, with 82 articles (61.6%) erroneously stating or suggesting that existing legislation permits family veto. INTERPRETATION: Family veto in organ donation was portrayed predominantly negatively. Many publications reflected a misunderstanding of the law concerning this issue. Although the framing of family veto highlighted important ethical and legal concerns as well as practice and policy considerations, research is needed to enhance the understanding of family veto in organ donation.

An Exception to the Rule or a Rule for the Exception? The Potential of Using HIV-Positive Donors in Canada.

Selected human immunodeficiency virus (HIV)-infected patients with end organ failure can safely receive an organ transplant from an HIV uninfected donor. Recent demonstration of the short term safety of organ transplantation between HIV-infected persons prompted a change in US American law to allow such transplantations. Prompted by the recent completion of the first organ transplantation between HIV-infected persons in Canada, we review Canadian law regarding the use of organs from HIV-infected donors, estimate the number of potential HIV-infected donors in Canada, and critically review considerations related to advancing organ transplantation from HIV-infected donors in Canada. Existing legislation allows organ transplantation from an HIV-infected donor under exceptional medical circumstances and therefore no change in legislation is required to increase utilization of organs from HIV-infected donors for transplantation in Canada. Among 335,793 hospital deaths between 2005 and 2009 in Canadian provinces excluding Quebec, 39 potential HIV-infected donors were identified. The actual number of HIV potential donors is estimated to be approximately 60% lower (3-5 potential donor per year), if the absence of viremia is required for transplantation. Although offering all Canadians the opportunity to donate organs is a laudable goal, further research to understand the need for HIV-positive donors and the willingness of HIV-positive recipients to accept organs from HIV-positive donors is needed to inform future policy regarding organ donation from HIV-infected persons in Canada.

Kidney Paired Donation and the "Valuable Consideration" Problem: The Experiences of Australia, Canada, and the United States.

As organ donation rates remain unable to meet the needs of individuals waiting for transplants, it is necessary to identify reasons for this shortage and develop solutions to address it. The introduction of kidney paired donation (KPD) programs represents one such innovation that has become a valuable tool in donation systems around the world. Although KPD has been successful in increasing kidney donation and transplantation, there are lingering questions about its legality. Donation through KPD is done in exchange for-and with the expectation of-a reciprocal kidney donation and transplantation. It is this reciprocity that has caused concern about whether KPD complies with existing law. Organ donation systems around the world are almost universally structured to legally prohibit the commercial exchange of organs. Australia, Canada, and the United States have accomplished this goal by prohibiting the exchange of an organ for "valuable consideration," which is a legal term that has not historically been limited to monetary exchange. Whether or not KPD programs violate this legislative prohibition will depend on the specific legislative provision being considered, and the legal system and case law of the particular jurisdiction in question. This article compares the experiences of Australia, Canada, and the United States in determining the legality of KPD and highlights the need for legal clarity and flexibility as donation and transplantation systems continue to evolve.

Controversies with Kalydeco: Newspaper coverage in Canada and the United States of the cystic fibrosis "wonder drug".

BACKGROUND: The cystic fibrosis drug, Kalydeco, has attracted attention both for its effectiveness in particular CF patients and its substantial price tag. An analysis of newspaper portrayals of Kalydeco provides an opportunity to examine how policy issues associated with rare diseases and orphan drugs are being represented in the popular press. METHODS: We conducted a content analysis of 203 newspaper articles in Canada and the U.S. that mention Kalydeco. Articles were analyzed for their main frame, discussion of Kalydeco, including issues of drug development, patient access, and reimbursement, and overall tone. RESULTS: In Canadian newspaper coverage, 77.4% of articles were framed as human interest stories featuring individual patients seeking public funding for Kalydeco, yet only 7.5% mentioned any budgetary limitations in doing so. In contrast, U.S. newspaper coverage was framed as a financial/economic story in 43.1% of articles and a medical/scientific story in 27.8%. CONCLUSIONS: Newspaper coverage varied significantly between Canada, where Kalydeco is predominantly a story about increasing patient access through full government funding, and the U.S., where Kalydeco is largely a financial story about the economic impact of Kalydeco. The difference in coverage may be due to differences in public funding between the healthcare systems of these two countries.

Physician liability and non-invasive prenatal testing.

Although non-invasive prenatal testing (NIPT) marks a notable development in the field of prenatal genetic testing, there are some physician liability considerations raised by this technology. As NIPT is still emerging as the standard of care and is just starting to receive provincial funding, the question arises of whether physicians are obligated to disclose the availability of NIPT to eligible patients as part of the physician-patient discussion about prenatal screening and diagnosis. If NIPT is discussed with patients, it is important to disclose the limitations of this technology with respect to its accuracy and the number of disorders that it can detect when compared with invasive diagnostic options. A failure to sufficiently disclose these limitations could leave patients with false assurances about the health of their fetuses and could raise informed consent and liability issues, particularly if a child is born with a disability as a result.

Bien que le dépistage prénatal non effractif (DPNE) constitue une innovation importante dans le domaine du dépistage génétique prénatal, la technologie qui la sous-tend soulève certains facteurs à prendre en considération en ce qui a trait à la responsabilité des médecins. Compte tenu que le DPNE cherche toujours à faire sa place à titre de norme de diligence et qu'il commence tout juste à bénéficier d'un financement provincial, nous faisons face à la question de savoir si les médecins ont l'obligation de divulguer la disponibilité du DPNE aux patientes admissibles dans le cadre des discussions médecin-patiente au sujet du dépistage / diagnostic prénatal. Lorsque l'on discute du DPNE avec les patientes, il est important d'en divulguer les limites en ce qui a trait à sa précision et au nombre des troubles dont il permet la détection, par comparaison avec les options diagnostiques effractives. Lorsque l'on ne déploie pas suffisamment d'efforts pour divulguer ces limites, les patientes pourraient se trouver faussement rassurées au sujet de la santé de leur fœtus; une telle situation pourrait également soulever des questions de consentement éclairé et de responsabilité, particulièrement dans les cas où la grossesse en question se solde par la naissance d'un enfant présentant une déficience.

Professional regulation: a potentially valuable tool in responding to "stem cell tourism".

The growing international market for unproven stem cell-based interventions advertised on a direct-to-consumer basis over the internet ("stem cell tourism") is a source of concern because of the risks it presents to patients as well as their supporters, domestic health care systems, and the stem cell research field. Emerging responses such as public and health provider-focused education and national regulatory efforts are encouraging, but the market continues to grow. Physicians play a number of roles in the stem cell tourism market and, in many jurisdictions, are members of a regulated profession. In this article, we consider the use of professional regulation to address physician involvement in stem cell tourism. Although it is not without its limitations, professional regulation is a potentially valuable tool that can be employed in response to problematic types of physician involvement in the stem cell tourism market.

Newspaper coverage of biobanks.

Background. Biobanks are an important research resource that provides researchers with biological samples, tools and data, but have also been associated with a range of ethical, legal and policy issues and concerns. Although there have been studies examining the views of different stakeholders, such as donors, researchers and the general public, the media portrayal of biobanks has been absent from this body of research. This study therefore examines how biobanking has been represented in major print newspapers from Australia, Canada, the United Kingdom and the United States to identify the issues and concerns surrounding biobanks that have featured most prominently in the print media discourse. Methods. Using Factiva, articles published in major broadsheet newspapers in Canada, the US, the UK, and Australia were identified using specified search terms. The final sample size consisted of 163 articles. Results. Majority of articles mentioned or discussed the benefits of biobanking, with medical research being the most prevalent benefit mentioned. Fewer articles discussed risks associated with biobanking. Researchers were the group of people most quoted in the articles, followed by biobank employees. Biobanking was portrayed as mostly neutral or positive, with few articles portraying biobanking in a negative manner. Conclusion. Reporting on biobanks in the print media heavily favours discussions of related benefits over risks. Members of the scientific research community appear to be a primary source of this positive tone. Under-reporting of risks and a downtrend in reporting on legal and regulatory issues suggests that the print media views such matters as less newsworthy than perceived benefits of biobanking.