Faculty publications - Faculty of Law

Permanent URI for this collectionhttps://hdl.handle.net/1807/75712

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The Promise and Peril of Adapting the Regulatory System to the Pharmacogenomic Context
(McGill University, 2015) Gibson, Shannon; Lemmens, Trudo
Pharmacogenomics – the study of the influence that genetic factors have on drug response – presents significant regulatory challenges. Pharmacogenomics products require the approval of both a pharmaceutical drug and a companion diagnostic, a situation which is further complicated by the fact that authority to regulate these two different types of products is fragmented between different levels of government, different provinces, and even different agencies within the same level of government. Although Health Canada reports that they are ramping up efforts to determine the most appropriate means of incorporating pharmacogenomics information into drug evaluation and regulatory decision-making throughout the stages of drug development, Canada continues to lag behind other jurisdictions in adopting substantial reforms. This is in marked contrast to the significant efforts made by the Food and Drug Administration in the US, which has taken a leadership role in proposing new draft guidance on reforms to improve the evaluation and regulation of pharmacogenomic products – documents that provide useful insight into how Canada may more effectively adapt existing regulatory practices to the pharmacogenomic context. Informed both by the literature and by interviews with key Canadian stakeholders, we explore how pharmacogenomic drugs and tests are evaluated and approved within the current Canadian regulatory system and what reforms may be necessary to more effectively evaluate and regulate these emerging health technologies. We begin by looking at, first, the split regulation of companion diagnostics by federal and provincial authorities and, second, how pharmacogenomic products are currently integrated into the drug regulatory system at the federal level. Subsequently, we consider possible reform efforts to better coordinate the review of drug and test components, to offer more flexible approaches to market authorization and to expand regulatory oversight during the post market phase. Our discussion focuses on the Canadian regulatory system, but our recommendation and discussion are also relevant for other jurisdictions in which pharmacogenomic products are being evaluated.
Conflict of interest: legal and ethical aspects
(Elsevier Ireland Ltd, 2005-12-12) Dickens, Bernard M; Cook, Rebecca J
Conflicts of interest arise when those who owe conscientious duties to others appear to have personal interests that might tempt them to subordinate those duties to their self-interest. Conflicts of interest are distinguishable from conflicts of commitment, which arise when individuals bear two or more mutually exclusive duties to others. If persons in conflicts of interest favor their self-interest, they may violate binding legal duties such as fiduciary duties. Conflicts arise when, for instance, medical practitioners refer their patients to other practitioners in exchange for payments (fee splitting), and when they gain secondary incomes such as from testing patients' samples in laboratories in which they hold ownership or investment interests. Financial dealings with commercial sponsors may place researchers in apparent conflicts of interest with research subjects. When conflicts of interest are unavoidable, they may be resolved by appropriate disclosure.
Emergency contraception, abortion and evidence-based law
(Elsevier Ireland Ltd, 2006-03-20) Cook, Rebecca J; Dickens, Bernard M; Erdman, Joanna N
Courts and legal tribunals increasingly decline to serve as religious or moral guardians, and require social evidence to support litigants' claims. Recent cases on emergency contraception and abortion are examined to show how judicial interpretations can take account of evidence of the impact that different understandings of the law will have for how ordinary people can plan their lives and reproductive choices. In an emergency contraception case, an interpretation was rejected that would have criminalized choices that millions of decent, law-abiding physicians, pharmacists and women routinely make. In an abortion case, three judges unanimously rejected a government ministry's defence of compliance with the law because the ministry had failed to investigate the needs within its jurisdiction for legal clarity, lawful services, and its responsibility to women returning from having lawful procedures elsewhere. In both cases, litigants prevailed who showed factual evidence that their claims better promoted reproductive health and choice.
Legal and ethical issues in telemedicine and robotics
(Elsevier Ireland Ltd, 2006-06-13) Dickens, Bernard M; Cook, Rebecca J
Modern medical concerns with telemedicine and robotics practiced across national or other jurisdictional boundaries engage the historical, complex area of law called conflict of laws. An initial concern is whether a practitioner licensed only in jurisdiction A who treats a patient in jurisdiction B violates B's laws. Further concerns are whether a practitioner in A who violates a contract or treats a patient in B negligently incurs liability in B, A, or both, and, if treatment lawful in A is unlawful in B, whether the practitioner commits a crime. Judicial procedures are set by courts in which proceedings are initiated, but courts may decline jurisdiction due to inconvenience to parties. If courts accept jurisdiction, they may apply their own substantive legal rules, but may find that the rules of a conflicting jurisdiction should apply. Cross-border care should not change usual medical ethics, for instance on confidentiality, but may mitigate or aggravate migration of specialists.
Women's access to health care: the legal framework
(Elsevier Ireland Ltd, 2006-07-05) Cook, Rebecca J; Ngwena, C G
The Millennium Development Goals set ambitious targets for women's health, including reductions in maternal and child mortality and combating the spread of HIV/AIDS. The law, which historically has often obstructed women's access to the health care they require, has a dynamic potential to ensure women's access that is being progressively realized. This paper identifies three legal principles that are key to advancing women's reproductive and sexual health. First, law should require that care be evidence-based, reflecting medical and social science rather than, for instance, religious ideology or morality. Second, legal guidance should be clear and transparent, so that service providers and patients know their responsibilities and entitlements without litigation to resolve uncertainties. Third, law should provide applicable measures to ensure fairness in women's access to services, both general services and those only women require. Legal developments are addressed that illustrate how law can advance women's equality, and social justice.
Legal abortion for mental health indications
(Elsevier Ireland Ltd, 2006-09-25) Cook, Rebecca J; Ortega-Ortiz, A; Romans, S; Ross, L E
Where legal systems allow therapeutic abortion to preserve women's mental health, practitioners often lack access to mental health professionals for making critical diagnoses or prognoses that pregnancy or childcare endangers patients' mental health. Practitioners themselves must then make clinical assessments of the impact on their patients of continued pregnancy or childcare. The law requires only that practitioners make assessments in good faith, and by credible criteria. Mental disorder includes psychological distress or mental suffering due to unwanted pregnancy and responsibility for childcare, or, for instance, anticipated serious fetal impairment. Account should be taken of factors that make patients vulnerable to distress, such as personal or family mental health history, factors that may precipitate mental distress, such as loss of personal relationships, and factors that may maintain distress, such as poor education and marginal social status. Some characteristics of patients may operate as both precipitating and maintaining factors, such as poverty and lack of social support.
Acquiring human embryos for stem-cell research
(Elsevier Ireland Ltd, 2006-12-21) Dickens, Bernard M; Cook, Rebecca J
Human tissue engineering and regenerative medicine may be considerably advanced by embryonic stem-cell research and cell line development, to provide preventive means, cures and treatment strategies for a range of debilitating conditions and injuries. Research may result in embryos from which stem-cells are derived losing viability, which offends some religious convictions. The different status religions and laws may attribute to embryos serves different purposes and results from different approaches. Neither need depend on, nor impose itself on, the other. Embryos surplus to IVF patients' needs may be donated to research with appropriate consent. In some circumstances, it may be ethical to ask patients to make their fresh embryos available for research. Prohibitions against deliberately creating embryos for research purposes are common, but not universally adopted, and are being challenged. Women who donate ova require information about risks, which for women considering donation for research may not be balanced by compensating benefits.
Respecting adolescents' confidentiality and reproductive and sexual choices
(Elsevier Ireland Ltd, 2007-06-19) Cook, Rebecca J; Erdman, Joanna N; Dickens, Bickens M
Adolescents, defined as between 10 and 19 years old, present a growing challenge to reproductive health. Adolescent sexual intercourse contributes to worldwide burdens of unplanned pregnancy, abortion, spread of sexually transmitted infections (STIs), including HIV, and maternal mortality and morbidity. A barrier to contraceptive care and termination of adolescent pregnancy is the belief that in law minors intellectually mature enough to give consent also require consent of, or at least prior information to, their parental guardians. Adolescents may avoid parental disclosure by forgoing desirable reproductive health care. Recent judicial decisions, however, give effect to internationally established human rights to confidentiality, for instance under the Convention on the Rights of the Child, which apply without a minimum age. These judgments contribute to modern legal recognition that sufficiently mature adolescents can decide not only to request care for contraception, abortion and STIs, but also whether and when their parents should be informed.
Reproductive health and public health ethics
(Elsevier Ireland Ltd, 2007-06-18) Dickens, Bernard M; Cook, Rebecca J
Individuals' reproductive choices are private matters, but sexual conduct and pregnancy impose significant public health burdens. Ethical principles of public health are distinguishable from principles applied in modern bioethics. Bioethical principles have been developed at the clinical or microethical level, affecting relations among individuals, whereas pubic health ethics applies at the population-based or macroethical level. Resolution of issues, for instance of consent to healthcare interventions and preservation of privacy, is different in public health practice from in clinical medicine. Public health aspects of human reproduction concern reduction of maternal mortality and morbidity, particularly in resource-poor countries, and the contribution to high rates of each of unsafe abortion, most prevalent where abortion laws are restrictive. Further aspects of public health ethics concern limited access to contraceptive services, the spread of sexually transmitted infections (STIs), including HIV, causes of infertility, especially due to STIs, and responses to each of these concerns.
Prenatal management of anencephaly
(Elsevier Ireland Ltd, 2008-07-07) Cook, Rebecca J; Erdman, Joanna N; Hevia, Martin; Dickens, Bernard M
About a third of anencephalic fetuses are born alive, but they are not conscious or viable, and soon die. This neural tube defect can be limited by dietary consumption of foliates, and detected prenatally by ultrasound and other means. Many laws permit abortion, on this indication or on the effects of pregnancy and prospects of delivery on a woman's physical or mental health. However, abortion is limited under some legal systems, particularly in South America. To avoid criminal liability, physicians will not terminate pregnancies, by induced birth or abortion, without prior judicial approval. Argentinian courts have developed means to resolve these cases, but responses of Brazilian courts are less clear. Ethical concerns relate to late-term abortion, meaning after the point of fetal viability, but since anencephalic fetuses are nonviable, many ethical concerns are overcome. Professional guidance is provided by several professional and institutional codes on management of anencephalic pregnancies.
Multiple pregnancy: legal and ethical issues
(Elsevier Ireland Ltd, 2008-10-14) Dickens, Bernard M; Cook, Rebecca J
Multiple pregnancy is increasingly considered a complication of in vitro fertilization (IVF) and ovarian stimulation for natural fertilization. Harms to fetuses, newborn and older children, mothers, families, and healthcare systems are encouraging single embryo transfer. When patients knowingly accept multiple pregnancy risks from IVF or ovarian stimulation, they are unlikely to succeed in litigation against healthcare providers for wrongful pregnancy or wrongful birth. More challenging are impaired children's claims for "wrongful life." These are unlikely to succeed against parents, but courts are ambivalent to claims against healthcare providers. Historically, courts rejected these claims, under the principle that live birth is not a legal injury. European and other courts, however, have been more sympathetic to these claims. Multiple pregnancy treated by fetal reduction is not usually found to offend abortion laws. This poses ethical concerns, however, of "lifeboat ethics," involving how fetal reduction choices are made.
Healthcare responsibilities and conscientious objection
(Elsevier Ireland Ltd, 2008-11-29) Cook, Rebecca J; Olaya, Mónica Arango; Dickens, Bernard M
The Constitutional Court of Colombia has issued a decision of international significance clarifying legal duties of providers, hospitals, and healthcare systems when conscientious objection is made to conducting lawful abortion. The decision establishes objecting providers' duties to refer patients to non-objecting providers, and that hospitals, clinics, and other institutions have no rights of conscientious objection. Their professional and legal duties are to ensure that patients receive timely services. Hospitals and other administrators cannot object, because they do not participate in the procedures they are obliged to arrange. Objecting providers, and hospitals, must maintain knowledge of non-objecting providers to whom their patients must be referred. Accordingly, medical schools must adequately train, and licensing authorities approve, non-objecting providers. Where they are unavailable, midwives and perhaps nurse practitioners may be trained, equipped, and approved for appropriate service delivery. The Court's decision has widespread implications for how healthcare systems must accommodate conscientious objection and patients' legal rights.
Dilemmas in intimate partner violence
(Elsevier Ireland Ltd, 2009-04-15) Cook, Rebecca J; Dickens, Bernard M
Intimate partner violence (IPV), usually men's violence against women, appears universal. It may be associated with pregnancy, but this may be because pregnant women receive more medical attention. Violence may cause bruises, abrasions, and cuts, but its extremes include hospitalization, death, and suicide. IPV is often disclosed when women are asked why they feel in poor health or depressed. A legal dilemma arises when healthcare providers consider that intervention such as law-enforcement is appropriate, but patients refuse approval. Patients may fatalistically accept violence, or fear loss of support for their children and themselves if their partners are held in custody. Legal reforms, such as punishing spousal rape, may provide some protection of women's autonomy. Ethical dilemmas concern intervention without patients' approval, and whether treating violent injuries without taking preventive action breaches the principle to Do No Harm. Professional advocacy and social action have been urged to expose and reduce IPV.
From reproductive choice to reproductive justice
(Elsevier Ireland Ltd, 2009-08) Cook, Rebecca J; Dickens, Bernard M
Since the 1994 Cairo Conference on Population and Development, the human rights movement has embraced the concept of reproductive rights. These are often pursued, however, by means to which objection is taken. Some conservative political and religious forces continue to resist implementation of several means of protecting and advancing reproductive rights. Individuals' rights to grant and to deny consent to medical procedures affecting their reproductive health and confidentiality have been progressively advanced. However, access to contraceptive services, while not necessarily opposed, is unjustifiably obstructed in some settings. Rights to lawful abortion have been considerably liberalized by legislative and judicial decisions, although resistance remains. Courts are increasingly requiring that lawful services be accommodated under transparent conditions of access and of legal protection. The conflict between rights of resort to lawful reproductive health services and to conscientious objection to participation is resolved by legal duties to refer patients to non-objecting providers.
Hymen reconstruction: ethical and legal issues
(Elsevier Ireland Ltd, 2009-08-29) Cook, Rebecca J; Dickens, Bernard M
A hymen may be ruptured by sexual intercourse and several other means. In cultures prizing unmarried women's virginity, premarital rupture may shame a woman, and her family. Women, including brides whose virginity is not proven at marriage, face humiliation, ostracism, divorce, and violence-at the extreme, "honor" killing. Nevertheless, gynecologists may oppose hymen reconstruction on grounds that it is deceptive, not medically required, or that the requirement of evidence of virginity discriminates against women and the procedure supports holding them to higher standards of virtue than are required of men. Gynecologists may justify the procedure, however, as serving health, which includes patients' mental and social well-being and women's human rights to control their own bodies. Further, many adolescents lose their virginity innocently, by rape or coercion, and, without hymen reconstruction, women may face violence and even death. The procedure is usually lawful, and distinguishable from female genital cutting or mutilation.
The legal effects of fetal monitoring guidelines
(Elsevier Ireland Ltd, 2009-11-22) Dickens, Bernard M; Cook, Rebecca J
The new American College of Obstetricians and Gynecologists' (ACOG) monitoring guidelines introduce a new category of interpretation of fetal heart rate tracings between reassuring and nonreassuring, namely intermediate. The purpose is to reduce unnecessary cesarean deliveries. The legal role of medical guidelines is ambivalent. Providers are expected to be familiar with such guidelines, but also to exercise clinical judgment in their patients' interests. Practice departing from guidelines requires justification, but simple compliance without regard to patients' circumstances may constitute negligence. Some courts defer to medical professional guidelines, but others hold that professional standards are set as a matter of law, not by the profession itself. Unlike conclusions in medical science, which are open to continuing review, courts determine facts in a case only once, at trial. Litigation to compel patients' compliance with medical advice based on guidelines may fail, as may prosecutions, more common in the US, of patients who defy such advice.
Unethical female stereotyping in reproductive health
(Elsevier Ireland Ltd, 2010-03-04) Cook, Rebecca J; Cusack, Simone; Dickens, Bernard M
Stereotypes are generalized preconceptions defining individuals by group categories into which they are placed. Women have become stereotyped as homemakers and mothers, with the negative effect of precluding them from other roles and functions. Legislation and judicial constructions show a history, and often a continuing practice, of confining women to these stereotypical functions. In access to reproductive and sexual health care, for instance, women's requests have been professionally subject to approval of their husbands, fathers or comparable males. Choice of abortion is particularly significant, because it embeds moral values. Women's capacity to act as responsible moral agents is denied by stereotypical attitudes shown by legislators, judges, heads of religious denominations, and healthcare providers who consider women incapable of exercising responsible moral choice. These attitudes violate ethical requirements of treating patients with respect and equal justice. They can also result in violations of human rights laws that prohibit discrimination against women.
Upholding pregnant women's right to life
(Wiley, 2012) Cook, Rebecca J.; Dickens, Bernard M.
Recent decisions of the Committee on the Elimination of Discrimination against Women (CEDAW), the Inter- American Court of Human Rights, and the High Court of Delhi have shown how the pregnancy-related deaths of individual women have been bases on which these authoritative tribunals have held Brazil, Paraguay, and India respectively accountable for avoidable maternal mortality not only in these cases, but also among their populations more generally. The right to life is the most fundamental of women's human rights, recognized in international human rights treaties and national laws. Failure of governments to apply their resources adequately to address, respect, and protect this right violates the law of human rights. These cases show, however, that governments may fail to allocate adequate resources to women's survival of pregnancy. Tribunals can build on the failures in individual cases to set standards of performance to which governments will legally be held to achieve safe motherhood.
A new surgical technique for hymenoplasty: A solution, but for which problem?
(Wiley, 2015) Shaw, Dorothy; Dickens, Bernard M.
Human rights to in vitro fertilization
(Wiley, 2013) Zegers-Hochschild, Fernando; Dickens, Bernard M.; Dughman-Manzur, Sandra
The Inter-American Court of Human Rights (the Court) has ruled that the Supreme Court of Costa Rica’s judg- ment in 2000 prohibiting in vitro fertilization (IVF) violated the human right to private and family life, the human right to found and raise a family, and the human right to non-discrimination on grounds of disability, financial means, or gender. The Court’s conclusions of violations contrary to the American Convention on Human Rights followed from its ruling that, under the Convention, in vitro embryos are not “persons” and do not possess a right to life. Accordingly, the prohibition of IVF to protect embryos constituted a dispropor- tionate and unjustifiable denial of infertile individuals’ human rights. The Court distinguished fertilization from conception, since conception—unlike fertilization—depends on an embryo’s implantation in a woman’s body. Under human rights law, legal protection of an embryo “from conception” is inapplicable between its creation by fertilization and completion of its implantation in utero.

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