The McGill Research Group on Health and Law presents l’évolution du droit de la procréation assistée: La bioéthique a la franéaise

Posted By The MJLH | RDSM Team – Jan. 5, 2011

The McGill Research Group on Health and Law will present its 4th Annual Lecture given by Frédérique Dreifuss-Netter, Justice of the first civil chamber of the Cour de cassation on assisted reproduction. The presentation will take place January 18, 2012 at 16h30 in room 312 NCDH.

Space is limited. Kindly RSVP to rghl.law@mcgill.ca.

Le RGHL présente la quatrième conférence annuelle en santé et droit au sujet de l’évolution du droit de la procréation assistée. Frédérique Dreifuss-Netter, conseillère à la première chambre civile de la Cour de cassation, présentera mecredi le 18 janvier, 2012 à 16h30, salle 312 NCDH.

Le nombre de participants est limité. SVP confirmez votre présence à rghl.law@mcgill.ca

For more information: http://www.mcgill.ca/channels/events/item/?item_id=212548

B.C. government sues the makers of Evra contraception patch

Posted By Meara Conway – Nov. 22, 2010

The B.C. government has launched a claim against the makers of the Evra contraception patch to recover past and future health care costs under the Health Care Costs Recovery Act, which took effect April 1, 2009. The legislation allows for the B.C. government to commence its own proceedings for past or future costs related to health care services or “piggy-back” on-going class actions or claims launched by individual beneficiaries.

The government is claiming that the defendants (Johnson & Johnson, McNeil Pharmaceutical Inc., Janssen-Ortho Inc.) were negligent in failing to provide adequate labeling, failing to conduct long-term studies of risks of continued use of Evra, and failing to provide Health Canada with complete and accurate information about the risks.

Johnson & Johnson Inc, one of the named defendants, resolved several costly U.S. lawsuits filed by women who suffered as a result of using Evra and agreed to settle similar claims in three Canadian provinces including Ontario, Quebec, and B.C.

While interpretation of the B.C. legislation is still at an early stage, this novel claim, if successful, would mark a significant development in pharmaceutical liability to governments for costs resulting from drugs negligently researched, marketed or labeled.

For more information see: <http://www.canada.com/story_print.html?id=734cd9c8-891e-4579-92b0-dfb22eed106a&sponsor=>.

_____________________________
Endnotes:

1 Health Care Costs Recovery Act, SBC 2009, c 27, s 8.
2 J
oe Schneider, “J&J agrees to settle Evra lawsuits in Ontario, Quebec, B.C.”, Bloomberg  (February 27, 2009) online: Drug Recall Watch Word Press <www.drugrecallwatch.wordpress.com>.

 

De Facto Incapacity and the Limited Utility of the Principle of Autonomy

Posted By Stefan Szpajda – Apr. 7, 2010

The approach taken by Canadian courts in deciding whether to honour the medical treatment decision of a patient who is mentally-ill is in need of reform. In Starson v. Swayze (2003 SCC 32), the Supreme Court of Canada identifies autonomy, effective medical treatment, and societal protection as three conflicting values that are affected by the Health Care Consent Act [HCCA]. Where an individual’s refusal of treatment is overturned on grounds of incapacity, effective medical treatment and societal protection take precedence, and individuals may be denied the exercise of their autonomy. Interference is restricted however, by a test used to determine whether a patient is capable and thus legally autonomous. According to the Court, “the HCCA preserves the value of individual autonomy” as only truly incapacitated individuals will have treatment imposed upon them. Indeed, courts have set a low threshold in upholding patient autonomy: they measure capacity to understand, and not actual understanding of (1) relevant information and (2) the reasonably foreseeable consequences of a decision. I argue that the test adopted by courts is neither theoretically sound nor consistently applied. As a result, it unjustly deprives mentally ill individuals of effective medical treatment. The existing approach should thus be amended to allow for more robust role for the principle of effective medical treatment.

In order to truly protect individual autonomy, the principle must be operationalized in a meaningful way. The distinction between autonomy and self-determination illustrates some of the challenges that courts face toward this end. Namely, where individuals are unable to benefit from highly relevant medical information, their autonomy is not meaningfully protected by the preservation of their right to self-determination. The test for capacity should thus be revised to ascertain actual understanding, as opposed to mere capacity to understand. Presently, sound medical opinion can be ignored on the basis of a mentally ill patient’s expressed wishes, even where that individual manifestly does not in fact understand anything about their circumstances. This is particularly troubling in light of the fact that before proceeding with treatment of fully capable individuals, doctors must typically procure informed consent; capacity to give consent does not suffice.

To deny necessary treatment to patients on the basis of a mere capacity to understand is functionally equivalent to carrying out a medical procedure without informed consent. In both cases, an act or omission with potentially deleterious effects occurs despite uncertainty as to the patient’s actual wishes were they aware of the risks involved. Where (1) a patient does not understand his situation, and (2) the consequences of refusal would not be tolerated by a reasonable person, the right to effective medical treatment should not be cast aside lightly.

Despite the laudatory aim of maximizing autonomy, the present test is both inconsistent in theory and problematic in practice. First, the test is theoretically unsound as it is only applied upon a patient’s refusal of treatment. If, for example, Mr. Starson would have accepted treatment, his decision to do so would have been no more or less autonomous than his refusal. Yet under the current approach his acceptance would have muted all further inquiry into his capacity. It is thus wrong to suggest that the test respects the principle of autonomy, as many patients are likely treated “voluntarily” despite not having had actual knowledge of the content of their decisions. In other words, anytime a de facto incapable patient accepts treatment, his autonomy is violated with his best interests in mind. The proper question is thus when, and not if, autonomy is justifiably set aside in favour of effective medical treatment.

Second, the test posits a principle of autonomy that does not acknowledge that some information is reasonably necessary to make a truly autonomous decision. This creates risk that mentally ill patients will be arbitrarily denied important health care services. To conceive of autonomy in the medical context as the freedom to act without some actual appreciation of consequences obviates the principles of informed consent and effective medical treatment. Moreover, it discards the fiduciary obligations that arise from the doctor-patient relationship that, in other contexts, allow carefully regulated incursions into individual autonomy. While autonomy cannot simply be abandoned, an obligation to maximize patients’ appreciation of the consequences of refusal should be found. If a patient persists in his refusal after being reasonably informed, his will must be respected. In ambiguous situations, however, decision-makers should not escape the responsibility to provide effective treatment by reflexively deferring to vague notions of autonomy.

It will sometimes be impossible to render patients cognizant of their circumstances. In such cases, the right to effective medical treatment should be open to evaluation against the principle of autonomy. Such an approach would be consistent with existing practices in analogous situations. Informed consent, for example, can be imputed where it cannot be given on the basis of an objective test which asks “whether the average prudent person in the plaintiff’s position, informed of all material risks, would have foregone treatment” (Reibl v. Hughes, [1980] 2 S.C.R. 880 at 889). While this clearly violates the principle of autonomy in favour of a reasonably ascertainable best interest standard, it ensures treatment where consent cannot be procured in a meaningful way. A similar test can be devised to ensure that mentally ill patients are not excluded from the benefits of our health care system.

Proceeding with treatment against individuals’ wishes on the basis of their best interest would never be uncontentious. Some authors deny that the principle should be used at all. Eike-Henner W. Kluge, for example, suggests that best interest is a discriminatory principle because it is an abstract notion that is not applied consistently. The same criticism, however, can be made of autonomy: it is almost impossible to satisfactorily define, much less apply, the principle of autonomy. Tellingly, despite insisting that autonomy is a foundational principle that must be respected, Kluge does not grapple with its definition. Moreover, while Kluge alludes to historical examples of atrocities done in the name of someone else’s best interest, autonomy lends itself to similar analysis. The principle is tied to individualism, which is not itself value-neutral. Inaction that perpetuates injustice has often been rationalized on the basis that individuals, uniquely responsible for their own condition, are not deserving of aid. Decisions made on the basis of another’s best interest must certainly be approached with appropriate respect for individual autonomy. In the context of health care, however, it is irresponsible to bind patients to the consequences of their uninformed decisions without minimal consideration of their best interests.

The ethical and legal complexities of substituted decision-making cannot be explored via reference to cognitive ability alone. The law should thus create space to evaluate salient medical factors that ensure effective treatment in ambiguous situations. The present approach to the problem has two major flaws. First, it bogs down the analysis in autonomy. Particularly in the context of borderline incapacity or youth, autonomy is an abstract and contentious concept that does not offer useful guidelines to decision-makers. Instead of providing clarity, it unnecessarily removes questions from their medical context and places them in a highly philosophical realm. Second, it diminishes the legitimate role of best interest in influencing decisions. Best interest directs care where the patient is capable, or factually incapable but acquiescent to treatment. It should likewise play a role in determining treatment of legally capable, but factually incapacitated patients. To treat an individual who is factually incapable as autonomous is to deny basic medical reality in the name of a poorly understood principle of dubious utility. We must not deny treatment to patients on the basis of decisions made with incomplete information. The law should evolve to better reflect the existing commitment to informed consent and the principle of effective medical treatment.

The 2nd McGill Student Colloquium on Health and Law: Universities as Global Innovators

Posted By Corri Longridge, Adrian Thorogood – Mar. 7, 2010

“Connecting the different stars in McGill’s constellation”

–         Opening words of Dean of Law, Prof. Daniel Jutras
In his opening remarks, Professor Daniel Jutras, McGill’s Dean of Law, Professor anticipated a “connecting of the different stars in McGill’s constellation.” No doubt, the keynote speakers of the McGill Health Law Colloquium fit this astronomic introduction. All four were able to draw on their experiences as directors of global health initiatives and offer enlightening perspectives on global health diplomacy, linking entrepreneurial projects to specific health issues, and designing intellectual property regimes in ways that facilitate the dissemination of medicines to the world’s poor. Beyond information, they shared their inspiration and leadership. These stars came not solely to shine, but also to guide us toward solutions and collaboration.

 

Global Diplomacy

Dr. Nick Drager, former Director of the Dept. of Ethics, Trade, Human Rights and Health Law at the World Health Organization (WHO), highlights access to clean water and adequate food, the development of sustainable sources of energy, and the consequences of climate change and population growth as the top global health issues. These complex issues construe health broadly and illuminate the need for actors from diverse disciplines to engage collaboratively.

The landscape of actors addressing global health issues is vast. Governmental actors and an increasing number of non-governmental organizations are actively negotiating to advance particular interests and shape the architecture of global health diplomacy. Clearly, the vastness of the landscape of actors has implications on rule making and raises issues of governance. Specifically, how can these actors build a global health regime capable of giving a voice to a plurality of interests while encouraging collaboration and facilitating policy coherence?

Not only is the number of actors increasing, the diversity in policy instruments available to promote global health is expanding. Actors, such as the government of Canada, need to decide where to engage, choose from the policy instruments available, and craft a comprehensive global health strategy.

 

Business

Similarly, Dr. Laurette Dubé, Chair of the McGill World Platform for Health and Economic Convergence (MWP) initiative, highlights the notion that health issues are broad in scope and necessarily involve a plethora of actors. Dubé goes further and highlights that although each actor always looks at global health issues from a distinct perspective, practices where individual actors adopt policies on health issues in isolation then converge with other actors is not as effective an approach as when convergence takes place at the outset.  Indeed, that is the principal objective of the MWP, an initiative that aims to bring “mainstream business into health and health into business” through creating a “think tank” to facilitate the convergence of ideas and policies in business and health. Ultimately, this “think thank” seeks to inspire dynamic change on the ground level by acting as a “spring board” for projects, such as the Business4Health Compact. The overall aim is to create sustainable business models and markets capable of driving innovation, education and social change at local, national, and global levels in ways that promote health and wealth for all.

 

Intellectual Property

Prof. Richard Gold, from the McGill Faculty of Law, illuminated two fundamental issues of concern in global health. First, Gold proclaimed, “the World’s medicine cabinet is empty.” Essentially, although research costs are increasing, innovation is decreasing. Second, pharmaceutical research and development (R&D) fails to address needs specific to the developing world. This failure, known as the 90/10 health gap, describes the reality that 90% of the health research expenditures worldwide are devoted to diseases afflicting only 10% of the world’s population. In response to these two problems, Gold asks: Where does Intellectual Property law (IP) fit into the puzzle of Global Health? How can IP increase innovation and shift more R&D resources onto neglected sectors?

Theoretically, IP can increase innovation in the short term by providing both an ingredient that allows actors to finance R&D projects, and leverage to negotiate to exchange information with the “big players” of a sector that hold patents. In the long term, IP can inspire innovation through encouraging actors to invest in R&D today, in the hopes of developing patentable medicines that will bring in royalties later. However, Gold emphasizes that actors must accept the limits of IP and must not exaggerate the effects IP has on increasing access to medicines. Specifically, IP only drives innovation when there is a market pull. Consequently, IP cannot foster innovation for medicines for diseases that affect a small population or when the populations affected by the disease do not have the resources to finance patenting. Moreover, because IP is only one tool working along side several other tools (e.g., subsidies, contracts, grants, tax credits, and prizes) within a greater innovation system, it is hard to distinguish and measure the effects of IP on innovation. Whether IP is the best tool to encourage innovation remains unknown.

Similarly, although IP is theoretically a tool that actors can use to reduce the 90/10 health gap, the challenge is to design a global health regime that ensures actors use IP in ways that are equitable and promote health and wealth for all. Gold suggests five potential ways to help reduce the 90/10 health gap:

1)                Increase the purchasing power of individual actors and strengthen weak markets by creating funds that save costs through the purchase of medicines in bulk or by using funds to subsidize drug purchases. However, this solution simply encourages actors to work within the existing global health framework and fails to redesign current regimes in a way that is more equitable.

2)                Lower the costs of medicines through compulsory licensing. Unfortunately, although international trade allows compulsory licensing, governments must be willing to craft compulsory licensing regimes that are not procedurally onerous for the generic companies and developing countries wishing to benefit from such regimes.

3)                Reduce transaction costs. For example, mechanisms could be created to reduce the cost of exchanging “know how” between generic companies and the companies that hold patents to produce “fixed-dose combination” medicines. However, this solution requires trust among the different actors, which is not always present.

4)                Develop alternative incentives. For example, creating prize funds to allocate financial rewards based on the magnitude of decrease in disease. Unfortunately, this solution depends on two things that don’t exist. First, good data and a method to calculate the impact of an individual actor on the fluctuation in rates of disease observed in the data. Second, it is critical to establish a causal link, to know whether a particular intervention is responsible for a particular positive effect.

5)                Lowering the cost of innovation through sharing information and patents. For example, creating Public Private Partnerships such as the Drugs for Neglected Diseases initiative, DNDi.

 

Clearly, as each approach has limitations, finding comprehensive solutions to global health issues will likely require combining several approaches and involve diverse actors. Ultimately, the actors need to work towards the establishment of a shared vision of global health and build regimes able to drive incentives that fit needs of global health.

 

Compulsory Licensing

Mr. Richard Elliott, Executive director of Canadian HIV/AIDS Legal Network also spoke to ways that IP laws could play a greater role in helping to build a more equitable global health regime. Specifically, through facilitating access to affordable generic medications in developing countries that have insufficient manufacturing capabilities. Under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), member countries, including Canada, are required to develop minimum standards of intellectual property protection within specific timeframes. Such standards effectively create temporary monopolies on the making and selling of medicines that increases the price of medicines and reduces access to medicines in developing countries. In an attempt to minimize the foreseeable negative impact of TRIPS on developing countries, the treaty provides for “flexibilities” in patent rules, including compulsory licensing. Compulsory licensing is a legal tool that allows generic manufacturers to produce and sell generic versions of a particular medicine without the consent of the company who holds the patent on the original product. This tool can effectively limit the ability of patents to create monopolies, create competition and ultimately drive down the prices of medicines. For example, compulsory licensing has helped reduce the price of AIDS medicines for developing countries by 95 percent.

In 2004, the Canadian Parliament unanimously passed Canada’s Access to Medicines Regime (CAMR) a federal law to improve public health in developing countries by facilitating access to medicines for epidemic diseases, including HIV/AIDS, tuberculosis, and malaria. Unfortunately, since the law was passed, it has only been used once – for one shipment of AIDS drugs to Rwanda, and it is unlikely to be used again because the procedure is onerous. Developing countries and generic companies who apply for compulsory licenses need to do so on a country-by-country and order-by-order basis. Moreover, each compulsory license is severely restricted: it is good for only a limited period and for a limited quantity of drug.

Essentially, Canada needs to reform CAMR. One idea for reform, the “one-license solution”, involves streamlining the process by issuing compulsory license for a particular medicine without limiting the quantity or the number of countries covered by the law.  Bill S-232 and Bill C-393, legislation currently before Parliament, embody the efforts of NGOs and parliamentarians to improve Global health and propose to streamline CAMR. These bills invite the Canadian government to improve CAMR, bring to fruition the intentions of including “flexibilities” in the TRIPS agreement, and ultimately “promote access to medicines for all” and protect Global public health.

 

Conclusion

The colloquium, made possible by students from both the medicine and law faculties, established the university’s role in global health as a forum for ideas, a loom capable of weaving unified purpose from disparate perspectives.

 

Maldoff workshop highlights health law beyond the ‘juridical’

Posted By Prof. Angela Campbell – Feb. 17, 2010

 

Last Tuesday evening (Feb 9), the Research Group on Health and Law was thrilled to welcome Me Eric Maldoff of the national law firm, Heenan Blaikie, to deliver our second workshop in health law for 2009-2010 entitled Health Law on the Ground. Me Maldoff is an exceptionally skilled jurist whose experience spans across an impressive breadth of topic areas. In his presentation, he offered a number of stories drawn from his practice as a lawyer and negotiator which spoke to the challenges of legal work that engages with health law and health care governance. Recounting tales of his own involvement with negotiations over the new MUHC super hospital, the creation of the CIHR and, as a student-at-law, in the Morgentaler litigation before the Supreme Court, Me Maldoff’s workshop offered incredible insight into the power that the legal profession can wield in developing and reforming social policy and law, specifically in connection with health and health care.

Based on the questions that followed the presentation, it seemed that the topic Me Maldoff addressed that engaged most strikingly with audience members was his work with the Innu of Davis Inlet as Chief Federal Negotiator. The issues raised touched on matters of education, development and poverty rather than explicitly on healthy. At the same time, health law-related matters were embedded in his discussion. Specifically, Me Maldoff suggested that questions about how to craft meaningful educational opportunities for a population that has been affected so adversely by a legacy of colonialism, poverty and social and political exclusion and neglect requires a careful analysis of the health status of a community. So, too, does this endeavour require an investigation into health care access in this setting. How is it possible to develop appropriate schooling programs and to ensure that the population accepts and completes these programs without working with the community and appreciating whether and how they members themselves as a healthy population in all respects? The workshop revealed how meeting these objectives required a careful and holistic analysis, a willingness to learn with and from negotiating partners, and a perception of well-being that extends beyond what can be provided by medical resources alone.

In sum, these experiences recounted by Me Maldoff illuminate how engaging with the world of health law must mean more than appreciating the doctrine of consent or the Canada Health Act. Rather, it is a world that demands openness to the study of various disciplines, to work across a range of cultural and community settings, and a solid degree of courage and vision with a view to effecting durable improvements in health outcomes. None of this, of course, should be viewed as new or surprising, but instead, should reaffirm an understanding of health law as necessarily drawing upon a range of skills and a body of knowledge that might not necessarily be construed as “juridical” at first glance but which undoubtedly benefits from the knowledge.

NOTE: The next workshop of the McGill Research Group on Health and Law will take place on Tuesday, April 13 at 5 pm. Our guest speaker will be Dr. Anne Crocker, Director, Services, policy and population health axis at the Douglas Mental Health University Institute (http://crocker.mcgill.ca/).

Professor Angela Campbell
Convener, McGill Research Group on Health and Law