What’s mine is yours: a commentary on the patenting of human genes

Posted By Rachel Tonelli-Zasarsky – Nov. 5, 2011

In light of the twelfth Annual Conference for Human Genetics, which took place in Montreal on the 14th of October, Le Devoirpublished an article entitled “À qui appartiennent nos gènes?”, or to whom do our genes belong? The article highlights the fact that 20% of the human genome is patented and quotes Professor Gold from McGill University as saying, “Il faut payer la compagnie pour travailler sur ces gènes. Est-ce ainsi que nous voulons considérer le corps humain?” (Translation: a company must be paid to work on our genes. Is it in this way that we want to consider the human body?)

In Canada, the issue of patenting genes has been recently addressed in two cases: Harvard College v. Canada and Monsanto Canada Inc. v. Schmeiser. Both of these cases deal with the patenting of life forms; the former establishes that humans and animals, or “higher life forms”, cannot be patented, whereas the latter establishes that engineered genes and cells are patentable, even when their intended use is insertion into life forms such as plants. Despite the ruling in these cases, the Canadian courts have not yet directly addressed the issue of patenting human genes that have not been genetically modified or engineered.

However the issue has recently arisen in the United States in the case of Association for Molecular Pathology v. United States Patent and Trademark Office, 2010, United States District Court: Southern District of New York.  The plaintiffs pleaded that Myriad’s patents relating to the human Breast Cancer Susceptibility Genes 1 and 2 (BRCA1, and BRCA 2) should be revoked given that they were broad enough to reach BRCA1/2 DNA isolated from any human being. The judgement for the case was delivered by Judge Sweet in favour of the plaintiffs, although the case is currently under appeal.

The patents under question in this case allowed Myriad to protect unmodified portions of DNA corresponding to BRCA1/2 genes (BRCA1/2 DNA sequences). In other words, everyone has BRCA1/2 DNA sequences in their genome and through its patents Myriad claimed ownership over these portions of DNA.

The following question arises: should companies be allowed to own a specific gene sequence? Or in other words, should Myriad be allowed to own my BRCA1/2 DNA sequence even though I have never interacted with them? Of course, my gut reaction to this question is no. Why should I give up the rights to gaining knowledge about the state of my genome, and have to pay some company to be able to have access to this information? But upon further reflection, answering yes is not so outrageous.

When a particular DNA sequence is determined to be indicative of the risk of a disease state, gene testing is used in the patient to look for DNA sequences that deviate from the known normal risk- free DNA sequences, or for DNA sequences that match sequences that are known to be indicative of disease. These techniques “look” directly at the patient’s DNA to ascertain whether information which codes for the disease is present, such that the risk of the occurrence of the disease may be identified before the disease manifests itself. Gene testing techniques are therefore useless without the knowledge of what DNA sequences code for the disease. Patents that protect genes provide protection for DNA sequences that code for the disease, as well as sequences that code for the normal disease-free state. These sequences are not artificially modified.

The main objection to patenting gene sequences that have not been modified is precisely the fact that they have not been modified, and are therefore not new. United States Code Title 35 –Patents, s.101 Inventions Patentable states that:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title

Similarly, s.2 of the Canadian Patent Act states that:

Invention means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter;

Judge Sweet in the Myriad case maintains that gene sequences are not patentable because they do nothing but describe DNA, and given that DNA in itself is descriptive, the gene sequences are not “new”. The function of DNA is to direct the composition of proteins; it is a recipe. The protein produced will then result in the manifestation of disease. Therefore Judge Sweet maintains that that the function of DNA is to describe the manifestation of the disease, and an unmodified DNA sequence which is used to aid in the description of what the DNA under scrutiny describes, is not patentable. While this argument may be compelling, I do not agree with it.

The role of DNA is to dictate protein formation, however it is not the role of DNA to describe the risk of disease manifestation. The calculation of risk is a human construct; the risk is not ascertainable by simply “looking” at the DNA. As such, using DNA to express the risk of disease is a repurposing of DNA.

Looking at the DNA and describing its content is content is not useful, however understanding the meaning of the description is. There is a difference between simply saying that a gene responsible for breast and ovarian cancer exists, and saying that certain deviations from a standard form of the gene lead to ovarian and breast cancer. I believe that the latter is the basis of a diagnostic tool and should be patentable, whereas the former is a statement of fact and should not be patentable. These genes are not being patented to exploit their function as a protein recipe; they are being patented as baseline comparison standards. This purpose is evident in Myriad’s methods claims. The novelty does not lie in a new composition or manufacture, then, but in the repurposing of the DNA from a protein recipe to a means of diagnosis.

What is being rewarded through the patent is not an observation of the existence of a cancer gene, but rather the ability to be able to diagnose the possibility of cancer before it manifests itself. Viewed in this way, I believe that Myriad’s patents, and patents which aim to protect gene sequences, should be read in accordance with their. If the methods claims suggest that the gene sequences are to be used as comparison standards, then I believe that this is the aspect of the gene sequence that should be protected. In other words, I do not think it is appropriate for Myriad to enforce its patents against laboratories who are researching the gene sequence for a purpose other than using it as a comparison standard, but it is ok for them to hold exclusive rights to use a particular gene sequence as a comparison standard.

The field of biotechnology is evolving and makes use of tools that mimic cellular functions in order better understand the role played by each of the cellular components. One of these cellular components is DNA, a recipe for protein encoding. Being able to understand what the recipe means constitutes the basis of diagnostic tools that act as predictors. The value of this understanding lies in the ability to repurpose DNA from a simple recipe to a diagnostic tool. A diagnostic tool attaches meaning to the recipe which was not there otherwise. In this way, I believe that gene sequences that are used as comparison standards are new and useful improvements of the function of DNA, which, as found in nature and unmodified by the human mind, do not on their own act as a predictor of disease.

Unanswered Questions on the Risks and Promises of Pharmacogenetics and Personalized Medicine

Posted By Daniel Mastine – Oct. 26, 2011

On October 5th the McGill Research Group of Health and Law convened an interdisciplinary panel to discuss emerging developments in the fields of Pharmacogenetics and Personalized Medicine (PM). The panel was moderated by Professor Richard Gold and included Professors Jennifer Fishman, Yann Joly, Michael Phillips and Dr. Agnes V. Klein.

One might initially ask how these two seemingly distinct subjects are linked, and what potential impacts they could possibly have on society and medicine? To answer these questions, one must first address what Pharmacogenetics and PM entail. It is important to keep in mind that neither are new areas of medicine, and that they have begun to interact in a concerted manner previously unheard of.

For those who may not be aware, Pharmacogenetics is a specialized subfield situated between clinical and research medicine. It seeks to catalogue the genetic makeup, or biomarkers, of individuals and populations. The results assist researchers to understand why no two patients react/respond to a drug in quite the same manner. This endeavor provides pharmaceutical researchers and medical practitioners with a better understanding of how genetic diversity influences why medications are metabolized differently.In so doing, the safety of pharmacological treatments and their efficacy are enhanced and a truer picture of drugs is achieved.

PM conversely, is a popular medical model which seeks to optimize patient outcomes by tailoring patient treatment plans to individual characteristics. Some examples include: family health histories, the presence of a chronic disease, behaviours or even personal habits of patients to name a few. Practitioners, who ascribe to PM, essentially question the one size fits all norms of standardized medical. They tweak, but do not necessarily alter, customary treatment modalities to suit their patients’ needs. Society is after all based on variation: gender, ethnicity, diet, socioeconomic class, environment, illness, and yes, even genetics. Imagine if medicine could better account for these differences!

So how exactly are Pharmacogenetics and PM linked? As genetic mapping has become more accessible and less costly, some PM practitioners have recently begun to incorporate information from genetic research and personalized testing to guide their treatments decisions. However the slow but steady proliferation of Pharmacogenetics in an era of PM has led some members within the greater medical community to question this budding relationship from legal and bioethical perspectives.

During the panel presentations and subsequent Q and A, four distinct concerns were raised. Three out of the four include: race, informed consent, and privacy/confidentiality. The notion of race within Pharmacogenetics and PM was highlighted as problematic due to conceptual ambiguity and its potential to foster new forms of societal discrimination. Informed consent was noted to be too broadly defined within Pharmacogenetics and PM, leaving research participants and the public with little understanding of the purpose or process. Concerns for privacy and confidentiality were raised regarding the ability to secure the identities of Pharmacogenetic research participants, and in considering the “who, when and how” of data storage and retrieval.

The fourth not yet elaborated element of the discussion focused upon how the emerging intersections between Pharmacogenetics and PM are altering the pharmaceutical industry and medical function. Specifically, what obligations arise or are altered for both as biomarker testing becomes more readily available? The panel discussion suggested that over time, for both researchers and practitioners, the duty of care will increasingly expand to account for genetic factors. This is likely to play out with the expansion of available frontline diagnostic testing to identify individuals at risk. In turn, patient expectations and medical standards will begin to emerge. This will foster a duty for practitioners to prescribe treatments that take into account biomarker testing results. How health care is delivered will be redefined.

Where do we go from here one might ask? The future of medicine may well involve visits to the doctor, where each patient will provide the doctor with their personal genetic information. This scenario would revolutionize PM. Presently however there are just too many uncertainties and unknowns about Pharmacogenetics. This limits its accessibility for practitioners and application to patients as an exercise in PM. The panelists stressed the potential value of a closer relationship between Pharmacogenetics and PM. But they also posed challenging questions which denote the need for both dialogue and transparency in moving forward. This may in turn enable society and the medical community to address the legal and bioethical concerns that Pharmacogenetic research raises.

Everything you wanted to know about the CMPA: The MJLH interviews Executive Director/CEO Dr John E Gray

Posted By The MJLH | RDSM Team – Oct. 22, 2011

The Canadian Medical Protective Association (CMPA) is a mutual defense organization which handles the legal defence of doctors across the country in malpractice lawsuits and disciplinary hearings. Dr John Gray is the head of the CMPA. Several months ago, the MJLH sat down with Dr Gray, Executive Director/CEO of the CMPA. The interview transcript follows.


The CMPA describes itself as a “mutual defence organization.” Can you explain how that differs from an insurance corporation?


We are actually in some respects different from most organizations in Canada because we exist by virtue of an act of federal parliament [link to act’s text: http://www.cmpa-acpm.ca/cmpapd04/docs/about_cmpa/com_by_laws-e.cfm]. We’re a so-called Special Act corporation; so we’re not a regulated insurer, and our articles of incorporation specify what we can and cannot do.  We offer services of a medico-legal nature to our members, who are defined as licensed physicians practicing in Canada by the act. We offer this assistance on a discretionary basis, rather than through an insurance contract. It’s not an insurance contract. Our by-laws go on to specify in great detail how members can access our services.


Probably what separates us most from insurance companies is that we use that discretion to find ways to assist our members, rather than looking for reasons to deny assistance. Increasingly over the years, as the number of areas that our members practice evolve and change we find very creative ways to come to their assistance.


Obviously we’re not for profit, which changes our incentives relative to a commercial insurance company. For instance, we are not motivated to settle cases on an economic basis, simply because it would be cheaper than defending one of our members at trial. We exist to protect the professional integrity of our members, so if we believe a case is defensible, we will defend it regardless of costs.


What sorts of liability assistance does the CMPA provide for its members?


Civil liability for medical matters is provided almost without exception. We also assist a range of college matters, since medical license issues and fitness to practice are obviously very important to our members. We also deal with matters related to hospital privileges, in order to ensure that hospitals take decisions about hospital privileges in ways that are consistent with their by-laws, and in accordance with procedural fairness. We also assist our members with administrative tribunals of different kinds, such as human rights tribunals, or public fatality inquests. There are very few areas where CMPA Council has said that we will not exercise our discretion to assist, or that we will limit it.


The by-law is very clear that criminal matters generally are outside the scope of our mandate. Council has decided that we will assist a member defending against allegations of criminal conduct or sexual impropriety, but if the member is convicted in a court of law, our assistance comes to an end. This applies to civil litigation arising from criminal or sexual matters as well – we don’t pay any damages or assist in any settlement.


Defamation is a bit trickier. Our approach is that if the allegedly defamatory statement relates to the member’s professional practice, and if the statement was made through “appropriate” channels then we will assist. If a member is concerned about a colleague, and expresses those concerns to the regulatory authority, or to the hospital chief of staff, we would say that this is an appropriate expression of concern. But if the member wrote a letter to the local paper expressing his concern to the public at large, we would say that this is not in our view an appropriate manner of channelling his concern.


So defamation cases tend to arise between physician colleagues?


No, not entirely. We had a situation in one province where a physician expressed concerns about an oil company and its impact on the local environment and the health of his patients.  He had expressed his concerns in an appropriate manner – to a medical officer of health and government officials, so we assisted in that case.


In the event of a trial or settlement, what level of legal costs, expenses, and damages are paid by the CMPA?


Essentially, once we have granted assistance, there is no limited. Again, I think this sets us apart from an insurance company, which would limit any coverage by the amount in the policy – whether that is $100,000 or $2 million, there is a set limit above which the insurance company will not go. Our approach has no built-in limits to legal assistance, or to damages.


How are premiums set at the CMPA?


Fees are set according to actuarial analysis of the risks of practicing in various areas [General surgery, psychiatry, pathology, etc – MJLH]. We don’t underwrite individuals, so we look at people who do similar types of work and pool those risks together to set fees.


Up until the 1980s in fact, every CMPA member paid the same fees. During the medical liability crisis of the 1980s that became untenable. Fees were rapidly escalating and lower-risk physicians felt that this was unfair since they were paying for the higher-risk practice areas. So in the mid-1980s the CMPA adopted fees commensurate with the medico-legal risk. We identified the highest-risk groups – the three high-risk groups being neurosurgeons, obstetricians, and orthopedic surgeons. The lowest risk group are physicians like me, who hold administrative positions who don’t see any patients.


In 2001 we moved to a regional fee structure, which incorporates both the type of practice and the location where the physician is practicing. For fee-setting purposes we have three regions: Québec, Ontario, and the rest of Canada. Risk is highest in Ontario and lowest in the rest of Canada, with Québec situated in the middle. Again this change was member-driven, since many Québec members felt that the fees they paid were not commensurate with their risk, so after consulting with the actuaries, we made the move to regional risk pools. But we don’t want to move any further down the road, towards smaller and smaller risk pools.


With respect to smaller risk pools, why does the CMPA not charge higher premiums to doctors who have experienced previous lawsuits?


Because we’re a mutual defence organization. We want to preserve the notion of mutuality, rather than personal experience-rating. Ideally everyone would pay the same fee, but our membership moved us in the direction of  practice-base fees and then region-based fees. But that is as far as the CMPA is prepared to go.


Doesn’t this approach create a moral hazard though, because doctors do not suffer any consequences for medical malpractice?


One can make that argument. Our members are generally satisfied that on those occasions where someone is perceived as using the services of the CMPA unnecessarily frequently, the hospitals or the regulatory authorities respond to the situation. We don’t need to deal with it through our fee structure because the regulatory bodies deal with it through disciplinary hearings or fitness-to-practice hearings.


The reality is that all of us understand that in many cases it’s the luck of the draw. Take obstetricians as an example. One obstetrician might have two shoulder dystocias [when the delivery of a baby is obstructed by difficulty passing the shoulders of the baby from the mother – MJLH] in two years, whereas your colleague might not have any. These are very, very expensive cases, but no one can predict when and where these complications will occur.


Why do doctors fight malpractice lawsuits, given that their premiums will not increase and that the CMPA pays all of their expenses?


There are important personal consequences for physicians that go beyond financial concerns. If a physician loses a medico-legal case, or settles a case out of court, they have to report this to the provincial college and to their hospitals. So it does have consequences. The colleges themselves may initiate investigations on the basis of these reports, and it can affect a physician’s ability to move from one jurisdiction to another, or the physician’s ability to get hospital privileges. It’s also a matter of professional integrity. So it’s not all about the money.


Related to professional integrity, what impact, if any, has the CMPA seen from apology legislation such as Ontario’s Apology Act?


I think it’s too early to say. Canadian jurisdictions were relatively late to enact apology legislation, so the CMPA has been watching this occur in other countries as well, and even in those jurisdictions I don’t think that there is any evidence that it prevents litigation. But I don’t really believe that was the purpose, either. I believe the purpose was to support patient safety, by removing any barrier between physicians being open and transparent with their patients when an adverse event occurred.


Historically, it was said that physicians were unwilling to discuss adverse events because they were afraid of lawsuits. We think that’s a falsehood. We think that when physicians are open and transparent with patients, that leads to the best outcomes for everyone. When an adverse event occurs, it’s often not clear what the role of the physician was, and this may not become clear until weeks or months later. But apologies are quite appropriate no matter what. Apology legislation takes another step, by reassuring health professionals that if they apologize in the process of disclosing the adverse event, that apology cannot be taken as evidence of liability. We have not yet seen a case where this has been tested, nor to do I think that we ever will. Proof of negligence is proof of negligence, not whether you apologized!


It seems from what has been said so far that doctors have fairly little input on how a case proceeds.  So when deciding whether to settle or defend a case, what factors guide the CMPA’s decision? How much input do doctors have?


Well, that’s not true. The physicians of course always want to be defended. But what we do is retain experts to comment on the doctor’s care. If the doctor’s care is supported by experts, and if the doctor wants to be defended – because sometimes physicians will say “I don’t want to go through five years of litigation, I want this to be over” – then we will defend them.


But conversely, if the doctor’s care is not supported, and the doctor still wants to be defended, we will use our best efforts to convince the doctor that this is a folly. At the end of the day, litigation in some circumstances would just prolong a situation in which a settlement is warranted. It may require frank discussion between the doctor and counsel, and sometimes we will look for additional experts, if the doctor feels that the original expert was wrong. But at the end of the day, most doctors recognize that the experts are who the courts will listen to, and doctors are satisfied that if we cannot find expert support, then the case is not worth defending.


Do doctors often “go it alone” if the CMPA thinks the case should be settled?


I guess we wouldn’t really know if that happens, since we don’t have any way to systematically gather that information. But certainly it happens at the college level.


A big part of CMPA’s defence work is college complaints against physicians – the CMPA defended roughly three times more college complaints than lawsuits in the last several years.  What kinds of issues are brought before the colleges and how does the CMPA’s approach differ here from its approach to medical liability lawsuits?


We think that until recently, the CMPA has handled about half of all college complaints against our members. In the past few years there has been a dramatic increase in the number of college assistance requests.  I think that is due to a growing awareness of our members about the importance of contacting the CMPA if a college complaint occurs, rather than an increase in the number of college complaints occurring. So we are probably now assisting 60-70% of the members who are going before the colleges.


Our approach to college complaints is quite different from the way we handle civil litigation. In fact, we don’t normally place those cases in the hands of counsel. In fact most of them are dealt with by one of our physician

medical officers. The medical officers review the complaint with the physician and explain what kind of response the college is expecting, what the time frame and process might be. This is important because often college complaints are black holes for doctors – they get the college complaint and then nothing happens for a year. If the college decides to take disciplinary action, that is when we engage counsel, because it has become a more serious matter.


Do most college complaints go to disciplinary hearings?


No, probably 90% of the complaints are resolved without hearings or requiring any sanction against the doctor.


The CMPA has raised the issue of wait times as a potent source of medical liability. Have lawsuits ever been launched against individual doctors on the basis of wait times?


Wait times are often obliquely referred to in statements of claim, and plaintiffs often allege that they have been waiting too long for various procedures or tests.  But it is almost unheard of for wait times to be the only issue in a lawsuit. That said, it’s not unusual to hear allegations that wait times or delays lead to unnecessary suffering or adverse outcomes. The typical case in which wait times are involved is where a patient’s condition deteriorates and the patient alleges that the responsible physician failed to expedite treatment.


We are concerned about the issue of wait times, and we’ve taken a position on the issue from a medical liability perspective. [link https://www.cmpa-acpm.ca/cmpapd04/docs/submissions_papers/com_wait_times_2007-e.cfm] One of the key issues for us is good communication between specialists and family doctors, so that everyone is aware of the patient’s condition, and also the availability of care.


Speaking of communication and coordination, to what extent has the growing emphasis on medical teams impacted the liability landscape?


We think it has the potential to significantly change the game, particularly with the increasing scopes of practice of other health professionals, and the increasing autonomy of other health professionals. We have two key messages in this area. First, that when independent health professionals are working with the same patient, there should be clear lines of responsibility, so that no one falls through coordination gaps between team members. Second, every health professional should have adequate liability protection. It is unacceptable for the deep pockets of the doctors to be fully liable even though the physician is minimally responsible, simply because the doctor is the only professional with any liability  protection.


Could you expand on that deep pockets problem? What exactly do you mean?


Well, based on the common law rule of joint and several liability for personal injury, any defendant held liable for the injury can be sued for the full amount, even if that person is only responsible for a fraction of the actual damages. The burden then shifts to that defendant to sue the other defendants in order to redistribute the costs appropriately. Often the CMPA ends up paying for all of the damages, since none of the other health professionals have liability coverage, and therefore they cannot pay their share.


We believe that as a condition for licensing as a health professional, there should be an absolute requirement for that professional to have adequate liability insurance. This will prevent these kinds of problems in the future.


Do you feel that provincial governments and regulatory bodies have been receptive to this argument?


Well, it’s now the law in Ontario. We’ve been making this argument for a number of years, and we’re beginning to see a growing recognition that the problem needs to be resolved. It’s not universally in place everywhere, but it’s a problem that’s beginning to be addressed.


Medical liability lawsuits have been declining over the past decade. What factors does the CMPA believe are behind this?


I wish I knew the answer [laughs]. First of all, it’s not unique to Canada. We have observed the same trend in the United Kingdom, Australia, and the United States. And it’s not unique to medical liability; we’re told that in many forms of professional liability there has been an observable decline. On the medical side, we’d like to think that our efforts and the efforts of others to promote patient safety have contributed to the decline, but that would not explain the decrease in other forms of professional liability, like that for architects. I think the explanation is multi-factorial, and I don’t feel that we know enough about it to say for certain.


It may also be coming to an end. In other jurisdictions the frequency is beginning to rise again. We’ve seen increases in both in the United Kingdom and in Australia, and in some areas of the United States. In Canada, we’ve seen an uptick in the absolute numbers in the last two years, but when you take in to account the growth in our membership, the rate of lawsuits on a per-member basis is flat. The reality today is that a physician today is half as likely to be sued as he or she was ten years ago.


Some commentators, have criticized the CMPA’s approach as “stacking the deck” against plaintiffs by generously funding physicians while their opponents have only their own resources.  How would you react to this?


I think there’s perhaps some underlying confusion about the source of funding for the CMPA. We are funded exclusively by our members. Our members pay fees to us and that’s 100% of our funding.


In the past, a small percentage of every clinical fee was nominally assumed to be included to hedge against liability. The reality was that in the medical liability crisis of the 1980s, the medical associations that negotiate fees for medical services were finding it increasingly difficult to build in a fair and equitable amount of money for liability protection into clinical fees. To return to the example of obstetricians, some of them might be performing 200 to 300 deliveries a year, and others might do primarily gynecology and perform only 20 deliveries a year. By building the liability protection in to the fee code, some physicians would get a windfall if they did not experience any adverse events, while others would  be left virtually unprotected.


So what happened across the country was a shift to funding medical defence costs entirely through higher fees paid to the CMPA. That shift was premised on two factors. First of all, there is no source of funding for physicians who provide care outside of the public system, so everyone is paid through Medicare. Secondly, individual physicians have relatively little control over the fees they are paid for their services, since the fee codes are negotiated between the provincial medical associations and the provincial government. So the provincial medical associations decided in the mid 1980s that in lieu of receiving increased fees for their clinical work, they would receive an equivalent amount and use this money to reimburse physicians for the money paid in CMPA fees. That money continues to be negotiated every year with provincial governments, and continues to be given in lieu of money that physicians would have otherwise received directly.


So physicians have chosen to divest, or give up, some portion of their clinical earnings in order to cover this important part of their practice costs. There is a single payer for healthcare in Canada, and physicians have chosen to take some of those payments and set them aside.


The CMPA’s report Towards the Right Balance [link: http://www.cmpa-acpm.ca/cmpapd04/docs/submissions_papers/piaa/com_home-e.cfm] outlines a number of “common sense” reforms and “achievable improvements.” What do you think are the most important reforms to the medical liability system in Canada?


One of the areas where we think there are unnecessary circular flows of money is when the government exercises its right to recover its subrogated health care costs from both physicians and hospitals. This flow is circular because arguably whenever the government collects substantial amounts of money via subrogated health care costs, the costs of liability insurance for doctors and hospitals goes up as well, and that is a cost that the government has to pay later on when it sets health care budgets.


But it’s not a benign circular flow. There are transactional costs involved, since often the government hires its own lawyers to advance their subrogated claims. We’ve also had cases where the plaintiffs and the CMPA have agreed on an amount of settlement, but we cannot agree with the government, so the plaintiff does not receive their money for a year or two while the CMPA argues with the government about what costs they will recover.


I think it’s a simple administrative matter, and they can simply agree to stop collecting that money.


In Canada the CMPA defends physicians and the CNPS defends nurses. Are there other mutual defence societies in Canada covering allied health professionals or do AHPs rely on private insurance or coverage through their workplace?


There is the new law in Ontario, but for the most part it’s private insurance. I’ve had discussions with pharmacist’s professional associations and regulatory bodies, and they have several possible sources for liability coverage. Our view is that it doesn’t matter where coverage comes from as long as each health professional is adequately insured.


I am told that some of the smaller health professional groups, such as physician assistants, have trouble getting private coverage since there are often so few of them in this country.  This problem is exacerbated since most other health professionals deal with liability coverage at the provincial level. This prevent national risk pooling that could lower costs and combine small risk pools in order to make them attractive to private insurers. And sometimes within provinces there are two or three competing insurance sources, further reducing the size of risk pools. Sadly that’s the Canadian reality right now.

The Disability and Law Portfolio and the MJLH Present Disability and Reproductive Rights: Complex Rights and Choices

Posted By Meara Conway – Oct. 21, 2011




Friday, October 28 at 12:30pm – Thompson House, Room 406


Roxanne Mykitiuk, Associate Professor of Law at Osgoode Hall Law School, teaches in the areas of Law and Disability, Family Law,  Health Law, and Bioethics.

Jeff Nisker is the Coordinator of Health Ethics and Humanities, and Professor of Obstetrics-Gynaecology and Oncology at the Schulich School of Medicine & Dentistry, University of Western Ontario (UWO).


Abby Lippman, Professor in the Department of Epidemiology, Biostatistics, and Occupational Health, is an Associate Member of the Departments of Family Medicine, of Social Studies of Medicine, and of Human Genetics at McGill University.

Vous êtes chaleureusement invités à un panel sur le handicap et les droits reproductifs, vendredi 28 octobre à 12h30, salle 406, co-organisé par le groupe sur le handicap et le droit et la Revue de droit et de la santé de McGill. Les présentations se feront en anglais.

Pour plus d’infos ou pour proposer votre aide pour l’organisation de l’événement, merci de nous contacter:

For more information or to volunteer for the organization of the event, please contact one of the coordinators:




The Counterfeit Drug Trade: A Growing Transnational Problem

Posted By Meara Conway – Mar. 24, 2011

A report published by the International Policy Network indicates the annual $75 billion global trade in illegal, counterfeit medicine is responsible for the deaths of over 700, 000 people annually.1 Ten percent of all medicines sold worldwide are fake medicines that are ineffectual or outright harmful.2 In the developing countries of Africa, Asia and Latin America, this statistic more than doubles,3 and is as high as fifty percent in some.4 Canada is not immune. In 2005, for example, pharmacies in Ontario were discovered selling a counterfeit version of a blood pressure medicine, Norvasc, after eleven patients inexplicably died.5

A recent article in the Journal of International Criminal Justice published by Amir Attaran and Megan Kendall of the University of Ottawa and Roger Bate of the American Enterprise Institute in Washington outlines the current challenges in addressing the transnational counterfeit drug trade through national regulation.6 Pitfalls include insufficient regulation, unsatisfactory enforcement of existing regulations, lack of political will, the complexity of transactions, and ineffective cooperation between transnational communities. Moreover, the authors argue such efforts are ultimately limited as national authorities lack the ability to address the transnational nature of the counterfeit drug trade.

The rise of online pharmacies has exacerbated problems of jurisdiction. A Canadian Internet pharmacy, RxNorth.com, sold falsely labeled “Canadian” counterfeits to American and other global consumers, including allegedly life-saving medicines. While the source of such counterfeits was China, they were shipped circuitously through Hong Kong, the United Arab Emirates, Britain, and the Bahamas,7 thus concealing their origin and avoiding national jurisdictional authority. Other countries in the supply chain, including the United Arab Emirates, the U.S., the UK and the Bahamas did investigate and prosecute intermediaries, but lacked jurisdiction to pursue either RxNorth.com or its former CEO, Andrew Strempler. Although Strempler’s pharmacy license was revoked and he faced professional disciplinary action, he was never charged in Canada. Strempler now distributes generic drugs from an online pharmaceutical business in a free trade zone on an island off the coast of Venezuela.8 This example illustrates the need for a transnational effort to tackle counterfeit medicines.

In response to deepening concerns, some propose a treaty be drafted under the auspices of the WHO similar to the Framework Convention on Tobacco Control. The FCTC marks the sole occasion the WHO has exercised its treaty-making power. The preamble of the treaty in fact acknowledges a number of issues commensurate with the challenges presented by counterfeit medicine. The authors believe this mechanism would effectively tackle the issue in both developed and developing countries, providing cross-border measures that would address problems at their source.

[1] Julian Harris, Philip Stevens & Julian Morris, “Keeping It Real: Combating the spread of fake drugs in poor countries” (International Policy Network: 2009), online: <http://www.policynetwork.net/sites/default/files/keeping_it_real_2009.pdf>.

[2] André Picard, “Trade in fake medicines needs a global fix”, Globe and Mail (17 February 2011) at L6.

[3] Supra note 1.

[4] Criminal Intelligence Service Canada, Counterfeit Pharmaceuticals in Canada (Ottawa: Criminal Intelligence Service Canada, 2006) at 1, online:<http://www.cisc.gc.ca/pharmaceuticals/pharmaceuticals_e.html>.

[5] Ibid.

[6] Amir Attaran, Roger Bate, & Megan Kendall, Why and How to Make an International Crime of Medicine Counterfeiting J Int Criminal Justice mqr005 first published online February 10, 2011, online: <http://jicj.oxfordjournals.org/content/early/2011/02/10/jicj.mqr005.full.pdf#page=1&view=FitH>.

[7] Walt Bogdanic, “A Toxic Pipeline: Counterfeit Drugs’ Path Eased by Free Trade Zones”, New York Times (17 December 2007)online: <http://www.nytimes.com/2007/12/17/world/middleeast/17freezone.html?_r=1&pagewanted=print>.

[8] J Skerritt, “Online Pharmacist Eludes Ban: Strempler Moves Business to Caribbean, Manitoba Regulators can’t Stop him now”, Winnipeg Free Press(26 February 2010) online: <http://www.winnipegfreepress.com/local/online-pharmacist-eludes-ban-85460077.html>.