Opinions

According to the latest statistics from the Canadian Cancer Society, about 1 in 2 Canadians will develop cancer in their lifetimes, and 1 in 4 will die of the disease.[i]  In the past, most cancer chemotherapy treatment has been delivered through intravenous administration in the acute care setting.

With advances in medical research and treatment, many cancer medications can now be taken at home. It is estimated that more than 50% of new cancer drugs are formulated for in-home administration.[ii] This results in lower hospital infrastructure utilization and human resource costs, and enables patients to safely receive care in the comfort of their own homes, minimizing the risk of nosocomial infections, lowering travel costs, and reducing the amount of time that patients need to spend away from work and family during treatment.

The geography of Canada presents an important case for driving innovative approaches to cancer therapy. Patients living in the more rural and remote parts of the country need to travel long distances to access hospitals where they can receive intravenous chemotherapy. The specialty knowledge required to safely prepare and deliver complex and often dangerous chemical treatments can be limited in more isolated regions. With the loss of a single specialist in smaller centres, there can be a complete halt to the organizational capacity to deliver chemotherapy, as was the case in the Haida Gwaii archipelago earlier this year when the Northern Health Authority was unable to recruit a new specialty-trained pharmacy technician, despite offering substantial incentives to fill the position.[iii]

A 2017 Cochrane review showed that amongst patients with colorectal cancer treated with the aim of cure, disease-free survival, and overall survival, there was no statistically significant difference in outcomes between those who received oral chemotherapy versus intravenous treatment.[iv] Take home oral treatments offer an innovative, patient-centred, and more efficient mechanism for delivering high quality, evidence based cancer treatment to Canadian patients.

Under the Canada Health Act, prescription drugs administered in Canadian hospitals are provided at no cost to the patient; however, outside of the hospital setting, provincial and territorial governments are responsible for the administration of their own publicly-funded drug plans.[v]

Given that the incidence of cancer spans the continuum of age and socioeconomic status, access to private insurance for coverage of take-home cancer drugs is variable amongst patients, as well as across provinces. As such, patients often encounter obstacles in accessing take home medications for cancer treatment, which can result in delays to treatment, or unnecessary utilization of hospital services.

Coordination of multiple reimbursement programs may be required for a single cancer patient to cover the cost of their take home treatment, and the process of obtaining authorization and reimbursement of approved cancer medications can be time consuming and challenging, particularly for patients and families grappling with a cancer diagnosis and its emotional and economic impact.

It is noted that Canadian caregivers are given 26 weeks of paid time off to care for a loved one living with cancer through the Compassionate Care Benefit; however, those actually living with cancer are only given 15 weeks of paid time off through the Employment Insurance Sickness Benefit. In addition to the potential economic burden of unpaid leave from employment, insufficient reimbursement and out of pocket expenses can present yet another economic hurdle for Canadian cancer patients.

One in six Ontario cancer patients report that their out-of-pocket expenses are significant or unmanageable.[vi]

The Atlantic provinces have different systems for intravenous versus take-home cancer therapies, with funding for the latter covered through a mix of private insurance, special programs, or out of pocket expenses.[vii] In Quebec, eligible take-home cancer treatments qualify for public coverage, though a deductible based on income may be required to be paid.[viii] In Manitoba, Saskatchewan, Alberta, and British Columbia, patients can also get coverage for take-home therapies.

A system in which some Canadians have access to modern cancer treatments and some do not presents an opportunity for all provinces to keep pace with innovation in cancer treatments. Provinces need to work to reduce barriers for Canadians to access the best possible cancer services and minimize the economic and personal burden of managing a cancer diagnosis, so that we do not simply transfer costs of care from health service institutions to the pocketbooks of cancer patients and their families.

The federal government has undertaken initial steps towards implementing a national pharmacare program. Questions will need to be addressed as to whether Canadians currently accessing cancer drug coverage through private insurance plans would be at risk of losing coverage for certain – or even all – therapies if their provinces shift to include some take home cancer therapies on their formularies, or to participate in a national pharmacare program, particularly if employment-based health benefits begin to be taxed as income following adoption of the national plan.

It is critical that Canada’s system of public health coverage keep pace with innovation in cancer therapy, particularly as escalating numbers of Canadians are impacted by cancer each year. This will require a carefully designed approach aimed at reducing disparities in access to innovative cancer treatment and mitigating unintended loss of current coverage for Canadians with cancer.

Roxana Sultan, Vice Chair and Member, Board of Directors, Canadian Cancer Society Ontario Division. The opinions expressed in this article are the independent views of the author and do not necessarily reflect the views of the author’s employers or affiliated organizations.

[i] https://www.cancer.ca/en/cancer-information/cancer-101/canadian-cancer-statistics-publication/?region=on

[ii] https://www.cancer.ca/en/get-involved/take-action/what-we-are-doing/take-home-drugs-on/?region=on

[iii] https://www.ctvnews.ca/health/remote-health-care-tested-as-haida-gwaii-loses-iv-chemo-treatment-next-month-1.4443517

[iv] https://www.cochrane.org/CD008398/COLOCA_oral-versus-intravenous-chemotherapy-colorectal-cancer

[v] https://www.canada.ca/en/health-canada/services/health-care-system/pharmaceuticals/access-insurance-coverage-prescription-medicines.html

[vi] https://www.cancer.ca/en/get-involved/take-action/what-we-are-doing/take-home-drugs-on/?region=on

[vii] https://www.cancer.ca/en/get-involved/take-action/what-we-are-doing/take-home-drugs-on/?region=on

[viii] https://www.cancer.ca/en/get-involved/take-action/what-we-are-doing/take-home-drugs-on/?region=on

Much enthusiasm exists for the use of real-world data (RWD) sources for drug reimbursement and pricing decisions in Canada. However, a recent report providing insight into the views of various stakeholders about the use of these resources for decision-making demonstrated that the participants had several misperceptions about RWD. These misperceptions are likely the result of the RWD resources currently available in Canada being predominantly administrative health care utilization data.

Researchers in Saskatchewan and Manitoba were innovative pioneers in the use of administrative data for health services research in the 1970s and for pharmacoepidemiology in the 1980s and 1990s. Later, researchers in other provinces also used their local administrative data for research purposes. However, Canada has failed to capitalize on its lead. Other nations have moved forward by combining administrative data with electronic medical records (EMRs), laboratory test data and, in some cases, social, psychological and genetic information to develop more comprehensive RWD.

Despite billions of dollars being spent on the Canada Health Infoway, a not-for-profit government corporation created to foster and accelerate the implementation of a pan-Canadian EMR network, Canada has been slow to introduce large-scale EMR systems, and few provinces have complete laboratory, screening and other test information that are fully linkable with their administrative data or other resources such as registries. This slowness to develop more advanced resources is perhaps not surprising when many physicians, hospitals and pharmacies still communicate about patients using faxes.

The existing RWD available in Canadian provinces are frequently challenging to access and use. Examples of access difficulties are a lack of a central point of data procurement in some provinces, data use restricted to local accredited academics, and lengthy time required to obtain administrative and ethics approvals. In addition, differences exist in how data are provided; some provinces deliver a tested dataset, while others provide a data dump that necessitates much effort by the end user to organize into a useable format. Moreover, there is a lack of consistent data standards across different provinces; for example, the primary hospital discharge diagnosis in Quebec is the most important condition encountered by the patient during hospitalization, which may not be equivalent to the most responsible hospital diagnosis (the one requiring the greatest consumption of resources) used in Saskatchewan.

Additional limitations in utilizing administrative health care data include the need to assess the validity of diagnoses in each use because diagnostic validity is not of high importance when services are recorded, and the restrictive clinical criteria that patients must fulfill to obtain access to many drugs in government programs that often vary between provinces, which can lead to biased results. These issues also make analyses based on amalgamated data from different provinces questionable because combining data from resources with differing recording criteria does not eliminate the variation – more likely, it accentuates differences resulting in misleading outcomes.

Canada has long had a need for better information on the effectiveness of its health care system, but progress towards this goal is hindered by the country’s fragmented health care system. Moreover, the siloed approach of separate branches within each provincial government supporting different health care services results in little evaluation of the impact of each branch’s expenditure on the others. For example, an increase in spending on a high-cost innovative drug is frequently seen solely as a problem for the budget of the pharmacy service branch, even if it reduces the need for hospitalizations resulting in a saving for the hospital service branch that exceeds the additional medication expenditure.

Canada’s provincial governments have generally failed to invest in improving and extending their data beyond the information recorded to manage their health care delivery budgets because they have little incentive to do so. Administrative health care utilization data mainly record diagnoses, procedures performed and dispensed prescriptions, which indicate that services were required. They do not record whether a patient benefited from a medicine or treatment. Administrative data have a role in drug safety research, but they are an inappropriate resource with which to evaluate the effectiveness of new therapies. The lack of repeat prescriptions or further visits to the physician does not necessarily mean that the patient’s condition improved. The patient may have given up on the treatment because it was not working or it caused unpleasant side effects and tried something else. Alternatively, an absence of data could mean that the patient moved away or, more extremely, that they died suddenly. An assessment of the effectiveness of new therapies requires linked access to both administrative and clinical outcome data.

When clinical data are in electronic form in Canada, they tend to be in small-scale EMR systems. The few large EMR systems that do exist are generally not linkable with administrative data and access is often restricted to specific researchers. Clinical data may also be available in registry systems, some of which have been highly successful (e.g. Cystic Fibrosis Canada has a registry that includes virtually all Canadians with this disorder that provides valuable information about sufferers), but again they are rarely linkable with government administrative data.

In June 2019, the federal government’s Advisory Council on the Implementation of National Pharmacare submitted its final report on how a national public drug insurance system should be introduced in Canada. One of the Advisory Council’s recommendations is the collection and analysis of real-world evidence to help inform formulary decision-making, especially about the benefits and risks of drugs for rare disorders.

However, except in unusual circumstances, no Canadian RWD about a drug’s use exist when a reimbursement recommendation is made about the drug and negotiations regarding its price are undertaken. Moreover, public payers and the Canadian Agency for Drugs and Technologies in Health (CADTH), which provides recommendations to the governments that fund and manage it regarding whether medications should be reimbursed by the public payers, continue to want to see randomized clinical trial results in health technology assessment submissions, even those for drugs for rare disorders where such trials are difficult to accomplish. CADTH and the public payers regard results from randomized clinical trials more highly because they are committed supporters of evidence hierarchies that place RWD at a lower level of reliability, regardless of the circumstances.

Unless RWD analyses are available from other countries and accepted by CADTH, reimbursement recommendations will most likely continue to be made on “cost-effectiveness” assessments based on the results of efficacy data derived from randomized clinical trials and the manufacturer’s anticipated list price. From July 2020, maximum prices for new drugs are also going to be based on these assessments. Although constituting the best available information at the time, efficacy is an inadequate estimate of effectiveness and the list price does not represent the discounted price offered by the manufacturer to the provincial drug programs. Only once a drug is in everyday clinical use in Canada can genuine cost-effectiveness analyses based on RWD be performed.

The Advisory Council’s recommendation for the use of RWD to inform formulary decision-making may be apposite, but the pertinent question is, are valid and reliable evaluations of the effectiveness of medicines possible with the RWD currently available? Even if the present resources were considered to be adequate for this purpose, the numerous issues related to accessing and using these data create a significant challenge, if not a total blockage, for putting this recommendation into action. The situation is only likely to change if the federal, provincial and territorial governments genuinely want improved drug reimbursement and pricing decision-making (as well as better safety evidence), become more cognizant of the problems of the inadequacy of their data resources for valid analyses, and invest in developing and expanding their RWD assets.

The 2019 federal budget announced that the government will take initial steps towards implementing national pharmacare to improve the affordability and accessibility of prescription drugs across Canada. The government’s plan includes the development of “three foundational” elements – a national Canadian Drug Agency (CDA), a comprehensive national drug formulary, and a national strategy for high-cost rare-disorder medicines.

The CDA will assess the cost-effectiveness of new prescription medicines and negotiate prices on behalf of public drug plans to recommend those that represent the best value-for-money. In other words, it will merge the present health technology assessment (HTA) agencies – the Canadian Agency for Drugs and Technologies in Health (CADTH), and INESSS, Quebec’s equivalent – and the pan-Canadian Pharmaceutical Alliance (pCPA), which currently negotiates prices for all public drug plans.

The government intends the CDA to be a powerful tool in reducing drug costs. Cost reduction aligns with the government’s commitment to provide affordable, accessible and appropriate prescription drug coverage for all Canadians.

As these documents usually are, the federal budget was long on generalities and short on details. The final report of the Advisory Council on the Implementation of National Pharmacare is consistent with the federal budget in the three foundational elements. The Council’s numerous recommendations provide greater insight into what is being proposed.

The CDA would not only bring together CADTH, INESSS and the pCPA but also resources and expertise from Health Canada, the Patented Medicine Prices Review Board (PMPRB), which currently regulates patented drug prices, and the Canadian Institutes for Health Research. The national formulary would start with “essential medicines” and only become a comprehensive list by January 2027. The national strategy for high-cost rare-disorder drugs would have a “distinct pathway” for the consideration of these medicines and a national expert panel “working with patients” to determine which drugs would be funded and which patients would receive them.

The most fundamental recommendation of the Advisory Council is that national pharmacare should be publicly funded and administered, eliminating the need for most of the current private and all the public drug insurance programs. The Advisory Council suggests that Canadians could purchase private insurance to cover the cost of copayments or provide extra benefits. However, since a totally public program is proposed, the federal government would probably tax employment-based health benefits as income, which would likely eliminate demand for private insurance.

Both the federal budget and the Advisory Council’s report leave important and concerning questions unanswered. These questions must be answered before such a sea change in the country’s pharmaceutical environment is allowed to occur.

Being part of national pharmacare would not be mandatory for the provinces and territories. They would have to choose to opt-in. Will they do this because they would be surrendering part of their autonomy over their prescription drug budgets and allowing the federal government to say which drugs they should fund? In particular, would Quebec relinquish its current comprehensive drug coverage programs for something potentially less inclusive, and would the province relinquish its jurisdiction by allowing INESSS to be combined with CADTH? Without a sufficient proportion of the Canadian population in the system, the bargaining power for pharmaceuticals needed to achieve the savings anticipated by the Advisory Council are unlikely to be realized.

The budget conspicuously did not mention the PMPRB, but the Advisory Council report recommends that  the substantial changes proposed by the federal government in 2018 to the PMPRB’s guidelines to further reduce drug prices should be implemented. The proposed changes could have far-reaching impacts for drug manufacturers that could delay or prevent the timely introduction of new medicines, which would deny Canadians with unmet pharmaceutical needs access to innovative therapies. The proposals have led to some serious concerns among patients. However, since the pCPA has achieved prices lower than the legal maximum for a growing number of drugs, the PMPRB’s pricing role has become less relevant to government drug plans. The question here is, is the PMPRB still needed?

Other questions relate to what is meant by a “comprehensive” national formulary and how it would be implemented across Canada. According to the budget, the development of a comprehensive, evidence-based list would “provide the basis for a consistent approach to formulary listing and patient access across the country.” Does this imply that the formulary would include the several thousand of medicines that many private insurance plans cover? Or would it be restricted to, for example, the 125 so-called essential medications proposed by some academics? Or, perhaps, it would resemble New Zealand’s formulary which, excluding vaccines, diagnostic products and oncology drugs, includes approximately 550 medicines (the often-criticized Ontario public plan has about 750 medicines)?

Provincial governments are protective of their autonomy in deciding which medicines are listed in their formularies based on perceived needs and priorities of residents and provincial budgets. Having provinces list all the medicines recommended for reimbursement by the CDA would likely be interpreted as federal interference and resisted, unless the federal government provided funding for the coverage of additional medicines. However, until all drug coverage plans are required to include every drug in the national formulary, inequity is likely to continue across Canada.

A national strategy to regulate high-cost rare disorder medicines is long overdue. Some CADTH staff recognize that the current rigid methods of the HTA do not work for rare disorder drugs and that a unique approach to assess their value is required. A relevant question here is, will a national strategy include more flexible HTA methods for these types of drugs? If so, will public and private drug plans accept the recommendations, or will they continue to impose restrictive clinical criteria that limits drug access to highly specific patient types?

How will the federal government pay for national pharmacare? The usual method of federal transfers provides provincial and territorial funding based on the size of their populations. Some provincial drug plans are less comprehensive than others and would need greater funds to bring their plans up to a national standard. Moreover, some of the same province have a higher proportion of elderly residents who frequently require more drugs. If equity is to be achieved, disproportionate funding would be required. Would provinces with better current drug plans accept this?

Different estimates of the cost of national pharmacare have been put forward. Given the federal government’s notorious under-estimating of spending on large-scale projects and the time required to implement them, can Canadians trust the Advisory Council’s estimate? The Phoenix pay system and plans to purchase planes and ships for the armed forces raise the question, can Canadians trust the federal government to introduce national pharmacare without large tax increases and much delay?

The national pharmacare program recommended by the Council seems designed primarily to reduce out-of-pocket costs from copayments and deductibles under existing public drug plans and safety-net programs. Canadians who have public or private insurance should be concerned about whether it would reduce their benefits and increase their expenses. Without answers to the questions raised here, Canadians will not know whether the plan is to create the truly comprehensive program the Advisory Council proposes or a tight cost-containment system with limited access and options.

Private sector support for patient groups is an ethical necessity in the absence of public funding.

Some academic authors have criticized pharmaceutical companies for funding patient advocacy groups because they see it as a conflict of interest. Media commentators also tend to take a negative view of industry funding for such non-profit organizations. Although it cannot be proved that funding from pharmaceutical companies influences the policy positions of patient groups regarding whether drugs should receive insurance coverage, the implication, with varying levels of subtleness, is that this is the case.

Authors of these articles and media reports are unlikely to have a child or partner suffering from a major debilitating or life-threatening condition for which the only effective therapy is an innovative costly drug. Otherwise, they might be less judgemental and investigate whether the private health insurance to which they and their employers contribute provides coverage for the required medicine. Since most universities and media corporations contribute to a comprehensive private insurance plan, they might be lucky. If not, they could look to their provincial public drug plan, but the likelihood of gaining reimbursed coverage would be substantially lower, because Canada has a two-tier drug insurance system.

Individuals with unmet needs often turn to a patient support group or create one. These groups are not new. The Infantile Paralysis Fellowship (now the British Polio Fellowship) was founded 80 years ago when poliomyelitis infection was relatively common. The Fellowship’s objectives included connecting victims to develop their interests and abilities, finding training for occupations so that members could support themselves, alleviating sufferers’ loneliness, linking those requiring advice and assistance with sources of help, arousing the social conscience on problems encountered by the paralyzed, and to influence policy and legislation.

Patient groups continue to have similar objectives, providing education, peer-to-peer support and encouragement, even hand-holding, during difficult times. In the present Canadian health care environment, these groups are essential and have proliferated. Support groups undertake advocacy activities to ensure better access to care and treatment that their members need but the health care system is not adequately providing. Patients with rare disorders frequently have a greater requirement for support due to their small numbers and isolation.

All patient groups need funding to be able to provide the support their members require. Only large groups representing common diseases that resonate with the public are likely to be sufficiently successful at awareness and donation campaigns to be able to sustain their activities from these sources alone. Most patient groups must look elsewhere for funding. Governments will not provide funding, particularly if it is likely to be used to lobby for access to expensive care or treatments.

Patient groups representing individuals with rare disorders suffer from a distinct disadvantage in that the public is usually unaware of the disorder and, unless directly confronted by individuals suffering from it, generally does not care. It is, therefore, no surprise if a patient advocacy group connects with the manufacturer of the drug that it wants governments to cover.

No comprehensive national strategy exists in Canada for making costly drugs available to patients with unmet needs in an affordable manner through private or public insurance plans. Just the opposite, numerous barriers exist to restrict access to expensive medicines, especially drugs for rare disorders. Only 73% of these drugs approved in the United States or Europe came to Canada in 2002-2016 and 25% of those that did took longer than 2.5 years to be approved. After regulatory approval, patients can wait years before costly drugs are adequately covered by public drug plans.

Five major barriers make Canada a less attractive jurisdiction in which to market drugs:

1. Canada is a second-tier country behind the United States and the European Union when pharmaceutical manufacturers seek regulatory approval for their products, resulting in a lag in access to innovation.
2. Current health technology assessment methods do not work for costly medicines, especially those for rare disorders.
3. The pan-Canadian Pharmaceutical Alliance can delay access to new medicines by being slow or inflexible in price negotiations, or just refusing to negotiate.
4. The Patented Medicine Prices Review Board can also impact access. The federal government has proposed changes that would not only require pharmaceutical manufacturers to reduce prices based on an international comparison with countries with lower drug prices but also include health technology assessment using a low cost-effectiveness threshold value and comparisons with an arbitrary low annual sales ceiling.
5. Individual provincial and federal government drug plans can ignore a positive health technology assessment reimbursement recommendation and/or a pan-Canadian Pharmaceutical Alliance price agreement and not cover a drug.

The 2019 federal Budget proposed a new Canada Drug Agency to evaluate drug effectiveness and negotiate drug prices for all drug plans, private and public. This was based on the interim report from the Advisory Council on the Implementation of National Pharmacare, which proposed a national drug agency that would amalgamate some functions of Health Canada, the health technology assessment agencies, the pan-Canadian Pharmaceutical Alliance and perhaps the Patented Medicine Prices Review Board. However, this will not eliminate barriers to access. In fact, a super-agency has the potential to be a huge barrier – bigger is not always better. Any additional deterrents to manufacturers launching new costly drugs are highly likely to lead to Canada falling from being a second-tier to a third-tier country. This would lengthen wait times for patient access to medicines.

Patients want precision medicines and welcome news of a disease being moved from untreatable to treatable or from treatable to curable. As the number of drugs targeting disorders previously untreatable increases, an urgent need continues for the development of processes to make these medicines available to patients in a non-discriminatory and transparent way. Without policies to provide fair, just and equitable access to new costly drugs and where public drug plans use every reason not to fund them, no one should be surprised that patient advocacy has become a major endeavour.

The connection between patient group and manufacturer is, of course, symbiotic; manufacturers want to sell their medicines and patients want access to them. However, the relationship should be a collaborative one with potential conflicts of interest being managed by strictly enforced and publicly available policies. For instance, Innovative Medicines Canada has a code of ethical practices requiring patient support programs to have a primary objective of improving health outcomes, not simply to influence reimbursement recommendations.

Patient groups should also have their own publicly accessible codes of ethical practice with regard to accepting money from pharmaceutical companies. The Best Medicines Coalition of 27 national and regional patient associations has a code of conduct regarding funding to ensure that relationships are ethical and transparent. Nevertheless, many academics do not believe that patients and manufacturers can collaborate ethically to promote public or private insurance coverage for expensive drugs, few of which, in their opinion, are worth their cost.

We should not forget that academics can also have conflicts of interest. Professors in Canada are employed by universities that are mainly dependent upon governments for their budgets including research. Academics may also undertake advisory or investigative activities on behalf of a government. If they do not wish to incur the displeasure of their ultimate employer (the government) or their government research funder, they will be careful about what they study and how they report any results that are contrary to government interests, because they do not want to bite the hand that feeds them. Commentators at government-funded media organizations can also be conflicted.

Instead of censuring patient support groups representing individuals with unmet or poorly met health needs, academic and media critics should be asking:

• In a wealthy country like Canada, why are advocacy groups a necessity in trying to obtain financial coverage for drugs that could significantly reduce the suffering or extend the lives of patients with diseases for which no real alternative treatments exist?
• When will governments introduce fair, accountable and transparent processes to make new drugs for rare disorders available in public drug plans without the necessity for patient support group advocacy?
• When the federal government has a mantra of “affordability, accessibility and appropriate use of prescription drugs,” why does cost-containment always take priority?
• Why do billions of taxpayers’ dollars continue to be squandered by the federal and provincial governments supporting activities that have poor financial oversight leading to wasteful spending, while patients in need of life-saving and life-changing drugs go untreated?

In the spirit of disclosure, no funding was received for this article. Our potential conflicts of interest over the past three years are: NSBR has received funding for consulting, research and publication from pharmaceutical companies and their associations, the Fraser Institute, the Canadian Health Policy Institute, Ward Health, and Canadian PKU and Allied Disorders Inc. JA has received funding for consulting, publication, research or conference travel and registration from Aptatek BioSciences, Best Medicines Coalition, Better Pharmacare Coalition of BC, BioMarin Pharmaceutical, Canadian Agency for Drugs and Technology in Health, Canadian PKU and Allied Disorders Inc, Global Association for PKU, and the Ontario College of Physiotherapists (on behalf of several regulatory colleges).

Nigel Rawson (Ph.D., M.Sc.)

Nigel Rawson is a pharmacoepidemiologist, pharmaceutical policy researcher, and President of Eastlake Research Group in Oakville, Ontario. Educated in the United Kingdom, he holds an M.Sc. in statistics and a Ph.D. in pharmacoepidemiology. Dr. Rawson has performed epidemiologic studies of the use of drugs and their outcomes for over 35 years and published more than 120 book chapters and articles in peer-reviewed journals. He is also the author of the monograph “Drug Safety: Problems, Pitfalls and Solutions in Identifying and Evaluating Risk” published by Friesenpress. He held academic research positions in the United Kingdom until the end of 1989 and subsequently held professorships at the University of Saskatchewan and Memorial University of Newfoundland in Canada. His research activities focused on population-based studies of the use and safety of drugs using administrative healthcare utilization data and the evaluation of issues impacting access to new drugs. Dr. Rawson has also been a senior researcher in an independent research centre in one of the United States’ largest health insurers, where he collaborated with the Food and Drug Administration on drug safety studies, and GlaxoSmithKline’s only epidemiologist in Canada providing advice and analysis for the company’s current and developing medicines and vaccines. Dr. Rawson established Eastlake Research Group in 2012 with a mission to create data-driven responses to pharmaceutical and health policy issues.

John Adams

Mr. Adams is Board Chair of the Best Medicines Coalition, Co-Chair of the Disability Tax Fairness Alliance, Co-founder, President & CEO of Canadian PKU and Allied Disorders non-profit and Co-Founder and Trustee of the Global Association for PKU. He is a former Chair of the Canadian Organization for Rare Disorders. Mr. Adams is a graduate of York University; worked as a reporter for The Globe and Mail; chief of staff to a Cabinet Minister in Ontario; elected three times to Toronto City Council, serving as Budget Chief and Acting Mayor; and served as a trustee of Canada’s largest hospital, the University Health Network.