I call this meeting to order.
Welcome, everyone, to meeting number 13 of the House of Commons Standing Committee on Health. The committee is meeting today to study the Patented Medicine Prices Review Board's guidelines. Then we will proceed to the clause-by-clause consideration of Bill , an act to amend the Canada Revenue Agency Act, regarding organ and tissue donors.
I thank the witnesses for appearing today. From Best Medicines Coalition, we have John Adams, who is the board chair. From Boehringer Ingelheim Canada Limited, we have Mehmood Alibhai, director, national policy and patient access, and Annie Beauchemin, executive director, patient access, pricing, health care affairs solutions. From Canadian Life and Health Insurance Association, we have Stephen Frank, president and chief executive officer, and from Independent Voices for Safe and Effective Drugs, we have Colleen Fuller.
I will start the meeting by providing you with some information, following the motion that was adopted in the House on Wednesday, September 13, 2020. The committee is now sitting in a hybrid format, meaning that members can participate either in person or by video conference. All members, regardless of their method of participation, will be counted for the purpose of quorum. The committee's power to sit is, however, limited by the priority use of House resources, which is determined by the whips. All questions must be decided by recorded vote unless the committee disposes of them with unanimous consent or on division. Finally, the committee may deliberate in camera, provided that it takes into account the potential risks to confidentiality inherent to such deliberations with remote participants.
The proceedings will be made available via the House of Commons website and, so you are aware, the webcast will always show the person speaking rather than the entirety of the committee.
To ensure an orderly meeting, I will outline a few rules to follow. Members and witnesses may speak in the official language of their choice. Interpretation services are available for this meeting. You have the choice at the bottom of your screen of floor, English or French. Before speaking, click on the microphone icon to activate your own mike, and when you have finished speaking, please put your mike on mute to minimize any interference.
As a reminder, all comments by members and witnesses should be addressed through the chair. Should members need to request the floor outside their designated time for questions, they should activate their mike and state that they have a point of order. Members should do likewise if they wish to intervene on a point of order that has been raised by another member. In the event that a debate ensues, members should use the “raise hand” function, which will signal to the chair your interest to speak and create a speakers list. In order to do so, you should click on “Participants” at the bottom of the screen. When the list pops up, you will see next to your name that you can click “raise hand”.
When speaking, please speak slowly and clearly. Unless there are exceptional circumstances, the use of headsets with a boom microphone is mandatory for everyone participating remotely. Should any technical challenges arise, please advise the chair. Please note that we might need to suspend a few minutes, as we need to ensure that all members are able to participate fully.
For those who are participating in person, proceed as you usually would when the whole committee is meeting in person in a committee room, keeping in mind the directives from the Board of Internal Economy regarding masking and health protocols. Should you wish to get my attention, signal me with a hand gesture, or at an appropriate time, call out my name. Should you wish to raise a point of order, wait for an appropriate time and indicate to me clearly that you wish to raise a point of order.
With regard to a speaking list, the committee clerk and I will do the best we can to maintain a consolidated order of speaking for all members, whether they are participating virtually or in person.
Thank you all for listening to that long housekeeping speech one more time.
Before I ask the witnesses to make their statements, I will advise the committee that we have received a letter from the law clerk indicating the status of the document production order. I would ask the committee for authorization to make this letter and its addendum public.
Do I have the approval of the committee to do this?
Some hon. members: Agreed.
The Chair: Thank you. The letter will be made public.
We will now continue with the witnesses.
Witnesses will have up to 10 minutes to make their statements. I will be using cards, a red card and a yellow card. The yellow card means there's one minute before your time is up. When you see the red card your time is up, so please try to wrap up fairly quickly. Thank you, all.
We'll start with the Best Medicines Coalition.
Mr. Adams, board chair, please go ahead for 10 minutes.
Chair and members, we appreciate your invitation to be here today, and we thank the committee and staff for their work throughout the pandemic challenges.
I represent a coalition of 30 patient organizations, national and regional, working together through the Best Medicines Coalition to support patients and advocate for better access to life-saving medicines. I volunteer as the chair of the board of directors of BMC.
Our non-profit supports any actions by governments, public or private insurers and civil society that can deliver greater access to medicines for Canadian patients. We're a small but mighty organization made up of broad-based charities and grassroots groups, including the one I lead, Canadian PKU and Allied Disorders, which involves rare brain-threatening diseases. These groups involve patients and caregivers to improve care and are active in research, patient services, education and issue advocacy.
BMC member organizations include diverse conditions, including mental illness, arthritis, asthma, blindness, Parkinson's, psoriasis and cancers, including breast, kidney, lymphoma and ovarian, and their survivors.
I am here today as a patient advocate, because when our youngest child arrived, the miracle of universal newborn screening discovered his rare genetic condition, enabling immediate therapy. As an adult, he volunteered for a clinical trial for its first drug, and that drug transforms his brain and life. His mother, my wife, died in 2014 of two neurodegenerative diseases, ALS and FTD, which still do not have effective treatments. It is a big deal when we can move lethal diseases like ALS from untreatable to treatable, and it is a big deal when we can permanently fix genetic problems, such as my son's, in the new era of cell and gene therapies.
Let me address the important question of real, perceived or imagined conflicts of interest. I happily completed the committee's disclosure form and want to address how the Best Medicines Coalition funds and governs its activities. We do not sell a service. We do not have union or other dues. We don't have university tenure or other job security. We don't charge patients to advocate on their behalf.
If governments establish a means to fund our efforts to support patients in the public interest, we will apply for that funding. This is not without precedent, as it exists in the context of climate change advocacy, telecommunications regulation or legal challenges for human or charter rights. We ask HESA to recommend such public interest funding.
BMC accepts funding from the pharmaceutical industry for our patient support activities. We make no secret of this and are aware of possible perceptions. It is why this funding is received with an explicit agreement that funding does not influence our policies, advocacies or operations in any manner. All activities and interactions are pursued within a framework of integrity. BMC and its member organizations adhere to a code of conduct regarding funding, which is publicly available on our website. All initiatives are conceived and developed in and by the organization, aligned with its missions and goals, without influence from any funder on content, messaging or execution. I'd be pleased to answer questions on this, and I trust that we all must be transparent about all our conflicts, perceived or otherwise.
The matter at hand today is the government's approach on drug prices and the critical risk this poses to some Canadian patients. Our focus is ensuring that all Canadians have access to medicines needed when needed. Medical necessity is paramount for all patients. We support the need to make medicines more affordable for all patients, especially those who pay out of pocket, and we support the goal of actual prices in line with similar countries. We also believe regulations and guidelines must encourage, not deter, new medicines and vaccines plus those clinical trials sponsored by drug developers, which are important to patient volunteers in providing early access to promising new therapies, as was the case for my son.
There's a natural tension between how much insurers are willing to pay and patient access to medicine. Whether we like it or not, pharmaceuticals are a global market and Canada is competing globally to be an attractive market. This is clear in terms of medicines, vaccines and PPE.
If Canada regulates prices too low, the patients we represent will not gain access to life-altering or life-saving medications. If prices go too high, public insurance systems could become overwhelmed and unsustainable. This would be disastrous for patients and taxpayers alike. The challenge for Parliament, government and PMPRB is to balance those interests. It's not an easy task.
The government and PMPRB decided to move forward with their approach despite uncertainties on patient impacts. This is at the core of our concern. At this committee, PMPRB was unable to tell when certain conditions in the guidelines will come into effect. Consider that a global entity is deciding on the sequence of product launches and Canada's processes and pricing rules lack clarity for the foreseeable future, why would it be a surprise that a new medication or indication would not be launched in Canada?
This government is unwisely taking on significant risks and the consequences will be borne by patients. We are not willing to provide informed consent. As written, the PMPRB regulations and guidelines have not balanced price and access. Specifically, anticipated price reductions go beyond original intent, and initial evidence shows significant negative impact: a decline in new drug introductions and reductions in new clinical trials.
This government confirmed the legitimacy of these concerns and, in my view, lost the moral high ground when it exempted COVID vaccines and drugs from the PMPRB rules. Why exempt COVID and not other lethal diseases?
A frequent criticism is that few new drugs provide significant additional benefits to patients. COVID vaccines reveal this but also show that it's not helpful. We have one approved vaccine today. It is a breakthrough. Other vaccines may be approved, but the others will not likely offer a substantial clinical benefit over that first approved vaccine. It's clear that our health systems and individuals will benefit substantially from access to many approved vaccines, even if only the very first one is a breakthrough. That is how innovation works.
A key marker for patient communities is whether medicines will be available to Canadians both affordably and in a timely manner. Since the announcement of the new rules, applications for new drugs have declined compared to similar countries. This is troubling.
Health Canada and PMPRB want to lower drug prices to reflect what the public health system is willing to pay or able to pay. Nothing in these changes makes it certain that health systems will deliver patient access to medicines at these prices. There could be a double whammy for patients. Price regulations might mean new drugs will not come and, if they do finally come, the system still may not cover them.
We wish to express four recommendations for this committee to consider.
First, the Best Medicines Coalition supports step-by-step implementation to lower drug prices. PMPRB indicated some phasing. They did not articulate when and what would be phased. We ask for clarity and decisions based on best evidence. We urge this committee to recommend that the federal government, through cabinet, direct a stay of implementation of parts of the regulations and guidelines, deferring the novel economic factors to a second stage pending further study and consultation. The new basket of comparator countries should proceed to bring down list prices immediately, especially for those patients who pay out of pocket, which, I point out, represents 21% of all drug spending in Canada.
Second, BMC recommends that this committee call for greater policy-making disclosure, and we support any efforts of the committee to bring about that transparency. The government should disclose inputs provided as part of formal consultations and otherwise, including analysis of the nature and breadth of concerns and how concerns have been addressed or will be mitigated. Further, it is important that the government and PMPRB disclose correspondence and other inputs from provinces and territories.
Third, the Best Medicines Coalition asks that this committee recommend that the government develop and publish comprehensive evidence, including initial impacts on critical markers of policy success or failure; that is, key metrics of introductions of new medicines and initiation of clinical trials sponsored by drug developers. There is a need for disclosure regarding the government's and PMPRB's assumptions, which the regulations and guidelines rely upon. We urge this committee to request that the PMPRB case studies on specific drugs back in 2018, prepared to show the impact of possible proposals, be updated and published based on the final regulations and guidelines.
Fourth, the Best Medicines Coalition asks that this committee recommend that the government study and provide public interest funding so that the voices of patients and their needs and interests can be more adequately represented in public policy and regulatory matters, including PMPRB.
I would be pleased to answer any questions.
My name is Annie Beauchemin, and I'm with Boehringer Ingelheim. I am joined by my colleague, Mehmood Alibhai.
Thank you, Mr. Chair and honourable members of the Standing Committee on Health, for the opportunity and for inviting us to provide testimony today. We appreciate it, especially given the circumstances we find ourselves in.
As we all know, the COVID-19 pandemic has truly transformed our society this year. We want to start by thanking you for all your ongoing work in the face of adversity, particularly your efforts to continue the important work that Canadians elected you to undertake in Parliament.
Since Boehringer Ingelheim began operating in Canada almost 40 years ago, we have proudly played an integral role in the health of Canadians. Headquartered in Burlington, Ontario, we employ approximately 600 people across Canada, and we are committed to finding medical breakthroughs and investing in research, development and medicine therapies that fulfill unmet medical needs.
We're a different kind of company in that we are one of the world's leading pharmaceutical companies, but what makes us unique is the fact that we're still family owned. We were founded over 130 years ago by Albert Boehringer, and we strive each day to live up to the high ethical standards he set.
Albert Boehringer set the tone for the company culture that we continue today, which prides itself in supporting employees and our local communities, guided by our values of trust, respect, empathy and passion for the work we do. Our vision is value through innovation. Simply put, this means that we aim to find new ways to improve health and provide value by being innovative. We are committed to the development of innovative, cost-effective medications that, again, fulfill unmet medical needs,
Through our participation in medical and pharmaceutical research for both humans and animals and health system change projects—we have many of those—we have contributed to the significant improvements in health care and have developed innovative and cost-saving medicines.
Our health care system improvement projects are pharmaceutically agnostic—they are unbranded—and the Boehringer family mandates that we have these initiatives that focus on optimizing patient outcomes and improving health—
Our vision is value through innovation. Simply put, this means we want to find new and better ways of improving health, and we provide value by being innovative. We are committed to the development of innovative, cost-saving medications that fulfill unmet medical needs.
Through our participation in medical and pharmaceutical research for both humans and animals and health system projects—we have a number of those ongoing—we've contributed to significant improvement in health care and have developed innovative and cost-effective medicines.
Our health care system improvement projects are unbranded and pharmaceutically agnostic. The Boehringer family mandates that we have these projects that focus on optimizing patient outcomes and improving health system efficiency, contributing to the sustainability of the health care system.
In Canada, Boehringer Ingelheim conducts and sponsors clinical trials to establish the safety and efficacy of the drugs we develop. Our key therapeutic areas in Canada are cardiometabolic diseases, specialty care including oncologies such as lung cancer and progressing fibrosing lung diseases, and respiratory diseases such as asthma and chronic obstructive pulmonary disease.
In a given year, Boehringer Ingelheim is involved in up to 70 clinical trials. As you can imagine, 2020 has not been a restful year for us either. Since we understood what the world was facing with COVID-19, we've been hard at work to understand the virus and create innovative ways to stem its catastrophic effects on our society and our most vulnerable.
In addition, we've been actively testing existing and new compounds that can help to prevent or alleviate some of the devastating organ damage experienced by individuals who contract COVID-19. We are now in phase two of a therapeutic option that could help up to 85% of our sickest patients afflicted with COVID-19 and who are admitted to ICUs with acute respiratory distress syndrome. Should the therapy be approved, it will reduce the need for ventilators among the most severely affected patients.
As a company founded in 1885, more than a century ago, we've always taken the long view of our work's impact. We plan in generations and focus on long-term performance. Being independent and family owned allows us to pursue that vision that we believe, in turn, has allowed us to have the greatest impact in life sciences.
Independence also allows us to pursue initiatives and endeavours where we believe we can do the most good. It means we can focus on solving some of the most complex health problems our country faces and give us an opportunity to be involved in evolving the patient experience and creating lasting change.
We've been involved in these system-changing initiatives for almost a decade in Canada. Unfortunately, none of the resources we've invested in these areas and in these projects are recognized by the Patented Medicines Prices Review Board.
For example, in September 2020 we were pleased to announce the creation of Bridging HOPE, helping others through palliative care education, an industry-first collaboration with Pallium Canada to improve the quality and accessibility of palliative care in Canada. Together we're equipping health care providers with the skills and tools to provide better palliative care and support patients with life-limiting illnesses and their families, addressing an urgent need that will only increase as our population ages.
I'll go over to you, Mehmood.
Thank you, Mr. Chair, and honorary members as well.
As a demonstration of our commitment to work with Canadians to solve problems that result in optimized outcomes, for the past three years we have been working with an indigenous-led health policy group to develop an indigenous health policy framework. I should say that one of you has participated in this endeavour. A number of you have been briefed about the work we're doing with the indigenous population.
This indigenous-led, indigenous-informed framework will guide, again, the principled approach that Boehringer will engage in with indigenous communities in partnerships in health system solutions, which are, as Annie mentioned, pharmaceutically agnostic. That is the mandate of the family. That again demonstrates our commitment.
Our mission compels us to invest deeply in research and innovation to bring some of the most advanced therapeutics and medicines to Canadians. The latest regulations would jeopardize our ability to continue funding these innovative projects and research.
Boehringer Ingelheim supports a sustainable health care system in Canada and invests heavily in R and D. We expect to bring new medications to market, and Canadians benefit from early access to life-changing medications through clinical trials, and thereafter, as a prioritized country seeking regulatory review and the launch of new drugs.
However, the model that has enabled us to serve our patients for over a century is threatened by the final guidelines issued by PMPRB. Simply put, we believe the guidelines will ultimately discourage or significantly delay the introduction of new, life-saving medicines and investments in research and development, and delay performing clinical trials in Canada and the prioritization of Canada as a market to launch new medicines.
This point cannot be ignored. The intent of the PMPRB will not matter if it ultimately creates fewer innovative medicines and treatments, fewer clinical trials, fewer innovative health care system change partnerships and less access for Canadians. Intention needs to be met with well-considered, well-developed policy, and that is not where the PMPRB has currently landed with its guidelines.
One of the central principles of the life sciences industry is a predictable process by which patentees can access the market for a drug, invest in research and innovation, and bring it forward for approval to be given to the patients who need it the most. The guidelines bring the PMPRB outside of its original intent as a patent abuse regulator and represent a substantial incursion into an exclusive provincial jurisdiction, namely price control. This process will undermine activities exercised by the provinces that today include input from patients and experts. PMPRB will create significant uncertainty for any company considering investing time and resources in bringing forward innovative medicines.
In keeping with the time, we urge the committee and the federal government to reconsider these guidelines and the regulations that underpin them. The current guidelines are creating uncertainty and will create unintended consequences on business viability and, therefore, access to life-saving drugs for patients.
Once again, Mr. Chair, honorary members, thank you for the opportunity to present and provide the briefing from Boehringer Ingelheim's perspective. We look forward to discussing this important topic, which will shape the future of health care in Canada.
Thank you, Mr. Chair and members of the committee, for giving us the opportunity to speak with you today.
Thank you for inviting me to talk to you today as part of your study on Patented Medicine Prices Review Board's guidelines.
The Canadian Life and Health Insurance Association is a voluntary association with member companies which account for 99% of Canada's life and health insurance business. These insurers provide 29 million Canadians with products that contribute to their financial security, including supplementary health insurance.
Our members strongly support the amendments that have been proposed to the Patented Medicine Prices Review Board and that are coming into effect on January 1. Our member companies, which include non-profit regional health insurers, provide prescription drug and other health benefit plans to over 142,000 businesses, large and small, across Canada. Over 26 million Canadians depend on these workplace insurance plans for such benefits as prescription medication, dental care, eye care, physiotherapy and mental health supports.
With so many Canadians struggling and worrying about their family's health and security, now more than ever Canadians want to know what they can count on. Canadians with workplace plans want to know they can count on those plans to be there when they need them. We know that 87% of Canadians value their existing coverage. Moreover, we know that while all Canadians support smart reforms to improve the current system, they do not want it to disrupt their existing coverage.
For the past nine months, as the COVID-19 pandemic has unfolded, insurers have been working with employers to ensure that Canadians can continue to rely on their workplace plans. To help them through this difficult time, employers have received direct assistance of several hundred million dollars, including discounts and premium reporting.
Like the health care system in general, private insurance plans were put to the test by the COVID-19 pandemic. I'm pleased to say that workplace plans have passed the test. The health crisis has shown that these plans are resilient.
More than 98% of the 26 million Canadians who had coverage through their health benefit plans in March continue to be covered. Canadian employers and their employees continue to rely on these plans for a wide range of supplementary health benefits, as I mentioned above. However, we cannot take this for granted.
Rising drug costs have been and will continue to be a strain on the sustainability of drug programs, both public and private, going forward. High and rising drug costs are a challenge that must be addressed. Currently, Canadians pay some of the highest prices in the world for patented medicines. These costs put pressure on both employer-sponsored and government plans. That's why the amendments to the Patented Medicine Prices Review Board are so important.
Over time, these changes will bring Canadian prices more in line with those in other prosperous countries around the world. This will lead to savings for Canadian provinces and employers, savings that will not only make programs more viable, but will also give them the ability to cover new drugs on the market, which are often very expensive.
It's not just about helping public and private insurance plans. The reforms will translate directly into savings for those who pay out of pocket.
Ultimately, we believe these amendments strike the right balance between reducing the high cost of prescription drugs in Canada, while also ensuring Canadians have access to affordable and necessary medications. As I mentioned, our life and health insurers are proud of the steps we've taken to keep workplace plans in place and provide benefits for 26 million Canadians. Ensuring we pay a fair price relative to other developed countries is important if we're to sustain coverage for Canadians into the future and make fiscal room to cover the newer, expensive medications that are in development.
After consultations that have spanned several years, the PMPRB put forward their final guidelines earlier this fall. Canada's life and health insurers are strongly supportive and urge members of this committee to support their implementation as planned on January 1. These are concrete and immediate measures that will lower patented drug costs for all Canadians and contribute to the future sustainability of prescription drug plans.
Thank you for your time. I look forward to your questions and the opportunity to provide additional detail to help your study if you have any questions for me later.
Thank you, Mr. Chair.
Thank you, and many thanks to the standing committee for inviting our organization to appear before you today.
I'm joining you from western Canada, the beautiful unceded territories of the Musqueam, Tsleil-Waututh and Squamish nations.
Our group focuses on overall pharmaceutical policy, but many of us also have expertise in specific areas, including drugs to treat cancer, Alzheimer’s and other conditions. My expertise is in the area of drugs to treat diabetes, with a focus on insulin.
The first time I appeared before the standing committee was in 2003. I was part of a national campaign, organized by a group called the Canadian Society for Diabetic Rights, to fight for ongoing access to animal-sourced insulin products. I appeared during the two days of hearings that the committee conducted to study the issue.
Insulin is sometimes called the “poster child” for pharmaceutical supply issues. Between 1995 and 2006, 26 different types of insulin were withdrawn from the market by Eli Lilly and Novo Nordisk, a move that left almost 45,000 people scrambling to find appropriate alternatives. That move had nothing to do with the safety and efficacy of the insulin products, all of which had been standard treatment since the 1950s and earlier.
The withdrawals were part of a marketing strategy to force people to switch to much higher-cost brands. At the time, and because of the work of this committee, Health Canada acknowledged that there was a significant minority of people whose lives and safety depended on ongoing access to animal insulin, and at the urging of the committee the ministry worked, and in fact, continues to work to this day, to ensure access.
What that experience taught me is that there are two key barriers that patients confront when trying to access medicines. One is supply, and the other is affordability.
It’s the job of the price review board to ensure that the introductory price of new drugs is fair. Our organization supports the PMPRB as an important regulatory tool, and we've spent the previous year and more arguing for stronger guidelines. We were pleased earlier this year to see that the guidelines developed by the board took a positive step in that direction. While there is always room for improvement, we hope the committee will support the price review board and, in fact, recommend that its role be strengthened even more.
The decisions of the price review board have a ripple effect across the country and they contribute either to fairness or to inequality in access. As the story of Lantus insulin shows, which was part of the brief we submitted, a decision that results in unreasonable prices for drugs shifts a significant burden to consumers, as well as to public and private insurers.
In the case of insulin, the overwhelming evidence showed that recombinant human insulins, which were introduced beginning in 1983, provided no additional benefit or significant reduction in harm compared to animal insulins, yet prices skyrocketed, including after the founding of the Patented Medicine Prices Review Board in 1987.
As Eli Lilly informed this committee in 2003, the introductory price of its beef-pork insulin was $4.87 for a 10-millilitre vial in 1980. Then, in 1983, the company introduced its recombinant DNA insulin, known as Humulin, at an introductory price of $12.50 for a 10-millilitre vial. That was a threefold increase in the price, yet according to the Cochrane Collaboration, which reviewed all the evidence, Humulin offered no therapeutic advantage over its animal-sourced counterparts.
Then, in 1995, the first analog was introduced at a price of $30, another insulin product that was shown not to offer any therapeutic advantage over recombinant human insulin, and by extension, animal insulin.
Since 1987, the price review board has approved the introductory prices of new insulins, and I would argue, has allowed the price of insulin to increase despite the evidence before it that patients not only don’t experience a significant increased benefit in terms of safety and efficacy, but also pay a price that is entirely unjustified. This is precisely why the tools available to the price review board have to be strengthened.
The ones affected the most by a weak price-review mechanism are those who are usually the least able to carry that burden, meaning people who are uninsured or under-insured, poor and in poor health. Of course, during this period when the COVID pandemic has been sweeping across the world, those numbers have increased.
A recent survey of people with disabilities and chronic conditions found that the average number of prescriptions for this group is five and the cost burden is between $200 and $3,000 per month. These are some of the people who need access to safe, effective and affordable medicines, and it is in their interest that the board should act when making decisions about what is fair and reasonable.
Governments often say that after marketing authorization has been granted, they have no control over supply. I don’t buy that, and I’m not alone. We believe governments have tools and that if they don’t have those tools, they can develop them. This is especially urgent now, in part because global pharmaceutical companies are threatening to stop supplying Canadians with new medicines if the guidelines go into effect. That is totally unethical.
In response, we urge the standing committee to recommend that the House of Commons implement legislation to strengthen its compulsory licensing capacity and to establish a public manufacturer of drugs and vaccines. If Canada utilized its ability to issue compulsory licences, it would mean that Canadians would no longer be vulnerable in situations in which patent holders are unable or unwilling to supply medicines. The Government of Canada could also work with other interested countries that want the intellectual property rules in the WTO TRIPS agreement to be relaxed. For example, other countries such as the Netherlands may be interested in developing policies that meet population needs while upholding obligations undertaken in the WTO.
Compulsory licensing—or even the possibility of compulsory licensing—would shift some of the power over price from the patent holder to government, while at the same time protecting the patent holder's right to make a profit. This would strengthen negotiations with manufacturers over bulk purchasing of essential medicines and strengthen the role of the prices review board.
Finally, Canada has a long history of publicly producing and supplying drugs and vaccines at cost to Canadians, including public and private drug plans, as well as consumers. Connaught Labs, where insulin was discovered and which became a major vaccine producer internationally, played a key role in the establishment of provincial drug plans, providing medicines and vaccines at cost. We continue to pay a very high price for the decision in 1984 to privatize Connaught, but if we can decide to privatize a Crown corporation, we can also decide to create one. We urge the committee to include this in its recommendations to the House of Commons.
The Patented Medicine Prices Review Board is an essential player in efforts to maintain some control over prices in Canada, especially since patents on medicines are granted for longer and longer periods. The new regulations and guidelines are a positive step in providing Canadians with more effective tools, but they aren't enough. The prices review board needs the backing of Parliament and the Government of Canada to ensure it plays a role in supporting access to medicines.
Canadians need to trust that the federal government is using all the tools at its disposable to support access to safe, effective and affordable medicines, and if those tools aren’t there, that Ottawa will develop and implement them.
Thanks again for allowing me to present our views and recommendations, and I hope that we've made a contribution to your discussions. I am happy to answer any questions you might have.
Quite simply, on the first point, the people who are most suffering from drug prices are the patients who are paying out of pocket. That represents about 21% of the total spend on prescription drugs in Canada. They don't have an ability to negotiate a better deal.
The second group of people—and they're represented here most ably by Mr. Frank—are the private insurance carriers. When they choose to, they have an ability to negotiate price on behalf of their plan sponsors.
The third group is the government drug programs which, after 60 years, have done the right thing and are bargaining collectively with drug providers through an informal organization, the pan-Canadian pharmaceutical alliance, which all the governments of Canada are participating in. The government drug plans are looking after themselves and they're doing a good job of it.
The problem is the new factors. The simple truth of it is that there is no other jurisdiction in the world that is using those economic factors for the purpose of price controls on drugs.
Let me make the distinction between price controls by regulation versus price negotiations, where individual patients don't have that clout. That's why we are in favour of the proposal and the regulation to change the comparison among countries to countries that are of a similar capacity to pay—gross domestic product.
The economic factors.... Frankly, if the committee and its analysts could take the time to go back to the six case studies of six different kinds of drugs that the PMPRB staff put forward back in 2008—which have not been updated with the final version of the regulations or the guidelines—you will see the problems there. I would invite a deeper dive by the committee and its analysts. I would be happy to help and point to the right documents.
It would be wonderful if the PMPRB had enough confidence in the rest of us that they would actually open their kimono and show us the details of their spreadsheets, their assumptions and their analysis, so that we could be happy to verify or be happy to dispute. There has been a lack of disclosure by the PMPRB staff of what the assumptions are and what the actual details of their analyses are on those case studies.
With all due respect, colour me skeptical when there is a lack of disclosure. Those are the reasons we are concerned about the significant risk that the government and PMPRB are taking by proceeding with all of the changes at the same time.
For my last point, let me use an analogy of a patient and a doctor. No doctor worth his salt would knowingly start a patient on four new drugs at the same time, because if something works, you don't know what is working. More importantly, if something does not work, you don't know what is causing the problem. The problem with these regulations and guidelines is that they're trying to do four different things at the same time. If something goes wrong, what is actually the central cause of the problem?
We ask for them to pause and reflect. Proceed with the change of basket of comparison countries and let's take a deeper dive into the more likely impacts of each of the three additional new economic factors. This is an experiment in public policy that has not taken place anywhere else in the world.
If I may I'm going to use the example of ALS. You watched one of your colleagues in Parliament live through the disease and the finality of that occursion, as I watched my wife go through it.
I want to put in a plug here for some wonderful folks at Health Canada. There was a drug out of Japan that slowed down the progression of the disease. It did not change the course of the disease. It was not available in Canada. We have a tradition of allowing individuals to bring in, by personal import, a 90-day supply of a drug that's not available in Canada. That's a real problem because there are lots of drugs that are not available in Canada, separate and apart from the discussion on PMPRB.
It was a big deal to go to Japan and bring a 90-day supply. Health Canada reinterpreted the rules in a very humanitarian way. They didn't have to go to Japan. They could ship it, and they could ship in a 180-day supply. That drug company from Japan came to Canada and went through the process. The good news is that the drug is now available in Canada, but they could not come to terms with PMPRB under the old rules—not the new rules, the old rules—so they did a really unusual thing. They allowed their patent to lapse. They fled the jurisdiction of PMPRB. The good news is that drug.... It's not the greatest drug in the world, but when you're dealing with ALS you'll take faint hope.
My concern is that, given the additional barriers to reimbursement and patient access, when there is a breakthrough for ALS, like we've had for COVID-19, Canada's going to be even further back on the list of when ALS patients.... ALS patients don't have very much time for process. They need help ASAP.
I use ALS, but there are lots of other diseases that have no useful therapies, or not adequate therapies, today. With respect, I'm not prepared to wait for governments to pay for all the R and D that will bring a breakthrough molecule for ALS or anything else. We need investors in the private sector to be partners in this. Please, we ought not to be in the business of kicking sand in their faces.
Thank you, Chair, and good afternoon, everyone.
Clerk, I believe you received the amendment and have distributed it to all committee members.
Chair, I will obviously be moving this amendment on Bill , and then I wish to speak on it.
Thank you, everyone, for making yourselves available and hearing me out for a few minutes.
First, it's great to be here. It's great to be speaking on a bill that I know is very important to deputy and is very important to MPs on all sides of the aisle. I'm very galvanized by that. It is within that spirit that I present this amendment. In my view, at the end of the day, it's about increasing the number of registered organ and tissue donors in Canada.
I have some prepared remarks for everyone. I thank you for the opportunity to join your committee today as we look at this legislation that seeks to promote a cause that, it's fair to say, all parliamentarians support—namely, increasing the number of registered organ and tissue donors in Canada. This is an extremely important issue to assist Canadians in desperate need. It is truly a matter of life and death. We need the best legislation possible.
I know we all support the intent of the legislation. I do personally, and I applaud the member for for his work and his desire to get this bill passed in the House and the Senate. I too am committed to advancing the bill's objective. That's why I'm advocating certain amendments to make Bill more workable for the Canada Revenue Agency so that it can be implemented as soon as possible. Hopefully, if Parliament can pass it quickly enough, it would be in for the 2021 tax-filing year. We need to ensure that the legislation proposes the most efficient and effective way for the Canada Revenue Agency to collect this information, and for the process to be efficient and useful for the provinces and territories, who are ultimately responsible and within their jurisdiction for organ and tissue donation.
As Parliamentary Secretary to the Minister of National Revenue, I've made it a priority to examine the legislation in great detail and to discuss it with experts at the CRA who would be asked to implement it. I truly believe this committee should hear directly from those professional experts at the CRA regarding this legislation, especially their experiences with the precursor legislation to Bill from the last Parliament, Bill , and the CRA's interactions with the provinces and territories on that legislation that occurred.
Nevertheless, I am proposing a strongly recommended amendment to make the legislation more straightforward for the CRA to implement with the provinces and territories, and also to make it so that it can be implemented in the quickest fashion possible. This amendment does not change the objective of the bill, but rather the manner in which the objective will be achieved, to remove potentially significant roadblocks and time-consuming delays.
This simple amendment would do as such. Rather than having the CRA directly collect organ and donor consent on behalf of the provinces and territories, the CRA would collect and share the personal information of individuals wishing to become organ and tissue donors with their respective provinces and territories, which would then obtain direct consent. The amendment, accordingly, would remove references set out in proposed subsections 63.1(1) and (2) of the bill, which would make reference to returns of income filed under paragraph 150(1)?(d) of the Income Tax Act.
Rest assured that under this approach, a form would be included within the T1 return, both a paper format and in certified tax software, asking if the individual wishes to be sent information by their province or territory on becoming an organ and tissue donor. It should also be noted that the notice of assessment would still advise the individual that, in accordance with their request, their information has been forwarded to their province or territory as a potential organ and tissue donor. Once the information would be sent to the relevant province or territory, the province or territory would then be able to follow up with the individual on the actual consent to organ and tissue donation.
This is an important and appropriate role for provinces and territories to undertake, as it is within their jurisdiction as opposed to that of the Canada Revenue Agency. Legal requirements for donor eligibility and informed consent are very complex and vary greatly by jurisdiction in Canada, meaning different provinces and territories have different roles. By having provinces and territories play their proper roles in obtaining consent, we are not only respecting their jurisdiction, but equally important, we are removing an obstacle by eliminating the need for protracted negotiations and complicated agreements with each of the provinces and territories on legal requirements for collecting the proper consent.
With the amendment I am proposing today, our hope is that we would put the federal government in a position to reach swifter agreements with provinces and territories on a more straightforward, simple and efficient approach, which, I understand from CRA officials, might need only months instead of potentially years to achieve.
I repeat, we all want the objectives of Bill to become a reality, and sooner rather than later. However, for the CRA to meet the earliest window of the 2021 tax-filing year—next year's income earned, when you file your taxes in January to March or the period in 2021—the provinces and territories have to come on board. We need to create the quickest path to make that happen.
I would like to add that the approach taken here, for the MPs who have been elected from the beautiful province of Ontario, would be a similar approach to where information is collected for what's called the Ontario trillium benefit, where a separate page is provided in the tax package, whether it is online or in paper format, and where the information is then passed to the Province of Ontario.
I am confident that our amendment today will do that and make the member for 's objective a reality, potentially—and most likely—saving the lives of thousands of Canadians.
Chair, thank you for the time today.
To the committee, I wish to again applaud deputy Webber for his efforts over the years in making the bill come to fruition and bringing it this way.
We are with you in the spirit of the bill, Mr. Webber, and I applaud your work on it.
I thank my colleagues for listening to me this afternoon.
I want to start off by saying hi to everyone. It's good to be back in a HESA committee meeting. I served for five years with you guys and I miss it, but I'm now on the public accounts committee, so that's quite interesting as well.
Mr. Chair, as all of you are aware because I sent you a document indicating my thoughts on the amendments here, in short I cannot support the proposed changes. It changes the scope and it changes the spirit of the bill, which is to get the initiative front and centre on the income tax form.
I want to talk a bit about the bill and the fact that it would not infringe on the provincial responsibilities of managing donor lists. It would just support their existing work.
My proposal is so simple and it could be implemented so quickly. The federal government, via the CRA, already successfully shares, every day, with the provinces and territories via these encrypted networks with strong privacy and reliability safeguards. The existing infrastructure is already in place so there would be virtually no cost to the CRA. The CRA, as you guys know, already shares dozens of data fields on information on every taxpayer with the provinces and territories. This would simply be one more data exchange.
The actual proposal by Mr. Sorbara, in my mind and in many people's minds, would change the scope of the entire bill. It would take it off where you can see it, which is right on the front page of the T1 form. By moving the question off the main income tax return, it becomes a footnote of irrelevance, and the effectiveness is dramatically reduced to the point of being basically pointless. These amendments would allow CRA to put the question somewhere less obvious and it could even be as obtuse as asking people to file a separate form, which nobody would do.
This issue came up in the last Parliament, in the HESA committee, and all the parties were clear that they wanted the question to be on the front page. The CRA was also clear about their ability to do this, as requested and expected by the members of Parliament.
I want to ensure today that the CRA hears loudly and clearly that the expectation of Parliament is to have this addition made on the front page of the T1 tax returns in all provinces and territories. This is déjà vu. We covered the same issue in the last Parliament. I testified at this health committee on the bill, which at the time was Bill . I said that I wanted to ensure that the CRA hears loudly and clearly that the expectation of Parliament is to have this addition made on the front page of the T1 tax returns in all the provinces and territories. I also wanted it made clear that we expect people to have the option to tick a box on that front page, which would basically be a call to action.
I have to indicate also that the CRA was at the committee meeting and it was made clear to them. In fact, Sheila Barnard was at that meeting. She is with the CRA. She is responsible for the legislative changes affecting the T1 returns. She testified and stated that they had understood the intention of the bill to be on the annual tax return.
Mr. Frank Vermaeten, the assistant commissioner with the Canada Revenue Agency, was also there, and he was more direct in confirming his understanding on this issue. He stated:
The front page is certainly a crowded page, especially when you move into the French version of it. That being said, we believe we can put it in that first page. That would be our intention.
Even our colleague Sonia Sidhu discussed it at HESA. She commented, “You said it's possible that, on the T1 layout, we can have a tick box on the front page so it can't be missed.”
That is the point here. If we allow this question or process to be buried, it will be ineffective. I completely agree with her.
Mr. Chair, you also said:
In our discussion, we have talked about the importance of this data capture appearing on the first page of the T1, but it doesn't specify that anywhere in the bill. Is there a way to ensure that this happens?
The CRA, Mr. Frank Vermaeten, said:
I don't think there's a clear legislative way to ensure that this happens. As I indicated, it would be our intent to put it on the front page.
The CRA, then, indicated at the time that it can be done and that they were going to do it. All of a sudden, here we are again: déjà vu.
We have to simply ask ourselves the question: Does the amendment that MP Sorbara put forth strengthen the effectiveness of the bill and better improve the outcomes for those awaiting a life-saving transplant? I believe the answer is painfully obvious and I would strongly welcome your agreement, committee members, in this regard.
We have all worked so hard. I have worked so hard. Parliament has passed this unanimously, up to this point. We have worked hard to make sure that this initiative has been unanimously supported, just as it was in the last Parliament.
There are many people awaiting a life-saving transplant. They would be bitterly disappointed if we wasted this important opportunity and buried the question on some form in the back pages that nobody is going to fill out. Let's show all Canadians that we are united and determined in our desire to truly improve Canada's organ and tissue donation procurement system here in Canada. Please do not support the proposed amendments.
Thank you, Mr. Chair.
Thank you. I don't have a lot to say, but I do have a question for clarification.
Just in general I want to thank Mr. Webber again for being so determined and persistent in this bill. I can say that I've worked with many parliamentarians, and—I said this in the House and I want to put it on the record here—there has been no more collegial or finer parliamentarian to work with in any venue than Mr. Webber. His contributions to this health committee were incredibly important.
I also want to second every single thing Mr. Webber said. I was privileged enough to serve on the health committee through the entire last Parliament, and I can vouch that every single fact and every single point that Mr. Webber just made is exactly true. I won't belabour the points. It's just that this is not just Mr. Webber's opinion; this is actually a very accurate recitation of what the evidence was.
My question, really, is to Mr. Sorbara. I want to make sure I understand what the purpose of his amendments is. It didn't strike me, when I was listening to Mr. Sorbara's remarks, that his purpose is aligning with what Mr. Webber says the changes are.
Mr. Sorbara, I'll ask you a direct question and feel free to elaborate if you feel it necessary.
Is it the intent of your motion, basically, to allow CRA to put the indication as to whether someone wants to have their information forwarded to a province for a potential organ donation anywhere on the form, including on a separate form or otherwise? Is that the main thrust of your amendment?
In other words, is Mr. Webber characterizing your amendment accurately?
Maybe I'll offer a little bit of follow-up.
The purpose of Mr. Webber's bill, and Mr. Webber can correct me if I am wrong, is...because of jurisdictional issues. I remember when the NDP proposed—I think MPs from all parties at that one time proposed—the national organ donation registry. The reason it couldn't be done, according to, I think, the Liberals, was because of jurisdiction. They felt that was the jurisdiction of the provinces, which I think has informed Mr. Webber's bill.
This means that what we're doing on the tax form is having each taxpayer check off a box that will authorize CRA to furnish the information—the name and the contact information, I suppose—to a province that is in control of organ donation and that would then contact the person and take it from there.
If that's the case—and maybe I will ask Mr. Webber to confirm it—it's my feeling that we should stay with Mr. Webber's position, because we want the most prominent placement possible. Again without belabouring the point, CRA said that, although it was a crowded first page, it could be done. They understood that, and they had the resources and the ability to do it.
Do I understand this correctly, Mr. Webber and Mr. Sorbara? Really, all the tax form is doing is indicating to the province that the person may want to be available for follow-up.
This is why I'm not quite clear, Mr. Sorbara, what else would be on this single form, when this is the process we're actually doing.
I appreciate that CRA is probably giving direction to the parliamentary secretary on this amendment, but I think Mr. Van Bynen brings up a really salient point here. I think the amendment is being characterized as this either-or dichotomy: Either we do this with a separate form or we're never going to get this implemented in an expedient period of time. I can't accept that. In this situation, the will and intent of Parliament is supreme. If Parliament gives direction to make this happen, with the intent of it being front and centre rather than buried in some separate form, then that's direction to the bureaucracy to make it happen.
I would rather that it happen properly than have it happen with limited impact. I think that's really the trade-off we're looking at here.
My understanding from Mr. Webber of the spirit of the bill is to incent as many Canadians as possible to think about making this decision and actually do it. I don't think that having assistance in a tax form is going to somehow remove consent. When you submit your tax return, even if you have assistance preparing it, you're still obligated as an individual to review that information and sign off on it that it's truthful and that you've disclosed everything. You are involved in informed consent in the submission of a tax form to begin with, so I think that's a bit of a false argument.
I think what's happening here is that perhaps the bureaucracy has given advice to the government that might make it easier for them to implement this, but in doing so it takes away the spirit and intent of the legislation. I don't think we can support the amendment while simultaneously supporting the spirit of the legislation, which is why I think we shouldn't support it.
With regard to the issue of provincial jurisdiction, in no way does the amendment remove the obligation to work with the provinces to make this acceptable within their jurisdiction. Again, I think that's been a bit of a false presentation; this would still have to happen. At this point, the time period to get that done is really a matter of the minister giving direction and overseeing the bureaucrats to make this happen between the provinces and the federal government. It's more of a matter of political will and efficiency within the bureaucracy than necessarily....
What I'm trying to say is that a statement that this is going to take years to happen is really a timeline being given by the bureaucracy, rather than political will or direction. I would like to think that, on an issue that's this urgent and that could save this many lives, we would see more political will.
The last thing is that I think the parliamentary secretary said that Nova Scotia had opted out. That's not correct. I believe they're moving to presumed consent, which is different from what was characterized.
I implore my colleagues, especially those from the Liberal Party, particularly Mr. Van Bynen. I think it's more important that we support the spirit of the legislation rather than the pedantry of a proposed implementation approach. This amendment would, I think, in effect neuter the spirit of the bill. I urge my colleagues that we can respect provincial jurisdiction, we can give direction to the minister and to the bureaucracy to make this happen within the spirit that it's being proposed, and we can actually do something that's going to save lives.
I strongly want to reiterate what my colleague Mr. Webber said about having this buried as a supplementary form in the back. The whole purpose of this bill is to have it up front so that people think about this and make a decision that could save lives. Having a form at the back might make the lives of a few bureaucrats a little easier, but I would rather that we, as Parliament, give direction to the government and to the bureaucracy to make this happen in a way that will actually save Canadian lives, rather than just put together a form.
Thank you, Mr. Chair. I won't take much time.
Ms. Rempel Garner articulated very well much of what I was going to say.
I was not part of the health committee during the original debate, but I've certainly spoken to Mr. Webber about this legislation many times. This amendment—no offence, Mr. Sorbara—is a very big change from what all parties agreed to in the previous Parliament and have agreed to all along. Looking through the blues at some of the previous debates at the health committee on this, for the CRA to say previously that this wouldn't be a problem, that they have the wherewithal, the funding and the guidance from Parliament to do this with that tick box on the front page, and then to come back with a completely different position is alarming.
As to Mr. Sorbara's amendment, I know he said there would be a separate form as part of the T1 paperwork, but we have no assurance that's what it would be. Would it just be line 247 on your income tax return? Would it be an actual form that would be easily read and visible? The essence of Mr. Webber's legislation is to have this on the front page of the tax return. Every Canadian will see it. It will be prominent and well displayed. The CRA agreed to do that. No offence to the bureaucrats, but parliamentarians are the ones who are supposed to be providing that guidance and that direction to the bureaucracy. It's not the other way around.
The CRA could have brought these concerns to a previous Parliament or any time up until now. The assurance that we had from the CRA previously was that this was doable and would be done. Now to come back with an amendment.... Mr. Sorbara is being the messenger here so I don't want to put too much on his plate, but there's no assurance for us as parliamentarians where this message on becoming an organ and tissue donor would be in the application. He's saying it would be a form, but we don't know that because now they have gone from “Yes, we will have this as a tick box on the front page” to “We don't really want to do that. We could kind of commit to do this but...”. There are no assurances in the amendment Mr. Sorbara has offered.
I know, Mr. Chair, you've spoken in strong support of Mr. Webber's initiative during my short time on this committee. It is so rare when all of us as parliamentarians of different political stripes come together and put forward something that we all support, we all agreed to and we all worked hard to get to this point, and something we know is going to benefit Canadians. I just don't think it's right for bureaucrats within the CRA to say, “You know what? It would be easier for us or less work if we did x instead of what Parliament and the House of Commons has unanimously supported us to do”. I think that sends a poor message to Canadians whom Mr. Webber and many of you on this committee have worked with on this legislation. They are looking to us to follow through on what we committed to do in a previous Parliament and what we have committed to do up until now.
In conclusion, I know how hard Mr. Webber has worked on this. To get that support from all parliamentarians is something I think we should respect and not change on the whim of the CRA, which again isn't giving us any assurance on what it will look like. In the spirit of the legislation, I cannot support these amendments and I would certainly encourage my colleagues on the committee not to support the amendments as well and to maintain what we had all agreed to over the past several years.
To get so close to the finish line...and I know Mr. Webber was so close in the previous Parliament and that was a tough pill to swallow. To get here again, so close to the finish line, and then get this wrench thrown into the system is really unfortunate. I hope we can all respect what we agreed to before, not support the amendment and support the spirit of this legislation for the benefit of all our constituents.
Thank you very much, Mr. Chair.
Thank you to all the MPs who have provided substantive feedback on their views. I'm going to take this on a couple of levels, and I'll answer Mr. Webber's question. It's a very important question because to say that we're in favour of the intent of the bill, for me, means that we're in favour of the effectiveness of the bill and the final result we'd get from the bill, which is increasing the number of individuals who will have signed up to become registered tissue and organ donors. That has to be the goal of the bill, and this is a very important issue for many Canadians and for the organizations you highlighted.
There's always a balance in crafting legislation and getting legislation done, and there are many stakeholders and many points of view. As I know Mr. Barlow commented, what does it mean to listen to bureaucrats and other representatives? We need to take advice from our government officials and listen. Obviously, the final decision is with the government in terms of the direction, but it is pertinent and very imperative for them to provide that feedback to parliamentarians. It doesn't mean that we don't see issues or flags or say yes or no, but it is important to receive that feedback, in this circumstance, from the CRA officials.
In my gut, in my honest estimation, in this process that I've been involved with in examining Bill , I would like to see, as Mr. Van Bynen commented, at the end of the day, the bill moving forward, absolutely. What I would like to see is a separate page within the tax package that clearly states...and that we could utilize with the provinces in a very quick and efficient manner. It would say what we could agree on with the provinces and what descriptive information may be needed to be put in there.
Again, I take it back. This is not simply, if I can use the analogy, our asking people if they wish to pass on their information to be registered by Elections Canada. Elections Canada is a federal agency. They pass on the information to them. They then make sure that individuals are on the electors list, and that is on the front page. On this example here, there are jurisdictional issues. Regarding the opt-out by Nova Scotia, I know Ms. Rempel Garner has commented on that. I'm going to take another look at that because I'm obviously always open to constructive feedback and learning if I've erred in interpretation.
Again, in terms of efficiency, effectiveness and getting this in the tax package, the quickest way to do that is to have it on a separate page, not on the T1 form, but within the tax package. It's still there. It would still be for everybody to see. We know that when the tax filers are preparing their information, it is important to ask. We need to ensure that Canadians have the information they need to make those decisions that are very personal in nature, including becoming a registered tissue and organ donor.
To Mr. Webber, that's a very long way of saying yes. I believe this still maintains the effectiveness of Bill .
Seeing no further speakers, I shall call the question.
(Clause 1 agreed to: yeas 11; nays 0)
The Chair: Thank you.
Shall the title carry?
(Title agreed to: yeas 11; nays 0)
The Chair: Shall the bill carry?
(Bill C-210 agreed to: yeas 11; nays 0)
The Chair: That brings us to our last question. Shall the chair report the bill to the House?
Some hon. members: Agreed.
The Chair: Thank you, all.
Congratulations, Mr. Webber.
I would certainly like to thank everyone for their earnest and sincere advocacy on all the issues before us today.
I see that Mr. Webber has his hand up.
Mr. Webber, if you wish to speak, go ahead.