43rd Parliament223Government response tabledJune 4, 2021e-3181e-3181 (Health)AngellaMacEwenDanielBlaikieElmwood—TransconaNDPMBFebruary 24, 2021, at 11:20 a.m. (EDT)March 26, 2021, at 11:20 a.m. (EDT)April 21, 2021June 4, 2021March 30, 2021Petition to the <Addressee type="3" affiliationId="" mp-riding-display="1">Government of Canada</Addressee>Whereas:India and South Africa have brought a motion forward at the World Trade Organization (WTO) to temporarily waive certain parts of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement around COVID-19 medical technologies;If the member countries of the WTO approve this temporary waiver, it would help ensure production of sufficient quantities of affordable COVID-19 diagnostics, treatments and vaccines, which would increase the global supply of these goods, benefiting the global pandemic effort;Without the waiver, low- and middle-income countries don't have the ability to manufacture vaccines, and any countries will have to rely on pharmaceutical companies and wealthy countries for charity, or go without access to lifesaving medicines and technology;Pharmaceutical companies have received unprecedented taxpayer funding to help develop COVID-19 vaccines; andMany countries are now facing new and more contagious variants of COVID-19, making the global deployment of vaccines even more urgent.We, the undersigned, people of Canada, call upon the Government of Canada to support the proposal from India and South Africa for a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19 at the WTO TRIPS Council without delay.
Response by the Minister of Small Business, Export Promotion and International TradeSigned by (Minister or Parliamentary Secretary): Rachel BendayanThe Government of Canada continues to actively work with all international partners to reach a rapid and just end to the COVID-19 pandemic. Our government recognizes the integral role that industry has played in innovating to develop and deliver life-saving COVID-19 vaccines, and firmly believes in the importance of protecting intellectual property (IP). Canada remains committed to finding solutions and reaching an agreement that accelerates global vaccine production and does not negatively impact public health, including being ready to discuss proposals on a waiver for IP protection, in particular for COVID-19 vaccines, under the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Canada will continue working closely with all WTO Members, including engaging on new proposals from any Member or group, in seeking a consensus-based outcome to address any IP challenges created by COVID-19. Since the introduction of the IP waiver proposal, Canada has actively worked with partners to identify barriers to vaccine access—many of which are unrelated to IP, such as supply chain constraints. For instance, Canada is actively engaged in the work of the Trade and Health Initiative at the WTO, which aims to strengthen global supply chains and support the delivery of essential medicines and medical supplies, including vaccines, around the world. Canada has also encouraged the WTO Director General’s efforts to enhance the WTO’s role in global dialogue with the pharmaceutical sector towards accelerating the production and distribution of affordable, safe, effective COVID-19 vaccines and other medical products in coordination with the World Health Organization and other relevant organizations. Canada has always been, and remains, a strong advocate for equitable access to vaccines and medical supplies around the world through our support for the Access to COVID-19 Tools (ACT) Accelerator and the COVAX Facility. To date, we have announced $1.3 billion to support low- and middle-income countries to access COVID-19 vaccines, tests, and treatments because we understand that the pandemic is not over anywhere, until it is over everywhere. The Government of Canada continues to support a robust, multifaceted, and global effort to address the pandemic, one that draws upon all of the necessary resources and tools available in the international rules-based trading framework, as well as new mechanisms for global cooperation on the procurement of COVID-19 vaccines and other medical products. As equitable, timely and affordable access to testing, treatments, and vaccines will be critical for controlling and ending this pandemic, Canada remains committed to continued engagement with all members of the international community to find solutions to these global challenges.
Agreement on Trade-Related Aspects of Intellectual Property RightsCOVID-19Intellectual propertyPandemicPharmaceuticals
43rd Parliament223Government response tabledJune 4, 2021432-00849432-00849 (Health)ElizabethMaySaanich—Gulf IslandsGreen PartyBCApril 21, 2021June 4, 2021February 26, 2021PETITION TO THE HOUSE OF COMMONS IN PARLIAMENT ASSEMBLEDWe, the undersigned Citizens of Canada draw to the attention of the House the following: THAT, WHEREAS today, more is spent on prescription drug costs than doctors, and skyrocketing drug costs threaten the sustainability of our health care system;WHEREAS there are over 3 million uninsured or under-insured Canadians for drug coverage;WHEREAS a patchwork of provincial programs and work based plans means that access to medicine depends on where you live and where you work;WHEREAS by negotiating purchases in bulk and combining administration costs, a single pharmacare program could save billions;WHEREAS drug safety can be undermined because drug companies influence research reports and pay for drug approvals; and WHEREAS Canada is one of the few industrialized countries without a national pharmacare program.THEREFORE, YOUR PETITIONERS call upon the Government of Canada, in cooperation with the provinces and territories, to:
  • Establish a Canada-wide prescription drug program, phasing in drug coverage for all citizens, beginning with catastrophic drug costs;
  • Reduce the costs of prescription drugs for Canadians by implementing a bulk purchasing plan; and
  • Introduce measures to ensure that new drugs are evaluated through evidence-based research to be more effective, before they are prescribed.
Response by the Minister of HealthSigned by (Minister or Parliamentary Secretary): Jennifer O'ConnellThe Government of Canada is committed to strengthening Canada’s health care system, supporting the health of Canadians, and working together with provinces, territories, and stakeholders to improve access to prescription medications.Prescription drugs are an important part of Canada’s health care system. They can help diagnose, cure, control and prevent disease and improve the well-being of Canadians. When Canadians are in good physical and mental health, they are able to live healthier and happier lives. No Canadian should have to choose between paying for prescription drugs and putting food on the table, yet many are still forced to make this impossible decision. This is why the government remains committed to a national, universal pharmacare program.The Government of Canada is working together with provinces, territories, and stakeholders to build the foundational elements of national universal pharmacare. These foundational steps include establishing a Canadian Drug Agency, a national formulary, and a national strategy for high-cost drugs for rare diseases, as outlined in Budget 2019, the Speech from the Throne and the Fall Economic Statement.The government has established a Canadian Drug Agency Transition Office and is taking steps to develop a national formulary. Health Canada has also initiated public and stakeholder engagement to support the development of a national strategy on high cost drugs for rare diseases, which will help patients and families with rare diseases access the medication they need. The government has allocated up to $1 billion over two years starting in 2022-23 and up to $500 million ongoing in support of this strategy.The Government of Canada has modernized the way patented drug prices are regulated in Canada by amending the Patented Medicines Regulations to provide the Patented Medicine Prices Review Board (PMPRB) with the tools and information needed to protect Canadians from excessive patented medicine prices. This was the first substantive update to the regulations since 1987 and it is expected that these amendments, published in Canada Gazette, Part II on August 21, 2019, will save Canadians billions in drug spending over the next 10 years. The federal government is also working with provinces and territories as an active member of the pan-Canadian Pharmaceutical Alliance (pCPA). The pCPA combines governments’ collective buying power to negotiate lower prices on brand name drugs for all public plans, and sets the price point for many generic drugs. As of May 6, 2021, the pCPA has completed more than 420 joint brand drug negotiations and achieved price reductions on nearly 67 of the most commonly prescribed drugs and, as of April 1, 2019, the pCPA was estimated to have achieved approximately $2.26 billion in annual cost savings for public drug plans.Under the Food and Drugs Act, Health Canada regulates the safety, efficacy, and quality of therapeutic products, such as drugs and vaccines for use by humans in Canada before and after the products enter the Canadian marketplace. This includes oversight at all stages of a product’s life cycle, from early testing in clinical trials, to the scientific review of submissions, to post-market surveillance of adverse drug reactions and compliance monitoring and enforcement activities.Fees are charged to industry in relation to these regulatory activities. Canada is not alone in this approach; other international counterparts, such as the European Medicines Agency, and the United States Food and Drug Administration, also charge fees for delivering similar regulatory services.Health Canada’s fees support unbiased, rigorous and independent scientific assessments. These fees are paid even if a drug is not approved.Before a therapeutic product is authorized for sale in Canada, the manufacturer must provide evidence of its safety, efficacy and quality, as defined by regulations, including:
  • manufacturing details and controls to ensure consistent quality;
  • pre-clinical data (animal and cell studies) to support safety; and,
  • clinical data to support the proposed indication, including substantial evidence of effectiveness.
Scientists review every drug submission to assess the product’s safety, efficacy and quality in order to determine whether the risks associated with the product are acceptable in light of its potential benefits. If authorized for sale in Canada, procedures for safety monitoring and plans to minimize identified risks outlined by the manufacturer are also reviewed.Health Canada reviewers are scientists and physicians with many years of experience reviewing therapies, and with expertise in different domains including, but not limited to, clinical medicine, toxicology and pharmacology, biochemistry, virology, immunology, microbiology, and other scientific disciplines relevant to the development, testing and manufacture, and quality control of drugs and vaccines. This expertise ensures high standards in the advice given to stakeholders, and in the review of health products before they are prescribed.Health Canada has also developed work-sharing agreements with leading and trusted international regulatory authorities, which helps us leverage international expertise, increase efficiencies in access to safe, effective and high quality medicines, and ensure our review processes are aligned and at the leading edge internationally.Health Canada is also developing ways to better use information from real world experience to assess and monitor drug and device safety and effectiveness. Through regulatory modernization initiatives, we are working with health system partners to optimize the use of information gathered from a variety of sources.Launched in 2018 as part of Health Canada’s Regulatory review of Drugs and Devices initiative, the process for “Aligned reviews between Health Canada and Health Technology Assessment (HTA) agencies” reduces the time between Health Canada approvals and HTA reimbursement recommendations, and contributes to important progress in building a program to provide early parallel scientific advice with HTAs to assist new drug development. These initiatives help to speed up access for patients to drugs.The Government of Canada will continue to take action to improve the affordability, accessibility and appropriate use of prescription drugs through regulatory improvements, enhanced partnerships and better integration of drug review processes.
Health care systemPharmacarePharmaceuticals
43rd Parliament223Government response tabledMarch 11, 2021e-2868e-2868 (Health)J. AlexCornettAnitaVandenbeldOttawa West—NepeanLiberalONOctober 7, 2020, at 12:31 p.m. (EDT)November 6, 2020, at 12:31 p.m. (EDT)January 26, 2021March 11, 2021November 6, 2020Petition to the <Addressee type="4" affiliationId="253395" mp-riding-display="1">Minister of Health</Addressee>Whereas:Spinal muscular atrophy is a rare disease impacting 1 in 6,000-10,000 people (majority children) that progressively reduces their ability to move, breathe, and swallow;The existing treatment, Spinraza, slows but does not prevent serious declines in functioning, is an invasive treatment administered via spinal injection three times per year for life (which carries its own risks), and costs over $6.7 million by age 18;Zolgensma, a gene therapy that is almost a cure when provided early (replacing the missing gene), is approved in Europe, Japan, USA, and is currently undergoing Health Canada, INESSS, and CADTH review with an anticipated decision on December 2, 2020, after which the pan-Canadian Pharmaceutical Alliance will begin pricing negotiations, which takes up to 12 months;Zolgensma is a one-time treatment that currently costs $2.8 million, making it unaffordable for everyday Canadians;Zolgensma must be administered before the age of two for safety;As of September 2020, there are eight children across Canada who must receive Zolgensma within the next 1-11 months (before they turn two) or they will no longer be eligible for the treatment;Many of these infants have permission to administer Zolgensma through Health Canada’s Special Access Programme but simply cannot afford to purchase it; andThe federal government has committed to work with provinces and territories to support high-cost treatments for rare diseases.We, the undersigned, citizens and residents of Canada, call upon the Minister of Health to immediately approve Zolgensma and financially and otherwise support all health jurisdictions to make this treatment affordable immediately for all children who need it.
Response by the Minister of HealthSigned by (Minister or Parliamentary Secretary): Darren FisherThe Government of Canada recognizes the importance of patients having access to drugs that may help treat their serious or life-threatening conditions, and is committed to supporting Canadians’ access to safe and effective health products.In Canada, the management of pharmaceuticals is a shared responsibility among the federal, provincial and territorial governments. The federal government is responsible for assessing the safety, efficacy and quality of drugs before authorizing them for sale in Canada. The provincial and territorial governments are responsible for the delivery of health care for their residents, including determining which drugs are reimbursed and under what conditions for their eligible populations.On December 16, 2020, Health Canada approved Zolgensma for sale in Canada. Once approval has been issued, provincial and territorial drugs plans then decide if the drug will be eligible for public reimbursement. To help inform this decision, public drug plans use the recommendations and advice of the Canadian Agency for Drugs and Technologies in Health’s (CADTH) Common Drug Review and, in Quebec, the Institut national d’excellence en santé et en services sociaux (INESSS). Health Canada, along with CADTH and INESSS, have introduced an option for sponsors to seek aligned reviews for submissions. This aligned review process reduces time lags between the market authorization of a drug and the Health Technology Assessments (HTAs) performed by CADTH and INESSS which support its listing on a public plan. Through this process Zolgensma qualified for an earlier HTA review by CADTH and INESSS, up to 180 days before Health Canada made its regulatory decision about the drug’s market authorization.CADTH is still in the process of evaluating the HTA submission; whereas, INESSS has completed its review and has recommended that Zolgensma be reimbursed with conditions. For more information on the reviews and their outcomes, Canadians may visit the following links:     CADTH: https://cadth.ca/onasemnogene-abeparvovec       INESSS: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Janvier_2021/Zolgensma_2020_12.pdfEven if a drug is not listed on their formulary, individual provincial and territorial drug plans may review certain claims for reimbursement on a case-by-case basis and inquiries may be made specifically to the respective province or territory.We know that for many Canadians who require high-cost prescription drugs to treat rare diseases, the cost of these necessary medications can be astronomically high. That is why Budget 2019 proposed to invest up to $1 billion over two years, starting in 2022-23, with up to $500 million per year ongoing to help Canadians with rare diseases access the effective drugs they need. As reaffirmed in the 2020 Speech from the Throne and Fall Economic Statement, this includes working with willing provinces, territories and stakeholders to establish a national strategy for high-cost drugs for rare diseases.To support the development of a national strategy for high-cost drugs for rare diseases, engagement efforts are underway with the provinces and territories, patients along with other key stakeholders, and the public. The government has released a discussion paper and welcomes input from Canadians through public town halls and/or responses to an online questionnaire. All Canadians are invited to share their ideas before the engagement closes on March 26, 2021.The engagement webpage can be accessed here: https://www.canada.ca/en/health-canada/programs/consultation-national-strategy-high-cost-drugs-rare-diseases-online-engagement.html.The Government of Canada will continue working with provinces, territories and other partners to lower the costs of medications and improve access. 
InfantsPharmaceuticalsRare and orphan diseasesSpinal muscular atrophy
43rd Parliament223Government response tabledJanuary 25, 2021432-00318432-00318 (Health)ElizabethMaySaanich—Gulf IslandsGreen PartyBCNovember 30, 2020January 25, 2021February 5, 2020Petition to the Government of CanadaTHEREFORE, YOUR PETITIONERS call upon the Government of Canada, in cooperation with the provinces and territories, to:
  • Establish a Canada-wide prescription drug program, phasing in drug coverage for all citizens, beginning with catastrophic drug costs,
  • Reduce the costs of prescription drugs for Canadians by implementing a bulk purchasing plan, and
  • Introduce measures to ensure that new drugs are evaluated through evidence-based research to be more effective, before they are prescribed.
Response by the Minister of HealthSigned by (Minister or Parliamentary Secretary): Darren FisherWe are committed to strengthening Canada’s health care system and to supporting the health of Canadians. No Canadian should have to choose between paying for prescription drugs and putting food on the table, yet many are still forced to make this impossible decision as Canadians face some of the highest prescription drug prices in the world. This adversely affects the ability of Canadians to access needed medications and challenges the sustainability of Canada’s health care system. Current high prices in Canada place an added financial burden on public and private insurers, as well as on individuals who pay out of pocket for medications. That is why the Government of Canada is committed to working with provinces, territories and stakeholders to continue to implement national universal pharmacare so that Canadians have the drug coverage they need. As stated in the Speech from the Throne and the Fall Economic Statement, we will work with provinces and territories willing to move forward without delay and accelerate steps to achieve this system including establishing a Canadian Drug Agency, a national formulary, and a national strategy for high cost drugs for rare diseases.Budget 2019 proposed to invest up to $1 billion over two years, starting in 2022-2023, with up to $500 million per year ongoing, to help Canadians with rare diseases access the drugs they need. We recognize that for many Canadians who require prescription drugs to treat rare diseases, the cost of these medications can be astronomically high. To support the development of a national strategy for high cost drugs for rare diseases, engagement efforts are commencing with the provinces and territories, along with stakeholders and the public.Budget 2019 also announced the Government’s intention to establish a Canadian Drug Agency that would take a coordinated approach to assessing effectiveness and negotiating prescription drug prices on behalf of Canadians. The new agency would build on existing provincial and territorial successes, including the Canadian Agency for Drugs and Technologies in Health (CADTH), which assesses clinical and cost-effectiveness and the pan-Canadian Pharmaceutical Alliance (pCPA), which combines governments’ collective buying power to negotiate lower prices. It could also leverage collaboration between Health Canada and CADTH to align their respective review processes to ensure effectiveness assessments are available as soon as possible to guide decision-makers. Budget 2019 allocated $35 million over four years to establish a Canadian Drug Agency Transition Office to support the development of this vision. This office is currently being created to provide dedicated capacity and leadership to advance work on pharmacare-related priorities.Additionally, as a foundational step towards national pharmacare, the Government of Canada recently modernized the way patented drug prices are regulated in Canada. The regulatory amendments to the Patented Medicines Regulations provide the Patented Medicine Prices Review Board with new tools and information to protect Canadians from excessive prices of patented medicines. This was the first substantive update to the regulations since 1987 and it is expected that these amendments will save Canadians billions in drug spending over the next 10 years. The amendments were published in Canada Gazette, Part II on August 21, 2019 and are available at: http://www.gazette.gc.ca/rp-pr/p2/2019/2019-08-21/html/sor-dors298-eng.htmlThrough these actions, we continue to work with provincial and territorial governments and other key partners to improve the affordability and accessibility of needed prescription drugs. 
Health care systemPharmacarePharmaceuticals
43rd Parliament223Government response tabledSeptember 24, 2020431-00290431-00290 (Health)GordJohnsCourtenay—AlberniNDPBCJune 18, 2020September 24, 2020June 15, 2020Petition to the Government of CanadaWe, the undersigned residents of the Province of British Columbia, draw the attention of the Government of Canada to the following: Whereas: The cost of prescription medications and necessary medical supplies in Canada is excessive and varies greatly between provinces and territories; The cost of prescription medications and medical supplies are continuing to rise significantly every year; many Canadians cannot afford to purchase their prescription medications and/or medical supplies or have to choose between purchasing prescription medications and medical supplies or providing for food and shelter. Therefore, your petitioners request the Government of Canada to develop a comprehensive pan-Canada single payer and universal Pharmacare program that ensures that all Canadians can access medically prescribed and necessary medications and supplies regardless of their ability to pay.
Response by the Minister of HealthSigned by (Minister or Parliamentary Secretary): Darren FisherWe are committed to strengthening Canada’s health care system and to supporting the health of Canadians. No Canadian should have to choose between paying for prescription drugs and putting food on the table, yet many are still forced to make this impossible decision.That is why we are committed to working with provinces, territories and stakeholders to continue to implement national universal pharmacare so that Canadians have the drug coverage they need. As part of Budget 2019, the Government of Canada announced the next critical steps towards the implementation of national pharmacare. This includes the establishment of a Canada Drug Agency, a national formulary and a national strategy for high-cost drugs for rare diseases.Additionally, as a foundational step towards national pharmacare, the Government of Canada recently modernized the way patented drug prices are regulated in Canada by amending the Patented Medicines Regulations. Implementation of this modernized regulatory framework will enable the Patented Medicine Prices Review Board to better protect Canadian consumers from excessive prices of patented medicines. These amendments are expected to lower drug prices in Canada, which are approximately 25% higher than international peers, and save Canadians $13.2 billion over the next 10 years. The amendments were published in Canada Gazette, Part II on August 21, 2019 and are available at:  http://www.gazette.gc.ca/rp-pr/p2/2019/2019-08-21/html/sor-dors298-eng.html         The federal government is also working with the provinces and territories as an active member of the pan-Canadian Pharmaceutical Alliance (pCPA). The pCPA combines governments’ collective buying power to negotiate lower prices on brand name drugs for all public plans, and sets the price point for many generic drugs. The pCPA has completed more than 369 joint brand drug negotiations and achieved price reductions on nearly 70 of the most commonly prescribed generic drugs. As of April 1, 2019, the pCPA was estimated to have achieved approximately $2.26 billion in annual cost savings for public drug plans.Through these actions, we continue to work with provincial and territorial governments and other key partners to improve the affordability and accessibility of needed prescription drugs.
Health care systemPharmacarePharmaceuticals
43rd Parliament223Government response tabledJuly 20, 2020431-00215431-00215 (Health)ElizabethMaySaanich—Gulf IslandsGreen PartyBCMay 27, 2020July 20, 2020February 5, 2020PETITION TO THE HOUSE OF COMMONS IN PARLIAMENT ASSEMBLEDWe, the undersigned Citizens of Canada draw to the attention of the House the following: THAT, WHEREAS today, more is spent on prescription drug costs than doctors, and skyrocketing drug costs threaten the sustainability of our health care system;WHEREAS there are over 3 million uninsured or under-insured Canadians for drug coverage;WHEREAS a patchwork of provincial programs and work based plans means that access to medicine depends on where you live and where you work;WHEREAS by negotiating purchases in bulk and combining administration costs, a single pharmacare program could save billions;WHEREAS drug safety can be undermined because drug companies influence research reports and pay for drug approvals; and WHEREAS Canada is one of the few industrialized countries without a national pharmacare program.THEREFORE, YOUR PETITIONERS call upon the Government of Canada, in cooperation with the provinces and territories, to:
  • Establish a Canada-wide prescription drug program, phasing in drug coverage for all citizens, beginning with catastrophic drug costs;
  • Reduce the costs of prescription drugs for Canadians by implementing a bulk purchasing plan; and
  • Introduce measures to ensure that new drugs are evaluated through evidence-based research to be more effective, before they are prescribed.
Response by the Minister of HealthSigned by (Minister or Parliamentary Secretary): Darren FisherWe are committed to strengthening Canada’s health care system and to supporting the health of Canadians. No Canadian should have to choose between paying for prescription drugs and putting food on the table, yet many are still forced to make this impossible decision.That is why we are committed to working with provinces, territories and stakeholders to continue to implement national universal pharmacare so that Canadians have the drug coverage they need. As part of Budget 2019, the Government of Canada announced the next critical steps towards the implementation of national pharmacare. This includes the establishment of a Canada Drug Agency, a national formulary and a national strategy for high-cost drugs for rare diseases.Additionally, as a foundational step towards national pharmacare, the Government of Canada recently modernized the way patented drug prices are regulated in Canada by amending the Patented Medicines Regulations. Implementation of this modernized regulatory framework will enable the Patented Medicine Prices Review Board to better protect Canadian consumers from excessive prices of patented medicines. These amendments are expected to lower drug prices in Canada, which are approximately 25% higher than international peers, and save Canadians $13.2 billion over the next 10 years. The amendments were published in Canada Gazette, Part II on August 21, 2019 and are available at:  http://www.gazette.gc.ca/rp-pr/p2/2019/2019-08-21/html/sor-dors298-eng.html        The federal government is also working with the provinces and territories as an active member of the pan-Canadian Pharmaceutical Alliance (pCPA). The pCPA combines governments’ collective buying power to negotiate lower prices on brand name drugs for all public plans, and sets the price point for many generic drugs. The pCPA has completed more than 369 joint brand drug negotiations and achieved price reductions on nearly 70 of the most commonly prescribed generic drugs. As of April 1, 2019, the pCPA was estimated to have achieved approximately $2.26 billion in annual cost savings for public drug plans.Through these actions, we continue to work with provincial and territorial governments and other key partners to improve the affordability and accessibility of needed prescription drugs.
Health care systemPharmacarePharmaceuticals
43rd Parliament223Government response tabledJuly 20, 2020431-00179431-00179 (Health)ScottReidLanark—Frontenac—KingstonConservativeONMay 12, 2020July 20, 2020May 8, 2020Petition to the House of Commons, the House of Commons in Parliament assembled, the Government of Canada, Prime Minister Justin Trudeau and Patty Hajdu, Minister of HealthWHEREAS
  • With the proposed changes to PMPRB, it is foreseeable that many companies will delay or even forgo the launching of new innovative medicines in Canada.
  • Trikafta, is a game-changing drug targeting the basic defect of cystic fibrosis. It can treat up to 90% of Canadians with Cystic Fibrosis.
  • TriKafta was approved for sale in the U.S.A., by the FDA in October 2019. Six months ahead of schedule. The FDA commissioner at the time of approval said: "...we used all available programs, including Priority Review, Fast Track, Breakthrough Therapy, and orphan drug designation, to help advance [Trikafta's] approval in the most efficient manner possible..."
  • This one drug alone has so much potential to help the majority of cystic fibrosis patients who previously had no other options to live longer and healthier lives... But due to the uncertain pricing environment in Canada, the chances of this treatment coming to Canada in the near future are slim to uncertain.
  • By Adopting a universal (legally binding) "value" index, namely an (Incremental Cost-Effectiveness Ratio) hereafter referred to as ICER; as currently recommended by PMPRB; of $60k/QALY for drugs for common conditions or $90k/QALY for a drug intended for a rare disease population, it would preclude consideration of many other factors, including severity of disease, other treatment options, challenges of administration, and, indeed, leaves no room for negotiation.
We, the undersigned, Cystic Fibrosis patients, family and friends of Cystic Fibrosis patients and other concerned citizens of Canada, call upon the House of Commons, the House of Commons in Parliament assembled, the Government of Canada, Prime Minister Justin Trudeau and Patty Hajdu, Minister of Health, to:
  • Rescind amendments to the PMPRB. They restrict Canadians from life saving medication (ie Trikafta);
  • Work with Provinces to immediately help and provide access to CF disease modifying drugs currently available in Canada to those who need them (such as CF drugs: Kalydeco, Orkambi and Symdeko);
  • Move quickly to improve and coordinate access to medicines and care for people with rare diseases by developing a separate pan-Canadian rare disease drug review and reimbursement approach to eliminate duplication in the system and ensure timely and equitable access to drugs for rare diseases like cystic fibrosis;
  • Take a leadership role in negotiating a price for gene modulators (Trikafta) for all provinces.
Response by the Minister of HealthSigned by (Minister or Parliamentary Secretary): Darren FisherThe Government of Canada recognizes the importance of patient access to new therapies for serious or life-threatening conditions.  To date, Health Canada has not received a submission for Trikafta although the Department has been in contact with Vertex Pharma, the manufacturer of Trikafta, with regard to this product.Any company that wishes to market a new drug in Canada must first obtain regulatory approval to do so. To obtain this approval, a company must file a drug submission to establish that the new drug meets the regulatory requirements relating to safety, quality and effectiveness. The price of a drug is not relevant in the process to obtain Health Canada’s regulatory approval to sell or advertise a new drug in Canada. While Health Canada encourages manufacturers to file drug submissions in Canada, it is ultimately up to a manufacturer to decide whether they choose to seek market authorization for their product in Canada.In some circumstances, drugs not yet approved in Canada may be accessed through Health Canada’s Special Access Programme (SAP). The SAP provides access to non-marketed drugs to practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or offer limited options. All requests are practitioner-initiated (generally by a physician) and considered on a case-by-case basis. Decisions are based on the information provided in the request, taking into consideration the severity of the condition, data supporting the use of the drug, other therapies considered and availability of the drug from the manufacturer. Although Health Canada has not received a new drug submission for Trikafta, as of June, 2020, 116 patients in Canada have accessed this drug through the SAP.Prescription medicine prices in Canada are among the highest in the developed world. This influences Canadians’ access to important medications and the sustainability of Canada’s health care system. Current high prices in Canada strain the budget of public and private insurers and place a financial burden on those who pay out of pocket for medications. The objective of the recent regulatory amendments to the Patented Medicine Regulations is to ensure that the Patented Medicine Prices Review Board (PMPRB) has the correct tools and information to fulfill its mandate to protect Canadian consumers from excessive medicine prices.Even with lower prices, Canada will remain an important pharmaceutical market and revenues from patented drug sales are expected to continue growing over the next ten years. Drug companies are expected to launch their products in Canada at the same rate as they do today. In fact, industry sponsored studies have found that many countries with lower prices than Canada have faster access to new medicines, including the Netherlands, Sweden, the United Kingdom and Norway. In general, new medicines are launched in all major markets within the same general timeframe, regardless of price.It is important to note that, due to the COVID-19 pandemic, the Government of Canada has delayed the coming-into-force of the regulatory amendments by six months to minimize the imposition of new administrative burden on the pharmaceutical industry and provide stakeholders with a longer period in which to submit feedback to the PMPRB’s Guidelines consultation process. More information on the delay is available in the Regulatory Impact Assessment Statement (RIAS), published in the Canada Gazette Part II and accessible at the following link: http://gazette.gc.ca/rp-pr/p2/2020/2020-06-10/html/sor-dors126-eng.htmlAs it relates to specific Incremental Cost-Effectiveness Ratios (ICERs), the PMPRB recently issued revised draft Guidelines (https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/draft-guidelines.html#submissions) that proposes new thresholds. The PMPRB is welcoming stakeholder comments on their revised Guidelines until July 20, 2020. We strongly encourage all interested stakeholders to take part in this consultation process.We will continue to work with provinces, territories, and other partners to improve the accessibility and affordability of medications. For instance, we know that for many Canadians who require high-cost prescription drugs to treat rare diseases, the cost of these necessary medications can be astronomically high. That is why, as part of Budget 2019, the Government of Canada proposed to invest $1 billion over two years, starting in 2022-23, with up to $500 million per year ongoing, to develop a national strategy for high-cost drugs for rare diseases. This will enable Canadians to achieve better access to the effective treatments they need.
Cystic fibrosisPatented Medicine Prices Review BoardPharmaceuticalsRare and orphan diseases
43rd Parliament223Government response tabledApril 11, 2020431-00054431-00054 (Health)RichardCanningsSouth Okanagan—West KootenayNDPBCFebruary 3, 2020April 11, 2020February 3, 2020Petition to the Government of CanadaWe the undersigned residents of the province of British Columbia draw to the attention to the Government of Canada the following: Whereas: the cost of prescription medications and necessary medical supplies are excessive and vary greatly between provinces and territories; the cost of prescriptions and medical supplies continue to rise every year, and many Canadians cannot afford to buy their medications and/or medical supplies and also provide for their food and shelter. Therefore, your petitioners request the Government of Canada develop a comprehensive Pan-Canada single payer and Universal Program that ensures that all Canadians are able to access prescribed and necessary medications and medical supplies regardless of their ability to pay.
Response by the Minister of HealthSigned by (Minister or Parliamentary Secretary): Darren FisherWe are committed to strengthening Canada’s health care system and to supporting the health of Canadians. No Canadian should have to choose between paying for prescription drugs and putting food on the table, yet many are still forced to make this impossible decision.That is why we are committed to working with provinces, territories and stakeholders to continue to implement national universal pharmacare so that Canadians have the drug coverage they need. As part of Budget 2019, the Government of Canada announced the next critical steps towards the implementation of national pharmacare. This includes the establishment of a Canada Drug Agency, a national formulary and a national strategy for high-cost drugs for rare diseases.Additionally, as a foundational step towards national pharmacare, the Government of Canada recently modernized the way patented drug prices are regulated in Canada by amending the Patented Medicines Regulations. Implementation of this modernized regulatory framework will enable the Patented Medicine Prices Review Board to better protect Canadian consumers from excessive prices of patented medicines. These amendments are expected to lower drug prices in Canada, which are approximately 25% higher than international peers, and save Canadians $13.2 billion over the next 10 years. The amendments were published in Canada Gazette, Part II on August 21, 2019 and are available at:  http://www.gazette.gc.ca/rp-pr/p2/2019/2019-08-21/html/sor-dors298-eng.html         The federal government is also working with the provinces and territories as an active member of the pan-Canadian Pharmaceutical Alliance (pCPA). The pCPA combines governments’ collective buying power to negotiate lower prices on brand name drugs for all public plans, and sets the price point for many generic drugs. As of December 31, 2019, the pCPA has completed more than 343 joint brand drug negotiations and achieved price reductions on nearly 70 of the most commonly prescribed generic drugs. As of April 1, 2019 the pCPA was estimated to have achieved approximately $2.26 billion in annual cost savings for public drug plans.Through these actions, we continue to work with provincial and territorial governments and other key partners to improve the affordability and accessibility of needed prescription drugs. 
Health care systemPharmacarePharmaceuticals
43rd Parliament223Government response tabledApril 11, 2020431-00055431-00055 (Health)RichardCanningsSouth Okanagan—West KootenayNDPBCFebruary 3, 2020April 11, 2020February 3, 2020Petition to the Government of CanadaWe the undersigned residents of the province of British Columbia draw to the attention to the Government of Canada the following: Whereas: the cost of prescription medications and necessary medical supplies are excessive and vary greatly between provinces and territories; the cost of prescriptions and medical supplies continue to rise every year, and many Canadians cannot afford to buy their medications and/or medical supplies and also provide for their food and shelter. Therefore, your petitioners request the Government of Canada develop a comprehensive Pan-Canada single payer and Universal Program that ensures that all Canadians are able to access prescribed and necessary medications and medical supplies regardless of their ability to pay.
Response by the Minister of HealthSigned by (Minister or Parliamentary Secretary): Darren FisherWe are committed to strengthening Canada’s health care system and to supporting the health of Canadians. No Canadian should have to choose between paying for prescription drugs and putting food on the table, yet many are still forced to make this impossible decision.That is why we are committed to working with provinces, territories and stakeholders to continue to implement national universal pharmacare so that Canadians have the drug coverage they need. As part of Budget 2019, the Government of Canada announced the next critical steps towards the implementation of national pharmacare. This includes the establishment of a Canada Drug Agency, a national formulary and a national strategy for high-cost drugs for rare diseases.Additionally, as a foundational step towards national pharmacare, the Government of Canada recently modernized the way patented drug prices are regulated in Canada by amending the Patented Medicines Regulations. Implementation of this modernized regulatory framework will enable the Patented Medicine Prices Review Board to better protect Canadian consumers from excessive prices of patented medicines. These amendments are expected to lower drug prices in Canada, which are approximately 25% higher than international peers, and save Canadians $13.2 billion over the next 10 years. The amendments were published in Canada Gazette, Part II on August 21, 2019 and are available at:  http://www.gazette.gc.ca/rp-pr/p2/2019/2019-08-21/html/sor-dors298-eng.html         The federal government is also working with the provinces and territories as an active member of the pan-Canadian Pharmaceutical Alliance (pCPA). The pCPA combines governments’ collective buying power to negotiate lower prices on brand name drugs for all public plans, and sets the price point for many generic drugs. As of December 31, 2019, the pCPA has completed more than 343 joint brand drug negotiations and achieved price reductions on nearly 70 of the most commonly prescribed generic drugs. As of April 1, 2019 the pCPA was estimated to have achieved approximately $2.26 billion in annual cost savings for public drug plans.Through these actions, we continue to work with provincial and territorial governments and other key partners to improve the affordability and accessibility of needed prescription drugs. 
Health care systemPharmacarePharmaceuticals