National Strategy for Drugs for Rare Diseases Initiative, Canada-Quebec Funding Agreement
Between
The Government of Canada, represented by the Minister of Health (hereinafter referred to as "Canada")
– and –
The Government of Quebec, represented by the Minister of Health and the Minister responsible for Canadian Relations (hereinafter referred to as "Quebec")
Hereinafter referred to as "the Parties."
Preamble
Whereas, in 1997, Quebec set up the Prescription Drug Insurance Plan (RGAM), which offers coverage to its entire population and consists of the Prescription Drug Insurance Plan and all private plans subject to the same requirements relating to coverage;
Whereas, in 2022, Quebec adopted the Politique québécoise sur les maladies rares [Policy for rare diseases], which was followed by the Plan d'action québécois sur les maladies rares [Quebec action plan for rare diseases 2023–2027], to improve the quality of care for people with rare diseases;
Whereas, on March 22, 2023, Health Canada announced investments of up to $1.5 billion over three years, from the 2019 federal budget, to implement the National Strategy for Drugs for Rare Diseases, including up to $1.4 billion for agreements with the provinces and territories;
Whereas, Quebec intends to exercise its jurisdiction in health matters and preserve its control over the planning, organization and management of services on its territory, including drugs for rare diseases;
Whereas, Canada acknowledges that Quebec intends to continue the administration of the RGAM according to the usual procedures and that this plan has the same major objectives of supporting access to drugs for rare diseases for all those eligible under Quebec's Health Insurance Act (chapter A-29) as the federal strategy;
Whereas, Canada is committed to paying Quebec its share of federal funds for the National Strategy for Drugs for Rare Diseases;
Whereas, the federal contribution will compensate Quebec for the coverage of current and emerging drugs for rare diseases by the RGAM as well as the implementation of screening and diagnostic testing for rare diseases, thus contributing to the achievement of the objectives of the Quebec action plan for rare diseases 2023–2027;
Whereas, Quebec recognizes the right of Indigenous peoples to receive drugs for rare diseases and to have access to adequate and personalized screening and diagnostic testing for rare diseases, and, in a spirit of reconciliation, it aims to foster collaboration with Indigenous peoples and support safe health service practices that take into account their cultural and historical values and realities;
Whereas, Quebec promotes equity in access to current and emerging drugs for rare diseases as well as screening and diagnostic testing for rare diseases for the entire population, including English-speaking Quebecers in the language of their choice, in compliance with the applicable laws of Quebec;
Therefore, Canada and Quebec agree as follows:
1. Definition
The following expressions, as used in this Agreement, shall have the meaning hereinafter defined:
"Agreement" means the Canada-Quebec Agreement regarding federal funding for drugs for rare diseases.
"Fiscal Year" means the period beginning on April 1 of one calendar year and ending on March 31 of the calendar year immediately following.
2. Term of agreement
This Agreement will come into effect when the last Party has signed and will remain in force until March 31, 2027, unless terminated earlier in accordance with this Agreement. The funding granted under this Agreement will cover the period from April 1, 2024, to March 31, 2027.
3. Objective
Canada and Quebec agree that the objective of this Agreement is to establish the terms and conditions for the payment of Canada's contributions to compensate Quebec for the Prescription Drug Insurance Plan it offers its population and to support the deployment of the Quebec action plan for rare diseases 2023–2027, as described in Annex A.
4. Contribution
Subject to Parliamentary approval of appropriations, Canada has designated the following maximum amounts to be transferred in total to all provinces and territories as part of the National Strategy for Drugs for Rare Diseases:
- $468,774,452 for the Fiscal Year beginning on April 1, 2024
- $468,774,452 for the Fiscal Year beginning on April 1, 2025
- $468,774,452 for the Fiscal Year beginning on April 1, 2026
For each Fiscal Year, Quebec's share will be calculated using the following formula: $1,500,000 + (F - (N x 1,500,000)) x (K/L), where:
"F" is the maximum annual amount indicated above, i.e., $468,774,452;
"N" number of jurisdictions (all 13) that will be provided the base funding of $1,500,000;
"K" is the total population of the particular province or territory, as determined using the population estimates from Statistics Canada minus the number of eligible clients of the Non-Insured Health Benefits program residing in that particular province or territory; and
"L" is the total population of Canada, as determined annually using the population estimates from Statistics Canada minus the number of eligible clients of the Non-Insured Health Benefits program.
For Fiscal Year 2024-2025, subject to the terms of this Agreement and based on the formula described above, Canada will make a contribution to Quebec of up to one hundred and one million eight hundred and ninety-eight thousand nine hundred and nine dollars ($101,898,909).
For the purposes of the formula described above, the population of Quebec for each Fiscal Year and the total population of all provinces and territories for each Fiscal Year will be determined by the population numbers released by Statistics Canada in March of each year. Non-Insured Health Benefit populations will be determined by the most recent figures available from Indigenous Services Canada as of calculation date of March 31. Allocations for each Fiscal Year will be determined at the beginning of each Fiscal Year in accordance with these population figures.
Quebec will use the federal contribution to reimburse the costs of the RGAM coverage available to its population and to support the Quebec action plan for rare diseases 2023–2027 (Annex A).
5. Payment of contribution
For the Fiscal Year beginning April 1, 2024, Canada will pay Quebec the contribution in one payment. This payment will be made within 15 working days of the date of the last signature of this Agreement.
Starting in 2025-2026, the first payment will be made on or about April 15 of each Fiscal Year and will be equal to 50% of the amount determined in accordance with the formula in section 4. The second payment will be made on or about November 15 of each Fiscal Year and will be equal to the balance of Canada's contribution to Québec for the Fiscal Year determined in accordance with the formula in section 4. The total of the two payments will constitute the total payment for one Fiscal Year.
Payments made by Canada under this Agreement are subject to appropriation by the Parliament of Canada, subject to the conditions in section 4.
Quebec shall reimburse Canada for any amount paid to it in excess of the amount to which it is entitled under this Agreement. Such an amount constitutes a debt due to Canada and must be repaid within sixty (60) calendar days of receipt of a written request for repayment.
6. Reporting and information sharing
Quebec agrees to ensure transparency with regard to the objectives of this Agreement, and will continue to report to the people of Quebec on the use of all funds, in accordance with its own accountability practices and indicators. It will recognize the federal funding obtained under this Agreement.
Quebec will make public reports available to Canada, in accordance with its own reporting practices.
7. Communication
Canada and Quebec agree on the importance of communicating with the public about the objectives of this Agreement in an open and transparent manner through appropriate public information activities.
Canada, with prior notice to Quebec, may incorporate all or any part of the data and information in section 6, or any part of the evaluation and audit reports made public by Quebec, in any report that Canada may prepare for its own purposes, including any report to the Parliament of Canada or any report that may be made public.
8. Dispute resolution
Canada and Quebec are committed to working together and avoiding disputes through government-to-government information exchange, advance notice, early consultation, and discussion, clarification, and resolution of issues, as they arise.
If a dispute arises between the Parties with respect to the interpretation and/or implementation of any of the terms and conditions of this Agreement, either Party may notify the other in writing of its concerns. Upon receipt of such notice, Canada and Quebec will seek to resolve the issue raised in a manner deemed appropriate by the designated officials. In the event of a dispute that cannot be resolved by the designated officials, the matter will be referred first to the Deputy Ministers of Health of Quebec and Canada and, if it cannot be resolved by them, to the Ministers of Health of Quebec and Canada.
9. Amendment of the agreement
This Agreement may be amended at any time by mutual written consent of the Parties. Any amendment will become effective on the date agreed to by the Parties.
10. Termination of the agreement
Neither Canada nor Quebec may terminate this Agreement unless the conditions of this Agreement are not being respected by the other Party. In this case, at least six (6) months' written notice must be given to the other Party of the intention to terminate the Agreement.
11. Funding subject to appropriation and initiative funding authorities
Notwithstanding any other provision of this Agreement, the amount of funding to be provided to Quebec pursuant to this Agreement is subject to there being an appropriation of funds by the Parliament of Canada for the Fiscal Year in which any commitment would come due for payment.
In the event that authorities for the initiative are amended or terminated, or if funding levels are reduced or cancelled by the Parliament of Canada for any Fiscal Year in which a payment is to be made under this Agreement, Canada may reduce or terminate any further payments to be made under this Agreement.
Where funding under this Agreement is to be reduced or terminated, Canada shall provide Quebec with at least ninety (90) calendar days written notice of the reduction or termination.
12. Disclaimer
The failure or delay by a Party to exercise any of its rights, powers or remedies under this Agreement shall not constitute a waiver of such rights, powers or remedies. Any waiver by either Party of any of its rights, powers, or remedies under this Agreement must be in writing, and no such waiver shall constitute a continuing waiver, unless explicitly stated.
13. General information
This Agreement shall be interpreted in accordance with the laws applicable in Quebec.
No member of the House of Commons or Senate of Canada or of the National Assembly of Quebec may be a Party to this Agreement, in whole or in part, of any contract or commission or derive any benefit therefrom.
If, for any reason, any provision of this Agreement which is not a fundamental term of this Agreement is held to be invalid or unenforceable, in whole or in part, such provision shall be deemed severable and stricken from this Agreement, but all other terms and conditions of this Agreement shall continue to be valid and enforceable.
14. Notice
Any notice, information, or document provided for under this Agreement will be effectively given if delivered or sent by letter or email, postage or other charges prepaid. Any communication that is delivered will be deemed to have been received as soon as it is received; any communication that is delivered by email will be deemed to have been received one (1) business day after the date it is sent; and, except in periods of postal disruption, any communication mailed by post will be deemed to have been received eight (8) calendar days after being mailed.
The address to be used for communications or notices to Canada shall be as follows:
Associate Assistant Deputy Minister, Health Policy Branch
Health Canada
Brooke Claxton Building
70 Columbine Driveway
Ottawa, Ontario K1A 0K9
Email: michelle.boudreau@hc-sc.gc.ca
The address to be used for communications or notices to Quebec shall be as follows:
Ministère de la Santé et des Services sociaux
1075 Chemin Sainte-Foy
Québec, Quebec G1S 2M1
E-mail: sous-ministre@msss.gouv.qc.ca
15. Signature in return
This Agreement may be signed in counterparts and each counterpart shall constitute an original document; these counterparts taken together shall constitute one and the same Agreement.
In witness whereof, the authorized representatives of Canada and Quebec have signed this Agreement.
Signed on behalf of Canada
Kamal Khera, Minister of Health
Signed on behalf of Quebec
Christian Dubé, Minister of Health
Simon Jolin-Barrette, Minister responsible for Canadian Relations
Annex A – Prescription Drug Insurance Plan (RGAM)Footnote 1
In January 1997, Quebec introduced the Prescription Drug Insurance Plan (RGAM), which consisted of a public plan and thousands of private plans covering the entire population of Quebec. The establishment of the RGAM was the result of a comprehensive reflection that began a few years prior to its creation. The selected approach was to create a unified plan to replace the fragmented coverage measures, by health condition, that existed previously and that raised significant issues regarding equity and efficiency. The financial participation of those insured, in the form of a contribution upon purchase and of the insurance premium, has also existed since 1997. This funding provides the best foundation for ensuring the continuity of the plan, given that for public plan members, this financial contribution is modulated based on the financial capacity of those insured, and that the most vulnerable users are entitled to free coverage.
The Act respecting prescription drug insurance defines the coverage provided by the public plan and, at a minimum, by private plans. The basket of "services" set out in the Act corresponds to the List of medications, updated nine times a year by the Minister of Health, based on recommendations from the Institut national d'excellence en santé et en services sociaux (INESSS). The INESSS is an independent scientific agency that handles requests for assessments from pharmaceutical manufacturers in order to make recommendations to the Minister responsible for deciding whether to enter a product on the list of medications. The Quebec list is the most extensive across all provinces and territories in Canada. It is designed to provide fair and reasonable solutions to all health problems, without making any judgments or establishing a hierarchy of priorities between health conditions.
The Quebec approach is equitable in that it does not create distinctions between health problems. The Quebec list of medications therefore includes drugs for rare diseases, accessible to both public and private plan customers under the RGAM umbrella.
In addition to this access to a very wide range of products, the RGAM includes a measure known as the "patient exception," which gives access to a medication (or for a therapeutic use), specific to a patient, not included in the list. This measure is unique in Canada and includes the coverage of drugs for rare diseases on a case-by-case basis.
Around 55% of the total cost of the public plan is financed by the government and 45% by public plan members (premiums and contribution upon purchase). Government funding comes from the taxes paid by all taxpayers.
Finally, since 2015, Quebec has been part of the pan-Canadian Pharmaceutical Alliance (PCPA). Over the years, the concerted negotiation work by the provinces and territories has resulted in substantial discounts from drug manufacturers over the years, making it possible to increase the coverage offered by provincial and territorial public plans year after year by integrating the new therapies that are constantly arriving on the market. The PCPA negotiation process has proved successful and must be preserved.
Quebec Action Plan for Rare Diseases 2023–2027
In June 2022, Quebec adopted the Politique québécoise pour les maladies raresFootnote 2 [Policy for rare diseases], positioning the province at the forefront of governments in terms of planning the organization of care and services as well as trajectories for rare diseases. This policy also includes screening and diagnostic testing, an important component in managing rare diseases, and the reimbursement of expensive drugs to treat existing and emerging rare diseases.
The actions proposed in the Plan d'action québécois sur les maladies rares 2023-2027Footnote 3 [Quebec action plan for rare diseases 2023–2027] resulting from this Policy are spread over a four-year period (2023–2027) and are in line with the Policy's three axes of intervention: awareness and training; easy and equitable access to diagnosis, care and services; and the promotion of research, innovation and data collection.