National Strategy for Drugs for Rare Diseases Initiative, Canada - Newfoundland and Labrador Funding Agreement

Between: His Majesty the King in Right of Canada, as represented by the Minister of Health (hereinafter referred to as "Canada")

And: His Majesty in Right of Newfoundland and Labrador, as represented by the Minister of Health and Community Services and the Minister for Intergovernmental Affairs (hereinafter referred to "Newfoundland and Labrador")

Canada and Newfoundland and Labrador are also referred to as a "Party" or collectively as the "Parties"

Table of contents

• Preamble
• 1. Definitions
• 2. Objectives
• 3. Term of agreement and review
• 4. Financial contribution and obligations
• 5. Use of funds
• 6. Performance measurement and reporting
• 7. Communications
• 8. Dispute resolution
• 9. Amendments to the agreement
• 10. General
• 11. Terminating the agreement
• 12. Notice
• 13. Signing in counterpart
• Annexe A Common Set
• Annexe B Evidence Collection Workplan
• Annexe C Reporting Template

Preamble

Whereas, the Parties have agreed to targeted federal funding over three (3) years, beginning in 2024-25, for investments to increase access to, and affordability of, promising and effective drugs for rare diseases (DRD) to improve the health of patients;

Whereas, in Budget 2021, the Government of Canada reaffirmed its announced plan to provide ongoing funding of $500 million per year to help Canadians with rare diseases access the drugs they need;

Whereas, in March 2023, the Government of Canada announced the National Strategy for DRD, which will make available up to $1.4 billion over three (3) years to provinces and territories through bilateral agreements;

Whereas, the Government of Canada authorizes the Minister of Health to enter into agreements with the provinces and territories, for the purpose of supporting activities provinces and territories will undertake to help improve access to New DRD, enhance access to existing DRD, invest in governance and infrastructure, and improve Screening and Diagnostics for rare diseases;

Whereas, the Executive Council Act and the Intergovernmental Affairs Act authorize the provincial Ministers to enter into agreements with the Government of Canada under which Canada undertakes to provide funding toward costs incurred by Newfoundland and Labrador, to help improve access to New DRD, enhance access to existing DRD, invest in governance and infrastructure, and improve Screening and Diagnostics for rare diseases;

Whereas, this Agreement constitutes an intergovernmental agreement pursuant to Newfoundland and Labrador's Intergovernmental Affairs Act and pursuant to s. 7 of the Intergovernmental Affairs Act, this Agreement shall be signed by the Minister of Health and Community Services and the Minister for Intergovernmental Affairs;

Whereas, Canada respects jurisdictional roles, and recognizes that Newfoundland and Labrador is responsible for the design and delivery of publicly insured prescription drug coverage to its residents;

Whereas, Canada respects and acknowledges the existing pharmaceutical management systems and the roles of the pan Canadian Pharmaceutical Alliance and Newfoundland and Labrador. The National Strategy for DRD will operate within the existing systems;

Whereas, Newfoundland and Labrador acknowledges to meaningfully engage and work with Indigenous organizations and governments responsible for the delivery of drug benefits to further support access to DRD;

Whereas, Newfoundland and Labrador acknowledges the overall importance of the meaningful support of official languages, including but not limited to the support of official languages minority communities; and

Whereas, Newfoundland and Labrador acknowledges the overall importance of the meaningful support of the use of Sex and Gender-Based Analysis Plus to address the different needs of diverse populations based on identity factors such as sex, gender, age, disability, Indigeneity, sexual orientation, ethnicity, religion and more.

Therefore, the Parties agree as follows:

1. Definitions

In this Agreement,

1.1. "Agreement" means this funding agreement and includes all annexes and any amendments made to this Agreement in accordance with section 9;

1.2. "Common Set" means the list of drugs in Annex A that has been established and is maintained through the collaborative process referenced in section 5.2 of this Agreement;

1.3. "Diagnostics" means the process of determining the nature of a disease or disorder and distinguishing it from other possible conditions in symptomatic patients or those that have screened positive;

1.4. "Election" means the designation of a drug on the Common Set by a provincial or territorial government as a drug to be made publicly available by that province or territory per section 2.2.a. and 5.1, as notified to Canada per section 12 upon the effective date of this Agreement and at any point thereafter up to and including March 31, 2026;

1.5. "Eligible Expenditures" means the costs described in section 5.6 of this Agreement that Canada has agreed to contribute to and that are incurred and paid by Newfoundland and Labrador in carrying out the Initiative;

1.6. "Evidence Collection Mechanisms" mean the processes and activities undertaken to support evidence collection in relation to the drugs in the Common Set, for New DRD not in the Common Set or other existing DRD as described in Annex B of this Agreement;

1.7. "Fiscal Year" means the twelve-month period beginning April 1st of any year and ending March 31st of the following year, and including parts thereof in the event that this Agreement commences after April 1st or expires or terminates before March 31st;

1.8. "Governance Mechanism" is defined as the Pharmaceuticals Executive Group (Assistant Deputy Minister working group comprised of public drug plans which is responsible for making recommendations to Deputy Ministers for decision) and its affiliated sub-groups as may be formed from time to time;

1.9. "Initiative" means funding available to provinces and territories through bilateral agreements as part of the National Strategy for Drugs for Rare Diseases;

1.10. "New DRD" means drugs for rare diseases which have received a Notice of Compliance (NOC) by Health Canada in 2019 or later; and

1.11. "Screening" means to assess the likelihood that an asymptomatic individual in a population has a health problem or condition.

2. Objectives

2.1. The Parties commit to work together to increase access to, and affordability of, effective DRD to improve the health of patients across Canada.

2.2. The Parties agree that with financial support from Canada, Newfoundland and Labrador will:

1. Improve patient access to drugs on the Common Set through the Election of drugs by Newfoundland and Labrador;
2. Improve coverage for New DRD not in the Common Set and/or other existing DRD; and
3. Work toward improving Screening and Diagnostics for rare diseases.

2.3. Further, the Parties commit to work together to establish and strengthen national governance and data infrastructure for DRD to improve information coordination and evidence for decision-making.

3. Term of agreement and review

3.1. This Agreement will come into effect when the last Party has signed and will end on March 31, 2027, unless terminated earlier in accordance with section 11 of this Agreement.

3.2. Notwithstanding section 3.1, this Agreement covers Eligible Expenditures incurred to carry out the Initiative during the period between: April 1 of the year in which it is signed and ending March 31, 2027.

3.3. Canada and Newfoundland and Labrador will have the opportunity to review and consider results achieved, lessons learned, and potential amendments for any future agreements through a review to take place in Fiscal Year 2026-27 through the Governance Mechanism. For greater certainty, this review will include Canada's commitment in Budget 2021, subject to appropriation by Parliament, to $500 million in ongoing funding annually.

4. Financial contribution and obligations

4.1. Canada has designated the following maximum amounts to be transferred in total to all provinces and territories under this Initiative on a "base plus per capita" basis for the duration of this Agreement:

1. $468,774,452 for the Fiscal Year beginning on April 1, 2024
2. $468,774,452 for the Fiscal Year beginning on April 1, 2025
3. $468,774,452 for the Fiscal Year beginning on April 1, 2026

4.2. Fixed annual funding for the duration of this Agreement has been allocated with a base amount of $1,500,000 for each province and territory and the remainder of the funding allocated on a per capita basis. The final total amount will be paid to Newfoundland and Labrador and has been calculated using the following formula: $1,500,000 + (F – (N x 1,500,000)) x (K/L), where:

F is total one-time funding amount available under this Initiative, which is equivalent to the maximum amount payable listed in section 4.1;

N is number of jurisdictions (all 13) that will be provided the base funding of $1,500,000;

K is total population of the Newfoundland and Labrador, as determined using the population estimates from Statistics Canada minus the number of eligible clients of the Non-Insured Health Benefits program residing in Newfoundland and Labrador; and

L is total population of Canada, as determined annually using the most recent population estimates from Statistics Canada minus the number of eligible clients of the Non-Insured Health Benefits program.

4.3. Allocation to Newfoundland and Labrador for Fiscal Year 2024-25:

Subject to the terms of this Agreement and based on the formula described in section 4.2, Canada will make a contribution to Newfoundland and Labrador of up to seven million four hundred thirty-five thousand five hundred and forty dollars ($7,435,540) toward Eligible Expenditures.

4.4. For the purposes of the formula in section 4.2, the population of Newfoundland and Labrador for each Fiscal Year and the total population of all provinces and territories for each Fiscal Year will be determined by 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. Adjustments to allocations for each Fiscal Year will be made at the beginning of each Fiscal Year in accordance with Statistics Canada updated population figures.

4.5. Payments

Canada's contribution will be paid as follows:

• 4.5.1. In the initial Fiscal Year, a single installment will be paid within fifteen (15) business days from the time this Agreement comes into effect and based on the amount set out in 4.3 for Fiscal Year 2024-25.
• 4.5.2. In each subsequent Fiscal Year, the first installment will be paid on or about April 15 and the second installment will be paid on or about November 15.
  • 4.5.2.1. The amount in the first installment will be equal to 50% of the amount determined pursuant to 4.2 for Fiscal Year 2025-26 and Fiscal Year 2026-27.
  • 4.5.2.2. The amount of the second installment will be equal to the balance of Canada's contribution to Newfoundland and Labrador for the Fiscal Year as determined under section 4.2.
  • 4.5.2.3. The sum of both installments constitutes a final payment for the Fiscal Year.

4.6. Adjustment

Notwithstanding any other provisions of this Agreement, Canada may withhold or reduce any payments to be made to Newfoundland and Labrador pursuant to this Agreement in the event that:

1. Newfoundland and Labrador has failed to make an Election of any Common Set drugs as outlined in sections 2.2.a. and 5.1 before signing this Agreement in Fiscal Year 2024-25 or has no Common Set drugs Elected at the beginning of Fiscal Years 2025-26 and 2026-27.
2. Any report has not been submitted by Newfoundland and Labrador in accordance with the requirements set out in section 6; or
3. Any such report or audit conducted pertaining to this Agreement indicates that Newfoundland and Labrador's actual Eligible Expenditures for the Initiative have been lower than the amount disbursed to Newfoundland and Labrador up to the time of such report or audit.

4.7. Overpayments

In the event payments made exceed the amount to which Newfoundland and Labrador is entitled under this Agreement, the amount of the excess is a debt due to Canada and, unless otherwise agreed to in writing by the Parties, Newfoundland and Labrador shall repay the amount within sixty (60) calendar days of written notice from Canada.

• 4.7.1. For greater specificity and without reducing the general application of the foregoing, a failure to meet the requirements of section 5.3, 5.3.1, or 5.4.2 after funds have been fully paid out will constitute an incidence of payments exceeding the amount to which Newfoundland and Labrador is entitled under this Agreement and the amount of excess payable as a debt due to Canada will be calculated as follows:
  • 4.7.1.1. For section 5.3: 50% x [Total funding amount determined under section 4.2 of this Agreement for Fiscal Year 2026-27] - [Amount of federal funds spent on Common Set per section 5.3] = debt due to Canada under this section (only if positive value).
  • 4.7.1.2. For section 5.3.1: 10% x [Total amount of Newfoundland and Labrador's Eligible Expenditures for the Common Set under section 5.3 in Fiscal Year 2026-27] - [Amount of Newfoundland and Labrador's own funding from sources other than this Agreement spent on Eligible Expenditures for the Common Set under section 5.3 in Fiscal Year 2026-27] = debt due to Canada under this section (only if positive value).
  • 4.7.1.3. For section 5.4.2: 10% x [Total funding amount determined under section 4.2 of this Agreement for fiscal year 2026-27] - [Amount of federal funds spent on Screening and Diagnostics per section 5.4.2] = debt due to Canada under this section (only if positive value).

4.8. Retaining Funds

For Fiscal Years 2024-25 and 2025-26, upon request, Newfoundland and Labrador may retain and carry forward to the next Fiscal Year the amount of up to 10% of the contribution paid to Newfoundland and Labrador for a Fiscal Year that is in excess of the amount of the Eligible Expenditures actually incurred by Newfoundland and Labrador in that Fiscal Year. Any request by Newfoundland and Labrador to retain and carry forward an amount exceeding 10% will be subject to discussion and mutual agreement in writing by their designated officials, at the Assistant Deputy Minister level, and is subject to monitoring and reporting to Canada on the management and spending of the funds carried forward.

4.9. Underspending

Newfoundland and Labrador shall inform Canada in writing of any potential underspending one hundred and twenty (120) calendar days before March 31 for any given Fiscal Year.

4.10. Funding Subject to Appropriation and Initiative Funding Authorities

1. Notwithstanding any other provision of this Agreement, the amount of funding to be provided to Newfoundland and Labrador 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.
2. 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.
3. Where funding under this Agreement is to be reduced or terminated, Canada shall provide Newfoundland and Labrador with at least ninety (90) calendar days written notice of the reduction or termination and shall reimburse Newfoundland and Labrador for any Eligible Expenditures incurred up to the date upon which the reduction/termination is to take effect.

5. Use of funds

5.1. Newfoundland and Labrador will use funds for Eligible Expenditures related to the Common Set of drugs, per all Elections made by Newfoundland and Labrador, for New DRD not in the Common Set and/or other existing DRD, and for the improvement of Screening and Diagnostics for rare diseases.

5.2. Newfoundland and Labrador will participate via the established Governance Mechanism in the collaborative process to:

1. update the Common Set, as required; and
2. contribute to the development and implementation of Evidence Collection Mechanisms for use in decision making on public plan drug listing as outlined in Annex B.

5.3. In Fiscal Year 2026-27, Newfoundland and Labrador will use a minimum of 50% of the federal funding made available under this Agreement for Eligible Expenditures incurred in that Fiscal Year that arise from the making available of Common Set drugs for which Newfoundland and Labrador has made an Election, per sections 2.2.a. and 5.1.

• 5.3.1. In Fiscal Year 2026-27, Newfoundland and Labrador will spend, using its own funding from sources other than this Agreement, a cost-share equal to a minimum of 10% of Eligible Expenditures incurred in that Fiscal Year that arise from the making available of Common Set drugs for which Newfoundland and Labrador has made an Election, per sections 2.2.a. and 5.1.

5.4. Newfoundland and Labrador will participate via established Governance Mechanism in a collaborative process to work towards the improvement of Screening and Diagnostics for rare diseases and identifying best practices and lessons related to rare disease initiatives.

• 5.4.1. In Fiscal Year 2024-25 and 2025-26 Newfoundland and Labrador may allocate a total of up to 10% of the Fiscal Year federal funding under this Agreement, on activities related to the improvement of Screening and Diagnostics for rare diseases.
  • 5.4.1.1. Newfoundland and Labrador, may, in accordance with their need and circumstances, allocate unutilized Screening and Diagnostic funds in Fiscal Year 2024-25 and 2025-26 to other Eligible Expenditures.
• 5.4.2. In Fiscal Year 2026-27 Newfoundland and Labrador will use 10% of the federal funding made available under this Agreement for Eligible Expenditures incurred in that Fiscal Year for activities related to the improvement of Screening and Diagnostics for rare diseases.

5.5. Newfoundland and Labrador will allocate the remainder of the federal funding under this Agreement not used in sections 5.3 and 5.4 to incrementally improve coverage for New DRD (not in the Common Set) and/or other existing DRD.

5.6. Newfoundland and Labrador will use funding under this Agreement only for expenditures that support the objectives of the Initiative, and are directly related to the activities set out herein. Eligible Expenditures include:

1. Operating costs including: salaries and benefits, contractual personnel, honoraria, training and professional development, travel and accommodation, materials and supplies, equipment, and rent and utilities;
2. Costs related to changes to public drug plans (e.g., the cost of adding new drugs to formulary, the cost of reducing out-of-pocket costs, the cost of planning, administrative, and communication activities related to DRD coverage changes);
3. Costs associated with improving and broadening rare disease treatments and services (e.g., DRD coverage, screening or diagnostic initiatives, surveillance, evidence collection, and research on enhanced DRD coverage including costs associated with drug pricing or reimbursement pilot projects);
4. Information technology and related investments, including enhancement of data collection, analysis, and sharing capacity; and
5. Activities associated with evaluation and reporting obligations.

5.7. Without reducing the applicability of the foregoing, Newfoundland and Labrador may use up to 2% of their funds on administrative costs associated with the Initiative.

6. Performance measurement and reporting

6.1. Newfoundland and Labrador will designate an official or official(s) for the duration of this Agreement to represent its interests related to performance measurement. This includes supporting, through committee structures as they may be established, the establishment and strengthening of national governance and data infrastructure for DRD by:

1. enabling the development of and reporting on performance measurement and other metrics relevant to improving national decision making on DRD, such as data sharing of evidence and outcomes with pan Canadian health organizations; and
2. identifying and sharing best practices and lessons learned related to rare disease initiatives.

6.2. As a condition of receiving annual federal funding under this Agreement, by no later than October 1, 2025, October 1, 2026, and October 1, 2027, Newfoundland and Labrador agrees to:

• 6.2.1. Provide to Canada an attested annual financial statement of the funding received from Canada under this Agreement during the prior Fiscal Year compared against sections 5.3, 5.4 and 5.5 of this Agreement as outlined in section 6.2.1.1.
  • 6.2.1.1. The financial statement shall show:
    1. the total amount of funding received from Canada under this Agreement;
    2. If applicable, the amount of any overpayment that is to be repaid to Canada under section 4.7;
    3. If applicable, the amount carried forward under section 4.8;
    4. the total amount of funding from Canada spent on the Eligible Expenditures for drugs in the Common Set (section 5.3);
    5. the total amount of PT funding (from sources other than this Agreement) spent on the Eligible Expenditures for drugs in the Common Set (section 5.3.1);
    6. the total amount of funding from Canada spent on Eligible Expenditures for Screening and Diagnostics (section 5.4);
    7. the total amount of funding from Canada spent on Eligible Expenditures for New DRD not in the Common Set (section 5.5); and,
    8. the total amount of funding from Canada spent on Eligible Expenditures for existing DRD (section 5.5).

6.3. Newfoundland and Labrador also agrees to report, by October 1, 2025, October 1, 2026, and October 1, 2027, and in accordance with the performance measures set out in Annex C, on the outcomes and results achieved using funding received from Canada under this Agreement during the prior Fiscal Year. Which includes:

1. Indicators to measure the performance of the National Strategy
2. Identification of Newborn Screening tests for rare diseases that are included on PT screening panels
3. List of drugs in the Common Set with a corresponding evidence generation plan (if applicable) for which PTs have made public funding available for in the last Fiscal Year
4. Consideration given to measures in support of Official languages, in particular the needs of Official Language Minority Communities under this Initiative
5. Consideration given to measures in support of the use of Sex and Gender-Based Analysis Plus to address the different needs of diverse populations based on identity factors such as sex, gender, age, disability, Indigeneity, sexual orientation, ethnicity, religion and more under this Initiative

6.4. Audit

Newfoundland and Labrador will ensure that expenditure information presented in the annual financial statement is, in accordance with Newfoundland and Labrador standard accounting practices, complete and accurate.

6.5. Evaluation

Responsibility for evaluating the Initiative rests with Newfoundland and Labrador in accordance with its own evaluation policies and practices.

7. Communications

7.1. The Parties agree on the importance of communicating with the public about the objectives of this Agreement in an open, transparent, effective, and proactive manner through appropriate public information activities. The Parties agree to coordinate their efforts on public communications related to this Agreement to ensure consistency in messaging.

1. The Parties agree that the identity of a drug on the Common Set will not be publicly disclosed until 60 calendar days, or sooner as may be agreed by the Parties, have passed following the conclusion of the Letter of Intent by the pan Canadian Pharmaceutical Alliance.

7.2. The Parties will each receive the appropriate credit and visibility when investments financed through this Agreement are announced to the public.

7.3. In the spirit of transparency and open government, Newfoundland and Labrador and Canada will make this Agreement, including any amendments, and subject to section 10.4, publicly available on a Government of Canada website, with the exception that Annex A is confidential and restricted from publication.

7.4. Newfoundland and Labrador agrees to make the results under this Agreement, subject to section 10.4, publicly available on its Government of Newfoundland and Labrador website.

7.5. Canada, with prior notice to Newfoundland and Labrador, may incorporate all or any part or parts of the data and information in section 6, or any parts of evaluation and audit reports made public by Newfoundland and Labrador into any report that Canada may prepare for its own purposes, including any reports to the Parliament of Canada or reports that may be made public.

7.6. The Parties reserve the right to conduct public communications, announcements, events, outreach and promotional activities about the National Strategy for DRD and this Agreement, and to give ten (10) business days advance notice and advance copies of public communications related to the National Strategy for DRD, this Agreement, and results of the investments of this Agreement.

8. Dispute resolution

8.1. The Parties 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.

8.2. If at any time either Party is of the opinion that the other Party has failed to comply with any of its obligations or undertakings under this Agreement or is in breach of any term or condition of this Agreement, that Party may notify the other party in writing of the failure or breach. Upon such notice, the Parties will endeavour to resolve the issue and dispute bilaterally through their designated officials, at the Assistant Deputy Minister level.

8.3. If a dispute cannot be resolved by the designated officials, at the Assistant Deputy Minister level, then the dispute will be referred to the Deputy Ministers of the Parties responsible for health, and if it cannot be resolved by them, then the respective Ministers of Canada and Newfoundland and Labrador, most responsible for health, shall endeavour to resolve the dispute.

9. Amendments to the agreement

9.1. This Agreement may be amended at any time by mutual consent of the Parties. To be valid, any amendments shall be in writing and signed, in the case of Canada, by Canada's Minister of Health, and in the case of Newfoundland and Labrador, by Newfoundland and Labrador's Minister of Health and Community Services and Minister for Intergovernmental Affairs.

10. General

10.1. Governing Laws

This Agreement shall be governed by, interpreted and enforced in accordance with the laws in force in Newfoundland and Labrador and the laws of Canada applicable therein.

10.2. Entire Agreement

This Agreement, including its preamble sets forth the entire Agreement between the Parties with respect to its subject matter and supersedes and cancels all prior agreements, understandings, negotiations and discussions, both oral and written, between the Parties with respect to the Initiative.

10.3. Members of Parliament

No member of the House of Commons or Senate or of the House of Assembly of Newfoundland and Labrador shall be admitted to any share or part of this Agreement or to any benefit arising from it that is not otherwise available to the general public.

10.4. Personal and Confidential Information

The Parties shall comply with applicable laws, contractual obligations and policies pertaining to privacy and confidentiality in dealing with information and records related to the Initiative.

10.5. Official languages

Newfoundland and Labrador agrees to consider how they can support Canada's official languages and the needs of official language minority communities in the implementation of this Agreement.

10.6. Diverse populations

Newfoundland and Labrador agrees to consider how they can support diverse populations based on identity factors such as sex, gender, age, disability, Indigeneity, sexual orientation, ethnicity, religion and more in the implementation of this Agreement.

11. Terminating the agreement

11.1. Either Party may terminate this Agreement at any time if the terms of this Agreement are breached by the other Party by giving at least six (6) months written notice of its intention to terminate.

11.2. As of the effective date of termination of this Agreement, Canada shall have no obligation to make any further payments.

11.3. All obligations under this Agreement shall expressly, or by their nature, survive termination or expiration of this Agreement until, and unless, they are fulfilled, or by their nature expire.

12. Notice

Communications, including reporting and any notice, information, document, request or other communication, shall be in writing and sent to the coordinates below. Communications that are delivered in person shall be deemed to have been received upon delivery; communications transmitted by facsimile or by e-mail shall be deemed to have been received one (1) business day after having been sent; and communications that are sent by mail shall be deemed to have been received eight (8) business days after being mailed.

Any notice to Canada shall be addressed to:

• Associate Assistant Deputy Minister, Health Policy Branch
• Health Canada
• 70 Colombine Driveway, Tunney's Pasture
• Building Brooke Claxton Building
• Ottawa, Ontario
• K1A 0K9
• Email: michelle.boudreau@hc-sc.gc.ca

Any notice to the Newfoundland and Labrador shall be addressed to:

• John McGrath
• Deputy Minister, Department of Health and Community Services
• Government of Newfoundland and Labrador
• P.O. Box 8700, St. John's, NL A1B 4J6
• Email: JohnMcGrath@gov.nl.ca

13. Signing in counterpart

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, this Agreement is duly executed by authorized representatives of the Parties.

Signed on behalf of Newfoundland and Labrador by the Minister of Health and Community Services this 15^th day of November, 2024.

The Honourable John Hogan, KC, Minister of Health and Community Services

Signed on behalf of Newfoundland and Labrador by the Minister for Intergovernmental Affairs this 15^th day of November, 2024.

The Honourable Dr. Andrew Furey, Minister for Intergovernmental Affairs

Signed on behalf of Canada by the Minister of Health this 6^th day of November, 2024.

The Honourable Mark Holland, Minister of Health

Annex A – Confidential

Annex B – Evidence collection

Purpose:

This document serves as an Annex to the National Strategy for Drugs for Rare Diseases Initiative Canada-Newfoundland and labrador funding agreement (the "Agreement") as referenced in section 5.2(b) of that Agreement.

1. Definitions:

   "Evidence" is Real World Evidence and Real World Data

   "Evidence Collection" means the processes by which Evidence is generated and collected for the further evaluation of drugs in the Common Set and may include, but is not exclusive to, work done by individual PTs, the PT DRD Working Group and other Strategy partners

   "Evidence Collection Work Plan" means the Evidence Collection Work Plan approved each quarter throughout the term of the agreement by the Pharmaceuticals Executive Group

   "Real World Data" are data relating to patient status and/or the delivery of health care routinely collected from a variety of sources

   "Real World Evidence" is evidence on the use, safety, effectiveness, and cost of health technologies that is derived from real-world data.

2. All other terms are defined as outlined in the Agreement
3. Newfoundland and Labrador will support the inclusion of Evidence Collection as part of the pan-Canadian Pharmaceutical Alliance negotiation process, as and where appropriate.
4. Newfoundland and Labrador will participate in the development of the Evidence Collection Work Plan, including the development and identification of mechanisms/options to support Evidence Collection in respect of drugs in the Common Set.
5. Newfoundland and Labrador will fulfill the duties of a PT in regard to Evidence Collection, as outlined in the Evidence Collection Work Plan, including but not limited to:
   1. Newfoundland and Labrador will support Evidence Collection Mechanisms in relation to drugs in the Common Set according to the Evidence Collection Work Plan;
   2. Newfoundland and Labrador will support projects / pilots related to drugs on the Common Set;
   3. Newfoundland and Labrador will participate in partnerships with identified organizations to support the collection/generation of evidence on Common Set drugs as and where appropriate / as determined by the Evidence Collection Work Plan;
   4. Newfoundland and Labrador will support data collection and sharing, as outlined in the Evidence Collection Work Plan.
6. Newfoundland and Labrador may also participate, at its option, in activities, as developed under the Evidence Collection Work Plan, for New DRD not in the Common Set and/or other existing DRD.

Annex C – Reporting requirements for Provinces and Territories under the National Strategy for Drugs for Rare Diseases

To measure the performance of the provincial/territorial component of the National Strategy for Drugs for Rare Diseases (National Strategy) over time, Provinces and Territories (PTs) will be required to report specific data on a yearly basis covering the previous Fiscal Year. The data will be used to report internally on the progress of the Strategy and may be used to report publicly or communicate on National Strategy implementation pending notification to PTs (pursuant to sections 7.4 and 7.5 of the Agreement, which allow for this).

The data will cover New drugs for rare diseases (DRD) (including those in the Common Set), other drugs for rare diseases, and Screening and Diagnostics.

Reporting deadline: October 1 for the period covering April 1 to March 31 of the previous Fiscal Year

• First reports to be submitted by October 1, 2025 covering April 1, 2024 to March 31, 2025
• Count indicators measure a point in time – i.e., the current status as of March 31 (e.g., on March 31, how many drugs in the Common Set have there been an Election for by the PT)

Data required from PTs on a yearly basis:

Definitions:

DRD – a drug for a condition with an orphan designation by the European Medicines Agency or US Food and Drug Administration.

Existing DRD – means a DRD that obtained Health Canada approval prior to 2019.

Genome-wide sequencing (GWS) – refers to whole exome sequencing (WES) and whole genome sequencing (genome sequencing refers to sequencing the entire genetic code of a person and exome sequencing refers to sequencing only the parts of the genome that contain protein-coding genes). Genome-wide sequencing technologies: A primer for paediatricians - PMC (nih.gov)

Routinely offering – means offered regularly as a normal part of diagnostic processes (even if testing is completed outside of the PT).

Reporting template for Provinces and Territories under the National Strategy for Drugs for Rare Diseases

Province or territory:

Reporting period: [April 1, YYYY to March 31, YYYY]

Table 2: Newborn Screening tests for rare diseases that are included on PT Screening panels

In order to simplify reporting we have provided a list of conditions that are included on newborn Screening panels in Canada. The Intergovernmental Newborn Screening Working Group Report Back to Ministers of Health – Provincial-Territorial Health Ministers' Meeting (January 2016) included a list of 22 diseases for the recommended national core panel. These diseases are highlighted in Table 2. All of these were also included in a recent document prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH) for discussion purposes at its Newborn Screening Panel meetings, with the exception of Methylmalonic acidemia (Cbl A, B). The additional conditions were included in CADTH's document.

This list is not exhaustive. Please add rows as needed.

Table 3: List of drugs in the Common Set for which the PT has made an Election with a corresponding evidence generation plan (if applicable) from [April 1, YYYY to March 31, YYYY]

Please add rows as needed

Table 4: Date the PT makes public funding available from [April 1, YYYY to March 31, YYYY] for each drug for which the PT has made an Election in the Common Set

Table 5: Date the PT makes public funding available from [April 1, YYYY to March 31, YYYY] for each New DRD not in the Common Set