The Best Medicines Coalition (BMC) was formed in 2000 as a grassroots group of consumer and advocate organizations. The BMC is a broad-based alliance of organizations and individuals working in or promoting education, care, research and consumer-focussed advocacy on issues related to drug review reform, drug access and related health policy development. The members of the BMC represent millions of Canadians living with or affected by chronic disease or illness.

The Best Medicines Coalition is committed to people-centred access to the best medicines for all Canadians and to ensuring consumer participation, engagement, transparency and accountability of the Canadian drug review and approval process.

We are also a member of GRI, Get It Right for Patients, an advocacy coalition of 10 disease groups. We have been pleased that representatives from GRIP have had several meetings to bring our specific concerns to the Drug Systems Secretariat and the Minister of Health and Long-Term Care.

Our three primary concerns with Bill 102 are related to the designation of drugs as interchangeable, the accountability of the Executive Officer and patient expertise on the Committee to Evaluate Drugs (CED).

Interchangeability of Drugs

- Ensuring Access to Treatments by Patients

• BMC was very alarmed by initial language in Bill 102 that would expand interchangeability to include similar as well as same, as the originally proposed language is so broad that it could create significant health and safety risks for patients; and
• New Dispenser Powers that would allow automatic switching of drugs even when they were not designated interchangeable and were similar. In particular, we expressed our concern at the proposal to add Section 3 of the Bill which would expand the ability of the pharmacist to interchange drugs that had “similar” active ingredients even where the drug was not designated as interchangeable.

Powers of the Executive Officer

- Ensuring A Re-Review Process When the Executive Officer Rejects the Listing of a Drug

Committee to Evaluate Drugs

- The other area of concern to BMC is with regard to consumer expertise on the CED and the policy committee. While we are pleased to see the addition of two patient representatives on the CED, we strongly recommend a formal selection process and a formal accountability mechanism be developed to ensure that those patient representatives get input from relevant disease groups for which drugs are under the CED’s consideration.

Moving Forward:

• We thank the Minister and his team for listening to and responding to the patient voice.
• BMC and the Minister have achieved an understanding that we believe will protect patient health re: interchangeability.
• We have helped the Minister and his team craft a legislative amendment which narrowly defines “Similar” for the purposes of interchangeability to non active binding agents.
• The Minster has confirmed that a proposed addition to the legislation to expand the powers of the dispenser will be removed.
• These two amendments to the Bill provide us with enough assurance that patient safety and health outcomes will not be compromised.
• We also have presented to the Minister’s team a proposal which enables the EO to be effective and ensure reasonable checks and balances in the system so that she/he is obtaining all information that is important when making listing decisions. We are proud to have come to a consensus on what the EO re-review process will be and thank the Minister’s team for recognizing the enhancements to their initial proposal that GRIP brought to the table.
• We accept the Ministers invitation to continue to work with him and his team on an ongoing basis to build Regulations, Policies and Procedures which will enhance our support for this legislation.

We strongly recommend that this Committee adopt and maintain the following:

1. The amendment to section 1.1(3.1) which defines similar active ingredients for purposes of interchangeability in section 1.1(3) – BMC’s bottom line: NO INTERCHANGEABILTY FOR SAME TO SAME AND SAME TO SIMILAR WITHOUT THE NO SUBSTITUTION PROTECTION. No Substitution when chemical entities are not the same.
2. The deletion of section 3 of Bill 102 and the restoration of the previous section (DIDFA) section 4(5).
3. The amendment to Section 6 of Bill 102 which clearly states that nothing in the Act or the DIDFA should be construed to permit therapeutic substitution.
4. A formal selection process and a formal accountability mechanism be developed to ensure that CED’s patient representatives get input from relevant disease groups who have expertise related to the drugs under CED’s consideration.
5. Finally, the new rapid review process for “breakthrough” drugs must recognize that demonstrable improvements in serious health outcomes include demonstrable quality of life indicators.
6. The legislation maintains and sustains that patients will be actively engaged in ongoing discussions and decisions.