Overview

The Transparent Drug System for Patients Act (Bill 102) represents an important development in Ontario’s legislative framework governing the review of reimbursement of drugs in the province. The legislation has far reaching implications with potential to profoundly affect the healthcare of Ontario’s patient population. As such, through the legislative and regulatory development phases of Bill 102, the Best Medicines Coalition (BMC) has remained actively engaged with government decision makers, working to ensure that the legislation delivers its stated objectives and that patient needs are met moving forward.

The BMC is encouraged by the progress of this legislative initiative to date, including the positive response of government officials to patient input. There has been every indication that the government has a sincere desire to put the interests of patients first, and have taken steps to translate this intent into action.

While optimistic that this spirit of transparency and inclusive policy development will continue as implementation of Bill 102 gathers momentum, the BMC will remain watchful through this phase. Specifically, the Government must demonstrate a continued commitment in the following areas:

• Continued efforts to engage BMC and other patients groups as the Executive Officer assumes control of the drug system.
• Refine and clarify key remaining ambiguities in the legislation and Regulations.
• Fulfill the fundamental promise of enhanced access for patients to the medicines we need.

In furtherance of these goals, BMC continues to seek improvements in the following areas.

Meaningful patient involvement

Bill 102 places considerable power in the hands of the Executive Officer, a reform designed to increase efficiency and allow more rapid decision-making, both benefiting patients. On the other hand, there are concerns that this concentration of power could lead to decisions which might be arbitrary or insufficiently oriented toward the patients’ interest.

The critical counterweight to this concentration of power is a strong voice for patients and patient associations in the governance of the drug system. The appropriate mix of patients and representatives of patient associations must be in place, both in the Committee to Evaluate Drugs and the Citizen’s Council.

In addition, while it is useful to review international models for citizen councils, the BMC urges the government proceed cautiously before adopting specific structures. Given the differences in various jurisdictions, it is critical to develop a framework that works specifically for Ontario. We understand that the Drug Secretariat is creating a ‘made for Ontario’ model. We look forward to reviewing and contributing to the development and implementation of this model.

In the interests of transparency and accountability, BMC will continue to monitor the situation closely and assertively advocate for suitable representation from patients and representatives of patient associations.

Elimination of drug substitution risk

Enforced substitution by the Ontario Drug Benefit program of one medicine for a different one is not in the best interests of patients. Bill 102’s provisions on this issue have been a major source of concern since the Bill’s introduction.

The Government of Ontario has provided many reassurances that it does not intend to force reference-based pricing, let alone therapeutic substitution, as is used in British Columbia with disastrous consequences. However, Bill 102’s language, and that of its Regulations, provide insufficient protection against this practice taking hold as decision-makers seek to cut costs. More worrisome is the fact that while legislation has been amended to accommodate some of these concerns, there has been strong resistance to efforts by BMC and other patient advocates to close the door completely on therapeutic substitution.

BMC insists on a firm, full and final change to the legislation and/or Regulations that makes therapeutic substitution impossible in Ontario. Specifically, the Bill should be amended to define the banned practice of “therapeutic substitution” as: “the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent, without authorization from the originating prescriber.” For greater certainty, the practices of “reference based pricing” and “maximum allowable cost pricing” and “lowest cost alternative” should be specifically included in the ban.

Broader access through new listings

Bill 102 is built on a promise from the government to the province’s patients: that savings from changes to the drug system will be reinvested in the drug system – in the form of greater access to medicine for patients. The BMC continues to hold the position that the government should invest in access, improving the ability of patients to make wise choices involving the use of appropriate available medications.

The government’s numbers tell us that it will save approximately $277 million each year in ODB program costs. It has provided a dollar-for-dollar accounting of which initiatives in Bill 102 will achieve the savings. In the interests of transparency, patients should be given a similar accounting, on an annual basis, showing how the savings will be reinvested in access to new medicines. In order to achieve full transparency, an annual accounting should also be provided of the costs associated with each new listing that occurs.

Efficient early access

BMC is supportive of Bill 102’s replacement of Ontario’s extremely cumbersome system for providing patients with early access to innovative drugs. The challenge now is to ensure that the new structure actually performs better than the one it replaced. Recent actions effectively removed 25 per cent of the existing Section 8 listings off the rolls, in effect upgrading patients’ access to those medicines. The BMC will continue to monitor progress on this front, hopeful that this valuable early action will continue in the same appropriate direction.

Pharmacists services to meet patient needs

The contribution that pharmacists make on the front lines of patient management, specifically medication management, is significant and has great potential. The BMC supports the creation of the Pharmacy Council and its active consideration of the broad area of professional services and reimbursement for those services.

It is the BMC’s position that when reviewing whether a specific professional service warrants reimbursement, criteria be applied so that the service is evaluated on its merit in terms of direct benefit to patient care. Indeed there are many services performed by pharmacists that would meet this broad criteria. A prime example is the time-consuming counselling, which pharmacists provide to aid patients in navigating the Trillium program. This necessary service has a direct positive impact on accessibility and patient health and therefore pharmacists should receive compensation for time expended.

Fairness Review checks and balances

In the spirit of transparency and accountability, the BMC supports the creation of a Fairness Review process to ensure that all proceedings of the Committee to Evaluate Drugs are conducted appropriately. The BMC’s position is that this process should be straightforward yet formalized. As such, BMC recommends that a Fairness Review checklist be developed in consultation with stakeholders including the BMC, and that this checklist be available for public review.