I would like to thank the Standing Committee on Health for the opportunity to discuss post-market surveillance in the pharmaceutical sector.
I am the director, Ontario public drug programs, with the Ministry of Health and Long-Term Care, and I assist in managing the Ontario drug benefit program, a drug reimbursement program primarily for seniors, social assistance recipients, and individuals with high drug expenses in relation to income.
I am also the co-chair of the national pharmaceutical strategy working group on real-world drug safety and effectiveness. Part of the mandate of this NPS working group was to look at opportunities to build upon post-marketing surveillance in Canada and the body of evidence that is being done in various research sectors to determine if there are opportunities to coordinate this work and improve collaboration across Canada.
Direction is still being sought from ministers regarding the NPS work. Therefore, the focus of my comments today will be primarily from a provincial drug plan perspective.
As noted in the terms of reference for the standing committee's study on post-market surveillance, there are a number of key issues that are very important with respect to the reimbursement of drug products as benefits under a provincial program, including monitoring a drug product's use, consumer safety, public access to information, and adverse drug reaction reporting.
Products are listed on the Ontario drug benefit formulary based on recommendations from the Canadian Expert Drug Advisory Committee, part of the common drug review; and the Committee to Evaluate Drugs, Ontario's expert advisory committee. Final decisions are made by the executive officer, Ontario public drug programs.
One of the key areas that are raised during a drug product's review by our clinical experts is how the product will be used in a real-world environment, compared to published studies that are often the basis of their recommendations. Drug studies are controlled environments, and there are many restrictions, including when and how the product is administered, patients who are eligible for the trial, and limits on what other medications the patient may receive during treatment.
This environment limits the ability of our experts to make recommendations on what is the appropriate place of therapy for a new drug product or indication. Very few studies do head-to-head trials with other drug products, so we do not have a clear understanding of the overall effectiveness and safety profile compared to other products that may be used to treat similar conditions.
In addition, this does not tell us how the product will be used in the real world. For example, are there higher risks associated with the product in certain patient groups, or is the product more effective for some individuals? Is it better to try other medications first, before moving to other products that have less solid evidence of clinical effect?
Some of the newer products coming to market may rely on surrogate markers as evidence of effectiveness. These markers are often used as a proxy. It may be assumed that a change in a marker is an indicator of clinical effect or outcome. This is particularly challenging because we often do not have the evidence to show the direct linkage between the surrogate marker and the outcome that's presumed.
If there is more reliance on this type of information to support access to new drugs and the drug approval process, post-market evaluation will become increasingly more important. la addition, there will be a need for long-term outcome studies to validate the clinical effects.
Once a product comes to market, manufacturers seem reluctant to complete these types of studies. As a result, we are often caught in a situation where the expert advisers do not have the right information to make recommendations for listing on the formulary, and manufacturers are not encouraged to complete longer-term studies to validate the initial findings upon gaining market approval.
It is imperative that data collected to support post-market research is beneficial for federal and provincial bodies. Although our roles are different, there is often a common link in the type of data that is required to assess drugs post-market. We would encourage manufacturers to continue to work in this area, as this is critical information that will be used by all sectors.
There are many examples of drug therapies that have had unexpected or negative effects when introduced to market. Some of these effects may be seen as a result of persons taking products for prolonged periods of time, well beyond the typical clinical research study period. In addition, these types of experiences will help validate some of the clinical effects that may have been assumed during the review process for new drug products and listing on provincial formularies.
Data collection and analyses are often done individually within different research centres across Canada, and the results of this work may not be communicated broadly. At this time, no organization has been given the mandate to collect and analyze these data. There may also be a lack of individuals who are trained in this area.
Funding to support research programs and linkages among those programs may help to reduce or eliminate duplication of research. It may also help to enrich the data that is collected by including a broader range of participants in the studies. This could be considered as an initial step to funding a larger centre and may help ensure that functions to support these programs and linkages to other national bodies involved in the drug review, funding, and monitoring processes are established with minimal overlap of functions. At this time, some stakeholders are looking at these opportunities to see how some of these networks could be established in Canada.
It is also important for us to clearly understand what information should be collected. Observational data is important for us to understand how broadly products are being used, and they may point to certain risks or concerns. But it may not be specific enough for one to know the actual impact of the drug, and this can create confusion within the marketplace.
The establishment of complex registries to collect data may provide the detailed information required to fully assess a drug post-market, but it will have a significant impact on resources required to collect this information.
The other important factor is timeliness of information. It is not enough to collect this information if the results are not disseminated in a timely manner so previous decisions regarding reimbursement of a drug can be re-evaluated if necessary.
In conclusion, as this work is developed it will be important to consider the impact on all stakeholders, including patients, health care professionals, manufacturers, researchers, governments, and others. A balance needs to be created to ensure that data is collected in a timely and accurate manner but does not overburden the health care sector.
Once again, I would like to thank the standing committee for allowing me to address you on this important issue.