Thank you. My name is Pier-Giorgio Fontana and I am a consultant for Canada's Research-Based Pharmaceutical Companies.
I am very pleased to appear before this committee on behalf of Canada's Research-Based Pharmaceutical Companies, Rx&D, to discuss the very important issues of post-market surveillance of pharmaceuticals.
Rx&D, as you know, is the national organization representing more than 50 research-based pharmaceutical companies in Canada and the 20,000 men and women who work for them.
Averaging more than $1 billion a year in research and development investments, we are one of the country's most R and D-intensive industries, second only to the telecommunications sector.
Let me begin by stressing that drug safety is of the utmost importance for Rx&D member companies. Evaluation of a drug's safety starts in the laboratory, continues through clinical development, and is pursued with diligence as long as a medicine is on the market. This sustained effort helps ensure that the therapeutic benefits of new medicines outweigh any potential risks to patients.
Innovative pharmaceutical companies worldwide invest significant resources in safety departments whose experts, in collaboration with the stakeholders, epidemiologists, and other researchers, focus on post-market surveillance as well as assessing and reducing risk. This work continues throughout the entire life cycle of a drug. The safety experts in each company are part of a system under which manufacturers have an obligation to report adverse events received from any source to national and international health regulatory authorities. These experts follow up individual cases with the health professionals or others involved in the initial report to ensure the accuracy and completeness of the information. This information is subsequently analyzed by the regulatory authorities. Adverse event data is also entered in the manufacturers' global pharmacovigilance database and analyzed for periodic safety update reports, also referred to as PSURs, which are submitted to the regulatory agencies.
Following discussion with health authorities, we communicate to health care professionals in institutions important changes to the safety profile of the product. These changes are reflected in documents approved by the regulator. Occasionally, due to new safety information altering the benefit-risk balance, a product may be withdrawn from the market or its use restricted. Furthermore, pharmaceutical companies have been discussing and reaching agreements with major regulatory authorities, including Health Canada, on approaches to post-market safety planning for individual products before their approval.
In addition to informing regulatory authorities of all clinical trial results and ongoing studies as part of submissions to these authorities, the innovative pharmaceutical industry is also committed to increasing the transparency of clinical trials information to healthcare practitioners, patients and others.
In keeping with the work of our industry's global association, the IFPMA, our member companies are committed to posting results of all clinical trials, other than exploratory trials, once a drug has been approved in any country. Moreover, these confirmatory trials are posted at their onset in publicly accessible registries.
This information can be found online at the IFPMA clinical trials portal. This portal and the global industry's guiding joint position statements issued in 2005 can also be accessed through the Rx&D website.
We note that major jurisdictions abroad have developed or are developing clinical trials disclosure requirements. We recommend that the requirements being developed by Health Canada should be consistent with the approaches taken by the regulatory authorities in the United States and the European Union.
We believe that the current health safety system provides a significant level of protection while making available to patients the therapeutic benefits of innovative medicines. However, there is always room for improvement.
Rx&D feels strongly that the post-approval safety efforts in Canada could be maximized by taking an international perspective, harmonized with regulatory authorities like the U.S. and the European Union and consistent with best practices found in other jurisdictions. Health Canada may wish to pursue this more vigorously in order to create greater synergies with these key regulatory agencies. This would allow companies in Canada to better contribute to post-market safety by building more efficiently on the efforts of their global counterparts.
The use of common worldwide definitions and procedures, as well as compatible databases and analysis tools, would maximize the value of all available post-market data. Health Canada would then be in a better position to detect and evaluate potential adverse events as early as possible. In this context, it should be noted that Canada may not have the population size that would allow detection of very rare events.
Similarly, the discussions between the manufacturer and Health Canada on post-market safety planning for individual product should be based on harmonized guidelines and international databases. In this way, the global nature of the plans would increase the value of these post-market safety initiatives. Indeed, Canada has been contributing to the development of international safety standards and guidelines through participation in working groups involving regulatory authorities and industry experts.
Spontaneous reporting of adverse drug events is a valuable means of detecting potential safety signals in the post-approval context; however, it is critically important that the information reported is of sufficient quality to contribute to a scientifically sound decision. Therefore, we suggest that improved means of training and interacting with health care professions be developed to heighten awareness of the need for detailed and accurate reporting.
Detecting and assessing causes of adverse events requires robust methodologies, with the information then disseminated to all stakeholders. By keeping the manufacturer fully informed when evaluating safety signals, Health Canada would allow us to better follow the evolving benefit-risk balance of our products and communicate it in a prompt, accurate, and effective way.
The safety of new medicines can be improved through research aimed at strengthening drug development science already taking place in collaboration among industry, regulatory authorities, and academic centres in the U.S. and Europe.
As an active partner, the global innovative pharmaceutical industry is pursuing research to improve models and predictors for evaluating the safety and efficacy of drugs under development and reliable tests for detecting patients more at risk to certain adverse events.
In conclusion, Rx&D believes it has been a reliable contributor to the current regulatory system, and we are prepared to continue to work with Health Canada on ways to improve it.
We encourage the committee to take a global perspective to harmonizing our definitions, procedures, tools, and requirements with those major regulatory authorities abroad; report quality safety data from the field as a fundamental feature for the capture of adverse incidents in Canada; promote a collaborative approach between industry, regulatory authorities, and academia to create synergies needed to expand our collective knowledge on how medicinal therapies affect patients; and measure the impact on safety of any new initiatives.
I would like to thank the committee for this opportunity to talk about our role in post-market safety within a multi-stakeholder regulatory system that is designed to provide—and does provide—a significant level of protection to Canadians.
Let me reiterate that as an industry and a community we are prepared to work with Health Canada in the most efficient manner to maintain favourable risk-benefit balance for our products so that Canadian patients can derive the maximum therapeutic value from the medicine they take.
Thank you very much.