CLHIA-ACCAP

CLHIA Report on Prescription Drug Policy

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7 Canadian life and health insurance industry believes that Health Canada could seek further efficiencies and improve the speed to market of prescription drugs by, for example, recognizing approvals in select other jurisdictions. THEREFORE, THE CLHIA RECOMMENDS THAT: • HEALTH CANADA SPEED UP ACCESS TO NEW DRUGS BY ENTERING INTO BILATERAL AGREEMENTS TO RECOGNIZE APPROVALS IN OTHER SELECT JURISDICTIONS, SUCH AS THE U.S. OR EUROPE, THAT HAVE PROCESSES SIMILAR TO CANADA'S WITHOUT IMPACTING PATIENT OUTCOMES. a.2.2 Post-Market Review of Prescription Drugs The post-market review of prescription drugs is important to ensure that the benefits promised during the initial drug review and approval stage have actually been realized. Once a new drug is on the market, actual population exposure to the drug often differs significantly from the clinical trial samples, both in terms of the number and diversity of people receiving treatment. For instance, general population exposure may include people with multiple medical conditions taking a number of other medications and groups that were not tested during clinical trials (e.g., children and pregnant women) and will necessarily span longer timelines than was the case during the clinical trial phase. As a result, different effects may be observed post-launch than were seen during the clinical trial and approval stages. Currently, there are limited regulatory requirements to ensure that drug companies conduct additional research into product safety and effectiveness once their drug has entered the market. Under the Food and Drugs Act, Health Canada has limited authority to deal with post market safety issues. Drug manufacturers are required by law to inform Health Canada of any serious adverse reactions to their products. If a serious health risk is identified, Health Canada can take action ranging from distributing new product safety information to the public and/or the health care community, to removing the product from the market. Health Canada does not itself do any follow-up analysis of effectiveness or adverse reactions; rather the onus is on the

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