CLHIA-ACCAP

CLHIA Report on Prescription Drug Policy

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5 efficacy, but it can also facilitate, in some instances, early access to new medicines. A well- functioning clinical trial system in Canada, and globally, is important in order to ensure Canadians have access to safe and effective drugs. Having a transparent, strong and vibrant clinical trial system in Canada also helps to protect and maintain the key medical expertise in the country. Ensuring a maximum degree of transparency of clinical trials is critical to give physicians and patients the opportunity to properly assess the effectiveness and potential dangers associated with a new drug. In this regard, it's important that clinical information from clinical trials - whether positive or negative - be transparent and available. Recently, the Canadian clinical trial system has been criticized for its relative lack of transparency. For example, a survey of the international registries "clinicaltrials.gov" and "controlled-trials.com" showed that between May 2011 and May 2012 only about 50 per cent of the patient clinical trials filed with Health Canada were publically registered. 3 In response, as of April 2013, Health Canada made their full database public. The Canadian life and health insurance industry supports Health Canada's commitment in this regard. Ultimately, payers in Canada leverage the data from clinical trials to help in the assessment of the potential benefits of adding a new drug to their list of covered drugs. Generally, clinical trials are conducted by comparing the new drug's effectiveness against a placebo. While it is important to understand if a new treatment provides benefits over no treatment, in the majority of cases what a payer is assessing is the benefit of a new drug versus an existing drug or drug therapy. THEREFORE, THE CLHIA RECOMMENDS THAT: • WHERE APPROPRIATE, CLINICAL TRIALS IN CANADA BE HEAD-TO-HEAD TRIALS BETWEEN THE NEW DRUG AND EXISTING DRUGS OR DRUG THERAPIES. 3 http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_ct_db_ec_bd-eng.php

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