Issue link: http://clhia.uberflip.com/i/406567
32 E. ENSURING ACCESS TO ORPHAN DRUGS The Canadian life and health insurance industry believes that ensuring access to prescription drugs that effectively treat rare diseases is an important policy objective. This is particularly challenging, however, with orphan drugs, that only affect a very small number of patients (typically less than 5 in 10,000 persons). 16 e.1 Collaborative End-to-End Approach to Approval and Funding of Orphan Drugs Currently, orphan drugs are approved in Canada through the same regulatory process as other drugs. Alternatively, under the present Canadian system, a patient can apply for access to an unapproved drug if his or her physician makes an application under the Special Access Program (SAP). In each SAP application, a Canadian physician makes a request in respect of a single patient for up to a 6 month supply of an unapproved drug for emergency treatment purposes. In October 2012, Health Canada announced that it is committed to developing a regulatory framework to be used specifically to approve orphan drugs. The new framework will be outlined in new regulations and these regulations will be subject to public consultation. The timeframe for the introduction of the regulations, however, is unknown at this time. The Canadian life and health insurance industry supports the development of an orphan drug regulatory framework in Canada to approve orphan drugs. However, we believe that developing a new approval process for orphan drugs without due consideration for how the system will fund such new drugs will be problematic going forward and lead to serious disappointment if a patient cannot afford an effective drug. Accordingly, we believe that it is important for Canada to design and implement an end-to-end review and approval process for orphan drugs that will include not only a safety and effectiveness review but also work towards the establishment of an an equitable and sustainable funding arrangement for such drugs. 16 http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-147a-eng.php