Issue link: http://clhia.uberflip.com/i/406567
37 12. The CLHIA recommends that: • during the upcoming review of the Patent Act that amendments be made to reduce the need for unnecessary litigation in order for generics to gain entry into the market; and • in the interim, that Canada introduce a 180-day exclusivity period for the first generic company to successfully file a generic application with a challenge to a brand patent. 13. The CLHIA recommends that where a brand drug is currently on a provincial formulary and a generic has been approved as bio-equivalent with the Canadian brand reference product by Health Canada, that the generic be automatically interchangeable without the need for additional review by the provinces and automatically listed. 14. The CLHIA recommends that regardless of whether a drug is listed on a provincial formulary, generic price caps apply to all generic drugs approved for sale in their respective province. 15. The CLHIA recommends that: • Health Canada clarify its approach to reviewing and approving SEBs through, for example, a specific regulatory process for the approval of SEBs; and • the PMPRB should review and regulate the pricing for SEBs going forward.