1. Patients and their needs come first.  Decisions about appropriate treatment are solely to be determined by patients and their physicians.
  2. Cost should never be the primary driver for decision-making. The doctor and patient should together consider all the information and make decisions based on what is best for the patient.
  3. SEBs have a role to play in providing additional alternatives for patients, rather than one which ends up limiting choices. Given that the SEBs are not identical to existing approved treatments, their introduction to formularies as additional options is encouraged.
  4. There should not be a presumption of substitutability or interchangeability by physicians, pharmacists, or public or private insurers.
  5. In order to protect the safety of our patients, we call on the  Canadian government to:
    1. Require any medication that is not clinically identical to a currently available drug to be subjected to the exact same rigorous safety and efficacy  Helath Technology Assessment safety and efficacy processes required of all new therapies in Canada. Specifically:
      1. Separate submission for each  disease  indication seeking approval
      2. Rigorous Canadian clinical trial data required of any new medication
    2. SEBs should have names that are distinct and different from the reference drugs, so there is no risk for accidental substitution, nor the incorrect perception that they are identical
  6. However, should Health Canada approve an SEB for a skin disease based on data referenced from either the original reference molecule or based on results for another non-skin disease indication there is a critical a requirement for rigorous post market safety monitoring.

 For a more in-depth discussion of these positions, please refer to

 CSPA Comments on CDR procedures and process for reviewing SEBs

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