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Approval Process for New Pharmaceuticals targeted by National Citizens Inquiry

Ottawa: The Final Report of the National Citizens Inquiry recommends that the new Federal pharmaceutical regulatory process be revoked and that Health Canada return to approving all therapeutics with its historical safety requirements.

Based on testimony during the the Inquiry Hearings, the Commissioners have concerns that the Government of Canada intends to apply a fast-track approval system to bring new pharmaceutical products to markets. They say the system would be based on a new regulatory framework that appears to limit or eliminate the need to prove safety and efficacy.

According to testimony, normally, vaccine development has a timeline of 5–10 years which involves first demonstrating safety in cells, tissues, and animals—through in vitro and animal testing—followed by three phases of human trials. This system is intended to test and prove the safety of drugs prior to approval for use in human populations.

The Commissioners heard that an abundance of caution should govern the testing and approval of novel biologics, which include gene therapy. The standard set out by the FDA for biologics is 15 years.

The Federal Government adopted a new process into law by burying it in an omnibus bill in December, 2020. The new pathway allows the Minister of Health to designate a drug for expedited clinical trials and product authorizations. The Report says three of the four justifications for the new pathway relate to promoting economic development and profit relating to therapeutics.

The Commissioners include these recommendations:

  • Maintain Rigorous Safety Standards: Prioritize patient safety by maintaining rigorous safety standards for drug approval. The safety of new pharmaceuticals should be thoroughly demonstrated through preclinical and clinical trials before approval.
  • Transparency in Regulatory Changes: Ensure transparency in any regulatory changes related to pharmaceutical approvals. Changes in the approval process should be subject to public consultation and should be clearly communicated to stakeholders, including healthcare professionals, and the public.
  • Independent Expertise: Appoint experts with relevant medical and scientific backgrounds to key positions in the regulatory process. Decision-makers, such as the Minister of Health, should have a strong understanding of medical and scientific principles to make informed decisions about drug approvals.
  • Independent Safety Review: Establish an independent body or commission responsible for conducting safety reviews of pharmaceuticals, especially novel biologics and gene therapies. This body should be free from industry influence and focused solely on patient safety.
  • Strengthen Informed Consent: Canada should reinforce the importance of Informed Consent, especially in the context of medical treatments like vaccines. It should ensure that individuals have access to comprehensive information about medical treatments, including potential risks and benefits, and have the right to refuse treatment without coercion.

 

Digital copies of the Report are available at https://nationalcitizensinquiry.ca/commissioners-report. Media inquiries concerning the National Citizens Inquiry should be directed to: [email protected].