Health Canada’s Considerations Respecting Proposed New vCJD Risk Reduction Measures for the Blood System FDA TSE Advisory Committee Meeting Silver Spring, MD 14 October, 2004 Dr. Peter R. Ganz, Director, Centre for Biologics Evaluation, BGTD HPFB, Health Canada Biologics and Genetic Therapies Directorate Direction des Produits Biologiques et Thérapies Génétiques

Variant Creutzfeld Jacob Disease (vCJD) vCJD –a new disease defined in 1996-defined as the human equivalent to BSE Terminal disease-no therapies currently available (currently over 150 deaths worldwide, mostly in U.K, 1 Case in Canada) Some recent evidence that vCJD may be transmissible through blood transfusion No blood tests available

General vCJD Risk Mitigation Efforts in Canada

vCJD Risk Mitigation General TSE control measures in place since 1996 Food chain control measures implemented Active surveillance system For blood system: Since 1996, Health Canada has carried out a number of vCJD risk assessments and consultations re: vCJD with stakeholders Health Canada exercised precautionary principle and put in place travel and residency deferrals based on balancing reduction of theoretical risks of transfusion transmission against loss of available supplies of blood

vCJD Risk Mitigation (2) For blood system: Although for reasons/benefits not related to reducing vCJD risks, Health Canada issued a Regulatory Directive on November 1998 requiring blood system operators to implement universal pre-storage leukoreduction (ULR) All blood in Canada has been leukoreduced since June, 1999 Recent published data sponsored in part by Health Canada showed that LR removed 42% of the total TSE infectivity from blood (Gregori et al, Lancet: 364: 529, 2004)

Ongoing Review of vCJD Risk Reduction Measures With issuance of previous Regulatory Directives concerning vCJD, Health Canada committed to periodically review any new scientific data and consider amending current deferral measures based on new information

Information Concerning Possible Transmission of vCJD via Blood Transfusion Data from experiments in animal model systems indicated that prions (such as vCJD) can be transmitted via blood transfusion Recent reports have indicated the presence of vCJD infection in individuals who received blood components donated from patients who died of vCJD.

Health Canada’s vCJD Risk Reduction Measures in Blood System: Deferrals

Health Canada’s vCJD Risk Reduction Measures in Blood System: Deferrals

Options for Further Risk Reduction Measures Biologics and Genetic Therapies Directorate Direction des Produits Biologiques et Thérapies Génétiques

Options for Further Risk Reduction Measures Option 1) Status quo. Risk reduction measures currently in place such as the three Regulatory Directives previously issued by Health Canada are adequate to protect Canada’s blood supply.

Options for Further Risk Reduction Measures (2) Option 2) Consider more stringent travel/residency donor exclusion policies such as reducing the times spent in the UK to less than 3 months; reducing times spent in Western Europe to less than 5 years & reduce the residency/travel to less than 3 months for France.

Options for Further Risk Reduction Measures (3) Option 3) Consider exclusion of individuals who have ever received a transfusion in Western Europe (incl France) since 1980.

Options for Further Risk Reduction Measures For options 2 and 3: Any proposed changes in Canada would have to consider the potential to create blood shortages.

Consultations September, 2004: Consultations and communications with key stakeholders including Canada’s blood system operators (Héma-Québec and Canadian Blood Services) concerning these various options. Commitment to review donor demographic data concerning options 2, 3 Impact of proceeding with option 3 on blood donor base is expected to be minor (based on number of deferrals for UK transfusions) and prior donor demographic surveys

Consultations September, 2004: Review of new information concerning vCJD transmission via blood and various options to further mitigate risk with Health Canada’s Expert Advisory Committee on Blood Regulation Opinions to move forward with expanding deferrals recognizing the need for further consultation/communication and a need to consider impact on blood supply (www.hc-sc.gc.ca)

The Way Forward Health Canada is committed to further consultation with blood operators and other stakeholders regarding these proposed measures Both operators will review opportunities to tighten travel/residency deferral measures for UK, France and WE (option 2) through demographic surveys Latter option is initially predicted to have a significant impact on donor base. Both operators need to review their donor demographic data to ascertain “true” impact of the proposed option 3 deferral measure

The Way Forward It is anticipated that the impact of moving forward with deferring donors who had ever received a blood transfusion in Western Europe would result in debarring of a very small number of donors. The risk to Canada’s blood supply would be reduced by a small degree below the level afforded by the 3 current Directives.

Acknowledgments Dr. Farid Hindieh, BGTD Dr. Francisca Agbanyo, BGTD Dr. Pierre Charest, BGTD Dr. Antonio Giulivi, PHAC Ms. Catherine Hanson, BGTD Mr. Jason Busby, HPFB Ms. Cathy Parker, BGTD Dr. Anil Dudani, BGTD Dr. Kwasi Nyarko, BGTD Biologics and Genetic Therapies Directorate Direction des Produits Biologiques et Thérapies Génétiques

For Further Information: Health Canada Website: www.hc-sc.gc.ca Biologics and Genetic Therapies Directorate Direction des Produits Biologiques et Thérapies Génétiques