# Presentation: 093940

## Health Canada’sConsiderations RespectingProposed New vCJD Risk Reduction Measures for the Blood System

**Biologics**** ****and Genetic Therapies Directorate**
**Direction des Produits Biologiques et Thérapies Génétiques**

- Dr. Peter R. Ganz,
- Director,
- Centre for Biologics Evaluation, BGTD HPFB, Health Canada

- FDA TSE Advisory Committee Meeting
- 		Silver Spring, MD
- 		14 October, 2004

##  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**