Directive 99-02: Donor Exclusion to Address Theoretical Risk of Transmission of Variant CJD through the Use of Commercial Blood Products

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Directive 99-02: Donor Exclusion to Address Theoretical Risk of Transmission of Variant CJD through the Use of Commercial Blood Products (PDF Version, 88 Kb)
Date: 2002-08-15

Therapeutic Products Programme
Holland Cross, Tower "B"
2nd Floor, 1600 Scott Street
Address Locator # 3102D1
OTTAWA, Ontario
K1A 1B6

99-025121

August 17, 1999

Canadian Establishment Licence Holder
Attention: Regulatory Affairs

Dear Sir/Madam:

Re: Directive: Donor Exclusion to Address Theoretical Risk of Transmission of variant CJD through the Use of Commercial Blood Products

Enclosed you will find a Directive issued by the Therapeutic Products Programme regarding Donor Exclusion to Address Theoretical Risk of Transmission of Variant CJD through Use of Commercial Blood Products.

A draft version of this Directive was mailed to you on July 8, 1999. If your company has already replied to the Bureau of Biologics and Radiopharmaceuticals that this Directive does not apply to the drugs which you produce, import or distribute in Canada, no further reply is necessary.

Original signed by Keith Bailey for

Dann M. Michols
Director General

DATE: August 17, 1999

FROM: Director General, Therapeutic Products Programme

TO: Canadian Firms Holding Establishment Licenses

SUBJECT: Donor Exclusion to Address Theoretical Risk of Transmission of variant CJD through the Use of Commercial Blood Products

1. PURPOSE

The purpose of this Directive is to advise all firms holding a Canadian Establishment Licence or who have applied or plan to apply for a Canadian Establishment Licence as a manufacturing or importing facility for drugs derived from human blood or containing human blood products as a reagent or excipient. Manufacturers of these products are to take measures to reduce the theoretical risks of transmission of variant CJD (vCJD) through the use of such products by excluding from donating blood, all persons who have spent time in England, Scotland, Wales, Northern Ireland, Isle of Man and the Channel Islands amounting cumulatively to a period of 6 months or more between the years 1980 to 1996, inclusive.

2. BACKGROUND

Variant Creutzfeldt-Jakob disease (vCJD), first described in 1996, is a "new" disease, linked with the outbreak of Bovine Spongiform Encephalopathy (BSE) in cattle.

While, to date, there have been no cases of vCJD attributable to the use of blood or plasma derivatives, lack of experience with this condition and the causative agent, together with certain biological effects associated with infection, suggest that vCJD may have the potential to spread through blood or blood derivatives.

In considering this potential risk and measures to deal with it, the principle has been adopted that one must seek to apply measures which will reduce the targeted risk without jeopardizing the safety of the blood system in other ways.

In consideration of data on donor demographics and following discussions in fora such as the Therapeutic Products Programme's Expert Advisory Committee on Blood Regulation and the National Blood Safety Council, the Regulator has concluded that collectors of blood and plasma should defer from donation such persons who have spent time in the UK amounting cumulatively to six months or more during the period January 1980 to December 1996 inclusive. This deferral criterion is chosen on the basis that it will greatly reduce donors' exposure to BSE risks (in terms of person-days of exposure) without having an insurmountable impact on the current donor base. Application of this criterion is therefore expected to reduce the theoretical risk of vCJD without jeopardizing the safety of the blood system.

In addition, these measures are expected to parallel those being developed by the USFDA and will assist in ensuring a common standard between Canada and our major trading partner.

The Therapeutic Products Programme, in conjunction with the Laboratory Center for Disease Control, will continue to monitor the developing science around vCJD and the impact of the policy on the blood system. Blood operators will be required to report semi-annually on the impact of this policy or their donor bases and the supply of blood. Should the risk equation change, changes in the 6 months criterion will be considered.

3. SCOPE

This Directive applies to the collection of plasma to be used for the purpose of further manufacture into blood products approved for sale in Canada.

4. LICENSING REQUIREMENTS

For products which are approved for sale in Canada a Notifable Change Submission in accordance with the Therapeutic Products Programme Policy on Changes to Marketed New Drugs, or a related type of submission for those products which are not in new drug status must be filed, detailing the changes in operating procedures to incorporate the above exclusion requirement. These submissions should be filed to TPP no later than October 1, 1999.

For those products which are manufactured outside Canada, it is the responsibility of the Canadian Importer to ensure compliance with this Directive.

Fabricators using blood products as excipients or reagents in the manufacture of their drugs are required to submit certification from their suppliers of compliance with this deferral requirement.

The Regulator recommends that the suppliers of plasma for further manufacturing make every effort to recruit replacement donors from persons who have a prior history of donation. Plasma suppliers are also encouraged to develop materials to be used in explaining these deferral actions to affected donors in order to foster an appropriate understanding of these actions.

5. COMPLIANCE DATE

This exclusion is to be introduced as soon as operationally feasible, but not later than six months from the date of this Directive.

6. ADDITIONAL INFORMATION

Questions concerning the Donor Exclusion to Address Theoretical Risk of Transmission of variant CJD through the Blood Supply should be directed to:

Director, Bureau of Biologics and Radiopharmaceuticals
3rd Floor LCDC Building #6
Postal Locator 0603D
Tunney's Pasture
Ottawa, Ontario
KIA 0L2

Attention: Dr. D. A. Kennedy, Senior Scientific Advisor

Questions concerning the filing of Notifiable Change Submissions should be directed to:

Regulatory Affairs Division
Bureau of Biologics and Radiopharmaceuticals
3rd Floor LCDC Building #6
Postal Locator 0603C
Tunney's Pasture
Ottawa, Ontario
KIA 0L2

Attention: Ms. C. Parker, A/Manager