Court Approved Protocol

CAP - NON-PRESCRIPTION INTRAVENOUS DRUG USE

Sections 3.01(1)(c) and (3), 3.02(1)(a) and (2) or 3.05(5) of the Transfused HCV Plan and Sections 3.01(1)(c) and (3), 3.02(1)(a) and (2) or 3.04(5) of the Hemophiliac HCV Plans)

Applicability of CAP

1. This CAP applies where:

a. there is an admission that the HCV Infected Person used non-prescription intravenous drugs;

b. there is no s.3.01(1)(c), 3.02(1)(c), 3.04(5) or 3.05(5) declaration that the HCV Infected Person has never used non-prescription intravenous drugs; or

c. despite receipt of a s. 3.01(1)(c) or 3.02(1)(c), 3.04(5) or 3.05(5) declaration, there is other evidence that the HCV Infected Person has used non-prescription intravenous drugs.

Eligibility Criteria Where This CAP Applies

2. The Administrator must be satisfied on the balance of probabilities that:

a. the HCV Infected Hemophiliac or person with Thalassemia Major was infected with HCV for the first time by Blood received in Canada; or

b. the HCV Infected Person was infected with HCV for the first time:

3. The burden to prove eligibility is on the claimant. The Administrator shall assist the claimant by advising what types of evidence will be useful in meeting the burden of proof in accordance with this CAP.

TRACEBACK

4. The Administrator shall conduct a Traceback under the Traceback CAP, unless:

a. in the case of a Hemophiliac or person with Thalassemia Major, the HCV Infected Person was a regular recipient of Blood prior to his/her attaining the age of 18; or

b. in the case of a person claimed to be a Secondarily-Infected Person, the person has no history of blood transfusion.

5. If the Traceback CAP does not apply, the Administrator shall perform the additional investigations required by paragraph 8 below.

6. If the result of a traceback investigation is such that the Traceback CAP requires the Administrator to reject the claim of the HCV Infected Person, the Administrator shall reject the claim.

7. The Administrator may not accept a claim based on the results of a traceback investigation without performing the additional investigations required by the provisions of paragraph 8 below.

Additional Investigations

8. If the claim is not rejected under the Traceback CAP, the Administrator shall perform the following additional investigations:

a. obtain such additional information and records pursuant to s. 3.03 as the Administrator in its complete discretion considers necessary to inform its decision; and

b. obtain the opinion of a medical specialist experienced in treating and diagnosing HCV as to whether the HCV infection and the disease history of the HCV Infected Person is more consistent with infection at the time of the receipt of Blood, the Class Period Blood transfusion(s) or the secondary infection or with infection at the time of the non-prescription intravenous drug use as indicated by the totality of the medical evidence.

9. The Administrator shall weigh the totality of evidence obtained including the evidence obtained from the additional investigations required by the provisions of this CAP and determine whether, on a balance of probabilities, the HCV Infected Person meets the eligibility criteria.

10. In weighing the evidence in accordance with the provisions of this CAP, the Administrator must be satisfied that the body of evidence is sufficiently complete in all of the circumstances of the particular case to permit it to make a decision. If the Administrator is not satisfied that the body of evidence is sufficiently complete in all of the circumstances of the particular case to permit it to make a decision, the Administrator shall reject the claim.

Examples of Additional Investigations

11. Examples of the evidence the Administrator may require to inform its decision include the following:

a. an independent medical examination with a physician of the Administrator's choice, to obtain opinion evidence on any medical issues which the Administrator believes will assist in making its decision;

b. the medical and clinical records from any or all hospitalizations and treating physicians for the HCV Infected Person for such time frame as the Administrator considers relevant;

c. the donation history, transmissible disease information, deferral codes or the results of any lookbacks pertaining to blood donated by the HCV Infected Person available from Canadian Blood Services and/or Hema-Quebec;

d. an affidavit from the HCV Infected Person and a person who knew the HCV Infected Person at the time he/she used non-prescription intravenous drugs describing:

e. a consent to conduct a criminal records search of HCV Infected Person; and

f. an affidavit or interview of any person the Administrator believes may have knowledge about the non-prescription intravenous drug use or disease history of the HCV Infected Person.

Results of the Investigations

12. Although none of these factors may prove conclusive in any individual case because the Administrator must consider the totality of the evidence, the following factors are examples of evidence that would be supportive of a finding that the person claimed to be an HCV Infected Person is eligible:

a. identification of a Class Period Blood transfusion from an HCV antibody positive donor;

b. the HCV Infected Person was under the age of 18 at the time of the receipt of Blood for the Hemophiliac or the Class Period Blood transfusions;

c. reliable evidence establishes that the non-prescription intravenous drug use took place after July 1, 1990;

d. an HCV disease history which is more consistent with the timing of:

e. reasonably reliable evidence that the non-prescription intravenous drug use history is subsequent to the receipt of Blood for the Hemophiliac, or the date of Class Period Blood transfusion(s), or the date of alleged secondary infection;

f. reasonably reliable evidence that the non-prescription intravenous drug use was limited to a single occasion and was done with sterile equipment which was not shared; and

g. no medical history of unspecified Hepatitis, Hepatitis B or Non-A, Non-B Hepatitis prior to the date of the receipt of Blood for the Hemophiliac, the Class Period Blood transfusion(s) or the date of alleged secondary infection.

13. Although none of these factors may prove conclusive in any individual case because the Administrator must consider the totality of the evidence, the following are examples of evidence that would not be supportive of a finding that the person claimed to be an HCV Infected Person is eligible:

a. failure to identify a Class Period Blood transfusion from an HCV antibody positive donor;

b. an HCV disease history which is more consistent with infection at the time of non-prescription intravenous drug use than with the timing of:

c. reasonably reliable evidence that the non-prescription intravenous drug use took place on more than one occasion or was done with non-sterile or shared equipment;

d. a medical history of unspecified Hepatitis, Hepatitis B or Non-A Non-B Hepatitis prior to the date of the receipt of Blood for the Hemophiliac, or the Class Period Blood transfusion(s) or the date of alleged secondary infection;

e. a refusal to permit the Administrator to interview any person the Administrator believes may have knowledge about the non-prescription intravenous drug use or disease history of the HCV Infected Person;

f. a CBS or Hema-Quebec donor file which indicates that the HCV Infected Person:

g. the file is in any other way consistent with infection with HCV by non-prescription intravenous drug use prior to the receipt of Blood for the Hemophiliac, or the Class Period Blood transfusion(s), or the date of alleged secondary infection.