Information
July 1999
Semen Banks: Why has Health Canada recommended that semen banks recall donors and recipients for testing?
The recommendation for follow-up testing is based on preliminary findings of Health Canada's investigation of the 49 Canadian semen banks. The investigation determined that a number of the semen banks have shown deficiencies in testing, and are non-compliant, in varying degrees, with the Semen Regulations as defined in the Foods and Drugs Act. The Semen Regulations incorporate a minimum standard for testing, to which all semen banks and other distributors must comply to reduce the risk of disease transmission through assisted conception. Although Health Canada has not received any reports of transmission of infection through semen since the Semen Regulations were put in place in 1996, and the risk of infection at this point is considered to be very slight, Health Canada deemed it necessary to exercise its regulatory authority to ensure the safety of recipients. A letter was issued to fertility clinics across Canada recommending that physicians take every precaution, and notify their patients of the small possibility of infection and test them for a number of infectious agents.
What is Health Canada doing about the situation?
When an Ontario semen bank first advised Health Canada of testing inconsistencies identified through its own internal audit process in March, Health Canada launched an investigation. The inconsistencies were found not only in testing of the semen collected at the bank itself, but were also found in testing of semen obtained by the Ontario semen bank of another processor. Shortly thereafter, Health Canada initiated an investigation of all Canadian semen banks to determine their compliance with the Semen Regulations.
As deficiencies in semen banks have been identified, Health Canada has directed that all affected product in stock at non-compliant banks be immediately quarantined. Semen banks have been cooperative in this process; in addition to immediately placing a quarantine on their product and initiating testing of donors, many have already notified and begun testing patients. On-site reviews of all 49 clinics have now been completed and the results are currently being evaluated. In the meantime, to address the potential risk, be it slight, of transmission of infection through semen, a letter has been sent to all physicians who have performed assisted conception procedures, in order to trigger patient notification and follow-up testing.
Health Canada has also briefed the Chief Medical Officers for the provinces and territories, the Society of Obstetricians and Gynaecologists of Canada, and other interested organizations including patient support groups. The Canadian Fertility and Andrology Society (CFAS), the largest non-governmental body dedicated to matters of reproductive technology in Canada, has been supportive throughout the investigation.
What are the next steps, to ensure that semen being used is safe?
The banks whose product is quarantined will not be able to distribute the quarantined product until Health Canada is satisfied that their testing practices are compliant with the Semen Regulations and that the semen being distributed is safe. As well, the Canadian Fertility and Andrology Society (CFAS), in conjunction with the Canadian Standards Association and many Canadian semen banks, has been collaborating with Health Canada in a review of the current 1996 guidelines that were incorporated into the Semen Regulations. The review is aimed at updating the testing requirements to reflect advances in diagnostic technologies related to assisted conception.
Following the recommendations of the Krever Commission, the Minister of Health announced a commitment of $125 million over five years to strengthen the blood regulation and disease surveillance system. As part of this package, funds were identified to augment inspection capacity for tissues, including semen. A recruitment campaign has now been completed and additional inspectors will be in place to augment the inspection program in the fall.
What is the potential risk for recipients?
The non-compliant semen banks varied in their degrees of non-compliance. In this case, non-compliance ranged from record-keeping errors, to lack of testing. Some of the tests that may not have been performed include hepatitis B and C, as well gonorrhea, chlamydia and syphilis. A more comprehensive understanding of the risk to recipients will be available once Health Canada has performed a thorough health assessment. However, it must be underlined that the majority of these diseases are rare, and the risk of transmission through donor semen is very slight. The recommendation for patient notification and follow-up is a precautionary measure.
What should a recipient do?
Health Canada recommends that any woman who is or has been a recipient of donor sperm, and who wishes to be tested, consult their physician or fertility clinic for more information.
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