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| New Regulations for Semen Donations | This is one step in the government's endeavor to protect those most affected by new reproductive and genetic technologies (NRGT).
The new regulations place the responsibility on doctors and sperm banks, who are the processors and distributors of semen donations, to:
• Properly screen donor and semen by first evaluating the medical and social history and testing for sexually transmitted disease, and then re-evaluate and retest the donor after the semen has been frozen for a minimum of six months.
• Mark each container of semen with an identification code so it can be linked back to the donor and to the date of donation.
• Keep records of the distribution of the semen.
• Stop distribution and perform a thorough investigation concerning all semen suspected of being infected with a disease.
These new regulations fulfill one of the recommendations of the Royal Commission on New Reproductive Technologies.
Processing and Distribution of Semen for Assisted Conception Regulation
* What is the purpose of these new regulations?
These regulations establish uniform national standards which will decrease the risk of infectious disease transmission through donor semen when used in assisted conception. The new regulations require appropriate procedures regarding donor screening and testing, labeling, quarantining and record keeping prior to semen being used in AC.
* How will the Regulations ensure an increased level of safety of semen?
They will minimize the risk of infectious disease transmission through a series of regulated procedures. Sooner than a semen donation is given, an evaluation of the donor including a physical examination, medical, blood and other laboratory tests will be performed. If following preliminary evaluation the semen from the donor is found to be acceptable, the semen will be frozen, and quarantined for a minimum of six months. Once six months pass, the donor and his semen would undergo a further series of tests. Offered the evaluation and the tests performed after that period are still negative, the semen may be released from quarantine. By quarantining and retesting donors and semen this way it will make possible to detect latent human immunodefiency virus (HIV) as well as other STDs, including hepatitis B and C, considerably reducing the risk of transmission.
Record keeping and labeling requirements in these regulations will allow the retrospective examination of the processing and distribution. Identification potentially contaminated semen donations and their distribution is an important safety feature.
* How can the new Regulations impact those receiving semen in assisted conception?
All recipients will be guaranteed of an increased level of safety of donor semen. There may not be any obvious changes in procedure for recipients, but there may be some minimal cost increase.
* What can be the impact of the new regulation on sperm banks and physicians?
There are lots of programs and numerous practitioners that will be directly affected by these regulations. Semen importers will also be required to comply with the processing and distribution of semen for assisted conception regulations.
The responsibility level will be reduced for sperm banks and physicians, because the sperm will have been processed in accordance with the regulations. Further costs related to donor screening, record keeping and freezing the sperm for storage may be incurred by sperm banks and physicians. Nevertheless, the cost increasing is expected to be minimal since most sperm banks and physicians already follow comparable standards. The advantages of safer frozen semen would outweigh the expected minimal cost increase.
* Will these new procedures affect the privacy of the donors?
Patient records privacy is an issue associated with any medical procedure, and patients are usually informed of privacy matters by their physicians. No circumstances would be there when the semen recipient would be able to trace the donor and vice versa.
* What steps should be taken to ensure that genetic information of semen donors is made available to those using the semen or to the children born from assisted conception?
The regulations are only limited to reducing the risk of infectious disease transmission from donor semen use in AC, and do not address the full range of ethical, legal and social concerns.
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