Since the BBC report on the misuse of donor gametes in a Northern Cyprus fertility clinic many people believe the EU provides safe guards. This is not necessarily true. Verbally a fertility clinic and/or their intermediary can make ANY claims. But the truth will be in the IVF consent form. It will state that you agree to let the clinic select the donor eggs or sperm.
You should NOT provide any money BEFORE confirming what the IVF consent form says.
The Gap Between SEC Traceability and Donor Selection
EU law generally requires the Single European Code (SEC) to be applied to or accompany tissues and cells distributed for human application, subject to limited exceptions.
But it does not expressly require:
- the SEC to appear on the donor’s marketing profile;
- the patient to be shown the SEC before fertilisation;
- the donor-selection profile to be incorporated into the IVF consent form;
- The patient to sign a document directly cross-referencing the profile code with the donor eggs and/or sperm with its full SEC.
That creates an opportunity for abuse. A clinic could show a patient a donor profile, while they use donor eggs and/or sperm from another traceable donation, and later place an internal UIN or SEC on a copy of the selected profile. Both the donor eggs or sperm and embryos might be coded internally, yet the documents given to the patient would not prove that the donor eggs or sperm used corresponded to the profile she selected.
The fertility clinic could also provide an SEC for the embryos they have created which is sufficient for transportation however, that SEC does not give any information about the SEC used for the donor eggs or sperm. That must be secured separately from the embryo SEC.
The absence of an SEC on the donor profile does not necessarily violate EU law, but it leaves the patient dependent on the clinic’s records and the regulator’s willingness to inspect them.
Operationally, a clinic could use donor eggs and/or sperm from a different donor while maintaining an internally valid SEC for those eggs and/or sperm. The SEC proves traceability, but it does not prove that the eggs and/or sperm match the donor profile shown to the patient.
However, that does not mean the clinic can lawfully use “any donor eggs or sperm.”
The donor eggs and/or sperm must still be:
- lawfully procured, screened and traceable;
2.used within the scope of the patient’s informed consent;
3.consistent with the contractual donor-selection terms; and
4.connected to the correct patient and treatment cycle.
It should be noted that a clinic employee, doctor and/or intermediary can still verbally inform you that your selection will be used. However, you should NOT trust any verbal information provided. The regulatory or justice system will give deference to the doctor.
If the signed IVF consent authorizes the clinic to select any donor meeting general criteria, the clinic has considerable discretion. But if the patient selected a donor profile and did not authorise substitution, using another donor could constitute misrepresentation, breach of contract and treatment outside the scope of consent—even if the substituted eggs and/or sperm had a perfectly valid SEC.
EU law requires establishments to maintain traceability and, where applicable, assign the SEC to reproductive material distributed for human application.
However, it does not establish a clear requirement that the recipient be shown the egg and/or sperm SEC and its connection to the selected donor profile before fertilisation or embryo transfer.
This patient-facing disclosure gap can be exploited because the recipient may not discover that the documentation fails to correspond with her donor selection until after embryos have been irreversibly created or transferred.
Unscrupulous actors can exploit the gap between regulatory traceability and patient-facing donor selection. A patient may be shown one donor profile while the clinic uses eggs or sperm from a different, separately traceable donation. The substituted donor eggs or sperm could possess a valid SEC, allowing the clinic to appear compliant with traceability rules, even though the material does not correspond to the donor the patient selected and authorised.
The opportunity for abuse is greatest where:
- the profile code is not linked to the SEC in the consent form;
- the patient is not shown the allocation documentation before fertilisation;
- the clinic reserves broad authority to select or substitute donors;
- an intermediary controls communications and payment;
5.the embryos are created before the patient receives laboratory records; and
6.regulators verify only that some traceability exists, rather than whether the eggs and/or sperm correspondence to the authorized profile.
Once embryos are created or transferred, the biological consequences are irreversible and the patient’s practical bargaining position is severely reduced.
This is why a valid SEC alone is insufficient: regulators should be verifying both traceability of the material and correspondence between that material and the donor selection forming the basis of the patient’s consent. However, the regulator may simply verify the traceability and not be bothered with verifying that the link between the phenotype selection and what was used. For that they will rely upon the doctor and what he explained to the patient. Please do not forget she/he can simply opt to NOT tell you the donor profile was marketing ONLY and then rely upon the common practice of clinic-led selection. Inform the regulator you were fully aware when you were not.
As an End Note:
If the clinic you are doing fertility at ends the package or treatment at the embryo transfer and does not test your thyroid or it is not part of the fertility package it is NOT about fertility outcomes.
As somebody who regularly sees patients we do NOT want to see a patient who has undergone a fertility treatment in another country. Why? We do not want to take on the responsibility and liability for any stages that were not properly handled. Such as the failure to properly prepare the lining of the uterus or the thyroid was not properly treated prior to the transfer.
The pregnancy success rate of patients who fly in and fly out of a foreign country are more than likely NOT included in their overall success rates. That is a serious problem.
