Guidance Document: Interim Compliance Approach Regarding Donor Ova Processed Prior to February 4, 2020

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Organization: Health Canada

Published: 2021-01-08

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable Guidance documents.

Table of contents

Introduction

Purpose/Overview

Health Canada is notifying establishments and health professionals who process, import, distribute and/or make use of donor ova for the purpose of assisted human reproduction (AHR) of its interim compliance approach with respect to the processing requirements for donor ova that were obtained prior to the Safety of Sperm and Ova Regulations (Safety Regulations) coming into force on February 4, 2020 ("pre-CIF donor ova").

The Safety Regulations establish a regulatory framework for donor sperm and ova, and are focused on reducing the risks to human health and safety, including the risk of the transmission of disease, arising from the use of donor sperm or ova intended for use in AHR in Canada. The regulatory framework includes technical requirements to conduct donor suitability assessment, as outlined in the Health Canada Directive: Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors (Directive), which is incorporated by reference in the Safety Regulations.

Before February 4, 2020, donor sperm was subject to the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations), made under the Food and Drugs Act in 1996, to mitigate the risk of infectious disease transmission from the use of donor semen in assisted conception. At the federal level, the safety of donor ova was unregulated in Canada until the coming into force of the Safety Regulations.

The Safety Regulations include transitional provisions which allow donor sperm that was processed before the coming into force of the Safety Regulations, but which was not processed in accordance with the Safety Regulations, to be distributed, imported, or used provided the donor sperm was processed in accordance with the Semen Regulations. However, as donor ova was not previously regulated at the federal level, the Safety Regulations have no such transitional provisions for donor ova and therefore must meet the requirements of the Safety Regulations, in order for it to be distributed, imported or used.

Since the coming into force of the Safety Regulations, the Department has learned from stakeholders that a significant number of pre-CIF donor ova do not meet all of the processing requirements outlined in the Safety Regulations, namely certain donor suitability assessment requirements. As such, where the requirements for directed donation or exceptional access cannot be met, the Safety Regulations are preventing the use of donor ova that was processed prior to the coming into force of the Safety Regulations for the purpose of building their families.

Therefore, on an interim basis, until the Safety Regulations may be amended to include transitional provisions to address pre-CIF donor ova, pre-CIF donor ova that do not meet all of the processing requirements outlined in the Safety Regulations will be considered of lower priority for enforcement provided certain processing requirements described below are met.

Policy objectives

Health Canada acknowledges the need to amend the Safety Regulations to better account for donor ova that was processed prior to February 4, 2020.

The objective of this interim compliance approach is to ensure that individuals continue to be able to make use of pre-CIF donor ova in order to build their families, while continuing to reduce the risks arising from the use of such ova.

Scope and application

This interim compliance approach applies to establishments and health professionals that process, import, distribute and/or use pre-CIF donor ova for the purpose of AHR.

Guidance for Implementation

In order for the distribution, importation and use of pre-CIF donor ova that were not processed in accordance with the Safety Regulations to be considered of lower priority for enforcement, the following conditions must be met.

All establishments and health professionals are still required to meet all other applicable regulatory requirements in respect of the pre-CIF donor ova they wish to distribute, import or use, including the applicable quality management, adverse reaction and error or accident requirements, and requirements for record keeping to ensure traceability.

Donor screening and physical examination

Donor testing

Action by the primary establishment

The primary establishment has a critical role in ensuring the safety of sperm or ova for the purpose of AHR. In order to consider the distribution, importation and use of pre-CIF donor ova not processed in accordance with the Safety Regulations to be of lower enforcement priority, the primary establishment must meet the following requirements:

Summary document

Storage

Labelling

Communication of risk

Contact Information

Inquiries and information requests regarding this interim compliance approach should be submitted directly to the Biological Product Compliance Program by email: hc.bpcp-pcpb.sc@canada.ca.

Footnotes

Footnote 1

A test is considered appropriate and effective if it is:

  • licensed for the detection of the infectious disease agent or marker;
  • used in accordance with the test kit manufacturer's instructions; and
  • used for the detection of an infectious disease marker that is relevant at the time testing is performed.

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Footnote 2

Risk mitigation measures could include prophylactic measures, such as any medication to prevent HIV infection, or retroactive donor testing.

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