Letter to Minister of Health re HC Notice of Intent

 Friday November 25, 2016

The Honourable Jane Philpott, Minister of Health

70 Colombine Driveway
Ottawa, ON
K1A 0K9

Copy sent to: Office of Policy and International Collaboration, Biologics and Genetic Therapies Directorate

Dear Minister Philpott,

The Canadian Fertility and Andrology Society (CFAS) is a non-profit professional organization representing the Canadian experts in Assisted Reproductive Technologies (ART) and the reproductive sciences for over 60 years.  We encompass a broad array of disciplines, including reproductive endocrinologists, reproductive scientists, and the allied professionals that have specialized in reproductive medicine, including nursing, counseling, social work, ethics, law, administrative services, and complementary alternative medicine.  Our members have dedicated their careers to excellence in reproductive medicine, to the benefit of both the 1 in 6 Canadians that suffer from infertility and the children born of the technologies used to manage this devastating disease.  CFAS hopes to partner with Health Canada in the development of any future regulations and standards that may affect the scientific advancement and practice of assisted reproduction in Canada.  The following are opinions of the CFAS Board of Directors.

We write in response to the October 1st Health Canada announcement that regulations are to be drafted for sections 10, 12 and 45 to 58 of the Assisted Human Reproduction Act (AHRA) and your request for comments on the same.  We very much welcome clarity on the regulations that will be brought forward, particularly with respect to the medical and infectious screening of donors for third party reproduction, and rules pertaining to the financial reimbursement of gamete donors and surrogates.  These sections of the Act have clear implications for the medical practices of our members, and those patients that require treatments utilizing gamete donation or gestational surrogacy.  Since the violation of these laws carries severe penalties, the vague and ambiguous sections of the Act have caused a great deal of anxiety for our members and patients and the donors and surrogates who have come forward to assist our patients for the twelve years since the law was enacted.

We have highlighted key aspects of the Act and potential regulations that we see as the most relevant for all concerned:

Section 10:  Regulations related to the safe use of reproductive material in third party treatments

We assume that the standards developed through the work of the CSA Expert Working Group on Safety of Organs and Tissues for Transplantation and Assisted Reproduction will be referenced in future regulations on assisted reproduction.  The most recent draft standard Z900 2 1-2016-11-11-PR was circulated to our members this month as part of the broader public consultation, which ends January 15th, 2017.  In terms of screening of gamete donors and surrogates, we encourage the Ministry to consider that any regulation should be evidence-based to allow for the safe, effective and timely delivery of care to our patients.  In keeping with this, we will be providing more detailed comments on this draft of the document prior to the January deadline.

In addition, as the experts practicing in the field and those who monitor the studies and scientific advancements we would like to continue to be consulted in future reviews of the CSA standards and redrafting of regulations under the AHR Act as we expect that both will need to adapt to the frequent advancements in this high-tech field of medicine.

Consolidation of federal regulation of all reproductive material under one Act

As outlined in the Health Canada announcement, the Health Products and Food Branch Regulations on the Processing and Distribution of Semen for Assisted Conception “Sperm Regs” will be incorporated into the new regulations under the AHR Act.  The CSA draft standards Z900 2 1-2016-11-11-PR nicely consolidates the unique requirements of the diverse users of third party reproductive services while attempting to address the infectious and genetic safety of these services.  Having all regulations in a single document will inherently make it easier to understand and comply with the law.  Over ten years after coming into law, confusion over fundamental aspects of the AHR Act persists 10 years later, even among the most senior members of our society.

Section 45 to 58:  Inspection and enforcement

Clinical practice guidelines in Assisted Reproduction are set by professional physician organizations such as the CFAS and the American Society of Reproductive Medicine (ASRM), and more recently through the provincial Colleges of Physicians and Surgeons, who are presently conducting regular inspections of assisted reproduction facilities and credentialed physicians for the practice of assisted reproduction.  CFAS expects all of its members to practice medicine ethically and legally with a focus on healthy outcomes for donors, surrogates, patients and their offspring.  At CFAS we have made renewed efforts to develop comprehensive clinical practice guidelines for our members and allied specialties in an effort to improve care.

Not surprisingly, our membership is having the most angst over inspections and enforcement, particularly our physicians and fertility clinic owners.  We ask that the inspection process serve as a means for quality improvement and to achieving the highest possible level of care for the Canadian fertility patient.  We also ask that the process respects the investment in time and resources that our medical community has made, and the dedication and expertise required to delivery these services.

Section 60 to 64:  Offenses and punishment

Violations of the present AHR laws carry what we feel are excessive penalties under the criminal code.  We simply request that the Act be removed from the criminal code with violations subject to fines, not incarceration.

Section 12:  Reimbursement of surrogates and gamete donors

Annex A of the CSA standards mentioned above, “Reimbursements of Expenditures for Donors and Surrogates”, was prepared by a task force of the CSA Technical Subcommittee on Assisted Reproduction.  The document was made available to our membership as part of the above-noted public consultation.  We request that regulation on section 12 reference this document and clearly define what expenses can be reimbursed to surrogates and gamete donors.

Some of our members have voiced concerns over the level of administrative support that will be required from both fertility centres and Health Canada to operate a system for tracking expenses.  Simpler viable systems exist in other countries.

Section 6 and 7:  Prohibition on the compensation of surrogates and gamete donors

The issue of reimbursement has brought the issue of compensation and payment of surrogates and gamete donors to the surface amongst our members.  Although comment on sections 6 and 7 was not requested in this public consultation, members have approach the Board with concerns over the state of third party reproduction in Canada.  Certainly, there is a multitude of moral and ethical issues tied to the payment of individuals for reproductive services like gamete donation and gestational surrogacy, and our member opinions are varied.  What is clear is that the existence of sections 6 and 7 has had a clear impact on the availability of donors and surrogates in this country, as few individuals participate altruistically.  For example, fewer than 20 Canadian sperm donors exist in Canada at any given time.  To understand the scope of this sentiment we surveyed our membership on the simple question of whether they support the compensation of gamete donors and surrogates.  The results are as follows:

  • 200 CFAS members responded to the survey over a two-week period.
  • A majority of CFAS members surveyed support compensation:

76% for surrogates while 9% remain undecided

74% for egg donation while 7% remain undecided

70% for sperm donation while 9% remain undecided

The CFAS Board of Directors and its membership appreciate the open discussions that Health Canada has afforded us in the past, and now through this public consultation on regulations under the Assisted Human Reproduction Act. We hope that regulation will bring clarity to the Act and improve the quality of medical care to Canadians.  We will continue to offer our expertise and resources to Health Canada on these standards and regulations, as well as future issues involving reproductive medicine and related sciences.  Our membership will also continue to provide comments on draft regulations as they appear, and we simply ask that dialogue be open, constructive, and aimed at the enhancement of our reproductive medicine community, that internationally serves as a model for the delivery of safe, ethical and effective Assisted Reproductive Technologies.

On behalf of the CFAS Board of Directors

Jeff Roberts MD, President CFAS

Cc: CFAS Board of Directors

 

CFAS Board of Directors

Heather Shapiro MD, Past President

Jason Min MD, President Elect

Jay Baltz PhD, Treasurer

Jason Hitkari MD, Director of Professional Development

Neal Mahutte MD, Director Clinical Practice Guidelines

Jeff Haebe, MD

Clifford Librach MD

Sherry Levitan LLB

Scot Hamilton PhD

Bruce Murphy PhD, Advisory Member – Research

Eileen McMahon NP, Advisory Member – Nurse education