Medicover Fertility Ethics Board

Leading IVF clinic in Western Europe

Intersono IVF clinic is proud to be part of the Medicover Fertility Family. Medicover fertility clinics are among the top fertility clinics in Europe, offering some of the highest success rates in the region. We adhere to the Medicover Code of Ethics for fertility centres to ensure that all our patients are treated according to the highest ethical standards.

Code of Ethics 

This Code of Ethics of the Medicover Fertility Division represents its professional and ethical standards when conducting Assisted Reproductive Technology (ART) treatments.

The Code is used as a benchmark for all Medicover fertility centers and seeks to ensure the highest standard of practice for all staff involved in clinical activities as well as in moral/ethical medical dilemmas.

By introducing this Code, Medicover wishes to show that it has a responsible and ethical approach when advising and treating patients in its centers so that it can continue to build a high level of trust within its markets.

The Code of Ethics is based on the four main principles existing in modern medicine:

  1. First, do no harm (primum non nocere): Patients’ safety and health is the most important value in medicine. Healthcare professionals should always make sure no harm will be caused to patients.
  2. Beneficence: Healthcare professionals should always act in the patient’s best interests, doing all in their power to improve the patients’ health situation and their quality of life. They are expected to choose the most suitable and beneficial methods for treatment.
  3. Autonomy: Patients should have the full right to make a free and independent decision when considering medical treatment. Consent to treatment will be sought only on the basis of clear and balanced information provided by the physicians.
  4. Justice: All patients should be treated equally and have a similar access to medical advice, diagnosis and treatment.

Frequent technological and scientific advances in the field of fertility medicine constantly raise new ethical dilemmas. The Code of Ethics will be a dynamic document requiring continuous development as new issues arise.

Key Principles

The Key Principles provide a clear statement of good medical standards which underpin the delivery of care within Medicover Fertility Centers. These key standards serve as a means of communicating to staff, patients, donors, donor-conceived people and the public to which Medicover Fertility Centers are committed.

  1. We shall treat prospective and current patients and donors fairly, and shall not discriminate against them unlawfully.
  2. We shall have proper respect for the privacy, confidentiality, dignity, comfort and wellbeing of patients and donors.
  3. We shall have proper respect for the special status of the embryo when conducting clinical and laboratory procedures.
  4. We shall take proper account of the welfare of any child who may be born as a result of the treatment provided by Medicover clinics.
  5. We shall provide prospective and current patients and donors with sufficient, accessible and up-to-date information in order to allow them to make informed decisions.
  6. We shall ensure that patients and donors have provided all relevant consents, before any licensed activity is undertaken.
  7. We shall conduct all activities with proper skill and care and in an appropriate environment, in accordance with good clinical practice, to ensure optimum outcomes and minimum risk for patients, donors and offspring.
  8. We shall ensure that all premises, equipment, processes and procedures used in the conduct of licensed activities are safe, secure and suitable for purpose.
  9. We shall ensure that all staff engaged in licensed activity are competent and recruited in sufficient numbers to guarantee safe clinical and laboratory practice.
  10. We shall maintain proper and accurate records and information about all clinical and laboratory activities.
  11. We shall keep records of all adverse incidents (including serious adverse events and reactions) and investigate all complaints properly and share lessons learned throughout the organization.
  12. We shall ensure that all licensed research undertaken meets proper ethical standards, and is only undertaken where there is a clear scientific justification.
  13. We shall conduct all activities with proper regard for the regulatory frameworks governing treatment and research involving gametes or embryos within the particular country in which services are provided.

The following section explores a number of specific scenarios encountered in the provision of fertility services which raise ethical questions of concern to professional staff and users of services. A brief background is provided, key issues are highlighted, and a policy for practice provided mapped to the Key Principles (above).

1.  The moral status of the pre-implantation embryo

Maps to Principles 3, 7, 8, 9, 10 and 12

The pre-implantation embryo is a symbol of human life. This special status of the embryo will be properly respected when conducting Assisted Reproductive Technology treatments, reflecting a responsible attitude towards the child to be born as a result of these treatments. The preimplantation embryo cannot achieve its potential to become a fetus and then potentially a child unless it is transferred into the uterus. Thus, the attitude towards the pre and post- implantation stages should be ranked based on their potential of leading to the development of a human being

2.  The management of cryopreserved embryos and the destination of surplus embryos

Maps to Principles 3, 5, 6, 10 and 12

Background

Following an IVF cycle, 1-2 of the pre-implantation embryos created are transferred into the patient’s uterus, while any remaining good quality embryos are cryopreserved. In some cases, when patients have not stated their wishes about the fate of their embryos and cannot be contacted, surplus cryopreserved embryos are left in storage, causing an issue for the fertility clinic due to the high maintenance costs.

Ethical Dilemmas

A.  The status of the cryopreserved preimplantation embryo, defined as the ‘beginning of life’.

B.  The balance between autonomy of the patients to decide about the fate of their pre-embryos and the needs of society, medicine and economic considerations.

C.  Absence of a consensus regarding the definition of abandoned embryos.

Policy

Cryopreserved pre-implantation embryos represent the very first stage of human life, their primary use will be for the original couple but the option of donation to another couple or to research is also accepted.

A.  At all Medicover Fertility centers, an agreement with the intended parents is signed before the initiation of treatment concerning the fate of supernumerary cryopreserved embryos; this includes a request to maintain them for the couple, including the obligation to cover the costs, and consent to donate them to another couple or to research. Within the contract/consent to storage it is imperative that patient(s) undertake to advise the clinic of any change in contact details. The consent must reference the issue of management of embryos if couples split up.

B.  In normal circumstances the duration of storage should be a maximum of 10 years. Medicover provides a mechanism for successive 10-years extensions of storage.

C.  Pre-implantation embryos may be offered for donation only after appropriate medical screening of the donating couple and following counseling and consent of both couples.

D.  Embryos donated for research may not be transferred for the achievement of a pregnancy and may only be used for research as long as the gamete providers gave their consent.

E.   Surplus ‘abandoned’ embryos:

1. Embryos may be considered as abandoned if:

  • payments for storing cryopreserved embryos have stopped and at least 10 years have passed since contact with the originating individual or couple
  • diligent efforts have been made to contact the individual or couple
  • no written instructions exist concerning the disposition

2. Under these circumstances, it is acceptable to dispose of the embryos by their removal from storage and thawing without transfer. In no case should abandoned pre-embryos be donated to other patients or used for research.

3. If one partner does not consent to disposal or continued storage, this can only be challenged through courts.

3. Oocyte Donation

Maps to Principles 1-7, 10 and 12

Background

When a woman is unable to use her own oocytes for IVF, donor oocytes can be used instead. Young, fertile women are willing to donate their oocytes. Usually, compensation is awarded to the donors to cover their efforts. Short term medical hazards (due to hormones used for ovarian hyperstimulation, anesthesia and the surgical procedure) and unknown possible long term health outcomes may be associated with the oocyte donation process.

Ethical dilemmas

  1. Young, fertile donors undergo the risks of an invasive surgical procedure without clinical benefit. The short and possible long-term risks for harm to the donor for the benefit of an infertile patient need to be taken into account.
  2. Since donors receive compensation for their participation, this could lead to pressures which affect their ability to make clear, informed decisions concerning the potential medical and emotional risks involved in the procedure.
  3. A child conceived by egg donation has the right to know his/her origins.

Policy                   

A.  All oocyte donors and recipients will be informed about potential legal, medical and emotional issues involved in oocyte donation.

B.  An egg donor can receive compensation to reasonably cover any financial losses incurred in connection with the donation.

C.  Donors should be offered the choice to enter the egg donation program as an identifiable or anonymous donor, but encouraged to remain identifiable in the interests of the resulting child or children.

D.  Donors will be informed that they no longer have dispositional control over their oocytes once they have been retrieved, and that they have no legal rights or duties to rear any resulting children.

E.  Donors will be informed that they will be screened for infectious diseases and other health-related risk factors, provided with the results of tests, and offered referral to further counseling or medical care if required following screening.

F.  Accurate records related to oocyte donation will be maintained to enable future information sharing with offspring.

G.  Medicover has a duty to provide written information on the manner and time of conception to both the recipient and other healthcare professionals involved in her care if requested.

4. Preconception gender selection for non-medical reasons

Maps to Principles 3 and 12

Background

Following natural conception, the chance of a child being of a particular gender is about 50%. People may desire to choose the sex of their baby for medical or non-medical reasons:

  • Medical reasons: avoiding or reducing the risk of inheriting known genetic diseases affecting children of a specific sex, or diseases showing unequal sex-incidence.
  • Non-medical reasons: social or economic reasons for preferring a child of a specific sex over the other, “sex balancing” when there are already children only or predominately of one sex.

Ethical dilemmas

A.  Patient autonomy and reproductive liberty to rear a child of a given sex or to balance their family when already having several children of the same sex.

B.  Unjustified possible harm to women undergoing IVF and possible long-term (unknown) risks to the offspring as a result of a Preimplantation Genetic Screening (PGS) procedure.

C.  Misuse of medical resources for non-medical purposes.

D.  Distortion of the numeric balance between the genders (evident in Asia).

E.  Risk of discrimination and perpetuation of social injustice by bias in favor of male children and prejudice against female children.

F.  Possible “slippery slope” toward selection of other traits in offspring.

Policy

A.  Sex selection should be allowed if aimed at avoiding health risks to the offspring, including reducing the chances of having a child affected by a disorder with an unequal sex-incidence.

B.  Gender selection for non-medical reasons is not accepted. It is also not accepted when it can be applied as additional selection in the context of medically indicated Preimplantation Genetic Diagnosis PGD/PGS procedures.

5. Fertility treatments when prognosis is futile or very poor

Maps to Principles 1, 5 and 12

Patients may reach a point where their chance of achieving a live birth is very low or nonexistent. Some of these patients have difficulties in ceasing treatment. These situations may raise conflicting interests between clinicians and their patients. While patients will try to do anything to bear a child and may desire to make autonomous decisions concerning medical treatments, clinicians have professional interests in minimizing harm and avoiding the frustration (and cost) of providing virtually useless treatments.

The following definitions are accepted when discussing futile or poor prognosis outcomes in assisted reproductive treatments:

  • Futile therapy: a treatment having a less than 1% chance of achieving a live birth
  • Very poor prognosis therapy: a treatment having a 1-5% chance of achieving a live birth

Ethical Dilemmas

A.  Chances of live birth (lower chance results in lower justification for treatment)

B.  Cost of treatment (higher cost results in lower justification for treatment)

C.  Financial source for treatment (Public / private sources)

D.  Severity of risk for the patient (higher risk results in lower justification)

E.  Balance of values between patient’s autonomy for treatment and clinician’s professional autonomy for refusing to provide treatment.

Policy

A.  In most cases, the provision of futile therapies is not ethically justified

B.  For treatments with very poor success rates, clinicians must be vigilant in their presentation of risks, benefits and alternatives.

6. The welfare of the child in medically assisted reproduction

Maps to Principles 1, 2, 4 and 12

Background

Fertility treatments treat or bypass medical problems which may be interfering with the ability to have children. Fertility specialists ordinarily focus on the medical aspects of the situation, but are sometimes faced with patients who do not appear to be well suited to provide safe and adequate care for children. Concerns about child rearing ability and the possibility of causing significant harm to a future child are legitimate.

Ethical dilemmas

A.  The decision on whether fertility treatment will be provided is determined according to medical factors. Evaluating the child-rearing ability of the patients is not perceived as part of the decision.

B.  Persons have autonomy to bear children if they choose. Since fertile couples are not selected or licensed to procreate, withholding services from sub fertile couples on the basis of concerns about the welfare of the future child could potentially be challenged in law.

C.  In cases where there is doubt about the welfare of the future child, the only way to protect the child from the risks of concern would be to avoid its birth.

D.  There is a balance between the obligation of physicians to treat all patients who seek their services and the autonomy to decide not to provide services to individuals as they choose.

E.  Significant costs and burdens imposed by parental unfitness on society.

Policy

A.  Those seeking treatment are entitled to a fair assessment. The wishes of all those involved will be considered and the assessment will be done in a non-discriminatory way.

B.  Services may be withheld on the basis of well-substantiated judgments of patient’s inability to provide minimally adequate or safe care for offspring. The assessment of the patient’s inability to care for a child or the potential to cause harm to a child should be made jointly among different professionals of the team always including an independent opinion. Psychological assessment will need to be complemented in some instances by professionals in social care.

C.  Persons with disabilities should not be denied fertility services solely on the basis of disability.

7. Medically assisted reproduction in singles, lesbian and gay couples and transsexual people

Maps to Principles 1, 2, 4 and 12

Background

Medically assisted reproduction is mostly offered to heterosexual couples (either married or in a stable relationship). There are, however, a growing number of applications from singles and people with other sexual identities including homosexual female (lesbian) couples, homosexual male (gay) couples and, more recently, transsexual men and women.

Ethical dilemmas

A.  Reproduction is a basic element of autonomy of individuals regardless of their sexual orientation. Medically assisted reproduction in the situations described above is morally sound in many cases. There is no good reason to a priori dismiss access in these situations.

B.  Health is not only defined by medical facts but also by social conventions and justifications. Medically assisted reproduction in these cases may be seen in this broader sense.

Policy

A.  Medicover Fertility Clinics will always be mindful of the legal frameworks in the countries where they operate while fulfilling their mission to help those who want to procreate and create a family

B.  If there are concerns about the implications of assisted reproduction on the wellbeing of any of the persons involved including the future child, a surrogate mother or the applicants themselves, these concerns have to be carefully considered in light of the available evidence (see Section 6 above).

C.  Practitioners who, because of a conscientious objection, feel unable to offer fertility treatment in these situations should refer these applicants/patients to other professionals.

8. Posthumous assisted reproduction

Maps to Principles 3, 4, 5, 6, 10 and 12

Background

The application of procreation through posthumous assisted reproduction is linked to the availability of techniques for obtaining and cryopreserving gametes, reproductive tissue and embryos. Two situations are distinguished: cases in which the gametes or embryos are requested by the surviving partner and cases in which the gametes or embryos are made available for third persons.

Ethical dilemmas

A.  Based on the principle of autonomy, only decisions that conform to the deceased person’s wishes can be made.

B.  Possible risks to the welfare of the future child must be considered.

Policy

A.  The option of posthumous reproduction should be offered in the consent form for cryopreservation. Even if the clinic objects to this kind of treatment and refuses collaboration, the informed consent form should enable patients to indicate what they wish to be the fate of their gametes and embryos in case of death. Couples who wish to keep the option of posthumous reproduction should have the right to transfer their gametes or embryos to another clinic that is willing to comply with their request.

B.  Consent should be obtained at the time of storage or before the start of the IVF cycle.

C.  In the absence of written consent, no action to obtain reproductive material can be performed, and no use can be made of the gametes or embryos.

D.  At Medicover, posthumous reproduction will be only allowed in the context of the initial parental project. Gametes and embryos of a deceased person will not be made available for a third person.

E.  Thorough counselling of the surviving partner during the decision-making period is necessary.

F.  A minimum waiting period of 1 year after death should be imposed before treatment can be started in order to prevent hasty and ill-considered decisions.

9. Surrogacy

Maps to Principles 1, 4, 5, 6, 10 and 12

Background

A gestational carrier (surrogate) is a woman who bears a child who is genetically unrelated to herself for an individual or couple who intend to be the legal, rearing parent(s) of the child. Initially, gestational surrogacy was applied to cases of intended opposite-sex parents who had fertility or medical problems that precluded the female partner from carrying the pregnancy. At present, the process is also used for individuals and same-sex couples desiring to become parents.

Ethical dilemmas

A.  The autonomy of the surrogate mother to make a decision concerning her own body.

B.  Young, healthy women undergo the risks of a pregnancy and a delivery without a reason as the born child is given to others.

C.  Since surrogates receive compensation for their participation, this could lead to pressures which affect their ability to make clear, informed decisions concerning the potential medical and emotional risks involved in the procedure. There is a potential for the exploitation of vulnerable women and their inappropriate inducement.

D.  A child conceived through surrogacy has the right to know this fact.

Policy

A.  Surrogacy may be facilitated through Assisted Reproductive Technology but only if allowed under the legislation within the country where the center operates.

B.  Legal agreements must be in place to spell out and then protect each participant’s roles and responsibilities.

C.  Surrogate mother should be at least 21 years of age, healthy, have a stable social environment, and have had at least one pregnancy that resulted in a delivery of a child.

D.  It is the duty of the treating physician to inform all parties about the medical, social, psychological, emotional, moral and legal issues involved in surrogacy.

E.  Where local legislation and regulations allow, gestation carriers should receive fair and reasonable economic compensation as determined by local practice; however, clinics should not normally act as an intermediary between the commissioning couple and the surrogate.

F.  Surrogate mothers have the right to appropriate medical care during the treatment and throughout the pregnancy and the choice of obstetrician should be mutually acceptable to the intended parent(s) and carrier.

G.  Surrogate mothers should be properly counselled to consider the potential impact of the surrogacy on their own families.

H.  The same precautions should be implemented as for gamete donation including screening for infectious diseases (HIV, hepatitis B and hepatitis C).

I.  Only one embryo of good quality will be transferred as a general rule.

References

  • UK Human Fertilization and Embryology Authority – https://www.hfea.gov.uk/184.html.
  • ESHRE (European Society of Human Reproduction and Embryology) Statements by the Task Force Ethics and Law.
  • ASRM (American Society for Reproductive medicine) Ethics Committee Documents.

 

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