L.S. 524.02 Regolamenti dwar il-Protokoll tal-Awtorita' għall-Protezz

EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 1 SUBSIDIARY LEGISLATION 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) REGULATIONS * LEGAL NOTICE 215 of 2022. 1.

(1)The title of these regulations is the Embryo Protection Authority (Protocol) Regulations. Citation and coming into force.

(2)These regulations shall come into force on such date or dates as the Minister responsible for health and the Minister responsible for justice, may by notice in the Gazette establish and different dates may be so established for different provisions and, or purposes of these regulations. 2. The Protocol as defined in article 2 of the Embryo Protection Act is hereby published by means of these regulations in the Schedule. *Not yet in force. Cap. 524. 2 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) SCHEDULE EMBRYO PROTECTION AUTHORITY PROTOCOL PROTOCOL Third Edition - July 2022 Contents User guide to the Protocol Regulatory principles for licensed tissue establishments Guidance Notes Staff 1. The licence holder and the Responsible person 2. Staff Treating people fairly 3. Treating people fairly Counselling 4. Infertility counselling and patient support Information and consent 5. Information to be provided prior to consent 6. Consent to treatment, storage, donation and disclosure of information 7. Legal parenthood and parental responsibility Multiple births 8. Multiple births Additional Fertilisations 9. Additional Fertilisation Permissions Welfare of the child 10. Welfare of the child EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 Preimplantation Genetic Testing 11. Pre-implantation Diseases (PGTM) Genetic Testing for Monogenic Donations 12. Donor recruitment, assessment and screening Use of gametes and embryos 13. Screening and storage of samples to prevent crosscontamination 14. embryos Procuring, processing and transporting of gametes and 15. Transfers, Imports and Exports of gametes and embryos previously stored 16. Storage of Gametes and Embryos 17. Embryo Adoption 18. Witnessing and assuring patient and donor identification 19. Traceability 20. Donor Assisted Conception 21. Intra-Cytoplasmic Sperm Injection (ICSI) Research and unlawful procedures 22. Research and unlawful procedures Facilities and administration 23. Quality Management System 24. Complaints 25. Third Party Agreements 26. Premises, practices and facilities 27. Equipment and Materials 28. Adverse Incidents Record keeping and other obligations 29. Confidentiality and privacy 3 4 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) 30. Record keeping and document control 31. Obligations establishments and reporting requirements of tissue 32. Fees to be paid to the Embryo Protection Authority (EPA) by all Service Providers of Tissue establishments/clinics both Public and Private User Guide to the Protocol What is the purpose of the Protocol? The Embryo Protection Act (the Act) covers the use and storage of sperm, eggs and embryos for human application. One of the ways we help licensed tissue establishments (Tissue Establishments) comply with the Acts by publishing the Protocol. We have a duty under the Act to maintain a protocol that gives guidance about licensed activities and the people who carry them out. This Protocol also serves as a useful reference for patients, researchers and those working in the fertility sector. How is the Protocol structured? The Protocol consists of: Regulatory principles for licensed tissue establishments whether private or public, and Guidance notes This Protocol has been prepared in line with EU Directives, National Legislations, HFEA Code of Practice as well as the BICA Practical Manual. Regulatory Principles for Licensed Tissue Establishments The Act requires the Embryo Protection Authority (EPA) to maintain a statement of the general principles that we consider should be followed in carrying out activities covered by the Act. The principles: A summary of the key behaviours and outcomes the EPA expects each licensed tissue establishment to demonstrate, and A means of communicating to the responsible person and staff at each licensed tissue establishment, patients, and the public the areas of compliance that the EPA regards as key. EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 Compliance and enforcement The EPA has a duty to promote compliance with: The Act, and The Protocol. Regulatory principles will inform the inspection process. If the EPA becomes aware that a tissue establishment has not complied with the legislation or the Protocol, we may take action in line with provisions in the Act. Regularity Principles The EPA expects the responsible person to ensure that their licensed tissue establishment demonstrates adherence to the following principles when carrying out activities licensed under the Embryo Protection Act. Licensed tissue establishments must: 1. Treat prospective and current patients fairly, and ensure that all licensed activities are conducted in a non-discriminatory way 2. Have respect for the privacy, confidentiality, dignity, comfort and well-being of prospective and current patients 3. Have respect for the special status of the embryo when conducting licensed activities 4. Take account of the welfare of any child who may be born as a result of the licensed treatment provided by the tissue establishment, and of any other child who may be affected by that birth 5. Give prospective, current patients and donors sufficient, accessible and up-to-date information to enable them to make informed decisions 6. Ensure that the patient or patients and the donors have provided all relevant consents before carrying out any licensed activity 7. Conduct all licensed activities with skill and care and in an appropriate environment, in line with good clinical practice, to ensure optimum outcomes and minimum risk for patients, donors and offspring 8. Ensure that all premises, equipment, processes and procedures used in the conduct of licensed activities are safe, secure and suitable for the purpose 9. Ensure that all staff engaged in licensed activity are 5 6 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) competent and recruited in sufficient numbers to guarantee safe clinical and laboratory practice 10. Maintain accurate records and information about all licensed activities 11. Report all adverse incidents (including serious adverse events and serious adverse reactions) and near misses to the EPA. As well as report all quality and safety issues relating to quality and safety of gametes and embryos during processes and storage. Investigate all complaints properly, and share lessons learned appropriately 12. Conduct all licensed activities with regard to the regulatory framework governing treatment involving gametes or embryos in accordance with the Embryo Protection Act 2012, the Embryo Protection (Amendment) Act 2018, and the Various Laws relating to Assisted Procreation (Amendment) Act 2022. including: maintaining up-to-date awareness and understanding of legal obligations responding promptly to requests for information and documents from the EPA, and co-operating fully with inspections and investigations by the EPA or other agencies responsible for law enforcement or regulation of healthcare. 13. Reporting of activities supported by EPA forms and documentation including testing results, should include but are not limited to: Request for permission to cryopreserve gametes in oncology cases Request for permission to cryopreserve gametes in fertility preservation Request for permission to cryopreserve gametes by transgender persons prior to starting hormone therapy treatment Request for permission to discard gametes Request for permission to transfer gametes/embryos between licenced tissue establishments in Malta Request for permission to transfer gametes/embryos from a Malta Tissue establishment to abroad and from abroad to a Malta Tissue establishment Request for ART Procedures (IUI, IVF, ICSI) as well as EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 procedures making use of thaw and transfer of cryopreserved embryos and storage of gametes for patients undergoing an ART cycle Request for Additional Fertilisation of oocytes to be made in line with the EPA Protocol as approved by the Parliament Health Committee Request for Embryo Cryopreservation and potential Embryo Donation Request for Use of Third-Party Donation and duly inform immediately every donation made with full identity details of the donor. Prior Authorisation by the Authority for patients to undergo PGTM. Prior Authorisation by the Authority for the donation of cryopreserved Embryos Prior Authorisation by the Authority of the Agreement between the prospective parent or prospective parents and the licensee to regulate the cryopreservation of embryos. Prior authorisation by the Authority to be granted to a prospective parent or prospective parents who had cryopreserved embryos in tissue establishments abroad to bring two cryopreserved embryos to be transferred locally into the prospective parent or prospective parents for each cycle Outcomes of all procedures and storage carried out. To provide the Authority with all documentation and data in regard to reporting obligation of the Authority to the House of Representatives To pass on information to the Authority without delay of all confidential registers held by the licensee with full details of every medically assisted procreation procedure, germ line cell donation, cryopreservation of germ line cells and cryopreservation of embryos. To pass on information to the Authority re any Alterations to premises and equipment within the Tissue Establishment. Henceforth, all requests for permissions are to be submitted before the actual activities are embarked upon. To pass on information to the Authority when new personnel join or existing personnel leave the Tissue Establishment. Any other documentation that the Authority as Regulator may request in terms of the Embryo Protection Act 7 8 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) 14. Ensure that all fees (as per schedule of fees) are paid to the Embryo Protection Authority within the timescale mentioned in the schedule of fees 15. Ensure that requests for information and/or documents from the Embryo Protection Authority are responded to promptly 16. Ensure that data provided to the Embryo Protection Authority about activities and data, which the Embryo Protection Authority is required to hold on its Register of Information, is accurate and provided by dates specified 17. Breaches in reporting duties with regards to the EPA may lead to prosecution by the Authority in accordance with the Embryo Protection Act. 18. Notify the Embryo Protection Authority immediately if s/ he becomes aware of any decision or proposal to close their tissue establishment. In the event of termination of activities, for whatever reason, the Responsible Person (RP) must ensure that all stored gametes and embryos are transferred to another licensed tissue establishment or licensed tissue establishments. The RP must ensure that all relevant information including traceability data and information concerning the quality and safety of gametes and embryos, is transferred with any stored gametes, embryos, or that records containing this information are made accessible as required. Guidance Notes 1. The Licence Holder and the Responsible Person 1.1 The licence holder and the Responsible person should be separate individuals. Clinics operating within a hospital or other healthcare organisation may find it advantageous for a senior hospital manager to hold the post of licence holder. 1.2 It is the responsibility of the licence holder to inform the EPA if the Responsible person is unable to perform their duties. Where the tissue establishment no longer has a Responsible person, the licence holder should seek the advice of the EPA as soon as possible on continuing to provide licensable activities. Either the Responsible person or the licence holder may apply for a licence or for its variation or revocation. EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 However, only the licence holder may apply to a licence Authority to vary a licence in order to designate another individual to be the Responsible person. Qualifications for the Role of the Responsible Person 1.3 The Responsible person should have enough understanding of the scientific, medical, legal, social, ethical and other aspects of the tissue establishment’s work to be able to supervise its activities properly. It is also important that the Responsible person possesses integrity, and managerial authority and leadership capability. 1.4 When applying to vary a licence in order to appoint a new responsible person, the licence holder must provide evidence that the proposed individual has the managerial authority and capability necessary to perform their duties. 1.5 The EPA expects the Responsible person to take any necessary specialist advice to allow them to run the tissue establishment professionally. 1.6 The role of the Responsible person should include: (

a)ensuring that human tissues and cells intended for human applications in the establishment for which that person is responsible are procured, tested, processed, stored and distributed in accordance with the Directives and the Acts. (
b)Maintaining an up-to-date understanding of legal obligations awareness and (
c)responding promptly to requests for information and documents from the EPA (
d)co-operating fully with inspections and investigations by the EPA or other agencies responsible for law enforcement, regulation or healthcare, and (
e)informing the EPA of any change to their professional registration. 1.7 The Responsible person is accountable for the overall performance of the Tissue Establishment and should ensure that there are clear responsibilities, roles and systems of accountability to support good governance. The RP is also to ensure that appropriate action is taken following feedback from the EPA, patients and staff including feedback outcomes from inspections, audits and any patient complaints. 1.8 The responsible person should ensure that all staff possess the competencies necessary for their role and have access to 9 10 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) learning and professional development. All staff are encouraged, as appropriate, to contribute to discussions and decisions about improving patient care. The RP is also to ensure that all staff maintain an up-todate awareness and understanding of legal obligations. 2. Staff Tissue Establishment Staff 2.1 The tissue establishment should establish documented procedures for staff management, ensuring all staff have: (
a)required initial basic training and updated training as (
b)an adequate knowledge and understanding of the scientific / technical process and principals relevant to their designated tasks (
c)adequate information of the broader legal, ethical and regulatory context of their work (
d)on-going competence assessment, with audits of this assessment (
e)an annual joint review (with their line manager) (
f)continuing development (
g)education and professional staff records (
h)appropriate communications, and access to meetings and (
i)A health care professional is under no obligation to participate in any procedure for the application of any technique of medically assisted procreation regulated by the Act when such professional considers such participation objectionable as a matter of conscience and declares his objection beforehand as per Article 20 of the Embryo Protection Act, 2012. 2.2 Staff records should include: (
a)job description that accurately reflects their task and responsibilities (
b)terms and conditions of employment (
c)a record of staff induction and orientation (
d)a record of health and safety training [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) (
e)a record of education and training, including continuing professional development (
f)relevant qualifications educational and professional (
g)certificate of registration, if relevant (
h)absence record (
i)accident record (
j)a record of annual joint reviews (
k)occupational health record, and (
l)a record of any disciplinary action. The tissue establishment should ensure that confidentiality of staff records is in line with best practice and relevant legislation. 2.3 All staff should maintain an up-to-date awareness and understanding of legal obligations and should support the responsible person in monitoring and improving the performance of the Tissue Establishment. 2.4 All staff should participate in an annual joint review that examines the needs of the tissue establishment and of the individual to improve the quality of the service to users and to encourage productive working relationships. Staff performing annual reviews must receive appropriate training. 2.5 The tissue establishment should have an effective way of communicating information to and receiving suggestions from staff. Tissue establishment management should also ensure that the accountabilities and reporting relationships shown in the tissue establishment’s organisational chart are communicated within the tissue establishment. 2.6 Tissue establishment management should ensure that staff members who are in contact with patients, donors and their partners where applicable: (
a)follow the tissue establishment’s patient support policy (
b)are prepared to offer appropriate emotional support to people suffering distress at any stage before, during and after treatment. (
c)understand counselling, and and can explain the role of 11 12 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) (
d)know when and how to refer people to the tissue establishment’s qualified and warranted counsellor. 2.7 Tissue establishment management is responsible for delivery of the patient support policy and for using intelligence to monitor and evaluate the effectiveness of the policy. Tissue establishment management should ensure that the policy addresses the emotional support needs of patients, donors, and their partners where applicable, in order to continuously improve their experience of treatment services. 2.8 Tissue establishments should require all prospective and existing staff to report promptly all criminal convictions they have had to the person responsible. In deciding whether or not an individual shall take part in a licensed activity at the tissue establishment, the responsible person should take into account relevant previous convictions and breaches of regulations. Medical Staff 2.9 The Responsible person should ensure that staff who must be registered with professional bodies are registered, their registration is up to date, and records of this are kept. 2.10 The individual with overall medical responsibility for treatment services involving in vitro fertilisation should: (
a)have completed training recognized by the Specialist Accreditation Committee. (
b)be on the General Medical Council’s Specialist Register, and (
c)participate in a recognised programme of continuing medical education and professional development. 2.11 If the centre is licensed to provide insemination services only, the individual with overall clinical responsibility should: (
a)be a registered medical practitioner, and (
b)have sufficient experience in an established fertility centre to be qualified to take full charge of the centre’s treatment services. 2.12 Other medical staff who takes part in providing treatment services should be registered medical practitioners with sufficient experience under supervision to qualify them to do so. Medical staff who do laparoscopies should be recognised by the Specialist Accreditation Committee. Medical staff in training should follow relevant training programmes under appropriate supervision. EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 Nursing Staff All nursing staff must be appropriately qualified and registered. 2.13 Nurses should be: (
a)working towards competencies set nationally, to ensure appropriate standards of clinical competence, and (
b)able to provide evidence of competence in the duties performed (for example, a certificate from a recognised body and qualification competent in that discipline or function). Counselling Staff 2.14 Treatment tissue establishments should ensure that Infertility counsellors are appointed to fulfil the role of counsellors. Every tissue establishment should see that enough counsellors are enrolled to offer a 24-hour service of counselling. All counsellors should have specialist competence in infertility counselling and: (
a)hold a recognised counselling, clinical psychology, counselling psychology, psychotherapy or family therapy qualification to the level of diploma of higher education or above, and (
b)have received Infertility training of the British Infertility Counselling Association (or an equivalent body). (
c)have a Warrant in Counselling. 2.15 A member of staff appointed to the role of counsellor should be able to provide evidence of being an accredited member of or working towards accredited membership of, a recognized professional counselling body. The body should have a complaint/ disciplinary procedure, and the individual should have agreed to abide by an appropriate code of conduct or ethics. Prospective parent or parents shall not be provided with treatment services of any kind unless they have been given a suitable opportunity to receive proper counselling about the implications of being provided with treatment. Before a person gives consent for treatment: (
a)s/he must be given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and (
b)s/he must be provided with such relevant 13 14 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) information as is proper. 2.16 Treatment establishments carrying out pre-implantation genetic diagnosis should ensure that patients have access to counsellors with appropriate knowledge and expertise in these specialisms, including a good understanding of the risks and implications for patients who have treatment and any children that may be born following such treatment. Staff Engaged in Scientific Services 2.17 Tissue establishment management should ensure that the Tissue Establishment has access to a nominated registered scientist to advise on and oversee scientific activities. 2.18 All healthcare scientists working in licensed tissue establishment should be registered or show evidence of working towards registration with a registered body where applicable. All staff should be registered with a registered body within oneyear of their becoming eligible, including those eligible as international applicants after training overseas. 2.19 Healthcare scientists from overseas who are registered in their own country but working in a licensed tissue establishment as a visiting scientist, should seek temporary registration with a registered body in Malta (such as Specialist Accreditation Committee or equivalent body). 2.20 Healthcare scientists employed in roles should follow an appropriate induction and training programme for the tasks performed. Each individual should maintain proper records of this training. 2.21 should: The individual responsible for the seminology laboratory (
a)possess a degree or higher national diploma in a relevant discipline (
b)have acquired sufficient experience in such a laboratory to supervise and be responsible for one, and (
c)be registered with a registered body as a clinical scientist or biomedical scientist, or be able to demonstrate equivalent training or expertise. 2.22 The individual responsible for the clinical embryology laboratory should: (
a)possess an appropriate scientific or medical degree EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 (
b)have had sufficient experience in such a laboratory to be able to supervise and be responsible for one, and (
c)be registered with a registered body as a clinical scientist with specific expertise in clinical embryology. Competence and Training of ICSI and embryo biopsy practitioners 2.23 The responsible person should ensure that micromanipulation procedures such as ICSI and embryo biopsy are carried out only by practitioners who have the necessary competence. 2.24 Following training, the competence of each person performing micromanipulation procedures and embryo biopsy should be evaluated at intervals specified in the quality management system. Retraining should be given when required. 2.25 In the case of embryo biopsy, only the embryologist(
s)practitioner(
s)who have been designated and named on the clinic’s licence may carry out the biopsy. If the clinic wishes to change the designated embryologist or add to the list of designated embryologists, the clinic will need to apply to the EPA Authority and the Licencing Authority. Staff involved in genetic testing 2.26 A senior clinical geneticist should be involved in the decision making process when deciding whether a patient should receive treatment involving embryo testing. 2.27 The tissue establishment should ensure that a multidisciplinary team is involved in providing the service. Where relevant the team should include reproductive specialists, embryologists, clinical geneticists, genetic counsellors, cytogeneticist and molecular geneticists. It should maintain close contact with the primary care physician or the referring clinician. 2.28 If the tissue establishment offers an embryo service, the individual responsible for this laboratory should (
a)hold an appropriate scientific or medical degree (
b)have acquired sufficient experience in an appropriately accredited medical genetics diagnostic laboratory to supervise and be responsible for one, and (
c)be registered with the equivalent body as a clinical scientist with specific expertise in clinical genetics. 15 16 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) 2.29 If genetic testing of those seeking treatment or considering donation is offered, the tissue establishment should ensure that an individual is available who understands the: (
a)nature of the tests conducted (
b)scope and limitations of the tests (
c)accuracy and implications of the tests, and 4 (
d)meaning of the test results. 2.30 The tissue establishment should ensure that people seeking treatment have access to clinical geneticists and genetic counsellors where relevant. 2.31 The centre should work closely with the local genetics team of those seeking treatment. 3. Treating People Fairly Relevant Legislation 3.1 The Maltese Legislation protects people (including Tissue Establishment staff, current and prospective parents) from direct and indirect discrimination, harassment and victimisation on the basis of: (
a)race (
b)any disability (
c)gender (
d)religion or belief (
e)sexual orientation, and (
f)age. 3.2 The responsible person should have and be familiar with documented procedures to ensure their tissue establishment complies with equalities legislation. 3.3 The responsible person should ensure that the tissue establishment’s systems, policies and procedures comply with current equality legislation and guidance. 3.4 Tissue establishments should ensure that staff, patients, donors and other visitors to the tissue establishment are treated fairly and with respect for their dignity and human rights. Tissue establishment staff should have received up-to-date training and be able to show they are competent in their obligations under equality law. EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 3.5 Attitudes towards assisted conception, gamete donation and the use of gametes and embryos may vary significantly between individuals, cultures and religions. All healthcare professionals should be sensitive to this. The responsible person should ensure employees have access to training and support to help them identify and meet the widest possible range of patients’ and donors’ needs and preferences. 3.6 Tissue establishments should be aware that for some patients, gender identity and sex orientation may be distinct and different. Tissue establishments treating trans patients should ensure that they take account of the particular needs of these patients and make appropriate changes to relevant processes and practices to accommodate their needs. 3.7 Tissue establishments should ensure that all activities and clinical structures and functions show respect for equality and diversity. Tissue establishments should review policies and procedures regularly to ensure they reflect equality and diversity adequately. Tissue establishments should also consider having equality policies. 3.8 The tissue establishment should ensure that all licensed activities are conducted in a non-discriminatory way and with proper respect for the privacy, confidentiality, dignity, comfort and well-being of all prospective and current patients. 3.9 A tissue establishment should provide or arrange investigations and treatments based on professional assessment and clinical judgment. They should take into account the needs and preferences of prospective or current patients, donors and others visiting the tissue establishment, including any reasonable adjustments, aids or help they may need. 3.10 Staff at a tissue establishment should not refuse or delay treatment because they believe that a patient’s actions have contributed to their condition. All prospective and current patients must be treated with respect, whatever their life choices or beliefs. 3.11 The responsible person for a National Public Health Service tissue establishment should consider relevant policies of their primary care before refusing treatment. 3.12 Staff at the tissue establishment must not harass or victimise patients or donors by allowing their own personal views or judgments (For instance, their views about a patient’s age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex or sexual orientation) to adversely affect their professional relationship with the patients or donors, or the treatment they provide or arrange should challenge colleagues if they believe their behaviour does not comply with this guidance, or with the relevant legislative requirements. 17 18 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) Conscientious objection 3.13 The tissue establishment should give prospective employees a full description of the tissue establishment’s activities, and at the interview draw their attention to the provision that anyone who has a conscientious objection to participating in a particular activity done in the centre must not be obliged to do so. 3.14 If a staff member has a conscientious objection to providing a particular licensed activity governed by the Act, they should inform the responsible person. The responsible person should ensure that the patient, patient’s partner or donor is given information on or referred to alternative sources of the treatment. 3.15 The responsible person should satisfy themselves that the staff member has a conscientious objection to providing a particular licensed activity and is not unlawfully discriminating against a patient on the basis of a protected characteristic. 3.16 If all staff at the tissue establishment conscientiously object to providing a particular licensed activity, the responsible person should: (
a)try to refer the person to another tissue establishment for treatment, and (
b)provide the patient with a written explanation of why the tissue establishment cannot treat them. 3.17 The responsible person should record: (
a)the reason(
s)for the conscientious objection of any member of staff (
b)their efforts to provide the particular activity at the tissue establishment, and (
c)if that activity cannot be provided at the tissue establishment, efforts they have made to ensure the patient receives treatment elsewhere. Addressing Communication Barriers 3.18 The tissue establishment should consider the needs of people whose first language is not Maltese or English and those who face other communication barriers. Where consent is obtained, the tissue establishment should record any difficulties in communicating the implications of giving consent and in providing other information to the person (e.g. language barriers or hearing impairment) and an explanation of how these difficulties were overcome(e.g. the use of an independent interpreter). EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 3.19 The tissue establishment should ensure it establishes and accommodates any disabled patient’s preferred means of communication. If appropriate, it should consider providing information in a variety of formats such as large print, ‘easy read’ or Braille. 4. Infertility Counselling and Patient Support The psychological and social stress of infertility and assisted conception treatment has been well documented. There is general agreement in the literature that stress and distress in some form are significant sequel of infertility. This may involve depression, anxiety, sexual dysfunction, damaged self-esteem and a range of difficulties in interpersonal relationships. A review of the evidence into the efficacy of counselling suggests that psychological therapies have benefit in a range of somatic complaints including gynaecological problems, bereavement/loss and depressive disorders. The purpose of counselling for infertility and assisted conception is to: (
i)Enable people to reflect upon and understand the implications of a proposed course of action for that person, their family, children born as a result and anyone else affected by the treatment (
ii)To provide emotional support before, during and after treatment, particularly if the person is experiencing stress, ambivalence or distress (iii) To assist people in developing successful coping strategies for dealing with both the short and longer-term consequences of infertility and treatment (
iv)To help people to try to adjust and to accommodate to their particular situation. The law requires that prospective parent or parents respectively receive independent clinical counselling to be offered before, throughout and after the procedures. Thus, counselling is to be offered when: (
a)prospective parents seek treatment that will create embryos in vitro (
b)prospective parents seek to store their gametes 4.1 The tissue establishment should provide counselling after the individual or couple has received oral and written information about the services to be provided and before they consent to treatment, donation, or to the storage or use of gametes or embryos. Counselling 19 20 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) should be accessible in terms of location. The timing and frequency of counselling sessions should be agreed between counsellor and the person or couple concerned, in order to meet their needs. 4.2 The tissue establishment should make patients, donors and their partners (if applicable) aware that the offer of counselling is obligatory as specified in the Act. The offer should include written information giving the name(
s)of the qualified counsellor(s), explaining their role, when they are available and how to access the service. The tissue establishment should allow enough time before treatment starts for patients to have counselling sessions. 4.3 The tissue establishment should take all practicable steps to provide counselling throughout the treatment, donation or storage processes, and afterwards if requested. Counselling should routinely be offered following adverse events and/or unsuccessful outcomes. If a person who has previously received treatment, or previously donated gametes or embryos requests further counselling at any point, the tissue establishment should take all practicable steps to help them obtain it. 4.4 If the possibility of treatment with donated gametes or embryos arises, the tissue establishment should give counselling about the implications of treatment with donated gametes and embryos, separately from counselling about the implications of treatment in general, and before treatment with donor gametes or embryos starts. 4.5 If the possibility of donating gametes or embryos for the treatment of others arises, the tissue establishment should give counselling about the implications of donation separately from counselling about the implications of treatment before the treatment starts. If treatment has already begun, it should continue only if the potential donor and, if applicable, his or her partner have been given counselling about the implications of donation. 4.6 The tissue establishment should offer people the opportunity to have counselling either with their partner or alone, depending on what each person prefers. In the case of counselling on the implications of treatment or donation, if two people are being treated together, then we would recommend they both attend the counselling session. Group sessions may also be offered in addition to individual and couple sessions. The Provision of Counselling 4.7 The provision distinguished from: of counselling should be clearly (
a)the assessment of a person’s suitability to receive treatment, or to store their gametes or embryos EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 (
b)the provision of information before obtaining consent or providing treatment. 4.8 The counselling service should comply with current professional guidance on good practice in infertility counselling. Counselling should be provided only by qualified and warranted counsellors. 4.9 The tissue establishment should ensure that arrangements are in place to provide, or refer people for, specialist counselling if appropriate, taking account of their duty of confidentiality under the EPA Act. This might include genetic counselling, and counselling for oncology patients or others requiring the long-term storage of gametes. 4.10 The tissue establishment should ensure that counselling facilities provide quiet and comfortable surroundings for private, confidential and uninterrupted sessions. The tissue establishment should also consider the use of other media for counselling sessions, such as video or audio calls in order to make counselling as accessible as possible for patients and donors. Counselling Records and Confidentiality 4.11 Information obtained during counselling should be confidential (although it may be disclosed in certain circumstances, for example if it gives rise to concerns about the suitability of a person to receive treatment). The written records of the professional counsellor should be kept in a secure place. These written records are confidential and should not be shared with others, including clinic staff. The Tissue establishment should ensure that their policies on record keeping and data protection include information on when the counselling records form part of the patient’s medical record and therefore could be disclosed to the patient. Oncology Sperm Preservation 4.12 Counselling for oncology sperm banking may take place prior to the start of medical or surgical treatment but not necessarily. Many patients do not have the time or opportunity for counselling at this stage. However, if oncology patients do present as clients, counsellors should be aware of the very considerable stress that they are likely to be experiencing as a result of dealing with both life and fertility threatening issues. Great sensitivity is needed and it may not be appropriate to explore many of the longer-term issues in a first session, but wherever possible, counsellors should encourage and support them in considering some or all of the following: (
i)the emotional and physical issues concerning the need to deposit sperm (
ii)where fertility issues fit into their priorities 21 22 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) (iii) thinking and planning for a future family in a present crisis situation (
iv)the reactions of partner, family and close friends (
v)issues around fertility to be considered for informed decision making (
vi)the future the assisted reproduction options open to them in (vii) the possibility that fertility treatments may fail or that other pregnancy related difficulties may arise (viii) the possibility of cancer recurrence after a child is born and the implications for the child and family (
ix)the eventual disposal of the preserved sperm (
x)current legal position Oncology Egg Preservation 4.13 Women who are considering egg preservation/ vitrification prior to the start of oncology medical and/or surgical treatment should be encouraged to consider counselling about the implications of this treatment before making any final decision. If oncology patients do present as clients, counsellors should be aware of the very considerable stress that they are likely to be experiencing as a result of dealing with both life and fertility threatening issues. Great sensitivity is needed and it may not be appropriate to explore many of the longer-term issues in a first session but, wherever possible, counsellors should encourage and support them in considering the same issues as those listed for oncology sperm preservation as well as: (
i)the emotional issues related to the need to go through egg collection at a time of crisis (
ii)the possible risks involved for their health by undergoing fertility treatment (iii) the possible risks associated with carrying a pregnancy after cancer therapy (
iv)the possibility of cancer recurrence after a child is born and the implications for the child and family (
v)the eventual disposal of stored eggs should they not be used in treatment EMBRYO PROTECTION AUTHORITY (PROTOCOL) (
vi)[ S.L. 524.02 the current legal position 4.14 It is important to note that in cases where the oncology patient is under18, counsellors should have particular expertise in counselling young people. Oncology Embryo Storage 4.15 Couples who are considering IVF procedures prior to the start of the women’s oncology medical and/or surgical treatment should be encouraged to consider counselling about the implications of embryo creation and storage before making any final decision. Tissue establishments should have sufficient counselling resources to ensure that they can respond quickly and appropriately to patient’s requests for counselling in these circumstances. If oncology patients and their partners do present as clients, counsellors should be aware of the very considerable stress that they are likely to be experiencing as a result of dealing with both life and fertility threatening issues. Great sensitivity is needed and it may not be appropriate to explore many of the longer-term issues in a first session but, wherever possible, counsellors should encourage and support them in considering the same issues as those listed for oncology egg preservation. Fertility Preservation (Social Reasons) Egg Preservation 4.16 Counselling for women who have requested egg storage for social reasons should be encouraged and counsellors should support these clients in considering the following issues: (
i)The emotional issues arising from the need to consider egg preservation. (
ii)Where fertility issues fit into her priorities at this time in her life. (iii) If the client is in a relationship: Whether both partners feel ready to commit having a family Whether embryo freezing has been considered (
iv)Whether the client feels any undue pressure to preserve eggs (
v)The attitudes of family and close friends (
vi)The realistic assisted reproduction options open to her / them in the future. 23 24 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) (vii) The possibility that treatment will fail when she / they decide to use the stored eggs (viii) stored eggs. The possibility of eventual disposal of unused Gamete Preservation for Transgender Persons 4.17 The Gender Identity, Gender Expression and Sex Characteristics Act of 2015 (Cap 540) of the Laws of Malta was enacted in 2015. The vision of the Maltese Government as detailed in the Consultation Document on Transgender Healthcare is to develop a trans inclusive health care system and to organise gender affirmative health care for transgender persons using a person-tissue establishment approach that tends to the physical, mental and social aspects of care of the individual whilst respecting the person’s gender identity. Some transgender persons will want to have children. Since feminising / masculinising hormone therapy limits fertility it is important for patients to make decisions concerning fertility such as cryopreserving of gametes, before starting hormone therapy or undergo surgery to remove / alter their reproductive organs. Trans patients, particularly those of a younger age, shall be able to store their gametes depending on their individual circumstances and if they comply with the requirements of the Embryo Protection Act. Embryo Storage and potential embryo donation 4.18 Couples who are considering IVF procedures with embryo cryopreservation should receive counselling about the implications of embryo creation, storage and potential embryo donation in circumstances as specified in the Embryo Protection (Amendment) Act, 2018, before making any final decision. Tissue establishments should have sufficient counselling resources to ensure that they can respond quickly and appropriately to patient’s requests for counselling in these circumstances. Counsellors should be aware of the very considerable stress that the prospective parent/s are likely to be experiencing as a result of dealing with both life and fertility issues. Great sensitivity is needed and Counsellors should be conversant with the Adoption Administration Act. Implications counselling for pre-implantation genetic testing 4.19 The tissue establishment should ensure that any person intending to begin treatment with PGTM has implications counselling. The implications counselling should be provided by a qualified EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 counsellor. This should address potential risks and implications of PGTM and should allow full opportunity for the prospective parents to ask questions and discuss any concerns. Patient support 4.20 The tissue establishment should develop a patient support policy, to outline how the centre ensures that patients, donors and their partners (where applicable) receive appropriate psychosocial support from all staff they encounter before, during and after treatment. Psychosocial support is delivered by all members of staff and includes, but is not limited to, access to counselling. All patients, donors and their partners (where applicable) should be treated with sensitivity and respect, and supported through all aspects of their treatment and, in particular, if they are suffering distress at any stage. 4.21 The policy should include: (
a)a definition of patient-centred care and how this will be delivered at the tissue establishment (
b)a statement regarding each individual staff member’s responsibility for supporting patients and managing their expectations (
c)a list of written and online information to be provided and how patients will be able to access this (
d)terms of what the tissue establishment will provide in (
i)support groups (
ii)forums for patients to engage with each (iii) signposting to external groups and forums (
iv)other events/groups/open evenings etc other (
e)the expectations about how all staff will communicate with patients, donors and their partners (
f)an outline of customised support interventions at different stages of treatment and for different types of patients (
g)the annual programme of training that will be provided to staff on different aspects of patient support, including skills training, adapted as appropriate to reflect staff members’ role within the clinic (
h)feedback mechanisms for collecting data on the 25 26 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) patient/donor experience and (
i)quality indicators for systematically monitoring and evaluating the tissue establishment’s provision of patient support and patient care as contained in this policy. 5. Information to be provided prior to consent Distinguishing the provision of information from the offer of counselling 5.1 The provision of information distinguished from the offer of counselling. should be clearly Information specific to the tissue establishment 5.2 Before treatment is offered, the tissue establishment should give the woman seeking treatment and her partner, if applicable, information about: (
a)patients the tissue establishment’s policy on selecting (
b)the tissue establishment’s statutory duty to take account of the welfare of any resulting or affected child (
c)the expected waiting time for treatment (
d)fertility treatments available, including any treatment add ons which may be offered and the evidence supporting their use (
e)the availability of facilities for freezing and storing eggs, sperm and embryos (
f)where patients freeze and store eggs, sperm or embryos the tissue establishment should provide information about future use including information about consent to posthumous use (
g)the importance of informing the treatment tissue establishment about the eventual outcome of the treatment (including if no live birth results) (
h)the tissue establishment’s complaints procedure. Information about the treatment 5.3 Before treatment is offered, the tissue establishment should give the woman seeking treatment and her partner, if applicable, information about: EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 (
a)the likely outcomes of the proposed treatment (data provided should include the national live birth rate and clinical pregnancy rate, and the tissue establishment’s most recent live birth rate and clinical pregnancy rate. Tissue establishments are encouraged to provide data per embryo transferred where relevant) (
b)the nature of the proposed treatment and any treatment add ons, including evidence of effectiveness. The tissue establishment should provide information in a lay format (
c)the implications of treatment, including for example, the possibility of a negative outcome which could cause distress or multiple pregnancy Information about the risks of treatment 5.4 Before treatment is offered, the tissue establishment should give the woman seeking treatment and her partner, if applicable, information about: (
a)the potential immediate and longer-term risks of the treatment and any treatment add ons used, including the risk to the patient and of any children conceived having developmental and birth defects (
b)the nature and potential risks of any alternative treatment options available so the patient can make an informed decision about their treatment (
c)the possible side effects and risks to the woman being treated and any resulting child (
d)the possibility of developing ovarian hyperstimulation syndrome (OHSS). Any information provided should include the possible symptoms of OHSS, what the woman being treated should do and who to contact if experiencing symptoms of OHSS (
e)the nature and potential risks (immediate and longer-term) of using emerging or unproven treatments, including reference to the clinic’s experience and wider evidence base (
f)the potential risk of emotional distress associated with negative outcomes both during and after treatment. Information about success rates 5.5 The tissue establishment should ensure that the information provided on its website complies with the following 27 28 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) guidance. This also applies to other relevant marketing communications of the tissue establishment and associated satellite and transport tissue establishments. (
a)The information should include the most recent data available from the past three years. (
b)Tissue establishments are encouraged to display live birth rate data per embryo transferred where relevant and this may be displayed alongside other success rate measures. The information should not highlight a high success rate that is not statistically significant where it applies only to a small, selected group of patients. (
c)The data should show split by maternal age and, if appropriate, by treatment type. (
d)The information should provide raw numbers rather than just percentages. (
e)The website should provide the national rate and like-for-like comparisons (the same year, maternal age, treatment type, etc.). (
f)The tissue establishment’s published success-rate data should refer to the EPA as the source of national information. (
g)The information must state clearly that information on success rates is of limited value in comparing tissue establishments and choosing where to seek treatment. (
h)If the information refers to comparative costs, it should indicate the likely total cost for a typical cycle, based on the actual costs for recent patients, not individual items in tariffs. Information about the cost of treatment 5.6 Before treatment, storage or both are offered, the tissue establishment should also give the person seeking treatment or storage, and their partner (if applicable) a personalised costed treatment plan. The plan should detail the main elements of the treatment proposed (including investigations and tests), the cost of that treatment and any possible changes to the plan, including their cost implications. The tissue establishment should give patients the opportunity to discuss the plan before. Further information to provide 5.7 There are different kinds of information tissue EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 establishments should give, where appropriate, to patients, patients’ partners and donors prior to obtaining consent to treatment, storage or donation. Tissue establishment staff should familiarise themselves with all the appropriate information to provide. This information is contained in the following list of guidance notes: (
a)Consent to treatments, storage, and disclosure of information (
b)Legal parenthood (
c)Multiple births (
d)Welfare of the child (
e)Donor recruitment, assessment and screening (
f)Procuring, processing and transporting gametes and embryos (
g)Storage of gametes and embryos (
h)Donor assisted conception (
i)Embryo donation (
j)Intra-cytoplasmic sperm injection (ICSI) (
k)Confidentiality and privacy Additional information for treating trans patients 5.8 The tissue establishment should be aware that there are multiple terms used to refer to trans people and that terminology in this area is evolving. For inclusivity, this Protocol uses the term "trans" to refer to all trans identities, including persons who consider themselves "non-binary" (ie, identify as somewhere, either fixed or moveable, on the male-female continuum) and "non-gendered" (ie, neither male, female, nor on the male-female continuum). 5.9 Before treatment or storage is offered to a trans person, the tissue establishment should (as with all patients) consider the treatment and storage options that are available to the patient, depending on their individual circumstances. For example, if a trans person is visiting the clinic prior to gender reassignment they may be seeking options for fertility preservation (ie, storage of either testicular or ovarian tissue, or eggs or sperm depending on whether they have undergone puberty); or if a trans person is visiting the clinic after gender reassignment they may be seeking ways to use their preserved tissue, eggs or sperm in treatment with a partner, or extend their storage periods due to premature infertility. 29 30 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) 5.10 Before treatment, storage or both are offered, the tissue establishment should inform a trans person (as with all patients) that they may need to be screened as a donor at the time of egg or sperm collection depending on the treatment options they may wish to pursue in the future and explain the reasons why. 5.11 Before treatment, storage or both are offered to a person who is yet to undergo gender reassignment or who is not yet living in their acquired gender, the tissue establishment should inform them that should they change their identity before returning for further treatment, it will be necessary for them to provide evidence of their acquired identity and to verify that they are the person previously treated. 5.12 The tissue establishment should recognise the sensitivities of treating trans patients, and have practical ways of accommodating their needs with dignity and respect. For example, rather than making assumptions about how a trans patient would like to be addressed, tissue establishments should ask how they would prefer to be addressed. Tissue establishments may also need to explain why gender at birth may be noted in medical records, should avoid making assumptions when referring to gender (eg, if a telephone enquiry is received regarding sperm storage, avoid assuming the caller is male), and should take privacy and sensitivity into consideration. 6. Consent to Treatment, Disclosure of Information Storage, Donation and 6.1 The tissue establishment should obtain written, effective consent from a person before using their gametes for their own treatment or their partner’s treatment. 6.2 When a woman is to undergo additional fertilisation and an embryo transfer, the tissue establishment should: (
a)obtain her consent to the proposed number of eggs to be fertilised (especially in cases where the medical practitioner has requested permission from the EPA to fertilise more than two eggs up to the maximum allowed by the Protocol), or embryos to be transferred (maximum two) and (
b)record her consent in her medical records. 6.3 The tissue establishment should establish and use documented procedures to ensure that no activity involving the handling or processing of gametes or embryos is carried out without the appropriate consent having been given. This should include a documented assurance process to ensure that all relevant consent forms have been properly and correctly completed before treatment. 6.4 If, following treatment, the tissue establishment discovers EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 errors in the consent provided by a patient or their partner, the tissue establishment should: (
a)take all reasonable steps to notify the affected patient at the earliest opportunity (
b)assess the error(
s)and potential impact, and consider the remedial actions that should be taken (
c)take all reasonable steps to support any affected patients (and their partner, if applicable), and (
d)report any error(
s)as an adverse incident. 6.5 The tissue establishment should ensure that the person giving consent is able to give their consent freely. The tissue establishment should not pre-complete consent forms on behalf of the person giving consent. For example, a person giving consent to the storage of their gametes and/or embryos should be free to choose how long to consent to store for, within what is permitted by regulations. 6.6 The tissue establishment should give anyone seeking treatment or considering donation or storage enough time to reflect on their decisions before obtaining their consent. The tissue establishment should give them an opportunity to ask questions and receive further information, advice and guidance. 6.7 If the possibility of donating gametes or embryos for the treatment of others, arises during the course of treatment, the tissue establishment should allow potential donors enough time to consider the implications and to receive counselling before giving consent. 6.8 The tissue establishment should ensure that consent is: (
a)given voluntarily (without pressure to accept treatment or agree to donation) (
b)given by a person who has capacity to do so (
c)taken by a person authorised by the establishment to do so, and (
d)given at the clinic (with both parties if a couple is being treated) where possible, clinics should record why a patient is not able to sign at the clinic and should have a documented process for ensuring consent forms being signed outside the clinic are signed by the correct person 6.9 The tissue establishment should ensure that anyone giving consent has been: (
a)given enough information to enable them to 31 32 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) understand the nature, purpose and implications of the treatment or donation (
b)given a suitable opportunity to receive proper counselling about the implications of the proposed procedures (
c)given information about the procedure for varying or withdrawing consent, and (
d)complete. given information in writing that is correct and 6.10 If gametes or embryos are to be transferred/exported to a tissue establishment outside the Maltese Islands, the tissue establishment must obtain the consent of the gamete provider(
s)to their transfer/export, to the country in which the receiving tissue establishment is situated. Such consent must then be provided to the tissue establishment receiving the gametes or embryos. 6.11 If gametes or embryos are to be transferred/imported into the Maltese Islands from a tissue establishment outside the Maltese Islands, the responsible person for the Malta tissue establishment must be satisfied that the provider has given written consent to the transfer/ import of the gametes or embryos to the Maltese Islands and has not withdrawn that consent. 6.12 The tissue establishment should inform prospective parent/s that, according to the Embryo Protection (Amendment) Act 2018 the cryopreservation of embryos shall be regulated by an agreement between the prospective parent or prospective parents and the licensee subject to the prior authorisation of the Embryo Protection Authority and shall have a maximum term of validity of five years renewable up to a maximum permissible age for the transfer thereof into the prospective parent. Provided further that when the maximum permissible age for the transfer of the embryo into the prospective parent is reached, the Embryo Protection Authority shall authorise the donation of the cryopreserved embryos. 6.13 Tissue establishments should take all reasonable steps to verify the identity of anyone accepted for treatment, including partners who may not visit the centre during treatment. The centre should establish the relationship between a patient and their partner and a record of this should be retained in the patients’ notes. If a patient’s identity is in doubt or if a tissue establishment has reason to question whether the person is who they claim to be, the tissue establishment should verify their identity, including examining photographic evidence such as a passport or a photocard driving licence. The tissue establishment should record this evidence in the patient’s medical records. Tissue establishments should have a process in place to verify the identity of a patient (and their partner, if applicable) if they return to EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 the centre for subsequent treatment, to ensure the patient and their partner are the same people they treated initially. The clinic should establish whether the patient and their partner’s personal circumstances have changed in the period since their last treatment, for example, whether the couple has divorced or separated since their previous treatment and give consideration to whether any changes in their personal circumstances impact on consent. 6.14 Where a patient has changed their name (eg, where someone has changed their name by deed, has married and taken their partner’s surname, or has obtained a gender recognition certificate) or has changed their physical appearance (eg, where someone has undergone gender reassignment or is living in the gender they most closely identify with but which is different from their gender at birth) since their previous consultation, examination or donation, centres should take all reasonable steps to verify the patient’s identity. This is to ascertain that a patient presenting for treatment or donation is the same person the centre previously engaged with or treated. Tissue establishments should verify a patient’s identity by asking for evidence of their previous name (eg, a passport or photocard driving licence) and verifying details against the person’s medical records. This can be a sensitive issue, and tissue establishments should take care to address identity issues with consideration. As evidence of their new name, centres should ask the person to provide one of the following: (
a)a marriage certificate, or (
b)evidence of a change in name (such as via deed) For trans patients: (
c)gender (
d)a birth or adoption certificate in an acquired a Gender Recognition Certificate, or (
e)a letter from a doctor or medical consultation confirming that the change of gender is likely to be permanent, and evidence of a change in name (such as via deed). Tissue establishments must ensure that a patient’s records are updated to accurately reflect their new identity. 6.15 To avoid the possibility of misrepresentation or mistake, the tissue establishment should check the identities of patients and their partners, against identifying information in the medical records. This should be done at each consultation, examination and treatment or donation. If the partner of a patient who is having treatment has not visited the clinic throughout the treatment, or does not return with the patient for subsequent treatment, tissue establishments should take reasonable steps to find out whether the patient’s partner still consents 33 34 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) to the treatment. This may include contacting the partner to confirm that their circumstances have not changed and that their consent is still valid. The tissue establishment should not commence treatment until it is satisfied that the partner in fact consents to the treatment. 6.16 The tissue establishment should consider the needs of people whose first language is not Maltese or English and those who face other communication barriers. Where consent is obtained, the tissue establishment should record: (
a)any difficulties in communicating the implications of giving consent and providing other information to the person (e.g. language barriers or hearing impairment), and (
b)an explanation of how these difficulties were overcome (e.g. the use of an independent interpreter). Recording Consent and Related Information The law requires consent, or any subsequent variation or withdrawal of consent, to be in writing and signed by the person giving consent. 6.17 The tissue establishment should keep a copy of a person’s signed consent form(
s)electronically or as a hard copy and make a copy available to those giving consent and to EPA and made available to them upon request. 6.18 The tissue establishment should ensure that it documents in the medical records, that relevant information has been provided to the person giving consent and that the person has been offered counselling before giving consent. Additional Consent Requirements for Storing Gametes and Embryos 6.19 Written consent to the storage of gametes must: (
a)specify the maximum period of storage, and (
b)state what should be done with the gametes, if the person giving the consent dies or cannot, because of mental incapacity, with draw or vary the terms of the consent. 6.20 The tissue establishment should normally ask patients to give consent to storage at the same time as consent to the use of gametes and embryos. However, the tissue establishment should accommodate anyone seeking long-term storage of gametes who may wish to consent to storage separately from consent to use. Any patient who has given consent to storage but who has not given consent to use, should be informed that their gametes cannot lawfully be used in EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 treatment unless they have given consent to use. 6.21 Provided that the cryopreservation of embryos shall be regulated by an agreement between the prospective parent or prospective parents and the licencee subject to the prior authorisation of the Embryo Protection Authority and shall have a maximum term of validity of five years renewable up to a maximum permissible age for the transfer thereof into the prospective parent in terms of Article 7 of the Embryo Protection (Amendment) Act, 2018. 6.22 When an individual gives consent to the use of gametes for the treatment of others, the tissue establishment need not get consent from the donor’s partner or spouse. However, if the donor is married, in a civil partnership or in a long-term relationship, the tissue establishment should encourage them to seek their partner’s support for the donation of their gametes. Consent to Examination and Treatment 6.23 Everyone has the right to withhold or give consent to examination and treatment. Unless there are exceptional circumstances, the tissue establishment may not examine, treat or receive gametes from people without first obtaining their consent. The only exceptional circumstance likely to arise during fertility treatment is: (
a)where the procedure is necessary to save the patient’s life, and (
b)the treatment cannot be postponed, and the patient is unconscious or mentally incapacitated so cannot indicate their wishes. 6.24 The tissue establishment should comply with current professional guidelines on consent. Consent to the Presence of Observers 6.25 If a member of the tissue establishment’s team wishes an observer to be present when a patient is being examined, treated or counselled, they should explain why beforehand and state who the observer is. The tissue establishment should give the patient appropriate information about the proposed observation and ask them whether they consent to the observer’s presence. Patients have the right to decide what identifying information should be disclosed and to whom. Tissue establishments should obtain a patient’s written consent before disclosing information relating to their treatment (or providing gametes for a partner’s treatment), or the storage of gametes. 35 36 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) In addition, consent is needed from any person who could be identified through disclosure of information about a person’s treatment or the storage of gametes. For example, consent would be needed from a patient’s partner if they could be identified through disclosure of information about the patient’s treatment. Consent to Disclose Identifying Information 6.26 Before obtaining consent to disclose information, the tissue establishment should give the person enough information for them to make a properly informed decision, including: (
a)precisely what information is to be disclosed (
b)the terms on which it is to be disclosed (
c)the reasons for disclosure (e.g. to keep the person’s general practitioner (GP) informed about the fertility treatment) (
d)the implications of disclosure (
e)the categories of people to whom the information is to be disclosed. 6.27 The tissue establishment should seek consent to disclosure to the following categories of people: (
a)the patient’s GP or the patient’s partner’s GP (
b)other healthcare professionals outside the tissue establishment (so they can provide the patient or the patient’s partner with the best possible medical care) (
c)auditors or administrative staff outside of the tissue establishment (so they can perform their functions in connection with the tissue establishment’s licensable activities), and (
d)medical or other researchers (so they can contact the patient about specific research projects or carry out noncontact research). 6.28 The tissue establishment should consider circumstances where they may need to disclose a person’s gender history (eg, to those within the tissue establishment who need to know of a trans patient’s previous identity to deliver safe and appropriate care) to determine whether they need to obtain the person’s consent to disclosure of this information. This should be discussed in detail with the person and any consent obtained should be filed with their medical records. 6.29 The tissue establishment should renew consent to disclosure if the nature of treatment changes after initial consent has [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) been given (eg, if during treatment, it is proposed that donor gametes are used instead of the patient’s own. 6.30 The tissue establishment should ensure that people to whom they disclose identifying information know that the information remains protected by the existing common law on confidentiality. Those receiving information should also be told: (
a)the precise terms upon which it was disclosed and for which consent has been given, and (
b)that if they disclose the information they have received, a child might learn in an inappropriate way that they were born as a result of fertility treatment. Cases where Consent is not required for Storage 6.31 Before storing someone’s gametes without their consent, the tissue establishment should judge that the person is not competent to consent to the storage of gametes. When assessing the competence of children and adults to consent, the tissue establishment should follow current guidance produced by the Department of Health, the Medical Council and other professional bodies. 6.32 The tissue establishment should presume that it is in the child’s best interests to store gametes unless circumstances suggest otherwise, (in cases of oncology treatment). When assessing whether it is in a child’s best interests to procure and store their gametes, the tissue establishment should consider the child’s short and long-term best interests. Consent should be sought from the child when they reach competence. 6.33 The tissue establishment should provide written information that children and young people can read and understand easily. This information should be given by a member of staff experienced in communicating with children. Competence 6.34 If the tissue establishment’s staff doubts someone’s competence to consent to a proposed procedure, or to the storage or use of gametes, they should: (
a)follow the current guidelines of professional bodies (
b)if they remain in any establishment should seek legal advice. doubt, the tissue 37 38 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) Variation and Withdrawal of Consent 6.35 If someone wishes to withdraw consent to the storage or use of gametes they must do so in writing, except if they are unable to do so because of illness, injury or incapacity. In these cases, they can direct someone to sign on their behalf, provided that the person withdrawing consent is present at the time, and that the signature is also witnessed and attested to by at least one other person. 6.36 The tissue establishment should check the identity of anyone withdrawing or varying consent against identifying information held in the medical records. The tissue establishment should also ensure that the person withdrawing or varying consent has been given sufficient information to enable them to make an informed decision about doing so. 6.37 The tissue establishment should have procedures for dealing with disputes that may arise when one gamete provider withdraws their consent to the use or storage of gametes (e.g. in cases of separation / divorce). In this situation the tissue establishment should stop treatment and notify all relevant parties. Tissue establishments should provide information about counselling or mediation services as appropriate. The End of Storage 6.38 The tissue establishment should make efforts to stay in contact with patients who have gametes in storage for their own treatment. The tissue establishment should also explain to gamete providers and current patients the importance of informing the tissue establishment of any change in their contact details. 6.39 Tissue establishments should inform patients who have gametes in storage for their own treatment when the end of the permitted storage period is approaching. Patients should be provided with information about the options available to them as the end of their permitted storage period approaches. They should be given enough notice to enable them to consider those options, and to access appropriate advice. 6.40 The Tissue Establishment should establish and use documented procedures to contact prospective parent/s who have gametes or embryos in storage for their own treatment when the end of the permitted storage period is approaching but long enough in advance to allow the Tissue Establishment and prospective parent/s to take any steps necessary to comply where extension of storage is an option for the prospective parent/s. 6.41 The Tissue Establishment should use all contact details available to them, including at least one written form of contact. EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 6.42 Prospective parent/s should be provided with information about the options available to them as the end of their permitted storage period approaches. 6.43 They should be given enough notice to enable them to consider those options and to access appropriate advice. 6.44 Options could include the donation of the gametes or embryos for the treatment of others. 6.45 If contact with the prospective parent/s is not possible, the Tissue Establishment should without delay inform the Embryo Protection Authority: (
a)adoption in the case of embryos these will be given for (
b)in the case of gametes, the Tissue Establishment is to record the steps it has taken in the patient’s medical records. 7. Legal Parenthood and Parental Responsibility 7.1 As defined in the "Embryo Protection (Amendment) Act 2018", "prospective parent" means "any person regardless of gender or sexual orientation, who has attained the age of majority and is a receiver or user of the medically assisted procreation techniques regulated under this Act. 7.2 For the purposes of this Protocol, the Embryo Protection Authority establishes that the woman who is entitled to treatment should be between the age of 18 and 48 years if using the woman’s own oocytes which have been retrieved prior to the women attaining 46 years. 7.3 It further establishes that the woman referred in Guidance Note 7.2 above, if after undergoing retrieval up to the maximum age of 45 years will still have cryopreserved embryos, then the maximum age of that woman will be extended to 48 years. 7.4 It further establishes that the woman who is entitled to treatment should be between the age of 18 and 48 years if using donated oocytes. 7.5 Prospective parent / parents referred in Guidance Notes 7.2 to 7.4 above are referred to treatment if they have one of the following: (
a)Identified causes of infertility amenable to treatment by IVF (
b)Unexplained infertility for at least 2 years. In all 39 40 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) cases where investigations show that there is no chance of pregnancy with expectant management and where IVF is the only effective treatment, the couple is to be referred directly for IVF without having to wait for the two-year period. (
c)Same sex lesbian couples making use of donated sperm (
d)Single/partnered biological woman, irrespective of legal identity (
e)Has a family history of a monogenic disease which is listed as one of the diseases in the Guidance Notes 11 for PreImplantation Genetic Diagnosis for Monogenic diseases 7.6 The maximum permissible age of the prospective parent for implantation of embryos shall be 48 years in all cases. 7.7 Article 19 of the Embryo Protection Act states that “Any child born as a result of any medically assisted procreation procedure, including cases where the child was born from donated germline cells or a donated embryo, shall be considered to be the child of the prospective parent or parents who have expressed their consent in writing as provided in article 18 of the same Act, and shall for all intents and purposes of law be deemed to have been naturally born of the same prospective parent or parents without the intervention of any procedure as aforesaid; and notwithstanding the provision of any other law, any such child shall be registered in any act of civil status as the direct descendant of such prospective parents who shall enjoy such rights and bear such duties according to law in respect of such child. 8. Multiple Births 8.1 The Embryo Protection Authority requires tissue establishments to have a documented strategy to minimise multiple births and should have documented standard operating procedures for egg and embryo transfer. Its purpose is to reduce the annual rate of multiple births resulting from treatments at the tissue establishment. The strategy must set out: (
a)how the tissue establishment aims to reduce the annual multiple birth rate following treatment at that tissue establishment (
b)the circumstances in which the clinician together with the responsible person would consider it appropriate to recommend single embryo transfer (SET) to a patient (in setting out such circumstances, the tissue establishment should give EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 proper consideration to relevant professional guidance) and (
c)the criteria for transferring eggs during gamete intra-fallopian transfer (GIFT). 8.2 The responsible person should ensure that the tissue establishment’s annual multiple birth rate are well recorded. 8.3 When implementing the tissue establishment’s strategy to minimise multiple births, the responsible person together with the clinician should consider the higher rate of multiple births from blastocyst transfers. The tissue establishment must document regular audits that: (
a)assess progress in reducing its multiple birth rate, (
b)help evaluate the effectiveness of its strategy. and Limits on Egg Fertilisation and Embryo Transfer 8.4 The tissue establishment should not transfer more than two embryos in any treatment cycle. 8.5 If the treatment involves the use of super ovulatory drugs or the transfer of multiple eggs or embryos (maximum of two embryos) in any one cycle (whether fresh or previously cryopreserved), the tissue establishment should give people seeking treatment information about the risks of multiple pregnancy for the woman, the embryo and any resulting child(ren), including: (
a)the higher risk of miscarriage and complications during pregnancy (
b)the higher rate of premature birth and the problems arising from low birth weight, the higher rate of still birth, and the higher rate of perinatal mortality (
c)the higher rate of disability and other health problems, plus the potential need for extended stays in hospital before and after birth, and (
d)the possible practical, financial and emotional impact on the family and any children. 8.6 The tissue establishment should give the woman the opportunity to discuss the number of eggs or embryos to be transferred before egg collection and just before embryo transfer. 8.7 If a woman is to undergo an egg or embryo transfer, the tissue establishment should: 41 42 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) (
a)obtain her consent to the proposed number of eggs or embryos to be transferred and the reasons for this (including her acceptance of the risk of multiple births), and (
b)record her consent in her medical records. 8.8 The tissue establishment should not fertilize more than two egg cells from one woman within one treatment cycle using her own eggs or donated eggs, where the prospective parent or prospective parents undergoing medically assisted procreation procedures do not expressly give their consent to the cryopreservation of embryos and to the donation of embryos if necessary in terms of Article 18 of the Act. 9. Additional Fertilisation Permissions 9.1 The medical practitioner in charge of the medically assisted procreation may, in consultation with the multidisciplinary team and with the permission of the Embryo Protection Authority, decide to fertilise more than two egg cells from one woman within one treatment cycle, provided that this is done in accordance with the established Protocol as discussed and approved in the Parliamentary Health Committee as per hereunder: Methodology of Applications and Process 9.2 The Clinical ART Multidisciplinary Team composed of the ART Consultant, Embryologists, Geneticist and Urologist assess on a case-by-case basis each patient that will be receiving ART treatment and the possibility of having additional fertilisation requests. The decision taken by the multidisciplinary team will be later communicated and discussed with the patient receiving treatment. 9.3 The ART Consultant together with and after discussions held with the prospective parent/s receiving infertility treatment, will take an informed decision on the number of oocytes that will be practical to fertilise, the two allowed by law and any additional oocytes to allow the possibility of having viable embryos that could result in a pregnancy and the possibility of a live birth. 9.4 The Consultant is then to apply to the Authority by filling the necessary required information on the already existing Additional Fertilisation Request Form (AFR Form), on the EEART online system. This is to be sent to the Authority together with a detailed report of why an additional request is being made. This is to be also accompanied by any supporting documentation. 9.5 The application is vetted by the Authority CEO. This application will then be presented in detail by the CEO in the next EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 Authority Board meeting. 9.6 During these Additional Fertilisation Request (AFR) sittings the Board is assisted by two representatives appointed by the Obstetrics and Gynaecology Association and representatives appointed by the Paediatric Association of Malta and a Urologist when necessary. Criteria for Permissions to allow Additional Fertilisation 9.7 The requests will be presented and discussed on a caseby-case basis and decisions for granting permission for additional fertilization will be based on the prospective parent/s receiving treatment infertility indicators, which include but not exclusive of: female factors (low ovarian reserve, PCOS, blocked tubes, etc.), male factor (azoospermia, oligospermia, evidence of testicular failure, morphology and motility issues), age of women receiving treatment, previous failed Assisted Reproduction Cycles, Oncology cases in male and female patients, fertility preservation, and any other medical conditions. 9.8 The decision taken by Board and Representatives is to clearly state either if no permission is granted and thus only two oocytes will be allowed to be fertilized; or if permission is granted, the number of oocytes that will be allowed to be fertilized: up to a maximum of twelve

(12)as per hereunder. (

a)Women who have not attained age 39 can be granted up to a maximum of 5 oocytes. (
b)Women aged 39 and who have not attained 46 years can be granted up to a maximum of 8 oocytes. (
c)Prospective parents undergoing PGTM will be allowed up to a maximum of 12 oocytes as per hereunder: (
i)Prospective parents where the woman has not attained 36 years of age will be allowed up to a maximum of 8 oocytes/embryos to undergo PGTM. (
ii)Prospective parents where the woman has attained 36 years of age and has not attained 46 years of age, will be allowed up to a maximum of 12 oocytes/ embryos to undergo PGTM. 9.9 The decision of the Authority is Final and will be communicated in writing on the EEART system by the CEO of the Authority to the Consultant who had made the original request. 9.10 The Consultant is to inform the prospective parent/s with the Authority’s decision before the IVF/ICSI cycle is performed. 43 44 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) Cases of Patients who already have Cryopreserved Embryos The Authority will not allow any fertilisation of oocytes, (Not even the two oocytes allowed by the EPA Act) if the person/s seeking treatment already have cryopreserved embryos, unless the embryos were cryo-preserved for medical reasons known to the Authority. 10. Welfare of the Child A woman must not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child who may be affected by the birth. 10.1 This guidance note applies to all fertility treatments regulated by the Embryo Protection Authority, including intrauterine insemination (IUI). 10.2 The tissue establishment should have documented procedures to ensure that proper account is taken of the welfare of any child who may be born as a result of treatment services, and any other child who may be affected by the birth. 10.3 The tissue establishment should assess each patient and their partner (where applicable) before providing any treatment, and should use this assessment to decide whether there is a risk of significant harm or neglect to any child referred to in 10.2. 10.4 Counsellors should make their own independent decision in line with their professional codes of ethical practice as to whether they undertake welfare of the child assessments. 10.5 If such assessments are undertaken by the counsellor, it should be explained to the patient(
s)that they are acting on behalf of the clinic and that this role differs from the typical therapeutic counsellor/client relationship. The tissue establishment should have an arrangement that enables patients to access support from another counsellor who may be a member of the team or who works independently. 10.6 Limitations to confidentiality should be discussed with the patient, including the extent to which information will be shared with other members of the multidisciplinary team. 10.7 If it is necessary to contact external agencies (such as Appogg, Sedqa, or any other designate Child Protection Agencies), prior approval for same is to be sought from EPA, for additional information. The patient or patients should be asked to give written consent by completing the necessary form. The patient or patients should receive a copy of any correspondence sent out to external EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 agencies. 10.8 If the assessment involves a couple, they would usually be seen together. A comprehensive history will be taken as part of the assessment process and this should include: (
a)Length of existing relationship (
b)Any existing children and their ages (
c)Number of children living with the prospective parent or parents (if any) (
d)Details of physical and mental health (
e)Details of substance or alcohol misuse (if any) (
f)Any safeguarding issues (including children and vulnerable adults) (
g)Any contact with police, probation, social services, and the reason for this contact (
h)The couple or individual’s perception of the welfare of the child issue (
i)Any other information that the couple or individual choose to provide 10.9 The information gathered at the assessment is recorded in accordance with the confidentiality conditions explained to the patient or patients. It is kept in a secure place, which may be separate from the medical notes and may be shared with other members of the licensed tissue establishment multidisciplinary team to help determine the next course of action. 10.10 External agencies may be contacted, after the tissue establishment has sought approval from the Embryo Protection Authority, and the case may be referred to an Ethics Committee as part of the decision-making process to offer or decline treatment. Information to be shared with an Ethics Committee should be agreed with the patient(
s)and presented in an anonymous way so that the patient(
s)cannot be identified. 10.11 The tissue establishment should inform the patient(
s)at each stage of this process and ensure that they are aware of their right to appeal and the opportunities for obtaining appropriate counselling if the decision made is not in their favour. 10.12 The tissue establishment should repeat the assessment if: (
a)the tissue establishment has been out of contact 45 46 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) with the patient for two years or more (
b)the patient has a new partner (
c)a child has been born to the patient since the previous assessment, or (
d)the tissue establishment has reason to believe that the patient’s medical or social circumstances have changed significantly. 10.13 Those seeking treatment are entitled to a fair assessment. The tissue establishment is expected to consider the wishes of all those involved, and the assessment must be done in a non-discriminatory way. In particular, patients should not be discriminated against on grounds of gender, race, disability, sexual orientation, religious belief or age. 10.14 The tissue establishment should take a medical and social history from each patient and their partner (when applicable). Where appropriate, the patient and their partner may be interviewed separately. The information gathered should relate to the factors in paragraphs 10.15–10.16 below. Factors to take into Account during the Assessment Process 10.15 The tissue establishment should consider factors that are likely to cause a risk of significant harm or neglect to any child who may be born or to any existing child of the family. These factors include any aspects of the patient’s or their partner’s: (
a)past or current circumstances that may lead to any child mentioned above experiencing serious physical or psychological harm or neglect, for example: (
i)children previous convictions relating to harming (
ii)child protection measures taken regarding existing children, or (iii) violence or serious discord in the family environment (
b)past or current circumstances that are likely to lead to an inability to care throughout childhood for any child who may be born, or that are already seriously impairing the care of any existing child of the family, for example: (
i)mental or physical conditions EMBRYO PROTECTION AUTHORITY (PROTOCOL) (
ii)[ S.L. 524.02 drug or alcohol abuse (iii) medical history, where the medical history indicates that any child who may be born is likely to suffer from a serious medical condition, or (
iv)circumstances that the tissue establishment considers likely to cause serious harm to any child mentioned above. 10.16 When considering a child’s need for supportive parenting, tissue establishments should consider the following. Supportive parenting is a commitment to the health, wellbeing and development of the child. It is presumed that all prospective parents will be supportive parents, in the absence of any reasonable cause for concern that any child who may be born, or any other child, may be at risk of significant harm or neglect. Where tissue establishments have concern as to whether this commitment exists, they may wish to take account of wider family and social networks within which the child will be raised. Obtaining further Information during the Assessment Process 10.17 The tissue establishment should obtain consent from the prospective parent and their partner (where applicable) to approach any individuals, agencies or authorities for any factual information required for further investigation if: (
a)information provided by the prospective parent or parents suggests a risk of significant harm or neglect to any child (
b)the prospective parents have failed to provide any of the information requested (
c)the information the prospective parents have provided is inconsistent, or (
d)there is evidence of deception. A refusal to provide consent to disclosure of information should not, in itself, be grounds for denying treatment but the tissue establishment should take this into account in deciding whether to provide treatment. The tissue establishment should discuss with the prospective parent or parents the reason for refusing to provide consent. Furthermore, the tissue establishment should inform the EPA about the refusal from the prospective parent or parents. 47 48 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) 10.18 If information has been provided in confidence to a member of staff, the staff member should seek consent from the information provider to discuss it with other staff. If such consent is refused and the member of staff considers the matter to be crucial to a decision, they should use their discretion, based on good professional practice, in deciding whether to break that confidence. In line with professional guidance, patients should normally be informed of the decision to break confidence and the reasons for it, before the information is shared with other members of staff. Refusing Treatment 10.19 The tissue establishment should refuse treatment if it: (
a)concludes that any child who may be born or any existing child of the family is likely to be at risk of significant harm or neglect, or (
b)cannot obtain enough information to conclude that there is no significant risk. 10.20 In deciding whether to refuse treatment, the tissue establishment should: (
a)take into account the views of all staff who have been involved with caring for the patient and their partner, and (
b)give the patient and their partner the opportunity to respond to the reason or reasons for refusal before the tissue establishment makes a final decision. 10.21 If treatment is refused, the tissue establishment should explain, in writing, to the patient and their partner: (
a)why treatment has been refused (
b)any circumstances that may enable the tissue establishment to reconsider its decision (
c)any remaining options, and (
d)opportunities counselling. for obtaining appropriate 10.22 Decision of refusal by the Tissue Establishment should be communicated immediately to the Embryo Protection Authority. Record Keeping 10.23 In all cases, the tissue establishment should record in the patient’s medical records the information it has considered during the EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 assessment. If further information has been sought or discussion has taken place, the record should reflect the views of those consulted in reaching the decision and the views of the prospective parents. 11. Pre-implantation Genetic Testing for Monogenic diseases (PGTM) 11.1 In Malta, PGTM is regulated by the Embryo Protection Authority (EPA). The Authority maintains a list of conditions for which PGTM has been approved, as per table reproduced hereunder: List of Conditions approved by EPA for PGTM Finnish Nephrotic Syndrome Gangliosidosis Huntington Disease Joubert Syndrome Maple Syrup Urine Syndrome Nemaline Myopathy Spinal Muscular Atrophy Tay-Sachs Disease Walker-Warburg Syndrome 11.2 For conditions not already on the list, the EPA considers a number of factors, including how serious the condition is, the likelihood of it being inherited and the testimony of people affected by the condition before deciding whether to approve it for PGTM testing. 11.3 In order for a new condition to be considered for PGTM testing approval, a couple must have a licensed PGTM clinic apply to the EPA on their behalf. 11.4 When pre-implantation genetic diagnosis (PGTM) is used to combine IVF and genetic testing as a means of avoiding the transmission of a genetic disease, the medical practitioners shall follow the principles of the Ethical Guidelines as per hereunder: 11.4.1 Pre-implantation genetic diagnosis (PGTM) is a technique that may be used to combine IVF and genetic testing as a means of avoiding the transmission of a genetic disease as listed in the protocol. PGTM shall not be allowed for the selection of embryos for 49 50 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) eugenic purposes. 11.4.2 PGTM should only be used for the detection of serious genetic conditions as approved by the Authority, and which conditions significantly affect the health of an individual who might be born. 11.5 The use of PGTM should be a matter of discussion between those seeking PGTM (i.e., the prospective parents) and the clinical team on the seriousness of the genetic condition. 11.6 A senior clinical geneticist should be involved in the decision-making process when deciding whether a particular patient should receive treatment involving PGTM. 11.7 The Tissue Establishment offering treatment should ensure that a multidisciplinary team is involved in providing the PGTM service. The team should include reproductive specialists, embryologists, clinical and molecular geneticists, genetic counsellors. It should also maintain close contact with the primary care medical doctor or the referring clinician. 11.8 If the Tissue Establishment offers the PGTM service, the individual responsible for this laboratory should: (
a)hold an appropriate scientific or medical degree (
b)have acquired sufficient experience in an appropriately accredited medical genetics diagnostic laboratory to supervise and be responsible for one, and (
c)be registered with a recognised body by the EPA as a clinical scientist with specific expertise in clinical genetics and is conversant on the nature of tests conducted, the scope and limitations of the tests, accuracy and implications of the tests and the meaning of the test results. 11.9 The Tissue Establishment should ensure that the prospective parents seeking treatment should have access to the clinical geneticists and the genetic counsellors. 11.10 Genetic counselling requires specialist training and knowledge. Tissue Establishments are to ensure, that genetic counselling should only be undertaken by an infertility counsellor if s/ he has additional qualification in genetic counselling. In the absence of this, patients should be referred to specialist genetic counselling services. Genetic counselling addresses the risk of patients using their own gametes, but it does not address the emotional issues associated with infertility. Therefore, the Tissue Establishment’s counselling service should continue to be available before, throughout and after the investigations, decision-making and treatment. EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 11.11 The Tissue Establishment should consider the following factors when deciding if PGTM is appropriate in particular cases: (
a)the views of the people seeking treatment in relation to the condition to be avoided, including their previous reproductive experience (
b)condition the likely degree of suffering associated with the (
c)the future the availability of effective therapy, now and in (
d)the speed of degeneration in progressive disorders (
e)the social support available, and (
f)treatment. the family circumstances of the people seeking 11.12 The Tissue Establishment may offer PGTM but withhold the patient’s test results (PGTM with non-disclosure). However, this should only be offered under the following conditions: (
a)that patients are given the opportunity to receive genetic counselling on the implications prior to giving consent, (
b)that protocols are established to limit, as far as possible, the risk of unwanted disclosure to the patients. Tissue Establishments should consider using a different embryology laboratory from their own, in order to minimise the number of Tissue Establishment staff who know the patient’s genetic status. 11.13 The Tissue Establishment should document its reasons for offering PGTM with non-disclosure to a patient. This record should include: (
a)written informed consent from the patient to perform PGTM with non-disclosure, (
b)a statement from the people seeking treatment confirming that they have been given the opportunity to receive genetic counselling and that they have, prior to giving consent, received information: (
i)on the risks of inadvertent disclosure, (
ii)that where all embryos are suitable for transfer this is not evidence of the patient’s genetic status, 51 52 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) (iii) that where no embryos are suitable for transfer this is not evidence of the patient’s genetic status. 11.14 The clinical team of the Tissue Establishment, having discussed with the prospective parents seeking PGTM, and determined the condition to be sufficiently serious to warrant PGTM, need to apply to the Regulatory Authority EPA and provide the EPA with a report prior to starting any PGTM procedure, detailing: (
a)the nature of the genetic condition, (
b)if testing is to be for Polar Body PGTM, Day 3 Blastomere PGTM or on a Day 5 Blastocyst PGTM, (
c)proof that the prospective parents have received genetic counselling and have given a joint informed consent to undergo the procedure, (
d)original or copy of results of genetic testing, karyotypes or other specific testing of the index patient, spouse or partner, children, or other family members (when appropriate), (
e)female reproductive history, gynaecological and fertility status, (
f)male reproductive history, andrological history, fertility status, results of sperm analysis (especially in cases where the genetic disorder(
s)for which PGTM is desired has effects on sperm parameters, (
g)reports on health problems of female and male partners that may affect genetic diagnosis, or the outcome of IVF and pregnancy (when appropriate). Health status may need to be re-evaluated over time, (
h)a genetic counselling report 11.15 The Authority, if the condition is listed in the approved conditions, will issue a permission for the prospective parents to undergo PGTM. It is only after an approval is granted that a PGTM procedure can go ahead as per hereunder: (
a)Prospective parents where the woman has not attained thirty-six

(36)years of age will be allowed up to a maximum of eight oocytes/embryos to undergo PGTM. (b) Prospective parents where the woman has attained thirty-six

(36)years and have not attained forty-six

(46)years of age will be allowed up to a maximum of twelve oocytes/ embryos to undergo PGTM. EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 11.16 The Tissue Establishment should ensure that people seeking PGTM are given the appropriate information about the treatment. This should include: (

a)the process, procedures and possible risks involved in IVF and biopsy procedures when providing a sophisticated genetic test, (
b)the experience of the Tissue Establishment in carrying out the procedure, (
c)that sophisticated genetic tests can reveal additional genetic information about an embryo(
s)and that the clinical effect of these findings on a child born may not be known, (
d)All information, oral and written, should be in language that can be understood by a layperson as technical terminology may lead to patient misunderstanding, (
e)Written information about treatment should be available prior to a consultation, (
f)When PGTM involves the treatment of a couple, both partners should, when possible, attend consultations, (
g)An independent interpreter should be present, when necessary, although a family member could act as translator in the absence of an alternative, (
h)Counselling should be offered both before, during and after each IVF/PGTM cycle. The counselling provided should be non-directive and include all reproductive options available to the couple, enabling them to reach their own conclusion about the suitability of treatment, (
i)Costs and timelines should also be discussed to ensure that patients are fully informed of all aspects of IVF and PGTM before treatment starts. The social and psychological impact needs to be considered, especially in couples already responsible for the care of affected children, (
j)Additional counselling may be needed after completion of the laboratory work-up, (
k)Individualised post-consultation letters should contain a summary of the information discussed, (
l)The patients should sign a written informed consent for all procedures they will undergo, and which are PGTM-related. 53 54 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) 11.17 The Tissue Establishment should also provide information to those seeking treatment to help them make decisions about their treatment, including: (
a)genetic and condition being tested for, clinical information about the (
b)the likely impact of the condition on those affected and their families, (
c)information about treatment and social support available, and (
d)information from a relevant patient support group or the testimony of people living with the condition, if those seeking treatment have no direct experience of it themselves. 11.18 If the person seeking treatment has already been given information about the particular genetic disorder, for example from another genetics Tissue Establishment, the Tissue Establishment need not provide this information again. However, the Tissue Establishment should ensure that the information has been provided to a satisfactory standard of breadth and clarity. 11.19 Before providing PGTM, the Tissue Establishment should ensure that those seeking treatment have had sufficient opportunity to fully consider the possible outcomes of genetic testing and their implications. 11.20 Embryos from which biopsies have been taken or resulting from gametes from which biopsies have been taken, should not be transferred with any other (non-biopsied) embryos in the same treatment cycle. 11.21 Embryos that after biopsies have been carried out result that they have a gene that will develop a serious disease, cannot be discarded as per the Embryo Protection Act, thus, such embryos are to be cryopreserved in a dedicated storage facility, separate from embryos not diagnosed with the disease. 11.22 Any embryos, that after undergoing PGTM biopsies have inconclusive diagnosis, are to be clearly labelled and cryopreserved in the same dedicated storage facility as the embryos diagnosed with the disease. 11.23 Any embryos that after undergoing PGTM result that they are not diagnosed with the disease being tested for but might be carriers of that disease can be transferred into the prospective parents requiring treatment and are to be cryopreserved with the embryos not diagnosed with the disease. EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 11.24 The use of an embryo known to have a gene of a serious disease as described above, should be subject to consideration of the welfare of any resulting child and should have approval from the Authority. Prior to use, the prospective parents must give their consent, after receiving adequate information for same use. 11.25 Embryos known to have a gene of serious disease as described above, will only be placed for adoption once an effective treatment for same disease has been found. 11.26 If a Tissue Establishment decides that it is appropriate to provide treatment services to a woman using an embryo known to have a gene of a serious disease as described above, it should document the reason for the use of that embryo and inform the Authority without due delay. 11.27 The Tissue Establishment should have an adequate labelling system, written or barcoded (electronic), with two unique patient identifiers plus the embryo/cell(
s)number is used to match the sample’s diagnostic result with the embryo from which that sample was taken. This should ensure traceability throughout the IVF and PGTM process until reporting of the final results. 11.28 The labelling system should be comprehensible and practical for both the IVF and PGTM centres. Printed sticker labelling may be superior to pens, as labelling should be legible and uneditable. 11.29 Labelling and sample identification should be confirmed for critical and high-risk steps by an independent observer and signed. 11.30 After biopsy, the sample may be analysed in house or sent for genetic testing in another centre. 11.31 The PGTM work-up report should contain at least the following information: (
a)administrative information including (
i)title or name of the report; (
ii)number of the report (as used for document control, when available); (iii) pagination including the actual and total number of pages (the patient identifier and report name/ number must be present on each additional page); (
iv)full date of the report; (
v)name and referring the patient; address of the physician 55 56 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) (
vi)identification of the person(
s)performing the diagnosis/authorising the release of the report and their signature; (vii) identity of the IVF/PGTM centre with full contact details; (
b)patient (male and female)/sample identification: (
i)full given name(
s)and surname, or unique patient identification code; (
c)(
ii)unequivocal date of birth; (iii) gender; specific for the preclinical work-up report: (
i)(
ii)laboratory; date of DNA sample collection; date of DNA sample arrival in the (iii) samples and genetic status of relevant family members can be mentioned only with their informed consent and should be in accordance with general data protection regulations (GDPR) and/or local privacy regulations; (
d)restatement of the clinical question, i.e., the indication(
s)being requested for analysis, the type of required testing, the referral reason, parental karyotypes/genomes; (
e)specification of genetic tests used: (
i)brief information on the methods used in the analysis; (
ii)full details of the extent of the tests, including software, where appropriate; (iii) where a commercially available kit is used, this should be clearly identified in the report, including the reference and version of the kit. (
f)a clear description and interpretation of results; (
g)a clear summary of the results; (
h)error rates/limitations of the test/misdiagnosis (a general figure should be stated for the overall cycle/treatment). EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 11.32 Before starting a clinical PGTM cycle, relevant documents should be available, labelling of samples should be checked, and genetic counselling provided to the prospective parent/s. 11.33 The PGTM laboratory should ensure that it has clearly documented procedures for all steps of the examination process (explicit instructions and a summary of validation results) and release of results (diagnosis, reporting, embryo transfer policy). These procedures should be covered in a service-level agreement between the PGTM and IVF centres. 11.34 The IVF Centre should ensure that the method used for PGTM should have been previously implemented, tested, and validated in the PGTM centre. 11.35 Clinical results are to be reviewed and signed or electronically validated by a suitably qualified person (name, qualification, date). 11.36 The PGTM clinical cycle report contains an interpretation of the clinical results and guidance on which embryos are genetically transferable. The same recommendations apply as specified for the preclinical work-up report, together with the following items: (
a)unique cycle/treatment code; (
b)date of oocyte retrieval; (
c)date of biopsy; (
d)date of biopsy sample arrival in the laboratory; (
e)information on the sample type (including number of samples and controls); (
f)unique ID number for each cycle and/or biopsy sample tested; (
g)indication for PGTM. 11.37 When scoring results from polar body (PB) testing, it is recommended to report what was detected in each PB and then infer the oocyte diagnosis. It is recommended to test both PBs. 11.38 When scoring results from blastomere/trophectoderm (TE) testing, it is recommended to report what was detected in the sample and then infer the embryo diagnosis. 11.39 A written or electronic report should be securely transmitted to the IVF centre to ensure transfer and/or cryopreservation of the correct embryos. Results should not be 57 58 [ S.L. 524.02 EMBRYO PROTECTION AUTHORITY (PROTOCOL) communicated orally. 11.40 Reporting time should be kept as short as possible and when fresh transfer is intended, reporting time should be adapted to allow the IVF centre to organise the embryo transfer. 11.41 The report should be clear, concise, accurate and easily understandable by non-geneticists and that the overall result and interpretation (including transfer recommendation) are presented per embryo. 11.42 In case of no diagnosis and re-biopsy to try and obtain a result, this should be included in the report. 11.43 The final clinical cycle report must be signed by appropriately qualified (authorised) personnel (name, qualification, date), and the clinical cycle results are discussed with the couple before embryo transfer. 11.44 The report is stored in the patient file in both the PGTM and the IVF centre, according to local regulations and a copy of which is sent to the Regulatory Authority EPA together with cryopreservation details of the embryos that can be transferred as well as the cryopreservation details of the embryos diagnosed with the disease. 11.45 Tissue establishments should compare PGTM live birth rates and matched non-PGTM [routine IVF or intracytoplasmic sperm injection (ICSI)] live birth rates within that IVF centre. 11.46 When in-house genetic analysis is not feasible, transport PGTM is an option. In transport PGTM, patients have the IVF treatment (oocyte retrieval, embryo culture, biopsy and transfer, pregnancy follow-
up)at their local IVF centre, but genetic testing is performed at a collaborating PGTM centre with significant experience in PGTM. 11.47 The IVF centre and PGTM centre should have in place an official agreement (Service-Level Agreement) dealing with legal, insurance and accountability issues about the transport PGTM procedures. 11.48 Transportation companies entitled to transport biopsied material should certify their suitability to transport the biopsied material, provide the likelihood of a sample loss or sample delivery delay and provide actions taken against these risks. 11.49 The IVF centre and outsourced PGTM centre should make arrangements to ensure that patients have had adequate PGTM counselling. 11.50 The IVF centre and PGTM centre should have in place a EMBRYO PROTECTION AUTHORITY (PROTOCOL) [ S.L. 524.02 set of clinical/laboratory validated protocols, including tubing/ spreading protocols, and shipment protocols specifying approximate transportation time and ensuring cell and/or DNA integrity. 11.51 In addition, practical and logistic arrangements on who will be responsible for the various stages of the PGTM treatment should be clearly established. 11.52 The IVF centre and PGTM centre should delineate clear and sufficient lines of communication as documented in written procedures and compliant with the GDPR during all stages of a transport PGTM treatment. 11.53 The IVF/PGTM centres should agree on the feasibility, the number, and the timing of transport PGTM cycles and define a schedule. 11.54 All diagnostic results and reports are sent in written form (complying with the GDPR). 11.55 PGTM centres should be accredited and certified, as PGTM is of a multidisciplinary nature, the various units involved should each be accredited/certified for their defined tasks and according to the most appropriate quality standards. For each unit, responsibilities should be clearly outlined/described and transition of responsibility from one unit to the other during the PGTM process should be well defined and guaranteed. 12. Donor Recruitment, Assessment and Screening 12.1 As per the Embryo Protection (Amendment) Act, 2018 Article 9

(1)"The donation of germ line cells for the purpose of medically assisted procreation shall be a confidential agreement between donor and the licensee". 12.2 The donation of germ line cells for the purpose of medically assisted

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AI explanation based on the official legal text. Indicative, not a substitute for legal advice.

L.S. 524.02 Regolamenti dwar il-Protokoll tal-Awtorita' għall-Protezzjoni tal-Embrijuni