Our Mission
The Authority treats all prospective parents referred by the licensed Clinics with dignity and respect, and all information provided to the Authority in confidence remains highly confidential and disclosed only in the circumstances permitted by law, as per Data Protection Act.
All decisions taken by the Embryo Protection Authority are in the best interest of the prospective parents and the child/children who may be conceived out of any assisted reproductive technology procedure undergone.
The Authority ensures that the highest levels of standards are being kept as specified in the laws governing the fertility sector by working closely with all stakeholders in the Fertility field.
Our Values
- Passion
To bring a sense of belonging and the importance of performing to the best of our abilities and resources.
- Responsibility
To act with honesty, fairness and integrity in all instances.
- Constant Improvement
To improve the processes, and services to all related stakeholders.
“Thank you very much for all your work. You have changed my life and as I embark on a new role as a pregnant woman (soon-to-be mum), know that you are very instrumental in my life, and I can’t thankyou enough.”
Prospective Parent
“In these difficult times you made our journey far less strenuous with all your help and support”.
Patient
“We truly appreciate as although to you it might seem your duty, to us it meant the world. Thankyou from the bottom of our hearts”.
Prospective Parents
“The Authority in Malta has been a key player to ensure that in an area that is very sensitive, the highest levels of standards are adhered to. The EPA has done this job well.”
License Holder
“The EPA had ranked highly in the EU. From our perspective, having opened a fertility clinic, the EPA has been helpful and meticulous.”
License Holder
About us
The Embryo Protection Authority (EPA) is a body corporate having a distinct and legal personality and is the sole Regulator of all Assisted Reproductive Technologies (ART) performed at both the public and private licensed clinics/hospitals in Malta.
It has been established as per the Embryo Protection Act 2012, (Chapter 524) which covers the procurement, processing use and storage of sperm, oocytes, and embryos for human application.
The Authority sets the standards and determines the policy framework (Protocol) while providing information to stakeholders, the general public, to the prospective parent/parents and to donors seeking treatments at licensed clinics at the public and private tissue establishments.
Functions and Responsibilities of the Embryo Protection Authority
- To ensure that high standards of ethics are maintained by all healthcare professionals involved in procedures of medically assisted procreation.
- To request and obtain, in cases of reasonable suspicion that the provisions of the Embryo Protection Act are not being followed, information and copies, in any form, of documents required by the Commission Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells to ensure traceability of human cells.
- To carry out inspections in order to ensure that the standards of best practice are being respected and implemented and that all information and documentation required under Article 18 of the Embryo Protection Act is being kept appropriately.
- To maintain a statement of the general principles which, in its opinion, should be followed in:
- Carrying out its activities under the Embryo Protection Act and
- Carrying out its functions in relation to such activities under the Embryo Protection Act.
- To ensure, in relation to activities under the Embryo Protection Act, compliance with:
- The obligations and requirements imposed by or under the Embryo Protection Act.
- The codes of practice established under paragraph (a) of the Embryo Protection Act.
- To perform such other functions as may, from time to time, be prescribed by regulations made under the Embryo Protection Act.
Corporate Identity
The Corporate Identity
The corporate identity of the Embryo Protection Authority includes a logo which represents the Authority’s objectives. The logo features an embryo icon within the womb. The womb represented in the logo, represents the parent/parents involved in the process whilst the outside circle represents the Authority’s structure giving a feeling of protection to all involved in the process.
Protocol
A consolidated Law was passed through parliament which provides protection of the human embryos through the establishment of the regulatory Authority (The Embryo Protection Authority).
The Protocol, for the first time, is part of the same consolidated law and reflect the changes in the Embryo Protection Act which came into force on the 29th of July 2022.
This is intended as a means of assisting licensed clinics to comply with their legal obligations whilst serving also as a useful reference for patients and professionals working in the fertility sector.
Authority Board and Executive Administration
Legal Representation
The legal representation of the Authority is vested in its Chairperson, Hon. Judge Antonio Mizzi and the Chief Executive Officer, Ms Simone Attard RR Couns, PGrad Cert Dip Systemic Practice (Tavistock and Portman NHS Trust UK), MBICA, GHZ, OLJ. (Systemic Practitioner and Counsellor).
The board appointed members are professionals coming from different sectors including the health field.
The Chief Executive Officer, Ms. Simone Attard RR Couns, PGrad Cert Dip Systemic Practice (Tavistock and Portman NHS Trust UK), MBICA, GHZ, OLJ. (Systemic Practitioner and Counsellor) is responsible for the executive conduct, administration and organisation of the authority.
Frequently Asked Questions
What are the treatments offered at licensed clinics at the public and private tissue establishments in Malta with regards to assisted reproductive technology?
The treatments offered at licensed clinics at the public and private tissue establishments in Malta are In Vitro Fertilisation (IVF), Intracytoplasmic Sperm Injection (ICSI), Intrauterine Inseminations (IUI), treatments with the use of third-party donations and Fertility Preservations.
All treatments can only be proceeded with, if both prospective parents/ parent are eligible according to the law and sign the necessary consent forms through the respective clinic.
Who is eligible for the services offered by the Assisted Reproductive Technology (ART) within the National Health Service?
Any person regardless of gender or sexual orientation, that has attained the age of majority where the prospective parent/parents have at least one of the following:
(i)Identified causes of infertility amenable to treatment by IVF
(ii)Unexplained infertility for at least 2 years. In all cases where investigations show 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.
(iii)Same sex lesbian couples making use of donated sperm
(iv) Single/ partnered biological woman, irrespective of legal identity.
(v) Has a family history of monogenic disease which is listed as one of the diseases in the Protocol for Pre-Implantation Genetic Diagnosis for Monogenic diseases.
How many families can be created with the use of gametes from the same donor, in Malta?
As per the Embryo Protection Authority (EPA) Act, a donor can be used to create only one family.
What is the maximum number of oocytes to be fertilised?
Women who have not attained the age of 39 (up to age 38) can be granted up to a maximum of 5 oocytes.
Women aged 39 and who have not attained 46 years (up to age 45) can be granted up to a maximum of 8 oocytes.
What is the maximum age limit of both female and male donors in Malta?
The maximum age limit of both female and male donors is up to age 35 years of age (not attained the age of 36), on date of donation.
Can parents who already have a child, apply to have up to two children through the National Health Service?
The National Health Service entitlement is extended and prospective parents who had their first child through IVF and also prospective parents who had their first natural child and are now facing difficulty having their second child can apply for an assisted reproductive technology (art).
Is the cost of stimulation medication refunded to everyone?
The refund for the cost of stimulation medication applies to prospective parents undergoing treatment under both the National Health Service and in privately licensed clinics in Malta.
Can gametes and embryos of prospective parents that have been cryopreserved abroad be distributed/imported to Malta?
Prospective parents that have gametes or embryos cryopreserved abroad can be distributed/imported to Malta only with the permission of the Embryo Protection Authority according to the Maltese Legislation.
What is the maximum age when IVF/ICSI and embryo transfers can be carried out?
IVF/ICSI and embryo transfers can be carried out before the woman attains age 49 (up to age 48).
As per EPA (Embryo Protection Authority) Protocol, what is the maximum number of oocytes to be fertilised for prospective parents undergoing PGTM?
As per EPA (Embryo Protection Authority) Protocol, Prospective parent or parents where the woman has not attained the age of 36 (up to age 35) can be granted up to a maximum of 8 oocytes/ embryos to undergo PGTM.
Prospective parents where the woman aged 36 and has not attained 46 years of age (up to age 45) can be granted up to a maximum of 12 oocytes/ embryos to undergo PGTM.
Those prospective parents who only have defective embryos cryopreserved, will be allowed to undergo another fresh cycle. This will only be allowed to these patients, as any other prospective parents including those undergoing PGTM who have embryos cryopreserved without the disease will have to use their cryopreserved embryos first, prior to undergoing another fresh cycle.
After the decision taken between the Senior Clinical Geneticist and prospective parents, can prospective parents apply for IVF with PGTM?
Prospective parents are entitled for IVF with PGTM irrespective whether they have infertility issues or not, unless there is a risk of any of the listed conditions in the Embryo Protection Protocol which can significantly affect the health of an individual who might be born.
What is the maximum age limit so that oocyte retrieval can be carried out?
Oocyte retrieval can be carried out before the woman attains age 46 (up to age 45).
How can prospective parent/parents apply for these treatments?
For treatments offered at licensed clinics at the public and private tissue establishments in Malta prospective parent/parents are encouraged to visit their General Practitioner and following a referral, contact the licensed clinic directly.
