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Assisted Reproduction in Poland

- professionals attitude to legal regulations

Prof. dr hab. n. med. Waldemar Kuczyński
Związany z Kliniką Ginekologii Uniwersytetu Medycznego w Białymstoku oraz Centrum Leczenia Niepłodności Małżeńskiej KRIOBANK. Członek polskich i zagranicznych towarzystw naukowych, w tym Polskiego Towarzystwa Ginekologicznego, Polskiego Towarzystwa Medycyny Rozrodu, Towarzystwa Biologii Rozrodu, Europejskiego Towarzystwa Medycyny Rozrodu i Embriologii.

1. Present day Situation

Despite many years of experience and significant achievements in the treatment of infertility using advanced techniques of assisted reproduction (ART), Poland   is unfortunately the only country in Europe that still has no reproductive law, or institutional control over   clinics that perform various fertilization procedures. Unlike the vast majority of  EU countries and the Americas, there are not any basic regulations  of the rank of the Act and any subordinate  and implementing regulations. In Poland, the ART activity is regulated actually by the professional guidelines,  rules of the medical code of medical ethics and general requirements for health care.

2. Professional medical regulations

Polish professional organizations have made efforts to implement the international standards and guidelines to the Polish ART centers editing official professional statements, documents devoted to  clinical and embryological  standards, quality assurement and quality control in the centers of reproductive medicine. The first attempts to regulate ART on professional level were made as  recommendations and principles of good medical practice developed by the Board of the Polish Gynecological Society in 1995 and 1996. In the following years, many documents devoted to the specific problems related to the quality of treatment, safety issues and application of new techniques were also issued. In 2005 Fertility and Sterility Special Interest Group (SIG) of the Polish Gynecological Society presented  the Recommendations for ART treatment which covered all problems related to clinical and embryological procedures. In 2011 Scientific Counsil of Polish Society of Reproductive Medicine issued comprehensive and upgraded version of recommendations for Infertility Treatment (including ART) and published them in Ginekol Pol (Polish Gynecology) – a leading professional journal in Poland. /in press /

3. Professional organizational attempts

In the early days of ART in Poland, Fertility and Sterility SIG of the Polish Gynecological Society was the only professional body to carry the following tasks:
  1. exchanging knowledge,
  2. educating ART practitioners and embryologists,
  3. setting clinical and embryological standards in ART centers,
  4. cooperating  with patients’ organizations,
  5. serving clinical and scientific information and analysis for official bodies.
In 2001 executive board of Fertility and Sterility SIG of the Polish Gynecological Society affiliated this organization to European and world professional bodies - ESHRE (European Society of Human Reproduction and Embryology) and IFFS (International Federation of Fertility Societies). Since then the national data has been collected every year on voluntary basis and included into the European reports (The European IVF-monitoring program (EIM) for the European Society of Human Reproduction and Embryology) and global ones (International Working Group for Registers on Assisted Reproduction (IWGROAR) and World’s Report issued by the International Federation of Fertility Societies (IFFS)). The list of centers practicing ART and reporting data is presented in the attachment. Polish representatives cooperated with ICMART in developing standards and monitoring treatment of infertility. In 2006 Prof Waldemar Kuczynski was nominated by Polish Ministry of Health as a National Regulator in the EACC (European Assisted Conception Consortium), the body overseeing the implementation of European law (EU Directive No. 2004/23/EC of derivatives) in the EU member states. Fertility and Sterility SIG of the Polish Gynecological Society has made efforts to develop and implement the National Central Registry of ART in Poland. Unfortunately, due to a lack of institutional oversight and sanctions as well as lack of the financial means the project has been stopped

4. Professional attitude to national reproductive law

As early as in  1995  Fertility and Sterility SIG of the Polish Gynecological Society underlined that it is appropriate to regulate assisted human reproduction  in a way which supports  benefits of scientific and technological progress and creates alternative solutions for those who might  be subjected to unresolved infertility.  Any of such regulations should respect quality of care and should seek to protect the later interests and safety of children born. Under  pressure of  medical society Ministry of Health appointed in 2005   a team of experts  in Reproductive Medicine which developed a "Draft Decree of the Minister of Health on standards of conduct and medical procedures for the treatment of infertility and in vitro fertilization." Unfortunately, the regulation has not entered into force. In 2006 the executive board of the Polish Gynecological Society presented to the Minister of  Health the position on the need to implement the EU Directive 23/2004 and the willingness to cooperate with its implementation. In many scientific papers and official statements (1995,1996, 2009) directed to the Polish Ministry of Health,  politicians and public, representatives of Polish professional bodies  have  presented their statements according to expectations related to the shape of National Reproductive Law.  In 2009 the following document was prepared by Section of Fertility and Infertility of Polish Gynecological Society and presented as official statement for Parliamentary Bioethical Commission (Gowin’s Commission) created for implementation of Reproductive Law. Warsaw, 15.01.2009
The scope and shape of the regulations in relation to assisted reproduction and proceding of germ cells and embryos arising from IVF (in vitro) in humans.
As a general assumption we accept the necessity to separate the general issues relating to bioethical issues, particularly relating to ratification of the Oviedo Bioethical Convention   from legislation of medical assisted reproduction (ART). This last issue is governed by the provisions of the Directive 2004/24/EU and the technical directives and this logic should be preserved in Polish law. Legal regulations on reproductive medicine should consider the following premises and assumptions: General Assumptions
  1. In vitro fertilization is one of the basic methods of treatment of  childlessness. It is used in patients treated unsuccessully by means of conventional therapy or as a method  of choice for the elimination of specific causes of infertility.
  2.  The proper functioning of assisted reproductive medicine requires regulations that should ensure the highest  quality  and  protection of interests of patients and children born following ART use.
  3. Legislation should establish a  specialized  supervision  (competent authority)   subordinated to the minister responsible for health care.
  4. Legal principles and their institutional implications should ensure effective use of scientific and technological achievements in the treatment of infertility, as well as compliance of  current law with recent knowledge.
  5. Techniques of assisted reproduction should be provided only by health care facilities that have obtained the appropriate permits and licenses for the performance of each activity.
  6. Services related to medically assisted reproduction should be available with respect for the rights of all persons concerned. The rights of people involved in the procedures related to assisted reproduction and welfare of children born as a result of treatment should always be placed in the first place.
  7. Any form of discrimination and limitation of access to treatment of childlessness should not occur. National law should be in this regard in line with international standards and in particular the binding of Poland international and European law. The biological competence of treated patients should be the only limit for accessibility to treatment.
  8.  The techniques of assisted reproduction should be reimbursed under the universal health insurance system in Poland. Due to the high costs  of  treatment and public health priorities, it is needed to consider the scope, access and participation of all parties involved in refundation  These measures should promote the proper solutions regarding the medical and social standpoints.
The detailed assumptions
  1. During in vitro fertilization human reproductive cells are used  in order to obtain embryos for reproductive purposes. Procedures of fertilization and embryo development take place  and proceed for a few days in the laboratory and     optimal conditions and maximum safety must be assured  according to the best knowledge and medical practice. 
  2. Just like  in natural reproduction, only a fraction (10-30%) of embryos have the potential for full development and implantation. For this reason, the number of embryos   created and the number of transferred embryos into the uterus of women should be tailored to the individual clinical patient’s situation and reproductive expectations . The principles of good medical practice in this area should be determined by competent authority according to current knowledge and best clinical practice.
  3. Cryopreservation (freezing) of human gametes and embryos should be permitted and made available as a complementary method of healing process in cases of  childlessness. Each person should be allowed  to take the advantage of freezing techniques to protect their fertility in future. The procedure of freezing embryos increases the chances of successful treatment, while reducing the number of attempts  which must be subjected  to fulfill the reproductive needs. In some cases embryo freezing reduces or eliminates the risk of serious health complications for women. For these reasons, this procedure should be seen as beneficial and a very important step  of treatment process.
  4. In some cases of infertility, the use of third parties reproductive cells or embryos for purposes of reproduction is the only way to parenthood. Therefore, donor’s sperm insemination and oocyte donation as well as embryo donation should be permitted and available. The principle of donor’s anonymity while maintaining the ability to monitor the path of reproductive cells from donor to recipient and vice versa should be preserved. Adopted legal regulations should assure high quality of donation services. The expression of informed consent by both the donor and recipient should be obligatory.  All the safeguards in accordance with current medical knowledge and good practice must be preserved.
  5. All cases of use of any form of donation in human reproduction should be regulated by law, with particular emphasis on parental rights and ensuring optimal conditions for child development. The rights and needs of the   children  born   as a result of donation of gametes or embryos, should be uppermost. National law must take into account the principles of safety and to ensure high quality treatment  in agreement with EU Directives.
  6. Prenatal tests/PGD,PGS/ are widely recognized as a diagnostic method  which should be allowed by  law. These tests should be applied only in clearly defined cases - in people at high risk of having a baby affected by severe genetic disease. The main advantage of PGD is that it protects a treated woman before the possible termination of pregnancy (medically justified abortion).
  7. Treatment of  childlessness by IVF should be preceded by obtaining a voluntary and fully informed consent to treatment. Creation  supernumerary embryos should be allowed on the condition that treated couples express their  consent to  transfer their embryos for a third party woman in the case of withdrawal from the trial of their use in a given time.
  8. The procedure of using a surrogate mother  could be the only opportunity for some subjects to obtain   their own (biological) children. Access to this procedure should be possible, but limited to the specific clinical situations and agreed with the competent authority or appropriate bioethical commission.
  9. Cloning procedure to reproduce human beings should be strictly prohibited. Any use of therapeutic cloning techniques with the use of human reproductive cells, tissues and their parts could be possible only after approval of ethical committee of high-level in the country (eg Ethics Committee at the Ministry of Health).
  10.  Temporarily unused frozen embryos with preserved developmental potential, not subjected to serious genetic defects (if previously performed preimplantation diagnostic testing) should be stored and protected as long as possible and reasonable.
  11. Assumptions to the technical regulations

    The scope of  technical regulations relating to the conduct of human germ cells and embryos has been defined precisely in the 2004/23/UE  Directive and the implementing directives. The obligation of implementation the above documents by Poland demands that  the national legal system should refer to:
    1. appointment of  National Center for the  childlessness (competent authorities),
    2. definition of the tasks of the  National Centre   and description of  the relationships with other entities whose activities affect the functioning of reproductive medicine such as the National Bioethical Council, National Transplantational Council, Centre of Tissues and Organs Banking, Fertility and Infertility Section Polish Gynecological Society, Polish Society for Reproductive Medicine etc.
    3. accreditation of centers and procedure licensing,
    4. appointment and fixing  National ART Register responsible for collection of  data relating to the diagnosis and treatment of   childlessness,
    5. requirements for quality assurance in centers treating childlessness,
    6. description of the system for  identification of reproductive cells and embryos (coding system),
    7. assurance of  the monitoring capacity of reproductive cells and their donors,
    8. cooperation of ART centers with tissue and cells banks,
    9. documentation relating to childlessness treatment,
    10.  range of inspection activities conducted by the competent authority,
    11.  monitoring of the ART centers,
    12. safety of reproductive cells and embryos in the event of adverse events,
    13. bans and obligations  in the field of procedures and activities,
    14. penalties for non-compliance with the law,
    15. transitional period to implement the law.
    The relevant statutory delegations and implementing rules should regulate these issues while maintaining standards of not less than EU requirements. Comment: Following the presentation of the above position, the important part of members of  Gowin’s commission  has expressed opposition to the restrictive project similar to the Italian Law, and initiated a broad discussion on the shape of reproductive rights in Poland, activating politicians, scientists,  patients organizations and mass-media. As a result the further drafts legislation banning in vitro in Poland, and extremely limiting the scope and availability of procedures have been rejected by the Polish Parliament.

    5. Current activity

    In the absence of national reproductive law Polish Gynecological Society and the Scientific Council of the Polish Society for Reproductive Medicine are making efforts towards fulfilling the recommendations of the EU directives by ART centers on the voluntary basis,  through the process of professional accreditation. A precondition for accreditation is to send data about the treatment of the national register on the  on-line, every 2 day basis. It is being decided on the presence of representatives of most centers operating in Poland to proceed the process of accreditation, according to all main areas addressed by the Directives, when appropriate: 1) 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 the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. 2) Commission Decision 2010/453/EU of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council [notified under document C (2010) 5278] Text with EEA relevance. This Decision establishes guidelines concerning the implementation of inspection and control measures in the field of human tissues and cells. It defines the responsibilities and the qualification and training requirements of inspectors. However, they are not legally binding. 3) Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells [Official Journal L 38 of 9.2.2006]. This implementing directive establishes specific technical requirements for each step in the human tissue and cell preparation process, in particular:
    • Requirements for the procurement of human tissues and cells;
    • Selection criteria for donors of tissues and cells;
    • Laboratory tests required for donors;
    • Tissue and/or cell donation and procurement procedures and reception at the tissue establishment;
    • Requirements for direct distribution to the recipient of specific tissues and cells.
    4) Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance) This Directive applies to the coding, processing, preservation, storage and distribution of human tissues and cells, and products derived from human tissues and cells. It was accepted by the most ART centers to proceed the process of accreditation in line with:
    1. Establishment of a register of centers operating in the field
    2. Implementation of a quality system for ART centers including specification of activities relating to a quality system (SOPs, guidelines, training & reference manuals, reporting forms, donor records, information on final destination of   reproductive cells and embryos)
    3. Introduction of system for notification of adverse events and reactions
    4. Organization of inspections and control measures
    5. Procedures for data protection and data confidentiality.
    6. Assurance of traceability of tissues and cells through laboratory identification procedures, record maintenance and an appropriate labeling system
    Bialystok, 25.09.2011 Prepared by Prof. Waldemar Kuczynski Attachement 1 Polish Clinics practicing ART Total N° of clinics with prooven ART  activity - 31. N° of reporting clinics - 27)

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