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Assisted Reproductive Technology Concepts and Issues


Glossary
  • ART = artificial procreation = incl. in vitro fertilization + many more. Excluding artificial insemination.
  • WHO Glossary 2009 – 87 terms.
  • Major terms not in the WHO Glossary:
    - “Partner donation” - intended for implantation between spouses or between a man and women, who represent partners under common law marriage.
    - “Non-partner donation” - intended for implantation between individuals who are not related through civil or common law marriage.
    - “Heterologous embryo transfer” - implanting an embryo conceived with oocytes (ova) and/or sperm from a donor.
    - “Couple” & “partners” (?). The place of Common Law marriage.
  • Where to use and define – the statute or regulation?
International legal frame for donation
  • The Convention on Human Rights and Biomedicine of 1997 [Oviedo] and the Additional Protocol of 2002 to this Convention are silent on the matter. Exceptions:
    - Art. 14 Convention: “The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child’s sex, except where serious hereditary sex-related disease is to be avoided.”
    - Additional Protocol on Transplantation of Organs and Tissues of Human Origin: excludes reproductive organs and tissues from its scope.
  • Directive 2004/23/EC explicitly provides that “this Directive should not interfere with the decisions made by Member States concerning the use of or non-use of any specific type of human cells, including germ cells and embryonic stem cells”. Preamble: “… this Directive should not interfere with provisions of Member States defining the legal term “person” or “individual”.
  • The principles adopted by the ad hoc committee of experts on progress in the biomedical sciences of 1989. Principle 11: in principle in vitro fertilisation shall be effected using gametes of the members of the couple. 
  • Then what the couple is?
The challenges

1. Procreative liberty and right not to procreate (right not to be genetic, legal or gestational parent) – not fundamental constitutional freedom and right.
2. Biotechnology always moves faster than law:
- Procreative technology more and more resembling “cookbook” while law is still based on thousand years old principles.
3. Religion and ethical rules of certain communities.
4. Required re-conceptualization of the notion of parenthood:
- How to manage the existing assumption of fatherhood?
- How to manage the existing rule of origin out motherhood?
5. What “individual” and “human embryo” are?
 
Human embryo definition

For inventions and patentability purposes - Art. 6(2)(c) Directive 98/44/EC on the legal protection of biotechnological inventions &  CEU – case Case C‑34/10 (Oliver Brüstle v. Greenpeace eV) Judgement of 18/10/2011:
  • “Human embryo” must be understood as:
    - any human ovum after fertilization, 
    - any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted, and
    - any non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis.
  • National jurisdictions are to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a “human embryo” within the meaning of Article 6(2)(c) of Directive 98/44.
Limits of research and patentability
  • Research on embryos in vitro (Art. 18 Oviedo Convention):
    - May be allowed by the national law. Then it shall ensure adequate protection of the embryo.
    - The creation of human embryos for research purposes is prohibited.
  • The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research.
  • Only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.
  • Art. 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.
ART public perception – scope and limits
  • Discretion given by Directive 2004/23/EC: to restrict or even prohibit the ART for religious, ethical or other specific reasons for certain communities.
  • Case law: S.H. and others v. Austria of 2011 [ECHR]: Austrian Artificial Procreation Act prohibiting the use of ova and sperm from donors for in vitro fertilisation - declared there has been no violation of Article 8 of the Convention (ECHR).
  • Resolutions on IVF taken by high national authorities on religious affairs and major denominations.
  • Do we accept common law marriage as a ground for application of ART (as a “partner donation” and “couple”)?
  • Shall we allow non-partner donation as a principle? The issue of single women.
How to describe ART?

Activities:
  • The use of medical methods for the fertilization of oocytes, located inside or outside the body of the woman.
  • Procurement, recovery, expertise, storage, processing, preservation, labeling, packaging and delivery (transportation) of oocytes, sperm, or zygotes/pre-embryos intended for ART.
  • Recovery of an oocyte and implantation of oocytes embryo (pre-embryo) into the body of a woman.
Prohibitions …
  • When applied in order to select the progeny gender, except when justified by the need to prevent hereditary diseases associated with gender (with ref to Art. 14 Oviedo Convention).
  • When aimed at transfer of genetic information from a single individual in his generation.
  • When carried out for reproductive human cloning (with ref to Oviedo and Protocol 1 on cloning), including aimed at generation and procurement of organs, tissues and cells.
  • When aimed at modifying the human genome, except when undertaken with prophylactic or therapeutic purpose, but without introducing modifications in the genome of the progeny.
  • Areas left for national authorities:
    - Non-couple transfer/insemination.
    - Relations between the donor and recipient.
    - Age thresholds for potential donors and/or recipients of sperm, oocytes or embryos.
… and their exceptions
  • Cryopreservation of gametes and embryos of patients under medical conditions, threatening their life or their reproductive ability and their subsequent use for producing their own progeny.
  • Subsequent donation from deceased donor (?).
  • For women over the age threshold (if applicable), when their health condition is established by independent medical panel to be suitable to the purpose of conception and child birth without risks for the recipient and the progeny, higher than the usual.
  • Where approval has been given by a court ruling for hosting an embryo from a donor to a couple, or for other specific cases.
ART regulatory frame in Bulgaria
  • ART - outside the scope of the Transplant Act (TA): neither in procurement, nor in transplantation part.
  • ART - part of “reproductive health” section of the Health Act and a medical standard enacted by regulation.
  • Substantial exception: import-export issues – TA is applicable.
  • Export vs. Intercommunity exchange.
  • Competent authority = Executive Agency on Transplantation.
General rules
  • Prohibition: between ascendants, or descendants, or collaterals up to 4th level (to be proved by written statement).
  • Informed consent of all participants.
  • Obligatory medical examinations.
  • Prohibition of financial gain.
  • Non-discrimination.
  • Prohibitions related to genomics:
    - Gender selection.
    - Human cloning or genomic modifications.
    - Single parent exclusive genetic transfer.
Recovery of donated oocytes (Heterologous embryo transfer)

Requirements:
  • Full legal capacity
  • Notarized informed consent
  • Demonstration of the risks awareness
  • Established good physical and mental conditions:
    - By commission of at least 3 physicians;
    - Not in conflict of interests
    - Appointed by the hospital CEO
    - Written conclusions.
Licensing
1. Request filing.
2. Inspection and certification by the EAT: for conformity with the Medical Standard of Assisted Reproduction.
3. Permit - by the Minister of Health.
4. Registration by EAT: public and official (restricted access) register.
5. Hospital (medical center): register, reporting, testing, labeling, preservation, safety, traceability, system of recall in case of SAR/SAE, archiving (30 years) etc.
 
Assen Dyulgerov
attorney-at-law, Sofia City Bar
 
   
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