Legal aspects of biomedical assistance in procreation

Predmetna disertacija preučuje pravne vidike biomedicinske pomoči pri spočetju, pri čemer biomedicinsko pomoč pri spočetju, oziroma oploditev z biomedicinsko pomočjo (OBMP) definira kot pomoč zdravnikov in embriologov tistim parom, ki otroka ne morejo spočeti s spolnim odnosom. Disertacija najprej naniza zgodovinske in trenutno zavezujoče pravne podlage, pri čemer je bistveni poudarek namenjen Zakonu o zdravljenju neplodnosti in postopkih z biomedicinsko pomočjo (ZZNPOB, 2000) ter razmejitvi ZZNPOB z nekaterimi novejšimi predpisi, zlasti Zakonom o kakovosti in varnosti človeških tkiv in celic, namenjenih za zdravljenje (ZKVČTC, 2007) ter Zakonom o pridobivanju in presaditvi delov človeškega telesa zaradi zdravljenja (ZPPDČT, 2015). Zaradi nejasnosti te razmejitve, disertacija de lege ferenda predlaga združitev zakonodajne materije v enoten normativni okvir (noveliranje ZZNPOB), ob doslednem spoštovanju specifik postopkov OBMP. Nadalje disertacija naniza etične in mednarodnopravne vidike obravnavanega področja, v okviru katerih preučuje zlasti osrednje etične teorije, vire biomedicinske etike in (mednarodnega) prava ter temeljna načela biomedicinske etike. V okviru obravnave nekaterih (bio)etičnih načel (dobrobit, neškodovanje, koristnost), disertacija na podlagi podatkov Kliničnega oddelka za reprodukcijo, Ginekološke klinike, Univerzitetnega kliničnega centra v Ljubljani, potrjuje, da so temeljni pogoji za izvedbo postopkov OBMP določeni ustrezno. Dokazana je ustreznost omejitev šestih ciklusov, prav tako starostne meje 43 let za ženskev obeh primerih je medicinska učinkovitost postopkov izkazana vse do meje predpisanih normativnih okvirjev. Disertacija, glede na dostopne vire in literaturo, kot prva začrta tudi mejo med absolutno in relativno medicinsko učinkovitostjo na področju postopkov OBMP. Kot absolutno neučinkovite opredeljuje postopke, pri katerih obstaja en odstotek ali manj (&#88041%) možnosti za dosego rojstva otroka, kot relativne tiste, ki prinašajo več kot en (> 1%) in največ pet odstotkov (&#88045%) možnosti za rojstvo otroka. V razpravljalnem delu, ob uporabi Hermagorove metode štirih statusov, disertacija med drugih išče odgovore glede štirih temeljnih problemov postopkov OBMP. (1) Glede položaja zarodka se disertacija, v okviru omejenega statusa, zavzema za priznavanje določenih pravic zarodku, zlasti pravice do dostojanstva. (2) Na področju upravičencev predlaga razširitev kroga upravičencev na ženske v partnerski skupnostizaenkrat je zadržana do omogočanja postopkov OBMP samskim ženskam in istospolno usmerjenim moškim. (3) Na področju posthumnih postopkov OBMP in surogatnega materinstva se disertacija ne zavzema za normativne spremembe. (4) Na področju izvajalcev in financiranja, ki sicer ne terja bistvenih normativnih popravkov, disertacija opozarja na potrebo po poenotenju poročanja in predstavljanja rezultatov, ki naj preprečuje zlorabo predstavljenih podatkov v komercialne namene. V okviru potrditve postavljenih hipotez, disertacija sklepno ugotavlja, da so normativne podlage (čeprav so vrsto let predstavljale ustrezen normodajni okvir na obravnavanem področju) potrebne določenih sprememb in dopolnitev, prav tako ponuja novo opredelitev samostojne (človekove) pravice do postopkov OBMP, kot osebnostne pravice, ki naj se umesti v širši ustavni in konvencijski okvir pravice do zasebnega in družinskega življenja (8. člen EKČP, 35. člen Ustave RS).Present dissertation deals with issues of biomedical assistance in procreation. Such assistance (which includes methods of assisted reproduction – MAR) is to be defined as activity of physicians and embryologists aimed to help couples who are unable to conceive children by the means of sexual intercourse. Firstlythe dissertation offers insight into historical and present legal grounds, while it emphasises the provisions of Slovenian Infertility treatment and procedures of biomedically-assisted procreation act (ZZNPOB, adopted in 2000) being assessed and compared with provisions of later adopted Act on quality and safety of human tissues and cells, for the purposes for medical treatment (ZKVČTC, 2007) as well with provisions of Act regulating the obtaining and transplantation of human body parts for the purposes of medical treatment (ZPPDČT, 2015). Since highlighted provisions lack mutual coherence (and legal certainty), single normative setting (achieved by ammending ZZNPOB) is proposed (being compliant with specifics of MAR). Secondlyethical and international law aspects are covered within the present dissertation, providing a brief study on ethical theories, sources of bioethics and (international) law, as well as analysis on principles on biomedical ethics. Certain principles (beneficence, non-maleficence, utility) are being discussed through evaluation of clinical data (of Reproductive Unit, Department of Obstetrics and Gynaecology, University Medical Centre Ljubljana), which confirm that conditions for MAR treatments in Slovenia are well regulated, especially in terms of: i) maximum age limit for women (43 years)and ii) six consecutive cycles of MAR treatment being available under medical insurance. It is confirmed that both conditions facilitate treatments which are executed within the limits of medical effectiveness (futility level). In the discursive part, four major problems of MAR are approached. (1) In fields of embryo, limited status is proposed, while a dignity right is to be granted to embryo in relation to MAR treatments. (2) In terms of persons being entitled to MAR treatments, arguments are listed in favour of legislative changes to include women in same-sex partnership, while the positions of single mothers and men in same-sex partnership are to be furtherly evaluated. (3) In posthumous treatments and surrogacy agreements, no legislative changes are proposed. (4) The same relates to the questions of treatment providers and financing, while common framework for reporting and publishing of results is to be established to avoid commercially-driven abuse or misinterpretation of data. In terms of core hypotheses, which are being confirmed, the dissertation acknowledges that normative grounds are to be revised (through changes and amendments of legislation) taking into account the newly proposed definition of a right to MAR treatments, as a personal right, falling within the scope of private and family life (Article 8 of ECHR, Article 34 of Slovenia)

Impact of multiple sclerosis on infertility and impact of infertility treatments on multiple sclerosis relapses in Slovenia: medical outline, legal and ethical outcomes

Multiple sclerosis (MS) is an autoimmune inflammatory disorder of the central nervous system. It is common in the reproductive period and can lead to infertility and significant disability. The treatment on multiple sclerosis is recently more successful and enables better quality of life, therefore rising hope and desire for the future parents, also in terms of successful infertility treatments. In this context the couples should be managed concerning the detrimental effect of the disease itself on fertility, detrimental effect of the drugs used for treatment on gonads and in terms of the implementation of drugs used for ovarian stimulation and their impact on the basic disease (MS). Article finds solutions on the legal outcomes in situations where infertility treatments may negatively impact the progress of MS, as well as the solutions on how to (successfully) provide infertility treatments to the patients with MS. It proposes interdisciplinary approach between gynecologists and neurologists to perform required weighting of benefits and risks (burdens), deriving from specific action or treatment, whereas for the patients who shall not undergo infertility treatments due to their medical status, related to MS, it proposes storage of gametes under conditions, set by the law

Rules on assisted reproduction on Slovenia - collision between legislation on biomedically assisted procreation and regulation relating to safety and quality of tissues and cells

Regulatory landscape on assisted reproduction (AR) has changed over the last 20 years in Slovenia. Notwithstanding the fact that in-field legislation (Infertility Treatment and Procedures of Biomedically Assisted Procreation Act - ZZNPOB) has not been amended or derogated since its adoption in 2000, the regulatory framework has been supplemented with legislative acts, implementing EU Directives on safety and quality of tissues and cells used in treatment. Implementation of the latter (also through adoption of Act on Quality and Safety of Human Tissues and Cells for the Purposes of Medical Treatment - ZKVČTC in 2007) has predominantly failed to acknowledge the specifics of assisted reproduction (regulated by ZZNPOB), resulting in regulatory framework which lacks legal certainty and predictability. Article therefore addresses the collision between ZZNPOB and ZKVČTC and proposes solutions de lege ferenda to avoid shortcomings of existing regulation

Oscillating thermal switch using electrostatic forces

Thermal control devices such as thermal switches, thermal diodes, thermal regulators and thermal capacitors can control the intensity and direction of heat flow, which has proven useful in various thermal management applications. Their operation is analogous to that of their electrical counterparts, where temperature differences correspond to voltage differences and heat flow corresponds to electric current. Here we design and fabricate a thermal switch that controls the heat flow from the heat source by changing the thermal conductance when switching ON and OFF. The thermal switch uses electrostatic forces for actuation and makes thermal contact between the heat source and the heat sink when in the ON state, and breaks contact when in the OFF state. The thermal switch is constructed using the commercially available materials. The heat sink and heat source are made of silicon, and the active part of the heat switch is a flexible gadolinium sheet with a thickness of 161 µm. The proof-of-concept device was evaluated for a magnetocaloric applicationhowever, the proposed thermal switch can be used in any thermal circuit for fast thermal regulation and advanced thermal control