| Abstract: | Naujųjų technologijų dėka atsirado daugybė naujų būdų, kuriais galima nuo žmogaus atskirti biologinę medžiagą bei ją panaudoti įvairiems tikslams. Tobulėjant technologijoms, kyla poreikis apsaugoti asmenų, iš kurių paimama biologinė medžiaga, bei mokslininkų, naudojančių šią medžiagą, interesus, susijusius su nuosavybės teisėmis į biologinius žmogaus audinius ir organus bei reglamentuoti biologinę medžiagą kaip nuosavybės teisės objektą. Taipogi svarbu nustatyti dirbtiniu būdu sukurto audinio ir organo statusą teisinėje sistemoje bei įvertinti genų inžinerijos įtaką nuosavybės teisės reglamentavimui.
Šis darbas susideda iš dviejų dalių. Pirmoje darbo dalyje analizuojamas žmogaus santykis su biologine medžiaga bei šios biologinės medžiagos kaip nuosavybės teisės objekto teisinis reglamentavimas. Antroje darbo dalyje nagrinėjama naujųjų technologijų išradimų įtaka iš žmogaus gaunamo produkto kaip nuosavybės teisės objekto teisiniam reglamentavimui. Abiejose dalyse atskleidžiamas žmogaus biologinės medžiagos kaip nuosavybės teisės objekto reglamentavimas Lietuvoje bei užsienio valstybėse.
Tyrimo metu nustatyta, kad biologinei medžiagai atitikus nuosavybės teisės objekto formalius reikalavimus ją galima laikyti nuosavybės teisės objektu. Priėjus šią išvadą buvo konstatuota, kad žmogaus biologinė medžiaga nuosavybės teisės objektu gali tapti tik ją atskyrus nuo kūno. Mokslininko išradimo ar dirbtiniu būdu sukurto audinio ar organo atveju biologinė medžiaga laikoma nuosavybės teisės objektu ją išskyrus iš natūralios aplinkos arba pagaminus techninio proceso metu. Atsinaujinančių biologinių medžiagų bankuose mokamos kompensacijos ar atlygis parodo, jog atsinaujinanti biologinė medžiaga gali būti nuosavybės teisės objektu. Genų inžinerijos procedūrose savo biologinę medžiagą suteikiantis donoras taip pat turi nuosavybės teisę į nuo jo kūno atskirtą medžiagą, kol ją perduoda pasirašydamas informuoto paciento sutikimą. Todėl genetinės medžiagos panaudojimas embriono dirbtiniam apvaisinimui genų donorui ateityje gali suteikti tėvo statusą bei sukurti teises ir pareigas vaiko atžvilgiu.
Atlikus visus darbe keliamus uždavinius, darytina išvada, jog žmogaus biologinei medžiagai atitinkant tam tikras sąlygas, tokias kaip atskyrimas nuo kūno, išskyrimas iš natūralios aplinkos ar gamyba techninio proceso metu, ginamasis teiginys: žmogaus biologinė medžiaga gali būti nuosavybės teisės objektu, pasitvirtino.
New technologies have created plenty of new ways to isolate human biological material and use it for various purposes: renewable biological material donation, medical researches and inventions, tissue engineering by artificially making tissues, organs and transplantation of them, genetic engineering and modification for curing genetic diseases.
As new technologies are rapidly evolving there is a need to protect those who provide biological material and researchers, who use this material. Legal interests related to property rights of human biological tissues and organs also need to be protected, as well as the ones who regulate human biological material as the subject of property rights. Furthermore, it is important to assess laboratory-grown tissue or organ position regarding the legal system and evaluate the impact of genetic engineering on property law regulation.
The thesis aims to investigate whether human biological material can be the subject of property rights by containing the following tasks:
1. To determine and compare human biological tissue as the subject of property rights’ legal regulation in Lithuania and other countries.
2. Delimit person‘s and researcher‘s right to human biological tissue and invention made from human biological material.
3. Examine the impact of new technologies, such as tissue engineering and genetic engineering, on human biological tissue as the subject of property rights’ legal regulation.
This paper consists of two sections. First section analyses human relation with biological material and its relation to property rights’ legal regulation. By analyzing this section it was concluded, that if human biological material fulfills property rights’ formal requirements, such as economic content that makes the property subject a part of the market, also possibility to possess and dispose of the subject – it can be the subject of property rights. The conclusion stated that human biological material can be the subject of property rights only when separated from the body. By paying compensation or money reward renewable biological material banks show that by transference of human biological material, renewable biological material can be the subject of property rights. Furthermore, courts’ practice about the inheritance of reproductive cells shows that renewable human biological material can be described as a personal property. In that way, in some cases, a person can have an ownership of human biological material.
These days researchers are able to create a product which contains another person‘s biological material or was created by using this material. They can patent this product and by doing so create exclusive rights to dispose of the invention in commercial ways. Also biological material becomes the subject of the patent. By analyzing researcher’s right to patent his invention, which is made by using another person‘s biological material, it is visible that the main legal principle that courts follow is whether the product is in its natural environment or is isolated from it or produced by the means of technical process. If invention contains biological material which is identical to natural biological material, but is isolated from its natural environment or is produced by the means of technical process, it can be the subject of the patent. Another rule for patenting invention holding biological material is to get the informed consent of the biological material donor. In some cases processing of human biological material so it changes its primal function can be assessed as a different subject from human biological material and also be granted a patent. Forasmuch as that patent grants researcher property rights and human biological material is the subject of the patent, it can be concluded that human biological material can be the subject of researcher’s property.
The second section of this paper analyses the impact of the products of new technological inventions on the regulation of human biological material as the subject of property rights. A tissue engineered product such as tissue or organ is considered to be the subject of property rights when it is isolated from its natural environment or produced by the means of technical process. Artificially made tissues, organs made of human biological material commercialization does not violate human dignity, integrity principles, because tissue or organ is extracted not from human body, but is made by the means of technical process. Also, the biological material which is used is being isolated from its natural environment. Because of its specific way of procuring, artificially grown tissue and organ also satisfy the patentable subject’s formal requirements. For the reasons described above tissue engineered product designed from biological material can be the subject of property rights. It is advisable for the legislator to regulate not only the tissue engineered advanced therapy medical products in European Union member states but also the tissue engineered product, such as artificially made tissue or organ, position in the legal system. It is advisable to ascribe such tissue or organ as a special category of human biological material, which could be described as the tissue engineered product – specifically human tissue or organ, made from human biological material.
By researching genetic engineering’s legal regulation towards the biological material, the conclusion was drawn that genetic material is part of human biological material. Therefore during the genetic engineering procedure performing mitochondrial replacement therapy and later artificial insemination, person who provided from his body isolated genetic material has ownership towards that material until he transfers this material to another person and by doing so it belongs to that person. For the reasons above genetic material can be the subject of property rights. Also, by examining the courts’ practice and legal literature it can be concluded, that the person, who holds property rights towards the genetic material can be acknowledged as a legal third parent of a child, if by donating his genetic material that person is an intentional lender of procreative genetic material and has a purpose raising a child as his own.
Accomplishing all the tasks described in this paper, it can be concluded that if human biological material satisfies conditions, such as separation from the body, isolation from its natural environment or production by the means of technical process, it can be the subject of property rights. |
