Alkio- ja kantasolututkimuksen sääntely bio-oikeudellisena mallina

Abstract

The Regulation of human embryonic and stem cell research - a model case for biolaw

Research on human embryos has been conducted for forty years, and in vitro embryos undeniably represent the most vulnerable form of human life. Until 1998, embryo research aimed at increasing the general understanding of early human development and at improving the success rate of assisted reproduction. The year 1998 was revolutionary and put human in vitro embryos in a remarkably more vulnerable position. An American research group showed that it is possible to maintain stem cells isolated from human embryos in a laboratory culture for a longer period of time. Stem cells are a potential material for cell replacement therapy for such degenerative diseases as Alzheimer’s disease, Parkinson’s disease, diabetes etc. This discovery led to a worldwide stem cell ‘hype’ and forced legislators worldwide to consider and re-consider their position on the early stages of human life. Adding to the complexity, human embryonic stem cell research was quickly linked to cloning techniques. Researchers foresaw that by using cloning techniques it might be possible to produce embryonic stem cells genetically identical to those of the patient’s in a process called therapeutic cloning. This could mean the avoidance of the rejection reaction of the cell grafts.

This study was conducted in order to clarify the regulation of human embryonic and stem cell research in Finland. Furthermore, it was envisaged that regulation of human embryonic and stem cell research would be a perfect case to enable analysis of the theoretical basis of a novel legal field, biolaw. More specifically, the aims of the research were: • To systematize the legal rules affecting human embryonic research in Finland, and based on the analysis, construct the legal position of the human embryo in Finnish law; • To analyse the legal restrictions, including restrictions to gain financial profit, for human embryonic research from the point of view of researchers; • To compare the regulation of human embryonic research in the Nordic countries against the framework of Convention on Human Rights and Biomedicine of the Council of Europe (ETS No. 164); • To study the legal status of tissue donors in Finland, and the possibilities to improve that status; and • To construct a theoretical framework of the emerging field of biolaw based on the results on the case of regulation of human embryonic and stem cell research.

As parts of the research were targeted to different audiences (national vs. international), the form of an article-based thesis was chosen. Individual topics were covered in six articles, and the summary concentrated on the synthesis and construction of biolaw. The main legal sources studied were the national legislation of Finland, Sweden and Norway, the Convention on Human Rights and Biomedicine of the Council of Europe and preparatory works of the mentioned legislation. The literature review was limited to legal articles published for an international audience and to the relevant national sources.

Article I published in 2006 analysed and systematized the legal rules concerning human stem cells and their therapeutic use. One of the main findings was that, while Finland had fairly recently enacted legislation concerning research on human embryos (Medical Research Act 488/1999), the law was already outdated. The main problem detected was that the definition of human embryo is linked to fertilisation in the Act, which leads to the fact that the Act does apply to entities resulting from therapeutic cloning. The implications of the Tissue Safety Directive (2004/23/EC) to national legislation were also studied, and it was observed that by the time of writing, the amendments required by the Directive had not been made to the Act of the Medical Use of Human Organs and Tissues (101/2001). These would mainly relate to the establishment, accreditation and control of tissue establishments. These changes were implemented May 2007. As for therapeutic use of stem cells, it was noted that the European Commission proposes to consider them as advanced medicinal therapies in order to bring them under the medicinal products legislation in the European Community. The resulting Regulation (2007/1394/EC) has been in force since 30 December 2008.

Article II of the thesis concentrated on analysing in detail the legal status of embryo under the Finnish law after the passing of Assisted Reproduction Act (1237/2006), which finally completed the legal protection of in vitro embryo in Finland. Specifically it was noted that apart from the ban to create embryos solely for research purposes, it appears that the pre-¬requisites for creation of in vitro embryos are not clearly spelled out in the cur¬rent legislation. The wording of the Assisted Reproduction Act was also criticised, as it is easy to get the impression – although a false one – that if a couple uses donated gametes for assisted reproduction and the resulting embryos are deemed unsuit¬able for that purpose, these embryos cannot be donated to research but are to be destroyed immediately. The basis of the legal status of the in vitro embryo in Finland was also studied. At first sight, because such expressions as ‘create’, ‘use’ and ‘destroy’ are used in the legislation, it seems that the human embryo should be categorised as an object. Intuitively this is somewhat uncomfortable, though, and a test was made of whether an in vitro embryo could be a legal subject in the Finnish legal order. It seems, however, that this category is fairly impervious to entities other than born human beings. Therefore it was proposed that the human embryo forms a third category between the traditional two categories, being saved from total objecthood by reference to human dignity. Finally, the legal concept of human dignity was developed, suggesting that a reading of human dignity based on the shared values of a given community might provide an answer to questions about the protection of human embryos and the human genome in the context of biolaw.

The scope of analysis was changed for Article III, which examined the ambiguity of embryo protection in the Convention on Human Rights and Biomedicine of the Council of Europe (ETS No. 164). The analysis concentrated on the scrutiny of Article 18 of the Convention, and its interpretative latitude was demonstrated: in order to achieve consensus among the parties, the wording of the Article leaves the fundamental definition of human embryo to be determined within national legislation. Hence it is possible that the three Nordic countries studied can have a very different approach to the human embryonic research in spite of the fact that they all have signed the Convention. Norway was found to be most forbidding, since there, even the research on embryonic stem cell lines was banned at the time of publication of the article in 2007. In contrast, Sweden was found to be most permissive, even allowing the creation of embryos for research purposes. Even though this is specifically forbidden in the Article 18 of the Convention on Human Rights and Biomedicine, this was possible because Sweden defines human life forms younger than 14 gestational days as fertilised eggs, not embryos. The legislation of Finland was described in the article to be outdated, and it was referred to the outlaw status of the results of therapeutic cloning. The meaning of the phrase “adequate protection of the embryo” in the context of Article 18 was also studied. As it clearly cannot refer to the protection of actual research embryos which are destroyed during the process, it was concluded that such measure as ensuring that the embryos are only used for scientifically justified projects for which there is no other alternative research material could be an element of fulfilling this provision. Furthermore, means to ensure that the use of human embryos is minimised in each project and that the personnel and equipment are appropriate for the proposed research could be other factors contributing to the fulfillment of adequate protection on embryos.

The other half of the articles concentrated on the issues related to commercialising the results of human embryonic and stem cell research. Article IV put embryonic stem cell research into a larger context of genetic research and presented the related current legislation in Finland for such techniques as biobanks, human embryonic and stem cell research, pre-implantation genetic diagnosis, gene therapy and genetically modified organisms. It was concluded that the regulation of this type of research takes place at four distinct levels, namely: legislation, administrative control, professional self-regulation and public opinion. Of these, administrative measures were shown to be of most importance. The Parliamentary legislation of course lays down the basis for the administrative means, but it is scarce and open to interpretation, whereas licensing measures consider all research projects at a very detailed level. Public opinion has traditionally been silent in Finland, and the level of activity of the scientific community towards the public has also been low.

Article V analysed a fairly recent and significant decision of the Enlarged Board of Appeal of the European Patent Office (G 02/06) from November 2008, in which the patentability of inventions that require the use of human embryos was rejected. The Board rejected the claim of the applicant by stating that the wording of the European Patent Convention (EPC) that forbids issuing patents to inventions using human embryos, does not refer only to actual patent claims, but to an invention as a whole, i.e. including all the necessary steps that need to be de facto taken in order to make the product. The Board also considered that any scientific development taking place after submitting the patent application was irrelevant for the evaluation of the current application. In addition, it was noted that the Board of Appeal was once more reluctant to use the ordre public clause of the EPC as grounds for rejecting a patent claim. Since patenting of embryos is so explicitly mentioned in the EPC, it was possible in this case to base the decision on that provision (Rule 28(c)) instead of Article 53(a) of the Convention. The overall importance of the decision for the scientific community was found to be immediate, as the line taken clearly decreased the economic incentive to pursue embryonic stem cell research. And although EPC and the Biopatent Directive (98/44/EC) are distinct legal documents, the case certainly set a precedent for the interpretation of the latter also, since the wording of the embryo clauses are identical. It was foreseen, though, that national patent offices may issue embryo patents that are not in line with the interpretation of the Enlarged Board of Appeal, which may lead to fragmentation of the patent regime in Europe in this regard – a situation that EPC was created to correct in the first place.

Modern biotechnology produces and uses a lot of human biological material that is potentially economically valuable. It is assumed that somewhere along the chain of action this human material acquires economic value and is owned by somebody. However, it has not been studied how the transition from human tissue to property happens. In the tradition of medical law the donor’s consent has been considered essential for the use of human tissue in biomedical research. This was the starting point for Article VI. It was argued that the consent doctrine does not give the donor an adequate role in modern society where human biological material might become a source of income. Instead, it was proposed that tissue donors should be able to claim ownership of the detached tissue and then donate it to biomedical research as a sui generic gift. If the donor so wanted, the gift would only concern the use of the tissue sample while the ownership still resides with the donor. However, allowing ownership of tissue samples would enable the donors to claim compensation if their samples were used against their consent and enable them to give the widest possible research consent if they so wished by giving up the ownership of a sample. In this way, the ownership model would allow tissue donors to become equal actors as compared to the other stakeholders interested in tissue samples. No provisions in current Finnish law seem to invalidate the ownership model, although it needs to be borne in mind that tissue samples, as such, can never have all aspects of property since human tissue cannot be a source of financial gain according to the law. In other words, a tissue sample cannot be a commodity although it is a physical object. By contrast, it was found that the ownership model would not be applicable to in vitro human embryos, which have a special position in the Finnish legal system. Whereas tissue samples are merely detached pieces of an existing human being, embryos have a unique human genome, and hence enjoy special protection due to the human dignity attached to them. This is reflected for example in the fact that one person cannot donate an embryo to research, but the consent of both gamete donors is needed.

Based on the results obtained in the individual Articles, a model for biolaw, a legal discipline situated between medical law and environmental law, was constructed in the summary of the thesis. The field would be identified based its regulatory object, namely living material as created by modern biotechnology. The following legal principles of biolaw were identified from the Convention on Human Rights and Biomedicine and the national legislation: respect for human dignity, self-determination, protection of private life, freedom of research, protection of life, banning of commercially benefit from human tissue and the precautionary principle. Legal concepts for biolaw were more difficult to recognise, but such concepts as scientific research, freedom of research, human dignity, research relationship, human, genetic research, gene technology and genetically modified organisms were proposed as legal concepts of biolaw. Finally, it was recognised that it is not desirable to create a new field of law just for the sake of doing it. However, it was argued that if the societal actions lead to a situation where such a field arises, it should not be artificially resisted either.

MIHIN IHMISALKIOITA JA KANTASOLUJA SAA KÄYTTÄÄ?

Väitöskirjassa selvitettiin alkioiden, kudosnäytteiden ja kantasoluviljelmien käytön oikeudellisia reunaehtoja alkion, tutkijan ja kudosnäytteen luovuttajan näkökulmasta.

Kritisoin kansallista sääntelyä siitä, että terapeuttisen kloonauksen tuloksen asema on kotimaisessa lainsäädännössä sääntelemättä sekä sitä, että alkiotutkimukseen liittyvät kriminalisoinnit on mielestäni liian vähäisesti perusteltu vetoamalla ainoastaan kriminalisoitujen tekojen ihmisarvon vastaisuuteen. Mikäli ihmisarvon vastaisuutta käytetään alkiotutkimuksen rajoittamisen perusteena, tulisi lakiehdotuksen perusteluissa avoimesti kertoa, miksi kiellettäväksi säädetty teko on ihmisarvon vastainen. Optimaalisessa tilanteessa tällainen arvio syntyisi laajemman yhteiskunnallisen keskustelun perusteella. Esitin, että eettisillä toimikunnilla voisi olla keskeinen rooli tällaisen keskustelun käynnistäjänä, analysoijana ja yhteenvetäjänä.

Vertailin myös Suomen, Ruotsin ja Norjan alkiotutkimusta koskevaa lainsäädäntöä suhteessa Euroopan neuvoston biolääketidespimukseen. Kun näitä kolmea eroavaa kansallista lainsäädäntöä peilattiin sopimuksen tekstiä vasten, oli ilmeistä, kuinka paljon harkintamarginaalia alkiotutkimuksen osalta sopimuksessa jää sopimusvaltioille. Ihmisalkioilla tehtävä tutkimus on toimintaa, jonka sallittavuudesta on hyvin erilaisia näkemyksiä Euroopan sisällä globaalista tarkastelusta puhumattakaan. Biolääketiedesopimuksen sanamuoto olikin tietoinen kompromissi, jota oli tarkoitus tarkentaa erillisessä lisäpöytäkirjassa. Pöytäkirjaa valmisteleva työryhmä on saanut jatkoaikaa toiminnalleen, ja sen tuorein mandaatti oli voimassa vuoden 2009 loppuun asti.

Tutkimuksessa analysoitiin myös kudosnäytteiden luovuttajan oikeusasemaa ja mahdollisuuksia parantaa sitä vallitsevan lainsäädännön puitteissa. Kaikki ihmiset ovat potentiaalisia kantasoluviljelmien lähteitä, ja soluviljelmien ja kudosnäytekokoelmien ollessa uuden genomitiedon valossa mahdollisesti kaupallisesti hyvinkin arvokkaita, oli tarpeen tarkastella takaavatko nykyiset oikeussäännöt riittävät oikeussuojakeinot kudosnäytteiden luovuttajille. Päädyin siihen, että sekä tutkijoiden että näytteenluovuttajien näkökulmasta olisi selkeämpää ja oikeudenmukaisempaa nähdä kudosnäyte esineenä, johon luovuttajalla on omistusoikeus, jonka hän voi sitten kokonaan tai osittain luovuttaa tutkijalle. Omistusoikeuskonstruktiossa olisi mahdollista sopia myös tulevan taloudellisen hyödyn jakamisesta. Niin ikään säännökset mahdollisesta hyvityksestä omistusoikeutta loukattaessa olisivat selkeämmät.

Myös alkioperäiset solutuotteet ovat potentiaalisesti taloudellisesti arvokkaita, ja tutkimuksessa pyrittiin selvittämään myös alkioiden kaupalliseen hyödyntämiseen liittyviä kysymyksiä. Tutkin Euroopan patenttiviraston marraskuussa 2008 antamaa ratkaisua, jossa yksiselitteisesti evättiin patentit sellaisilta tuotteilta, joiden valmistaminen vaatii alkioiden tuhoamisen. Patenttioikeudellisesta näkökulmasta eurooppalainen alkio- ja kantasolututkimus joutui ratkaisun myötä aikaisempaa huonompaan asemaan kahdesta syystä: ensinnäkin taloudellinen kannustin alkio- ja kantasolututkimuksen tekemiselle pieneni selvästi ja toisaalta eurooppalainen käytäntö pirstaloitui jälleen, kun kansalliset alkiopatentit ovat ainakin toistaiseksi periaatteessa mahdollisia niin kauan kuin EY-tuomioistuin ei ole antanut vastaavaa tulkintaa bioteknologiadirektiivistä.

Väitöstutkimuksen tavoitteena oli paitsi analysoida edellä kerrotuista näkökulmista alkio- ja kantasolututkimuksen säätelyä myös tutkia, voisiko tuon analyysin perusteella hahmottaa bio-oikeuden yleisiä periaatteita ja käsitteitä, ja voisiko bio-oikeus tällä perusteella olla mahdollisesti itsenäinen oikeudenala. Esitin, että bio-oikeus on itsenäistymässä oleva oikeudenala, jolla on lääkintäoikeudesta erilliset kysymyksenasettelut johtuen siitä, että sääntelyn kohde on eri, modernin bioteknologian tuottamat objektit. Tästä seuraten bio-oikeuden periaatteet ja käsitteet ovat osittain toiset kuin lääkintä-oikeuden, vaikka niiden pohjana olevat oikeuslähteet ovatkin pitkälti samat. Toiselta laidaltaan bio-oikeus on siis kiinni lääkintäoikeudessa, toiselta laidaltaan puolestaan ympäristöoikeudessa. Ainoastaan aika näyttää, miten oikeusjärjestyksemme kehittyy ja vakiintuuko bio-oikeus siihen itsenäisenä oikeudenalana.