Patents, Ethics and Stem Cell Research : The Case of hESC Innovation in Australia, Europe and the United States

Embryonic stem cells offer potentially a ground-breaking insight into health and diseases and are said to offer hope in discovering cures for many ailments unimaginable few years ago. Human embryonic stem cells are undifferentiated, immature cells that possess an amazing ability to develop into almost any body cell such as heart muscle, bone, nerve and blood cells and possibly even organs in due course. This remarkable feature, enabling embryonic stem cells to proliferate indefinitely in vitro (in a test tube), has branded them as a so-called miracle cure . Their potential use in clinical applications provides hope to many sufferers of debilitating and fatal medical conditions. However, the emergence of stem cell research has resulted in intense debates about its promises and dangers. On the one hand, advocates hail its potential, ranging from alleviating and even curing fatal and debilitating diseases such as Parkinson s, diabetes, heart ailments and so forth. On the other hand, opponents decry its dangers, drawing attention to the inherent risks of human embryo destruction, cloning for research purposes and reproductive cloning eventually. Lately, however, the policy battles surrounding human embryonic stem cell innovation have shifted from being a controversial research to scuffles within intellectual property rights. In fact, the ability to obtain patents represents a pivotal factor in the economic success or failure of this new biotechnology. Although, stem cell patents tend to more or less satisfy the standard patentability requirements, they also raise serious ethical and moral questions about the meaning of the exclusions on ethical or moral grounds as found in European and to an extent American and Australian patent laws. At present there is a sort of a calamity over human embryonic stem cell patents in Europe and to an extent in Australia and the United States. This in turn has created a sense of urgency to engage all relevant parties in the discourse on how best to approach patenting of this new form of scientific innovation. In essence, this should become a highly favoured patenting priority. To the contrary, stem cell innovation and its reliance on patent protection risk turmoil, uncertainty, confusion and even a halt on not only stem cell research but also further emerging biotechnology research and development. The patent system is premised upon the fundamental principle of balance which ought to ensure that the temporary monopoly awarded to the inventor equals that of the social benefit provided by the disclosure of the invention. Ensuring and maintaining this balance within the patent system when patenting human embryonic stem cells is of crucial contemporary relevance. Yet, the patenting of human embryonic stem cells raises some fundamental moral, social and legal questions. Overall, the present approach of patenting human embryonic stem cell related inventions is unsatisfactory and ineffective. This draws attention to a specific question which provides for a conceptual framework for this work. That question is the following: how can the investigated patent offices successfully deal with patentability of human embryonic stem cells? This in turn points at the thorny issue of application of the morality clause in this field. In particular, the interpretation of the exclusions on ethical or moral grounds as found in Australian, American and European legislative and judicial precedents. The Thesis seeks to compare laws and legal practices surrounding patentability of human embryonic stem cells in Australia and the United States with that of Europe. By using Europe as the primary case study for lessons and guidance, the central goal of the Thesis then becomes the determination of the type of solutions available to Europe with prospects to apply such to Australia and the United States. The Dissertation purports to define the ethical implications that arise with patenting human embryonic stem cells and intends to offer resolutions to the key ethical dilemmas surrounding patentability of human embryonic stem cells and other morally controversial biotechnology inventions. In particular, the Thesis goal is to propose a functional framework that may be used as a benchmark for an informed discussion on the solution to resolving ethical and legal tensions that come with patentability of human embryonic stem cells in Australian, American and European patent worlds. Key research questions that arise from these objectives and which continuously thread throughout the monograph are: 1. How do common law countries such as Australia and the United States approach and deal with patentability of human embryonic stem cells in their jurisdictions? These practices are then compared to the situation in Europe as represented by the United Kingdom (first two chapters), the Court of Justice of the European Union and the European Patent Office decisions (Chapter 3 onwards) in order to obtain a full picture of the present patenting procedures on the European soil. 2. How are ethical and moral considerations taken into account at patent offices investigated when assessing patentability of human embryonic stem cell related inventions? In order to assess this part, the Thesis evaluates how ethical issues that arise with patent applications are dealt with by: a) Legislative history of the modern patent system from its inception in 15th Century England to present day patent laws. b) Australian, American and European patent offices presently and in the past, including other relevant legal precedents on the subject matter. c) Normative ethical theories. d) The notion of human dignity used as the lowest common denominator for the interpretation of the European morality clause. 3. Given the existence of the morality clause in form of Article 6(1) of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions which corresponds to Article 53(a) European Patent Convention, a special emphasis is put on Europe as a guiding principle for Australia and the United States. Any room for improvement of the European morality clause and Europe s current manner of evaluating ethical tensions surrounding human embryonic stem cell inventions is examined. 4. A summary of options (as represented by Australia, the United States and Europe) available as a basis for the optimal examination procedure of human embryonic stem cell inventions is depicted, whereas the best of such alternatives is deduced in order to create a benchmark framework. This framework is then utilised on and promoted as a tool to assist Europe (as represented by the European Patent Office) in examining human embryonic stem cell patent applications. This method suggests a possibility of implementing an institution solution. 5. Ultimately, a question of whether such reformed European patent system can be used as a founding stone for a potential patent reform in Australia and the United States when examining human embryonic stem cells or other morally controversial inventions is surveyed. The author wishes to emphasise that the guiding thought while carrying out this work is to convey the significance of identifying, analysing and clarifying the ethical tensions surrounding patenting human embryonic stem cells and ultimately present a solution that adequately assesses patentability of human embryonic stem cell inventions and related biotechnologies. In answering the key questions above, the Thesis strives to contribute to the broader stem cell debate about how and to which extent ethical and social positions should be integrated into the patenting procedure in pluralistic and morally divided democracies of Europe and subsequently Australia and the United States.

"Towards 'a real reunion'?" : Archbishop Aleksi Lehtonen's efforts for closer relations with the Church of England 1945–1951

Mika KT Pajusen väitös "Towards 'a real reunion'?" – Archbishop Aleksi Lehtonen's efforts for closer relations with the Church of England 1945–1951 on yleiseen kirkkohistoriaan lukeutuva tutkimus Englannin kirkon ja Suomen evankelis-luterilaisen kirkon välisistä suhteista Aleksi Lehtosen arkkipiispakaudella 1945–1951. Suhteita on tutkittu kolmesta näkökulmasta: ekumeenisesta, poliittisesta ja kirkkopoliittisesta. Tutkimuskausi alkaa pastori H.M. Waddamsin joulukuussa 1944 Suomeen tekemän vierailun jälkimainingeista ja päättyy arkkipiispa Lehtosen kuolemaan pääsiäisenä 1951. Kirkollisten suhteiden kehitystä rytmittivät lukuisat vierailut, jotka osoittivat Englannin kirkon asenteen muuttumisen sodan aikaisesta neuvostomyönteisyydestä kylmän sodan aikaiseen täysin vastakkaiseen kantaan. Englantilaiset vieraat kohtasivat Suomessa sekä kirkon että yhteiskunnan ylimmän johdon. Molemmat maat olivat valmiita tukemaan hyviä kirkollisia suhteita tilanteen niin salliessa, joskaan eivät kovin suunnitelmallisesti. Suomen evankelis-luterilainen kirkko käytti hyviä suhteita Englannin kirkkoon saadakseen tukea ja ymmärrystä omalle kirkolleen ja yhteiskunnalleen kokemaansa Neuvostoliiton uhkaa vastaan erityisesti vaaran vuosina 1944–1948. Englannin kirkko halusi tukea suomalaista sisarkirkkoaan, mutta varoi, ettei tuottaisi tuellaan enemmän haittaa kuin hyötyä suhteessa Neuvostoliittoon. Sodan jälkeinen ekumeeninen jälleenrakentaminen lähensi kirkkoja toisiinsa. Lehtonen pyrki jatkamaan 1930-luvun kirkkojen välisiä, ehtoollisvieraanvaraisuuden saavuttaneita neuvotteluita kohti täyttä kirkollista yhteyttä. Häntä motivoi sekä evankelis-katolinen teologia että pyrkimys tukea oman maan ja kirkon läntisiä yhteyksiä. Tämä haastoi Englannin kirkon ekumeenisen linjan, joka Suomen kirkon sijasta pyrki jatkamaan neuvotteluja Tanskan, Norjan ja Islannin luterilaisten kirkkojen kanssa, joilla ei vielä ollut virallista ekumeenista sopimusta Englannin kirkon kanssa. Lehtosen pyrkimyksistä huolimatta Englannin kirkko päätyi jättämään Suomen tilanteen hautumaan. Sillä se tarkoitti suhteiden koetinkivenä olleen historiallisen piispuuden leviämistä läpi Suomen kirkon ennen kuin katsoi olevansa valmis jatkamaan kohti täyttä kirkollista yhteyttä. Molemmissa kirkoissa vaikutti pieni, innokkaiden, lähempiä suhteita toivoneiden kirkollisten vaikuttajien ydinjoukko. Englantilaisia Suomen-ystäviä motivoi tarve auttaa Suomea hankalassa poliittisessa tilanteessa. Suomessa arkkipiispa Lehtonen tuki korkeakirkollista liturgista liikettä, jolla oli läheinen yhteys anglikaanisuuteen, mutta joka sai vastaansa vanhoilliset pietistit. Suomen kirkon yleinen mielipide asettui etupäässä pietistiselle kannalle, jolle anglikaanisuus näyttäytyi teologisesti sekä liian katolisena että liian reformoituna. Kirkolliset suhteet tasaantuivat vuoden 1948 Lambeth-konferenssin jälkeen, joka rohkaisi anglikaanisia kirkkoja hyväksymään 1930-luvun neuvottelujen lähempiin kirkollisiin suhteisiin tähtäävät suositukset. Lehtonen näytti tyytyvän tähän. Samaan aikaan lähempää kirkollista kanssakäymistä tukenut ekumeeninen jälleenrakennus tuli tiensä päähän. Lehtonen jatkoi läheisempien suhteiden edistämistä, mutta hänen intonsa hiipui yhdessä heikkenevän terveydentilan kanssa. Osoituksena Lehtosen linjan kapeudesta Suomen evankelis-luterilaisen kirkon piispoista ei löytynyt hänen kuoltuaan ketään, joka olisi jatkanut hänen aktiivista anglikaanimyönteistä linjaansa.

Meillä ei ole ikuisia ystäviä eikä ikuisia vihollisia. Ikuisia ovat meidän omat etumme. : Suomen suhteet Kiinan kansantasavaltaan 1949 - 1989

"We have neither Eternal Friends nor Eternal Enemies. We have only Eternal Interests .Finland's Relations with China 1949-1989 The study focuses on the relations between Finland and the People s Republic of China from 1949-1989 and examines how a small country became embroiled in international politics, and how, at the same time, international politics affected Finnish-Chinese relations and Finland s China policy formulation. The study can be divided into three sections: relations during the early years, 1949-1960, before the Chinese and Soviet rift became public; the relations during the passive period during the 1960s and 1970s; and the impact of China s Open Door policy on Finland s China policy from 1978-1989. The diplomatically challenging events around Tiananmen Square and the reactions which followed in Finland bring the study to a close. Finland was among the first Western countries to recognise the People s Republic and to establish diplomatic relations with her, thereby giving Finland an excellent position from which to further develop good relations. Finland was also the first Western country to sign a trade agreement with China. These two factors meant that Finland was able to enjoy a special status with China during the 1950s. The special status was further strengthened by the systematic support of the government of Finland for China's UN membership. The solid reputation earned in the 1950s had to carry Finland all the way through to the 1980s. For the two decades in between, during the passive policy period of the 1960s and 1970s, relations between Finland and the Soviet Union also determined the state of foreign relations with China. Interestingly, however, it appeared that President Urho Kekkonen was encouraged by Ambassador Joel Toivola to envisage a more proactive policy towards China, but the Cultural Revolution cut short any such plan for nearly twenty years. Because of the Soviet Union, Finland held on to her passive China policy, even though no such message was ever received from the Soviet Union. In fact, closer relationships between Finland and China were encouraged through diplomatic channels. It was not until the presidency of Mauno Koivisto that the first high-level ministerial visit was made to China when, in 1984, Foreign Minister Paavo Väyrynen visited the People s Republic. Finnish-Chinese relations were lifted to a new level. Foreign Minister Väyrynen, however, was forced to remove the prejudices of the Chinese. In 1985, when the Speaker of the Finnish Parliament, Erkki Pystynen visited China he also discovered that Finland s passive China policy had caused misunderstandings amongst the Chinese politicians. The number of exchanges escalated in the wake of the ground-breaking visit by Foreign Minister Väyrynen: Prime Minister Kalevi Sorsa visited China in 1986 and President Koivisto did so in 1988. President Koivisto stuck to practical, China-friendly policies: his correspondence with Li Peng, the attitude taken by the Finnish government after the Tiananmen Square events and the subsequent choices made by his administration all pointed to a new era in relations with China.

Kirkko, Kekkonen ja kommunismi poliittisina kriisivuosina 1958-1962

This study explores the relationship of the Evangelical Lutheran Church of Finland to communism and political power during the period of crises in Finnish foreign relations with the Soviet Union from 1958 to 1962. During this period the USSR repeatedly interfered in Finland´s domestic affairs and limited her foreign political freedom of action. The research subjects for this dissertation are the bishops of the Church of Finland and the newspaper Kotimaa, which can be regarded as the unofficial organ of the church at the time. A typical characteristic of the Church of Finland from the beginning of the twentieth century was patriotism. During the interwar years the church was strongly anti-communist and against the Soviet Union. This tendency was also evident during the Second World War. After the war the Finnish Church feared that the rise of the extreme left would jeopardize its position. The church, however, succeeded in maintaining its status as a state church throughout the critical years immediately following the war. This study indicates that, although the manner of expression altered, the political attitude of the church did not substantially change during the postwar period. In the late 1950s and early 1960s the church was still patriotic and fear of the extreme left was also evident among the leaders of the church. The victory of the Finnish People's Democratic League in the general election of 1958 was an unwelcome surprise to the church. This generated fear in the church that, with Soviet support, the Finnish communists might return to governmental power and the nation could become a people's democracy. Accordingly, the church tried to encourage other parties to set aside their disagreements and act together against the extreme left throughout the period under study. The main characteristics of the church´s political agenda during this period of crisis were to support the Finnish foreign policy led by the president of the republic, Urho Kekkonen, and to resist Finnish communism. The attitude of Finnish bishops and the newspaper Kotimaa to the Cold War in general was generally in agreement with the majority of western Christians. They feared communism, were afraid of the USSR, but supported peaceful co-existence because they did not want an open conflict with the Soviets. Because of uncertainties in Finland's international position the Finnish Church regarded it as necessary to support the Finnish policy of friendship towards the USSR. The Finnish Church considerer it unwise to openly criticize the Soviet Union, tried resist the spread of communism in Finnish domestic policy. This period of foreign policy crises was principally seen by the church as a time when there was a need to strengthen Finland's unstable national position.

Bridging East and West : The Establishment of the International Institute for Applied Systems Analysis (IIASA) in the United States Foreign Policy of Bridge Building, 1964-1972.

The dissertation examines the foreign policies of the United States through the prism of science and technology. In the focal point of scrutiny is the policy establishing the International Institute for Applied Systems Analysis (IIASA) and the development of the multilateral part of bridge building in American foreign policy during the 1960s and early 1970s. After a long and arduous negotiation process, the institute was finally established by twelve national member organizations from the following countries: Bulgaria, Canada, Czechoslovakia, Federal Republic of Germany (FRG), France, German Democratic Republic (GDR), Great Britain, Italy, Japan, Poland, Soviet Union and United States; a few years later Sweden, Finland and the Netherlands also joined. It is said that the goal of the institute was to bring together researchers from East and West to solve pertinent problems caused by the modernization process experienced in industrialized world. It originates from President Lyndon B. Johnson s bridge building policies that were launched in 1964, and was set in a well-contested and crowded domain of other international organizations of environmental and social planning. Since the distinct need for yet another organization was not evident, the process of negotiations in this multinational environment enlightens the foreign policy ambitions of the United States on the road to the Cold War détente. The study places this project within its political era, and juxtaposes it with other international organizations, especially that of the OECD, ECE and NATO. Conventionally, Lyndon Johnson s bridge building policies have been seen as a means to normalize its international relations bilaterally with different East European countries, and the multilateral dimension of the policy has been ignored. This is why IIASA s establishment process in this multilateral environment brings forth new information on US foreign policy goals, the means to achieve these goals, as well as its relations to other advanced industrialized societies before the time of détente, during the 1960s and early 1970s. Furthermore, the substance of the institute applied systems analysis illuminates the differences between European and American methodological thinking in social planning. Systems analysis is closely associated with (American) science and technology policies of the 1960s, especially in its military administrative applications, thus analysis within the foreign policy environment of the United States proved particularly fruitful. In the 1960s the institutional structures of European continent with faltering, and the growing tendencies of integration were in flux. One example of this was the long, drawn-out process of British membership in the EEC, another is de Gaulle s withdrawal from NATO s military-political cooperation. On the other hand, however, economic cooperation in Europe between East and West, and especially with the Soviet Union was expanding rapidly. This American initiative to form a new institutional actor has to be seen in that structural context, showing that bridge building was needed not only to the East, but also to the West. The narrative amounts to an analysis of how the United States managed both cooperation and conflict in its hegemonic aspirations in the emerging modern world, and how it used its special relationship with the United Kingdom to achieve its goals. The research is based on the archives of the United States, Great Britain, Sweden, Finland, and IIASA. The primary sources have been complemented with both contemporary and present day research literature, periodicals, and interviews.