Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD

Submitted: 5 October 2017; Revised: 1 January 2018; Accepted: 11 January 2018; Published online first: 24 January 2018

Introduction

A country’s regulations can influence the innovation of industries, companies and entire economies. Yet, the impact of regulations in the empirical literature is judged with ambivalence when it comes to innovation [1]. Different regulations generate different results and even a single type of regulation can affect innovation in diverse ways depending on how the regulation is interpreted [1].

In this paper, several Christian countries with different embryonic stem cell regulations are examined. The countries in which the Roman Catholic denomination is largest are Austria, Canada, France, Italy, The Netherlands, Spain and Switzerland. The predominantly Protestant countries examined in this paper are Australia, Denmark, Finland, Germany, Sweden, the UK and the US. The percentages of predominant religious denominations in these countries are shown in Tables 1 and 2.

One would be inclined to assume that countries with the same religious background should have similar embryonic stem cell regulations. Predominantly, Protestant countries might be expected to be permissive of embryonic stem cell research while predominantly Roman Catholic countries should be restrictive. This, however, is not true. To illustrate this, the predominantly Roman Catholic countries of Italy and Spain are compared, as are the predominantly Protestant countries of the UK, Germany and the US.

Embryonic stem cell regulations in Christian countries

Italy’s citizenry is predominantly Roman Catholic and embryonic stem cell research regulations are restrictive [2, 4]. One could argue that this is due to lobbying by the Roman Catholic Church and to the fact that 90% of Italians follow its teachings. On the other hand, Spain’s public is also predominantly Roman Catholic, with 94% of the public following the church’s teachings [2]. However, embryonic stem cell research is carried out in Spain using leftover embryos from in vitro fertilization (IVF) [5]. In addition, Spain legalized therapeutic cloning becoming the fourth country in Europe to do so [5]. In 2004, Spain also created Europe’s third stem cell bank and established three research centres exclusively studying regenerative medicine and stem cells [5]. Based on that, one cannot generalize that if a country’s public is predominantly Roman Catholic, the country’s regulations would be opposed to human embryonic stem cell research.

The same is true for Protestant countries. However, it cannot be argued that if a country were predominantly Protestant it would have permissive regulations regarding this controversial form of research. Not all Protestants approve of human embryonic stem cell research. And conservative Protestants and mainline Protestants have different views regarding such research. Official positions on the moral status of the embryo vary from country to country and, therefore, so do positions on the morality of embryo research in general. For instance, the UK is a predominantly Protestant country known for its permissive human embryonic stem cell regulations. However, Germany is also a predominantly Protestant country, but it is restrictive to human embryonic stem cell research [6].

The Evangelical Protestant Church of Germany is also divided on the topic of stem cells [6]. These divisions demonstrate how personal the views on embryonic stem cell research can be. For the public and the aforementioned churches, weighing up the need to help suffering people and the moral status of the embryo is not a simple issue. Therefore, from the observed differences between the predominantly Roman Catholic and the predominantly Protestant, it is not possible to establish a relationship between the predominant religion in a given country and embryonic stem cell regulations that can be generalized to other countries not included in this thesis.

Why do countriess such as the UK, Germany and the US, which all have a strong Protestant background, have different embryonic stem cells regulations?

It can be a difficult ethical and scientific balance for policies to reflect the importance of retaining the shared moral views of a nation, along with the desire to advance in disease management. Human embryonic stem cell research is a topic still fraught with dispute, both between and within nations. Protestants are also divided on ethics of embryonic stem cell research. The discrepancy in policies throughout the world demonstrates the ethical criticisms of stem cell research coupled with their therapeutic potential. The following will provide a historical background regarding the UK, Germany, and the US, and the events that led to the establishment of such different restrictive or permissive regulations in countries with similar Protestant backgrounds [7].

The UK
The UK is a predominantly Protestant Christian country with permissive human embryonic stem cell regulations. These regulations can be traced back to a 1982 committee that was known as the Committee of Inquiry into Human Fertilisation and Embryology, also known as the Warnock Committee. The committee was headed by Helen Warnock, a British philosopher of education, mind and morality. This committee was established to make recommendations regarding potential and recent developments in science and medicine related to human fertilization and embryology [8]. The recent developments referred to the birth of Louise Brown, the world’s first ‘test-tube baby’, who was born in England in 1978 [8]. One aim of the committee was to consider what safeguards and policies should be put in place, including reflection of the moral, social and legal implications of these developments [8]. In 1985, the Report of the Committee of Inquiry into Human Fertilisation and Embryology (Warnock Report) was made public by the committee in the UK.

The committee recommended that research on human embryos only be performed for clear purposes that are considered necessary and desirable. In addition, such research can only be performed on an embryo 14-days-old or younger [8]. Not all members of the committee agreed on these recommendations. Three took the view that life begins at conception and did not agree with these recommendations [8]. In addition, other bioethicists outside the committee did not agree with all the recommendations. For example, John Harris, a philosopher, argued that the 14-day limit on embryo research was arbitrary and too short [9]. On the other hand, Harris also said that the 14-day limit has been valuable. He said that ‘by pure luck, huge amounts have been learned: it does turn out that most of the things we needed to do in terms of stem cell research can be done before the 14-day limit [10]’.

In 1990, The Report of the Committee of Inquiry into Human Fertilization and Embryology gave rise to the Human Fertilisation and Embryology Act and the Human Fertilisation and Embryology Authority (HFEA). This authority regulates human fertility experimentation and treatment using human embryos This means that they regulate the licensing for procedures, such as in vitro fertilization (IVF) and they oversee the ban on research using human embryos older than 14 days [11]. In 2002, the HFEA issued the first license for human embryonic stem cell research in the UK, using surplus embryos from IVF [11]. These events shaped the UK embryonic stem cell regulations in place today. Now, the UK has permissive embryonic stem cell regulations and it is considered one of the world’s pioneers in reproductive and regenerative medicine. The UK allows the production of embryonic stem cell lines from leftover IVF embryos. Furthermore, the cloning of embryos to generate stem cell lines for therapeutic purposes is only legally allowed in the UK [12].

Germany
Much like the UK, Germany is predominantly a Protestant country. However, unlike the UK, Germany has one of the strictest embryonic stem cell policies seen worldwide [13]. In 1990, the Embryo Protection Act was passed by the German Parliament. This act gave the German Government control over the therapeutic measures used in reproductive medicine to overcome human infertility. One of the goals of this act was to prevent unwanted commercial uses of human embryos [13]. As far as reproductive medicine is concerned, the Embryo Protection Act constitutes the world’s most restrictive law for embryonic research. The act outlaws any research on human cleavage stages or blastocysts not clearly designed to safeguard the embryo’s survival [14]. Embryo research can now be carried out only as long as a clinical pregnancy remains possible and the embryo is not harmed during or following the study. The Embryo Protection Act contains the following punishable stem cell research related acts:

• Anyone who acquires, disposes of, or uses for a purpose not serving its safeguarding, a human embryo produced outside the body, or removed from a woman before the conclusion of implantation in the uterus, will be imprisoned for up to three years or receive a fine [14].
• Similarly, anyone who causes a human embryo to develop further outside the body for any purpose other than pregnancy will be punished [14].

The Director of Education at the National Catholic Bioethics Center, Dr Tadeusz Pacholczyk, on the topic of embryonic stem cell research noted, ‘Germany, which has a strong historical memory of the consequences of ignoring human dignity, declines to participate in these charades [7]’. Reverend Pacholczyk was referring to the history of unethical medical experimentation conducted by the Nazi regime throughout World War II. Germany now strongly regulates IVF treatments and only allows the production of no more than three embryos for each IVF procedure; all three embryos must be implanted into the womb [15]. Germany outlaws genetic testing of embryos, cloning of embryos, experimentation on embryos, and the production of extra embryos [15].

Even though the Embryo Protection Act makes the use and production of human embryos for research purposes a punishable offense, it does not clearly make illegal the importation of human embryonic stem cells from other countries. In 2002, the German Parliament exploited this loophole and established the Stem Cell Act. This act allows the import of human embryonic stem cells for research purposes in Germany [13]. To ensure that no human embryonic stem cells lines are directly produced for German research purposes, only human embryonic stem cell lines produced from surplus embryos from IVF prior to the 1 January 2002 can be lawfully imported [13]. In 2008, the ban on creating human embryonic stem cell lines in Germany was upheld by the national parliament of the Federal Republic of Germany. However, the cutoff date was changed from 1 January 2002 to 1 May 2007 [16]. Here it is important to point out that there is a German ethical double standard in this law and it is illogical to allow an act that is banned on German embryos to be carried out on embryos imported from other countries.

The US
Unlike Germany, in the US, research with human embryonic stem cells is not forbidden, but scientists can only use cell lines produced from surplus IVF embryos created prior to 9 August 2001 if the research is financed with federal money [4]. Privately funded research on human embryonic stem cell or the production of human embryonic stem cell lines is not regulated by federal law [4]. Human embryonic stem cell research is nationally inconsistent in the US. Several states such as California, Massachusetts and New Jersey have passed legislation that can be described as permissive. Other states such as Arkansas, Iowa, Kansas, Louisiana, North Dakota, South Dakota and Virginia have banned human embryonic stem cell research [4].

The restrictions on embryonic research can be traced back to 1977. In that year, the Federal Policy for the Protection of Human Subjects was enacted. It stated that ‘No application or proposal involving human in vitro fertilization may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Ethical Advisory Board and the Board has rendered advice as to its acceptability from an ethical standpoint [17]’.

In 1993, former President Bill Clinton instigated the National Institutes of Health Revitalization Act, which abolished the Federal Policy for the Protection of Human Subjects [13]. This paved the way for federal backing of grant applications to research human fertilization with no need for supplementary examination by an Ethical Advisory Board. However, President Clinton received thousands of letters urging him to overturn his previous decision. He agreed, and federal funding of embryonic research was suspended 1994 [13].

In 1995, through the Dickey-Wicker Amendment, Congress banned federal funding for research on embryos. This amendment forbids the use of federal funds for the production of human embryos for research purposes; or research in which human embryos are discarded, destroyed, or consciously subjected to risk of damage or death larger than that tolerated for research on fetuses in utero [13]. In 2006, Congress passed a bill that would relax restrictions on federal funding for human embryonic stem cell research. The bill was known as the Stem Cell Research Enhancement Act. However, then-President George W Bush vetoed this bill, citing his religious beliefs as grounds for his decision [18]. Thus, restrictions on research continued throughout the Bush presidency.

In March, 2009, President Barack Obama reversed Bush’s executive order, removing barriers to federal funding of scientific research involving human embryonic stem cells [19]. However, in August 2010, an injunction blocking President Obama’s Executive Order was issued by Federal District Court Judge Royce Lamberth [20]. Judge Lamberth argued that Obama’s Executive Order goes against the Dickey-Wicker Amendment [20]. The court’s decision is the result of a lawsuit filed in August 2009 against the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) in Maryland. Dr James Sherley, one of the plaintiffs in the case argued that federal funding for research on human embryonic stem cells is unlawful since the destruction of embryos is necessary [21]. The plaintiffs contended that the new policy infringed the Dickey-Wicker Amendment. In response, the Obama Administration’s lawyers argued that the new policy would fund human embryonic stem cells research after the stem cells are already extracted from the embryos [21] and that no funding is to be given to the actual destruction of the embryos. Therefore, the Obama Administration contended that the NIH guidelines do not violate the Dickey-Wicker Amendment. In September 2010, The US Court of Appeals for the D.C. Circuit lifted Judge Lamberth’s injunction that stopped funding throughout the lawsuit [22]. In July 2011, Judge Lamberth dismissed the case. He said that ‘the NIH reasonably interpreted an executive order by President Obama directing it to remove some restrictions on the support of stem-cell research [22]’. These circumstances demonstrate the uncertain nature of the legal standing of human embryonic stem cell research in the US. These events that were initiated by President Clinton and continued through the Bush and Obama presidencies show that human embryonic stem cell research regulations are ambiguous in the US and that these regulations are influenced by both politics and religion. Legislation should be put in place to remove this uncertainty.

Conclusion

One would be inclined to assume that countries with the same religious background should have similar embryonic stem cell regulations. However, this paper showed that predominantly Protestant Christian countries have different human embryonic stem cell regulations to one another. Several Christian countries with different regulations were examined including Italy, Spain, the UK, Germany and the US. The UK has permissive embryonic stem cells regulations. In Spain, regulations are moderate whilst in Italy, Germany and the US they are restrictive.

Competing interests: The author has no affiliations with or involvement in any organization or entity with any financial or non-financial interest in the subject matter discussed in this paper.

Provenance and peer review: Not commissioned; externally peer reviewed.

Authors

Hajaj M Alhomaidan, MBBS Senior Student
Street No. 60, House No. 9B, Alyasmin District, Riyadh 13322, Saudi Arabia

Ali M Alhomaidan, PhD
Executive Director for Products Evaluation
Saudi Food and Drug Authority, 3292 North Ring Road – Al Nafal Unit (1), Riyadh 13312-6288, Saudi Arabia

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