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Major genetic paradigms within the field of bioethics

including regenerative medicine, predictive genetic testing and antenatal genetic screening.

Having discussed the cultural philosophies held within China, the UK and the US, we can regard examples of genetic concern which have arisen following the inception of bioethics as a field of discipline both within these countries and through international organisations.

An analysis of regulations and guidelines from these countries will be made below with legislative documentation taken from government departmental and international websites; representing the primary empirical research material. The aim of this review is to establish any present consensus or discord between these countries; which will act as a framework with which to build upon the idea of a global bioethical discourse.

Literature searches were performed across the fields of sociology, politics and philosophy; sociological data proved most relevant within this field and the search criteria adhered to included: Bioethic*, ethic*, bioethical council*, bioethics*/ethic* committee*, bioethics*/ethic* bodies as well as topic searches relevant to each country. In the case of regulations and guidelines being written in a foreign language, documents were first translated using PowerTranslator 13® and again with GoogleTranslate; both results were then compared for any grammatical discrepancies.

Regulations and guidelines in China, UK and US

Regenerative Medicine and the Embryo

The future of regenerative medicine is perhaps one of the most frequently debated and hotly disputed biomedical and ethical paradigms of the last 20 years. The totipotent capacity of the human stem cell (hSC) within the various fields of molecular biology, genetic engineering and regenerative medicine, represents the Holy Grail of medical intervention (Fischbach and Fischbach 2004; Coleman and Burely 2001; Wainwright and Williams 2006). The promise of a medical revolution through the development of treatments for Parkinson’s disease, diabetes, spinal cord injuries (SCI) and multiple sclerosis (MS) has captured the ideas of both the scientific community and the public alike. As a result, the ethical discourse surrounding the generation and extraction of pluripotent cells has come under the social and political magnifying glass. Wainwright, discussing stem cell science, states that the “bioethics has become grounded within the practices and units of analysis”, resulting in an exclusive social and scientific history, unique to any other scientific practice (Wainwright and Williams 2006). It is therefore applicable to study the many sociological aspects influencing such decisions within this field of work, as applying an all-encompassing model of bioethics to all fields of science would be both naive and futile (Wainwright and Williams 2006).

Embryonic generation and destruction provides the heart of the debated topic; with biopolicy makers, practitioners and the general public asking questions concerning the start of human life and the moral distinction of the embryo. From a purely sociological perspective, this provides a wealth of ethical discourse surrounding contentious arguments; stem cells merely represent a case study into the engagement of the public, scientific and regulatory communities. These engagements are grounded in traditions, cultural norms and scientific history, the assessment of which may allow for a detailed understanding of contentious policies and ethical practices of the East and West, providing fuel in the race toward a global bioethical understanding.

The United Kingdom has a very clear cut approach to stem cell science, identifying the uterus as the barrier between potential life and life; whilst the US recognises any fertilised oocyte as having the same protection as an adult human (Coleman and Burley 2001). Current UK legislation authorises the creation, storage and use of human embryos for the purposes of a research (HFEA 2008). The Human Fertilisation and Embryology Authority (HFEA) state that no research can be conducted on embryos over 14 days, representing a bioethical cut-off point. In amendments to the 2001 HFEA act, the HFEA is able to license the generation of stem cells from embryos surplus to in-vitro fertilisation (IVF) requirements, created through IVF and therapeutic cloning. The framework advising stem cell science in the UK is also substantial, with governmental guidelines, the HFEA and public regulatory organisations all helping establish public awareness and aid those working with stem cells (Hauskeller 2004).

The US outputs approximately 59% of all bioethical discourse, and is the leading global contributor to hSC science and its application (Borry, Schotsmans 2004). This can, in part, be contributed to current regulations surrounding federal funding for research into the current 81 hSC lines and private funding into somatic cell nuclear transfer (SCNT) from stored embryos. Federal funding for stem cell research in the US is detailed. Subpart B of the in 1991 title 45 of the CFR* protects the products of conception from implantation to delivery; and following subsequent revision, also protects human embryos from research. The result of this means that hSCs are federally protected and all embryos for research must be derived from IVF treatments whereby cells are in excess of the clinical demand (NIH 2010; Fischbach and Fischbach 2004). Furthermore, different states hold different policies, ranging from Louisiana which strictly prohibits any research on embryos (including those sourced from IVF) to California, New Jersey and Massachusetts who all condone research and therapeutic cloning (UK Stem Cell Initiative 2005). This immediately raises the issue of a state ‘brain drain’, whereby scientists may move from one state to another depending on the socio-political republican/democratic support or rejection of stem cell research.

China has been seen to emulate the regenerative legislation seen in the UK, however the Ministry of Health classify stem cells and the embryo as a clinical medical technology and not as a ‘life’. Legislation up to May 2009 has therefore condoned the clinical use of stem cells, with little enforcement of safety trials (Ren Zong 2010; Cyranoski 2009, MOH). In May 2009, new MOH regulations now labels hSCs as a category 3 medical technology which allows for the enforcement of fines for those practicing with stem cells without safety and efficacy regulation (Cyranoski 2009; MOH).

Consumer based Predictive Genetic Testing

Genetic testing represents a bioethical issue of choice, choosing genetic uncertainty or gaining knowledge into the prediction of future diseases. With the advent of genetic biomedicine particular markers for diseases are becoming wide ranging and their etiology progressively multifactorial, one major consequence of this is the introduction of consumer based screening for these markers (Human Genetics editorial 2008). Offering asymptomatic individuals genetic screening solutions is now commonplace in China, US and the UK. The differing levels of legislation and network of supporting guidelines is fundamental to the operation of these genetic screening companies and practices.

Within China, authorisation through the MOH offers direct to consumer predictive genetic testing (DTC-PGT) through a series of hospitals and biotechnology companies (Sui and Falkner 2007). This authorisation does not come with any explicit guidelines and the commercialisation of genetic testing in China, through the push of a knowledge-based economy, is leading to widespread social concerns (Sui and Falkner 2007; Faulkner 2007). Private companies offering genetic testing are only governed through the requirement of a business license which entails no stipulation of a medical qualification or professional requirement, a direct consequence of Chinas current market economy. The 1997 business guidelines state that all companies have the right to their own trade as long as it complies with the law. The law only stipulates measures for prenatal diagnosis, ensuring that prenatal testing is performed by a qualified medical professional, not by a commercial business.

The United States has written federal law which demands a degree of analytical validity for all genetic testing undertaken in research and clinical labs, however it does not stipulate any specific requirements for PGT (clinical laboratory improvement amendments of 1988). Whether or not a company is permitted to providing individual genetic information is down to state law; with approximately half of all states banning such testing. The genomics and personalised medicine act of 2007 requires that the Centres for Disease Control and Prevention (CDC) conduct a suitable analysis of public health and direct impact of DTC-PGT. The legislation also requires the implementation of guidelines for the construction of informed consent forms and for the appropriate design of procedures, protocols and policies (Section 4 paragraph 8). Guidelines provided by the American Society of Human Genetics (ASHG) in a 2007 ASHG report identified consumer informed consent and the blind nature of internet commerce as being the most contentious issues. The ASHG promote transparency of the predictive nature of genetic testing and recommend enhancing forms of consumer education. The report highlights major concerns for the quality of PGT due to the ‘fragmented regulatory environment’, seen between the federal government and state law (ASHG 2007).

Informed consent is also highly stated in the UK guidelines recently drafted by the Human Genetics Commission (HGC) ( DTC-PGT principles 2010). The advisory body has developed a series of principles which highlights the ethical, legal and social implications associated with consumer based genetic testing. They recommend the application and adherence to stricter controls of genetic testing and the implementation of a funded NHS genetics service with a primary care workforce; as currently, it is not necessary to be a qualified healthcare professional in order to conduct these screening procedures in the UK (Lucassen and Montgomery (2010); HGC section 5.2-5.6). The majority of legislation refers to the Human Tissue Act 2004(HTA) which emphasises informed consent in relation to the law and ‘DNA theft’. The Human Tissue Act states that an offence is committed if any human DNA is analysed without qualifying consent, therefore the guidelines surrounding PGT makes it very clear that informed consent is paramount (HTA 2004). The guidance implemented by the various advisory bodies and organisations act a decision-making framework for policy makers, all of which argue for greater restrictions on both public education and DTC PGT .

European regulations seen with various organisations are detailed and not only incorporate legal aspects but also demonstrate progressive analysis of moral obligation, questioning the role of family in individual PGT (LE Forrest 2007). The Public and Professional Policy of the European Society of Human Genetics (ESHG) are concerned with the implementation of screening companies outside of the conventional healthcare system; setting guidelines opposing ‘aggressive marketing strategies’, ensuring the transparency of informed consent and the promotion of employing healthcare professionals within this sector (ESHG 2010). International legislation also provides a regulatory structure for genetic testing. ‘The Oviedo Convention’ limits all genetic testing of individuals for health purposes only, following adequate genetic counselling. It also ensured an embargo on any forms of individual genetic discrimination (Regniault, Kupecz 2009; Convention on human rights and Biomedicine 2008).

Prenatal Genetic Screening/Prenatal Genetic Diagnosis

The advancement of medical screening technologies has caused a rise in the number of targets available for selective abortion. Prenatal genetic screening (PGS) encompasses medical genetic testing; amniocentesis, blood sampling and chronic villus sampling (CVS)can be performed for the chromosomal analysis of fetal cells and the establishment of a diagnosis for a genetic condition. More controversially, PGS can produce a similar result to PGT with the establishing of potential risk factors for multifactorial diseases. The information provided by such testing can prove highly controversial as it raises the primary bioethical concern of a justifiable selective abortion.

The ideals of maternal rights prevail in the UK with PGS considered to be an acceptable form of eugenic practice in the instance that a child may have a ‘debilitating disease’ (Science and technology committee, recommendation 25, 2005). The HGC issued a revised report with recommendations for the advancement and practice of PGS, having a wholly utilitarian approach. Complying to the abortion act of 1967, and justifying fetal screening through the principles of reproductive choice, the HGC identifies PGS as a ‘public service’, with women having the right to an abortion under parliamentary conditions. The report also recommends ‘social justice’ and equal opportunities for those mothers who wish to willingly have a child with a genetic defect, suggesting a strong research programme aimed at enhancing services for genetic screening, treatments and social support.

Further guidance is provided by the UK National Screening Committee (NSC) which advises parliament, ministers and national assemblies, on new screening technologies and policies. It also recommends various screening conducted on the NHS, which must then comply with the National Institute for Health and Clinical Excellence (NICE) guidelines (no.62).

China has implemented an only child policy in 1979 due to an unsustainable population growth, as a result parents have a high expectation for their offspring (Chinese Population and Family Planning Law 2002; Isasi and Knoppers 2006; Suia and Sleeboom-Faulkner 2010). Chinese population planning law is internationally notorious, promoting an improved ‘quality of a population’ which is seen to be the sole purpose of the Ministry of Health appointed ‘National Population of Family Planning Commission’ (NPFPC) (Suia and Sleeboom-Faulkner 2010). Stemming from the ‘one child policy’, China introduced the Maternal and Infant Healthcare Law (MIHCL) in 1995 which listed a series of genetic and infectious diseases which were considered to be medically inappropriate for reproduction (MIHCL article 38). Also enforced by this law was pre-marital genetic testing, with an aim to reduce the level of genetic conditions in offspring. In 2001 the MIHCL was revisited following Western media insight and substantial criticism; the result was a revised law which was deemed more socially progressive with premarital testing being made voluntary and an implemented ban on genetic sex selection. Currently, the NPFPC have instated a regulation to help facilitate prenatal screening for young couples. Though not compulsory, the regulations make genetic screening more widely accessible, promoting China’s ‘genetic quality’ amongst its population (Fui ng 2010).

The MOH’s ‘measures for the administration of prenatal diagnosis technology 2003’ stipulates that only specified hospitals are allowed to perform prenatal diagnostic testing, which requires strict permission from the local or provincial health authorities. Screening is not compulsory with PGS conditioned on the family who make the decisions as to the health and development of the unborn child. The hospitals which do offer PGD also often offer a form of genetic counselling, which is governed by the MOH in the ‘2003 guidelines for genetic counselling’. A result of this is reflected in a more directive form of genetic counselling, with a heavy influence on selective abortion. A lack of state laws and guidance associated with the prohibition of genetic discrimination is also directly relevant. Most critically, there is a general refusal of medical insurance offered to those with a genetic condition which consequently insights further social prejudices.

The American federal government does not have direct control over medical practice, therefore a collage of state laws and federal guidelines are in place (Isasi and Knoppers 2006). The CDC implemented the Fertility Clinic Success Rate and Certification Act (FCSRCA) in 1992 which calls for national guidelines for all assisted reproduction technologies (ART) to be facilitated by the Secretary of Health and Human Services. Reporting of use or outcomes of PGD/PGS is not required by the act, governance here is often self-regulated by medical institutions. Due to this lack of direct regulation, the now defunct President’s Council on Bioethics and put forward suggested alterations to state laws it also highlights the professional ‘self-regulation’ of PGD by professional societies. The American Society of Reproductive Medicine (ASRM) provides clinical guidelines and treats all screening as clinical, not experimental procedures (section 3d). Sex selection is regarded as non permissible, only acceptable in the instance of linked genetic condition.


Genetic technology has been able to completely redefine reproduction and diagnosis in the 21st Century, and in doing so, it has raised boundary concerns with regard to the start of human life, the definition of eugenics the autonomy of mother and child within society. These concerns are reflected in the legislative and regulatory differences exemplified between China, the UK and the US. The difference in political views and ethical concerns is extensive, resulting in comprehensive discourse on genetic reproduction and diagnostic issues. In its wake, a patchwork of national governing bodies and private advisory groups have arisen; all of which delineate the acceptable from the non acceptable through an analysis of biopolitical attitudes influenced by cultural traditions.

Western Liberalisation

A libertarian view of genetics is portrayed by the UK, which takes into consideration the dominant Western view of autonomy as well as the utilitarian views of Bentham and Mill. Stem cell research in particular has led to the UK in adopting a fairly liberal utilitarian approach, regarding forms of intrinsic deontology less highly. Deontological bioethical reasoning here is minimal, as the traditional case-based approach to embryo research is less about the individual embryo itself and more about the maximal scientific benefit to society. The philosophy of HM Hare demonstrates this lack of autonomy given to the individual embryo, arguing that an embryo is not yet sensory, has no desires and therefore perishing is not considered by an embryo to be ‘unpleasant’. The UK does not provide the embryo with agency; instead it gives it potential, which enhances the concept of ‘viability of life’ rather than actual life, the boundary of which is uteri implantation.

Liberal views are also reflected in the accessibility of HFEA act regulations by the general public. Hauskeller argues that the existence of the HGC and HFEA is the main difference setting the UK apart from the rest of the world in relation to genetic research and biopolicy. Due to these institutions’s exemplary level of transparency, public access to detailed and technical information provides the public with confidence and high expectations, one which could benefit society (Hauskeller 2004). This is not to say that a lax, transparent position concerning the regulation of genetic technologies is one shared by all. Ethnographic data on UK stem cell scientists identify them as being ‘predisposed to taking a more ethically stringent position’, and attempting to demarcate the ethical boundaries between various sources of embryos for stem cell research (Wainwright 2006). Reasons for this stringent position echo the concerns of the first stem cell research expert statement, the ‘Donaldson Report’. The report details ethical implications of SCNT stating that they are created ‘only as a means to an end’(DoH 2000, 319, p.8.). It is also true to say that all embryos are in some way used as a means to an end for research purposes, therefore this statement applies to all forms of embryo research which results in the destruction of an embryo. The UK utilitarian approach is pragmatic, considering the benefits and repercussions from such controversial research in order to arrive at an informed decision.

The lucid nature of UK genetic regulation is contrasted with the capping of stem cell research funding and the federal protection of the embryo during the US Bush administration. The embryo was considered to have equal rights to that of a grown human and thus, given full autonomy and human rights resulting in the restriction of research funding for new stem cell lines. The US has taken the principle of autonomy and applied it so that ‘individual rights’ are prioritised over the interests of science and society. De Vries points out that this is not only an ‘absurd’ stance to take but it is also dangerous as it flaws advancement of NMT on purely ethical grounds, preventing maximal societal benefit (Chattopadhyay and DeVries 2009).

The duty based Chinese bioethical ideals are interwoven with Confucian and Taoist tradition. Naturally the regulations concerning bioethics are younger than that of China’s Western counterparts and consequently legislation is changing rapidly. In a view put forward by Ren Zong, the bioethical issues surrounding genetic medicine technologies have taken a back seat to the scientific advancement within this sector. Regenerative medicine has now become a matter of prestige to the Chinese government; developing a strong knowledge based economy in an attempt to become a country of Nobel-prize excellence (Ren Zong 2010). We are therefore witnessing a rise of international acceptance of bioethical norms through Chinese national policy. This could even be considered a rejection of Confucian ideals and a national decision to adopt Western policy, which agrees with De Vries theory that the West is generating a ‘one-size-fits all’ policy in relation to bioethics; generating a meta-cultural ethical discourse derived from secular Western beliefs (De Vries and Chattopadhyay 2008). This, somewhat brash statement is backed with evidence from the ‘Universal Declaration on Bioethics and Human Rights’ distributed by UNESCO. It emphasises the heavy weighting on Western bioethical norms of deontology and the individual, with the individual having a priority within society.

Reorientation of China

Is China attempting to orientate their genetic policies in accordance with the US and UK? On a national level, this would appear the case. The Chinese MOH has imposed the same 14 day destruction deadline for all embryos used for research purposes as held in the UK and the implementation of genetic counselling for the select hospitals providing PGS is resonant of the approved screening by the UK NSC. Furthermore, China is adhering to informed consent across a wide range of genetic technologies, banning human cloning and prohibiting forms of biological commercialisation (Doring 2004).

Doring, on the other hand highlights the positivist principles held with biomedical regulations in China, summing up the attitude of the scientific community: “if an action is not illegal, by definition it is legal”, this is bioethical adventurism; taking advantage of the fluid social and legal frameworks within China, in order to conduct controversial research (Doring 2004). As scientific policymaking is lagging behind scientific advancement, the frameworks in place are also being abused by overseas scientists, contributing to a surge in research, with academics being attracted to the opportunities of experimental investigation banned in their home countries.

– Somehow evolve this to talk about counselling and the difference between directive and non directive counselling in China and the West. The boundaries between choice and coercion – patient autonomy being experienced by patients and abandonment? Williams paper.

An International agreement?

The international presence of foreign institutes has creating air of acceptability in the regulations of genetic technologies within China. This positive regulatory atmosphere has resulted in the cooperation of the Chinese government, leading them to question the necessity and desirability of genetic regulations and the moral philosophies upon which they should base them (Renzong 2010) .

– Romanticised ideals of Taoism

– Stem cells complying with Taoism – but then countered with ‘against Confucian philosophy’

– idea of community in relation to Confucian ideals has become blurred – Chinese communities are monolithic, natural, local? Difficult to implement into a contemporary society

– Problems with Westen ideals of individual/autonomy central ideals – can easily fail to adapt to societal norms when out of the society it was created in

– The exceptionalism of genetic testing: inherently different from other types of testing: quantify individuality and putting a language to describe the individual. It should therefore be made exceptional and be protected. Due to damaging effects of accurate genetic predictions.

– Genetic illness definition – partial social construction manipulation through the zeitgeist of a community.

– Global market of PGT is causing us to take into account all regulations (recreational genomics editorial)

– “The ESHG states that ‘genetic services should support the identification of relatives who are at risk’ but goes on to qualify that statement with ‘who are at risk of serious genetic disorders’.26 The UK Human Genetics Commission takes amore generalistic view by suggesting that ‘clinics maysupport and indeed encourage the process of family communication and genetic counsellors may give adviceon how such information may be disseminated to those for whom it may be most relevant’.31″

– “Greater medicalisation will lead to pregnancy being considered tentative until the fetus has passed a battery of quality control tests. In time, this could affect the way we view children, abrogating the principle of their acceptance as a gift (of God) and contributing to their being seen more as the product of parental will.”

A Vicar

– idea of causing legitimate targets for abortion with enhanced genetic screening

– Parents with a handicapped child: able to have a second child – possible incentive to circumvent the only child policy?

– concept of quality? china

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