Public health, ethics and reproductive technology: new challenges

Dr Lorna Watson, Consultant in Public Health Medicine NHS Fife,

Hon Senior Lecturer in Public Health University of St Andrews

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Outline

• What are new reproductive technologies?

• Why is this an issue?

• What are the regulatory frameworks?

• What needs reviewed?

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New technologies

Screening gametes from healthy donors Screening healthy couples for recessive conditions Non invasive prenatal testing blood test from mother at 10 weeks- NSC approved evaluative roll out for Down’s, Edwards, Patau Syndrome In other countries, dramatic fall in births What is public health benefit where compatible with a long healthy life?

People with Downs’ Syndrome- ‘we are the canaries in the mine of eugenics’ Frank Stephens to

US Congress #don’t be sorry Saving down’s Don’t screen us out ‘very little support before during and after testing and there is an assumption of termination at

every stage’ ‘

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• World Without Down's Syndrome? Documentary about Down's syndrome and the ethics of pregnancy screening, fronted by Sally

Phillips. This film explores the science and thinking around the proposed new screening test

for Down's syndrome and its possible availability on the NHS.

Driven by the experience of raising her son Olly, who has Down's syndrome, Sally explores

some of the ethical implications of our national screening policy.

By talking to experts in the Down's syndrome community, the world's top scientists and

including people with Down's syndrome in the debate, Sally investigates a thorny subject that

begs questions relevant to us all: what sort of world do we want to live in and who do we want

in it?

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“Down syndrome is not a medical condition but presents a common recognizable variation of the human form created through a random biological event.” Newton 2015

“Over the decade, the global non-invasive prenatal testing (NIPT) has shown a healthy growth. The rise in the global average of maternal age, coupled with the increasing incidence of Down syndrome in newborns, has boosted the market to a significant level” “The global NIPT market stood at US$0.5 bn in 2013. Expanding at a CAGR [Compound Annual Growth Rate] of 17.50% over the period from 2014 to 2022, the market is projected to reach US$2.38 bn by the end of the forecast period.” http://www.transparencymarketresearch. com/noninvasive-prenatal-diagnostics-market

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‘The majority of people with Down’s Syndrome live happy and fulfilling lives, and almost all parents love their children and are proud of their accomplishments. Skotko 2011

Regulatory frameworks (1)

NSC • All the cost-effective primary prevention interventions should have been implemented as far as

practicable.

• There should be an effective intervention for patients identified through screening, with evidence that intervention at a pre-symptomatic phase leads to better outcomes for the screened individual compared with usual care.

• There should be evidence that the complete screening programme (test, diagnostic procedures, treatment/ intervention) is clinically, socially and ethically acceptable to health professionals and the public.

• Clinical management of the condition and patient outcomes should be optimised in all health care providers prior to participation in a screening programme.

• All other options for managing the condition should have been considered (such as improving treatment or providing other services), to ensure that no more cost effective intervention could be introduced or current interventions increased within the resources available.

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Regulatory Framework (2)

Nuffield report 2017: NIPT can change the way we view pregnancy, disability and difference: • May adversely affect disabled people- Use only where the potential wider harms are

minimised : balanced information • tackle discrimination, exclusion and negative social attitudes Restrict to more serious conditions, not sex selection Marketing and use in private sector BMA annual representative meeting 2018: ‘This meeting recognises that the advent of new technologies can bring new ethical challenges to light and; believes that given the advent of NIPT and the potential for whole genome sequencing the time is right for consultation to determine the views of the public and the profession on the need for limits to the scope of NIPT in practice.’

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Regulatory frameworks (3)

CHARTER OF FUNDAMENTAL RIGHTS OF THE EUROPEAN UNION 2012/C 326/02

Article 3 Right to the integrity of the person 1. Everyone has the right to respect for his or her physical and mental integrity. 2. In the fields of medicine and biology, the following must be respected in particular: (a)the free and informed consent of the person concerned, according to the procedures laid down by law; (b)the prohibition of eugenic practices, in particular those aiming at the selection of persons;

UN CRPD 2017 Concluding Observations 2017 UK The lack of consistency across the State party in the understanding of, adapting to and applying the human rights

model of disability and its evolving concept of disability; Equality and non-discrimination (art. 5) 12. The Committee is concerned about perceptions in society that stigmatize persons with disabilities as living a life of

less value than that of others and about the termination of pregnancy at any stage on the basis of fetal impairment.

13. The Committee recommends that the State party amend its abortion law accordingly. Women’s rights to reproductive and sexual autonomy should be respected without legalizing selective abortion on the ground of fetal deficiency.

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Regulatory Frameworks (5)

Reproductive autonomy is having the power to decide and control contraceptive use, pregnancy, and childbearing. For example, women with reproductive autonomy can control whether and when to become pregnant, whether and when to use contraception, which method to use, and whether... to continue a pregnancy.

....look beyond the clinical encounter to identify the financial, familial, cultural, and other pressures limiting people's reproductive options. Indeed, we would go so far as to say that reproductive autonomy cannot exist without attention to context—to supports, to barriers, to social policy, to social norms.

The Hastings Center Cleveland

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Regulatory Frameworks (4)

Equality Act 2010 Background Institutionalised discrimination following Stephen Lawrence Inquiry

1. In carrying out this activity are we sure there is no unlawful discrimination? 2. In carrying out this activity are we advancing equality of opportunity between those who have a protected

characteristic and those who do not? 3. In carrying out this activity are we fostering good relations between persons who share a relevant protected

characteristic and persons who do not share

FPH Equality and Diversity Statement Approved by FPH Board – 16 May 2017 The Faculty of Public Health’s (FPH) mission is to promote and protect the health and wellbeing of everyone in society, and the

vision is ‘Better health for all’. Public Health action is underpinned by codes of professional practice and ethical principles, particularly justice, which are

designed to uphold human rights and human dignity. The FPH endorses the principles (below) identified by UK Academy of Medical Royal Colleges and Faculties with respect to the

Public Sector Equality Duty, which applies to those College or Faculty activities which may be considered ‘public functions’. As the FPH acts in the public interest to promote the public health, it is relevant and good practice to apply these principles to all FPH activity. This includes policy, procedures and standards, education and training, employment and services for members and stakeholders, and procurement of goods, services and facilities.

The FPH is committed to: Integrating PSED requirements into normal management processes rather than as an add-on. Recognising this is a cultural exercise as well as about process and procedure Consistently asking the questions relating to any piece of activity

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Regulatory Framework (5)

Public health ethics principles, Schroder-Back 2014

Non-malificence- increase stigma, negative attitudes

Benificence- preparation

Health maximisation- not quantifiable

Efficiency- not quantifiable

Respect for autonomy- information accurate

Justice- discrimination, stigma, social cohesion

Proportionality- alternative improve lives of those with disability

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Reproductive autonomy

• We have learned that some clinicians and patients do not discuss the fact

that prenatal testing can lead to a decision about whether to terminate a pregnancy—they just don't talk about it.3

• And while the decision whether to agree to prenatal screening and diagnostic testing is to be made with women's free and informed consent, many screening tests have been routinized in such a way that some women do not even recall agreeing to testing, while others feel that agreeing to testing is what their clinicians expect of them or that the testing is necessary to protect themselves and their families from the significant financial hardship of raising a child with a disability.4

• In the face of these pressures, can one really say that women are freely choosing to undergo testing or are freely choosing to continue or terminate a pregnancy following receipt of test results?

Hastings Center

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Public health and eugenics

• Eugenics is a set of beliefs and practices that aims at improving the genetic quality of a human population. The exact definition of eugenics has been a matter of debate since the term was coined by Francis Galton in 1883. Wikipedia

• Public health and eugenics much in common Lancet 1912

• Supporters of human enhancement through genetic and other reproductive technologies claim that the new liberal eugenics, based on science and individual consent differs from the old eugenics which was unscientific and coercive. Supporters claim it is the parent's moral obligation to produce the best children possible. ...The new eugenics, although based on science, continues to pursue the same goal as the old eugenics, the development of a superior individual and the elimination of those considered inferior. Vizcarrondo 2014

• medicine and bioethics have frequently been disrespectful of basic, universal human rights of disabled people. Medicine and bioethics have widely ignored international human rights treaties in their application to disabled people.

Lancet 2008

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Conclusions

Prenatal testing should be subject to Equality impact assessment

Prenatal testing should take account of human rights approaches

NSC criteria should be amended to take account of these

Transparency with respect to conflict of interest and decision making

Future- more complex and difficult ethical questions

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