Body politics: the dilemmas of regulating new technologies
The 3rd annual Philomathia Symposium was held on Friday, 18 November 2016 at Cripps Court, Magdalene College. Three interdisciplinary panels addressed the broad theme: ‘Body politics: the dilemmas of regulating new technologies’. The sessions culminated with a roundtable which considered the policy implications of the research examined in the panels, which was followed by a plenary lecture by Professor Sheila Jasanoff (Harvard Kennedy School). Pre-circulated position papers produced by Philomathia Forum convenors exploring the central themes framed and shaped the day’s conversations and informed much of the discussion.
In his opening remarks, Professor Martin Daunton, Director of the Philomathia Social Sciences Research Programme, emphasized the distinctiveness of social sciences at Cambridge; that is, the University’s ability to link social sciences and STEMM in a way that is unrivalled in the UK.
Session one: Should we change EU law to disallow DNA patents?
Professor Timo Minssen (University of Copenhagen) began the panel discussion with the observation that DNA-related technology has been at the heart of public debate since Watson and Crick announced their discovery of the ‘secret of life’ in Nature in April 1953. Since then, there has been public concern about how DNA is regulated and commercialised which continues to raise social, ethical and religious questions. Coupled with more recent developments around epigenetics, DNA has now been shown to be multi-functional with intergenerational implications, further complicating the debates. For lawyers, the question of whether genetic discoveries (e.g., specific DNA proteins) meet the basic requirements of patentability and whether it is ethical to do so continues to challenge courts around the world.
An international standard was set in 1980 when the US Supreme Court, in a ruling known as ‘Chakrabarty’, determined that any man-made process could be patented which came to include the patenting of DNA sequences. Human intervention was key to patentability; that is, the process had to be removed from natural phenomena. Since then, the rule of ‘human intervention’ has informed other rulings, including the EU BioTech Directive which was adopted in the EU 1998. Despite these precedents, there is little ‘harmonisation’ in laws with many individual European courts differing in their interpretation of the Directive. EU law is distinct from US and Australian law which has, in various Supreme Court decisions, disallowed the patenting of isolated gene sequences. ‘Myriad’ was a 2013 US Supreme court decision which ruled that isolated DNA sequences could not be patented – thus overturning ‘Chakrabarty’. The Australian Supreme Court came to a similar decision as the US when they ruled that there is limited scope for the patentability of DNA, excluding patents around biomarkers and genomic information. In a move toward alignment with other countries, EU law has determined that patents cannot simply isolate sequences, but must show a patentable intervention with ‘real world use’.
Professor Minssen proposed four questions to the rest of the panel:
- Should isolated DNA sequences be patentable?
- What are the international effects of the decisions from the US and Australia?
- How have these decisions influenced policy debates in the EU?
- Is there a need for reform in the EU to come into alignment with the US and Australia?
Strictly-coded legal regulation can limit innovation, however. Minssen argues that the strict interpretation of patentability can create an atmosphere of secrecy in the DNA sciences thus limiting future developments. He advocates a ‘push and pull mechanism’ to complement and respond the current system which would, in turn, support diagnostic inventions and biomedical innovation. He added that patent law can be seen as a ‘tool’ and concluded that further conversations and better empirical data could align approaches to the issue of patentability around the world thus incentivising innovation within a coherent legal framework.
In contrast to Professor Minssen, Dr John Liddicoat (Philomathia Fellow, Law) argued for better EU alignment with the US and Australian decisions (which has disallowed the patenting of gene sequences) on the basis of two practicalities: 1) they are not needed for the development of drugs; 2) they are not needed for the advancement of diagnostic tests. He contends that there is a ‘fundamental problem’ with drawing fences around innovation in that we can only know if a patent has been violated after the fact.
Dr Liddicoat argued that whilst the patenting of these sequences has not negatively affected research, it is has not had a positive effect either. His research suggests that biotech companies developing diagnostic tests have not needed patents to innovate with the development of new tests steaming ahead as usual. He adds that while blanket bans are not useful, political capital would be needed to change EU law. Could Brexit, he asked, be an opportunity to exclude DNA patents? He ended by suggesting that a unified patent court with consistent laws in the 25 member states could go some way in harmonising legal approaches to the issue.
Professor Mateo Aboy (Oregon Institute of Technology) began with the observation that experienced judges and lawyers have reached different decisions on the issue of isolated DNA sequences interpreting the same legal language. Advocating an empirical approach to the issue, he proposed assessing to what extent the ‘Myriad’ decision affected patents and biotech developments. The 2013 US Supreme Court decision invalidated Myriad Genetics’ patents on the isolated genes BRCA 1 and BRCA 2. Simply put, isolating genes was no longer sufficient to show ‘invention’ in an otherwise natural process. Aboy argues that both gene-related and biomarker patents went up following the 2013 decision and that the proposed negative impact of the decision has not, in fact, fully materialised.
Looking at the evidence, Aboy posited that the number of gene-related patents has declined, but that the decrease began well before the ‘Myriad’ decision. Applications for gene-related patents were being rejected as the ‘invention’ step was already a criterion for patenting. The 2013 decision could be understood as the codification of a system that was already ‘self-correcting’.
The discussion following the talks addressed several key themes. Dr Kathy Liddell (Philomathia PI in Law) asked whether there could have been better harmonisation in laws relating to gene-related patents if these legal decisions had been made in 2000 or earlier. She also wondered what happened to the women who could not get BRCA 1 testing in the decades it took to change the law? Professor Minssen responded that there was a realisation in the 1990s that patenting isolated gene sequences had become too easy and that something had to be done to correct the system. Dr Ron Zimmern (Chairman, PHG Foundation) asked whether research relating to the practical applications of laws should take higher precedence? Dr Liddicoat added that the law could augment research by forcing companies to be explicit about the function of diagnostic tests. Professor Minssen believed, however, that this could open up a ‘new battlefield’ around trade secrecy. Yet, Liddicoat noted that patents are not enforced when used for research purposes as there is no profit to be gained. The discussion ended with observations around the governance of technological change and its relationship to the recent political turn in which the public appears to have lost trust in experts. How should lawyers respond to these broader issues around public trust especially when it comes to this most sensitive of information – DNA?
Session two: Reproduction in an era of bio-tech revolution
Professor Sarah Franklin (Philomathia PI, Sociology and Director, ReproSoc) opened the panel with the observation that the fertility sector is the opposite of the DNA patenting system in that there is very little regulation. If there were regulation in the sector, she asked, who would have the authority and how would they be implemented?
Dr Nitzan Peri-Rotem (Philomathia Fellow, Sociology) began her talk by noting that Assisted Reproductive Technology (ART) has developed in parallel with a change in fertility patterns. Many factors have contributed to a decline in fertility including delay of first union, rising age at first birth and declining union stability – all leading to higher incidences of involuntary childlessness. She added that the WHO has recently added infertility to its list of global health issues as it can cause increased levels of stress and depression with far-reaching negative effects on relationships and overall well-being. Dr Peri-Rotem estimates that 1 in 7 UK couples are infertile.
ART is a medical solution to infertility. It refers to a ‘family of technologies’ which includes egg freezing and IVF. The spread of ART has been impressive with nearly six million children born as a result of the technologies. Dr Peri-Rotem asked, ultimately, ‘can ART overcome age-related infertility?’ Indeed, she argues that it is ‘far from a perfect solution’. Many factors make the successful implementation of ART difficult, including high costs, legal regulations in certain countries and religious restrictions. In practice, Dr Peri-Rotem argued that this means ART ‘can only partially compensate’ for the decline in fertility due to age. To overcome these challenges, she advocated better research to inform policy. She suggested we address the following:
- A better understanding of why people delay childbearing;
- Improve conditions that support early family planning (e.g., better childcare, family-friendly work policies);
- Increase the recognition and acceptance of different families and lifestyles including same-sex couples, adoptive families and childless couples.
Professor Arne Sunde (Norwegian University of Science & Technology) offered a different understanding of ART; that is, the economic and business trends behind the technology. Professor Sunde began his presentation noting that just ten years ago ART was an emerging sector. Today the sector is worth $11 billion and is considered safe with good, constant growth. The ART sector attracts investments from banks, pension funds and venture capitalists as it is considered a solid investment. In the last ten years, large companies have come to dominate the sector. For example, LG owns many fertility clinics in Asia and has plans to expand further. Large chains of clinics with strong corporate backing are becoming more common as smaller, practitioner-led clinics have lost market share. In parallel to these trends, ART practitioners want to be on the cutting edge to attract the most patients/customers leading to the marketing of questionable techniques. These techniques may be innovative, but are they better? Will they lead to better outcomes? It often doesn’t matter as companies are keen to sell techniques, even if little documentation is available, and patients are willing to try them.
What does the future hold for the business end of ART? Professor Sunde posited that small, independent clinics will continue to decline as large, integrated companies offering the ‘total package’ (e.g., drugs and treatment together) will come to dominate the market. He noted that ART is an ‘industrial service’, not a health sector, with patients often left unprotected by false claims.
Sarah Norcross (Director, Progress Educational Trust) took the audience on a trip through the ‘Fertility Show’ – an event held in November at London Olympia. The show promises to offer women all that they need for their ‘fertility journey’ – more like a ‘fertility rollercoaster’, Norcross quipped. She put it simply, this show and the technologies it promotes ‘sells promises to women’. She showed photos and clips of the services available – ranging from dietary supplements to questionable methods – all using the guise of science to sell the services. Norcross’ satirical presentation ended with the note that the women who attended the Fertility Show are desperate and the fertility industry is all too interested in taking advantage of this desperation. Too little regulation, she argued, has given these women too much choice and that ART should not be a ‘free for all’.
The discussion that followed the three talks was wide-ranging. One delegate asked whether ART had become divorced from the underlying natural process? Norcross responded that ART has many parallels with cosmetic surgery. Many people want the technology, but the question is whether they should have it and whether better regulation is needed? Professor Sunde argued that UK regulation is robust and does provide consumer protection to balance out the commercial side of the sector. Professor Sunde added that patients want to know if they are going to be successful, but no practitioner can guarantee this. What doctors can offer is new technologies and procedures. It is important to balance this with education so that patients are able to see through any ‘biased information’. Norcross suggested that patients want to believe that they will be successful and not hear the negatives (e.g., that a new technology may have little effect) – ‘If there’s a chance, I’ll give it a go’ is an often heard phrase in fertility clinics. These ‘variations on snake oil’, in the words of Sally Cheshire (Chair, Human Fertilisation & Embryology Authority), can be a challenge to those in the field of regulation. Norcross wondered if better state funding for ART would, in turn, regulate the industry as 60% of people pay privately for fertility treatment. Dr Lucy van der Wiel (ReproSoc) asked whether clinics should have a role in educating patients. Professor Sunde responded that all companies are rational, so if there is a demand for transparency then they are likely to deliver.
Session three: The regulation of transplanting suboptimal organs
Dr Kathy Liddell opened the panel by tracing the lineage of a new research group comprised of lawyers, scientists and surgeons which, interestingly, formed on the back of conversations in College. The group has been able to think in new ways about the intersection of their respective disciplines and have been able to take advantage of a particular ‘policy moment’ for these sorts of questions.
Echoing Dr Liddell’s sentiments, Mr Kourosh Saeb-Parsy (Department of Surgery, Cambridge) admitted that prior to this unique collaboration he had had very little experience with the legal and ethical implications of his clinical work. The group has provided him an opportunity to consider the broader societal issues around the difficult decisions he makes every day.
Mr Saeb-Parsy painted a sobering picture of the state of organ transplantation in the UK. A dearth of good organs means approx. 1000-1300 people die on organ waiting lists every year or become too sick for a transplant. While transplantation can save lives, the quality of organs varies greatly. The surgeon must assess the suitability of the recipient with the organ allocated through a multi-stage process. Computer-generated algorithms are able to identify suitability and assign a risk factor which the patient must carefully consider in consultation with the surgeon. None of these are ‘exact sciences’, however, and clinics may vary in which organs they accept or decline.
A November 2013 tragedy highlighted the potential complications of using sub-optimal organs. A kidney donor had a rare brain inflammation infection unbeknownst to surgeons and the retrieval and testing teams. Whilst the kidneys had been rejected by two clinics, they were eventually accepted by a third clinic and transplanted into two men. Sadly both of the men died from the brain infection shortly after the transplant. Whilst these tragedies are rare, co-morbidities such as cancer, smoking, alcohol, diabetes and high donor age mean most organs fall on ‘the spectrum of sub-optimality’. Organs, he argues, are always ‘second hand’ with sub-optimality considered the norm rather than the exception.
Dr Matt Dyson (Faculty of Law, Oxford) weighed the legal implications of tort law in the field of organ transplantation. Tort law is a recourse for those who have been wronged, but the threshold has been low for doctors and the law is rarely applied. Tort law allows for a victim to be vindicated and compensated which incentivises ‘finding the truth’. Historically doctors have been protected against negligence claims by patient consent.
The law of product liability is an alternative to tort which suggests that the manufacturer of a product is liable for a product’s defectiveness. What is a considered a product, however? While blood has been determined to be a product, would a defective organ be considered so? Questions about who ‘produces’ an organ, when it would be considered defective and who is to be held responsible can arise. It is difficult to legally ascertain what a person is entitled to expect in a field with many uncertainties and few guarantees.
As both a consultant and an ethicist, Dr Antonia Cronin (Consultant Nephrologist, King’s College, London) argued that the thinking around sub-optimal organs has evolved to adapt to the many challenges and risks involved. In some ways, she suggests, ‘transplantation is a victim of its success’.
Following a series of tragedies related to organ transplantation in the 2000s, politicians pushed for an opt-out system which resulted in a 31% increase in transplants. However, the organs received were far more likely to be sub-optimal. Whilst more transplants were taking place, there was no increase in transplants from ‘ideal donors’. Dr Cronin argued that surgeons have been forthright about the risks of sub-optimality, but ethical challenges remain. She called for ‘pragmatic solutions’ such as optimisation techniques in vivo and laws which deem consent – both of which could increase the number of transplants but also their chance of success.
With the panel discussion opened to the floor, the conversation turned to the legal and ethical implications of sub-optimality. One delegate asked whether better information around risks would minimise the potential for litigation. Mr Saeb-Parsy advocated for better data that may more accurately predict outcomes. Even the best algorithms are only ever able to measure risk at the population level which then must be balanced with a recipient’s unique situation. These conversations, he added, happen under ‘emotive circumstances’ (e.g., the patient having been rung up in the middle of the night after years on a waiting list) further complicating the balance of risk and outcome. Dr Cronin advocated for better, more nuanced algorithms so that surgeons can face patients ‘armed with information’.
Session four: Policy roundtable
The policy roundtable was chaired by Dr Rob Doubleday (Executive Director, Centre for Science and Policy) who welcomed the four contributors: Sir Roy Calne (Emeritus Professor of Surgery, Cambridge), Professor Michael Parker (Director, Ethox Centre, Oxford), Sally Cheshire (Chair, Human Fertilisation and Embryology Authority) and George Freeman MP (Chair, Prime Minister’s Policy Board and MP for mid-Norfolk).
Each of the contributors gave a five minute talk to begin the discussion. Sir Roy Calne argued that there is an ‘unhinged link between human nature and advances in science’ as ‘humans are curious’ but nature is unchanging. ‘Science cannot be unlearned’, he suggested, ‘and there’s no delete button’.
Professor Michael Parker argued that advances in science and medicine require us to think anew about ethics and for the complexities of new technologies to be taken seriously. He sees policy as a means of supporting people in their work and contended that ‘twentieth-century ethics are no longer fit for purpose’. He called for a new ethical framework that is able to respond to the day-to-day issues around practice. Scientists care about moral problems, he concluded, but they need a coherent policy structure around them that is able to respond to innovation.
Sally Cheshire described the role of the HFEA as a ‘monitor’ of scientific developments. The organisation must consider when a new development is suitable to move into treatment and is tasked with balancing scientific innovation with safety and effectiveness. The HFEA must come to a democratic consensus about what is likely to work well in a way that allows innovation to flourish whilst also protecting people.
George Freeman MP called for a better dialogue between industry, ethics and government. He believes that the UK can become a global leader in twenty-first century bioethics, but we must first ‘get the discourse right’ or good research could risk falling on deaf ears. He suggested that battlefields could continue if no global framework is put into place that balances innovation with safety and rights. He concluded that the UK could be poised to ‘write the playbook’ on these issues.
The broader discussion began with Professor Franklin asking whether ‘British pragmatism’ – regarded by Professor Mary Warnock as the practical basis of ethics in the UK – could itself be considered an ethical system. Mr Freeman responded that parliament has a tendency to avoid difficult questions and while Warnock’s model was well-informed, our frameworks must evolve and adapt to reflect contemporary circumstances. Professor Parker added that we need new language to work through these practical issues and new ethical thinking to accommodate new technologies and developments.
The discussion then turned to methods, technologies and the unintended consequences of algorithms. Professor Parker said that algorithms pose significant ethical issues. Using the example of driverless cars, he asked who would have the duty of care if there was crash – would it be mathematicians, the developers? Professor Andy Hopper (Head, Computer Laboratory) posed a practical question to the panel. As a professor of computer science, he has watched as methods developed in his lab have been used for ill, citing the example of algorithms employed to generate fake news and click bait stories. He asked whether there could be an ethical framework for algorithms. Sally Cheshire advocated for better ethical education at all levels.
Professor Hopper responded that, despite decades of ethics training, he has been surprised by the ‘unexpected results of automation’. Mr Freeman cautioned against urgent legislation as it is likely to skirt big questions in favour of quick results.
A final question around informed consent was posed to the panel. The delegate wondered whether the ‘fine print’ of Terms and Conditions incentivises people not to know or care about their rights. Mr Freeman countered that companies like google want to ask these questions because they want to avoid any potential backlash. Professor Parker agreed but emphasised that we place too much weight on consent when the focus should be on protecting the ‘half-consented’ person. Sally Cheshire concluded that people are only likely to care once harm is done, but that there is education needed to alert people of these harms in advance.
Professor Sheila Jasanoff (Pforzheimer Professor of Science and Technology Studies, Harvard Kennedy School of Government) began her keynote lecture by emphasizing ‘the value of carrying on work as usual’ despite recent political events and that the Symposium was an opportunity to consider how we can continue these conversations.
New technologies, she began, have come together to form a ‘collective frontier’ which poses threats to the current regulatory apparatus. NBIC – that is, the collective acronym for nanotechnology, biotechnology, information technology and cognitive science – has become all-encompassing and uncontainable. This ‘Anthropocene moment’, she argued, has taken hold and should give us pause to re-consider the definition of nature and culture.
Citing the proliferation of ‘markers’ such as fingerprints, Professor Jasanoff argued that we have ‘reached a splitting of the human subject’ whereby humans have become a composite ‘wafting through cultural space’. Humans are now a combination of a physical and digital self – a ‘genomic human’. The capability of cell lines, data banks and google searches to save, collate and examine the data we have provided has added a permanence to the human record heretofore unimaginable. Ethically, we are left with ‘conflicting states of parallel selves’ and unresolved ethical enquiries.
Whilst representations of the human have evolved, who will imagine human entitlements and with what resources, she asked. Each domain around the human body will raise its own set of issues and practices as the human body is affected by a ‘thick’ set of emotive and ethnographic questions and practices.
She posed a set of constitutional questions:
- What are the definitions and boundaries of the ‘human’ – beginnings and ends of life, human vs non-human;
- Ontological questions – how do we classify these moments?
- What is the nature of the resulting entitlements?
Practically, should human life be considered common property? She pointed to decisions in Iceland, Spain and the US – all differing in their interpretation of laws around consent, privacy and limitations. She noted that the UK and the US have diverged on the issue of data and privacy. The UK has favoured a ‘right to be forgotten’ framework whilst the US has determined that big data is necessary, but privacy limits must be considered.
Problems around property such as IP or cell lines have become contested sites of regulation. She cited the emergence of ‘data oligarchs’, the politics of biotech advancement and ownership and international disharmony caused by alternative interpretations of legal frameworks.
Whilst law and science, she contends, are no longer on the same page, what is a reasonable expectation of policy today? She points to a recent decision by the US Supreme Court which ruled that a cell phone could be considered a part of the body and therefore should not be subject to warrantless searches. This vision of the ‘hybridised human’ asks whether technologies are integral to the human body and self. American presidents have varied in their interpretation of bioethics. For example, George W. Bush ‘repeatedly drew lines’ between life and not-life especially with regard to human embryos whilst Barack Obama has approached decisions like these with more nuance.
Ultimately, she asked, who should be making these decisions? What if there are disagreements? Whose responsibility is it to inform citizens in the digital age?
Dr Poornima Paidipaty (Philomathia Fellow, History) began the Q&A with a question about the legal case of the children of the disappeared in Chile. The state, she described, had decided that they could not compel these individuals to provide DNA to determine their parentage, but shed DNA like hair could be used for these purposes. Professor Jasanoff responded that the law does ‘a good job’ already and we should looks to practices within forensic and family law. There are places to begin but ‘morality can be complicated’.
Lord Martin Rees wondered whether global regulations are possible in light of commercial pressures and techniques that challenge current frameworks. Professor Jasanoff countered that while global regulations may be impossible, ‘global norms’ are achievable. Scientific practice, she argued, ‘can be codified’ so that ideas will one day converge with results.
Mr Freeman queried the extent to which developments around epigenetics oblige us to consider the effects of our actions on future generations (e.g., the effect of smoking on DNA health). Professor Jasanoff believes we are in a ‘dangerous period’, but that there are good examples of ‘normative coercion’ which can create harmonisation in approach to these issues.
Dr Liddell had a practical question for Professor Jasanoff; specifically, how are we to know when it is right to challenge something or be pragmatic? How do we evaluate a good policy? Professor Jasanoff encouraged sceptical thinking and rejected the notion that we should be policymaking the ‘things of the moment’. Yet, she cautioned against giving up and cited the old adage, ‘If I give up, the fate of my endeavours are certain’.
Several key themes and policy points emerged over the course of the day’s discussions.
- What are the risks of legal disharmonies? Should courts align their decisions to achieve harmony? Could this provide the basis for global legal frameworks?
- Twentieth-century ethics is no longer fit for purpose. We need a new language and policy structure to respond to the swift development of new technologies.
- Good practice can be a means of establishing global norms and thus regulation.
- Balancing change and pragmatism in the current political atmosphere will remain an ethical challenge.