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Diagnosis lies at the heart of the medical encounter, yet it has received much less attention than treatment. It is widely assumed that negligent diagnosis claims should be governed by the Bolam test, but we demonstrate that this is not always the case. First, we disaggregate the diagnostic process into three different acts: forming the diagnosis, communicating it to the patient, and recording it. Second, we consider alternatives to Bolam for defining negligence, including less deferential profession-led standards, patient-led standards, and even a reasonable person standard. Third, bringing together these distinctions—within the diagnostic process, and between standards of care—we reveal the unappreciated complexity of negligent diagnosis. Analysing the standard of care that might apply to the three different acts in the diagnostic process, we identify reasons to think that Montgomery should apply to the communication of a diagnosis. We also argue that even in areas where the law is well-established, such as the application of Bolam to the formation of a diagnosis, challenging questions arise that require further attention. Throughout, the framework and analysis that we develop have significant implications for a set of negligence cases, as well as for medical education, clinical guidelines, and patient care.

RATIONALE, AIMS AND OBJECTIVES Six years ago, the Supreme Court judgement in Montgomery v Lanarkshire changed medical law. It introduced a new patient-based standard of care for the communication of treatment risks and alternatives, rejecting the doctor-based standard that had long governed all aspects of medical negligence. This is the first systematic review to analyse the literature on Montgomery. Our aim is to appraise and synthesize the literature on Montgomery's impact on medicine and the law and to identify areas for further academic enquiry and implications for professional guidance and training. METHODS Searches were run in Medline, Embase, PsycINFO, Web of Science, Scopus, Westlaw UK, HeinOnline, and LexisNexis. Two reviewers screened papers. Extracted data was analysed and discussed by an interdisciplinary team. PRISMA guidelines were followed. RESULTS Of the 1134 papers identified, 100 met the inclusion criteria. These papers revealed significant disagreement on four core sets of issues, focusing on Montgomery's impact on: (1) legal and professional duties; (2) medical practice; (3) the patient experience; and (4) litigation. The first set addresses whether the case actually changed doctors' legal and professional duties, the relationship between GMC guidance and medical law, and the boundaries of Montgomery. The second explores whether the decision has incentivized defensive medicine, its resource implications, and doctors' knowledge of it. The third concerns whether and how the decision has promoted patient autonomy and involvement in their own care. The fourth focuses on whether the case has caused an increase in litigation. CONCLUSIONS Despite the abundance of legal and medical literature on Montgomery, many issues remain unresolved. Empirical research is required for many of the questions. Doctrinal analysis informed by medical knowledge is also required to assess whether Montgomery may have unrecognized ramifications-for example, whether it will require the disclosure of risks associated with diagnostic uncertainty, where doctors advise patients without performing procedures.

Drug repurposing is a strategy for identifying new uses for approved or investigational drugs that are outside the scope of the original medical indications.[1] Finding new therapeutic uses for existing medicines holds significant potential, since it is often faster to develop a drug for a new use if it is already known to be safe and well tolerated by the human body. Repurposing de-risked compounds with previously known therapeutic effects is also an attractive drug development strategy because it can potentially result in lower overall drug development costs and shorter timelines to market introduction.[2] If successful, the public at large benefits from the repurposing of “old” drugs (known products) to treat more common and rare diseases. An ongoing debate surrounding pharmaceutic repurposing is whether the current intellectual property (IP) regime, particularly with regards to the patent protection for medical uses of known compounds and substances, may be hindering repurposing activity. This debate is taking place on both sides of the Atlantic.[3,4] Commentators often argue that the patent system is failing to provide adequate incentives to promote innovation in the field of drug repurposing— medical use patents, they allege, are too difficult to obtain.[5]

Commentators claim that drug repositioning (ie developing new uses for authorised drugs) significantly slows when generics are authorised and, therefore, law reform is necessary to encourage more R&D. This study empirically examines this claim by analysing records of clinical trials. It finds that once generics are authorised: i) commercial trials continue at ‘active’ rates for approximately half of the drugs studied, and ii) the number of hospital and university trials actually increases. These findings cast doubt on whether additional incentives are needed. They also indicate that a more effective way to reposition drugs is for recently established government programmes to embrace IP strategies and leverage the hospital and university trials as an R&D pipeline.Keywords: drug repositioning, patent law, regulatory protection, clinical trials, empirical study, generic drugs.

Most countries active in pharmaceutical innovation provide some sort of patent protection for new medical uses of known products. This provides market exclusivity, for example, when investigators find a new, non- obvious medical indication for a drug previously patented as a new, non-obvious molecule. Yet, despite clear policy importance of developing new treatments quickly and cheaply, surprisingly little is known about the scale and impact of these patents. Without more information, it is perilous for judges, policymakers and patent offices to presume they can propose or interpret rules on the validity and infringement of patents for new medical uses with reasonable chances of desirable social outcomes. How sought-after are new medical use patents? Is their popularity waxing or waning? Who is benefitting from this government- granted market protection? What types of claims are being used to protect these inventions? Is it true that serious disadvantages would follow if such patents were harder to obtain or to enforce? Should they be easier to obtain and enforce? Who will be the winners and losers if rules on acquisition and infringement are adjusted?

This article answers two questions from the perspective of United Kingdom law and policy: (i) is health information property? and (ii) should it be? We argue that special features of health information make it unsuitable for conferral of property rights without an extensive system of data-specific rules, like those that govern intellectual property. Additionally, we argue that even if an extensive set of rules were developed, the advantages of a property framework to govern health information would be slight: propertization is unlikely to enhance patient self-determination, increase market efficiency, provide patients a foothold in the data economy, clarify legal uses of information, or encourage data-driven innovation. The better approach is to rely less, not more, on property. We recommend a regulatory model with four signature features: (i) substantial protection for personal health data similar to the GDPR with transparent limits on how, when, and by whom patient data can be accessed, used, and transmitted; (ii) input from relevant stakeholders; (iii) interoperability; and (iv) greater research into a health-data service, rather than goods, model.

On the first anniversary of Vanda, 1) to what extent have legal arguments and claim amendments based on Vanda been effective in overcoming 35 USC 101 Mayo-based rejections?; and 2) How are applicants transforming diagnostic patent claims into method of treatment claims to overcome Mayo-based subject matter eligibility rejections?

Standard contractual clauses (SCCs) have long been considered the most accessible method to transfer personal data legally across borders. In July 2020, the Court of Justice of the European Union (CJEU) in Data Protection Commissioner v Facebook Ireland Limited, Maximillian Schrems (Schrems II) placed heavy conditions on their use. The Schrems II Court found that SCCs were valid as ‘appropriate safeguards’ for data transfers from EU entities to others outside the EU/EEA as long as unspecified ‘supplementary measures’ were in place to compensate for the lack of data protection in the third country. Data protection officers are under intense pressure to explain these measures and allow routine transfers to continue. Some authorities interpret the decision as preventing the use of SCCs to transfer personal data outside of the EU because private contracts cannot comprehensively redress gaps in national law. This article argues that these authorities are mistaken and that notwithstanding Schrems II SCCs can still be useful instruments for cross-border transfers. This is especially true in highly regulated contexts such as medical research. This paper traces the history of SCCs under the General Data Protection Regulation (GDPR) and shows how the CJEU in Schrems II misunderstood the purpose of SCCs and other Article 46 GDPR ‘appropriate safeguards’. The CJEU mistakenly approached Article 46 safeguards such as SCCs as being similar to country-specific adequacy rulings under Article 45 GDPR. But unlike Article 45 adequacy rulings, SCCs were not intended to provide a stand-alone mechanism for transfer reliant on the law of the importing country. Rather SCCs provide an alternative, multi-layered standard for data protection that encompasses law, technology and organizational commitments. Their purpose is to be used in situations where legislation alone is insufficient to protect data subject rights. The European Commission’s new draft SCCs support this analysis.

This article investigates the lawfulness of isolating residents of care and group homes during the COVID-19 pandemic. Many residents are mobile, and their freedom to move is a central ethical tenet and human right. It is not however an absolute right and trade-offs between autonomy, liberty and health need to be made since COVID-19 is highly infectious and poses serious risks of critical illness and death. People living in care and group homes may be particularly vulnerable because recommended hygiene practices are difficult for them and many residents are elderly, and/or have co-morbidities. In some circumstances, the trade-offs can be made easily with the agreement of the resident and for short periods of time. However challenging cases arise, in particular for residents and occupants with dementia who 'wander', meaning they have a strong need to walk, sometimes due to agitation, as may also be the case for some people with developmental disability (e.g. autism), or as a consequence of mental illness. This article addresses three central questions: (1) in what circumstances is it lawful to isolate residents of social care homes to prevent transmission of COVID-19, in particular where the resident has a strong compulsion to walk and will not, or cannot, remain still and isolated? (2) what types of strategies are lawful to curtail walking and achieve isolation and social distancing? (3) is law reform required to ensure any action to restrict freedoms is lawful and not excessive? These questions emerged during the first wave of the COVID-19 pandemic and are still relevant. Although focussed on COVID-19, the results are also relevant to other future outbreaks of infectious diseases in care and group homes. Likewise, while we concentrate on the law in England and Wales, the analysis and implications have international significance.

In Europe, drugs that are shown to have new therapeutic indications can receive additional market protection. This study analyses all instances this extra protection was awarded up until the end of 2020. This study pioneers a method to analyse what type of new indications receive the extra protection and shows that it was awarded for treating new patient cohorts as often as new medical conditions. No evidence supports granting extra protection for new patient cohorts. Therefore, this paper argues to pare back the circumstances the extra protection is awarded.

Funder: University of Cambridge, EU law incentivises drug marketing authorisation holders (MAHs) to find new uses for their compounds (research known as “repositioning”) by offering them an extra year of market protection if the new use is authorised. This extra year, known as the “+1”, was enacted on limited evidence, and no study has examined its effect since it began. Yet, several leading commentators suggest lengthening the +1. This study assesses the effectiveness of the +1 by analysing all the relevant instances of MAHs repositioning their drugs before and after the +1 came into effect. The results show that: (i) 42.2% of MAHs repositioned their drugs before the +1 came into effect, and (ii) once the +1 did come into effect, it did not increase the percentage of MAHs that repositioned their drugs. This study finds that the +1 failed to increase repositioning and then proceeds to consider reform options, including repealing the law. In doing so, this study takes the first steps towards an evidence-based policy for the topic.

There is an urgent need for an ethical framework to help us address the local and national challenges that we face as clinicians during the COVID-19 pandemic. We propose four key commitments from which a practical and consistent ethical approach can be derived. These commitments are to articulate the needs, rights and interests of the different stakeholders affected by any policy; to be accountable and transparent, recognising that people are autonomous individuals with values and concerns of their own; to consider the impact of our actions on the sustainability of the NHS, infrastructure, service demands and staff welfare; and to treat everybody equitably, with all deserving of consideration and care. Implementing these commitments will require a number of specific actions. We must put in place frameworks enabling clear advocacy for each competing objective; communicate policy and practice effectively to the public; promote integration of decision-making among social, primary, secondary and tertiary care and reduce or stop unnecessary or inefficient interventions; minimise health inequalities; and build spare capacity into the system. In this article, we expand on these actions, and note the legal context in which this would be delivered.

Biobanks are repositories that collect, store and distribute large quantities of biological samples and associated data (collectively called biobank `material'). Although biobanks have different modes of operation, all face a variety of similar challenges. Some of these challenges, such as donor consent and privacy, have been rigorously debated, but comparatively less attention has been paid to biobanks' intellectual property (IP) practices. IP rights (particularly patents) are integral to the translation of research into clinically relevant outcomes and, therefore, are key features in the business models of many biobanks. As a foundation for such research, commentators have identified five IP clauses of interest: (i) non-obstruction clauses; (ii) march-in clauses; (iii) grant-back clauses; (iv) return-of-results clauses and (v) reach-through clauses (also commonly called `reach-through rights'). In the limited literature that discusses the five clauses, commentators have largely debated their advantages and disadvantages in the abstract. The IP terms that biobanks actually use have not been empirically examined, apart from some small case studies. In particular, no industry-wide evidence exists on three points of biobanks' IP practice: (i) if and how biobanks implement these five types of IP clauses, (ii) whether any norms or standards have emerged, and (iii) whether the norms and standards align with commentators' recommendations for using the five IP clauses. To address these three gaps, the authors conducted a systematic, global survey of the IP clauses used by large, human biobanks. The results indicate that biobanks draft bespoke policies to meet their own needs, and probably do so without knowledge of the gamut of IP terms available. This study also revealed that, in general, biobanks are using IP terms differently from the advice of the commentators. On reviewing the differences, we encourage the use of march-in and grant-back clauses, discourage biobanks from using redundant non-obstruction clauses, and call for more research on return-of-results clauses. We also encourage the use of reach-through clauses to claim royalties (not IP), but only in limited circumstances; for example, where user access fees do not cover a biobanks' operational costs.

"The COVID-19 pandemic has taught us the terrible cost of being unprepared for global health emergencies. The lack of treatments, vaccines, and sufficiently coordinated responses resulted in many unprecedented challenges that must now be analyzed and tackled rapidly. The crisis has raised awareness of the urgent need to improve the design of health systems, as well as the practical implementation of new strategies and technical solutions to better prepare for future pandemics. These preparations must also consider harms secondary to the pandemic, including the resulting effects on antimicrobial resistance (AMR). While drug-resistant infections pose a well-known and severe threat to human and animal health, the COVID-19 pandemic is compounding this already problematic situation. Although often considered only a medical problem, antimicrobial resistance is an evolutionary challenge accelerated by social, cultural and economic factors that lead to the misuse, overuse and abuse of life-saving antimicrobial medicines. The antimicrobial resistance challenge is compounded by inadequate attention to disease prevention and response, global circulation of people and products, differences in industry and market regulations across countries, and a fragile pipeline of new antibiotics and their alternatives. While the discovery of new antimicrobials will provide temporary solutions, sustainable success requires rigorous social science research that explores the drivers of antimicrobial resistance. These solutions should promote balance between equitable access to, conservation of, and innovation for antimicrobials, adapted to local conditions across the globe. To encourage collaboration and to address this challenge, we have created the International Network for Antimicrobial Resistance Social Science (INAMRSS).12 The network is an open consortium of social science researchers focused on addressing the global challenge of antimicrobial resistance. We believe antimicrobial resistance is only surmountable through efforts that consider social, political and economic factors. We intend to champion social science as part of a broadly defined One Health perspective to inform global initiatives. INAMRSS is a member of the Global AMR R&D Hub stakeholder group, which has built a system to track antimicrobial resistance research investment, but has not yet started monitoring relevant social science research funding. We endorse the recommendation of the United Nations Interagency Coordination Group on Antimicrobial Resistance for creating an Independent Panel on Evidence for Action against such resistance, with appropriate expertise across disciplines including the social sciences, and with a focus on the ways that humans are driving this problem and can contribute to solutions" (Less)

Standard contractual clauses (SCCs) have long been considered the most accessible method to transfer personal data legally across borders. In July 2020, the Court of Justice of the European Union (CJEU) in Data Protection Commissioner v Facebook Ireland Limited, Maximillian Schrems (Schrems II) placed heavy conditions on their use. The Schrems II Court found that SCCs were valid as ‘appropriate safeguards’ for data transfers from EU entities to others outside the EU/EEA as long as unspecified ‘supplementary measures’ were in place to compensate for the lack of data protection in the third country. Data protection officers are under intense pressure to explain these measures and allow routine transfers to continue. Some authorities interpret the decision as preventing the use of SCCs to transfer personal data outside of the EU because private contracts cannot comprehensively redress gaps in national law. This article argues that these authorities are mistaken and that notwithstanding Schrems II SCCs can still be useful instruments for cross-border transfers. This is especially true in highly regulated contexts such as medical research. This paper traces the history of SCCs under the General Data Protection Regulation (GDPR) and shows how the CJEU in Schrems II misunderstood the purpose of SCCs and other Article 46 GDPR ‘appropriate safeguards’. The CJEU mistakenly approached Article 46 safeguards such as SCCs as being similar to country-specific adequacy rulings under Article 45 GDPR. But unlike Article 45 adequacy rulings, SCCs were not intended to provide a stand-alone mechanism for transfer reliant on the law of the importing country. Rather SCCs provide an alternative, multi-layered standard for data protection that encompasses law, technology and organizational commitments. Their purpose is to be used in situations where legislation alone is insufficient to protect data subject rights. The European Commission’s new draft SCCs support this analysis.

COVID-19 is a highly contagious infection with no proven treatment. Approximately 2.5% of patients need mechanical ventilation while their body fights the infection.1 Once COVID-19 patients reach the point of critical illness where ventilation is necessary, they tend to deteriorate quickly. During the pandemic, patients with other conditions may also present at the hospital needing emergency ventilation. But ventilation of a COVID-19 patient can last for 2–3 weeks. Accordingly, if all ventilators are in use, there will not be time for patients to ‘queue up’ to wait for those who arrived earlier to recover. Those who need a ventilator will die if they do not receive access to one quickly. Many nations now face the prospect that they failed to prepare appropriately for this foreseen risk of pandemic (another issue worthy of legal analysis) and that their populations will need far more ventilators than the health service can supply. For many weeks, the UK has been anticipating a surge of COVID-19 infections that could leave patients queuing in hospitals for ICU care. Luckily, social distancing has ‘flattened the curve’ and this problem might not arise. There is still a degree of risk, however, and other countries will not be so lucky. At some point, during this pandemic or the next, all countries will need to answer hard questions about whether and when scarce ICU resources (such as ventilators, beds and staff) should be either withheld or withdrawn from certain groups of patients solely for the purpose of providing them to others. Attempts to answer these questions can be found in a wide range of ICU triage protocols and ethical guidance documents, many of which embrace the foundational principle of ‘save the most lives’. Unfortunately, this worthwhile goal has generated many suggestions that could violate the law. This article identifies …

Recent US Supreme Court decisions have invalidated patent claims on isolated genomic DNA, and testing methods that applied medical correlations using conventional techniques. As a consequence, US genetic testing laboratories have a relatively low risk of infringing patents on naturally occurring DNA or methods for detecting genomic variants. In Europe, however, such claims remain patentable, and European laboratories risk infringing them. We report the results from a survey that collected data on the impact of patents on European genetic testing laboratories. The results indicate that the proportion of European laboratories that have refrained from providing associated testing services owing to patent protection has increased over the last decade (up from 7% in 2008 to 15% in 2017), and that the non-profit sector was particularly strongly affected (up from 4% in 2008 to 14% in 2017). We renew calls for more readily available legal support to help public sector laboratories deal with patent issues, but we do not recommend aligning European law with US law at present. Watchful monitoring is also recommended to ensure that patents do not become a greater hindrance for clinical genetic testing laboratories.

International health research increasingly depends on collaboration and combination using medical data to advance treatment and drug discovery. The European Union (EU), through its General Data Protection Regulation, has tightened the rules for sharing data across borders to protect individual privacy. These new rules threaten cooperation between the EU and the USA, the two largest public funders of biomedical research. This article analyzes the primary pathway for sharing research data with the USA, the US–EU Privacy Shield††, and argues that the Shield is ill-suited to support complex health studies. Its legitimacy is in question under both EU and US law, and its terms are too restrictive for the variety of exchanges underlying research, treatment, and care. As an alternative, we propose that the USA seek an additional sector-based adequacy determination based on the existing US health privacy law, the Health Insurance Portability and Accountability Act. A sector-specific approach to adequacy for health would avoid many of the most contentious issues that divide the USA and EU on data protection. It could also serve as a model for other third-party jurisdictions and facilitate international harmonization of health research practices.

Digital surveillance has played a key role in containing the COVID-19 outbreak in China, Singapore, Israel, and South Korea. Google and Apple recently announced the intention to build interfaces to allow Bluetooth contact tracking using Android and iPhone devices. In this article, we look at the compatibility of the proposed Apple/Google Bluetooth exposure notification system with Western privacy and data protection regimes and principles, including the General Data Protection Regulation (GDPR). Somewhat counter-intuitively, the GDPR’s expansive scope is not a hindrance, but rather an advantage in conditions of uncertainty such as a pandemic. Its principle-based approach offers a functional blueprint for system design that is compatible with fundamental rights. By contrast, narrower, sector-specific rules such as the US Health Insurance Portability and Accountability Act (HIPAA), and even the new California Consumer Privacy Act (CCPA), leave gaps that may prove difficult to bridge in the middle of an emergency.

At some point during this pandemic or next, all countries will need to answer hard questions about whether and when scarce ICU resources (such as ventilators, beds and staff) should be either withheld or withdrawn from certain groups of patients solely for the purpose of providing them to others. Attempts to answer these hard questions can be found in ICU triage protocols and ethical guidance documents, many of which embrace the foundational principle of ‘save the most lives’. Unfortunately, this worthwhile goal has generated many suggestions that could violate the law. This article identifies 10 ways in which the withholding or withdrawal of a clinically indicated ventilator might violate a patient’s rights, along with recommendations on how to avoid doing so. While our analysis is based on UK law, its lessons are relevant for other countries with similar legal systems. If the issues we identify are not addressed, doctors may act unlawfully. Worse, patients may die unlawfully.

Examining the types of claim amendments that have transformed isolated gene claims from patent-ineligible into eligible subject matter provides clarity into the threshold of eligibility for gene-related patents.

How will today’s patent law affect tomorrow’s innovation in the areas of biomarkers and nature-based products; diagnostics; and algorithms, big data and AI?

On the sixth anniversary of Mayo v. Prometheus, what impact has the US Supreme Court decision had on patent subject-matter eligibility and the prosecution of biotech-related patent applications before the US Patent and Trademark Office?

Much research in synthetic biology (SB) and genomics (Gx) is reliant on the use of large-scale collections of biological materials and data, often referred to as ‘biobanks’ or ‘bioresources’. Following substantial investment in the form of time, money, and personnel, some of these bioresources have reached a point where they can be regularly accessed by researchers and can realistically hope to facilitate innovation. At the same time, their maturity brings several challenges including how to promote access, ensure stewardship, and address financial sustainability. All these facets must be managed for on-going utility. Access promotes the likelihood of significant scientific findings and avoids under-utilisation; stewardship earns trust from sample donors and funders; and sustainable sources of income are crucial if the bioresources are to serve as infrastructure (rather than projects) and assist with longitudinal studies. A key part in managing these challenges – much less studied than issues of consent, return of incidental findings, and researchers’ eligibility for access – is the stance taken by large bioresources on intellectual property (IP) and financial conditions of access. Acquisition, ownership and sharing of intellectual property in life sciences is ethically charged, and financial conditions of access are controversial where they preclude or discourage external researchers from using the bioresource. There is limited guidance available for developing such policies in the fields of Gx and SB . Moreover – and this goes to the heart of this chapter – discussion of IP and business models for bioresources is a topic that falls in the shadow of hyperbole about openness. This chapter aims to bring the issue of IP policies for large bioresources out of the long shadows of rhetoric about openness. It will highlight two fictions: first, that the idea of openness is clearly defined; and second, that organisations are committed to openness. It will also highlight the fantasy that harmonisation of bioresources’ access policies is feasible and desirable. The chapter will conclude by outlining future research to improve openness and intellectual property policies for large Gx and SB bioresources.

Three years later, the landmark Myriad decision on gene patents has led to some striking and unforeseen implications.

US Supreme Court decisions in Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics Inc. caused US and European law on what is patentable subject matter to diverge significantly. Both cases related to molecular tests and changed decades of patent practice. Whether the decisions adversely affect the development of molecular tests in the United States and Europe has been a matter of much speculation but limited empirical investigation. This interview-based study has three main findings. First, Myriad and Mayo have negatively affected the development of some molecular tests. Notably, half of the US university technology-transfer offices interviewed decided not to develop tests, and many other organizations have found the legal uncertainty following the cases problematic. Second, small "patent-precarious" organizations—those that rely heavily on patents for competitive advantages, such as technology-transfer offices—have been the most affected because patent protection is now often weaker and more difficult

Five years later, what are the wider impacts of the US Supreme Court's Myriad decision on subject-matter eligibility and patent prosecution for nature-based products beyond isolated DNA?

While human subjects research once consisted primarily of research on people, advances in biobanking, genetics and big data have transformed the research landscape. Personal data and biospecimens are increasingly at the centre of research, giving rise to difficult questions about whether and how to apply legal and ethical principles - such as informed consent - that were developed for research on people. The first part of this article explores questions about consent that arise in the context of authorising research on personal data and biospecimens, focusing on the legal and ethical basis of the consent requirement, the use of specific versus broad consent, and the significance of anonymisation. The second part of the article looks at issues of consent that arise beyond the individual’s decision to participate, focusing on the return of individualised research results, community consent, and the ownership of biospecimens. This article is intended to be an encyclopaedia entry. It is forthcoming in the eLS.

On 7 and 8 April 2016, the Centre for Medical Ethics & Law (University of Hong Kong) together with the Centre for Law, Medicine and Life Sciences (University of Cambridge) hosted a conference at the University of Hong Kong on the legal and ethical challenges facing the realisation of precision medicine. The aim of precision medicine is to revolutionise disease treatment and prevention by utilising personal variation in factors such as an individual’s genetic information, biochemistry, environment and lifestyle. Genomic data, for example, can be used to determine predispositions to particular diseases, predict the efficacy and safety of different treatment options, and help develop drugs that are targeted to the causes of diseases rather than their clinical manifestations. In these and other ways, scientific and technological advances have the potential to bring about an unprecedented tailoring of health care to the individual characteristics of patients. In order to realise the potential of precision medicine, however, we must rethink components of the legal and ethical foundation on which it will be built. The reason for this is that our current legal and ethical frameworks were built with a very different generation of medical products and practices in mind. At this conference, world experts convened to identify and explore the challenges that precision medicine brings to the fore. Part I of this report provides a summary of the presentations that were given at the conference. Section A of this part focuses on challenges in the implementation of precision medicine and is divided into two categories: implementation at the level of health care systems, and implementation at the level of clinical treatment. Section B addresses challenges in the development of precision medicine and is likewise divided into two categories: development at the level of foundational research, and development at the level of translational medicine. Part II categorises and summarises the key challenges that were explored in the roundtable discussions that followed the four categories of presentations, as well as some of the broader questions that emerged out of the conference.

This report is from a Cambridge Workshop on the openness of large bioresources in synthetic biology and genomics (e.g. the 100,000 Genomes Project), held on 28 January 2016. Research in SB and Gx depends on the use of collections of tissue and data, commonly known as bioresources. Substantial amounts of time and money are being spent on creating these bioresources and it is likely that significant scientific breakthroughs and development of end-products may be missed or delayed if the tissue and data in these resources are not shared. Accordingly, the ‘openness’ of these bioresources — in other words, the ability for other researchers to access, use, and share these resources (which is typically recorded in a bioresource’s IP and access policy) — is a key issue for the success of bioresource initiatives and the progress of SB and Gx. There are, however, many different approaches to openness, and the development and dissemination of new knowledge are not necessarily advanced by distributing material at low cost or without any restrictions; time-limited rights of control (e.g. IP rights) may provide a useful incentive. It is a significant challenge to develop a fit-for-purpose openness policy that balances the advantages (and disadvantages) of different approaches to openness. The Workshop addressed this challenge by: reviewing openness policies adopted by large bioresources; eliciting ideas about access and intellectual property; debating the applicability of different openness policies; and identifying relevant areas for future research.

This article focuses on the increased scope for tension between obligations under investment treaties, particularly fair and equitable treatment, and the interpretation of national patent law by domestic courts. Precisely because investment treaties were created to protect investors from State-led mistreatment and bias, and investment treaties include intellectual property (IP) rights in their definition of investment, the question is how much flexibility national courts retain in applying, interpreting and developing IP laws. The implication of international investment treaties limiting longstanding flexibilities in IP law could be serious and profound. What more precisely are the implications of the IIL fair and equitable treatment standard for patent law and domestic court interpretations? Our main conclusions are: first, that investment tribunals should defer substantially to interpretations of patent law by domestic courts, limiting themselves to reviewing decisions for lack of a rational basis or lack of elementary procedural fairness (denial of justice). They should not engage in closer scrutiny. Second, if investment tribunals engage in closer scrutiny (for instance, in relation to patent decisions by other State organs, or if they reject our first conclusion), fair and equitable treatment provides limited stability for existing patents and for patent law. Investors have no legitimate expectation that national patents will be irrevocable, that national courts will interpret domestic rules of patentability – such as utility – in a particular way, or that patent law will be static over time. However, domestic courts (and other State organs) breach FET if they contradict settled patent law and apply this to existing patents in such a way that the patent rights are diminished, or adopt an interpretation with no rational basis.

Contrary to the thrust of some government guidelines, pre-mortem interventions in organ donation after circulatory death (DCD) – even those involving some risks – can support (rather than conflict with) a potential donor’s legal “best interests” by ensuring that a donor’s organs have a better chance of saving other lives. It is important that UK law and guidelines which affect transplantation and transplantation research allow such conclusions to be reached when supported by the evidence for example a donor’s expressed wish to be an organ donor after death. It is also important that the law, guidelines and research ethics committees support further research studies. There are many ways in which pre-mortem interventions could be improved and new interventions are likely to emerge. Research will also generate data that enables better and more informed risk-benefit analyses to ensure a donor’s best interests have been considered as carefully as possible. We recommend more specialised input into the UK research ethics committee approvals process, and caution against an overly narrow interpretation of section 31 of the Mental Capacity Act 2005(UK). The Court of Protection may also have a role to play. In situations where the pre-mortem intervention qualifies as “serious medical treatment”, the Court’s current Practice Directions recommend (or require) that doctors and researchers seek a declaration of lawfulness prior to carrying out a pre-mortem intervention. In time it is hoped that the particular pre-mortem interventions that fall within this category will become clearer and that the process of seeking a declaration will not be unfeasibly burdensome for the rapid time-frames of DCD donation. An issue for further research is the legality and ethics of pre-mortem interventions with DCD donors in other jurisdictions such as the US, Belgium and Australia.

In the first half of the current decade, the US Supreme Court substantially restricted the patentability of isolated DNA sequence patents and methods of genetic diagnosis through its decisions in Mayo Collaborative Services v Prometheus Laboratories Inc in 2012, and in Association for Molecular Pathology v Myriad Genetics Inc in 2013. A key question for Europeans – and Britons – is whether European law should follow the legal directions in the US: should we also disallow DNA patents? Relatedly, should we disallow genetic diagnostics patents? This paper set the scene for an expert debate on this topic. It focusses on the patentability of DNA sequence patents. The debate was held on 18 November 2016 at the University of Cambridge before a general academic audience.

Ethical issues implicitly permeate all aspects of patent doctrine, including definitions of invention, novelty, inventive step, utility, disclosure and so forth. Interestingly, and in addition, many patent systems allow explicit ethical objections. This is most notable in the European Patent Convention (‘EPC’) which states at Article 53(a) that: ‘European patents shall not be granted in respect of inventions the commercial exploitation of which would be contrary to “ordre public” or morality.’In broad terms, this provision means that patent protection is denied to immoral inventions, no matter how novel or inventive the invention may be. Intriguingly, it requires lawyers (including patent examiners and judges) to define morality. Recent cases concerned the morality of commercially exploiting mammals genetically programmed to develop cancer (Harvard Oncomouse) and stem cells obtained from human embryos (WARF and Brustle). These raised difficult questions about genetic engineering, animal experimentation, the moral status of embryos, the morality of patenting animals and parts of the human body. With such troubling ethical issues in the frame, it is not surprising that Article 53(a) itself has proven highly controversial. The principal difficulty is how to implement such a rule. How does a patent examiner or court assess whether an invention is immoral to the point that, unlike other inventions, it should not be granted patent protection? It is a question that runs headlong into the complex intersection of law and morality or, put another way, the intersection of intellectual property and philosophy. Section III explains some of the contentious issues in the interpretation of Article 53(a). In light of these issues, many authors and patent practitioners have thrown their hands in the air in frustration, suggesting that the problems are insurmountable and that patent law would be better off abandoning the explicit morality exclusion. In the meantime they tend to interpret the provisions in a highly legalistic and usually narrow way, dissecting the words of the statute in fine detail. Often the words might be ascribed more than one meaning, but alternative interpretations are swept away for a legally plausible, but normatively doubtful, reason leaving the decisions mired in controversy and cast adrift in interpretative uncertainty. In contrast there is very little discussion of what might be the jurisprudential underpinnings of a morality exclusion in the patent system. This is considered briefly in Section IV and leads into the main contention of this chapter.The principal argument is that a better appreciation of the nature and purpose of the immorality exclusion provides some vital clues as to how it should be interpreted (Section V). More specifically, it will be argued, building upon Burk and Lemley’s seminal paper in 2003, that the explicit morality exclusion is a ‘policy lever’, similar to the thirteen already identified in their paper, which tailors patent law to its overarching utilitarian objective of promoting socially beneficial inventions in a manner compatible with fair and just social organisation. As such, the explicit morality provision is a valuable opportunity to optimise patent policy, and an advisable inclusion in all national patent systems. Countries like the US which lack an explicit morality provision are disadvantaged by its omission. The exclusion calls for policy analysis, which requires more normative input by judges (and patent examiners) than linguistic textual analysis, but considerably less than a search for moral truth. It is thus well within the ordinary duties and capabilities of skilled legal decision-makers, who appreciate that law sensibly leaves discretion for judges (and other decision makers) to develop and shape the law in ways that promote desirable goals and behavior. This is not to say that this is how the immorality exception has been used to date, but rather how it could be used in the future. Sections V and VI also discuss some of the implications of seeing the explicit morality exception as a policy lever. Section V revisits the debates in the literature, and Section VI considers the topical issue of embryo stem cell patents. These comments are necessarily general rather than detailed or prescriptive. More definitive answers require a more fine-grained case-by-case analysis, which the judiciary and examiners would need to tackle in any given case. And although it might be tempting to argue that judges and patent examiners should not be given such an active role in shaping economic and social policy, the fact is that they are doing it at the moment, and it would better that they do it consciously and critically, rather than inadvertently or furtively.

The essays in this volume focus upon the Trade-Related Intellectual Property Agreement, which is an important element in the constitution and practice of the World Trade Organisation (WTO). Known to all as the TRIPS Agreement, it reached its twentieth anniversary in operative effect on January 1, 2015. It is unlikely that the text of the TRIPS Agreement will be substantially amended by the Member states of the WTO for at least another decade or two. Our contributors therefore take its current terms as a continuing authority in international law for its immediate future. They do so, however, questioning how far the Agreement was adequate for its own time and how far it remains so in a world that has been changing so extraordinarily during the intervening 20 years and doubtless will continue to do so for the twenty to follow.

Adverse outcomes from sub-optimal organs – including the death of two kidney recipients in the UK in 2013 – raise questions about the potential for surgeons to be held liable for using sub-optimal rather than standard or optimal organs. Could surgeons, transplant teams, ICU physicians, or hospitals be liable if the sub-optimal organ passes on an infection or cancer? When should transplant teams decline the offer of an organ from a compromised donor? How much detailed information should transplant teams pass on to potential recipients about the risks associated with the sub-optimal organ? If the recipient accepts the risks associated with a sub-optimal organ, does this absolve the surgeon of responsibility for those risks? This paper set the scene for an interdisciplinary academic discussion of these questions on 18 November 2016 at the University of Cambridge. The paper encourages readers to engage with higher order questions about regulatory design.

This amicus brief was submitted to the NAFTA arbitral tribunal in Eli Lilly v. Canada (ICSID Case No. UNCT/14/2). The arbitration arises out of the decisions by Canadian courts to invalidate two of Eli Lilly’s pharmaceutical patents. The case involves issues of significant public interest because the tribunal’s decision is likely to impact on the legal regimes governing pharmaceutical patent protection in Canada and many other countries. Relatedly, it also bears upon international issues of access to medicines and public health. In particular, findings made in this arbitration are likely to affect, the ability and willingness of countries around the world to use the acknowledged flexibilities of the international intellectual property system, in particular under the TRIPS Agreement, for the purpose of public health and access to medicines. It will also increase the likelihood of similar investment law challenges being brought by IP owners dissatisfied by domestic courts’ decisions on the validity of their patents. This will be a new and concerning development; to date intellectual property norms have only been challenged at an international level in state-to-state proceedings.The Brief examines, amongst other issues: • the scope of Canada’s obligations under NAFTA Articles 1105 and its relationship with both domestic and international intellectual property laws; • the intersection of NAFTA’s standards of protection, in particular fair and equitable treatment (FET) with Canada’s domestic patent law;• the relationship between NAFTA Chapter 17, the TRIPs Agreement and the Patent Cooperation Treaty; • the appropriate standard of review for judicial conduct; • the importance of patent law flexibilities; and• the frequency of patent invalidations.

Overly strict interpretation of the law is hampering epidemiological research. Here, one research team shows why regulators and organisations holding data should adjust their approach

Since the sequencing of the human genome, a key goal has been to make personalised medicine an everyday reality. Research that recognises a correlation between genetic make-up and a future health outcome is not enough. Considerably more research is necessary to understand how genes, drugs and other environmental factors work together, and how they work in particular individuals. Only then will we have enough knowledge for genomic medicine to be useful in a clinical setting. An important and complex policy issue is whether intellectual property policies are working effectively to support the achievement of this bold objective. On 1 May 2015 the University’s Centre for Law, Medicine and Life Sciences (LML) and the Centre for Science and Policy (CSaP), both based at the University of Cambridge, hosted an expert workshop to discuss these issues. This paper reports on the results of the meeting. It covers diverging views on the role of IP for the realisation of genomic medicine, expert reactions to recent US Supreme Court rulings, recent trends in IP strategies, and emerging issues for IP policies and biobanks.