16.1 Introduction
Affordable access to quality healthcare is generally recognised as a basic human need and one of the grand challenges our society currently faces, especially in the wake of the COVID-19 pandemic.Footnote 1 However, according to the World Health Organization (WHO), the cost of healthcare has continually risen globally since 2000, reaching 10 per cent of global GDP in 2018.Footnote 2 Although healthcare systems are financed in different ways across the world, current global data demonstrates that the demand for healthcare generally exceeds the available resources.Footnote 3 These statistics are often reviewed and discussed in the context of the common values and principles represented by United Nations Sustainable Development Goals (SDGs), particularly SDG 3 ‘Global Health and Well-being’ to ‘healthy lives and promote well-being for all’, in part by providing access to quality essential healthcare services through universal health coverage.Footnote 4 However, similar to the One Health approach, SDG 3 is not meant to be considered independent of the other SDGs, which includes animal and environmental health represented by SDG 13 Climate Action, SDG 14 Life Below Water, and SDG 15 Life on Land.Footnote 5 One Health advocates for a balanced approach to optimise the health of people, animals, and the environment.Footnote 6 At the core of the SDGs and the One Health approach is a holistic strategy and global responsibility to collaboratively achieve well-being for the planet and all beings that inhabit it.
Unfortunately, there is increasing criticism that the focus on public health is driving a predominantly human-centric approach to One Health initiatives, with a disproportionate emphasis on human health at the expense of giving adequate consideration to animal and environmental health.Footnote 7 For example, in June 2017, the European Commission adopted the EU One Health Action Plan against Antimicrobial Resistance (AMR), setting out concrete actions to combat AMR and to encourage research and innovation to develop new effective antibiotics.Footnote 8 Because bacteria naturally evolve over time and develop resistance to antibiotics, there will come a time when existing antibiotics become ineffective to treat an infection. The misuse and overuse of antibiotics in both human and veterinary medicine attributable to prioritising human health without sufficient consideration to the impact on the entire ecosystem has accelerated the development and transmission of AMR with significant consequences on the health of humans, animals, and the environment.Footnote 9 According to the WHO, the increasing global threat posed by the rapid spread of AMR requires immediate and coordinated action across multiple sectors to attain better public health outcomes.Footnote 10 Under the One Health approach, the WHO, the Food and Agriculture Organization, and the World Organization for Animal Health joined forces to promote cross-sectoral collaboration to assess, control, and prevent the spread of AMR in human and animal populations and in the environment.Footnote 11 Without effective antibiotics to prevent and treat an increasing range of infectious diseases from a holistic One Health approach, an estimated 10 million human lives per year may be lost by 2050 as a consequence of the rise in drug-resistant infections and at a cost of US$100 trillion in lost global production.Footnote 12
However, the ongoing concerted reliance society has placed on innovation and technology-driven solutions may exacerbate the problem because innovators are primarily focused on addressing societal challenges from a human perspective without being required or incentivised to consider the broader environmental and ecological impact of their innovations. Continuing with the global AMR example, current research and data on the numerous models to incentivise and encourage the development of new antibiotics has generated mixed results, from ambivalence to cautious optimism.Footnote 13 The often-discussed disconnect between intellectual property (IP) or exclusivity-based incentives and the development of new antibiotics to address the AMR problem is well documented and discussed in the literature.Footnote 14 Other push and pull incentives to reduce barriers to market entry and to encourage investment in the later stages of development and commercialisation have also been equally extensively examined in the literature, with hopeful prospects that the right combination of incentives along the entire value chain – from discovery to commercialisation – can be devised.Footnote 15 Because the responsible use of antibiotics to mitigate against AMR means limited financial returns for those developing and bringing new antibiotics to market, even if the innovation can be protected by proprietary rights, some scholars question whether IP and exclusivity-based rights are effective tools to be used as part of the solution to drive antibiotic innovation to address the AMR challenge.Footnote 16 Relying on technology to address the AMR problem by incentivising and encouraging the development of new antibiotics primarily for human use ignores the broader One Health considerations of safeguarding animal and environmental health through conservation and stewardship approaches to preserve the future effectiveness of antibiotics. The question is how can society achieve the goal of global access to quality health and well-being while recognising the economic realities of rising healthcare expenditures and safeguarding the environment and animal welfare?
To encourage and incentivise the development of new innovations that adopt a true and balanced One Health approach, there needs to be a framework that captures the social value as well as the technological value of innovations, while recognising the economic challenges of a more value-based approach, such as stewardship in the case of AMR.Footnote 17 For greater clarity, because AMR stewardship advocates for the judicious use of antibiotics, diminished commercial returns associated with prescribing less antibiotics would discourage innovation (under a traditional business model perspective) despite the societal need for developing new antibiotics. Without the appropriate legal and policy framework to incentivise and capture the social value of research and innovation, there is a risk the resulting solutions will fail to achieve the balance between animal, environment, and human health. Drawing on socio-legal theory, this chapter presents a legally supported approach to innovation, informed by the intellectual property framework and the principles of Responsible Research and Innovation (RRI) and Value-Based Health and Care (VBHC), to support the implementation of a true One Health framework. The objective is to ensure that innovation incentives are responsive to all stakeholder interests from the early stages of research and throughout the innovation process.Footnote 18 To achieve this, the second section of this chapter will contextualise One Health in the policy landscape of RRI and VBHC. This analysis of the policy landscape will then be used in section three to inform and enable the development of legal tools that will give credibility, legitimacy, and accountability to the design, development, and implementation of a sustainable One Health framework through meaningful and inclusive societal engagement. Overall, the proposed framework described in the third section helps redefine the balance of rights and limitations of public, private, and global health interests to (1) promote innovation, (2) prevent the creation of scientific and access barriers, and (3) provide a governance structure to support a balanced and holistic approach to the EU One Health Action Plan where human, animal, and environmental considerations can be given equal consideration.
16.2 The Policy Landscape
16.2.1 One Health
The One Health Initiative, working at the local, regional, national, and global levels,Footnote 19 has the goal of achieving optimal global health outcomes through recognising the interconnection between people, animals, plants, and their shared environment.Footnote 20 However, the environment is certainly the most neglected pillar of the One Health triad, including in addressing the AMR challenge.Footnote 21 Misuse and overuse of antibiotics in humans and animal production globally needs to be understood in the context of the physical, biological, and societal drivers as pathways for AMR to find its way into the environment and subsequently to humans and animals.Footnote 22 There is growing support in the literature raising the alarm for a more integrated and holistic approach for any global One Health action plan to be effective and complete.Footnote 23 There is a need to generate innovative ideas and put them into action to ensure a more sustainable global ecosystem in the years to come, including production methods and systems with high animal welfare and health and less climate and environmental impact as ways to ensure human health. Research and innovation alone are not sufficient to achieve societal transformation. They need to be supported by policy and practice to foster inclusive participation by stakeholders (i.e. government, industry, society, academia, scientists, and special interest groups) to ensure effective societal uptake of the resulting solutions.Footnote 24 For example, because AMR surveillance requires access to data, legal questions associated with privacy, data protection, and intellectual property, as well as data security concerns relating to transparency, accountability, and responsibility can manifest as barriers.Footnote 25 By better understanding the interests and concerns of each of the relevant stakeholders, there is an informed basis to design, develop, and implement initiatives and solutions that are responsive to stakeholders’ needs. This in turn will foster greater trust and accountability, along with a change in perception to reduce societal opposition to innovative solutions.
16.2.2 Value-Based Health and Care (VBHC)
Globally, the cost of delivering health and care has increasingly become unsustainable, with the aging world population placing significant pressure and demand on health systems.Footnote 26 Without an integrated and holistic value-based approach to achieving a balance between human, animal, and environmental health, there is a real risk that the global health ecosystem will become unsustainable. The concept of ‘one medicine’ has been explored in the literature to emphasise the dangers of siloed approaches to human health without considering the social-ecological or human-environmental context.Footnote 27 The inextricable interconnectedness and interdependence between human, animals, and the environment requires an alignment in practice and framework structures to deliver comprehensive health and care solutions that do not negatively impact the planet. Sustainability of the entire health and care ecosystem therefore needs to be assured to continue to meet the current and future needs of the people and the planet through a value-based strategy that optimises human, animal, and environmental health.Footnote 28
The core principle of VBHC is to achieve the best possible health outcomes within the resources available.Footnote 29 VBHC is currently defined by the National Health Services as ‘[t]he equitable, sustainable and transparent use of the available resources to achieve better outcomes and experiences for every person’.Footnote 30 In view of growing demand and limited resources, it comes as no surprise that VBHC is gaining acceptance as a model to address increasing health and care demands by including patients, public authorities, industry, and healthcare providers in a coordinated effort to collectively achieve improved outcomes for all.Footnote 31 In principle, the adoption of VBHC approaches will lead to long-term social and economic benefits from optimising the use of available resources to support a health and care system that delivers a productive and healthy population. Society as a whole stands to benefit from lower costs and improved public health by sharing risks and rewards through a system of mutual accountability. However, to achieve value, the stakeholders that make up the health and care ecosystem need to come together in a coordinated effort to collectively define what constitutes value from a One Health perspective. Most of the literature on the concept of value in VBHC focuses mainly on the relationship between value and financial cost with the aim of lowering costs without sacrificing human health outcomes.Footnote 32 There appears to be a disconnect between the concept of value as understood in the literature compared to the proposed practices aimed at implementing and achieving VBHC outcomes, which seem to focus predominantly on devising funding models and strategies to optimise effective resource management by lowering cost without One Health objectives in mind.Footnote 33
One of the key challenges to successfully develop and implement VBHC practices is the lack of a common definition or shared understanding of the concept of ‘value’. For example, what may be the best solution for the treatment of a particular disease from a clinician’s or scientist’s perspective may not be viable to industry because the value proposition from a commercial standpoint does not justify the time and costs required to bring the product on the market. Alternatively, what may be an affordable treatment from a hospital or public authority’s perspective may not be the best solution for the intended user because of undesirable side effects that interfere with the patient’s ability to take part in everyday life. The flip side of that example is the long-term personal health and societal benefit of expensive, potentially curative solutions that will enable patients to contribute more to society over a longer period of time as a healthy individual. Furthermore, curative solutions will also enable family members of patients to be more productive if they are relieved of care responsibilities. Similarly, the healthcare system will also be relieved of the long-term financial investment to treat patients over the course of their lifetime.
Understandably, efforts focused on cost reduction are pragmatic given the public scrutiny and accountability for the use of limited public resources to meet health and care needs. There is evidence in the literature of overuse and underuse of healthcare services and technologies, both of which contribute to waste of resources in addition to causing potential harm to patients and the planet.Footnote 34 However, if the concept of value focuses (or is even perceived to focus) too heavily on reducing expenditure without sufficient and inclusive consultation with different stakeholders and impact on environmental and ecological sustainability, there may be very little support and uptake of practices aimed at achieving VBHC outcomes due to lack of transparency and trust and insufficient consideration to achieve broader One Health goals.Footnote 35 In addition to health gains to humans, the environmental footprint and impact on animal health also need to be measured and considered as a concrete value.
Without a framework that is upheld by legally supported governance structures and informed by policy objectives such as One Health, SDGs, the principles of RRI, and the Health System Governance strategy,Footnote 36 effective implementation of VBHC practices to address global health will continue to remain elusive and challenging. Decisions driven mainly by cost containment or reduction efforts without considering the impact on environmental and animal health will likely obscure innovative opportunities to improve outcomes and lower the true cost to the system.Footnote 37 The value proposition of incentivising the development of new innovations from a VBHC perspective requires a mindset of prioritising patient-centred outcomes as well as environmental and animal health considerations.
Even if there is a sufficient level of societal readiness from patients to adopt a solution, the innovation may not be commercially viable to industry to justify the time and costs required to translate and develop the solution into a market-ready product because the value proposition does not justify the resources required. Alternatively, a patient-preferred and scientifically supported treatment may not be sustainable from an environmental and global common good perspective. Bioprospecting under the banner of sustainable drug discovery may lead to conservation, biopiracy, and cultural appropriation concerns if not governed properly. For example, natural compounds derived from bioresources such as plants are considered more sustainable than creating chemical compounds in drug discovery and development,Footnote 38 but have also attracted criticism when the resources and knowledge of Indigenous communities are exploited and appropriated through commercial activity without any benefit sharing.Footnote 39 As such, value in terms of efficacy of treatment, value in terms of financial costs, value in terms of profitability, value in terms of societal acceptance, and value in terms of patient welfare are all ‘valued’ differently from the perspective of different stakeholders. Despite a shared intent, because stakeholders define and perceive value very differently, there may be very divergent opinions and approaches to achieving the same goal of improving health outcomes through a One Health approach. For example, when making decisions on the allocation and use of healthcare resources from a VBHC perspective, understanding value based on a short-term assessment of efficiency at the expense of considering investments in the long-term One Health outcomes may be short-sighted and give rise to health inequities, especially for those suffering from rare or neglected diseases. Advanced therapy medical products (ATMPs) are an example of a very expensive personalised medicine treatment that has the ability to cure rare diseases compared to lower cost solutions that are currently being offered to treat the same diseases. Despite the high upfront cost of ATMPs, this investment needs to be considered in light of the financial, environmental, and well-being cost of resources required for the care and treatment of the disease over the course of the patient’s lifetime, which may far exceed the cost of the curative potential of ATMPs. The long-term environmental impact, healthcare, and social outcomes of more expensive solutions do not seem to fit well with the current economic models of, and approaches to, VBHC despite recognition on a policy level of the importance of equity, One Health considerations, and value judgments.Footnote 40
The literature therefore supports the argument that a value-based approach to capturing and incentivising the social value as well as technological value of innovations may be a viable solution to encourage the development of health- and care-related innovations. By focusing on the blended value of private and social return on investment and rewarding innovations with high social benefits by translating social value into economic value, a responsible, sustainable, and value-based innovation framework emerges to reinvigorate the innovation pipeline.Footnote 41 However, without an appropriate legal framework that takes into consideration and balances the social, political, financial, and administrative pressures associated with innovation development and procurement, there will always likely be implementation challenges and frustrations. As will be described in greater detail below, the procurement of innovative technologies is well suited to value-based procurement as a way to encourage and incentivise the development of innovations that are socially, economically, and environmentally sustainable.
For new models or framework designs to have legitimacy in the eyes of those who will implement and operationalise VBHC, as well as those that VBHC intends to benefit, there needs to be meaningful engagement to align stakeholder interests and needs through responsive dialogue to include One Health perspectives. This is where the law and the principles of RRI can play a key role in providing the necessary legal and policy framework to give credibility and accountability to ensure that stakeholder interests and concerns are reflected and taken into to account as part of the process of implementing and adopting VBHC initiatives.Footnote 42 A more nuanced and holistic approach to global health requires exploring how the principle RRI can help achieve the objectives of VBHC in a more balanced, inclusive, and equitable manner in line with a One Health approach. Existing legal tools can also be leveraged to operationalise RRI to practically align societal needs with the economic realities of healthcare systems to achieve One Health objectives and VBHC outcomes.
Through the inclusive engagement envisioned and described under RRI, a foundation for collaborative partnerships based on a system of mutual accountability and understanding of the underlying interests can be formed. Legitimacy, trust, and accountability are essential to ensure that the development of VBHC solutions that include a One Health approach is sustainable in terms of effective societal uptake.
16.2.3 Responsible Research and Innovation (RRI)
Research and innovation have been identified as key pillars of the EU’s strategy to create sustainable growth and prosperity.Footnote 43 RRI was therefore adopted as an approach to govern research and innovation in a manner that is interactive, transparent, and responsive to public concerns to reduce the risk of societal opposition to new innovations arising from research efforts.Footnote 44 One of the main objectives of RRI is to align research with societal values through inclusive engagement to make science more responsive to societal needs and to ensure effective uptake of the resulting innovations.Footnote 45 Broadly speaking, RRI refers to efforts aimed at enhancing the accountability of research through societal engagement and societal inclusion.Footnote 46 The premise is that research done responsibly will help form the foundation for the sustainable development of resulting innovations.
There has been an increasing policy focus on meaningfully engaging different stakeholders in the process of research and innovation to ensure that research and development takes social considerations, values, and interests into account so that the outcomes of research meet societal needs.Footnote 47 While there is an ongoing demand for greater reflection of responsibility, particularly on emerging science and technologies,Footnote 48 interests in responsibility need to be considered along with real-world dynamics such as economic complexities and accountability to public interests,Footnote 49 particularly in the field of healthcare.Footnote 50 Because of the uniquely high costs and sector-specific dynamics associated with innovating health-related technologies,Footnote 51 the principles of RRI can be a useful policy tool to reconcile the objective of global access to affordable and quality healthcare without stifling innovation.Footnote 52
For example, in response to the COVID-19 pandemic, significant public funds were invested into the research and development (R&D) of innovations with the aim of securing global health for everyone everywhere. In 2020, an estimated €16 billion in pledges from governments and international donors worldwide were used to fund R&D of diagnostics, treatments, and vaccines for COVID-19.Footnote 53 In 2021, a further estimated €20 billion was provided, largely from government sources, to continue to fund the global response to COVID-19.Footnote 54 In addition to concrete funding, other public initiatives were introduced to further support international cooperation and collaborative efforts to develop health innovations. For example, the WHO and its partners launched the COVID-19 health technology access pool (C-TAP), a global initiative to facilitate access to data and open sharing of scientific knowledge by removing legal barriers such as intellectual property (IP) and other proprietary rights.Footnote 55 The express intent of C-TAP was to accelerate the discovery of innovations through open science and to ensure that ‘the latest and best science benefits all of humanity … and made universally available’.Footnote 56 A second initiative launched by the WHO and its partners known as the Solidarity Trial was an international collaborative clinical trial effort to rapidly assess promising treatment options by adopting an adaptive design that significantly reduced the time needed to generate the necessary evidence on safety and efficacy.Footnote 57 Similarly, the United States Food and Drug Administration (FDA) launched its Coronavirus Treatment Acceleration Program to accelerate the development and approval of treatments by reducing the regulatory burden and increasing the efficiency of the evaluation process.Footnote 58
The result of these publicly funded initiatives and investments into open and collaborative R&D efforts have largely proven to be successful. However, as various innovations approached market readiness, private rights and commercial return on investment interests began to overshadow the previously shared spirit of collective action towards achieving global public health.Footnote 59 The assertion of IP and proprietary rights were used by the pharmaceutical industry to maintain market exclusivity by limiting access to the use of knowledge and know-how. Traditionally, IP rights have been justified in the pharmaceutical sector because of the time and cost associated with drug discovery and development.Footnote 60 However, if the cost of research for COVID-19-related innovations have largely been subsidised by the public through public research grants and the time and risk for development has been significantly reduced through publicly funded initiatives, should IP rights be asserted on innovations that have largely already been paid for by the public? In response to a global pandemic, there must be legally supported mechanisms to ensure the pharmaceutical industry and national interests cannot undermine the ability to rapidly distribute essential medicines worldwide at the expense of environmental considerations. While commercial interests need to be recognised to incentivise innovation, private profits should not be subsidised by the public purse that supported the development of essential medical solutions.
The proactive approach of RRI to critically assess the broader impact of innovation on society in a responsive and reflexive manner makes the RRI framework particularly relevant to the healthcare context as a way to align the values, needs, and expectations of relevant stakeholders in a holistic and balanced manner.Footnote 61 Examples of stakeholders that form a part of the healthcare ecosystem broadly include patients, healthcare providers, public health authorities, funding agencies, and industry. However, in practice, the notion of alignment is often confounded with agreement, making the challenge of imparting the core values and reasoning of RRI and social impact into traditional science and technology research practices even more difficult to implement.Footnote 62 For example, despite the trend towards collaborations between academia and industry and the shared commitment to optimise the impact of research and innovation for the benefit of society,Footnote 63 significant ‘cultural’ obstacles continue to hinder successful partnerships between stakeholders.Footnote 64 The translation of policy into practice requires the reassembling of policy ideas into context-specific settings.Footnote 65 To be successful, science-society policies need to recognise competing cultural norms and logics of different institutional and professional settings in order to connect the underlying reasoning of the policy objectives in a relatable way to different stakeholders.Footnote 66
Because RRI focuses on the interdependent relationship between science, innovation, and society,Footnote 67 the principles of RRI could be used to inform the concept of value in a One Health context to include a reflexive, inclusive, and responsive understanding of beneficial outcomes for human, animal, and environmental health. The scholarship on RRI continuously highlights that the concept of responsibility is multiple and changes its shape and meaning depending on the context of use.Footnote 68 By adopting an RRI approach to engage each of the stakeholders in the One Health ecosystem to better understand what motivates them, a holistic innovation framework that incentivises collaborative participation can be developed.Footnote 69 As recognised in the RRI literature, translating policy into practice has proven to be challenging.Footnote 70 Similarly, translating One Health goals into practice could encounter similar difficulties if steps are not proactively taken to identify and create conditions necessary to adopt One Health practices that reflect the culture of the specific healthcare setting and ecosystem. By instilling a sense of ownership, control, and self-determination of what value-based outcomes means in a One Health context, there is a greater likelihood that a VBHC model co-created by the relevant stakeholders through an inclusive dialogue to better understand the reasoning and objectives underlying VBHC initiatives will be successfully adopted. To achieve this, the generally practiced stakeholder engagement activities such as focus groups, interdisciplinary involvement, public outreach, and semi-structured interviews remain the same.
Although the literature suggests these alone do not lead to successful implementation of science society policies,Footnote 71 the background training and education leading to and in support of the engagement activities aimed at contextualising the core values and principles of VBHC will create a common basis for stakeholders to engage in meaningful and responsive dialogue. By identifying and understanding the root cause, real or perceived, underlying the reluctance to implement and adopt VBHC initiatives, there is an informed basis to design, develop, and implement policy and legal structures that are responsive to stakeholder interests and concerns. This in turn will foster greater trust, accountability, and willingness to collaborate. Furthermore, as discussed in greater detail in the next section, a legally supported governance structure to incentivise and de-risk the adoption of VBHC initiatives would encourage all participants to be active, responsible, and accountable for achieving VBHC outcomes.
16.3 Legally Supported Approach
Although soft law plays a leading role in setting strategic agendas and guiding the interpretation and implementation of legal principles to achieve policy objectives, hard law also has a commensurate role to safeguard shared interests and ensure accountability with binding force to help build trust and legitimacy of new policy frameworks. In the context of VBHC, collaboration to create value requires a closer alignment of stakeholders to collectively achieve value-based outcomes.Footnote 72 Similarly, RRI requires close cooperation between all stakeholders and a setting that supports and fosters collaboration. The reality of meaningful stakeholder engagement in both RRI and VBHC frameworks is that it is a complex collaborative process involving multiple and potentially conflicting interests, agendas, and interpretations of ways to achieve socially responsible and desirable One Health objectives.Footnote 73 This is where hard law plays a key role in creating the infrastructure necessary to support, incentivise, and hold stakeholders accountable to do their share in the collaboration to make the whole (i.e. One Health-informed VBHC outcomes) greater than the sum of its (policy) parts.
16.3.1 Dispelling Legal Misconceptions
One of these pressure points is the tension between ‘law according to the books’: what the law says according to those in the legal field; and ‘law in reality’: how the relevant stakeholders interpret or experience and put the law into practice in their particular setting. In the context of VBHC and One Health, and other data reliant initiatives, there is an observed reluctance by parties who have access to valuable data to allow and operationalise the use of the data to support the development of data-driven solutions by third parties.Footnote 74 By understanding and dispelling misconceptions of what are perceived as opposed to actual legal barriers, there is a greater likelihood of achieving policy objectives and realising value propositions. For example, as recognised in the VBHC literature, access to available data is essential to determine metrics by which to align health outcomes with the impact of health interventions on the environment and society as part of the assessment of any VBHC framework.Footnote 75 The inability to measure and determine what metrics demonstrate a value-based outcome, how should the metric be assessed, and over what period of time for the promised reward to be earned under the VBHC model becomes a significant barrier to adoption.Footnote 76
The European Commission estimates that US$20 billion are spent every year to develop innovations and technologies that have already been developed elsewhere because existing knowledge is not being shared or made available.Footnote 77 The reluctance to share and operationalise the use of existing data can only be understood and solved through meaningful engagement with the relevant parties that have control over the data. Based on the principles of RRI, if there is a mutual understanding by all stakeholders of both ‘law according to the books’ and ‘law in reality’, there is an informed basis to articulate and shape legally supported data sharing agreements to better align VBHC initiatives with stakeholder interests and concerns.Footnote 78 For example, stakeholders have expressed concerns related to potential liability under existing data protection laws,Footnote 79 as well as relinquishing intellectual property (IP) interests and entitlements to benefit should the use of data lead to some commercialisable success.Footnote 80 There is also the confusion between IP rights and the broadly accepted policy mandate for data sharing, open science, and open access to support the advancement of scientific research and free exchange of knowledge.Footnote 81 Many large health and innovation-related organisations adopt a data sharing policy,Footnote 82 encouraging the sharing of available data in accordance with FAIR principles (findable, accessible, interoperable, and reusable) to foster scientific progress by reducing barriers for the reuse of available knowledge. However, the ‘IP status’ of data is not generally well understood but it is commonly recognised as proprietary information that has significant potential value.Footnote 83 Because of this gap in knowledge and limited access to resources, guardians of valuable data are often paralysed into inaction and opt for the safest option, which is to not permit access to data under their control.Footnote 84 If proprietary information necessary to create innovations and solutions cannot be adequately protected by traditional forms of IP, stakeholders are likely to safeguard their personal interests at the expense of sharing data despite the potential advantages of open science.Footnote 85
16.3.2 Leveraging the Law to Safeguard Stakeholder Concerns
By involving and consulting with stakeholders at the outset, there is an opportunity to identify and characterise the observed hindrances and opportunities from the perspective of the relevant stakeholders to have an informed understanding of how each stakeholder group perceives the role of law and regulations that impact the use and sharing of existing data. This type of engagement will allow for a better alignment of objectives with the expectations of stakeholders. Legal mechanisms can be used to support what VBHC and One Health initiatives want to achieve by defining the ‘rules of engagement’ to safeguard the interests and concerns underlying the reluctance to operationalise the use of available data. Like a marionette puppet, pulling on one string to address a concern of a single stakeholder might get one step closer to the desired outcome, but the rest of the stakeholders that make up the healthcare ecosystem need to readjust and have an incentive to readjust to accommodate the change to get to a new equilibrium. The law can be a useful tool to help strike a balance and define a legally protected framework where the stakeholders can reach an understanding on what conditions need to be in place to continue to function within the new norm. Value-based agreements have slowly gained traction globally in the healthcare context and require a mutually shared understanding of the financial and operational impact of adopting a new model delivering healthcare.Footnote 86 Without a bespoke legal framework to alleviate real and perceived challenges, One Health-informed VBHC initiatives will encounter implementation challenges no matter how sound the model may theoretically be. The relationship between RRI and the sustainable implementation of VBHC practices requires the law to de-risk and incentivise the partners between the stakeholders. In other words, the law can be used as a tool to manage and reduce the real and perceived risk associated with achieving VBHC outcomes. For example, contractual obligations can be used as neutral arbiters to compel and capture the value of sharing data on the one hand while protecting against free-riding and unauthorised use of the data on the other through the threat of enforcement measures.
16.3.3 Leveraging Public Procurement to Drive One Health Policy
The public procurement framework also has a key role to play in realising the One Health objectives as part of Europe’s strategy to achieve smart, sustainable, and inclusive growth through R&D.Footnote 87 For example, in 2016, new rules governing the innovation partnership procedure introduced in the EU Public Procurement Directive enabled public authorities to combine the development and purchase of successfully developed innovative products.Footnote 88 By comparison, the procedure that preceded the innovation partnership where the pre-commercial procurement of R&D services is followed by a separate procurement process for the large-scale commercial rollout of the product itself would not have been suitable to incentivise the development of One Health value-based innovations because it failed to take into account any benefits beyond the technological capabilities of new innovations.Footnote 89 With the introduction of the combined development and procurement procedure, innovations with high social, environmental, and ecological value can be strategically procured as part of a collaborative R&D process to address societal challenges such as One Health approach to human healthcare, while respecting wider socio-economic, environmental, and policy agendas.Footnote 90 The Guidance on Innovation Procurement document states that innovation partnerships can only be used to procure solutions tailored to address a specific challenge identified by the authority where the market ‘does not offer a satisfactory solution or where an adaptation of existing solutions is unlikely to meet the needs’.Footnote 91 A strong argument can be made that innovation partnerships are a viable solution for a public buyer to enter into long-term partnerships with suppliers of innovation to co-develop innovative solutions that adopt a One Health perspective. Through the innovation partnership framework, public authorities will have a legal basis to exercise decisive influence over stakeholders to achieve One Health objectives through the procurement of innovations that prioritise One Health considerations. The purchasing power of public authorities combined with the health and care decisions that naturally follow from choosing to purchase one solution over another makes public procurement an extremely influential tool that public authorities can wield to strategically steer different stakeholders towards achieving One Health objectives. Value-based procurement integrates the concept of quality health and care with environmental, societal, and ecological impact and translates them into tender criteria that can include technical merit as well as One Health characteristics to drive long-term goals beyond traditional considerations of cost, making this a useful tool, for example, with ATMPs that do not fit with the traditional cost model.
16.4 Conclusion
Science and technology alone are not sufficient to address issues that healthcare systems are currently facing globally. The reality is incorporating the use of available healthcare technologies into a One Health VBHC framework and translating that into practice in a healthcare setting requires the involvement of multiple stakeholders. None of the individual players have all the necessary skills and resources to achieve One Health VBHC outcomes independently. Adopting a VBHC approach needs to be supported by behaviour and attitude change to ensure the solutions society invests time, effort, and resources into developing stand a better-than-average chance of being adopted as long-term solutions. This requires leveraging people with experience and credibility from working in interdisciplinary environments to decipher and translate discipline-specific perspectives into a common language and common purpose that all stakeholders in the healthcare ecosystem can understand and support. There also needs to be a clear legal framework to support One Health VBHC initiatives, informed by policy objectives, to ensure that outcomes of publicly funded efforts can ultimately reach the intended public. While commercial interests of industry need to be recognised to incentivise innovation, private profits should not be subsidised by public funds that supported the development of essential medical solutions. Value-based procurement can be leveraged to encourage industry to proactively develop innovations with One Health objectives in mind. The incentive of a lucrative procurement contract places some onus on industry to become an active responsible player. RRI principles therefore govern the responsible participation of stakeholders, and the law can be used to provide legally supported and incentivised ways to help implement One Health VBHC practices and to give credibility and accountability to ensure that stakeholder interests and concerns are reflected and taken into to account as part of the implementation process.
