"It's going to get pretty tippy": Stakeholder perspectives on the (dys)function of a four pillars drug strategy.

A 'drug strategy' is a policy document that structures the priorities and directions for interventions for drug related issues within a particular jurisdiction and/or context. A 'pillars' drug strategy concentrates efforts through clustering separated columns of activity, such as law enforcement, harm reduction, treatment, and prevention. In this study, we examined drug policy stakeholders' perspectives on the structure, function, and fit of a four pillar drug strategy framework in Vancouver, Canada. Utilizing qualitative interview data from fifteen drug policy stakeholders, we examine perspectives on Vancouver's four pillar drug strategy that was implemented over 20 years ago. Our findings are organized under three main themes: (1) the notion of 'balance' of efforts, resources, and attention across the pillars; (2) how the pillars function as a cohesive whole; (3) whether the pillars' architecture is still fit-for-purpose. The architecture of four discrete pillars did not enable a sense of cohesion and collaboration of efforts, and instead elicited a sense of competition, conflict, fragmentation, simplicity, and rigidity of the strategy as a whole. These findings suggest that, in practice, a four pillars framework may be structurally dysfunctional in working towards a common goal. Our study questions the effectiveness of a commonly used 'pillars' framework and whether it needs to be reenvisaged.

Reducing privacy risks of China's healthcare big data through the policy framework.

While healthcare big data brings great opportunities and convenience to the healthcare industry, it also inevitably raises the issue of privacy leakage. Nowadays, the whole world is facing the security threat of healthcare big data, for which a sound policy framework can help reduce privacy risks of healthcare big data. In recent years, the Chinese government and industry self-regulatory organizations have issued a series of policy documents to reduce privacy risks of healthcare big data. However, China's policy framework suffers from the drawbacks of the mismatched operational model, the inappropriate operational method, and the poorly actionable operational content. Based on the experiences of the European Union, Australia, the United States, and other extra-territorial regions, strategies are proposed for China to amend the operational model of the policy framework, improve the operational method of the policy framework, and enhance the operability of the operational content of the policy framework. This study enriches the research on China's policy framework to reduce privacy risks of healthcare big data and provides some inspiration for other countries.

How integration of refugees into national health systems became a global priority: a qualitative policy analysis.

BACKGROUND: Despite a long history of political discourse around refugee integration, it wasn't until 2016 that this issue emerged as a global political priority. Limited research has examined the evolution of policies of global actors around health service provision to refugees and how refugee integration into health systems came onto the global agenda. This study seeks to fill this gap. METHODS: Drawing on a document review of 20 peer-reviewed articles, 46 global policies and reports, and 18 semi-structured interviews with actors representing various bilateral, multilateral and non-governmental organizations involved with refugee health policy and funding, we analyze factors that have shaped the global policy priority of integration. We use the Shiffman and Smith Policy Framework on determinants of political priority to organize our findings. RESULTS: Several important factors generated global priority for refugee integration into national health systems. Employing the above-mentioned framework, actor power increased due to network expansion through collaborations between humanitarian and development actors. Ideas took hold through the framing of integration as a human rights and responsibility sharing. While political context was influenced through several global movements, it was ultimately the influx of Syrian refugees into Europe and the increasing securitization of the refugee crisis that led to key policies, and critically, global funding to support integration within refugee hosting nations. Finally, issue characteristics, namely the magnitude of the global refugee crisis, its protractedness and the increasing urbanicity of refugee inflows, led integration to emerge as a manageable solution. CONCLUSION: The past decade has seen a substantial reframing of refugee integration, along with increased financing sources and increased collaboration, explains this shift towards their integration into health systems. However, despite the emergence of integration as a global political priority, the extent to which efforts around integration have translated into action at the national level remains uncertain.

Process of developing the National Health in All Policies Framework to address social determinants of health in Tanzania Mainland: lessons learned, 2018 - 2022.

Introduction: social determinants of health (SDH) are the non-medical factors that contribute to various infectious and non-infectious diseases in Tanzania. Studies suggest that SDH account for 30-55% of health outcomes globally. Most SDH are outside the mandate of the health sector; hence, multi-sectoral collaboration through Health in All Policies (HiAP) is critical. Health in All Policies looks at public policies across sectors that consider health implications of decisions, seek synergies, use resources and avoid harmful health impacts to improve population health and health equity. This paper demonstrates lessons learned from the process of developing National HiAP Framework in Tanzania Mainland to address SDH. It is expected that countries will be able to learn and adopt what deems fit in their context as they address SDH to improve population health. Methods: different methods were used to promote multi-sectoral collaboration in addressing SDH through HiAP. They included consultations with Prime Minister's Office (PMO) as the coordinator of Government business for their buy-in. High-level advocacy meetings of Directors of Policy and Planning and Permanent Secretaries from sectoral ministries were conducted to move forward the HiAP agenda. Capacity building was provided for sectoral Ministries to understand HiAP concept and SDH. Interministerial collaboration meetings were convened to bring sectors together to identify SDH issues and key areas for inter-sectoral collaboration and develop National HiAP Framework to address SDH. Health in All Policies Secretariat coordinates the HiAP activities. Results: it has been noted that almost every sectoral ministry has a health component in its policy which contributes to the Tanzanian population's health. In this regard, every sectoral ministry has a role to play in addressing SDH for sustainable development. Political will is key in moving forward the HiAP agenda. The role of PMO is significant to ensure inter-sectoral collaboration. Achieving the national and Sustainable Development Goals require strong collaboration among sectors and stakeholder coordination at all levels through HiAP. Conclusion: implementing HiAP is a win-win situation. It enhances inter-sectoral collaboration, benefiting each sector to achieve its health-related strategic indicators and ultimately achieve national and global goals.

Aflatoxins posing threat to food safety and security in Pakistan: Call for a one health approach.

Aflatoxins are among the most important mycotoxins due to their widespread occurrence and adverse impacts on humans and animals. These toxins and/or their metabolites cannot be destroyed with cooking or boiling methods. Therefore, consumption of aflatoxin-contaminated food may lead to impaired growth, compromised immunity, stomach and liver cancer, and acute toxicity. These adverse effects along with food wastage might have detrimental consequences on a country's economy. Several studies from Pakistan reported a high prevalence of aflatoxins in food and feed commodities (Range; milk = 0.6-99.4%, cereals, and grains = 0.38-41%, animal feed = 31-100%). Notably, Pakistan reported very high figures of impaired child growth-stunted 40.2%, wasted 17.7% and underweight 28.9%-that could be associated with the higher aflatoxin prevalence in food items. Importantly, high aflatoxins prevalence, i.e. 100%, 69% and 60.5%, in children has been reported in Pakistan. Food and feed are more prone to aflatoxin contamination due to Pakistan's hot and humid climate; however, limited awareness, inadequate policy framework, and weak implementation mechanisms are the major obstacles to effective control. This review will discuss aflatoxins prevalence, associated risk factors, adverse health effects, required regulatory regime, and effective control strategies adopting the One Health approach to ensure food safety and security.

Professional and governmental policy on community pharmacy: A 10-year policy review and comparative analysis (2008-2017).

Background: An increased role for community pharmacy might bring considerable value to healthcare systems, for example by relieving workload elsewhere in primary care through the provision of medicines-related services. This requires support from appropriate policy. Objectives: To explore the representation of community pharmacy in governmental and professional health policies in England (2008-2017) using the Walt and Gilson policy framework. Methods: Relevant policies were identified using a systematic search. The content of these policies was analysed using thematic analysis. The transparency of evidence use during the policymaking process was scored in four keys areas using a recognised tool: diagnosis; proposal; implementation; testing and evaluation. Key actors involved in the development of each policy were summarised. Results: 18 governmental policies and 7 pharmacy profession policies were included. Convergence between governmental and professional policy content was identified in 6 areas: healthcare workforce; behaviour and collaborations; utilising technology; urgent care; long-term health conditions; service provision. Divergence was identified in 5 areas: enquiry-driven culture; quality in healthcare; cancer care; mental health care; commissioning. Professional policies were less transparent in their use of evidence and had less documentation of the involvement of key actors, such as professionals and the public. Conclusions: The profession has limited influence and/or representation in governmental policies. This may be because professional policies did not reflect concerns expressed in governmental policies and had low credibility due to limited stakeholder involvement and transparency about evidence use.

Towards a dialogical and progressive educational policy framework: Manoeuvring a middle way among the polarised constructs.

Policy science and practice around the world, including educational policies, are dominated by popular, extreme approaches such as market-orientated approaches at one end and critical argumentative approaches at the other end. This study therefore aims to manoeuvre a middle way to propose a dialogical and progressive educational policy framework and explores the research question: 'how could a middle way (a dialogical and progressive framework) be manoeuvred among the polarised policy constructs?' The study embraces Lynham's five phases of theory building as the basis for this research, which includes conceptual development, operationalisation, confirmation/disconfirmation, application, and continuous refinement. The study explores some of the known existing policy frameworks for conceptual mapping, investigates the underlying dynamics and discourses to operationalise, uses diverse arguments in the literature to confirm/disconfirm and proposes to mark the emerging patterns, trends, and gaps in policy research to apply and refine. The study contends that if it is possible to have a polarised market-oriented and critical argumentative policy frameworks, it is then possible to have a dialogical, progressive middle-way policy framework. The study had to limit to the most important and related theories, and models to focus. Future works could explore a wide range of other relevant theories and models to further investigate this framework. Furthermore, application of the proposed dialogical, progressive educational policy framework in specific context/case may help to refine it. The study contends that the proposed middle way is not a perfect space but a potential space in which a dialogical and progressive educational policy may thrive.

Policy frameworks and regulations for the research and development of cell-based meats: Systematic literature review.

Cell-based meats have been discussed in terms of improving sensory factors for consumer acceptance and remedying the environmental problems of conventional livestock production. The improvement accompanies the modification of the production process and the consumption habit regarding cell-based meats. This review analyzed the current status of policies that promote cell-based meats, the related literature, and policy frameworks for the regulation and promotion of cell-based meats in the European Union, Singapore, the United States, Israel, and Japan. Sample selection was based on language, that is, English and Japanese. Further selection was exploratory to analyze the diverse degree of the integration of cell-based meats in policies. The region and countries were selected as leading cases, thereby enabling a policy comparison because they host global corporations that produce cell-based meat. The literature review examined peer-reviewed social science articles from 2013 to early 2022 on policies that promote cell-based meats. The results of the policy surveys revealed that regulations focused on the safety of and measures to display these novel foods by conducting a premarket assessment. These regulations are the basis for developing cell-based meats. Furthermore, some countries and the region being studied justified their support for cell-based meats by implementing action plans for decarbonization and food security. However, unclear communication regarding the nomenclature of cell-based meats is likely to slow down the development of cell-based meats. Moreover, religious beliefs and other cultural perceptions, including animal welfare, leave much room to research such promotion. Similarly, environmental impact assessments of cell-based meats demand further considerations and discussions to accompany evidence-based policymaking for cell-based meats.

eHealth policy framework in Low and Lower Middle-Income Countries; a PRISMA systematic review and analysis.

BACKGROUND: Low and lower middle-income countries suffer lack of healthcare providers and proper workforce education programs, a greater spread of illnesses, poor surveillance, efficient management, etc., which are addressable by a central policy framework implementation. Accordingly, an eHealth policy framework is required specifically for these countries to successfully implement eHealth solutions. This study explores existing frameworks and fills the gap by proposing an eHealth policy framework in the context of developing countries. METHODS: This PRISMA-based (PRISMA Preferred Reporting Items For Systematic Reviews and Meta-Analyses) systematic review used Google Scholar, IEEE, Web of Science, and PubMed latest on 23rd May 2022, explored 83 publications regarding eHealth policy frameworks, and extracted 11 publications scrutinizing eHealth policy frameworks in their title, abstract, or keywords. These publications were analyzed by using both expert opinion and Rstudio programming tools. They were explored based on their developing/developed countries' context, research approach, main contribution, constructs/dimensions of the framework, and related categories. In addition, by using cloudword and latent semantic space techniques, the most discussed concepts and targeted keywords were explored and a correlation test was conducted to depict the important concepts mentioned in the related literature and extract their relation with the targeted keywords in the interest of this study. RESULTS: Most of these publications do not develop or synthesize new frameworks for eHealth policy implementation, but rather introduce eHealth implementation frameworks, explain policy dimensions, identify and extract relevant components of existing frameworks or point out legal or other relevant eHealth implementation issues. CONCLUSION: After a thorough exploration of related literature, this study identified the main factors affecting an effective eHealth policy framework, found a gap in the context of developing countries, and proposed a four-step eHealth policy implementation guideline for successful implementation of eHealth in the context of developing. The limitation of this study is the lack of a proper amount of practically implemented eHealth policy framework cases in developing countries published in the literature for the review. Ultimately, this study is part of the BETTEReHEALTH (More information about the BETTEReHEALTH project at https://betterehealth.eu ) project funded by the European Union Horizon's 2020 under agreement number 101017450.

The gaps between the new EU legislation on in vitro diagnostics and the on-the-ground reality.

The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years - a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the In Vitro Diagnostic Regulation (IVDR) across Europe, and only limited awareness of the different structures of national systems involved in implementing IVDR, with consequent risks for patient and consumer access to in vitro diagnostics (IVDs). The tentative conclusion from these consultations is that despite a will across the sector to seek workable solutions, the obstacles remain formidable, and the potential solutions so far proposed remain more a matter of aspirations than of clear pathways.

Empowering quality data - the Gordian knot of bringing real innovation into healthcare system.

OBJECTIVES: The introduction of Personalised Medicine (PM) into healthcare systems could benefit from a clearer understanding of the distinct national and regional frameworks around the world. Recent engagement by international regulators on maximising the use of real-world evidence (RWE) has highlighted the scope for improving the exploitation of the treasure-trove of health data that is currently largely neglected in many countries. The European Alliance for Personalised Medicine (EAPM) led an international study aimed at identifying the current status of conditions. METHODS: A literature review examined how far such frameworks exist, with a view to identifying conducive factors - and crucial gaps. This extensive review of key factors across 22 countries and 5 regions revealed a wide variety of attitudes, approaches, provisions and conditions, and permitted the construction of a comprehensive overview of the current status of PM. Based on seven key pillars identified from the literature review and expert panels, the data was quantified, and on the basis of further analysis, an index was developed to allow comparison country by country and region by region. RESULTS: The results show that United States of America is leading according to overall outcome whereas Kenya scored the least in the overall outcome. CONCLUSIONS: Still, common approaches exist that could help accelerate take-up of opportunities even in the less prosperous parts of the world.

Fighting Cancer around the World: A Framework for Action.

Tackling cancer is a major challenge right on the global level. Europe is only the tip of an iceberg of cancer around the world. Prosperous developed countries share the same problems besetting Europe-and the countries and regions with fewer resources and less propitious conditions are in many cases struggling often heroically against a growing tide of disease. This paper offers a view on these geographically wider, but essentially similar, challenges, and on the prospects for and barriers to better results in this ceaseless battle. A series of panels have been organized by the European Alliance for Personalised Medicine (EAPM) to identify different aspects of cancer care around the globe. There is significant diversity in key issues such as NGS, RWE, molecular diagnostics, and reimbursement in different regions. In all, it leads to disparities in access and diagnostics, patients' engagement, and efforts for a better understanding of cancer.

Making Sure That Orphan Incentives Tip the Right Way in Europe.

The delicate balance of funding research and development of treatments for rare disease is only imperfectly achieved in Europe, and even the current provisional equilibrium is under a new threat from well-intentioned policy changes now in prospect that could-in addition to the intrinsic complexities of research-reduce the incentives on which commercial activity in this area is dependent. The European Union review of its pharmaceutical legislation, for which proposals are scheduled to appear before the end of 2022, envisages adjusting the decade-old incentives to meet objectives that are more precisely targeted. However, researchers, physicians, patients and industry have expressed concerns that ill-considered modifications could have unintended consequences in disrupting the current balance and could reduce rather than increase the flow of innovative treatments for rare diseases.

How Can the EU Beating Cancer Plan Help in Tackling Lung Cancer, Colorectal Cancer, Breast Cancer and Melanoma?

Cancer is the second leading cause of mortality in EU countries, and the needs to tackle cancer are obvious. New scientific understanding, techniques and methodologies are opening up horizons for significant improvements in diagnosis and care. However, take-up is uneven, research needs and potential outstrip currently available resources, manifestly beneficial practices-such as population-level screening for lung cancer-are still not generalised, and the quality of life of patients and survivors is only beginning to be given attention it merits. This paper, mainly based on a series of multistakeholder expert workshops organised by the European Alliance for Personalised Medicine (EAPM), looks at some of those specifics in the interest of planning a way forward. Part of this exercise also involves taking account of the specific nature of Europe and its constituent countries, where the complexities of planning a way forward are redoubled by the wide variations in national and regional approaches to cancer, local epidemiology and the wide disparities in health systems. Despite all the differences between cancers and national and regional resources and approaches to cancer care, there is a common objective in pursuing broader and more equal access to the best available care for all European citizens.

Tackling Thyroid Cancer in Europe-The Challenges and Opportunities.

Thyroid cancer (TC) is the most common malignancy of the endocrine system that affects the thyroid gland. It is usually treatable and, in most cases, curable. The central issues are how to improve knowledge on TC, to accurately identify cases at an early stage that can benefit from effective intervention, optimise therapy, and reduce the risk of overdiagnosis and unnecessary treatment. Questions remain about management, about treating all patients in referral centres, and about which treatment should be proposed to any individual patient and how this can be optimised. The European Alliance for Personalised Medicine (EAPM) hosted an expert panel discussion to elucidate some of the challenges, and to identify possible steps towards effective responses at the EU and member state level, particularly in the context of the opportunities in the European Union's evolving initiatives-notably its Beating Cancer Plan, its Cancer Mission, and its research funding programmes. Recommendations emerging from the panel focus on improved infrastructure and funding, and on promoting multi-stakeholder collaboration between national and European initiatives to complement, support, and mutually reinforce efforts to improve patient care.

European Health Data Space-An Opportunity Now to Grasp the Future of Data-Driven Healthcare.

The May 2022 proposal from the European commission for a 'European health data space' envisages advantages for health from exploiting the growing mass of health data in Europe. However, key stakeholders have identified aspects that demand clarification to ensure success. Data will need to be freed from traditional silos to flow more easily and to cross artificial borders. Wide engagement will be necessary among healthcare professionals, researchers, and the patients and citizens that stand to gain the most but whose trust must be won if they are to allow use or transfer of their data. This paper aims to alert the wider scientific community to the impact the ongoing discussions among lawmakers will have. Based on the literature and the consensus findings of an expert multistakeholder panel organised by the European Alliance for Personalised Medicine (EAPM) in June 2022, it highlights the key issues at the intersection of science and policy, and the potential implications for health research for years, perhaps decades, to come.

Tackling Mantle Cell Lymphoma in Europe.

An expert panel convened by the European Alliance for Personalized Medicine (EAPM) reflected on achievements and outstanding challenges in Europe in mantle cell lymphoma (MCL). Through the prism of member state experience, the panel noted advances in outcomes over the last decade, but highlighted issues constituting barriers to better care. The list notably included availability of newer treatments, infrastructure and funding for related testing, and shortages of relevant skills and of research support. The prospect of improvements was held to reside in closer coordination and cooperation within and between individual countries, and in changes in policy and scale of investment at both national and EU levels.

Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring.

Liquid biopsy (LB) is a minimally invasive method which aims to detect circulating tumor-derived components in body fluids. It provides an alternative to current cancer screening methods that use tissue biopsies for the confirmation of diagnosis. This paper attempts to determine how far the regulatory, policy, and governance framework provide support to LB implementation into healthcare systems and how the situation can be improved. For that reason, the European Alliance for Personalised Medicine (EAPM) organized series of expert panels including different key stakeholders to identify different steps, challenges, and opportunities that need to be taken to effectively implement LB technology at the country level across Europe. To accomplish a change of patient care with an LB approach, it is required to establish collaboration between multiple stakeholders, including payers, policymakers, the medical and scientific community, and patient organizations, both at the national and international level. Regulators, pharma companies, and payers could have a major impact in their own domain. Linking national efforts to EU efforts and vice versa could help in implementation of LB across Europe, while patients, scientists, physicians, and kit manufacturers can generate a pull by undertaking more research into biomarkers.

Meeting the Need for a Discussion of Unmet Medical Need.

As Europe and the world continue to battle against COVID, the customary complacency of society over future threats is clearly on display. Just 30 months ago, such a massive disruption to global lives, livelihoods and quality of life seemed unimaginable. Some remedial European Union action is now emerging, and more is proposed, including in relation to tackling "unmet medical need" (UMN). This initiative-directing attention to the future of treating disease and contemplating incentives to stimulate research and development-is welcome in principle. But the current approach being considered by EU officials merits further discussion, because it may prove counter-productive, impeding rather than promoting innovation. This paper aims to feed into these ongoing policy discussions, and rather than presenting research in the classical sense, it discusses the key elements from a multistakeholder perspective. Its central concern is over the risk that the envisaged support will fail to generate valuable new treatments if the legislation is phrased in a rigidly linear manner that does not reflect the serpentine realities of the innovation process, or if the definition placed on unmet medical need is too restrictive. It cautions that such an approach presumes that "unmet need" can be precisely and comprehensively defined in advance on the basis of the past. It cautions that such an approach can reinforce the comfortable delusion that the future is totally predictable-the delusion that left the world as easy prey to COVID. Instead, the paper urges reflection on how the legislation that will shortly enter the pipeline can be phrased so as to allow for the flourishing of a culture capable of rapid adaptation to the unexpected.

Towards Better Pharmaceutical Provision in Europe-Who Decides the Future?

Significant progress has been achieved in human health in the European Union in recent years. New medicines, vaccines, and treatments have been developed to tackle some of the leading causes of disease and life-threatening illnesses. It is clear that investment in research and development (R&D) for innovative medicines and treatments is essential for making progress in preventing and treating diseases. Ahead of the legislative process, which should begin by the end of 2022, discussions focus on how Europe can best promote the huge potential benefits of new science and technology within the regulatory framework. The challenges in European healthcare were spelled out by the panellists at the roundtable organised by European Alliance for Personalised Medicine (EAPM). Outcomes from panellists' discussions have been summarized and re-arranged in this paper under five headings: innovation, unmet medical need, access, security of supply, adapting to progress, and efficiency. Some of the conclusions that emerged from the panel are a call for a better overall holistic vision of the future of pharmaceuticals and health in Europe and a collaborative effort among all stakeholders, seeing the delivery of medicines as part of a broader picture of healthcare.