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BACKGROUND: Point 7 of the Rome Declaration is aimed at improving data sharing and technological and knowledge transfer as instruments to implement health policies. OBJECTIVE: The objective of the current paper is to understand if the legal framework (especially at a transnational level) may actually help to achieve the objectives laid down by Principle 7 or if some interpretative or legislative actions will be necessary. METHODS: The paper analyses the legal sources at international and EU levels. RESULTS: The applicable rules are based on the idea that the information and material are forms of ‘property’ of the individuals or of the states (i.e., the sovereign). According to the traditional idea of property, the owner has a sort of absolute power over the res and is entitled to exclude others from any rights over the thing. The ‘property paradigm’ may be useful to protect some relevant interests, but it can also affect collective interests, such as those concerning health during the COVID-19 pandemic. CONCLUSIONS: In order to build a global system for the exchange of data and materials as provided for by Principle 7 of the Rome Declaration, a new legal approach should be elaborated which takes into consideration the international corpus of fundamental rights, including research freedom, the right to health and the principle of transnational ‘digital’ solidarity.

Best practice consent forms in company clinical trials detail the financial coverage for medical treatment of injuries. In trials undertaken for licensing purposes these arrangements can raise concerns. We detail three cases in which elements of the consent forms appear misleading and designed to elicit a consent to participation that might not be forthcoming if volunteers for these clinical trials were aware that what is outlined in principle is not likely to happen in practice. Beyond clinical trial participants, these consent forms have wider implications. Medical coverage of injuries sustained in a clinical trial is a nexus where business, scientific and ethical considerations meet. It is not clear that anyone to date has grappled with the issues posed. This paper uses three clinical trials to illustrate the problems to be addressed.

BACKGROUND: The prescription opioid epidemic in the United States (US) is well documented, and recent measures have reduced prescribing rates in that country. Evidence suggests opioid prescriptions have been rising recently in other countries too. OBJECTIVE: The current paper aimed to compare trends in opioid prescribing in England and the US. METHODS: Trends in rates of prescriptions per 100 members of the population were calculated for England and the US using publicly available government data on prescriptions and population statistics. RESULTS: Rates of prescribing are converging. At the peak of the US epidemic in 2012, there were 81.3 prescriptions per 100 people, but this had fallen to 43.3 by 2020. Prescribing peaked in England in 2016 at 43.2 prescriptions per 100 people, but has fallen only slightly, so that in 2020 there were 40.9 prescriptions per 100 people. CONCLUSION: The data indicate that levels of opioid prescribing in England are now similar to those in the US. They remain high in both countries, despite recent falls. This suggests the need for further measures to prevent over-prescribing and to support people who would benefit from withdrawing from these drugs.

BACKGROUND: Public access to data has been a major step in attempting to reduce bias in scientific literature. Data to verify efficacy outcomes are now more accessible; however, little has been done to ensure public access to harms data from RCTs, which are equally important in ascertaining possible misreporting and protecting safety. OBJECTIVE: The treatment for adolescents with depression study (TADS) has influenced most international practice guidelines for treating children and adolescents with depression, supporting first-line prescription of fluoxetine in combination with cognitive behavioural therapy (CBT). However, after over 30 publications by the TADS team, reporting on harms remains highly deficient and we aimed to redress this lack. METHODS: In undertaking a restoring invisible and abandoned trials (RIAT) reanalysis of TADS’ effectiveness and safety outcomes, we sought access to de-identified serious adverse events (SAE) data. RESULTS: This paper describes our unsuccessful efforts to obtain more detailed SAE data from TADS’ data custodians, highlighting several problematic blocks to comprehensive safety reporting. CONCLUSION: Comprehensive access to clinical trial data is necessary to ensure safe and fully informed guidelines for treating children and adolescents with depression.

BACKGROUND: The new type of virus (SARS-CoV-2 or COVID-19) from Coronaviridae family, discovered in 2019, caused a global pandemic with several massive lock-downs around the globe. Science and politicians became the center of world attention, receiving many questions without having clear answers. The hopes of many rested on vaccine development, which was done fast, facing novel challenges such as the massive production and distribution for several billions of people. OBJECTIVE: In this paper, the global reaction to the pandemic is reviewed along with some critical comments. METHOD: Different groups, including nations, took part in global lockdowns, while vaccine development was running in parallel without having enough capacity for some of the biggest medical demands in history. This review will bring together views from all interested groups in this pandemic crisis. RESULTS: The Western world waited too long (4 months), after the first case was confirmed in China, to introduce lock-down and safety measures. On the other side, vaccine development was done too fast to give clear long-term safety profiles of the medications developed. Due to the focus on development, it was overlooked that production and distribution of sterile products such as vaccines might have limitations globally. Usually when such limitations occur, power comes to the surface. Therefore, buyers who had power will get the vaccines they need first. However, we should recognize the economic impact that directly influenced healthcare funding. All of this will lead to post-crisis challenges, including depression, violence, suicide, migration, and many other social problems. CONCLUSIONS: The COVID-19 pandemic is a test for all of us, which many governments, industries and non-state actors are failing. It is a perfect “general probe” to detect some of the weaknesses of the current structure of global health. If politics and science do not work together to make a global production plan for vaccines and learn from this pandemic, then all of the lives lost were for nothing.

BACKGROUND: The health sector has long been affected by programs, actions, plans to digitize data and care processes with a view to better protecting individual health, as well as public health, resulting in a slow and uneven development of different and often incompatible national services. OBJECTIVE: This paper aims to explore the grounds behind the urgency of turning the digital priority into concrete actions, as acknowledged by political leaders in the Rome Declaration, by explaining the capacity of digital tools to enhance healthcare management and the current obstacles. METHODS: It considers the progressive extension of the EU institutions’ scope of action during the pandemic, the related supporting financial strategies launched and some examples of digital contact tracing systems. RESULTS: It emerged that the pandemic highlighted the inadequacy of purely national policies and the advantages of leveraging the digital health data processing for governance, surveillance and response to cross-border and global threats. CONCLUSIONS: Considering what emerged during the pandemic and the solemn commitment of the world’s major political leaders, the solution to the still existing technical and organizational interoperability issues will no longer be postponed.

BACKGROUND: The right to fully enjoy the highest possible state of health is certainly nothing new in the agenda of the world’s governments, and yet today it becomes a top priority not just in the restructuring of the health care system, but also in the promotion of multi-sector policies aimed at fostering and safeguarding the potential of every individual to achieve what could be defined, in general terms, as “common good”. OBJECTIVE: The current paper aimed at singling out the most useful strategies to promoting and achieving a healthy, more resilient and fairer society. METHODS : Starting from principles 1 and 14 of the Declaration of Rome, the aim was to analyse and develop the concepts of resilience and health, questioning their possible future variations against the background of the current health emergency and the increasingly radical widespread use of new technologies as universally-applied and cross-sectional tools for human progress. RESULTS: The “health for all” objective can only be achieved if we act on three key aspects: 1. Adding life to years; 2. Adding life to life; 3. Adding years to life. CONCLUSIONS: Each individual should raise their health awareness as a key resource to leading a fulfilling existence and to developing the required qualities to fully tap into health possibilities – whether integral or residual – to tackle life.

BACKGROUND: The COVID-19 pandemic represented a global earthquake that made the review of health policies aimed at strengthening common governance necessary. OBJECTIVE: The paper analyses the reasons for which the One Health approach has become fundamental in the control of pandemic phenomena, by arguing the necessity to place it at the basis not only of health policies but also of intersectoral policies. METHODS: The documents of the world organizations published before and after the pandemic were analyzed and studied in order to unpack the close relationship between new lifestyles and the increase of health risks. RESULTS: It emerged that the One Health approach is a paradigm that has been advanced for more than 30 years, but due to the inadequacy of local and world health policies, this approach was never translated into concrete actions to protect health, feeding problems at the cause of the COVID-19 pandemic. CONCLUSIONS: Having ascertained that the adoption of a One Health approach can no longer be postponed, this must be insisted on several interconnected sectors that establish the new concept of healthcare which, in addition to being interdisciplinary, necessarily takes on a global perspective.