International Journal of Risk & Safety in Medicine - Volume 33, issue 2
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: BACKGROUND: The Global Health Summit was held in Rome on 21 May 2021, co-hosted by the European Commission and Italy, as chair of the G20. Leaders, heads of regional and international organizations met to share lessons learned from the COVID-19 pandemic and to define the path ahead. OBJECTIVE: The present paper analyses the Rome Declaration as the first global health programme shared among the G20 Member States and based on the One-Health approach. METHODS: Documents such as preparatory work, official documents and observations from international organizations were analysed in order to provide a comprehensive review of…the Rome Declaration. RESULTS: Core principles of the Rome Declarations have emerged as well as the goal to improve cooperation among existing international organisations and national authorities. CONCLUSIONS: Governments’ future decisions will be the key to determine the end of the pandemic. The interconnected impacts on health, the environment, and social and economic dimensions will be a central theme of the overall narrative aiming at bringing the G20 process towards achieving a more inclusive and sustainable society.
Abstract: BACKGROUND: In the COVID-19 pandemic, coordination was certainly late, also due to the scarcity of information disseminated at the very beginning of the pandemic, when countries were inevitably taken by surprise. The lack of information, mainly attributable to the country from which everything seems to have started, has produced a huge delay and numerous uncertainties in the feedback of the WHO and international organizations. OBJECTIVE: The inevitably relevant issue, from a legal point of view, concerns the legitimacy, formal or in any case shared, of the authority in charge of coordinating reactions and policies. The paper analyses the…current legislation, soft and hard law, and the undertaken policies concerning emergency responses. METHODS: International and EU legislation analysis. RESULTS: The G20 understood that sustainable, flexible and agile funding systems for health emergencies are essential elements of pandemic prevention, preparedness and response. In EU there are many regulations about coordination and response to emergencies in practice in the EU and the Regulation (EU) 2021/522 (EU4Health programme), broadly extends the Union’s competence in the field of health and has the objective of strengthening the Union’s capacity for prevention, preparedness and rapid response in the event of serious cross-border threats to health. CONCLUSIONS: It is essential to formalize, within international agreements, the institutionalization of relationships, procedures, and the possible recognition of the reference figure. If in the European Union, at least partially, the protocols are there (even if the COVID-19 emergency has blown them up in principle), certainly in relations with non-EU countries the story is complicated, requiring specific agreements. This is the goal of the path started by the Rome Declaration of 21 May 2021 within the G20 – Global Health Summit.
Abstract: 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.
Keywords: Health, resilience, global development, new technologies, equality, inclusion, cooperation, subsidiarity
Abstract: 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.
Abstract: BACKGROUND: Member States (MSs) retain the powers to arrange their own national health care systems. However, EU has progressively developed an important co-ordination role. Such an institutional and legal framework has had a significant impact on how citizens’ right to health is dealt with at the European level. OBJECTIVE: The article intends to prove that the greater the cooperation among MSs the better for citizens’ right to health. METHODS: EU law – Directive 2011/24/EU. RESULTS: The Rome Declaration highlights the importance of all-of-society and health-in-all-policies approach. This underlines the “strategic” importance of the right…to health. CONCLUSIONS: The Rome Declaration may contribute to identifying public health not only as an individual, fundamental right but also as an obligation on both EU and Member States to ensure that right.
Keywords: Health care system, EU citizenship, cross-border health care
Abstract: BACKGROUND: The research is placed in the context of interdisciplinary medical-legal studies on the importance of promoting physical activity as a public health tool. OBJECTIVE: The aim was to highlight the tools that can be used by EU members for planning interventions aimed at overcoming the consequences of the COVID-19 pandemic and for responding to a future crisis. METHODS: First, the medical resources relating to the indirect and direct effects of the COVID-19 pandemic are analysed. Then, the results are compared with the measures of the EU bodies to verify the correspondence of the scientific arrests,…with the political-regulatory interventions. RESULTS: It was found that the prolonged closure of sports centres and the contagion from COVID-19 produce affects the body in a way that can only be recovered by motor activity. However, in the EU, there does not exist a regulatory harmonization about health issues that can directly impose the Members to implement their legislation to promote motor activity. CONCLUSIONS: The signing of the Rome Declaration at the Global Health Summit on 21 May 2021 constitutes an important and concrete commitment for the exchange in the medical-scientific field, and for an effective co-design of intervention strategies for the relaunch of physical activity within projects such as EU4Health and the two-year HealthyLifestyle4All campaign.
Abstract: BACKGROUND: The health emergency provoked by the worldwide pandemic requires immediate action to achieve the immunization of the population and to stop further contagion. The systems of public procurement needed to adapt in a very short time to reach agreements with the pharmaceutical industry. OBJECTIVE: Proposing options between the waiving of patent protections and innovative public procurement, principally the European Advance Purchase Agreements (APA). METHODS: A description of the actual situation and the necessary regulatory reforms. The sources are scientific articles, legislative compendiums and opinion pieces and the current press. RESULTS: The debate…over the waiving of patent protections at this time is both misleading and ineffective due to the economic and legal problems involved. The path of the APA has proven to be very effective, although some deficits should be corrected, principally regarding questions of transparency and confidentiality. CONCLUSIONS: Among the possible options for the acquisition of the COVID-19 vaccine and its universal access, agreements and cooperation between States and innovative industry are desirable. One successful path is that of the advance purchase agreements utilized by the European Union, another could be that of voluntary licensing. We propose following these routes as opposed to the waiving of patent protections.
Abstract: 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.
Keywords: Digitalization, data, public health, surveillance, tracing, interoperability
Abstract: 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.
Keywords: Data, information, open science, freedom of research, right to health