Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.

BACKGROUND: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At "midterms" of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward. METHODS: During the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation's implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session. RESULTS: Overall "readiness" for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process. CONCLUSIONS: At "midterms" of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA's Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run.

The Italian National Institute of Health helpline to quit tobacco and nicotine dependence: 20 years of activity.

INTRODUCTION: Tobacco use is one of the world's leading preventable causes of death and is a major preventable risk factor of non-communicable diseases. Although smokers are aware of the health risks, their attempts to quit often fail, primarily due to the strong nicotine and/or tobacco dependence. Antismoking helplines have become an integral part of tobacco control efforts in many countries. In Italy, the ISS Antismoking Helpine is active since 2000. MATERIAL AND METHODS: The professional staff of the ISS Antismoking Helpline have gathered socio-demographic and smoking-related data via an electronic form, related to the received calls. The collected data have been processed in a dedicated database and analyzed to monitor the use and the quality of the service. In this study, a descriptive statistical analysis was conducted to inform about the activity of the helpline over the years. RESULTS: From May 2003 to June 2023 the helpline received 99,423 calls. Most smokers called to receive "support to quit" (82.6%). Counselling was provided in 11.4% of cases, and in the last two years has been strongly increased (40.0% of cases). The percentage of users requesting information on emerging tobacco and nicotine products is 1.2%, even if in 2023 this percentage has risen significantly (6.0%). Two legislative measures (in 2012 and in 2016) required to add the helpline number to all packets of tobacco cigarettes. Accordingly, the offer of counselling increased from 2.6% to 12.2%. CONCLUSIONS: The available resources in tobacco control, including the helpline, are still not sufficient to meet all the users needs. Adequate policies and stable funding to fight tobacco and nicotine dependence need increased commitment from government institutions to ensure equal access to treatments for all Italian citizens.

A Brief Overview of the Development and Significance of Modern Scientific Medicine in China: Take Chinese Academy of Medical Science and Peking Union Medical College as an Example.

Since the early 20th century, China has gradually established a clinical, educational, and research system centered around modern scientific medicine, which has now become the dominant force in China's medical and health system and services, with the construction and development of the Chinese Academy of Medical Sciences and Peking Union Medical College as the most prominent symbol. The scientific medicine in the new era requires close cooperation across multiple disciplines and fields to build a high-quality and efficient medical and health service system. It also involves combining the excellent traditional Chinese culture with Western medicine to explore a unique path of modern scientific medicine with Chinese characteristics.

Patient engagement in a Canadian health research funding institute: implementation and impact.

BACKGROUND: Patient engagement (PE) or involvement in research is when patient partners are integrated onto teams and initiatives (not participants in research). A number of health research funding organisations have PE frameworks or rubrics but we are unaware of them applying and reporting on their own internal PE efforts. We describe our work at the Canadian Institutes of Health Research's Institute of Musculoskeletal Health and Arthritis (CIHR IMHA) to implement, evaluate and understand the impact of its internal PE strategy. METHODS: A co-production model was used involving patient partners, a PE specialist and staff from IMHA. A logic model was co-developed to guide implementing and evaluating IMHA's PE strategy. Some of evaluating the PE strategy and understanding its impact was a collaboration between the Public and Patient Engagement Collaborative (McMaster University) and IMHA. RESULTS: IMHA convened a PE Research Ambassador (PERA) group which co-led this work with the support of a PE specialist. In doing so, PERA had a number of meetings since 2020, set its own priorities and co-produced a number of outputs (video, publications, webinars, blog and modules called the How-to Guide for PE in Research). This work to evaluate and measure impacts of IMHA's PE strategy revealed positive results, for example, on PERA members, Institute Advisory Board members and staff, as well as beyond the institute based on uptake and use of the modules. Areas for improvement are mainly related to increasing the diversity of PERA and to improving accessibility of the PE outputs (more languages and formats). CONCLUSIONS: Implementing a PE strategy within CIHR IMHA resulted in several PE activities and outputs with impacts within and beyond the institute. We provide templates and outputs related to this work that may inform the efforts of other health research funding organisations. We encourage health research funders to move beyond encouraging or requiring PE in funded projects to fully 'walk the talk' of PE by implementing and evaluating their own PE strategies.

[Analysis of the work of the Immunohistochemical Quality Control Center of the Russian Medical Academy of Continuous Professional Education of the Ministry of Health of Russia in 2023]. / Analiz raboty Tsentra kontrolya kachestva immunogistokhimicheskikh issledovanii FGBOU DPO «RMANPO¼ Minzdrava Rossii v 2023 godu.

The article demonstrates a detailed analysis of the results of the rounds of quality control of immunohistochemical studies conducted by the Central Committee of the Immunohistochemical Quality Control Center of the Russian Medical Academy of Continuous Professional Education of the Ministry of Health of Russia in 2023. Typical shortcomings and errors in the immunohistochemical examination of various tumors have been identified and ways to eliminate them are given. Particular attention is paid to defining a panel of standard breast cancer markers and eliminating the shortcomings of immunohistochemical examination of markers of accompanying diagnosis.

Germany's national public health gets reorganized: A new institute shall take center stage.

In the aftermath of the COVID-19 pandemic, the German federal government recently orchestrated a fundamental change to its public health infrastructure. This reconstruction centers around the founding of a National Institute for Prevention and Education in Medicine (Bundesinstitut für Prävention und Aufklärung in der Medizin, BIPAM) at the cost of two federal institutions, the Robert Koch-Institute (RKI) and the Federal Center for Health Education (Bundeszentrale für gesundheitliche Aufklärung, BzGA). Thus, the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) plans to dissolve the BzGA and integrate its personnel into the future BIPAM. Further, all RKI research and surveillance activities related to non-communicable diseases, including AI methods development will be transferred into the BIPAM. The RKI responsibilities will solely focus on infectious diseases. According to announced plans of the BMG the primary objective for establishing the BIPAM is to address non-communicable diseases and enhance overall population health. However, the medical specialist training for public health remains non-academic at a state institution. Simultaneously the BMG already replaced two thirds of experts of the permanent commission on vaccination (Ständige Impfkommission, STIKO) and determined new procedures for appointing future expert commissioners. With these changes, Germany embarks on an extraordinary reshuffling of its national public health organizations and responsibilities, by fundamentally separating all issues around non-communicable diseases from those of infectious diseases. Germany's unraveled research tasks of public health authorities however remains unmet. Thus, 2024 marks a pivotal caesura for public health in the modern history of Germany.

The Journey of the Asian Forensic Sciences Network (AFSN) through Fifteen Years.

The Asian Forensic Sciences Network was formed in 2008 by a small group of six forensic institutes from six countries in Asia, with the vision to create a common platform for scientists in the region to come together to advance forensic science, raise quality standards, and foster collaboration. Since its inception, the network has experienced remarkable growth, now comprising 70 member institutes from 18 countries across Asia. An Annual Meeting & Symposium, hosted by a member institute each year, serves as a cornerstone event for the network. In addition, the network runs nine technical workgroups covering areas in Crime Scene Investigation, Digital Forensics, DNA, Fingerprint, Forensic Medicine, Illicit Drugs, Questioned Document, Toxicology, and Trace Evidence, alongside a dedicated Quality Assurance and Standards Committee. These workgroups and committee work in tandem with the AFSN Board to formulate strategies aligned with the network's core objectives. This paper chronicles AFSN's journey over the past fifteen years, highlighting the pivotal role of the Board and the Workgroups, as well as the dedicated passion and unwavering commitment of the members in shaping the network through numerous activities.

Collaborative science in action: A 20 year perspective from the Health and Environmental Sciences Institute (HESI) Cardiac Safety Committee.

The Health and Environmental Sciences Institute (HESI) is a nonprofit organization dedicated to resolving global health challenges through collaborative scientific efforts across academia, regulatory authorities and the private sector. Collaborative science across non-clinical disciplines offers an important keystone to accelerate the development of safer and more effective medicines. HESI works to address complex challenges by leveraging diverse subject-matter expertise across sectors offering access to resources, data and shared knowledge. In 2008, the HESI Cardiac Safety Committee (CSC) was established to improve public health by reducing unanticipated cardiovascular (CV)-related adverse effects from pharmaceuticals or chemicals. The committee continues to significantly impact the field of CV safety by bringing together experts from across sectors to address challenges of detecting and predicting adverse cardiac outcomes. Committee members have collaborated on the organization, management and publication of prospective studies, retrospective analyses, workshops, and symposia resulting in 38 peer reviewed manuscripts. Without this collaboration these manuscripts would not have been published. Through their work, the CSC is actively addressing challenges and opportunities in detecting potential cardiac failure modes using in vivo, in vitro and in silico models, with the aim of facilitating drug development and improving study design. By examining past successes and future prospects of the CSC, this manuscript sheds light on how the consortium's multifaceted approach not only addresses current challenges in detecting potential cardiac failure modes but also paves the way for enhanced drug development and study design methodologies. Further, exploring future opportunities and challenges will focus on improving the translational predictability of nonclinical evaluations and reducing reliance on animal research in CV safety assessments.

Technology transfer for COVID-19 vaccine in the Institute of Technology in Immunobiologicals (Bio-Manguinhos), Oswaldo Cruz Foundation. / Transferência de tecnologia para vacina contra COVID-19 no Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos), Fundação Oswaldo Cruz.

Innovation is an essential element for development and growth, but it consists of a long process of knowledge accumulation, so technology transfer is used to accelerate this process. This study mapped the particularities of the technology transfer process for the COVID-19 vaccine between AstraZeneca and the Institute of Technology in Immunobiologicals (Bio-Manguinhos), Oswaldo Cruz Foundation, and identified enablers, obstacles, and gaps. Our analysis investigated the process from selection of the most suitable partner to incorporation of the new technology based on a comprehensive literature review on this topic, combined with a case study. The results showed that, although many actions still have to be performed to maximize technology capacity gains, the lessons learned from the technology transfer process will be used in future and ongoing agreements.

A inovação é um elemento fundamental para o desenvolvimento e crescimento, mas constituída por um processo demorado de acúmulo de conhecimento. Uma das formas de acelerar tal processo é por meio da transferência de tecnologia. Este artigo mapeou as particularidades da transferência de tecnologia para a vacina contra COVID-19, celebrado entre a AstraZeneca e o Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos), Fundação Oswaldo Cruz, bem como reconheceu os seus facilitadores, seus entraves e suas lacunas. Para tanto, foi realizada uma análise desde a etapa da seleção do parceiro mais adequado até a incorporação da nova tecnologia. A metodologia utilizada se baseou em uma ampla revisão bibliográfica sobre o tema, aliada ao estudo de caso. Os resultados apontaram que, apesar de muitas ações ainda precisarem ser realizadas para que os ganhos de capacidade tecnológica sejam potencializados, as lições aprendidas com o processo de transferência de tecnologia servirão de aprendizado e serão utilizadas nos acordos futuros e em andamento.

La innovación es un elemento fundamental para el desarrollo y el crecimiento, pero consiste en un proceso de acumulación de conocimiento que requiere mucho tiempo. Una de las formas de acelerar este proceso es mediante la transferencia de tecnología. Este artículo mapeó las particularidades del proceso de transferencia de tecnología para la vacuna contra la COVID-19, celebrado entre AstraZeneca y el Instituto de Tecnología en Inmunobiológicos (Bio-Manguinhos), Fundación Oswaldo Cruz, además de reconocer los facilitadores, obstáculos y brechas. Para ello se realizó un análisis, desde la etapa de selección del socio más adecuado hasta la incorporación de la nueva tecnología. La metodología utilizada se basó en una amplia revisión bibliográfica sobre el tema, combinada con el estudio de caso. Los resultados mostraron que, si bien aún es necesario llevar a cabo muchas acciones para maximizar las ganancias de capacidad tecnológica, las lecciones aprendidas del proceso de transferencia de tecnología servirán como lecciones y se utilizarán en acuerdos futuros y en curso.

The impact of Covid-19 pandemic on the research portfolio and approval turnaround time at the Kenya Medical Research Institute.

BACKGROUND: The Covid-19 pandemic led to an unprecedented impact on many sectors globally including research. We assessed the impact of the Covid-19 pandemic on the research portfolio, and on the approval turnaround time for research protocols submitted to the Scientific and Ethics Review Unit (SERU), at the Kenya Medical Research Institute (KEMRI). METHODS: We compared research protocols submitted between October 01, 2019 and March 31, 2020 (Period 1), to those submitted between April 1 and September 30, 2020 (Period 2). A document review tool was used to extract data from the 198 research protocols reviewed and approved over the two periods. RESULTS: In the two periods under review, the single largest percentage of protocols (89/198, 45.4%) involved infectious and parasitic diseases, and the single largest percentage of study designs was cross-sectional (75/198, 38%). Before the pandemic, the median time taken to review KEMRI-linked protocols was 87 days and for non-KEMRI linked protocols it was 121 days. During the pandemic, approval turnaround time dropped for both KEMRI and non-KEMRI protocols to 66 days and 92 days, respectively, due to the streamlined processes at the KEMRI SERU. CONCLUSION: The research portfolio was minimally affected by the pandemic. The adoption of email submission, and faster-than-usual processing and review protocols during the pandemic reduced the approval turnaround time.