The new Italian National Immunization Technical Advisory Group (NITAG) and its commitment to endorse a new efficient National Immunization Plan in COVID-19 times.

Among the objectives of the WHO Global Vaccination Action Plan 2020-2025, there is the establishment, in all countries, of a National Immunization Technical Advisory Group (NITAG), an independent body with the aim of supporting and harmonising vaccination policies. Italy firstly established a NITAG in 2017; it contributed to the nation's immunization policies but fell short of its goal of becoming a true reference group. The newly appointed NITAG, made up of 28 independent experts, has the ambitious goal to promote the new National Immunization Prevention Plan (PNPV), to harmonise the current vaccination schedule with the anti-COVID-19 campaign, and to recover the vaccination coverage decline that occurred during the pandemic. The contact with the ECDC EU/EEA, the WHO Global NITAG networks, and all the national stakeholders needs to be reinforced in order to accomplish these aims. This paper describes the structure, organisation, and strategy of the new Italian NITAG.

The right to live independently and be included in the community.

The segregation and isolation of people with disabilities are global problems, rooted in legislation and policy, social norms and traditional practices. The right to live independently and be included in the community, contained in article 19 of the United Nations Convention on the Rights of Persons with Disabilities, was created to combat the phenomenon of institutionalization and to spur efforts towards its eventual eradication. This essay offers a commentary on article 19, drawing on its drafting history, on the interpretation provided by the responsible UN body and on the efforts by that body to monitor and encourage compliance. It emphasizes the extent of the transformation required to realize the full ambition of the article and the need for cooperation across UN treaty bodies.

The First 10 Years: Reflecting on Opportunities and Challenges of the Tobacco Products Scientific Advisory Committee of the United States Food and Drug Administration.

Introduction: Tobacco control policies have helped to reduce the health, social, and economic burden of commercial tobacco use worldwide. Little is known about the long-term impact of regulatory policies and functioning bodies that make recommendations to inform policies. The Tobacco Products Scientific Advisory Committee (TPSAC) of the U.S. Food and Drug Administration (FDA) was formed in 2009 to evaluate the safety, health, and dependence of tobacco products and provide related advice and recommendations to the FDA and the Secretary of Health and Human Services. This article describes the first 10 years of the TPSAC activities and reflects on the impact of their service on regulatory actions.Methods: We reviewed public documents from the 2010-2019 TPSAC meetings to examine the purposes, TPSAC decisions, public health participation in meetings, and concordance of the TPSAC recommendations with regulatory actions. Meeting agendas, transcripts, public testimony, and presentations were reviewed to obtain this information.Results: Since 2010, the TPSAC held 25 public meetings with 178 speakers who provided oral public testimony. Sixty-four percent of meetings were held from 2010 to 2012, when three congressionally mandated reports were due on the topics of menthol cigarettes, harmful and potentially harmful constituents in tobacco products, and dissolvable tobacco products. Forty-four percent of meetings focused on menthol cigarettes, 32% on modified risk tobacco products, 16% on harmful and potentially harmful constituents, 12% on dissolvable tobacco, and 4% on tobacco addiction/dependence. FDA regulatory actions were largely nonconcordant with voting decisions by TPSAC.Conclusions: The TPSAC has evaluated an enormous amount of science during the first 10 years, but their influence on regulatory policies has been limited. The TPSAC roles and functioning should be reevaluated to determine how TPSAC can better fulfill its mandate to inform the FDA's regulatory decision making, which could ultimately reduce the burden of tobacco use in the United States.

LeRoy Walters's Legacy of Bioethics in Genetics and Biotechnology Policy.

LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades.

The National Vaccine Advisory Committee at 30: Impact and opportunity.

Thirty years after passage of legislation that created the National Vaccine Advisory Committee (NVAC) "to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines," this review reflects NVAC's role and impact on the U.S. vaccine and immunization enterprise as an external advisor to the Department of Health and Human Services. We reviewed the history of NVAC in the context of the principles of its establishment, with a focus on its reports and recommendations. We performed a systematic literature review to identify NVAC reports published in widely-accessible public health journals, and we reviewed the available archives to identify other reports and resolutions approved by the committee not published in journals. We characterized key issues considered by NVAC according to the five goals of the 2010 National Vaccine Plan. The predominance of NVAC activities to date related to the implementation of immunization across the lifespan and the many aspects of the system needed to foster the goal of full immunization. Reflecting on the impacts of NVAC to date, this review identified 30 NVAC approved reports published in journals, 22 stand-alone resolutions, and 26 unique unpublished reports. The development of new and improved vaccines continues to represent a significant priority for NVAC, and we identified several challenges related to future vaccine innovation. Given the many factors that impact on policy changes in the vaccine and immunization enterprise, we encountered challenges associated with demonstrating attribution of specific policy changes to NVAC recommendations. Although difficult to quantify, this review suggests that NVAC played an important role in the improvements in the U.S. immunization enterprise over the past 30 years and that NVAC can and will continue to play an important role supporting U.S. immunization going forward.

The political economy of bovine tuberculosis in Great Britain.

A brief history of bovine tuberculosis (bTB) and its control in Great Britain (GB) is presented. Numerous diverse policies to control the disease in humans, cattle and wildlife have been pursued over the last 100 years and many millions of pounds have been spent. After notable success in reducing the incidence and prevalence of bTB in cattle in GB from the 1950s to the mid-1980s, the geographical spread of the disease and the number of cattle slaughtered have increased continually since that time, with a high point of bTB incidence in 2008. This increase appeared to coincide with changing policy regarding the control of the disease in badgers, with a more humane approach adopted and with strengthened protection for badgers through legislation. Indeed, there has been much controversy in the debate on the role of badgers in disease transmission to cattle and the need for their control as vectors of the disease. The issue has attracted the attention of the media and there have been various commissioned research projects, trials and public consultations. The findings of two social science investigations presented as examples showed that citizens generally believed that bTB in cattle is an important issue that needs to be tackled, but objected to badgers being killed, whilst cattle farmers were willing to pay around £17/animal/year for a bTB cattle vaccine. It is noted that successes regarding the control of bTB in other countries have combined both cattle and wildlife controls and involved industry working in close partnership with government.

L'auteur retrace brièvement l'histoire de la tuberculose bovine et de la lutte contre cette maladie en Grande-Bretagne. Diverses mesures sanitaires ont été appliquées au cours des cent dernières années afin de maîtriser la maladie chez l'homme, chez les bovins et dans la faune sauvage, pour une dépense totale de plusieurs millions de livres. Après la chute remarquable de l'incidence et de la prévalence de la tuberculose bovine en Grande-Bretagne enregistrée depuis les années 50, la situation s'est inversée au milieu des années 80 et tant la distribution géographique de la maladie que le nombre de bovins abattus n'ont cessé de croître depuis cette date, l'année 2008 marquant le pic de l'incidence de la tuberculose bovine. Il est désormais établi que cette hausse a coïncidé avec l'évolution des politiques de lutte contre la tuberculose chez les blaireaux, à la faveur d'une approche plus respectueuse du bien-être animal qui s'est traduite par une protection renforcée des blaireaux dans la législation. En effet, le rôle des blaireaux dans la transmission de la tuberculose aux bovins et l'impératif de lutter contre les blaireaux en tant que vecteurs ont fait l'objet de très fortes controverses. Cette question a attiré l'attention des médias et il y a eu de nombreux projets de recherche commandités sur le sujet, d'expériences et de consultations publiques. D'après deux enquêtes sociologiques citées par l'auteur, les citoyens étaient généralement convaincus de l'importance de la tuberculose chez les bovins et de la nécessité de s'y attaquer mais ils s'opposaient aux mesures d'abattage des blaireaux, tandis que les éleveurs de bovins étaient disposés à payer environ 17 livres par bovin et par année pour pouvoir vacciner leurs bovins contre la tuberculose bovine. L'auteur fait observer que les succès enregistrés dans d'autres pays dans la lutte contre la tuberculose bovine sont liés à l'application combinée de mesures de contrôle chez les bovins et dans la faune sauvage et à une étroite collaboration entre les éleveurs et le gouvernement.

El autor repasa sucintamente la historia de la tuberculosis bovina y de su control en Gran Bretaña. En los últimos 100 años se han aplicado numerosas y variadas políticas y se han invertido muchos millones de libras para combatir la enfermedad en el ser humano, el ganado vacuno y la fauna silvestre. Entre mediados del decenio de 1950 y mediados del de 1980 se trabajó con notable éxito para reducir la incidencia y prevalencia de la enfermedad en el ganado vacuno británico. Pero a partir de ahí hubo una progresión constante en la propagación geográfica de la enfermedad y en el número de cabezas de ganado sacrificadas, con un máximo de incidencia registrado en 2008. Tal incremento parece coincidir con una inflexión de la política aplicada para luchar contra la enfermedad en los tejones, con la adopción de métodos más clementes y de medidas legislativas que instauraban un mayor nivel de protección de los tejones. Ha habido en efecto una gran controversia acerca del papel de los tejones en los procesos de transmisión de la enfermedad al ganado vacuno y la necesidad de controlar a esos animales como vectores de la infección. El tema ha suscitado gran atención mediática y ha sido objeto de una serie de proyectos de investigación, experimentos y consultas públicas. Según demuestran las conclusiones de dos investigaciones de ciencias sociales presentadas como ejemplo, en general los ciudadanos pensaban que la tuberculosis bovina en el ganado era un problema importante al que había que dar respuesta, pero se oponían al sacrificio de los tejones, a la vez que los ganaderos estaban dispuestos a pagar alrededor de 17 libras/animal/año por la vacunación antituberculosa de sus rebaños vacunos. El autor señala que los éxitos obtenidos en otros países a la hora de combatir la tuberculosis bovina pasan por instaurar controles a la vez en el ganado y en la fauna silvestre y por lograr que la industria trabaje en estrecha asociación con las instancias públicas.

A History of the International Commission on Non-Ionizing Radiation Protection.

Concern about health risks from exposure to non-ionizing radiation (NIR) commenced in the 1950s after tracking radars were first introduced during the Second World War. Soon after, research on possible biological effects of microwave radiation in the former Soviet Union and the U.S. led to public and worker exposure limits being much lower in Eastern European than in Western countries, mainly because of different protection philosophies. As public concern increased, national authorities began introducing legislation to limit NIR exposures from domestic microwave ovens and workplace devices such as visual display units. The International Radiation Protection Association (IRPA) was formed in 1966 to represent national radiation protection societies. To address NIR protection issues, IRPA established a Working Group in 1974, then a Study Group in 1975, and finally the International NIR Committee (INIRC) in 1977. INIRC's publications quickly became accepted worldwide, and it was logical that it should become an independent commission. IRPA finally established the International Commission on Non-Ionizing Radiation Protection (ICNIRP), chartering its remit in 1992, and defining NIR as electromagnetic radiation (ultraviolet, visible, infrared), electromagnetic waves and fields, and infra- and ultrasound. ICNIRP's guidelines have been incorporated into legislation or adopted as standards in many countries. While ICNIRP has been subjected to criticism and close scrutiny by the public, media, and activists, it has continued to issue well-received, independent, science-based protection advice. This paper summarizes events leading to the formation of ICNIRP, its key activities up to 2017, ICNIRP's 25th anniversary year, and its future challenges.

The IMIA History Working Group: Inception through the IMIA History Taskforce, and Major Events Leading Up to the 50th Anniversary of IMIA.

Background: The 50th Anniversary of IMIA will be celebrated in 2017 at the World Congress of Medical Informatics in China. This takes place 50 years after the International Federation of Information Processing (IFIP) Societies approved the formation of a new Technical Committee (TC) 4 on Medical Information Processing, which was the predecessor of IMIA, under the leadership of Dr. Francois Grémy. The IMIA History Working Group (WG) was approved in 2014 to document and write about the history of the field and its organizations. Objectives: The goals of this paper are to describe how the IMIA History WG arose and developed, including its meetings and projects, leading to the forthcoming 50th Anniversary of IMIA. Methods: We give a chronology of major developments leading up to the current work of the IMIA History WG and how it has stimulated writing on the international history of biomedical and health informatics, sponsoring the systematic compilation and writing of articles and stories from pioneers and leaders in the field, and the organization of workshops and panels over the past six years, leading towards the publication of the contributed volume on the 50th IMIA Anniversary History as an eBook by IOS Press. Conclusions: This article leads up to the IMIA History eBook which will contain original autobiographical retrospectives by pioneers and leaders in the field, together with professional organizational histories of the national and regional societies and working groups of IMIA, with commentary on the main themes and topics which have evolved as scientific and clinical practices have changed under the influence of new insights, technologies, and the changing socio-economic, cultural and professional circumstances around the globe over the past 50 years.