The Horizon Scanning System at The Italian Medicines Agency

Marangi, Michele; Ivanović, Jelena; Pistritto, Giuseppa

doi:10.1016/j.drudis.2019.04.010

Cited by 6 publications

(3 citation statements)

References 5 publications

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“…One of the oldest horizon scanning systems is the Italian Horizon Scanning Project [ 29 ], [ 30 ], [ 31 ], [ 32 ]. Established in the Veneto Regional Health Unit in 2006, it aims to inform payers (the Veneto region and other regions) and the national Medicines Agency AIFA (Agenzia Italiana del Farmaco) on upcoming medicines as well as medical devices with medicated coating.…”

Section: Resultsmentioning

confidence: 99%

“…To the author’s knowledge, this is the first survey on the existence of national and cross-national horizon scanning systems throughout the WHO European region. Previous studies – some of which were performed more than 15 years ago – only considered existing horizon scanning systems, usually with a focus on specific aspects, such as selection or search methodologies [ 32 ], [ 58 ], [ 59 ]. This study, which applied a wide geographic scope, showed that national systems with systematic use of horizon scanning for emerging health technologies are in place in a rather limited number of countries.…”

Section: Discussionmentioning

confidence: 99%

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“Ready for the future?” – Status of national and cross-country horizon scanning systems for medicines in European countries

Vogler

2022

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Background: Horizon scanning aims to systematically identify upcoming health technologies and thus allows policy-makers to be better prepared for the entry of new medicines with possibly high price tags into the national health system. The aim of this study is to survey the existence of national and cross-national horizon scanning systems for medicines in European countries. Methods: Experts working in public authorities (members of the Pharmaceutical Pricing and Reimbursement Information/PPRI network) in the WHO European region participated in surveys in 2014 and 2019 and informed about the status of horizon scanning in their country (response rate: 14 and 44 countries, respectively). Identified advanced horizon scanning systems as of 2019 were further investigated based on a literature review. Results: In 2019, six countries (Iceland, Italy, the Netherlands, Norway, Sweden, United Kingdom) reported systematic use of horizon scanning for some new medicines, and four countries (Austria, Denmark, France, Ireland) had some horizon scanning activities ongoing. No systematic use of horizon scanning was reported from the remaining 34 countries. The findings of the survey undertaken five years earlier were similar, with even fewer systems in place. A recent development is the establishment of cross-country initiatives of governments that aim, among others, to jointly perform horizon scanning; the International Horizon Scanning Initiative (IHSI) initiated by the Beneluxa collaboration is the most advanced undertaking in this respect. Countries with systematic use tend to have horizon scanning fully integrated in a system for the management of new medicines, and they use horizon scanning outcomes to inform decisions as to whether or not a Health Technology Assessment will be conducted and price negotiations be started. Differences between existing horizon scanning systems mainly concern the timings of scanning and reporting, the sources for the inputs and the accessibility of the findings. Conclusion: There appears to be a discrepancy between the perceived importance of horizon scanning based on some eye-opening examples in the past and its actual implementation in European health systems. The latter is likely attributable to horizon scanning being resource-intensive. The establishment of new national and international horizon scanning systems offers the opportunity to investigate their impact on sustainable access to affordable medicines from the start.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“Ready for the future?” – Status of national and cross-country horizon scanning systems for medicines in European countries

Vogler

2022

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“…These and other emerging types of therapeutics challenge current regulatory practices and regulators are responding by using horizon scanning to be more alert to the new technologies coming through development to ensure they can meet expertise gaps in the regulation of these technologies (15,(57)(58)(59). Independent horizon-scanning groups are also developing to support regulatory and policy development such as the Innovation Observatory, which is a national horizon scanning facility funded by the National Institute for Health Research in the UK.…”

Section: Evolving Therapeutic Landscapementioning

confidence: 99%

Future directions in regulatory affairs

Chisholm

Critchley²

2023

Front. Med.

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The field of regulatory affairs deals with the regulatory requirements for marketing authorization of therapeutic products. This field is facing a myriad of forces impacting all aspects of the development, regulation and value proposition of new therapeutic products. Changes in global megatrends, such as geopolitical shifts and the rise of the green economy, have emphasized the importance of manufacturing and supply chain security, and reducing the environmental impacts of product development. Rapid changes due to advances in science, digital disruption, a renewed focus on the centrality of the patient in all stages of therapeutic product development and greater collaboration between national regulatory authorities have been accelerated by the COVID-19 pandemic. This article will discuss the various trends that are impacting the development of new therapies for alleviating disease and how these trends therefore impact on the role of the regulatory affairs professional. We discuss some of the challenges and provide insights for the regulatory professional to remain at the forefront of these trends and prepare for their impacts on their work.

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