Commentary on the European Medicines Agency's extended mandate: Protecting public health in times of crisis and improving availability of medicines and medical devices

Abed, Inga; González‐Quevedo, Rosa; Mura, Manuela; Dias, Monica; Dias, Silvy da Rocha; Burgos, Juan García

doi:10.1111/bcp.15567

Cited by 4 publications

(3 citation statements)

References 2 publications

(7 reference statements)

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“…The extended mandate, introduced by the European Commission and applicable since 1 March 2022, aims to improve the EU's preparedness and response to health threats and has a strong focus on transparency. Stakeholder engagement plays an important role in the various operations of the mandate and ensuring that stakeholders are given a platform to interact and discuss issues with the EMA [58]. While the regional survey revealed that information in English was not a barrier to understanding the information, the above-mentioned reasons prompt consideration of the possibility of translating more EMA documents into local EU languages to promote the wide dissemination of information to the public and to reach people with low health literacy and limited knowledge of English.…”

Section: Discussionmentioning

confidence: 99%

Stakeholders’ Understanding of European Medicine Agency’s COVID-19 Vaccine Information Materials in EU and Regional Contexts

Castro,

Van Tricht,

Bonaccorso

et al. 2023

Vaccines

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The COVID-19 pandemic posed challenges to communicating accurate information about vaccines because of the spread of misinformation. The European Medicines Agency (EMA) tried to reassure the public by communicating early on about the development and approval of COVID-19 vaccines. The EMA surveyed patients/consumers, healthcare professional organizations, and individual stakeholders, both at the EU level and in an Italian regional context. The objectives of the study were to see if the EMA’s core information materials were informative and well-understood and which communication channels were preferred by the public. The main findings showed that individual patients/consumers generally prefer to obtain information about COVID-19 vaccines from the internet or mass media, while organizations and individual healthcare professionals prefer to obtain information from national and international health authorities. Both at EU and local levels, participants had a good understanding of the key messages from regulators and found the materials useful and relevant. However, some improvements were recommended to the visual, text, and dissemination formats, including publishing more information on safety and using a more public-friendly language. Also, it was recommended to maintain the EMA’s approach of using media, stakeholder engagement, and web-based formats to communicate about COVID-19 vaccines. In conclusion, user-testing of proactive communication materials aimed to prebunk misinformation during a public health crisis helps to ensure that users understand the development and safety of novel vaccine technologies. This information can then be used as a basis for further evidence-based communication activities by regulators and public health bodies in an emergency context.

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Section: Discussionmentioning

confidence: 99%

Stakeholders’ Understanding of European Medicine Agency’s COVID-19 Vaccine Information Materials in EU and Regional Contexts

Castro,

Van Tricht,

Bonaccorso

et al. 2023

Vaccines

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show abstract

“…A strategy to secure the supply of health products is being implemented at the European level (16,23,(30)(31)(32)(33).…”

Section: Strengthening European Cooperation and Regulation To Better ...mentioning

confidence: 99%

“…In Europe, the number of drug shortages has grown 20-fold between 2000 and 2018, compromising European healthcare systems (20,21). The COVID pandemic has highlighted the vulnerability of health products availability in a public health emergency situation (6,(22)(23)(24). European Medicine Agency's (EMA), whose role has been strengthened by a new European regulation (25), took up the issue of managing health products shortages at the time of the health crisis with coordination actions (11,16).…”

Section: Introductionmentioning

confidence: 99%

Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience

Belgodère,

Emmerich,

Albin

et al. 2023

Front. Public Health

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Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including the French National Agency for Medicines and Health Products Safety (ANSM). To highlight perspectives for a better prevention, we described and analyzed the management of shortages in the availability of health products in France over the last 10 years. The supply chain was mapped to identify the main causes of shortages and stakeholders involved in managing shortages throughout the supply chain. National and European initiatives and regulatory measures were reviewed. A retrospective nationwide data analysis from the French reporting system of health product shortage reports was conducted over 10 years for drugs (2013–2022) and over an 18-month period for medical devices, from 1st March 2022 to 31st August 2023. An increase in drug shortage reports was observed, rising from 404 in 2013 to 3,761 in 2022 for drugs, with a relatively constant distribution of affected therapeutic classes. In 2022, the main reported causes of drug shortage risk were insufficient production capacity (27.1%), increased sales volume (21.5%), or lack of supply (13.6%). Over half of the reports on medical devices (55.4%) were objectified as indispensable, and their causes were mainly due to a lack of supply (48.2%), discontinuation of marketing (14.9%), increased sales volume (13.2%), and regulatory reasons (9.6%). ANSM and French authorities have engaged a public health policy for prevention and management of health product shortages including financial penalties, minimum safety stocks for Major Therapeutic Interest drugs, and a shortage management plan. Based on 10 years of experience, four priority measures have been identified to anticipate the risk of heath products shortages based: the importance of a national coordination from raw materials to local market, the implementation of new prevention and management actions in the supply chain, strengthening European cooperation and regulation including the establishment of a list of critical drugs, and promoting transparency and information.

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WITHDRAWN: Post-Brexit implications: Review of marketing authorisations in Malta

Patrocinio,

Szijj,

Inglott

et al. 2024

Health Policy OPEN

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Commentary on the European Medicines Agency's extended mandate: Protecting public health in times of crisis and improving availability of medicines and medical devices

Cited by 4 publications

References 2 publications

Stakeholders’ Understanding of European Medicine Agency’s COVID-19 Vaccine Information Materials in EU and Regional Contexts

Stakeholders’ Understanding of European Medicine Agency’s COVID-19 Vaccine Information Materials in EU and Regional Contexts

Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience

WITHDRAWN: Post-Brexit implications: Review of marketing authorisations in Malta

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