Towards a sustainable rare disease and orphan drug ecosystem in Saudi Arabia: policy insights from a multi-stakeholder workshop

IntroductionRare diseases (RDs) present significant challenges worldwide, including Saudi Arabia (SA), where access to orphan drugs (ODs) is suboptimal. This study summarizes key insights from a multi-stakeholder workshop conducted in SA to explore and address challenges related to RD and OD accessi...

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Main Authors: Ghada Mohammed Abozaid, Hussain Abdulrahman Al-Omar, Abdulaziz Alrabiah, Asma AlMuaither, Amy Jayne McKnight
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-05-01
Series:Frontiers in Pharmacology
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Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1583477/full
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author Ghada Mohammed Abozaid
Ghada Mohammed Abozaid
Hussain Abdulrahman Al-Omar
Abdulaziz Alrabiah
Asma AlMuaither
Amy Jayne McKnight
author_facet Ghada Mohammed Abozaid
Ghada Mohammed Abozaid
Hussain Abdulrahman Al-Omar
Abdulaziz Alrabiah
Asma AlMuaither
Amy Jayne McKnight
author_sort Ghada Mohammed Abozaid
collection DOAJ
description IntroductionRare diseases (RDs) present significant challenges worldwide, including Saudi Arabia (SA), where access to orphan drugs (ODs) is suboptimal. This study summarizes key insights from a multi-stakeholder workshop conducted in SA to explore and address challenges related to RD and OD accessibility. Strategies to improve the healthcare landscape for RDs in SA have also been recommended.MethodsA 1-day workshop, conducted at the Saudi Health Council in Riyadh, SA on 5 June 2023, gathered stakeholders from the government, private sector, pharmaceutical industry, legislators, regulators, providers, payers, academia, and insurance companies. Through a series of presentations, educational sessions, and plenary discussions, participants examined the current landscape of RDs in SA, identified barriers to accessing ODs, and recommended strategies and initiatives to improve the accessibility, innovation, and sustainability of ODs.ResultsThe workshop highlighted key challenges recognized by a diverse group of 59 participants, including the absence of a national strategy, absent of local RDs and ODs definitions in the Saudi context, limited awareness and understanding of RDs among healthcare professionals, delayed diagnoses, scarcity of treatment and diagnosis centers for RDs, insufficient screening and prevention programs, regulatory hurdles in approving and importing ODs, and financial constraints. These challenges significantly impact patient access to ODs, imposing additional burdens on patients, families, healthcare systems, and society.DiscussionThe recommended strategies to enhance RD and OD accessibility include multifaceted approaches, such as increasing medical education and awareness, accrediting and investing in expanding the number of centers of excellence for RD diagnosis and management, streamlining regulatory processes for OD approval and importation, fostering international collaborations for knowledge exchange and capacity building, and implementing national policies to improve the affordability and reimbursement of ODs. Stakeholder collaboration is crucial to overcome the accessibility challenges of RDs and ODs. The development of comprehensive national RD strategies ensures equitable resource allocation, a national RD registry, and infrastructure improvements. These measures are vital for ensuring equitable access to ODs and the efficient provision of healthcare services in SA.
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spelling doaj-art-67bb9c7fc89144409e19adfa0c3958552025-08-20T03:51:58ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-05-011610.3389/fphar.2025.15834771583477Towards a sustainable rare disease and orphan drug ecosystem in Saudi Arabia: policy insights from a multi-stakeholder workshopGhada Mohammed Abozaid0Ghada Mohammed Abozaid1Hussain Abdulrahman Al-Omar2Abdulaziz Alrabiah3Asma AlMuaither4Amy Jayne McKnight5Centre for Public Health, Institute of Clinical Sciences B, Royal Victoria Hospital, Queen’s University Belfast School of Medicine, Dentistry and Biomedical Sciences, Belfast, United KingdomPharmacy Practice Department, College of Pharmacy, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi ArabiaGeneral Directorate of National Health Policies and Economics, Saudi Health Council, Riyadh, Saudi ArabiaCenter for Health Technology Assessment, Ministry of Health, Riyadh, Saudi ArabiaCentre for Public Health, Institute of Clinical Sciences B, Royal Victoria Hospital, Queen’s University Belfast School of Medicine, Dentistry and Biomedical Sciences, Belfast, United KingdomIntroductionRare diseases (RDs) present significant challenges worldwide, including Saudi Arabia (SA), where access to orphan drugs (ODs) is suboptimal. This study summarizes key insights from a multi-stakeholder workshop conducted in SA to explore and address challenges related to RD and OD accessibility. Strategies to improve the healthcare landscape for RDs in SA have also been recommended.MethodsA 1-day workshop, conducted at the Saudi Health Council in Riyadh, SA on 5 June 2023, gathered stakeholders from the government, private sector, pharmaceutical industry, legislators, regulators, providers, payers, academia, and insurance companies. Through a series of presentations, educational sessions, and plenary discussions, participants examined the current landscape of RDs in SA, identified barriers to accessing ODs, and recommended strategies and initiatives to improve the accessibility, innovation, and sustainability of ODs.ResultsThe workshop highlighted key challenges recognized by a diverse group of 59 participants, including the absence of a national strategy, absent of local RDs and ODs definitions in the Saudi context, limited awareness and understanding of RDs among healthcare professionals, delayed diagnoses, scarcity of treatment and diagnosis centers for RDs, insufficient screening and prevention programs, regulatory hurdles in approving and importing ODs, and financial constraints. These challenges significantly impact patient access to ODs, imposing additional burdens on patients, families, healthcare systems, and society.DiscussionThe recommended strategies to enhance RD and OD accessibility include multifaceted approaches, such as increasing medical education and awareness, accrediting and investing in expanding the number of centers of excellence for RD diagnosis and management, streamlining regulatory processes for OD approval and importation, fostering international collaborations for knowledge exchange and capacity building, and implementing national policies to improve the affordability and reimbursement of ODs. Stakeholder collaboration is crucial to overcome the accessibility challenges of RDs and ODs. The development of comprehensive national RD strategies ensures equitable resource allocation, a national RD registry, and infrastructure improvements. These measures are vital for ensuring equitable access to ODs and the efficient provision of healthcare services in SA.https://www.frontiersin.org/articles/10.3389/fphar.2025.1583477/fullorphan drugsaccessstakeholderSaudi Arabiachallengesrare diseases
spellingShingle Ghada Mohammed Abozaid
Ghada Mohammed Abozaid
Hussain Abdulrahman Al-Omar
Abdulaziz Alrabiah
Asma AlMuaither
Amy Jayne McKnight
Towards a sustainable rare disease and orphan drug ecosystem in Saudi Arabia: policy insights from a multi-stakeholder workshop
Frontiers in Pharmacology
orphan drugs
access
stakeholder
Saudi Arabia
challenges
rare diseases
title Towards a sustainable rare disease and orphan drug ecosystem in Saudi Arabia: policy insights from a multi-stakeholder workshop
title_full Towards a sustainable rare disease and orphan drug ecosystem in Saudi Arabia: policy insights from a multi-stakeholder workshop
title_fullStr Towards a sustainable rare disease and orphan drug ecosystem in Saudi Arabia: policy insights from a multi-stakeholder workshop
title_full_unstemmed Towards a sustainable rare disease and orphan drug ecosystem in Saudi Arabia: policy insights from a multi-stakeholder workshop
title_short Towards a sustainable rare disease and orphan drug ecosystem in Saudi Arabia: policy insights from a multi-stakeholder workshop
title_sort towards a sustainable rare disease and orphan drug ecosystem in saudi arabia policy insights from a multi stakeholder workshop
topic orphan drugs
access
stakeholder
Saudi Arabia
challenges
rare diseases
url https://www.frontiersin.org/articles/10.3389/fphar.2025.1583477/full
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