HILDE STEVENS - Academia.edu (original) (raw)

Papers by HILDE STEVENS

Research paper thumbnail of TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Pharmaceutics, 2021

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual ... more Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have ...

Research paper thumbnail of Public-Private Partnerships as drivers of innovation in healthcare

Frontiers Research Topics, 2019

This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics... more This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contac

Research paper thumbnail of Patient Preferences for Multiple Myeloma Treatments: A Multinational Qualitative Study

Frontiers in Medicine

Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are ass... more Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are associated with a range of characteristics and uncertainties regarding long term side-effects and efficacy. This raises questions about what matters most to patients living with this disease. This study aimed to understand which characteristics MM patients find most important, and hence should be included as attributes and levels in a subsequent quantitative preference survey among MM patients.Methods: This qualitative study involved: (i) a scoping literature review, (ii) discussions with MM patients (n = 24) in Belgium, Finland, Romania, and Spain using Nominal Group Technique, (iii) a qualitative thematic analysis including multi-stakeholder discussions.Results: MM patients voiced significant expectations and hopes that treatments would extend their lives and reduce their cancer signs and symptoms. Participants however raised concerns about life-threatening side-effects that could cause p...

Research paper thumbnail of Human Papillomavirus Is Dangerous—But a Vaccine Can Save You!

Frontiers for Young Minds

Human papilloma virus (HPV) is a virus that can cause disease in the skin and mucus membranes of ... more Human papilloma virus (HPV) is a virus that can cause disease in the skin and mucus membranes of both women and men. There are more than 100 types of HPV. While most of them cause harmless infections, some types of HPV are more harmful and can lead to cancers. HPV infection cannot be cured. The only solution is to prevent infection by vaccinating girls and boys at the age of 9–15. HPV vaccination prevents the infection and also stops the spread of the virus from one person to another. This article will help you to understand the basics about HPV, the diseases it causes, and why the HPV vaccine is an important solution.

Research paper thumbnail of Stakeholder perspectives towards patient preferences in the medical product life cycle: A focus on patient preferences for regulatory benefit-risk assessment

Research paper thumbnail of Vaccines: Accelerating Innovation and Access

This Global Challenges Report describes the innovation process for vaccines. It explains how the ... more This Global Challenges Report describes the innovation process for vaccines. It explains how the restricted availability of vaccines is due to impediments at every stage of the process. Most of these obstacles are manageable, and intellectual property (IP) rights are associated with only some of them. The analysis aims to put into perspective debates around health innovation and the availability of health technologies in developing countries, especially with respect to the role of IP. In particular, it provides an overview of how IP has been used to meet global health challenges in the vaccines field, and considers whether lessons can be drawn to inform other important health technologies. The report proceeds as follows: Section 2, following the introduction, outlines the basic principles of vaccination, while also giving an overview of the history of vaccine research. Section 3 presents the social, economic, and health benefits of vaccines. Section 4 describes the research and deve...

Research paper thumbnail of Human papillomavirus, a dangerous virus - but a vaccine can save you!

Frontiers for Young Minds, 2020

Research paper thumbnail of The role of Intellectual Property Rights (IPRs) in Precompetitive Public-Private Partnerships (PPPs)

Research paper thumbnail of Public-Private Partnerships, Global Intellectual Property Governance and Sustainable Development

Research paper thumbnail of Case study analysis: SUMMIT - IMIDIA – Open PHACTS NEWMEDS – eTOX – U-BIOPRED Innovative Medicines Initiative Joint Undertaking (IMI)

Research paper thumbnail of The Role of Intellectual Property in (Precompetitive) Public-Private Partnerships in the Biomedical Sector

Research paper thumbnail of Chapter 06 - Intellectual Property in Early-Phase Research Public–Private Partnerships in the Biomedical Sector

To assess the nature of intellectual property (IP) in early-phase research or precompetitive publ... more To assess the nature of intellectual property (IP) in early-phase research or precompetitive public–private partnerships (PPPs) in the biomedical field, more understanding is required of the ecosystem in which biomedical PPPs function. In essence, biomedical PPPs are knowledge communities. Pooling complementary resources and expertise, as well as sharing the risks and other (often administrative) burdens between the public and the private stakeholders, increases the effectiveness of PPPs. But diverse social, economic, legal, regulatory, and scientific factors make the PPP model a rather complex collaborative one. Depending on several criteria, (bio)pharmaceutical research and development (R&D) PPPs may be classified into four different types based on the type of projects they conduct. Upstream research projects entail precompetitive (or early-phase) research and the proof-of-concept (POC) phase. This chapter focuses primarily on these upstream PPPs. Downstream development projects i...

Research paper thumbnail of Patient Preferences for Multiple Myeloma Treatments: A Multinational Qualitative Study

Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are ass... more Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are associated with a range of characteristics and uncertainties regarding long term side-effects and efficacy. This raises questions about what matters most to patients living with this disease. This study aimed to understand which characteristics MM patients find most important, and hence should be included as attributes and levels in a subsequent quantitative preference survey among MM patients. Methods: This qualitative study involved: (i) a scoping literature review, (ii) discussions with MM patients (n = 24) in Belgium, Finland, Romania, and Spain using Nominal Group Technique, (iii) a qualitative thematic analysis including multi-stakeholder discussions. Results: MM patients voiced significant expectations and hopes that treatments would extend their lives and reduce their cancer signs and symptoms. Participants however raised concerns about life-threatening side-effects that could cause...

Research paper thumbnail of Key Performance Indicators - report for Innovative Medicines Initiative (IMI)

Research paper thumbnail of Case study analysis on behalf of IMI JU Executive Office under a service contract procedure: SUMMIT - IMIDIA – Open PHACTS - NEWMEDS – eTOX – U-BIOPRED: Innovative Medicines Initiative Joint Undertaking (IMI). Summary in the Annual Activity Report 2013

Research paper thumbnail of Intellectual Property (IP) Principles and concepts in precompetitive public-private partnerships

Research paper thumbnail of Human Papillomavirus Is Dangerous—But a Vaccine Can Save You!

Marie Neunez, 2021

Human papilloma virus (HPV) is a virus that can cause disease in the skin and mucus membranes of ... more Human papilloma virus (HPV) is a virus that can cause disease in the skin and mucus membranes of both women and men. There are more than 100 types of HPV. While most of them cause harmless infections, some types of HPV are more harmful and can lead to cancers. HPV infection cannot be cured. The only solution is to prevent infection by vaccinating girls and boys at the age of 9–15. HPV vaccination prevents the infection and also stops the spread of the virus from one person to another. This article will help you to understand the basics about HPV, the diseases it causes, and why the HPV vaccine is an important solution.

Research paper thumbnail of Market access of gene therapies across Europe, USA, and Canada: challenges, trends, and solutions

Research paper thumbnail of PCN297 Understanding What Matters to Multiple Myeloma Patients: A Qualitative Study

Research paper thumbnail of Editorial: Medicine and Society

Research paper thumbnail of TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Pharmaceutics, 2021

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual ... more Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have ...

Research paper thumbnail of Public-Private Partnerships as drivers of innovation in healthcare

Frontiers Research Topics, 2019

This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics... more This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contac

Research paper thumbnail of Patient Preferences for Multiple Myeloma Treatments: A Multinational Qualitative Study

Frontiers in Medicine

Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are ass... more Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are associated with a range of characteristics and uncertainties regarding long term side-effects and efficacy. This raises questions about what matters most to patients living with this disease. This study aimed to understand which characteristics MM patients find most important, and hence should be included as attributes and levels in a subsequent quantitative preference survey among MM patients.Methods: This qualitative study involved: (i) a scoping literature review, (ii) discussions with MM patients (n = 24) in Belgium, Finland, Romania, and Spain using Nominal Group Technique, (iii) a qualitative thematic analysis including multi-stakeholder discussions.Results: MM patients voiced significant expectations and hopes that treatments would extend their lives and reduce their cancer signs and symptoms. Participants however raised concerns about life-threatening side-effects that could cause p...

Research paper thumbnail of Human Papillomavirus Is Dangerous—But a Vaccine Can Save You!

Frontiers for Young Minds

Human papilloma virus (HPV) is a virus that can cause disease in the skin and mucus membranes of ... more Human papilloma virus (HPV) is a virus that can cause disease in the skin and mucus membranes of both women and men. There are more than 100 types of HPV. While most of them cause harmless infections, some types of HPV are more harmful and can lead to cancers. HPV infection cannot be cured. The only solution is to prevent infection by vaccinating girls and boys at the age of 9–15. HPV vaccination prevents the infection and also stops the spread of the virus from one person to another. This article will help you to understand the basics about HPV, the diseases it causes, and why the HPV vaccine is an important solution.

Research paper thumbnail of Stakeholder perspectives towards patient preferences in the medical product life cycle: A focus on patient preferences for regulatory benefit-risk assessment

Research paper thumbnail of Vaccines: Accelerating Innovation and Access

This Global Challenges Report describes the innovation process for vaccines. It explains how the ... more This Global Challenges Report describes the innovation process for vaccines. It explains how the restricted availability of vaccines is due to impediments at every stage of the process. Most of these obstacles are manageable, and intellectual property (IP) rights are associated with only some of them. The analysis aims to put into perspective debates around health innovation and the availability of health technologies in developing countries, especially with respect to the role of IP. In particular, it provides an overview of how IP has been used to meet global health challenges in the vaccines field, and considers whether lessons can be drawn to inform other important health technologies. The report proceeds as follows: Section 2, following the introduction, outlines the basic principles of vaccination, while also giving an overview of the history of vaccine research. Section 3 presents the social, economic, and health benefits of vaccines. Section 4 describes the research and deve...

Research paper thumbnail of Human papillomavirus, a dangerous virus - but a vaccine can save you!

Frontiers for Young Minds, 2020

Research paper thumbnail of The role of Intellectual Property Rights (IPRs) in Precompetitive Public-Private Partnerships (PPPs)

Research paper thumbnail of Public-Private Partnerships, Global Intellectual Property Governance and Sustainable Development

Research paper thumbnail of Case study analysis: SUMMIT - IMIDIA – Open PHACTS NEWMEDS – eTOX – U-BIOPRED Innovative Medicines Initiative Joint Undertaking (IMI)

Research paper thumbnail of The Role of Intellectual Property in (Precompetitive) Public-Private Partnerships in the Biomedical Sector

Research paper thumbnail of Chapter 06 - Intellectual Property in Early-Phase Research Public–Private Partnerships in the Biomedical Sector

To assess the nature of intellectual property (IP) in early-phase research or precompetitive publ... more To assess the nature of intellectual property (IP) in early-phase research or precompetitive public–private partnerships (PPPs) in the biomedical field, more understanding is required of the ecosystem in which biomedical PPPs function. In essence, biomedical PPPs are knowledge communities. Pooling complementary resources and expertise, as well as sharing the risks and other (often administrative) burdens between the public and the private stakeholders, increases the effectiveness of PPPs. But diverse social, economic, legal, regulatory, and scientific factors make the PPP model a rather complex collaborative one. Depending on several criteria, (bio)pharmaceutical research and development (R&D) PPPs may be classified into four different types based on the type of projects they conduct. Upstream research projects entail precompetitive (or early-phase) research and the proof-of-concept (POC) phase. This chapter focuses primarily on these upstream PPPs. Downstream development projects i...

Research paper thumbnail of Patient Preferences for Multiple Myeloma Treatments: A Multinational Qualitative Study

Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are ass... more Background: Investigational and marketed drugs for the treatment of multiple myeloma (MM) are associated with a range of characteristics and uncertainties regarding long term side-effects and efficacy. This raises questions about what matters most to patients living with this disease. This study aimed to understand which characteristics MM patients find most important, and hence should be included as attributes and levels in a subsequent quantitative preference survey among MM patients. Methods: This qualitative study involved: (i) a scoping literature review, (ii) discussions with MM patients (n = 24) in Belgium, Finland, Romania, and Spain using Nominal Group Technique, (iii) a qualitative thematic analysis including multi-stakeholder discussions. Results: MM patients voiced significant expectations and hopes that treatments would extend their lives and reduce their cancer signs and symptoms. Participants however raised concerns about life-threatening side-effects that could cause...

Research paper thumbnail of Key Performance Indicators - report for Innovative Medicines Initiative (IMI)

Research paper thumbnail of Case study analysis on behalf of IMI JU Executive Office under a service contract procedure: SUMMIT - IMIDIA – Open PHACTS - NEWMEDS – eTOX – U-BIOPRED: Innovative Medicines Initiative Joint Undertaking (IMI). Summary in the Annual Activity Report 2013

Research paper thumbnail of Intellectual Property (IP) Principles and concepts in precompetitive public-private partnerships

Research paper thumbnail of Human Papillomavirus Is Dangerous—But a Vaccine Can Save You!

Marie Neunez, 2021

Human papilloma virus (HPV) is a virus that can cause disease in the skin and mucus membranes of ... more Human papilloma virus (HPV) is a virus that can cause disease in the skin and mucus membranes of both women and men. There are more than 100 types of HPV. While most of them cause harmless infections, some types of HPV are more harmful and can lead to cancers. HPV infection cannot be cured. The only solution is to prevent infection by vaccinating girls and boys at the age of 9–15. HPV vaccination prevents the infection and also stops the spread of the virus from one person to another. This article will help you to understand the basics about HPV, the diseases it causes, and why the HPV vaccine is an important solution.

Research paper thumbnail of Market access of gene therapies across Europe, USA, and Canada: challenges, trends, and solutions

Research paper thumbnail of PCN297 Understanding What Matters to Multiple Myeloma Patients: A Qualitative Study

Research paper thumbnail of Editorial: Medicine and Society