|
|
NEED is a 3-year research project aiming to identify and measure unmet health-related needs for a more needs-driven healthcare policy and innovation. |
|
|---|
Newsletter #1
December 2023
|
|
|---|
We are pleased to present the first edition of the NEED newsletter. NEED (Needs Examination, Evaluation and Dissemination) was launched in April 2023 to develop an independent research infrastructure that collects evidence on unmet health-related needs, both from the patients’ perspective and that of society, and stores it in a database that can be used by all relevant stakeholders. The availability of explorable evidence on patient and societal needs is a prerequisite for moving from a supply-driven innovation system towards a more needs-driven system. NEED should provide the infrastructure and content to allow for such policies.
This newsletter is the best way for you to discover what we are doing, to receive regular updates on our work packages, their outcomes and next steps, highlights of NEED's events you may have missed, hand-picked articles or interesting papers related to unmet needs, the health innovation ecosystem, the EU pharmaceutical legislation and more!
We invite you to share this newsletter and the sign-up link with your colleagues so that they, too, can stay informed about our efforts in shaping a needs-driven healthcare policy and innovation.
Happy reading!
The NEED team
|
|
|
|
|---|
Recent events
|
|
NEED was present at the ISPOR Europe 2023 conference in Copenhagen, which gathered more than 6000 attendees. Muriel Levy, representing KCE, showcased the NEED project in a panel session themed "How to determine unmet needs for more needs-driven product development and healthcare decision-making." Other panellists included Professor Isabelle Huys (KUL), François Houÿez (Eurordis) and Zilke Claessens (KUL).
In addition, NEED's research on the applicability of its approach to rare diseases was featured in two engaging posters. Jolien Broekmans (KUL) presented a poster titled "Definitions of the concept of rare diseases: insights from a grey literature review", while Zilke Claessens (KUL) presented another poster titled "Shining a light on Unmet health-related needs: a generic framework to advance the identification and assessment of unmet needs tailored to rare diseases".
|
|
|---|
|
NEED International and National Advisory Committee Meetings |
NEED convened its international and national advisory committee meetings on November 20th and 28th, respectively. The international advisory committee meeting brought together stakeholders from 14 EU member states, EU institutions, and various European and international organizations. The national advisory committee meeting gathered key stakeholders from the Belgian healthcare system.
During these sessions, the NEED team presented the project's progress and early findings, including the NEED assessment framework, insights from the case studies, the 4-step implementation model, and the applicability of the NEED approach to rare diseases. Discussions encompassed topics like the organisation, governance, and financing of a NEED research infrastructure at the EU level. For more information on these advisory committee meetings, explore the flash reports.
|
|
|
|
|
|---|
What we are reading - Interesting publications |
|
|---|
|
Output current R&D ecosystem: Analysis of pharmaceutical market introductions since 1995
January 2023
|
In June 2022, the Dutch minister of Health, Welfare and Sports (‘VWS’) submitted the report The Financial Ecosystem of Pharmaceutical R&D to the House of Representatives of the Netherlands. This report describes how the current financial ecosystem of drug research and development operates, and concludes that a drug’s expected financial return ultimately determines whether it is developed, not the expected societal impact. VWS is now considering whether better prioritisation of societally relevant drugs is possible given the current financial ecosystem. As a first follow-up to the report, VWS wants to know for which conditions the current ecosystem produces many or few new drugs. This information can then form the starting point for follow-up research into the largest ‘pharmaceutical gaps’ in the Netherlands. More info here.
|
|
|
Qualitative in-depth analysis of gaps in drug development
August 2023
|
As a result of a possible suboptimal alignment of drug development to the societal need, there may be conditions for which pharmacological treatment is desirable, but for which no or only limited medication is developed. In this study, this is referred to as "gaps in drug development". Other terms often used to indicate the discrepancy between the development of drugs and the societal need for drugs are unmet medical need or pharmaceutical blind spots.
The Dutch Ministry of Health, Welfare and Sport asked KPMG to study "gaps in drug development". KPMG translated this into the following research questions:
Research question 1: For which conditions is R&D activity in imbalance with the societal need? Can the need for medicines for these conditions be categorised?
Research question 2: Can these conditions be broken down into subindications?
Research question 3: What are the causes of limited R&D activity and what can the government do to encourage R&D activity for these conditions? More info here.
|
|
|
EPF proposal for a patient-centred framework for defining Unmet Medical Needs
October 2023
|
As the voice of patient organisations in Europe, the European Patients' Forum (EPF) perceives the current Commission's definition as restrictive, offering only a limited scope for genuine health innovation. EPF expresses not just concern but a resounding call for patient involvement in drawing up the definition. Ultimately, the concept of "unmet medical need" should aim to distinguish innovative medicines that provide real and significant added therapeutic value for patients from other new medicines.
In this context, EPF proposes a future framework to characterise "unmet medical need" as part of the revision of EU pharmaceutical legislation. More info here.
|
|
|
Improving access to medicines and promoting pharmaceutical innovation
November 2023
|
Health is a fundamental human right, and achieving equality in access to medicines is crucial for ensuring public health. The current system of innovation strongly relies on the private sector, while remuneration of innovation is mainly based on exclusivities. This system presents several issues, such as innovation being driven by market size, the partial misalignment between industry’s research and development (R&D) priorities and public health goals, access constraints, and the scarcity of disruptive innovations. In this context, the STOA Panel of the European Parliament launched this study to analyse the impact of different R&D incentive mechanisms and alternative frameworks that may contribute to pharmaceutical innovation and public health. In particular, the study analyses the implications for innovation and accessibility, both in terms of prices and availability. More info here.
|
|
|
Joint ESIP-MEDEV Position Paper on The Revision of the EU Pharmaceutical Legislation
November 2023
|
High pharmaceutical prices coupled with low level of evidence on patient-relevant outcomes and solid comparative data affect national pricing & reimbursement decisions and consequently access to affordable treatment. ESIP and MEDEV welcome the revision of the EU pharmaceutical legislation insofar as it builds a pharmaceutical ecosystem that preserves the sustainability of healthcare systems, emphasises the corporate social responsibility of pharmaceutical companies, and prioritises societal needs.
This document presents a set of common recommendations from public bodies responsible for health technology assessment, pricing and reimbursement and public health insurers, towards producing solid evidence across the product lifecycle and promoting affordable and sustainable access to treatment. More info here.
|
|
|
Scoping study on evidence to tackle high-burden under-researched medical conditions
December 2023
|
The European Commission (EC) supports the improvement of health and healthcare across the European Union (EU). This is in part done by allocating funding for research and innovation to, amongst others, increase our understanding of specific medical conditions and to stimulate advances in diagnosis, prevention and treatment. However, some medical conditions fail to be sufficiently recognised, diagnosed, prevented or treated, and may therefore be under-researched. These conditions can however, pose a considerable burden on patients and society. The aim of the current study is to explore the definition, identification and research needs of high-burden under-researched medical conditions in the EU. More info here.
|
|
|
Upcoming events |
DIA Europe 2024 - 12-14 March 2024, Brussels
DIA Europe 2024 is set to concentrate on sustainability, innovation, and collaboration—three fundamental pillars essential for influencing the trajectory of healthcare in the future. Delving into areas such as the environmental implications of pharmaceuticals and the entire drug development lifecycle, as well as exploring sustainable partnerships and healthcare systems, the event offers a platform to explore how collaborative efforts and innovative approaches can bolster sustainability in healthcare. More info here.
5th PPRI Conference 2024: Ensuring access to affordable medicines through innovative policies - 25-26 April 2024, Vienna
The PPRI conference seeks to bring together global thought leaders for discussions on pressing matters related to pricing and reimbursement policies for medicines, both from a global and an European perspective. The topics that will be addressed are "Local challenges, global learning?", "Strenghtening the evidence base", and "Futureproofing pharmaceutical policies". More info here.
EHMA 2024 - 5-7 June 2024, Bucharest
The theme of EHMA 2024 is "Shaping and managing innovative health ecosystems". The conference will cover major health trends, from the digital transformation of healthcare systems and services to the ever-growing importance of sustainability. The aim is to delve into how the health ecosystem is responding to these transformations and how different stakeholders can collaborate to drive innovation and address pressing challenges. More info here.
HTAi Annual Meeting 2024 - 15-17 June 2024, Seville
The theme of the HTAi Annual Meeting 2024 is "A Turning Point for HTA? Sustainability, Networks and Innovation". The Meeting will center on exploring the possibilities and obstacles in developing meaningful networks for HTA and how collaborative efforts can enhance the assessment of innovative healthcare solutions through shared knowledge. More info here.
|
|
|
|---|
NEED is financially supported by the Belgian Federal Science Policy (BELSPO) through the INFRA-FED call. |
|
|---|
|
|
