Agenda

The 2024 Fair Pricing Forum will be held in a virtual format from February 6 to 8, 2024. The Forum will be hosted on the Zoom Events platform. Registered participants will receive a universal link that they will use to access all forum sessions across the three days.

Please note that the below agenda is provisional and subject to change.

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Day 1
Day 2
Day 3

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Break
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Welcome to the 4th Fair Pricing Forum

Welcome to the inaugural session of the Fair Pricing Forum 2024! We are honored to have leaders and experts in health from all over the world here today to discuss the most pressing issues facing affordability access to safe and effective health products.

The Forum will begin with opening remarks from our distinguished panel of speakers and will continue with an inaugural plenary and set of parallel sessions on the status of market transparency, supply chain resilience, and utilizing real-world evidence for pricing decisions.

Inaugural Plenary 1 - UTC 10:00 - 11:30

Post-pandemic construction of health product market transparency, efficiency and fairness

The emergency phase of the COVID-19 pandemic is now officially behind us, but the world is still grappling with its ongoing risks and impacts. A return to a business-as-usual policy or policy vacuum on market transparency and fair pricing of health products would be a great letdown. This session discusses the need to rebuild health systems with a blueprint for political actions and a catalog of policy solutions to improve market transparency and the fair pricing of health products.

Parallel Session 1 - UTC 13:00 - 14:30

Improving market transparency of health products where to from now?

Since resolution WHA72.8 was adopted by Member States in 2019, countries have made efforts and advances in enhancing the availability of information on the markets for health products. Renewed and sustained commitment remains essential if countries are to make progress towards transparency of markets for health products. In addition, in some instances, the ultimate impact of market transparency on availability and affordability remains unknown. To that end, this panel will provide experiences from countries that have endeavored to improve market transparency for health products. Panelists will discuss the processes of setting and implementing a transparency policy agenda in their countries. The aim will be to uncover potential drivers and barriers to success and any early indications of impact on availability and affordability. Such learnings aim to support Member States and all stakeholders in their efforts to achieve and monitor transparency of markets for health products toward improving access.

Parallel Session 2 - UTC 13:00 - 14:30

Strengthening Pharmaceutical Supply Resilience for Times of Crisis: Ensuring access and affordability

This session offers a global perspective on crafting resilient pharmaceutical pricing and supply policies amidst disease outbreaks and economic crises. Panellists will draw from real-world case studies, highlighting critical themes, such as shortages, trade restrictions, hoarding, and off-label use. Delving into issues of affordability, accessibility, and equitable access, the session addresses measures taken by governments, industry, and implementing partners to ensure medicines are accessible to all, even in emergencies. Additionally, it explores regulatory complexities related to the inclusion of new medicines within an environment of rapidly evolving evidence. The panel will also examine challenges in rural access, resilience in the face of climate change, and unique supply issues in small markets during health crises. With an eye to the future, experts will define top-priority activities on how to ensure affordability and access by strengthening global pharmaceutical supply chain resilience.

Parallel Session 3 - UTC 13:00 - 14:30

Using real-world data to generate real-world evidence, with a view to informing healthcare decisions, has been a topic of growing interest in recent years. In high-income countries, the growing interest has manifested itself as the increasing use of real-world evidence in the decisions for regulatory approval and reimbursement of medicines and health products, including insurance coverage on the condition of further evidence development through a “managed entry” arrangement.

In lower income countries, a lack of data infrastructure to systematically collect health data continues to pose a challenge in leveraging health data to inform healthcare decisions, including resource allocation. The persistent under-representation in the clinical trials of medicines also means that low- and middle-income countries must rely on real-world data, or at least some set of local knowledge, to adapt the clinical trial and cost-effectiveness evidence generated from high-income countries to their respective contexts.

To what extent have such endeavours to use real-world evidence been useful in achieving health system goals? In this session, the panellists will present initiatives to build data infrastructure and the application of real-world evidence to inform policy recommendations. They will discuss whether and how real-world evidence would contribute to regulatory and pricing decisions that are aligned with health system goals, such as research, universal coverage, affordability, timeliness, efficient resource allocation, and transparency of decisions.

Inaugural Plenary 1 - UTC 10:00 - 11:30

Post-pandemic construction of health product market transparency, efficiency and fairness

Parallel Session 1 - UTC 13:00 - 14:30

Improving market transparency of health products where to from now?

Parallel Session 2 - UTC 13:00 - 14:30

Strengthening Pharmaceutical Supply Resilience for Times of Crisis: Ensuring access and affordability

Parallel Session 3 - UTC 13:00 - 14:30

Building real-world evidence in the real world: are regulatory and pricing decisions better aligned with health systems?

Session Speakers

UTC 10:00 - 11:30

Inaugural Plenary 1

Post-pandemic construction of health product market transparency, efficiency and fairness

90 min

Break

UTC 13:00 - 14:30

Parallel Sessions

Parallel Session 1: Improving market transparency of health products: where to from now?

Parallel Session 2: Strengthening pharmaceutical supply resilience for times of crisis: Ensuring access and affordability

Parallel Session 3: Using real-world evidence in the real world: are regulatory and pricing decisions better aligned with health system goals?

The Forum Continues

Day 2 of the 2024 Fair Pricing Forum begins with a plenary session to discuss obstacles and solutions for pricing strategies that balance incentives for innovation with affordable health coverage for those who need it. The day continues with another set of parallel sessions of biosimilar access, orphan drug access, and medical device pricing.

Plenary 2 - UTC 10:00 - 11:30

Negotiating fair pricing - opportunities, powers, promises

Over the last decade, there has been a call for greater transparency in pharmaceutical markets to support national decisions regarding the selection, reimbursement, and pricing of essential medicines. In 2019, 194 Member States of the WHO adopted the ‘Transparency Resolution’ (WHA resolution 72.8) that urges Member States to take steps to publicly share information on the net prices of health products (official/list prices less rebates and discounts) and calls on Member States to work collaboratively to improve the reporting by suppliers of sales revenue, prices, units sold, marketing costs, investments and subsidies. Though the resolution expressed a high level of commitment and support from Member States, the progress toward achieving its objectives has been uneven and limited.

All countries face budget constraints and an ever-increasing demand for quality health care, including access to effective, safe and affordable medical treatments. However, inequities and gaps in access are often the largest in many low and middle-income countries where public health insurance or other public sector schemes have limited capacity to provide all the necessary coverage for essential medicines. Many of these countries are exploring different pricing policies/operational changes to achieve desired efficiencies and the best possible health outcomes, given their limited budgets.

How pricing can be negotiated in this changing context is the topic of the roundtable. A successful strategy to achieve fair pricing assures new medicines are affordable to health systems, allows for an acceptable profit margin that maintains incentives for further innovation, fair access to pricing data and other information, and will necessitate cooperation among sellers, buyers and other stakeholders. Participants in this roundtable will consider obstacles and potential solutions for strategies that can encourage buyers and sellers to negotiate fair prices that are affordable over the long term to provide the necessary health coverage for the patient populations that need it, while also providing the necessary incentives and investment for needed innovation to respond to global health needs.

Parallel Session 4 - UTC 13:00 - 14:30

The untapped potential of biosimilars: how to ensure affordable access?

The world is now approaching 20 years since biosimilar medicines were first developed and introduced. Yet, their promise in contributing to access and affordability remains largely unrealized throughout much of the globe. Connecting the dots between availability, affordability, and access has proven difficult, considering increasingly constrained health budgets where biosimilars would still represent a significant cost. This panel will focus on potential methods of enhancing access to essential biosimilar medicines. Specific examples from countries will be raised to discuss challenges in selection and procurement to bridge regulatory approval and post-market access.

Parallel Session 5 - UTC 13:00 - 14:30

Advancing accessibility and affordability of medical devices and in vitro diagnostics by bridging the information gap and complexity

Following the 2021 Fair Pricing Forum, this session will discuss further market dynamics, pricing strategies and national policy approaches, highlighting the persistent lack of pricing information for medical devices and in vitro diagnostics. We'll spotlight key findings from recent WHO surveys, focusing on medical device pricing for non-communicable diseases. Moreover, we'll delve into the recent impactful WHA76 resolutions, which seek to bolster diagnostics capacity and improve access to life-saving medical oxygen. Responding to WHO's call for dialogue on the availability and affordability of diagnostics, medical oxygen, and related medical devices, this session will underscore the need for standardized nomenclature, supporting the WHA75(25) decision, to facilitate greater access. Join our panel of experts in this dynamic conversation aimed at shaping global access to essential health technologies.

Parallel Session 6 - UTC 13:00 - 14:30

How to pay for universal access to medicines for rare diseases and by whom? The great conundrum

The dramatic rise in the number of medicines receiving regulatory approval with a rare disease/orphan designation is both encouraging and worrying. It is encouraging because it shows that scientific advances, government policies and market conditions have collectively stimulated the research and development of new therapies to address previously neglected health needs. It is also worrying because introducing these medicines to the health systems at prices at least in the hundreds of thousands has already resulted in deep financial impacts, even for the wealthiest countries. With diverse disease profiles and a collective 300 million people living with rare diseases globally, the sector is broad. Providing universal coverage for even a fraction of the medicines with well-established efficacy and safety to people across countries of all incomes would be tremendous, if not impossible. It is also important to recognize the significant skills and infrastructure investments required to integrate these new medicines into health systems. Finally, the exorbitant pricing of rare disease medicines has a human cost as it causes significant psychological distress to patients and families, as well as to decision makers who are constrained by financial resources available to them but unable to meet the demand. In this session, the panel will discuss questions such as whether the market has been over-incentivised, whether universal coverage would be realistic under the status quo, and what it would take to better prepare health systems and policies to meet the pace of development and public expectations for access to medicines for the treatment of rare diseases.

3 Parallel Session

Using real-world evidence in the real world: are regulatory and pricing decisions better aligned with health system goals?

This summit session will delve into the use of real-world evidence (RWE) and its impact on the alignment of regulatory and pricing decisions with the goals of health systems.

The discussion will focus on the importance of RWE in providing a more complete picture of a drug or medical device’s safety and efficacy in real-world settings.

The panel will explore the challenges associated with incorporating RWE into regulatory and pricing decisions, as well as the potential benefits for health systems. The session aims to provide a platform for stakeholders to exchange insights and perspectives on how RWE can be effectively integrated into decision-making processes to ensure better alignment with health system goals.

Attendees can anticipate a thought-provoking and informative discussion on the future of RWE and its role in shaping regulatory and pricing decisions to improve patient outcomes and population health.

Session Speakers

UTC 10:00 - 11:30

Plenary 2

Negotiating fair pricing – opportunities, powers, promises

90 min

Break

UTC 13:00 - 14:30

Parallel Sessions

Parallel Session 4: The untapped potential of biosimilars: how to ensure affordable access?

Parallel Session 5: Advancing accessibility and affordability of medical devices and in vitro diagnostics by bridging the information gap and complexity

Parallel Session 6: How to pay for universal access to medicines for rare diseases and by whom? The great conundrum

Final day of the Fair Pricing Forum 2024

The final day of the 2024 Fair Pricing Forum will start with a last set of parallel sessions on health technology assessments, intellectual property rights, and drug shortages. The Forum will end with a final plenary to discuss lessons learned and sustainable solutions towards fair pricing.

Parallel Session 7 - UTC 10:00 - 11:30

Using HTA to improve affordable access to essential medicines

Discussants at the 2021 Fair Pricing Forum raised the important question of whether pricing based on value assessment is the right tool among a suite of policy instruments to bring about more affordable access to medicines and health products, particularly in lower income countries and in line with broad public health objectives. While recognizing the significant growth in using value assessment through HTA to inform pricing, recent publications suggest that there are multiple barriers to using HTA, especially in low- and middle-income countries. These range from “lack of data, lack of technical skills for HTA, the technocratic nature of the work, the lack of explicit decision rules” to the perception that HTA puts a “price on life”. In high income countries, the advent of complex health technologies has also challenged the usefulness of HTA. Experts in this session will debate and provide their views on some of these barriers and describe potential ways to overcome them. The panellists will also discuss how HTA could be used in different contexts to inform the pricing and affordability of health products.

Parallel Session 8 - UTC 10:00 - 11:30

Intellectual property challenges to promote innovation and timely global equitable access and affordability

Intellectual property rights do not and should not prevent Member States from taking measures to protect public health. The WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI) highlighted key principles for the achievement of WHO’s Constitution objective of the attainment by all people of the highest possible level of health. Accordingly, WHO plays a strategic and central role in the relationship between public health, innovation and intellectual property within its mandates, capacities and constitutional objectives, bearing in mind those of other relevant intergovernmental organizations. Achieving universal health coverage, including financial risk protection, access to quality essential healthcare services and safe, effective, quality and affordable essential medicines and vaccines, is a priority. To support the research and development of vaccines, medicines and other medical devices for communicable and non-communicable diseases that primarily affect developing countries, as well as to provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the TRIPS Agreement regarding flexibilities to protect public health, and, in particular, provide access to medicines for all.

International negotiations on issues related to intellectual property rights and health should be coherent in their approaches to the promotion of public health. Strengthening the innovative capacity of developing countries is essential to respond to public health needs. Intellectual property rights are considered an important incentive in the development of new health products; however, this incentive alone does not meet the need for the development of new products to fight diseases where the potential paying market is small or uncertain. Several factors contribute to the price of health products and medical devices, and public policies should address these factors to increase their affordability and accessibility. Among others, IP policies and competition law and policies could contribute to reducing prices.

Parallel Session 9 - UTC 10:00 - 11:30

In a post pandemic world, how can policies mitigate drug shortages and increase access to patients while maintaining affordability?

Drug shortages are a multifaceted issue; in recent years, it has become more prevalent with a direct impact on consumers, healthcare institution, and governments. Pricing is part of the identified factors and the suggested solution for this issue, along with providing a favorable regulatory environment that improves and incentivizes stakeholders to maintain product availability, especially those old legacy essential drugs.

In this session, the panel will discuss several initiatives and policy changes that try to solve availability issues while considering affordability.

Plenary Session 3 - UTC 13:00 - 14:30

Optimizing pricing policies and strategies by buyers and sellers—getting it right + Closing Remarks

Pricing policies and strategies are among the tools buyers and sellers use to achieve their goals, e.g., providing access to quality health products with high efficiency in utilizing finite resources or achieving business goals and generating revenue for growth and continued innovation and R&D.

Countries recognizing the need for more effective pricing policies to achieve affordable prices have been using collaborations to strengthen their buying powers, share key market information or use the power of collective negotiations.

There are a variety of initiatives across every WHO region on HTA, pricing procurement, and many public-private partnerships that have been attempting to reduce price-& affordability-related access barriers through cross-country multi-stakeholder collaborations.

The pharmaceutical industry recognizes the major differences in the abilities of countries to pay for their product and has been testing various market access and pricing strategies to make their products available earlier and at a more affordable price in low and middle-income countries.

Lessons learned from these initiatives must be considered to further identify sustainable and effective policies, collaborations and partnerships.

This roundtable will discuss potential future solutions for effective collaborations between countries and stakeholders toward pricing policies that can reduce inequities in access to essential health technologies in a sustainable manner.

3 Parallel Session

Using real-world evidence in the real world: are regulatory and pricing decisions better aligned with health system goals?

This summit session will delve into the use of real-world evidence (RWE) and its impact on the alignment of regulatory and pricing decisions with the goals of health systems.

The discussion will focus on the importance of RWE in providing a more complete picture of a drug or medical device’s safety and efficacy in real-world settings.

Session Speakers

UTC 10:00 - 11:30

Parallel Sessions

Parallel Session 7: Using HTA to improve affordable access to essential medicines

Parallel Session 8: Intellectual property challenges to promote innovation and timely global equitable access and affordability

Parallel Session 9: In a post pandemic world, how can policies mitigate drug shortages and increase access to patients while maintaining affordability?

90 min

Break

UTC 13:00 - 14:30

Plenary 3 and Closing

Optimizing pricing policies and strategies by buyers and sellers—getting it right

Welcome to the 4th Fair Pricing Forum

Session Speakers

Andrew Mirelman

Dr Alejandro Ernesto Svarch Pérez

Dr Daniela Marreco Cerqueira

Anchalee Jitruknatee

Dr Ali Alshahrani

Vishakha Sharma

Dr Katrina Perehudoff

Adriana María Robayo García

Christopher Lim

Abdulrazaq Al-Jazairi

Suzannah Chapman

Dr Nehal Gamal El-Din Ebrahim Abou Youssef

Prof Abderazzek Hedhili

Mansour Al Howaimel

Mustaqeem de Gama

Boyan Konstantinov

Friederike Windisch

Ashodra Jaishika Gautam

Lisa Hedman

H.E. Prof Adel A. Alharf

Dr Yupadee Sirisinsuk

Judit Rius Sanjuan

Dr Haruka Nakada

Deusdedit Mubangizi

Dr Yukiko Nakatani

Victor Mendonca

Jim Keon

Dr Richard Torbett

Julie Maréchal-Jamil

Abdullah H. AL-Hatareshah

Millicent Alooh

Saudamini Vishwanath Dabak

Dr Hana Al-Abdulkarim

Dr Sunu Alice Cherian

Ellen F. M. ‘t Hoen

Dr Sabine Vogler

Dorthe Bartels

Dr Suerie Moon

Simone Boselli

Thomas Cueni

Lovisa Gustafsson

Dr Fatima Suleman

Salomé Meyer

Yusi Anggriani

Claudia Martínez

Dr Joseph S. Ross

Tamara Schudel

Anne-Sophie Chalandon

Adriana Velazquez Berumen

Dr Bhagwan Singh Charan

Heba Wanis

Dr Graciela Fernández

Paul Fure Torkehagen

Andrew Rintoul

Dr David Henri Beran

Dr Anban Pillay

Fatimah Al Hussain

Kevin Pothier

Dr Izzuna Mudla Mohamed Ghazali

Dr Jessica Ochalek

Dr Prashant Yadav

Valérie Paris

Abraham S.T. Weekes

Dr Mouna Jameleddine

Sultan Al Harbi

Prof Dr Andres Pichon-Riviere

Sharmila Nebhrajani

Dr Quinn Grundy

Dr Susan Horton

Dr Andy Gray

Sergiy Kondratyuk

Anthony D. So

Dr Viviana Muñoz Tellez

Dr Charles Senessie

Mohamad Wehbi

Adrian van den Hoven

Ashley Miller