Implementing sustainable liver health in Europe: a second EASL–Lancet Commission

Funding

We dedicate this report to the memory of Michael P Manns who passed away following the completion of the Commission report. Michael Manns always wished that the Commission should not only emphasise the major contribution of alcohol and unhealthy diets to the development of liver disease, but that it should also highlight the incredible physiology of this complex organ and the many vital medical developments and innovations that have resulted from the study of it and its related diseases (see appendix 1 pp 95–97 for “The way forward for hepatology”). We thank Sven Franque for help in developing the text related to hepatology training needs in Europe. We thank Francesco Paolo Russo for assistance with the survey on hepatology training in Europe. We thank Jakob Nikolas Kather and Eric Trepo for input to the text on artificial intelligence. We thank Andrew Aronsohn, Markus Cornberg, Tracy Swan, Gregory Dore, Françoise Degos, Mila Maistat, Wahid Doss, and Robert Flisiak for input and helpful discussions. We thank Stine Johansen for help in developing figure 1. We thank Jordi Bruix for helpful discussions. We thank Morgane Guex and Maraika Black at the European Association for the Study of the Liver (EASL) office for assistance in arranging the in-person and online meetings of the EASL–Lancet Commission. We thank Kari C Toverud for help in developing figure 12. Authors alone are responsible for the views expressed in this publication and they do not necessarily represent the views, decisions, or policies of WHO. The opinions expressed and arguments used herein are solely those of the authors and do not necessarily reflect the official views of the Organisation for Economic Co-operation and Development or of its member countries. The views and opinions expressed herein are the authors' own and do not necessarily state or reflect those of the European Centre for Disease Prevention and Control (ECDC), and ECDC is not responsible for the data and information collation and analysis and cannot be held liable for conclusions or opinions drawn. EASL provided financial support to enable the in-person meetings of the EASL–Lancet Commission. The work of the EASL–Lancet Commission was performed by Commissioners and contributors in capacity as individuals, and relevant funding sources for individual co-authors as indicated in the declaration of interests section had no role in data collection, analysis, interpretation, writing, or the decision to submit the report for publication. All authors have access to all data relevant to presentations in the manuscript and accept responsibility to submit for publication. We dedicate this report to the memory of Michael P Manns who passed away following the completion of the Commission report. Michael Manns always wished that the Commission should not only emphasise the major contribution of alcohol and unhealthy diets to the development of liver disease, but that it should also highlight the incredible physiology of this complex organ and the many vital medical developments and innovations that have resulted from the study of it and its related diseases (see appendix 1 pp 95–97 for “The way forward for hepatology”). We thank Sven Franque for help in developing the text related to hepatology training needs in Europe. We thank Francesco Paolo Russo for assistance with the survey on hepatology training in Europe. We thank Jakob Nikolas Kather and Eric Trepo for input to the text on artificial intelligence. We thank Andrew Aronsohn, Markus Cornberg, Tracy Swan, Gregory Dore, Françoise Degos, Mila Maistat, Wahid Doss, and Robert Flisiak for input and helpful discussions. We thank Stine Johansen for help in developing figure 1 . We thank Jordi Bruix for helpful discussions. We thank Morgane Guex and Maraika Black at the European Association for the Study of the Liver (EASL) office for assistance in arranging the in-person and online meetings of the EASL–Lancet Commission. We thank Kari C Toverud for help in developing figure 12 . Authors alone are responsible for the views expressed in this publication and they do not necessarily represent the views, decisions, or policies of WHO. The opinions expressed and arguments used herein are solely those of the authors and do not necessarily reflect the official views of the Organisation for Economic Co-operation and Development or of its member countries. The views and opinions expressed herein are the authors' own and do not necessarily state or reflect those of the European Centre for Disease Prevention and Control (ECDC), and ECDC is not responsible for the data and information collation and analysis and cannot be held liable for conclusions or opinions drawn. EASL provided financial support to enable the in-person meetings of the EASL–Lancet Commission. The work of the EASL–Lancet Commission was performed by Commissioners and contributors in capacity as individuals, and relevant funding sources for individual co-authors as indicated in the declaration of interests section had no role in data collection, analysis, interpretation, writing, or the decision to submit the report for publication. All authors have access to all data relevant to presentations in the manuscript and accept responsibility to submit for publication. At the regulatory level, the approval of new treatments in the EU is overseen by a single entity, the European Medicines Agency. However, prices and reimbursements are handled nationally, resulting in diverse approaches across member states. Adapting the reimbursed price of a new medicine to local purchasing power could mitigate the cost effect, although in low-income and middle-income countries with a high disease prevalence, the overall affordability of innovative medicines—priced based on the price agreed in high-income countries—is, in most cases, completely out of reach. The Medicines Patent Pool enables voluntary licenses that allow these countries (including those in the upper-middle income lending group) to access otherwise unaffordable medicines, 477 leading to substantial savings due to competition among generic manufacturers. 478 Access can be further facilitated by a combination of additional factors, as shown by Egypt's national hepatitis C virus elimination programme ( table 4 ). Here, success was achieved by the combination of bilateral agreements between originator companies and local generic manufacturers, a strong political commitment, and logistical and financial support from WHO, the Global Fund, and two World Bank loans. This case could serve as a model for other agreements designed to guarantee access to novel medicines in low-income and middle-income countries and any country with limited purchasing power, balancing affordability with quality assurance.