The European Medicines Shortages Research Network and Its Mission to Strategically Debug Disrupted Pharmaceutical Supply Chains

Abstract

The problems created by supply shortages of medicines have been widely reported by healthcare professionals and patients over recent years and acknowledged by the European Medicines Agency and European Commission. Shortages result in the suffering of individuals and negative consequences for an economy. An option to overcome shortage situations is to use a different medicine as a substitute. However, alternatives are not always feasible and available. When shortages arise, risk increases through substitution from other excipients, other concentrations, foreign language vials, or untranslated package leaflets. Such risks have not yet been quantified in a scientifically credible way. Thus, a decrease of the number of shortages will have a global economic and societal impact which is in the interest of clinicians, patients, public health, and of taxpayers. The supply chain can be parted into processes such as production of active ingredients, manufacturing, wholesaling, clinical need, and measures of poor clinical, financial and quality of life outcomes arising from shortages. The cited causes are multifaceted ranging from production disruptions, natural disasters, discontinuations, difficulties created by various restrictive and disincentive legal, trade and pricing frameworks, unfavorable decision making in medicines production and trade, insufficient stocks, as well as conflicts of interest of stakeholders. The European Medicines Shortages Research Network addresses these causes and debugging strategies by the bottom-up approach of COST (cooperation in science and technology) Action CA15105 which joins together all stakeholders and particular interests along the supply chain. The COST platform is sustained by nationally funded research projects which aim to respond to clinical, financial and quality of life interests, to achieve analytical clarity on disruption causes, to simulate decision making in order to anticipate new shortages, and to reflect on best coping practices. Approach to improvements of the situation comprises novel approaches such as System Dynamics and the repromotion of hospital pharmacy manufacturing and preparation. Activities of the European Medicines Shortages Research Network will make a significant contribution to strategic thinking about how to respond to product shortage problems by systematically analyzing the situation from key player perspectives. This includes round table negotiations with the stakeholders. It is the declared aim of the project to bring together all the primary stakeholders in the medicines supply chain process to find an agreement on the paths towards resolution by a bottom-up approach. The final objective is to stimulate constructive agreement between all participating stakeholders and to reveal any restrictive legal and economic frameworks, erroneous incentives in the supply chain, conflicts of interest, and problematic cost-benefit ratios that induce or exacerbate shortages.