Article Text
Abstract
Background and importance Medicines shortages are recognised by the World Health Organization as a challenge threatening health outcomes. Shortages have tripled since 2017.
Aim and objectives To propose options for action to health policy decision makers.
Material and methods Stakeholder interviews, two Delphi rounds and system dynamics simulation with Vensim.
Results Most promising recommendations are:
Governance
Determination of system leverage points
Designation of an integrating leader
Allocation and demarcation of responsibilities and duties
Expansion of stockpiling by the federal office for national economic supply
Reframing the primacy of constitutionally guaranteed freedom of trade: ensuring the availability of medicines even in less profitable business domains
Subsidies for allocation of higher capacities over the entire supply chain
API synthesis and trade
Ensuring the synthesis of active ingredients in Switzerland and/or Europe
Admittance of non–Ph Eur qualities for non–parenteral products
Obligations to licence holders:
Registration of ≥2 API suppliers/manufacturers
Stockpiling of both API and medicinal product
Production
Subsidies for products threatened by economic reasons
Financial incentive systems (price, taxes, subsidies)
Resizing of production scales (large, intermediate and small scale) and/or licensing to SMEs in economically weak regions
Merger requirements: to keep products on the market or to sell them to SMEs
Reinsurance for liability risks of SMEs
Backup supply of formula products from hospital pharmacies, universities, army
(Pre-)wholesalers/trade
Risk based differentiation of pharmaceutical supply chains
direct-to-hospital line
retail pharmacy line
Fewer serial stocks, but higher buffer capacity per stock
Backup supply by medicinal products with English documentation (for medical use, not for dispensing)
GPS monitoring of international medicines transportation
Healthcare providers
Definition of formularies considering supply security
Limiting tendering
DCI prescription (instead of brands)
Investment in higher capacities, technical equipment for production, personalised medicine
Revision of outdated therapy paradigms
Expanding diagnostics to differentiate responders/non-responders
Outcomes
Pharmacoeconomic evaluation of added values (cost benefit, cos effectiveness, cost minimisation, cost of QALYs)
Keeping cost neutral (costs=unit price×quantity)
Reinsurance financial risks of stock bound capital
System financing
Revision of the pricing system
Charging employers for added health values and regained productivity of their employees
Acquisition of patents and intellectual properties by states
Conclusion and relevance Coping with medicine shortages by quota and rationing will not delete the root causes of shortages. Supply from additional sources (eg, SMEs, hospital pharmacies, army, universities) will replenish empty shelves.
References and/or acknowledgements
SNF_database (download: http://p3.snf.ch/project-174566)
Funding COST_Action_CA15105, SNF/COST_Switzerland (grant C16.0038), BFH_own_funding
Conflict of interest No conflict of interest