Patient Access to Life-Saving Medication; Preventing Stock-Outs Due to Parallel Trade

Manufacturers and suppliers of potentially life-saving drugs must ensure adequate supplies of in-date drug formulations for all markets across Europe. Failure to do so risks patient lives, but stock-outs have occurred even when a manufacturer has “over-supplied” a market with many times the amount of drug expected to meet local demand. These stock-outs have occurred as a result of parallel trade. In these cases, as little as a 10% variance on pack cost is enough to trigger parallel trade, which can result from price variations at launch across the EU and currency fluctuations following launch. These situations form a useful series of case studies to determine supply chain issues leading to stock-outs. Based on this case study analysis, a model is being developed to estimate the degree of exposure to risk of parallel trade and its associated potential cost to the manufacturer/supplier, and to patient access. The model identifies and quantifies trade flow patterns and key elements. Consequently, supply planning is possible based on essential metrics identified in the trade flow patterns. An allocation scheme to meet local needs is the key output of the model. The allocation scheme is applied to limit stock to the country to be in line with demand, plus a smaller variance (depending on local conditions) for that market compared to that previously applied. The model is intended for use in key EU markets (France, Germany, Italy, The Netherlands, Spain, Italy, UK) as well as countries in Central and Eastern Europe. The model should help to optimise supply chain planning and operations, thereby minimising the risk of stock-outs. Consequently, all patients requiring specific, potentially life-saving drugs should have access to these treatments.