Japan Outlines Measures to Ensure Stable Drug Supply

TOKO, Japan — The Ministry of Health, Labor and Welfare (MHLW) presented to its panel on stable drug supplies an outline of measures involving a key medicine list, supply chain mapping, risk assessments, stable supply schemes, and pricing regulation, reported Pharma Japan.

MHLW announced that 551 products have been cited by 58 scientific societies as candidates to be defined as key medicines that need to be prioritized in view of their annual manufacturing volume and supply chain situations. Previously, MHLW unveiled 418 products that had been submitted by 36 scientific societies by June 22, but the numbers have since grown.

The drugs that need to be secured will be selected towards the end of this fiscal year through March 2021, according to MHLW’s outline.

The panel on stable drug supplies was launched in March after Japan suffered from antibiotic supply shortages last year, which brought attention to the country’s over-dependence on APIs made overseas, a problem made worse by the COVID-19 pandemic.

In April, MHLW asked scientific societies through the Japanese Association of Medical Sciences (JAMS) to compile a list of 10 key drugs in each area that are widely used in clinical practices and deemed medically essential.

The final selection is expected to involve consideration of serious diseases, substitute drugs or alternative treatments, and the number of patients for which the drug is prescribed.

To prevent supply disruptions, the outline calls for supply chain mapping through collaborative efforts between the government, drug makers, and API suppliers, starting with products that carry the highest priority.

The outline also calls on drug makers to collect risk information pertaining to APIs and originating substances for selected products, and conduct risk assessments to deliberate on necessary measures to secure supplies, such as increasing inventories, diversifying sources, repatriating manufacturing, and making joint API purchases.

The Ministry further requests setting specific rules for companies to report possible supply concerns to the government, which would apply to selected key drugs and others.

Additionally, drug makers are requested to create a stable supply scheme that would enable substitute medicines to be quickly delivered to high priority medical institutions.

In terms of pricing, the outline calls for preventing pharmaceutical makers and wholesalers from making losses by distributing these key medicines, and using existing pricing mechanisms to shore up prices for loss-making products or products that will likely become unprofitable.

The outline was generally agreed upon by the panel, but some members wondered if pricing should be addressed by this forum as perhaps it should be left to discussions by the Central Social Insurance Medical Council (Chuikyo) or the “Ryukaikon” council for the improvement of ethical drug distribution.

The handling of pricing at the panel will, therefore, be reassessed by MHLW and a report on stable supply measures will be prepared for its next meeting planned for August at the earliest.

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