Japan has been plagued by a prolonged shortage of common medications such as cough suppressants, expectorants and antimicrobial agents.
According to a survey by a pharmaceutical industry organization, since September, shipments of about 20 percent of all drugs have been either suspended or limited in quantity. Seventy percent of them are generic drugs, which are primarily sold as more affordable alternatives.
Regarding generic drugs, a drugmaker in Fukui Prefecture was embroiled in a scandal three years ago for accidentally mixing sleeping pills with its internally used generic skin medication, leading to deaths and injuries.
Since then, more than 10 drugmakers have received business suspension orders and other sanctions for violating laws and regulations, which has been a major cause of the supply shortage.
Since the capacity to expand the production of medicines in short supply is limited, it is necessary to get through the winter, when an increase in demand is expected due to the outbreak of infectious diseases, limiting as much medication prescriptions as possible.
We urge industry and government to closely monitor the drug supply situation to avoid excessive stockpiling and uneven distribution.
There is a serious lack of awareness regarding compliance with laws and regulations related to manufacturing and quality in the industry.
Some observers also say the industry is grappling with structural problems caused by the tendency of many generic drugmakers to prioritize production efficiencies and shipping schedules to take advantage of growing demand. rapid growth.
The industry must make a concerted effort to restore public trust and prevent this from happening again, instead of leaving the challenge to individual companies.
The government has encouraged the use of generic drugs to curb the growth of health spending through various incentives.
They include higher medical costs paid to health care providers under the public health insurance program when hospitals and pharmacies choose generic drugs. The rate of use of generic drugs is approaching the target of 80 percent.
In 2005, licensing requirements to manufacture and sell generic drugs were relaxed. This has led to an influx of small and medium players in the booming generic drug sector.
As government-set prescription drug prices have steadily declined, competition between drugs has intensified.
But it’s difficult for generic drugmakers to stop production of even unprofitable products as long as there is demand.
This situation was further aggravated by the rising costs of imported raw materials and packaging materials.
To guarantee their profits, generic drug manufacturers have had no choice but to launch new product lines. As a result, many companies have become accustomed to producing a wide range of products in small quantities.
Their production lines, operated on long-term fixed schedules, cannot be adjusted flexibly. As a result, they are unable to fill supply gaps created by other companies shipping suspensions.
The government bears some responsibility for this situation. It should take policy measures to support the transformation of the industry towards one capable of ensuring a regular supply of necessary items while maintaining quality.
Above all, it is essential to create a system in which companies capable of manufacturing and supplying products of appropriate quality are fairly rewarded by the market.
It is also crucial to take steps to improve transparency regarding each company’s production capacity, distribution and inventory while avoiding shortages and unforeseen disruptions.
One of the policy questions facing the government is how prescription drug prices should be reviewed and adjusted to promote these reforms.
The government should carefully review and reconsider the drug pricing system with a view to ensuring a stable supply and reducing healthcare costs.
–The Asahi Shimbun, October 31
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