Experts say the new catalog will ensure supply and help prevent frequent shortages of children’s drugs.

By Ni Dandan and Zhu Jingyi

China is on track to unveil a dedicated list of essential medicines for children for the first time to guarantee accessibility and affordability of such drugs, according to a draft regulation published by the country’s top health authority Monday.

While the National Health Commission didn’t disclose the names or number of drugs included, experts believe the list will span vital supplies for children and help minimize shortages. On a previous list published in 2018, only 22 of the 685 drugs, including Western and traditional Chinese medicines, were specifically medications to treat emergency conditions among children.

Defining essential medicines — those required to satisfy people’s priority health care needs — helps make them affordable and accessible to the general public. China's first comprehensive essential medicines list in 2009, which is updated every three years and used a guide for hospitals, included over 300 generic medicines.

Monday’s draft regulation came months after the State Council, China’s Cabinet, issued a 10-year outline on the development of children. The document underscored the timely need to explore and compile a list of essential medicines for children and update the catalog of prohibited drugs.

Of the 7,710 medicines used for pediatric patients in 2017, only 610 were researched and developed specifically for children, state-run Economic Information Daily reported, citing surveys conducted by a medical research firm among the country’s insured patients. The surveys also indicated some 92% of the drugs used on those same patients didn’t have indications they could be administered on children.

The consequences of using medicines meant for adults on children have frequently resulted in adverse drug reactions. Around 30,000 children in China were left with hearing impairments every year after inappropriate usage of medicines, according to a 2016 white paper on the safety survey of medications for children.

The limited variety of children’s medicines and supply shortages have also troubled the country’s pediatricians. Such shortages often stem from pharmaceutical companies’ reluctance to research and produce children’s medicines as there are too many challenges, including more investment and complicated clinical trials, financial outlet Caixin reported as early as 2016.

“For the same medicine, different dosage forms need to be produced for children in different age groups,” a person in charge of a domestic pharmaceutical company was then quoted saying. “Besides, there are additional requirements on flavor and route of administration, which also add cost for pharmaceutical companies.”

In 2017, a shortage of mercaptopurine, an essential drug to treat children with leukemia, resulted from the medication’s low price, which discouraged pharmaceutical companies from producing it.

A pediatrician surnamed Huang from the Children’s Hospital of Shanghai told Sixth Tone that most drugs used by pediatricians domestically are intended for adults. He added that most are not researched and produced specifically with kids in mind.

“The shortage of drugs for children is complicated,” he said. “Chinese people are very conservative toward clinical trials, there isn’t sufficient support from the government level, and pharmaceutical companies are reluctant to produce due to concerns over return on investment.”

The pediatrician added that the new drug list for children would likely include imported medicines.

“It’s a good sign that there’s greater attention paid to this issue,” Huang said. “There’s a long way to go before the situation can fundamentally improve,” he added.