China passed the Physician Law in August in an attempt to regulate off-label prescriptions for the first time. The new law, set to take effect March 1, 2022, will grant physicians the right to use off-label drugs that could benefit drugmakers.
Permitting off-label use is expected to bring more market opportunities to drug makers, as their drugs, once launched in the market, can be administered on more patients.
The Chinese Pharmacological Society defines off-label drug use as the use of drugs for an unapproved indication or in an unapproved dosage, treatment course, route of administration and patient group. It has long been practiced by physicians in China due to the delay in drug approvals and updating package inserts despite the legal risks.
The Physician Law stipulates that when no effective or better treatments are available, physicians may, upon patient consent, use drugs in a way that is not indicated in the package insert but is supported by medical evidence.
The bottom line is that physicians shall adhere to the principles of safe, effective, economical and reasonable medication in accordance with clinical guidelines and medication guides, under Article 29 of the new law.
China passed the law to protect the lawful rights and interests of physicians. The law also clarifies the qualification examination and registration, rules of practice, training, assessment, supporting measures and legal liabilities for physicians.
Common in hospitals
The delay in updating medication guides has led to off-label drug uses, which has become common in Chinese hospitals, Wu Jinchang, lead oncologist at Xuzhou Mining Group General Hospital, told state media The Health Times.
A survey by the Chinese Pharmacological Society showed that 24 hospitals, over half of the respondents, had been practicing off-label prescribing.
The 24 hospitals recorded 1,652 off-label uses of 998 drugs, which were mostly indicated for oncology, immunomodulatory, cardiovascular, digestive, endocrine and infectious diseases.
Non-indicated usage accounted for 90% of all cases of off-label use. Physicians also changed the dosage or administration routes and use the drugs in a different group of patients.
Previous regulatory attempts
Before the Physician Law came along, local groups had made efforts in regulating off-label drug use.
In 2014, the Guangdong Pharmaceutical Society issued an expert consensus on off-label drug use, which suggested such prescriptions should meet five conditions:
1.There are no alternative treatments in situations that affect the quality of life of patients or are life-threatening.
2.The purpose of using the drug is not for clinical studies.
3.There is reasonable evidence in clinical practice.
4.The use is approved by the hospital’s pharmacy management committee.
5.The consent rights of the patients are protected.
The Guangdong organization subsequently updated the list for off-label drug uses for seven times. The 2021 version includes 242 drugs, including oxaliplatin, bevacizumab and docetaxel that are mostly anti-tumor drugs.
Legal protection for off-label drug use
Previously, oncologists had criticized their peers for prescribing drugs not in accordance with the standard clinical guidelines, and subsequently, those who were found doing so were punished, The Health Times reported.
Now, the legal issues surrounding off-label drug use seem to have been resolved. Physicians like Wu welcome the new law.
“The articles on off-label use in the new law not only benefit the physicians and hospitals, but also protect the rights of patients,” he told the paper.
But there are also concerns of physicians prescribing drugs without limits.
To address them, Wu said that the hospital's pharmacy department should keep monitoring off-label use, regularly collect data and report to the relevant authorities.
He added that the health administrative offices should monitor the situation in the hospitals, assess the legal risks and clinical value, hold those violate the law accountable and develop protocols for off-label use to ensure patients have given their consent.
Editing by Justin Fischer and Elise Mak