The "Physician Law" has opened the legal floodgate for the implementation of off-label drug use today?

The "Physician Law" revised from the original "Practicing Physician Law" will be officially implemented on March 1, and the "Physician Law" has many highlights

The medical and legal risks of off-label drug use

The risk of off-label drug use comes from the double risk of medical risk and legal risk

Off-label and on-label medication

Off-label drug use (OLDU) is also known as "off-label drug use" or "drug unregistered drug use".

In contrast, taking medication according to the instructions is in line with both the medical norms for clinical medication and the relevant legal norms

The medical risks of off-label use

Analyzing the relevant laws and regulations of drug administration in China, it can be seen that drug inserts are public, normative documents authorized and licensed by relevant authorities.

Each drug indication is established after obtaining superiority results through rigorous clinical trials compared with the standard drugs at that time.

It can be seen that the use of drugs in accordance with the instructions of the drug is required by the medical science and technology standards of clinical medical treatment and clinical pharmacy

Legal risks of off-label use

Article 72 of the Drug Administration Law, Article 25 of the former Law on Licensed Physicians, Article 14 of the Measures for the Administration of Prescriptions and other existing laws and regulations all clearly require that the rational use of drugs in accordance with the instructions is legal.

Medical and ethical needs of off-label drug use

Medical needs for off-label use

Disease diagnosis and treatment is the most complex science, exploratory and unpredictable

However, due to the complicated approval process for updating the contents of drug inserts, pharmaceutical companies need to spend a lot of time and expense to complete the clinical research evidence that meets the registration requirements.

Ethical needs for off-label use

The ultimate and highest goal of medicine is to cure disease and restore health, and all measures that take this as the starting point and destination are in line with the principles of medical ethics

In 1982, the U.

The duty of a doctor is to cure diseases and save lives.

If the medicine can only be used in accordance with the instructions in clinical practice, it is sometimes difficult to achieve the purpose of medical treatment and even bring medical disadvantages: leading to the stagnation of the development of medical pharmacy and the impact of patients' rights and interests in treatment

There are differences between individual patients, and different drugs are selected according to different individuals

The road to legal regulation of off-label drug use in my country

Of course, the risk of off-label medication is greater than that of on-label medication.

The main risk for patients is that off-label medication fails to achieve the expected curative effect, or even has unexpected side effects and complications.
The prevention of this risk depends on the doctor's familiarity with the relevant data of off-label medication and the grasp of the disease indications
.

The risk of doctors In the medical environment where the contradiction between doctors and patients is prominent in China, the risks of doctors should not be underestimated
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Off-label drug use has always existed in our clinical diagnosis and treatment, but due to the lack of standard and standardized management, the good and the bad are mixed
.
Some off-label drugs are used under the recommendation of diagnosis and treatment guidelines or on the basis of sufficient clinical evidence, while others lack relevant evidence or even blindly use them
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Off-label drug use is not uncommon in medical disputes, and it only arouses people's attention after the repeated occurrence of related medical disputes
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When faced with the widespread off-label drug use in reality, China began to explore the standardized supervision of off-label drug use
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In March 2010, the Guangdong Pharmaceutical Association took the lead in publishing the "Expert Consensus on the Use of Unregistered Drugs"
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Since then, some academic associations have issued consensus in this regard
.
From a legal perspective, these consensuses are only non-mandatory norms, not mandatory and binding, and lack the basic provisions of higher laws
.

The reality of off-label drug use calls for legislation, and the revised "Physician Law" finally includes relevant provisions
.

The new "Physician Law" establishes the legal principle that medication according to the instructions is the foundation, and medication that is off-label is the exception.

Medication according to the label is the basic, off-label medication is an exception

The "Physicians' Law" was written into off-label medication for the first time, which does not mean that off-label medication can be implemented clinically at will from now on
.
Carefully study the law, it is not difficult to find that the "Physician Law" establishes the legal principle that medication according to the instructions is the basis, and medication that is not prescribed is the exception
.

Article 28 of the Physician Law: Physicians shall use drugs, disinfectants, and medical devices that have been approved or filed in accordance with the law, and adopt legal, compliant, and scientific methods of diagnosis and treatment
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From the perspective of legislative technical specifications and legal interpretation, Article 28 clearly stipulates that the drugs that doctors choose to use must be drugs approved according to law.
Obviously, drugs approved according to law include approved drug instructions
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Therefore, the basic principle for doctors to use drugs is still to follow the instructions
.

There are two clauses in Article 29.
Both clauses emphasize how physicians use medicines.
The first clause states: Physicians should adhere to the principles of safe, effective, economical and reasonable medication use, and follow the guidelines for the clinical application of drugs and the guidelines for clinical diagnosis and treatment.
Rational use of drugs, such as drug instructions
.
The first paragraph once again clarifies the rational use of drugs according to the instructions
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Paragraph 2 of Article 29: In special circumstances such as no effective or better treatment methods, after obtaining the patient's explicit informed consent, the physician may use the drug usage that is not specified in the drug insert but has evidence-based medical evidence to implement treatment
.
Medical institutions shall establish management systems, review the suitability of physicians' prescriptions and medication orders, and strictly regulate physicians' medication behavior
.

The second paragraph is the off-label drug use clause
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From the external form and logical arrangement of the legislation, it is obvious that the second paragraph belongs to the exception clause of Article 29
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Strict restrictions have been imposed on off-label drug use, and the responsibility for regulating off-label drug use has also been delegated to the medical institution where doctors work
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Medical institutions are required to establish relevant management systems for off-label drug use, and review and approve the suitability of off-label drug use by physicians
.
As for the specific operation process, it depends on the establishment of lower-level laws or relevant judicial interpretations
.

The specific implementation of off-label drug use

Regarding the specific implementation measures for off-label drug use, the "Expert Consensus on Off-label Drug Use" that has been published in China has been explored for a long time, and relevant experience has been accumulated.
Technical specifications have risen to mandatory binding laws and regulations
.