A clear process for importing the use of chlorpalcan is being proposed. Once the plan is officially implemented, patients will no longer have to risk "smuggling, transportation, drug trafficking" and other risks to purchase drugs privately, and can rely on medical institutions to apply for compliant use. (Courtesy of the patient's family/photo)
The ice is breaking – thousands of children with epilepsy have been saved, but the original drug purchaser, the Iron Horse Glacier, is still in prison.
On March 29, 2022, the National Health Commission issued an announcement on its official website on the "Temporary Import Work Plan for Urgently Needed Clinical Drugs" and the "Temporary Import Work Plan for Chlorpaljan", and the deadline for feedback is April 28.
According to the draft for comments, a clear process is being proposed for the import of the use of chlorpoise. Once the plan is officially implemented, patients will no longer have to risk "smuggling, transportation, drug trafficking" and other risks to purchase drugs privately, and can rely on medical institutions to apply for compliant use.
Eleven days ago, on March 18, a buyer of Chlobazan, known online as "Iron Horse Glacier," was tried at the Zhongmu County Court in Zhengzhou City on charges of smuggling, trafficking, and transporting drugs. As an anti-epileptic drug, chlorpakhan is a state-controlled second-class psychotropic drug that falls under the scope of "drugs" according to the provisions of the mainland criminal law.
Since Chlorpachan is not listed in China, in the past few years, parents of children with epilepsy have been introduced by word of mouth to buy this drug overseas and purchase this drug by mail, courier and other means. In July 2021, with the purchase of the "Iron Horse Glacier" and the families of 4 children under the control of the police, this underground drug purchase channel was blocked (see December 9, 2021, Southern Weekend reported "Behind the Release of 'Drug Trafficking' Mothers: Thousands of Children Are In Emergency Medication, When Will the "Life-Saving Drugs" Be Approved?). 》）。
As soon as the National Health Commission's draft for comment was released, the suggestions of the patients' families poured in like snowflakes. At 10:00 p.m. on March 30, 2022, Ma Xin, a representative of the family of a child with epilepsy, told Southern Weekend reporters that in order to solve the real needs of the patient's family, they launched a questionnaire survey for the patient's family, and the link was online for less than 3 hours, and 263 submitted feedback were received.
"I hope that the plan can be implemented as soon as possible, and many children can't afford to wait for the 'drug'." The group leader of the patient organization "One Meter Sunshine Baby Spasm Patient Group" "Songsong Daddy" told Southern Weekend Reporter. At the end of 2021, "Songsong Dad" led the release of a joint letter of help from thousands of parents of children with epilepsy, which aroused widespread concern from all walks of life.
At present, when the policy will be officially introduced, what problems should be avoided in the landing process, and how to simplify the process to improve the accessibility of drugs, these issues that are of concern to the families of children with epilepsy, and even the entire rare disease group, are still inconclusive.
"This time the program not only involves chlorpal accounting for a drug, in the field of rare diseases, there are many similar drugs that are available abroad and not available at home." Long Tianwei, chief medical and innovation officer of the Beijing Pain Challenge Public Welfare Foundation, told Southern Weekend that advocating the establishment of a sound set of temporary import work plans for urgently needed clinical drugs is bound to benefit more patients.
Five medical institutions are planning to be temporarily imported
Ma Xin's daughter is more than 5 years old in 2022 and should soon enter elementary school. At the age of 4 months, she was diagnosed in Beijing with Dravet syndrome, a rare progressive epilepsy caused by genetic factors, which is more severely impaired by the child's cognitive dysfunction and poorly treated with drugs due to the high frequency of seizures.
Lifelong medication is the most important way to control seizures and reduce brain damage in children. There are more than ten kinds of drugs that can be used to control seizures, such as Kaipurin, Debakin, oxcarbazepine, and totax. For those children who cannot control their condition after using at least 2 or more anti-seizure drugs and suffer from drug-refractory epilepsy, the use of uncarted clobats in China to control seizures has become a no-way.
This is a chemical drug that has long passed the patent protection period and is inexpensive. It was first developed by the Danish Lingbei Pharmaceutical Company (Lundbeck), which is deeply cultivated for central nervous system diseases, and produced by the French pharmaceutical company Sanofi and the British pharmaceutical company MartindalePharma, and listed in the United Kingdom, France, Germany, Italy, Argentina, India and other countries.
However, in China, as a state-controlled Class II psychotropic drug, the private sale and purchase of chlorphazan is an illegal act, and some purchasers have been prosecuted and detained by the procuratorate, and the families of the children have also fallen into the problem of medication.
The National Health Commission released a draft for comment on its official website. (Screenshot/photo of the official website of the National Health Commission)
According to the newly released "Chlorpal-Based Provisional Import Work Plan (Draft for Solicitation of Comments)", the proposed application process is divided into the following steps: the National Health Commission organizes the clinical demand for Chlobar-Baba-cham, determines the list of medical institutions to be used, and selects the medical institutions leading the import; the leading import medical institutions should submit a temporary import application to the State Food and Drug Administration and provide relevant materials as required; after the State Food and Drug Administration receives the relevant applications of medical institutions, it will reply to the letter within 3 working days and issue an import permit certificate for those that meet the requirements The importing unit holds the import permit to go directly to the customs for customs clearance procedures. Such imported drugs do not need to be inspected at the port.
"The draft for comments issued this time clarifies the work functions, rights and responsibilities of several relevant departments." Liu Yao, a senior oncology drug project manager working in pharmaceutical companies, told Southern Weekend that the applicant for temporary imported drugs was clearly defined as a clinical medical institution, excluding individuals, rare disease tissues and other forms. The management of the use of drugs after importation, including clinical use, safety and effectiveness, adverse reaction reports, etc., also belongs to medical institutions.
The list in the appendix to the draft for comments shows that the list of medical institutions that intend to lead the import and use of chlorphazan covers 31 provinces and municipalities directly under the central government, including 50 such as Peking Union Medical College Hospital, Huashan Hospital affiliated to Fudan University, and Shenzhen Children's Hospital, and intends to rely on the "China Rare Disease Diagnosis and Treatment Service Information System" and the National Rare Disease Diagnosis and Treatment Collaboration Network to strengthen the scientific management of drug use.
Patients' families recommend "simplifying the process and prescribing more drugs"
"Article 65 of the Drug Administration Law, which the patient's family appealed for, was finally activated and put forward a relatively clear work path." Ma Xin's husband, Chen Tong, told Southern Weekend reporters.
At the end of 2021, the State Food and Drug Administration said in an interview with Southern Weekend reporters that for drugs that have not been approved for marketing in China, if clinical treatment is urgently needed, medical institutions can apply to import a small amount of drugs for the treatment of patients in accordance with Article 65 of the Drug Administration Law, which will be approved by the State Food and Drug Administration or the provincial government authorized by the State Council (the State Council has authorized Hainan Province and Guangdong Province). In order to control the risk of safety and effectiveness in the process of use, the medical institution shall submit an application and be responsible for the specific use of the drug. (For details, see the Southern Weekend report on December 15, 2021, "State Food and Drug Administration Answers Nan zhou: How to enter the country for urgently needed rare disease drugs such as Clopazan?") 》）
In the "Work Plan for the Temporary Import of Urgently Needed Clinical Drugs (Draft for Comment)" recently released by the National Health and Health Commission, it is further clarified that the policy applies to "a small number of drugs that are urgently needed for overseas listed drugs that are not registered and listed in China, have no enterprise production, or cannot resume production in a short period of time". There are 3 types of drugs that can go through this channel, including: drugs for the treatment of rare diseases; drugs for the prevention and treatment of serious life-threatening diseases, and there is no effective treatment or prevention means; drugs for the prevention and treatment of serious life-threatening diseases and drugs with obvious clinical advantages.
After Klabasan was included in the category, the most concerned issue for the family was how to better implement the policy in practice.
"In medical institutions that really contact patients, including doctors, hospital leaders and administrators in clinical departments, do they have the motivation to promote the real landing of temporary imported drugs?" As a clinical surgeon at a tertiary hospital in Beijing, Chen Tong hopes that the draft for comments will further simplify the process and minimize the resistance of medical institutions to use drugs.
For example, the "Work Plan for the Temporary Import of Urgently Needed Drugs in Clinical Practice (Draft for Comments)" mentions that if it is a rare disease drug, in principle, it should rely on the "China Rare Disease Diagnosis and Treatment Service Information System" and the National Rare Disease Diagnosis and Treatment Collaboration Network to strengthen the scientific management of drug use. Chen Tong suggested that "in principle should" be changed to "encourage use" - leaving a path for hospitals within the non-collaborative network to apply, so that more hospitals can participate, and patients are more likely to have easy access to drugs.
"Matsumatsu Daddy" is more concerned about the convenience of medication. The "Chlorpaljan Temporary Import Work Plan (Draft for Comments") shows that prescribing physicians need to meet the needs of those who have been engaged in the diagnosis and treatment of epilepsy or childhood epilepsy for more than 10 years, deputy chief physicians or chief physicians, have the right to prescribe narcotic drugs and psychotropic substances, are familiar with the dosage of chlorpramidan, treatment effect evaluation, adverse reaction monitoring and treatment, etc., and when prescribing, they should follow the current requirements for the use of benzodiazepines in their respective hospitals, and each prescription shall not exceed a maximum of 1 month.
"According to this regulation, the patient's family has to run to the hospital almost once a month, and it is difficult to hang up the expert number of the big hospital, and now that the epidemic is so severe, it is even more difficult to go to the hospital across the city." "SongSong Dad" said that many patient families are calling for the provisions in the draft for comments to be upgraded to no more than 3 months per prescription.
In response to the problem of drug dosage, some patients' families expressed their understanding, and a patient's mother in Beijing told Southern Weekend reporters that according to the "Regulations on the Administration of Prescriptions for Narcotic Drugs and Psychotropic Substances", chlorambachan belongs to the second class of psychotropic drugs, and each prescription generally must not exceed 7 days. However, in this draft for comments, the dosage of 1 month can be prescribed every time the drug is prescribed, which is "already a big breakthrough and is still worth affirming."
The most concerned issue for the family is how to better implement the policy in actual operation. (Visual China/Photo)
The person who purchased the drug is looking forward to release
The news that makes the families of children with epilepsy even more exciting is that the children are one step closer to eating the chlorbazan produced by domestic pharmaceutical companies. On the evening of April 11, Renfu Pharmaceutical, a listed company, issued an announcement that its holding subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., had recently received the "Notice of Acceptance" of the declaration and production of chlorappa tablets approved and issued by the State Drug Administration.
Compared with these good news, the "Iron Horse Glacier" has been detained for more than eight months due to the overseas purchase of Chloe Bazhan. On March 18, the "Iron Horse Glacier" case was heard at the Zhongmu County Court in Zhengzhou City.
Li Fang, wife of "Iron Horse Glacier", told Southern Weekend reporters that her 9-year-old daughter is also a patient with a rare disease "infant epilepsy accompanied by wandering focal seizure syndrome", with intelligence of only two or three years old, needs 24-hour care, and needs to take clopazhan daily to control the disease.
Since July 4, 2021, after the "Iron Horse Glacier" was taken away from his home in Anhui Province by the police in Zhongmu County, Henan Province, the child's mood has been bad, and the medicine mainly relies on online patients to help, intermittently, and can only change a medicine.
In court, whether the drug involved in the case, chlorappazam, is a drug or a drug is still the focus of the dispute between the prosecution and defense. Prosecutors insist that the "Iron Horse Glacier" act constitutes a drug offense.
Liu Chang, a defense lawyer for "Iron Horse Glacier," told Southern Weekend that the "Iron Horse Glacier" only sold chlorambuzhan from abroad to other patients in China, and did not serve as a substitute for drugs, but as a medicine for treatment, nor did it flow to the drug market or drug-using groups, and it did not obtain profits far beyond the normal drug business. In this case, chlorpakan should obviously be considered a "drug" rather than a "drug".
"This is not the story of how a drug dealer who is desperate for profit sells drugs, but the story of a father of a sick child who establishes a WeChat group, serves the patient's family, and carries out self-help and mutual assistance among the patients in order to save his daughter and more children with epilepsy like his daughter." Liu Chang wrote in his defense.
In the mouths of some family members of patients who have purchased drugs, the "Iron Horse Glacier" has an image of honesty, great family care, and no profit from drug markups. Before the trial began on the same day, 132 parents of the children jointly called "Iron Horse Glacier" to ask for acquittal. The court said that the final verdict would be pronounced at a later date, and the family and the lawyer applied for release on guarantee pending further investigation, but the court did not approve it.
Now, Li Fang runs a small food shop making soy sauce and pickled pickles in her hometown of Anqing, getting up early every day to prepare, season, deliver, and busy with endless farm work, she said that she did not dare to imagine the picture of the child's illness again, "has been trembling, spitting white foam, rolling on the ground, especially painful."
In Li Fang's circle of friends, her daughter with a round face held up a cup of milk tea and walked leisurely in the mall. While lamenting that the child has grown tall again, Li Fang carefully avoids the suffering of this family: "If... That would be nice, don't want to think about it, as long as you grow up happily. ”
"At present, the state has paid attention to the drug problem of the patient group, taken action to help the children, and hopes that the court can also acquit my husband as soon as possible, and the family is waiting for him." Li Fang said.
(At the request of the interviewee, Ma Xin, Li Fang, Chen Tong, and Liu Yao are pseudonyms)
Southern Weekend reporter Cui Huiying