The Director General of the World Health Organization is Dr. Tedros Adhanom Ghebreyesus.

The United States experienced medication shortages, specifically a lack of amoxicillin.

Authorities suggest addressing medication shortages through increased transparency, investment, and swift decision-making, as well as establishing a permanent treatment center and optimizing supply information transmission.

China's national medical insurance directory includes 58 kinds of rare disease medications, covering about 67% of listed rare disease drugs, to make these medications more affordable for patients.

Medication shortages are caused by low production and pursuit of short-term profits, resulting from extremely low prices negotiated by Group Purchasing Organizations (GPOs) with wholesalers.

A global medication shortage, including antibiotics like penicillin and amoxicillin, is attributed to insufficient supply from manufacturers or distributors, exacerbated by pandemic-related difficulties, high energy prices, and unexpected demand spikes.

Medication shortages in Taiwan affected a range of products including antibiotics, painkillers, and treatments for tuberculosis and skin infections.

Sterile injectable drugs, including cancer chemotherapy and emergency drugs, are in short supply.

Medication shortages have affected cancer chemotherapy drugs, including carboplatin and cisplatin, as well as emergency medicines, with high shortage rates reported by treatment centers.

Carboplatin and cisplatin were the chemotherapy medications in short supply in US cancer centers, with 93% and 70% of treatment centers reporting shortages, respectively.

Medications in short supply, apart from antibiotics, include pain relievers, tuberculosis medications, and skin infection treatments.

The Director General of the World Health Organization is Dr. Tedros Adhanom Ghebreyesus.

Title:

Content: Friday 23 Dhu al-Hijjah 1443 AH - 22 July 2022 |
Programs
Watch our latest episodes online
Good news for cancer and diabetes patients
Cancer and diabetes are among the most common diseases in the world, affecting millions of people.
The World Health Organization (WHO) on Friday published the new version of its model lists of essential and pediatric medicines, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetics and antibacterial and antifungal agents.
The lists aim to address global health priorities and identify the drugs that provide the greatest benefits, which should be available and affordable to all, yet the high prices of both new patented medicines and older medicines, such as insulin, continue to keep some essential medicines out of the reach of many patients.
Dr Tedros Ghebreyesus, Director-General of the World Health Organization (WHO), said: “Diabetes is on the rise globally and rising faster in low- and middle-income countries, and many people who need insulin face financial difficulties getting it or going without it and lose their lives.
Cancer, on the other hand, is the leading cause of death worldwide, causing nearly 10 million deaths in 2020, and seven in ten cases occur in low- and middle-income countries.
New breakthroughs in cancer treatment have been made in recent years, such as drugs targeting tumor-forming molecular properties, some of which offer much better results than “traditional ” chemotherapy for many cancers.
Four new cancer drugs have been added to the model lists: Epiraterone has been replaced by anzalotamide for prostate cancer, Iverolimus has been added to treat Sega tumor that spreads in children, Iproteinib for chronic lymphocytic leukemia, and Razboricis for tumor lysis syndrome, which is a serious complication associated with cancer treatment.

The United States experienced medication shortages, specifically a lack of amoxicillin.

Title:

Content: Experts have recorded a shortage of antibiotics in the world due to the increase in the number of infectious diseases.
On December 21, writes the Financial Times with reference to the head of the group of the World Health Organization (WHO) for the supply of medicines and ensuring access to them Lisa Hedman, reports Day.Az.
Twenty-eight of the 35 countries for which WHO collects data are deficient in penicillin-type drugs.
In the United States and Canada complained about the lack of amoxicillin.
Less is known about the situation in poor or small countries, according to Hedman.
It is noted that in addition to the difficulties experienced by pharmaceutical manufacturers in the pandemic, the current situation is complicated by high energy prices, and this leads to a decrease in profits of companies.
In addition, countries, according to Hedman, did not expect that in the first year without masks, respiratory infections would hit the population so hard.
In addition to antibiotics, pharmacists also complain about the lack of painkillers, drugs for tuberculosis and drugs for skin infections.

Authorities suggest addressing medication shortages through increased transparency, investment, and swift decision-making, as well as establishing a permanent treatment center and optimizing supply information transmission.

Title:

Content: The lack of medicine continues to burn!
The Ministry of Health and Welfare has proposed a short, medium and long-term strategy to deal with the current 5 coping mechanisms.
Journalist Yen Zhenzhen / Taipei Report
According to the Ministry of Health and Welfare, the shortage of drugs is not a single factor, but includes supply problems, manufacturing problems, clinical demand factors, uneven distribution of drugs, drug use habits and drug prices. In addition to dealing with the relatively high clinical demand items, it is properly allocated to all levels of medical institutions and pharmacies to fully meet the needs of clinical end-use drugs.
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In the face of the shortage of drugs, Wang said, the existing health insurance uses five major coping mechanisms, including 1, a single processing window, a dedicated person to help deal with the problem of drug purchase, and contact the Food and Drug Administration to put relevant information on the website of the NHI. (4) Drug price adjustment mechanism that does not meet the cost can be re-checked according to the way of raising the price of special drugs; (5) Alternative drugs can still declare the cost, if they are not irreplaceable, they can be replaced at the same price or lower than the original prescription drug price.
In addition, Wang pointed out that in the face of the international epidemic, the Russian-Ukrainian war, and labor shortage, drug shortage is a problem facing all countries. In order to strengthen the stable supply mechanism of drugs in China, the Ministry of Health and Welfare continues to actively respond to the short-term strategy to solve the problem of drug shortage. The Food and Drug Administration (FDA) and the pharmaceutical industry have made every effort to actively arrange production lines, strive for early import, increase production / import quantity, and properly distribute to all levels of medical institutions and pharmacies to fully meet the demand for clinical end use drugs.
In addition, to properly handle the issue of drug price adjustment, the Central Health Insurance Administration of the Ministry of Health and Welfare intends to implement the "Universal Health Insurance Cost Distribution Target System (DET)" in April this year, which will adjust the number of drug prices and adjust the quota in a suitable manner, taking into account factors such as the epidemic, the Russian-Ukrainian war and inflation.
In terms of medium-term strategy, Wang said that he will establish a permanent drug shortage treatment center and optimize drug supply information transmission.
In order to speed up the handling of drug shortage incidents, we will adopt dedicated personnel and cross-departmental cooperation to develop drug shortage prevention policies to prevent drug shortage in advance, strengthen cross-departmental data integration and proactive monitoring to detect drug shortage incidents at an early stage, and intervene early through cross-departmental cooperation to stabilize drug supply.
At the same time, the Food and Drug Administration (FDA) continues to disseminate drug supply and alternative drug information through various channels. In addition to posting on the “Drug Supply Information Platform ”, the FDA will notify medical institutions and pharmacies through VPN, and weekly letters to relevant medical associations and public associations to inform members. Management system.
In the long-term strategy section, it includes reviewing the current health insurance drug pricing policy and encouraging the production of domestically manufactured generic drugs.
Wang Bi-sheng pointed out that in the review of the current health insurance drug price policy, including the development of the price protection of indicative drugs, drug price review for the lack of drugs; start the review of drug expenditure target (DET), plan the establishment of a risk control mechanism, plan the national unified procurement trial plan; comprehensively review the health insurance drug price policy, give an appropriate price protection mechanism for necessary drugs, and also target the patent period. To encourage the production of domestic manufacturers to ensure that when there is a shortage of original pharmaceutical products, there are domestic famous drugs to respond.
Wang also stressed that the Food and Drug Administration has set up a "Drug Supply Information Platform" (https: / / dsms.fda.gov.tw /), reporting hotline (02) 27878249. If medical institutions and pharmacies have any shortage of drugs, they can go to the platform for enquiry or notification, and the department will deal with it immediately.
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China's national medical insurance directory includes 58 kinds of rare disease medications, covering about 67% of listed rare disease drugs, to make these medications more affordable for patients.

Title:

Content: Health · Life
Let rare disease patients have a doctor, medicine, and protection
Li He
January 11, 2023 07: 51 Source: Science and Technology Daily
53%
In recent years, relevant departments have strongly supported the prevention and protection of rare diseases, and strengthened the supply of rare diseases research, diagnosis and treatment and drug research and development.
According to statistics, as of the end of November 2022, 89 drugs for the treatment of 45 rare diseases have been approved in China, and the number of rare diseases that can be treated in China accounts for 53% of the number of rare diseases that can be treated in the world.
On January 8 this year, the on-site negotiations on the national medical insurance drug catalog in 2022 were officially concluded.
Among them, 19 drugs for rare diseases, including Fabric's disease, Pompeii's disease, Gosher's disease, pulmonary hypertension and spinal muscular atrophy, set a new record.
Rare diseases are also called "orphan diseases".
According to the definition given in the "China Rare Disease Definition Research Report 2021", diseases with a neonatal incidence of less than one in 10,000, a prevalence of less than one in 10,000, and a number of diseases with a disease of less than 140,000, can be rare diseases.
Although the incidence of rare diseases is extremely low, but there are many kinds of diseases, the total number of patients is not a lot.
As of February 2022, there are more than 20 million rare disease patients in China, and more than 200,000 new patients are added every year.
Qiao Jie, an academician of the Chinese Academy of Engineering and executive vice president of Peking University, said that more than 7,000 rare diseases have been found in the world, about 80 percent of which are hereditary diseases and about 50 percent of which occur in childhood.
"Disease without medicine", "medicine without medicine" and "medicine without insurance" are common "crux" faced by patients with rare diseases.
Build a network of diagnosis and treatment, solve the problem of "no medical care"
Because rare diseases are rare and the number of patients with a single disease is very small, doctors, especially grass-roots hospitals, have insufficient ability to recognize and diagnose rare diseases, which restricts the improvement of rare diseases diagnosis and treatment ability.
The first step in the treatment of diseases is correct diagnosis, and difficult to diagnose is the first difficulty encountered by rare disease patients. In September 2021, a rare disease patient weighing only 18 kg was admitted to Beijing University of Aeronautics and Astronautics.
A Beijing doctor who happened to return to his hometown to visit his family suggested that he go to Peking University First Hospital for detailed investigation, so that sail, who is suffering from congenital muscular dystrophy, has an opportunity for early treatment.
According to the "2020 China Rare Disease Comprehensive Social Survey" released by the China Rare Disease Alliance, 15.5% of the more than 20,000 patients participating in the survey need to experience 1-4 years of diagnosis, and 5% of patients need to experience 5-20 years of diagnosis, with an average diagnosis time of 4.26 years.
Of these, 42% also experienced a misdiagnosis.
In order to improve the diagnosis and treatment of rare diseases, in 2018, the five departments of the National Health and Health Commission, the Ministry of Science and Technology, and the Ministry of Industry and Information Technology jointly issued the "First Catalogue of Rare Diseases". 121 diseases were included in the list of rare diseases. In October 2019, China launched the registration of rare disease diagnosis and treatment information. In February 2020, the office of the national rare disease diagnosis and treatment network was officially established.
The implementation of a series of policies has made the diagnosis and treatment of rare diseases in China continue to improve.
Zhang Liyang, president of Beijing Union Hospital and deputy director of the office of the National Rare Disease Diagnosis and Treatment Network, said that as the national leading hospital of the National Rare Disease Diagnosis and Treatment Network, in 2018 Beijing Union Hospital set up a multi-disciplinary consultation platform for rare diseases, which has registered 93 rare diseases in the National Rare Disease Direct Reporting System, involving more than 60,000 cases.
With the support of all parties, Beijing Union Hospital has taken the lead in carrying out many training sessions in many parts of the country, involving more than 80 rare diseases and covering more than 50,000 doctors.
Strengthen drug research and development and get rid of the dilemma of "medicine without medicine"
Due to the small market demand, difficult research and development, high cost and long cycle, there are not many pharmaceutical companies involved in the R & D and production of rare disease drugs, which leads to less rare disease drugs, known as "orphan drugs".
The data show that of the more than 7,000 rare diseases currently known, there are no more than 400 corresponding treatment drugs.
Strengthening the research and development of rare diseases is an important part of helping the treatment of rare diseases.
Domestic pharmaceutical companies are already working in this area.
Beihai Kangcheng, Kantini Pharmaceutical, Deyi Sunshine Bio, Shufang Medicine, Luang Yu Group, Faith Pharmaceutical Technology, etc. have invested huge funds and energy in the field of rare diseases drugs.
Beihaikang, for example, has received an exclusive global license from the Massachusetts State University School of Medicine to develop, produce and commercialize a new second-generation gene therapy for spinal muscular atrophy.
Huang Guo, deputy director of the State Drug Administration, said that we need to continue to promote rare disease drug research and development innovation in the future, and encourage foreign innovative drugs to synchronously research and development, clinical and synchronous declaration in China, and strive to synchronize the listing, so that rare diseases patients in China can use drugs faster and use good drugs.
In recent years, relevant departments have strongly supported the prevention and protection of rare diseases, and strengthened the supply of rare diseases research, diagnosis and treatment and drug research and development.
According to statistics, as of the end of November 2022, 89 drugs for the treatment of 45 rare diseases have been approved in China, and the number of rare diseases that can be treated in China accounts for 53% of the number of rare diseases that can be treated in the world.
The introduction of multiple guarantees to reduce the worry of "drug no guarantee"
"Although the incidence of rare diseases is extremely low, the cost of medical treatment is very high, and the annual cost of medical treatment for rare diseases can reach tens of millions of yuan," said Shan Xiaoou, a member of the Rare Disease Group of the Chinese Medical Association.
In addition, medical insurance reimbursement is difficult, and many drugs for rare diseases with extremely high prices are not included in the list of basic medical insurance drugs.
Most of the medicines cannot be reimbursed by the basic medical insurance and the major diseases insurance fund, and they can only pay for themselves.
In order to enable more rare disease patients to afford drugs, the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalogue (2021) has included 58 rare disease drugs, accounting for about 67% of the listed rare disease drugs.
For example, Nocina sodium injection, which used to be 700,000 yuan per needle, was included in medical insurance after medical insurance negotiations with more than 30,000 yuan, and children with spinal muscular atrophy became "lucky children".
Various localities have also actively explored the mechanism of drug protection.
More than 10 provinces and cities across the country have set up drug protection mechanisms involving high-value drugs for rare diseases, including special funds, major medical insurance, financial contributions, medical assistance, and policy-oriented commercial insurance.
In many places, it is not just a single system guarantee, but by the government, the market and society to provide multiple guarantees, supplementing the national basic medical insurance, and realizing the "access to medication" of rare disease patients who need high-value drug treatment.
For example, Zhejiang is the first province to introduce a provincial medical guarantee mechanism for rare diseases. In 2015, according to the economic and social development level of Zhejiang Province, the balance of medical insurance fund and the diagnosis and treatment of rare diseases.
In terms of commercial supplementary medical insurance, the "West Lake Benefit Joint Insurance" has set up special medical insurance for three rare diseases such as spinal muscular atrophy.
The medical insurance will be paid at a rate of 60 percent after deducting the initial payment line of 10,000 yuan for the year, and the maximum payment limit for the year will be 100,000 yuan.
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Rare diseases must be prevented.
"There are many kinds of birth defects, there are more than 8,000 kinds, a considerable proportion of which are rare diseases." Song Li, director of the Department of Maternal and Child Health of the National Health and Health Commission, said that the number of pre-screening institutions in China has reached more than 4,800, prenatal diagnostic institutions reached 498, and newborn genetic and metabolic disease screening institutions have been popularized in many provinces and cities.
Song Li pointed out that rare diseases should be prevented and controlled from the source.
China has adopted three levels of prevention and control measures to prevent birth defects, and has moved forward through marriage, childbirth and newborn screening, so as to ensure early detection, early intervention and early treatment, and reduce the incidence of rare diseases.
"In the case that more than 90% of rare diseases are not solved, prevention is the most cost-effective health strategy," Yu Xuejun, deputy director of the National Health Commission, said.
(Editor: Sun Hongli, Yang Di)
Related News

Medication shortages are caused by low production and pursuit of short-term profits, resulting from extremely low prices negotiated by Group Purchasing Organizations (GPOs) with wholesalers.

Title:

Content: |

FTC, US Health Dept Launch Probe Over Chemo Drug Shortages

The investigation is targeting so-called middlemen that broker deals between hospitals and pharmaceutical companies.

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Each year, roughly 2 million Americans are diagnosed with cancer, and for some, getting the proper treatment has become a very serious waiting game.

This week, the Federal Trade Commission and the US Department of Health jointly launched a probe seeking information on how middlemen — group purchasing organizations (GPOs) and drug wholesalers — may be contributing to a lack of chemotherapies and other generic drugs.

The Cost of Cheap Drugs

While various cancer treatments have gone in and out of short supply for years, the problem became particularly acute in 2023. In May, a survey from the National Comprehensive Cancer Network found that 93% of treatment centers reported they were short on carboplatin and 70% reported they were short on cisplatin. Those two drugs are used together and are prescribed to 10% to 20% of cancer patients. Those shortage rates dropped in the fall, but still sat at uncomfortably high levels, with many patients experiencing longer wait times between chemo sessions.

Access to raw materials for making drugs and an increase in patients play a part in the shortages, but the FTC and the Health Department suspect the middlemen buying and selling the medications might be at the heart of the issue:

  • Hospital transactions for medications are controlled almost entirely by three GPOs — Vizient, Premier, and HealthTrust — that purchase drugs on behalf of health centers, and three wholesalers — AmerisourceBergen, Cardinal Health and McKesson — that supply 90% of the pharmaceuticals, The Wall Street Journal reported.
  • Doctors, drugmakers, and patient advocate groups have argued that because the three GPOs represent so many hospitals, they’re able to win extremely low prices from wholesalers. But the prices may be so low that some drugmakers slash production or stop making the drugs entirely if they feel they can no longer turn a profit.

“For years Americans have faced acute shortages of critical drugs, from chemotherapy to antibiotics, endangering patients,” said FTC Chair Lina Khan. “Our inquiry requests information on the factors driving these shortages and scrutinizes the practices of opaque drug middlemen.”

A Growing Concern: A short supply of cancer treatments isn’t a great development, especially with new evidence that the disease is on the rise among younger generations. Most cancer patients are 65 and older, but one study published in JAMA last summer found cancer rates among people 50 and younger are going up, mostly driven by women and people in their 30s.

A global medication shortage, including antibiotics like penicillin and amoxicillin, is attributed to insufficient supply from manufacturers or distributors, exacerbated by pandemic-related difficulties, high energy prices, and unexpected demand spikes.

Medication shortages in Taiwan affected a range of products including antibiotics, painkillers, and treatments for tuberculosis and skin infections.

Sterile injectable drugs, including cancer chemotherapy and emergency drugs, are in short supply.

Title:

Content: General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
An Unexpected Catastrophe in the World ’ s Largest Country: The Complete Story of U.S. Drug Shortages
The deficit is at a record level.
According to data from the American Society of Health System Pharmacists and the University of Utah Drug Information Service, organizations began tracking drug shortages for the first time in 2001. Steady since 2021 – now reaching a record high of 323 drugs in the first three months of 2024.
Paul Abramowitz, CEO of the American Society of Health System Pharmacists, wrote in a blog post on Thursday: “It ’ s been a long time to end drug shortages, ” and wrote:“ All drug classes are vulnerable to shortages, some of the most worrisome shortages include sterile injectable generic drugs, including cancer chemotherapy drugs and emergency drugs stored in hospital vans and procedural areas. It is dangerous for doctors and patients. ”
In addition to the 32 chemotherapy drugs that are deficient, the five categories of drugs with the greatest deficiency include central nervous system stimulants, antimicrobials, hormonal agents, and intravenous fluids. [1] The Drug Deficiency Database maintained by the American Society of Health System Pharmacists and the University of Utah is based on voluntary reports from practitioners, patients, and others that have been confirmed by manufacturers. The U.S. drug is in short supply, because it captures broader effects on service providers and patients.
The crisis has lasted a year and a half.
More than half of the treatment shortages have lasted for more than two years, according to an analysis by health consultancy IQVIA, and the average shortage affects at least half a million patients, many of them elderly, according to the US Office of Health and Human Services under the Assistant Secretary for Planning and Evaluation, which shared its analysis with Congress in May.
Growing demand can play a role in drug shortages, as with the recent shortage of weight-loss drugs, but often manufacturing and quality problems, such as supply chain gaps and downtime, are the root cause. And varied.
But the American Society of Health System Pharmacists has “serious concerns ” about parts of this proposal, especially financial sanctions imposed on hospitals that lack the resources to comply with the recommendations, Abramowitz wrote:“ We all know that managing shortages is not enough and is not a sustainable solution to the worsening crisis, and there is still a lot of work to be done at the federal level to fix the root causes of drug shortages. ”
Why Shortage Occurs
Shortages can be caused by high demand, as with the recent shortage of weight-loss drugs, but this is not usually the main problem.
The FDA also blames manufacturing and quality problems, supply chain gaps, and downtime, and Dr. Emily Tucker, a drug shortage expert and an assistant professor of industrial engineering at Clemson University, says that when there is an indication of shortages, large health systems often also proactively place large orders, adding to the system ’ s stress.
“I don ’ t blame anyone.
“When I talk to all the stakeholders – whether it ’ s wholesalers, manufacturers, or the government – everyone wants this problem to end, ” she said.
Lack of transparency
Dr. Julie Grallo, chief medical officer and executive vice president of the American Society of Clinical Oncology, told the House Committee earlier that the shortage puts providers in a terrible position: “The drug shortage crisis is forcing providers to make impossible choices, and it is also hindering the development of new drugs. Health drugs are purchased only on a price basis, and manufacturers do not have to disclose the source of their acquisition of the ingredients.
The shortage of this generic chemical drug came due to the closure of one factory in India that manufactures the active ingredient after a surprise FDA inspection found “significant quality issues, ” says Jarallo:“ We didn ’ t know, and there was no transparency regarding the company ’ s supply of the majority of active pharmaceutical ingredients to all manufacturers across the board.
Knowing this in advance, we could have responded much faster, ” Dr. Steven Schundlemeyer, director of the PRIME Institute of the University of Minnesota School of Pharmacy, which focuses on economic and management issues, told the committee that as with defense contractors in the United States, New Zealand requires manufacturers to disclose their suppliers, and that information is required.
Easily accessible in the database.
Related Topics

Medication shortages have affected cancer chemotherapy drugs, including carboplatin and cisplatin, as well as emergency medicines, with high shortage rates reported by treatment centers.

Carboplatin and cisplatin were the chemotherapy medications in short supply in US cancer centers, with 93% and 70% of treatment centers reporting shortages, respectively.

Medications in short supply, apart from antibiotics, include pain relievers, tuberculosis medications, and skin infection treatments.


The Director General of the World Health Organization is Dr. Tedros Adhanom Ghebreyesus.

The United States experienced medication shortages, specifically a lack of amoxicillin.

The US experienced medication shortages, including chemotherapies and generic drugs, prompting an investigation by the Federal Trade Commission and the US Department of Health into the role of middlemen in the supply chain.

The US has experienced medication shortages, including shortages of critical drugs such as chemotherapy and antibiotics.

The US experienced medication shortages due to a drug shortage crisis, which forced providers to make difficult choices and hindered the development of new drugs.

The United States experienced a 30% increase in medication shortages compared to 2021, posing a threat to national security.

Authorities suggest addressing medication shortages through increased transparency, investment, and swift decision-making, as well as establishing a permanent treatment center and optimizing supply information transmission.

"Experts recommend increased transparency, investment, and swift decision-making to address medication shortages, citing examples like New Zealand's supplier disclosure requirements."

Authorities suggest addressing medication shortages by increasing investment in healthcare, particularly primary health care, and promoting innovation in the life sciences to improve supply chain resilience.

Authorities suggested addressing medication shortages through increased transparency, investment, and swift decision-making, while the government has invested in domestic vaccine and therapeutic drug production to enhance economic security and respond to health crises.

"Authorities have explored mechanisms for drug protection, including setting up special funds and medical insurance for high-value drugs for rare diseases, to improve access to medications for patients with rare diseases."

China's national medical insurance directory includes 58 kinds of rare disease medications, covering about 67% of listed rare disease drugs, to make these medications more affordable for patients.

Medication shortages are caused by low production and pursuit of short-term profits, resulting from extremely low prices negotiated by Group Purchasing Organizations (GPOs) with wholesalers.

Medication shortages, including those for rare diseases, may be caused by a lack of production and pursuit of short-term profits, as pharmaceutical companies face challenges such as small market demand and high development costs.

A global medication shortage, including antibiotics like penicillin and amoxicillin, is attributed to insufficient supply from manufacturers or distributors, exacerbated by pandemic-related difficulties, high energy prices, and unexpected demand spikes.

The medication shortage was caused by multiple factors including supply problems, manufacturing issues, and clinical demand factors.

The medication shortage is caused by insufficient supply from manufacturers or distributors due to low prices negotiated by Group Purchasing Organizations (GPOs), leading to reduced production or discontinuation of certain drugs.

"The medication shortage is primarily caused by insufficient supply from manufacturers or distributors, which can be due to manufacturing and quality problems, such as supply chain gaps and downtime."

The medication shortage was caused by insufficient supply from manufacturers or distributors, as well as other factors such as supply chain gaps and manufacturing problems.

Medication shortages in Taiwan affected a range of products including antibiotics, painkillers, and treatments for tuberculosis and skin infections.

Medication shortages in Taiwan affected many medications, with authorities implementing coping mechanisms such as alternative drugs and price adjustments.

Medication shortages are a global concern, and many medications were affected by shortages.

Medications were affected by shortages in Taiwan, prompting the government to implement measures to adjust drug prices and quotas, as well as establish a permanent drug shortage treatment center.

Medications were affected by shortages in Taiwan, with authorities implementing measures to prevent and respond to drug shortages.

Sterile injectable drugs, including cancer chemotherapy and emergency drugs, are in short supply.

Medication shortages have affected cancer chemotherapy drugs, including carboplatin and cisplatin, as well as emergency medicines, with high shortage rates reported by treatment centers.

Medication shortages have affected critical drugs such as chemotherapy and antibiotics.

Medication shortages affect cancer chemotherapy drugs, and possibly emergency medicines, with cancer treatments being a specific area of concern due to rising cancer rates among younger generations.

Medication shortages affect various types of drugs, with cancer chemotherapy drugs and emergency medicines being particularly impacted.

Medication shortages affect various types of drugs, including cancer chemotherapy and emergency medicines, due to supply chain disruptions and manufacturing issues.

The medication shortage is attributed to multiple factors, including supply problems, manufacturing issues, clinical demand, uneven distribution, and drug prices, with low prices negotiated with drugmakers being a suspected contributing factor.

The suspected contributing factor to the medication shortage is the low prices negotiated with drugmakers, which may lead to reduced production or discontinuation of certain drugs.

Medication shortages are caused by manufacturing problems and quality issues, affecting various drug classes, including sterile injectable generic drugs and cancer chemotherapy drugs.

The root causes of medication shortages are primarily due to manufacturing problems and quality issues, including supply chain gaps and downtime.

Medication shortages are caused by manufacturing problems and quality issues, contributing to a growing global concern.

Medication shortages are caused by manufacturing problems and quality issues, as seen in the case of a factory in India being closed due to quality issues, leading to a shortage of a generic chemical drug.

Carboplatin and cisplatin were the chemotherapy medications in short supply in US cancer centers, with 93% and 70% of treatment centers reporting shortages, respectively.

Medications in short supply, apart from antibiotics, include pain relievers, tuberculosis medications, and skin infection treatments.

Medication shortages are a growing concern globally, with various types of medications being affected, including pain relievers, tuberculosis medications, and skin infection treatments, in addition to antibiotics.

The shortage of cancer medications is attributed to systemic challenges, including supply problems, manufacturing issues, and clinical demand factors, among others.

Medication shortages are caused by various systemic challenges, including manufacturing issues, supply chain problems, and downtime, which can be exacerbated by the actions of large health systems.

The Director General of the World Health Organization is Dr. Tedros Adhanom Ghebreyesus.

Title:

Content: Friday 23 Dhu al-Hijjah 1443 AH - 22 July 2022 |
Programs
Watch our latest episodes online
Good news for cancer and diabetes patients
Cancer and diabetes are among the most common diseases in the world, affecting millions of people.
The World Health Organization (WHO) on Friday published the new version of its model lists of essential and pediatric medicines, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetics and antibacterial and antifungal agents.
The lists aim to address global health priorities and identify the drugs that provide the greatest benefits, which should be available and affordable to all, yet the high prices of both new patented medicines and older medicines, such as insulin, continue to keep some essential medicines out of the reach of many patients.
Dr Tedros Ghebreyesus, Director-General of the World Health Organization (WHO), said: “Diabetes is on the rise globally and rising faster in low- and middle-income countries, and many people who need insulin face financial difficulties getting it or going without it and lose their lives.
Cancer, on the other hand, is the leading cause of death worldwide, causing nearly 10 million deaths in 2020, and seven in ten cases occur in low- and middle-income countries.
New breakthroughs in cancer treatment have been made in recent years, such as drugs targeting tumor-forming molecular properties, some of which offer much better results than “traditional ” chemotherapy for many cancers.
Four new cancer drugs have been added to the model lists: Epiraterone has been replaced by anzalotamide for prostate cancer, Iverolimus has been added to treat Sega tumor that spreads in children, Iproteinib for chronic lymphocytic leukemia, and Razboricis for tumor lysis syndrome, which is a serious complication associated with cancer treatment.

The United States experienced medication shortages, specifically a lack of amoxicillin.

Title:

Content: Experts have recorded a shortage of antibiotics in the world due to the increase in the number of infectious diseases.
On December 21, writes the Financial Times with reference to the head of the group of the World Health Organization (WHO) for the supply of medicines and ensuring access to them Lisa Hedman, reports Day.Az.
Twenty-eight of the 35 countries for which WHO collects data are deficient in penicillin-type drugs.
In the United States and Canada complained about the lack of amoxicillin.
Less is known about the situation in poor or small countries, according to Hedman.
It is noted that in addition to the difficulties experienced by pharmaceutical manufacturers in the pandemic, the current situation is complicated by high energy prices, and this leads to a decrease in profits of companies.
In addition, countries, according to Hedman, did not expect that in the first year without masks, respiratory infections would hit the population so hard.
In addition to antibiotics, pharmacists also complain about the lack of painkillers, drugs for tuberculosis and drugs for skin infections.

The US experienced medication shortages, including chemotherapies and generic drugs, prompting an investigation by the Federal Trade Commission and the US Department of Health into the role of middlemen in the supply chain.

Title:

Content: |

FTC, US Health Dept Launch Probe Over Chemo Drug Shortages

The investigation is targeting so-called middlemen that broker deals between hospitals and pharmaceutical companies.

Sign up for smart news, insights, and analysis on the biggest financial stories of the day.

Each year, roughly 2 million Americans are diagnosed with cancer, and for some, getting the proper treatment has become a very serious waiting game.

This week, the Federal Trade Commission and the US Department of Health jointly launched a probe seeking information on how middlemen — group purchasing organizations (GPOs) and drug wholesalers — may be contributing to a lack of chemotherapies and other generic drugs.

The Cost of Cheap Drugs

While various cancer treatments have gone in and out of short supply for years, the problem became particularly acute in 2023. In May, a survey from the National Comprehensive Cancer Network found that 93% of treatment centers reported they were short on carboplatin and 70% reported they were short on cisplatin. Those two drugs are used together and are prescribed to 10% to 20% of cancer patients. Those shortage rates dropped in the fall, but still sat at uncomfortably high levels, with many patients experiencing longer wait times between chemo sessions.

Access to raw materials for making drugs and an increase in patients play a part in the shortages, but the FTC and the Health Department suspect the middlemen buying and selling the medications might be at the heart of the issue:

  • Hospital transactions for medications are controlled almost entirely by three GPOs — Vizient, Premier, and HealthTrust — that purchase drugs on behalf of health centers, and three wholesalers — AmerisourceBergen, Cardinal Health and McKesson — that supply 90% of the pharmaceuticals, The Wall Street Journal reported.
  • Doctors, drugmakers, and patient advocate groups have argued that because the three GPOs represent so many hospitals, they’re able to win extremely low prices from wholesalers. But the prices may be so low that some drugmakers slash production or stop making the drugs entirely if they feel they can no longer turn a profit.

“For years Americans have faced acute shortages of critical drugs, from chemotherapy to antibiotics, endangering patients,” said FTC Chair Lina Khan. “Our inquiry requests information on the factors driving these shortages and scrutinizes the practices of opaque drug middlemen.”

A Growing Concern: A short supply of cancer treatments isn’t a great development, especially with new evidence that the disease is on the rise among younger generations. Most cancer patients are 65 and older, but one study published in JAMA last summer found cancer rates among people 50 and younger are going up, mostly driven by women and people in their 30s.

The US has experienced medication shortages, including shortages of critical drugs such as chemotherapy and antibiotics.

The US experienced medication shortages due to a drug shortage crisis, which forced providers to make difficult choices and hindered the development of new drugs.

Title:

Content: General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
An Unexpected Catastrophe in the World ’ s Largest Country: The Complete Story of U.S. Drug Shortages
The deficit is at a record level.
According to data from the American Society of Health System Pharmacists and the University of Utah Drug Information Service, organizations began tracking drug shortages for the first time in 2001. Steady since 2021 – now reaching a record high of 323 drugs in the first three months of 2024.
Paul Abramowitz, CEO of the American Society of Health System Pharmacists, wrote in a blog post on Thursday: “It ’ s been a long time to end drug shortages, ” and wrote:“ All drug classes are vulnerable to shortages, some of the most worrisome shortages include sterile injectable generic drugs, including cancer chemotherapy drugs and emergency drugs stored in hospital vans and procedural areas. It is dangerous for doctors and patients. ”
In addition to the 32 chemotherapy drugs that are deficient, the five categories of drugs with the greatest deficiency include central nervous system stimulants, antimicrobials, hormonal agents, and intravenous fluids. [1] The Drug Deficiency Database maintained by the American Society of Health System Pharmacists and the University of Utah is based on voluntary reports from practitioners, patients, and others that have been confirmed by manufacturers. The U.S. drug is in short supply, because it captures broader effects on service providers and patients.
The crisis has lasted a year and a half.
More than half of the treatment shortages have lasted for more than two years, according to an analysis by health consultancy IQVIA, and the average shortage affects at least half a million patients, many of them elderly, according to the US Office of Health and Human Services under the Assistant Secretary for Planning and Evaluation, which shared its analysis with Congress in May.
Growing demand can play a role in drug shortages, as with the recent shortage of weight-loss drugs, but often manufacturing and quality problems, such as supply chain gaps and downtime, are the root cause. And varied.
But the American Society of Health System Pharmacists has “serious concerns ” about parts of this proposal, especially financial sanctions imposed on hospitals that lack the resources to comply with the recommendations, Abramowitz wrote:“ We all know that managing shortages is not enough and is not a sustainable solution to the worsening crisis, and there is still a lot of work to be done at the federal level to fix the root causes of drug shortages. ”
Why Shortage Occurs
Shortages can be caused by high demand, as with the recent shortage of weight-loss drugs, but this is not usually the main problem.
The FDA also blames manufacturing and quality problems, supply chain gaps, and downtime, and Dr. Emily Tucker, a drug shortage expert and an assistant professor of industrial engineering at Clemson University, says that when there is an indication of shortages, large health systems often also proactively place large orders, adding to the system ’ s stress.
“I don ’ t blame anyone.
“When I talk to all the stakeholders – whether it ’ s wholesalers, manufacturers, or the government – everyone wants this problem to end, ” she said.
Lack of transparency
Dr. Julie Grallo, chief medical officer and executive vice president of the American Society of Clinical Oncology, told the House Committee earlier that the shortage puts providers in a terrible position: “The drug shortage crisis is forcing providers to make impossible choices, and it is also hindering the development of new drugs. Health drugs are purchased only on a price basis, and manufacturers do not have to disclose the source of their acquisition of the ingredients.
The shortage of this generic chemical drug came due to the closure of one factory in India that manufactures the active ingredient after a surprise FDA inspection found “significant quality issues, ” says Jarallo:“ We didn ’ t know, and there was no transparency regarding the company ’ s supply of the majority of active pharmaceutical ingredients to all manufacturers across the board.
Knowing this in advance, we could have responded much faster, ” Dr. Steven Schundlemeyer, director of the PRIME Institute of the University of Minnesota School of Pharmacy, which focuses on economic and management issues, told the committee that as with defense contractors in the United States, New Zealand requires manufacturers to disclose their suppliers, and that information is required.
Easily accessible in the database.
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The United States experienced a 30% increase in medication shortages compared to 2021, posing a threat to national security.

Title:

Content: The New York Times Original
Continue reading Growing drug shortage in the United States has become a threat to national security
The shortage of medicines in the United States last year increased compared to 2021 by 30%, according to The New York Times.
However, the article notes that the growing shortage of inexpensive but critical drugs poses a national security threat to the United States.
The growing shortage of inexpensive but critical drugs poses a threat to U.S. national security and forces hospitals to make “terrible ” choices, writes The New York Times, citing a report prepared for hearings in the U.S. Senate.
According to this report, the shortage of medicines last year increased by almost 30% compared to 2021, with an average shortage of medicines observed for 18 months, and for some drugs – 15 years.
Among the drugs in short supply are conventional antibiotics and anesthetics, the article said.
Senator Gary Peters, a Democrat from Michigan and chairman of the Senate Committee on Homeland Security and Government Affairs, said that these problems are related to economic factors, an opaque supply chain and the fact that 80% to 90% of some products are made abroad.
“Taken together, these underlying causes not only raise serious concerns about ensuring proper patient care, but also pose a serious threat to national security, ” Peters said.
Dr. Andrew Schumann, an oncology surgeon from Michigan, told senators at the hearing that the shortage of drugs in his field is "a tragedy occurring in slow motion."
As Schumann noted, recently due to the shortage of one cheap, but well-proven cancer drug, he had to choose which patients will receive this drug.
The article notes that many of the cheapest drugs tend to be made in countries such as India and China, where they are inexpensive to manufacture.
However, this concentration of production capacity creates an additional level of vulnerability to problems such as natural disasters and political unrest, emphasizes The New York Times.
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Authorities suggest addressing medication shortages through increased transparency, investment, and swift decision-making, as well as establishing a permanent treatment center and optimizing supply information transmission.

Title:

Content: The lack of medicine continues to burn!
The Ministry of Health and Welfare has proposed a short, medium and long-term strategy to deal with the current 5 coping mechanisms.
Journalist Yen Zhenzhen / Taipei Report
According to the Ministry of Health and Welfare, the shortage of drugs is not a single factor, but includes supply problems, manufacturing problems, clinical demand factors, uneven distribution of drugs, drug use habits and drug prices. In addition to dealing with the relatively high clinical demand items, it is properly allocated to all levels of medical institutions and pharmacies to fully meet the needs of clinical end-use drugs.
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In the face of the shortage of drugs, Wang said, the existing health insurance uses five major coping mechanisms, including 1, a single processing window, a dedicated person to help deal with the problem of drug purchase, and contact the Food and Drug Administration to put relevant information on the website of the NHI. (4) Drug price adjustment mechanism that does not meet the cost can be re-checked according to the way of raising the price of special drugs; (5) Alternative drugs can still declare the cost, if they are not irreplaceable, they can be replaced at the same price or lower than the original prescription drug price.
In addition, Wang pointed out that in the face of the international epidemic, the Russian-Ukrainian war, and labor shortage, drug shortage is a problem facing all countries. In order to strengthen the stable supply mechanism of drugs in China, the Ministry of Health and Welfare continues to actively respond to the short-term strategy to solve the problem of drug shortage. The Food and Drug Administration (FDA) and the pharmaceutical industry have made every effort to actively arrange production lines, strive for early import, increase production / import quantity, and properly distribute to all levels of medical institutions and pharmacies to fully meet the demand for clinical end use drugs.
In addition, to properly handle the issue of drug price adjustment, the Central Health Insurance Administration of the Ministry of Health and Welfare intends to implement the "Universal Health Insurance Cost Distribution Target System (DET)" in April this year, which will adjust the number of drug prices and adjust the quota in a suitable manner, taking into account factors such as the epidemic, the Russian-Ukrainian war and inflation.
In terms of medium-term strategy, Wang said that he will establish a permanent drug shortage treatment center and optimize drug supply information transmission.
In order to speed up the handling of drug shortage incidents, we will adopt dedicated personnel and cross-departmental cooperation to develop drug shortage prevention policies to prevent drug shortage in advance, strengthen cross-departmental data integration and proactive monitoring to detect drug shortage incidents at an early stage, and intervene early through cross-departmental cooperation to stabilize drug supply.
At the same time, the Food and Drug Administration (FDA) continues to disseminate drug supply and alternative drug information through various channels. In addition to posting on the “Drug Supply Information Platform ”, the FDA will notify medical institutions and pharmacies through VPN, and weekly letters to relevant medical associations and public associations to inform members. Management system.
In the long-term strategy section, it includes reviewing the current health insurance drug pricing policy and encouraging the production of domestically manufactured generic drugs.
Wang Bi-sheng pointed out that in the review of the current health insurance drug price policy, including the development of the price protection of indicative drugs, drug price review for the lack of drugs; start the review of drug expenditure target (DET), plan the establishment of a risk control mechanism, plan the national unified procurement trial plan; comprehensively review the health insurance drug price policy, give an appropriate price protection mechanism for necessary drugs, and also target the patent period. To encourage the production of domestic manufacturers to ensure that when there is a shortage of original pharmaceutical products, there are domestic famous drugs to respond.
Wang also stressed that the Food and Drug Administration has set up a "Drug Supply Information Platform" (https: / / dsms.fda.gov.tw /), reporting hotline (02) 27878249. If medical institutions and pharmacies have any shortage of drugs, they can go to the platform for enquiry or notification, and the department will deal with it immediately.
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"Experts recommend increased transparency, investment, and swift decision-making to address medication shortages, citing examples like New Zealand's supplier disclosure requirements."

Authorities suggest addressing medication shortages by increasing investment in healthcare, particularly primary health care, and promoting innovation in the life sciences to improve supply chain resilience.

Title:

Content: Healthcare is the best investment to boost development
T + T - normal size
No one would have expected the extent to which COVID-19 could undermine decades of progress in global public health, and parts of the world are still reeling in shock, but we have the opportunity and the duty to learn the right lessons to mitigate the effects of the ongoing pandemic, while reducing the risk of similar events in the future.
Despite the new threats looming on the horizon, we should not allow our focus to be distracted from COVID-19.
The pandemic has highlighted major gaps in global health systems, and failing to address these gaps would be bad public policy and bad economic management, because there is no trade-off between health and economic development.
The pandemic has demonstrated that health is critical to promoting development, prosperity and national security.
Pandemic disruptions, hampering the health services sector, have caused a rise in HIV, tuberculosis, malaria, and many non-communicable diseases – in the number of unreported infections and deaths.
These are diseases that the world has previously made great gains in controlling, making matters worse that the pandemic has led to a decline in life expectancy, a decline in coverage of basic immunizations, and increasing mental health challenges.
The pandemic ’ s painful legacy is compounded by the ongoing war in Ukraine, which has triggered a widespread humanitarian crisis, jeopardized global food supplies, increased food and energy prices, and threatened to cause recession and economic hardship around the world.
In September, the International Monetary Fund warned that “the impact of rising food and fertilizer import costs on countries highly vulnerable to food insecurity will add $9 billion to their balance of payments pressures – in 2022 and 2023, eroding countries ’ international reserves as well as their ability to pay for food and fertilizer imports. ”
Moreover, rising interest rates and tighter fiscal conditions have raised the specter of widespread debt distress in low- and middle-income countries, by subjecting public finances to severe pressures, with recent global shocks putting long-term investment in health at risk.
Global solidarity and equality are fundamental pillars of any effective response to the challenges we face.
We must advance on three fronts to maintain the central role that health systems – specifically primary health care – play at all times, especially when economic crises erupt.
First, investment in primary health care must be increased, because health investment gaps widen during times as difficult as the ones we are living through.
In turn, these gaps increase the risks people face from global threats, whether man-made or otherwise.
It is in everyone ’ s interest to help all countries that lack the resources to invest adequately in the resilience of health systems and in pandemic preparedness and response.
Second, innovation in the life sciences needs more funding, especially to scale it up in a sustainable way, and that means supporting local production or delivery innovations of mental health services capable of reaching millions of people, which can be integrated into primary health care systems.
Third, multilateral organizations must work together to prepare us all to face future health threats more effectively, and initiatives such as a legally binding pandemics agreement, developed and ratified by countries and rooted in the WHO Constitution, could provide the much-needed rulebook for pandemic prevention and response.
Sadly, even before the COVID-19 pandemic broke out, the world was lagging in the race to meet globally agreed health goals, including many set out in the 2030 Sustainable Development Goals (SDGs), and now, the pandemic has pushed us further back.
In times of rising debt and increasing risks, which threaten debt sustainability, governments, international organizations, and financial institutions need to work closely together to get us back on track.
While the COVID-19 pandemic illustrated the many shortcomings of global cooperation, it also demonstrated the importance of collaborative action.
For this reason, our organization has committed to combining our strengths, to promote and increase investments in health.
For example, with support from the European Investment Bank, the World Health Organization, the Wellcome Fund, and other institutions, the AMR Action Fund is investing in innovative solutions to address antimicrobial resistance and ensure that new drugs continue to emerge to meet basic needs.
Indeed, the scientific community already views antimicrobial resistance as a “silent pandemic ” and a serious threat to global health and development.
Furthermore, we are working to channel additional resources from other partners, such as the European Commission, development finance institutions and private sector actors, to strengthen health services where they are most needed.
Earlier this year, we announced a partnership, in close collaboration with the European Commission and the African Union, to strengthen health systems, especially primary health care, in Africa, and the EIB has pledged to provide at least €500 million (US $520 million) to mobilize more than €1 billion for investment purposes, with a particular focus on primary health care in sub-Saharan Africa.
New collaborative projects are already making significant progress in Africa and the Middle East.
In Rwanda, WHO will be providing direct advice to the government on rebuilding the national health laboratory there, funded by the European Commission and the European Investment Bank.
The new lab will conduct more than 80,000 tests a year, serving a population of more than 12 million.
To make a measurable impact in these countries, we focus on using innovative financing mechanisms to catalyse domestic financing, advancing our shared goal of health for all.
At the same time, we are committed to promoting sustainability in debt management, so that the investments of our health partners do not lead to financial hardship.
Again, investing in health means promoting sound economic policy.
To accelerate the deployment of innovative health solutions, countries and institutions need to work together to strengthen cooperation not only between countries, but also between governments and the private sector.
President of the European Investment Bank
* * Director General of the World Health Organization
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Authorities suggested addressing medication shortages through increased transparency, investment, and swift decision-making, while the government has invested in domestic vaccine and therapeutic drug production to enhance economic security and respond to health crises.

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In his policy speech to the parliament on Dec. 6, Prime Minister Fumio Kishida touched on the importance of economic security.

“With countries around the world engaging in fierce competition to secure strategic goods and acquire key technologies, economic security is a matter of great urgency,” he said.

To cope with the COVID-19 pandemic, Kishida said the government will make investments of some ¥500 billion to fund domestic production of vaccines, development of therapeutic drugs and installment of dual-use facilities that can easily be switched from producing biopharmaceuticals to vaccines when needed.

Kishida also pledged to strengthen “the control tower function” to respond quickly to infectious disease crises and other health crises.

While vaccines and therapeutic drugs are the most essential strategic supplies that countries around the world have been fiercely competing to obtain, it is not clear how the government intends to integrate the two policy areas of economic security and health crisis management.

COVID-19 has taken the lives of more than 18,000 people in Japan. The number is similar to the total number of victims killed in the March 2011 earthquakes and tsunami combined with those who later died of illness or stress linked to the disaster.

The pandemic was the last crisis that hit former Prime Minister Shinzo Abe’s administration, after various crises and threats including serious disasters caused by typhoons and heavy rain, as well as North Korea’s nuclear tests and ballistic missile launches.

Following the Abe administration, former Prime Minister Yoshihide Suga’s administration had been completely absorbed in coping with COVID-19. And now the Kishida administration is the third to try tackling the pandemic.

Health crises, including infectious diseases, are a national security threat just like major disasters and armed attacks.

How should Japan build its economic security to prepare for and respond to such crises to protect the lives and health of its people?

Health threats

There are two major threats that could lead to health crises.

One threat is infectious disease — “disease-X,” which represents a serious threat of outbreaks of emerging or re-emerging infectious diseases that could be caused by unknown pathogens.

There are concerns over the possible emergence of “COVID-X,” which spreads from infected people without symptoms and is, like COVID-19 that emerged in 2019, very hard to contain and even more deadly. If such a virus emerges in 2030, for example, it will be named “COVID-30.” Though it could come earlier.

Due to global warming, there is also an increasing risk of an outbreak of a tropical disease such as dengue fever.

The increasing prevalence of antimicrobial resistance (AMR), which occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines, making infections harder to treat and increasing the risk of the spread of disease, severe illness and death, would also pose a serious public health crisis.

In Japan, roughly 8,000 people die every year due to AMR.

The other threat is chemical, biological, radiological and nuclear (CBRN) terrorism, which includes but is not limited to potential threats from nuclear power plants and North Korea’s attacks using weapons of mass destruction.

Medical supplies

There are three key items that the government must prepare to achieve economic security in the field of health crises.

First, drugs, including therapeutic drugs and active pharmaceutical ingredients (APIs), and vaccines, as well as the raw materials and equipment needed to produce them.

APIs are manufactured mainly in China and India, and most of the raw materials needed to produce APIs are supplied by China.

Second, medical supplies and devices, including personal protective equipment such as masks and gloves, as well as alcohol hand sanitizers.

Third, testing devices and test reagents.

As countries battled against the COVID-19 pandemic, they rushed to secure masks and vaccines.

It should be noted that demand for certain goods and necessities has changed dramatically over the past two years.

Now that the production capabilities of vaccines have significantly increased, the main issue has become the disparity in vaccine supply between developed and developing countries. And developed countries are now racing to obtain oral therapeutics.

Key technologies and items to cope with health crises change dynamically even in the midst of a crisis, depending on the kind of threats, the supply and demand situation in markets and the degree of dependence on certain countries.

Developing drugs

It is not easy, however, for Japan’s pharmaceutical companies to respond quickly and flexibly to health crises.

While Japan, the United States and Europe all focus on drugs and APIs as a priority area in economic security, Japan lags behind.

Of the top 100 prescription drugs by global sales, 49 are sold by American firms, 40 by European firms and only nine by Japanese firms.

Furthermore, just as Taiwan Semiconductor Manufacturing Co. (TSMC) caused an earthshaking change in the semiconductor industry by dominating outsourced manufacturing, contract development and manufacturing organizations (CDMOs) are rapidly growing in the pharmaceutical industry as well.

Switzerland’s Lonza Group AG leads the market, followed by South Korea’s Samsung Biologics Co., which together make up half of the global pharmaceutical contract manufacturing capabilities.

In May, when U.S. President Joe Biden and South Korean President Moon Jae-in agreed on a comprehensive partnership on COVID-19 vaccines during Moon’s visit to Washington, Samsung Biologics signed a fill-finish manufacturing deal with Moderna Inc. for its mRNA COVID-19 vaccine. Samsung Biologics began shipping the vaccine in South Korea in October.

Moderna had been awarded funds from the Defense Advanced Research Projects Agency (DARPA) in the U.S. to research and develop potential mRNA medicines.

The mRNA vaccine developed in the U.S. and produced in South Korea will support the demand for booster shots in Asia.

On the other hand, Japan depends on imports to secure mRNA vaccines.

In order to develop new drugs, it usually takes more than 10 years and requires hundreds of billions of yen, going through the process from conducting clinical trials to receiving marketing approval.

Moreover, the approval success rate of drugs has been declining.

The success rate of a drug candidate to gain approval has declined from one in about 13,000 two decades ago to one in some 20,000 to 30,000.

Even if drugmakers manage to gain approval to market new drugs, they are substituted with generic drugs after the patents expire, giving the makers limited time to secure funding for research and development.

While the government’s policy is to domestically develop vaccines and therapeutic drugs, a difficult road lies ahead for Japan to put it into practice.

Deepening collaboration

How should the Kishida administration cope with health crises issues and achieve economic security?

First, politics, bureaucracy, industry and academia should deepen cooperation in normal times.

Regarding pharmaceuticals, different strategies and playmakers exist, including the vaccine development and production system strengthening strategy from the Cabinet Secretariat’s Office of Healthcare Policy, the pharmaceutical industry vision 2021 by the health ministry and the bio strategy compiled by the Cabinet Office’s science, technology and innovation promotion secretariat.

The government should work with like-minded countries to clarify economic security needs and construct a comprehensive working group consisting of government, academic and industry leaders focusing on health crises.

Health crisis management

Second, in order to integrate intelligence and policies under the Prime Minister’s Office, the government should create a permanent body within the Cabinet Secretariat to lead health crisis management, which focuses on policy planning and coordination by utilizing the secretariat’s authorities.

The body can be either a secretariat, headed by a secretary-general who will be ranked immediately below the Deputy Chief Cabinet Secretary — just as the Deputy Chief Cabinet Secretary for Crisis Management and the Secretary-General of National Security Secretariat — or an office, with its head ranked immediately below the Assistant Chief Cabinet Secretary.

The Cabinet Secretariat has the Office for COVID-19 and Other Emerging Infectious Disease Control, but the new body would be in charge of wider issues related to health crises.

In times of emergency, the body should be allowed to appoint experts from outside the government as aides or counselors.

Targeting key technologies

Third, it is important to designate target technologies and items for economic security, as well as identify potentially threatening health crises.

The so-called Quad grouping of Japan, the U.S., Australia and India has agreed to map the supply chains of critical technologies and materials.

The working group comprising politicians, bureaucrats, industry officials and academics should closely analyze the threats that pose risks and identify target technologies and items that are important to Japan, while sharing sensitive technological information.

Furthermore, it is urgent for the working group to establish a system to make patent application information confidential, as well as a security clearance system that limits access to classified national security information only to authorized individuals.

Fourth, the government should classify core capacities — minimum requirements to guarantee a public health response in normal times — and surge capacities — the increased capacity available during mass casualty situations and disasters — for critical items, and conduct appropriate public health preparedness planning.

It is extremely important to maintain the quality and stable supply of medicines, as medications that are taken regularly should be available at all times.

In September 2020, the health ministry designated 21 so-called stable supply medicines as essential in clinical practices. Maintaining core capacities means having the ability to supply these products.

The government should also regularly check the availability of medical supplies and medical equipment, including commodities such as masks, so that it can create surge capacity in times of emergency.

Pull incentives

Fifth, the government should protect technologies and items with which Japan has a competitive advantage and solve supply chain vulnerabilities through offering pull incentives, rewarding successful development by increasing or ensuring future revenue.

The government should buy up such items in emergency situations and stockpile them at normal times to maintain production facilities.

To cope with the COVID-19 pandemic, the U.S. invoked the Defense Production Act to urge companies to accelerate mass production of medical supplies, such as ventilators and vaccines, and prioritize government contracts.

Unless the government obligated itself to buy those supplies in times of emergency, companies cannot make bold investments.

Japan should consider establishing a version of the Defense Production Act so that the government will be able to flexibly ask companies to increase production of essential items, buying them up in case of a future health crisis.

In order for drug makers to maintain production in times of emergency, it is important for the government to offer constant support and nurture CDMOs.

Human resources

Sixth, the government needs professionals with an excellent eye for competitive technologies and the ability to connect experts from various fields.

The government should also launch a research and development project financed by both public funds and risk money from the private sector that acts as a “push incentive” to put new technologies to practical use.

A country that can generate innovation enough to develop mRNA vaccines will be able to contribute to containing the global pandemic, while also expanding national wealth.

If Japan can develop technologies that enable it to gain strategic indispensability and establish control of the choke points in supply chains, these will become critical assets for the Japan-U.S. alliance.

However, the government should be careful not to repeat the failure of the Japanese semiconductor industry which, since the latter half of the 1990s, has tried to pursue a made-in-Japan, self-reliance approach.

The recent trends of technological development, such as open innovation and pharmaceutical research and development ecosystem, go beyond national borders.

A typical example is the world’s first mRNA vaccine rolled out in the United Kingdom, which was produced by U.S. drugmaker Pfizer Inc., based on research and development by German biotech startup BioNTech SE.

In addition, startups are highly likely to fail. Seeds from academia take time to reach the market. It is desirable to build a portfolio and have as many candidates as possible lining up in the pipeline.

The government must seek entrepreneurs and researchers who share the sense of crisis regarding economic security and views on how the country should be, and support efforts to get their technologies adopted while respecting entrepreneurship and market aspirations.

Japan should integrate intelligence and policies, and work together with all parties to cope with the ongoing COVID-19 pandemic and future health crises.

People’s lives and health depend on economic security in the field of health.

Yoshiyuki Sagara is a fellow at the Asia Pacific Initiative, an independent think tank based in Tokyo. API Geoeconomic Briefing, provided by API, is a series that looks into global political and economic trends, with a particular focus on technology and innovation, global supply chains, international rule-making and climate change.

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"Authorities have explored mechanisms for drug protection, including setting up special funds and medical insurance for high-value drugs for rare diseases, to improve access to medications for patients with rare diseases."

Title:

Content: Health · Life
Let rare disease patients have a doctor, medicine, and protection
Li He
January 11, 2023 07: 51 Source: Science and Technology Daily
53%
In recent years, relevant departments have strongly supported the prevention and protection of rare diseases, and strengthened the supply of rare diseases research, diagnosis and treatment and drug research and development.
According to statistics, as of the end of November 2022, 89 drugs for the treatment of 45 rare diseases have been approved in China, and the number of rare diseases that can be treated in China accounts for 53% of the number of rare diseases that can be treated in the world.
On January 8 this year, the on-site negotiations on the national medical insurance drug catalog in 2022 were officially concluded.
Among them, 19 drugs for rare diseases, including Fabric's disease, Pompeii's disease, Gosher's disease, pulmonary hypertension and spinal muscular atrophy, set a new record.
Rare diseases are also called "orphan diseases".
According to the definition given in the "China Rare Disease Definition Research Report 2021", diseases with a neonatal incidence of less than one in 10,000, a prevalence of less than one in 10,000, and a number of diseases with a disease of less than 140,000, can be rare diseases.
Although the incidence of rare diseases is extremely low, but there are many kinds of diseases, the total number of patients is not a lot.
As of February 2022, there are more than 20 million rare disease patients in China, and more than 200,000 new patients are added every year.
Qiao Jie, an academician of the Chinese Academy of Engineering and executive vice president of Peking University, said that more than 7,000 rare diseases have been found in the world, about 80 percent of which are hereditary diseases and about 50 percent of which occur in childhood.
"Disease without medicine", "medicine without medicine" and "medicine without insurance" are common "crux" faced by patients with rare diseases.
Build a network of diagnosis and treatment, solve the problem of "no medical care"
Because rare diseases are rare and the number of patients with a single disease is very small, doctors, especially grass-roots hospitals, have insufficient ability to recognize and diagnose rare diseases, which restricts the improvement of rare diseases diagnosis and treatment ability.
The first step in the treatment of diseases is correct diagnosis, and difficult to diagnose is the first difficulty encountered by rare disease patients. In September 2021, a rare disease patient weighing only 18 kg was admitted to Beijing University of Aeronautics and Astronautics.
A Beijing doctor who happened to return to his hometown to visit his family suggested that he go to Peking University First Hospital for detailed investigation, so that sail, who is suffering from congenital muscular dystrophy, has an opportunity for early treatment.
According to the "2020 China Rare Disease Comprehensive Social Survey" released by the China Rare Disease Alliance, 15.5% of the more than 20,000 patients participating in the survey need to experience 1-4 years of diagnosis, and 5% of patients need to experience 5-20 years of diagnosis, with an average diagnosis time of 4.26 years.
Of these, 42% also experienced a misdiagnosis.
In order to improve the diagnosis and treatment of rare diseases, in 2018, the five departments of the National Health and Health Commission, the Ministry of Science and Technology, and the Ministry of Industry and Information Technology jointly issued the "First Catalogue of Rare Diseases". 121 diseases were included in the list of rare diseases. In October 2019, China launched the registration of rare disease diagnosis and treatment information. In February 2020, the office of the national rare disease diagnosis and treatment network was officially established.
The implementation of a series of policies has made the diagnosis and treatment of rare diseases in China continue to improve.
Zhang Liyang, president of Beijing Union Hospital and deputy director of the office of the National Rare Disease Diagnosis and Treatment Network, said that as the national leading hospital of the National Rare Disease Diagnosis and Treatment Network, in 2018 Beijing Union Hospital set up a multi-disciplinary consultation platform for rare diseases, which has registered 93 rare diseases in the National Rare Disease Direct Reporting System, involving more than 60,000 cases.
With the support of all parties, Beijing Union Hospital has taken the lead in carrying out many training sessions in many parts of the country, involving more than 80 rare diseases and covering more than 50,000 doctors.
Strengthen drug research and development and get rid of the dilemma of "medicine without medicine"
Due to the small market demand, difficult research and development, high cost and long cycle, there are not many pharmaceutical companies involved in the R & D and production of rare disease drugs, which leads to less rare disease drugs, known as "orphan drugs".
The data show that of the more than 7,000 rare diseases currently known, there are no more than 400 corresponding treatment drugs.
Strengthening the research and development of rare diseases is an important part of helping the treatment of rare diseases.
Domestic pharmaceutical companies are already working in this area.
Beihai Kangcheng, Kantini Pharmaceutical, Deyi Sunshine Bio, Shufang Medicine, Luang Yu Group, Faith Pharmaceutical Technology, etc. have invested huge funds and energy in the field of rare diseases drugs.
Beihaikang, for example, has received an exclusive global license from the Massachusetts State University School of Medicine to develop, produce and commercialize a new second-generation gene therapy for spinal muscular atrophy.
Huang Guo, deputy director of the State Drug Administration, said that we need to continue to promote rare disease drug research and development innovation in the future, and encourage foreign innovative drugs to synchronously research and development, clinical and synchronous declaration in China, and strive to synchronize the listing, so that rare diseases patients in China can use drugs faster and use good drugs.
In recent years, relevant departments have strongly supported the prevention and protection of rare diseases, and strengthened the supply of rare diseases research, diagnosis and treatment and drug research and development.
According to statistics, as of the end of November 2022, 89 drugs for the treatment of 45 rare diseases have been approved in China, and the number of rare diseases that can be treated in China accounts for 53% of the number of rare diseases that can be treated in the world.
The introduction of multiple guarantees to reduce the worry of "drug no guarantee"
"Although the incidence of rare diseases is extremely low, the cost of medical treatment is very high, and the annual cost of medical treatment for rare diseases can reach tens of millions of yuan," said Shan Xiaoou, a member of the Rare Disease Group of the Chinese Medical Association.
In addition, medical insurance reimbursement is difficult, and many drugs for rare diseases with extremely high prices are not included in the list of basic medical insurance drugs.
Most of the medicines cannot be reimbursed by the basic medical insurance and the major diseases insurance fund, and they can only pay for themselves.
In order to enable more rare disease patients to afford drugs, the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalogue (2021) has included 58 rare disease drugs, accounting for about 67% of the listed rare disease drugs.
For example, Nocina sodium injection, which used to be 700,000 yuan per needle, was included in medical insurance after medical insurance negotiations with more than 30,000 yuan, and children with spinal muscular atrophy became "lucky children".
Various localities have also actively explored the mechanism of drug protection.
More than 10 provinces and cities across the country have set up drug protection mechanisms involving high-value drugs for rare diseases, including special funds, major medical insurance, financial contributions, medical assistance, and policy-oriented commercial insurance.
In many places, it is not just a single system guarantee, but by the government, the market and society to provide multiple guarantees, supplementing the national basic medical insurance, and realizing the "access to medication" of rare disease patients who need high-value drug treatment.
For example, Zhejiang is the first province to introduce a provincial medical guarantee mechanism for rare diseases. In 2015, according to the economic and social development level of Zhejiang Province, the balance of medical insurance fund and the diagnosis and treatment of rare diseases.
In terms of commercial supplementary medical insurance, the "West Lake Benefit Joint Insurance" has set up special medical insurance for three rare diseases such as spinal muscular atrophy.
The medical insurance will be paid at a rate of 60 percent after deducting the initial payment line of 10,000 yuan for the year, and the maximum payment limit for the year will be 100,000 yuan.
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Rare diseases must be prevented.
"There are many kinds of birth defects, there are more than 8,000 kinds, a considerable proportion of which are rare diseases." Song Li, director of the Department of Maternal and Child Health of the National Health and Health Commission, said that the number of pre-screening institutions in China has reached more than 4,800, prenatal diagnostic institutions reached 498, and newborn genetic and metabolic disease screening institutions have been popularized in many provinces and cities.
Song Li pointed out that rare diseases should be prevented and controlled from the source.
China has adopted three levels of prevention and control measures to prevent birth defects, and has moved forward through marriage, childbirth and newborn screening, so as to ensure early detection, early intervention and early treatment, and reduce the incidence of rare diseases.
"In the case that more than 90% of rare diseases are not solved, prevention is the most cost-effective health strategy," Yu Xuejun, deputy director of the National Health Commission, said.
(Editor: Sun Hongli, Yang Di)
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