The global medication shortage problem is caused by multiple factors, including supply problems, manufacturing issues, clinical demand, uneven distribution, drug use habits, and drug prices.

The director-general of the World Health Organization is Dr Tedros Ghebreyesus.

"The United States is experiencing a severe shortage of medicines and drugs, with a 30% increase in shortages last year compared to 2021."

"China's national health insurance covers 58 rare disease medications, which is approximately 67% of the listed rare disease drugs."

There are more than 7,000 known rare diseases globally, with the majority being hereditary and often occurring in childhood.

Carboplatin and cisplatin, used in cancer treatments, have been in short supply, with 93% and 70% of treatment centers reporting shortages, respectively.

The healthcare system faces challenges such as disparities in vaccine supply and the inability of some countries' pharmaceutical companies to respond quickly to health crises.

"Antibiotics, including penicillin-type drugs like amoxicillin, are experiencing shortages globally due to pandemic-related manufacturing difficulties, high energy prices, and increased respiratory infections."

The supply of pharmaceuticals has been affected by the international epidemic, the Russian-Ukrainian war, and labor shortage, leading to drug shortages worldwide.

The medication shortage in the US affects chemotherapies and other generic drugs.

The text suggests that generic drugs can be an alternative to brand-name medications, which could help alleviate medication shortages.

Besides antibiotics, other medications in short supply include painkillers, drugs for tuberculosis, and drugs for skin infections.

"Open Source Pharma is an alternative model that proposes collaborative research and development to reduce costs and increase access to medicines."

The global medication shortage problem is caused by multiple factors, including supply problems, manufacturing issues, clinical demand, uneven distribution, drug use habits, and drug prices.

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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The director-general of the World Health Organization is Dr Tedros Ghebreyesus.

Title:

Content: Friday 23 Dhu al-Hijjah 1443 AH - 22 July 2022 |
Programs
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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 is experiencing a severe shortage of medicines and drugs, with a 30% increase in shortages last year compared to 2021."

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.
The materials of InoTV contain estimates of exclusively foreign media and do not reflect the position of RT
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"China's national health insurance covers 58 rare disease medications, which is approximately 67% of the listed rare disease drugs."

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.
Related Links
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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There are more than 7,000 known rare diseases globally, with the majority being hereditary and often occurring in childhood.

Carboplatin and cisplatin, used in cancer treatments, have been in short supply, with 93% and 70% of treatment centers reporting shortages, respectively.

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.

The healthcare system faces challenges such as disparities in vaccine supply and the inability of some countries' pharmaceutical companies to respond quickly to health crises.

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Content:   • SHARE

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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PHOTO GALLERY (CLICK TO ENLARGE)

"Antibiotics, including penicillin-type drugs like amoxicillin, are experiencing shortages globally due to pandemic-related manufacturing difficulties, high energy prices, and increased respiratory infections."

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 supply of pharmaceuticals has been affected by the international epidemic, the Russian-Ukrainian war, and labor shortage, leading to drug shortages worldwide.

The medication shortage in the US affects chemotherapies and other generic drugs.

The text suggests that generic drugs can be an alternative to brand-name medications, which could help alleviate medication shortages.

Besides antibiotics, other medications in short supply include painkillers, drugs for tuberculosis, and drugs for skin infections.

"Open Source Pharma is an alternative model that proposes collaborative research and development to reduce costs and increase access to medicines."

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Content: The COVID-19 pandemic has brought the issue of access to affordable medicines to the forefront of Intellectual Property (IP) debate in recent months. The tension between the patenting and circulation of drugs is nothing new, but it is felt most keenly in the least-developed and middle-income countries, which suffer under heavy burdens of infectious diseases such as Ebola, HIV, tuberculosis and malaria. South Africa, though 36th in the world in terms of Gross Domestic Product (GDP), is one such belabored country, with a high level of economic inequality and multiple health crises.

The crux of the matter is that patented medicines are costly, often prohibitively for the poorest nations. Ultimately, this impediment derives from the fact that the research and development (R&D), testing and approval processes required to bring a drug to market are exorbitantly expensive – with the average cost per product exceeding $1 billion USD. Patents provide the incentive to conduct the R&D necessary to develop new medicines, as the patentee can be confident they will be able to recover their costs and reap sufficient reward through profits.

How, then, should the needs of the consumer, that is to say, of patients, for reasonably priced medicines be balanced against the needs of the producer to recoup their massive financial investments? The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) proposes various solutions to this quandary, discussed here using South African law as a case study.

Flexible by design

Article 1 and Article 8 of TRIPS provide for broad adaptability. Article 1, dealing with how member states are to implement the framework appropriately in the context of their national laws, permits countries to afford more extensive patent protections than the minimum standard set by the Agreement, provided that the same is not contravened in doing so. In addition, Article 8 allows members to adopt measures to protect and promote the public interest. Between them, these provisions grant leeway for public health considerations and, consequently, appropriate access to medicines.

Article 66 of TRIPS addresses the availability of medicines and advanced technologies in the least-developed countries. This is vital as many such countries do not have the manufacturing capabilities to produce required medicines domestically, and hence compulsory licensing is not an appropriate way for them to obtain patented products.

Overall, TRIPS provides both flexibility in implementing the Agreement and specific measures for improving access to life-saving medicines, particularly for the most vulnerable populations. However, challenges still exist in fully utilizing these provisions and ensuring equitable access to necessary medications.

Articles 30, 31 and 31bis provide greater specificity in this respect and allow for the unauthorized use of patented subject matter under rigorous conditions as well as for compulsory licensing.

Walk-in rights

Section 4 of South Africa's Patents Act No. 57 of 1978 (the Act) provides for the use of a patent by the state, while Section 78 outlines the state's acquisition of a patent. These provisions are what would be used to facilitate ready access to medicines in the event of a national emergency or pandemic. However, these solutions are only effective when the state can manufacture the drug or import it from a country where patent protection is not in place. Therefore, this mechanism is not ideal for low- and middle-income countries.

Compulsory licensing: reasonability and controlled pricing

Section 56 of the Act permits compulsory licensing in the case of an abuse of rights, with paragraphs 56(c) and 56(e) specifically outlining that unreasonable licensing terms and excessive pricing constitute abuse. These stipulations allow for compulsory licensing to a licensee who will locally manufacture the drug. Once again, as with the walk-in rights, this is premised on the assumption that local manufacturing capability is available, which is not often the case in South Africa.

Open Source Pharma, the Bolar Provision and generic medicines

Open Source Pharma (OSP) is a project akin to the openly licensed software movement, going so far as to describe itself as "Linux for Drugs." This model centers around collaborative R&D and drug trials around the world to produce medicines more quickly and cheaply. We witnessed the speed with which the various COVID-19 vaccines were developed, in no small part due to concerted data-sharing efforts and cooperative research across both the private sector and academic institutions. Partnerships between universities are commonplace, but the idea of combined trials is an intriguing one, as this is where the highest costs of drug development lie. Typically, pharmaceutical companies shoulder these costs and seek to ensure adequate recompense through patents and supplementary protection certificates (SPCs).

OSP proposes an alternative model, where costs are shared among member organizations and any profits from successful drugs are pooled and reinvested into future research and development.

As a parallel option, open-source test data for generics would expedite the drug approval process and allow faster access to cheaper alternatives once patent protection for a medication has expired.

While open test data is not provided for in South African law, the Bolar Provision (Section 69A of the Patents Act No. 57 of 1978) grants a manufacturer of generic medicines the ability to exercise the rights reserved by a patent solely to obtain regulatory approval for the distribution of the product once exclusivity expires. However, each manufacturing company is required to submit its own docket to the medicine regulatory authority, resulting in a great deal of redundancy. Perhaps a middle-ground solution would be to allow the submission of regulatory approvals in other jurisdictions for the same formulation, thereby walking a line between OSP and the Bolar Provision and slightly expediting the process of making generics available. This approach could be considered "open test data."

Substantive examination, patent opposition and the prevention of evergreening

South Africa has a formal examination system as opposed to a substantive examination procedure. This means a patent application is not examined in relation to the novelty and inventive step conditions provided for in the Act, and only administrative requirements are assessed. There is no post-grant opposition period save for full-scale litigation before the Court of the Commissioner of Patents. In contrast to a substantive examination jurisdiction, where the patentee bears the costs for reviewing the subject matter of a patent, litigation is a financially burdensome way for a party to apply for revocation or compulsory license in South Africa. This is, of course, a preferential situation for a patentee in the pharmaceutical industry, as the fees for patenting are low, the validity of the subject matter is not open to immediate question and litigation is discouraged by high costs.

South Africa's patent law has certain provisions that are favorable to the pharmaceutical industry. One such example is the Bolar Provision, which allows generic manufacturers to research and develop their own versions of patented drugs before the patent expires, as long as they do not commercially exploit them until then.

Restricted evergreening is also present in South Africa in that the Companies and Intellectual Property Commission (CIPC) accepts second medical use applications as well as claims premised on specific and narrow dosage regimes. This practice, coupled with the fact that only a formal examination is conducted, invariably leads to a patent register that contains potentially invalid patents that must be questioned before the courts. Specific dosage regimes and second medical uses are not contentious per se but can be problematic in an environment that does not carry out substantive examinations. Non-allowance of second medical use and / or dosage regime patents would tighten the noose on evergreening and is perhaps an option to be considered in a way that fairly accounts for the R&D and trial costs associated with developing drugs.

Public-private partnerships and tax incentives

South Africa delivers tax incentives for R&D and has laws that regulate public-private partnerships for certain entities and where public funding is used in R&D (Intellectual Property Rights from Publicly Financed Research and Development Act No. 51 of 2008). This legislation can make the innovation landscape difficult to negotiate and less attractive for private partners, given that they control the ownership of patents stemming from such R&D.

It may be interesting to see tax incentives not only for R&D but also for licensing regimes – facilitating lower costs in medication production and correspondingly increasing capacity, but without necessarily raising patent holder profits.

The most feasible solution to affordable medicine access is to be found not so much in national patent law or the TRIPS Agreement but in a broader survey of the economics of drug development, manufacture and distribution. By increasing production volumes, tax and licensing incentives could boost sales figures to levels that a patentee does not necessarily have to forfeit any profit in light of lower consumer-end prices.

A version of this article was first published in WIPR Issue 3, 2022.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.