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🏥 | [Re-notification of the Ministry of Health, Labor and Welfare] Inappropriate cases of retail sales / "You can buy without a prescription" is inappropriate / Advertisements for the general public are not allowed


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[Ministry of Health, Labor and Welfare Re-disseminate] Inappropriate cases of retail sales / Inappropriate "You can buy without a prescription" / Advertisements for the general public are not allowed

 
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Advertisement In order to avoid making decisions based solely on the judgment of those who intend to use pharmaceuticals, we will continue to prohibit advertising of all pharmaceuticals, including non-prescription pharmaceuticals, to the general public. What not to do.
 

[Delivered on August 2022.08.08, XNUMX] On August XNUMX, the Ministry of Health, Labor and Welfare announced about sales methods of ethical drugs other than prescription drugs... → Continue reading

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Wikipedia related words

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Medicine

Medicine(No, noBritish: medication) IsHuman capital,Animal Ofdisease OfDiagnosis-治療-preventionGive to doMedicine..It can be used as something to drink (oral medicine) or something to apply (internal medicine).External medicine),injectionWhat to do (Injection)and so on(Dosage formSee).Prescribed and by seeing a doctorpharmacistAdministered by dispensingPrescription medicines, You can buy it at the pharmacyOTC drugsThere is.PharmaceuticalsClinical trialIf the efficacy is shown, it will be approved as a generic drug (new drug).After 20 years have passed since the launch of the new drug,Generic drug(Generic drugs) will also be sold.

Definition and classification of medicines

Japan

Definition by the Pharmaceuticals and Medical Devices Act

JapanesePharmaceuticals and medical devices lawIn Article 2, it is defined as follows:[1].

  1. Japanese PharmacopoeiaWhat is stored in
  2. People or Animal OfdiseaseItems intended to be used for diagnosis, treatment or prevention of, not mechanical instruments, dental materials, medical supplies and sanitary supplies (Quasi-drugexcept for. )
  3. Items intended to affect the structure or function of the human or animal body and are not mechanical instruments, dental materials, medical or hygienic items (quasi-drugs andCosmeticsexcept for. )

1'sJapanese PharmacopoeiaThe medicines listed inJapanese PharmacopoeiaThat is.It is roughly divided into Part 5 drugs and Part 2 drugs.The Pharmacopoeia is revised about once every five years, but during that time, a supplementary edition is issued about once every two years, and the listed drugs are reviewed.The latest version is20113/24The XNUMXth revised Japanese Pharmacopoeia was announced.The Japanese Pharmacopoeia has listed only those with clear usage, effects, mechanism of action, etc., but the United States Pharmacopeia (en: United States PharmacopeiaCompared to USP), etc., it has been pointed out that the number of listed drugs and their contents are not based on the current drugs, so new drugs are being actively listed.However, some problems remain due to drug prices and their handling.In addition, it was listed in the second partGinger,honeySome of them are used as food.

To distribute as a drug in Japan, including transferMinister of Health, Labour and WelfareManufacture and marketing approval is required.Drugs, quasi-drugs, cosmetics or products without approvalMedical equipmentThose who do not fall under the above cannot claim "efficacy" or "effect".Health functional foodProducts claiming efficacy as a drug are subject to punishment as "unapproved drugs", except when advocating within the permitted range.

Classification of medicines

Japanese medicines are classified as follows (excluding veterinary medicines).

  • Prescription drugs- DoctorUsed by etc. or of these personsprescriptionOr a drug prescribed for use by instruction.Face-to-face sales required[2].. In September 2000, the naming method for sales names was unified, and the sales names of existing products were changed as alternative new applications.[3].. In 2015, it accounted for about 88% of the value of pharmaceutical production in Japan.[4]
    • Prescription medicines
      Doctors, etc.prescriptionWithout it, medicines that the general public cannot buy.Clinic etc. to obtainMedical institutionTo seeDoctor or DentistYou will need a prescription.
    • Medical drugs other than prescription drugs
      As with prescription drugs, prescription-based drug deliveryprincipleHowever, if the conditions are met in the 2005 notification, it has become possible to purchase medical drugs other than prescription drugs without a prescription.[5]..However, in general pharmacies, it is for the general publicZero saleBecause of the self-restraint, sales without a prescription are handled only by so-called zero-selling pharmacies.
    • Pharmacy manufacturing and sales pharmaceuticals- ApprovalAuthorizationBy takingpharmacyManufacture in the dispensing room is permittedFormulation.. Internet sales have been lifted in principle due to the revision from June 2014, 6.[2].
  • OTC drug
    So-called over-the-counter drugs and over-the-counter drugs that do not require a doctor's prescription at the time of purchase.[6].. In 2015, it accounted for about 12% of the value of pharmaceutical production in Japan.[4].
    • Drugs requiring guidance
    In the category newly established by the revision from June 2014, 6, in the risk classification, "Of the drugs that may cause health hazards to the extent that side effects interfere with daily life, special attention should be paid to their use. , A drug containing newly marketed ingredients, etc. "[2]..Drugs requiring guidance must be sold face-to-face[2].
    • OTC drugs
      Medicines that can be purchased without a doctor's prescription.インターネットEven above, it became possible to purchase after 2014[7]..Over-the-counter drugs are classified into three types, first, second, and third, from the one with the highest risk.[8].
      • First-class drugs High risk, sales by pharmacists and delivery of documents to users at the time of sale are obligatory[9].
      • The risk of second-class drugs is rather high, and even registered sellers can sell them, and it is obligatory to make efforts to deliver documents to users at the time of sale.[9].
      • Third-class drugs The risk is relatively low, even registered sellers can sell, and there is no need to issue a document to the user at the time of sale.[9].

Food category

FoodAs a result of advanced research on the pharmacological action of the ingredients insidediseaseProclaimed the effect of prevention etc.healthy foodHas emerged, and the distinction from pharmaceutical products has become ambiguous.This created the need for a clear distinction between food and medicine.

1971(Showa 46), "Regarding the control of guidance on unapproved and unlicensed drugs" (June 46, 6, Pharmaceutical Issue No. 1, Notification of Director General of Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, (Attachment) Standards on the scope of drugs) was issued. The classification of medicines and foods is clearly stated (commonly known as 476 notifications).[10].

First of all, as something classified as food

  1. Vegetables,fruit,Confectionery, Cooked foods, etc. that are clearly recognized as foods due to their appearance, shape, etc.
  2. Health promotionArticle 26 (old)Nutrition improvement methodSpecial-purpose foods (foods for the sick, for pregnant women and lactating women) that display the contents of the label approved based on the provisions of Article 12)Milk powder, Infant formula, Elderly food,Health functional food(Food for specified health useNutritionally functional foodApplicable)

And if it does not correspond to the above, it is judged whether it is a drug or a food from the following four factors.

  1. Contains the essence of ingredients (raw materials) used exclusively as pharmaceuticals.However, this excludes cases where it is used for purposes such as coloring and flavoring in an amount that cannot be expected to have a pharmacological effect.
    1. toxicityStrongalkaloid,toxicityProteinEtc., Those containing other components equivalent to the designated components of poisonous and powerful drugs (see the attached sheet).
    2. medicine,Psychotropic drugsandstimulant drugThings that have an effect.
    3. A drug that contains ingredients equivalent to a designated drug or a drug requiring instructions and that needs to be regulated as a drug from the viewpoint of health and hygiene.
  2. Advocacy of medicinal effects (treatment or prevention of diseases, enhancement and enhancement of tissue function of the body, and indications implying them)
  3. Pharmaceutical shape (ampoule)
  4. Indication of pharmaceutical dosage

Those that meet one or more of the above four factors are classified as pharmaceuticals and are regulated by the Pharmaceuticals and Medical Devices Act.

2001(13), Director General of Pharmaceutical Affairs Bureau, Ministry of Health, Labor and Welfare "Revision of Standards for Scope of Pharmaceuticals" (Pharmaceutical Issue No. 243, March 13, 3, Director General of Pharmaceutical Affairs Bureau, Ministry of Health, Labor and Welfare) However, if it was clearly stated that it was a food product, the standard was relaxed if it was not judged to be a drug based on its shape alone.

France

In FrancePrescription medicinesAnd for the treatment of benign early symptomsPrescription optional medicineare categorized[11].

Germany

In GermanyPrescription medicines, Designated as one that has few side effects and has been confirmed to have a certain level of safetyDrugs sold at pharmaciesDesignated for the purpose of tonicity, improvement of health condition, function protection of internal organs, prevention of diseases, and without specific efficacy or therapeutic effect.Free-selling medicinesare categorized[11].

United Kingdom

In the UKPrescription medicinesDesignated as one that has a certain degree of safety but needs to be supervised by a pharmacistDrugs sold at pharmaciesDesignated as one that can be sold at general retail stores as safety is widely established and pharmacists do not need to supervise sales.Free-selling medicinesare categorized[11].

Pharmaceutical development

In the case of new drug development, compounds are first extracted or synthesized from various materials, basic research is conducted, and then animals are used.非 臨床 試 験And then divide into 3 stagesClinical trialI do.After the test is completed, the government will conduct an approval review, and if approved, the production system will be set up and sales will begin.This series of processes takes a very long time and takes at least 10 years.[12]..This series of processesDrug discoveryと 呼 ば れ る[13].

In addition to making certain profits by developing new drugs (original drugs / new drugs), it is epoch-making.BlockbusterIf this happens, it will bring enormous profits to pharmaceutical companies, and development competition between companies continues.On the other hand, it takes a long time to develop (more than a dozen years).Huge costRequires (tens of billions of yen)[14]..The pharmaceutical industry has the highest ratio of R & D expenses in the world, and 2006% of sales were allocated to R & D expenses in FY15.9.[15]..A similar trend is shown in Japan, where 2014% of sales were R & D expenses in FY12.2.[16]..The risk of not being able to commercialize is also high compared to other industries. Since the late 1990s, R & D costs have continued to rise, while research success rates have declined.[17].

さ ら にMinister of Health, Labour and WelfareNeeds the process of getting approval for a new drugPatentWill expire in 20 years after application (Patent OfficeIf a request for extension of the patent is made and approved, the extension of up to 5 years is permitted by the Patent Law).Therefore, the patent protection period after launch is shorter than that of other products, and research and development of new drugs are constantly required.In addition, R & D costs continue to rise due to the depletion of proteins that are the target of new drug development.From the above, the pharmaceutical industry has been reorganized globally, and it is a global super-major company (Multi national company) Is being aggregated.Japan is no exception, and the reorganization of pharmaceutical manufacturers is progressing rapidly.

Drugs made with expired patentsGeneric drugIt is called (generic drug), and there is also a drug manufacturer specializing in generic products.Since the active ingredient that has already been proven by the original manufacturer is used, the development period is short and there is little new investment, so the cost is cheaper than the original product and it contributes to the national medical insurance finance. In 2007, generic drugs accounted for 6.2% of Japan's drug sales.[18].

Manufacturing of pharmaceutical products

For manufacturing pharmaceutical products in JapanPharmaceuticals and medical devices lawByPharmaceutical manufacturing licenseIs needed.In addition, in order to put a manufactured drug on the market, a drug manufacturing and marketing license is required according to the type of drug to be marketed (Type 1 and Type 2).

In the manufacturing process of pharmaceutical products, the active ingredient is first manufactured, then molded, filled, packaged and shipped.The production of active ingredients may be outsourced, but the manufacturer usually performs molding, filling, and packaging.[19].

Sales of pharmaceutical products

Japan

Not everyone can sell medicines, in principlePrefectural governorIt can only be sold in the following places with more permission.Clinic,hospitalThe only things that can be handled by pharmaceutical products areDoctor lawOrDentist lawIt is based on the exception provisions of.

pharmacy

Under the Pharmaceuticals and Medical Devices Act,pharmacistWhere is the dispensing business for the purpose of selling or awarding,pharmacyIs defined as.Dispensing outside the dispensing room isPharmacist methodIn principle, it is not permitted by the provisions of.however,在 宅 医療There are exceptions in such cases.A pharmacy that dispenses based on a prescription is sometimes called a dispensing pharmacy, but it is an unnatural name because it can be dispensed in principle if it is a pharmacy, and whether "pharmacy" and "dispensing pharmacy" are different forms. To prevent misidentification, new pharmacies are required to avoid the name "dispensing pharmacies," although they are not legally enforceable.

Store sales

To the general public at stores in the pharmaceutical sales businessOTC drugsIt is a business format that sells drugs other than over-the-counter drugs.So-calledDispensingDo not do drug storesDrug storeThe format called.TraditionalGeneral sales businessandDrug businessBy transitional measures2012Until May, it is regarded as a store sales business and can be operated.2009A business format newly established by the revised Pharmaceutical Affairs Law.

Placement sales business

Placement sales businessWhat is a mechanism in which a staff member (salesperson) visits a consumer's home, places a box containing medicines (placement box), pays for the amount used at the next visit, and collects money ("First". It is a drug placement and sales business of "Senyoukouri").Drugs that are sold by placement are also called placement medicines.Previously, placement staff in the placement sales business did not require qualifications such as pharmacists,2009In the placement sales business under the revised law, pharmacists orRegistered sellerIt was decided that non-qualified staff members would not be able to sell medicines other than collecting payments and replenishing medicines.When engaging in placement salesPrefecturesIt is necessary to issue the governor's ID card.

Wholesale sales

It is a so-called drug wholesaler, and is a business format that wholesales drugs to medical institutions and pharmacies in the drug sales business.WarehouseMainly does not have a store.MunicipalitiesTovaccineIt is forbidden to sell medicines directly to anyone other than medical personnel, except in special cases such as paying.

France

In France, the only formats that can sell medicines are pharmacies.[11]..It is necessary to always have pharmacists in pharmacies, and in pharmacies that exceed a certain sales amount, it is necessary to assign a fixed number of pharmacists for each sales amount.[11].

Germany

In Germany, prescription drugs and pharmacy-sold drugs can be sold only at pharmacies, and free-selling drugs can be sold only at pharmacies and drogerie.[11]..It is necessary to have a pharmacist at all times to sell prescription drugs and medicines sold at pharmacies, and all medicines need to be available to the pharmacy manager at all times.[11].

United Kingdom

In the UK, the formats that can sell prescription drugs and drugs sold at pharmacies are limited to pharmacies.[11].. Free-selling medicines can also be sold at general retail stores[11]..It is necessary to have a pharmacist at all times to sell prescription drugs and drugs sold at pharmacies.[11].

Pharmaceutical industry

The pharmaceutical industry, including the above-mentioned pharmaceuticals, distribution, and sales, is a huge scale and is a major industry. In 2005OECDOn average, 1.5% of the GDP of member countries was spent on medicines[20]..This spending is on the rise at a fast pace[21].. The largest drug-producing country in 2004 was the United States, followed by EU countries, but its share of GDP is not very high.The pharmaceutical industry makes up a large proportion of the economyIrelandSwitzerlandIt is also a major exporter of chemicals.[22].

There are many pharmaceutical companies all over the world, but due to the pressure on R & D expenses, etc.oligopolyIn 2006Mega PharmaThe market share of the top 10 companies, also known as, has reached 46%.[15]..In 2014, drug sales exceeded $ 1 trillion, and the figures are on the rise.The largest market for pharmaceuticals is North America, followed by China, Japan, Germany, and France.[23].

Problems with pharmaceuticals

Fraud

Monitoring of adverse reactions (side effects) of medicines is not properly organized, and information on adverse reactions may be kept private, and patient reports of adverse reactions in less information are allowed by the regulatory agency. There are even things that are not done[24]..until nowPrescription medicinesWhat wasOver-the-counter drugsIt also tends to weaken the system for grasping side effects.[25].

Prescription drug fraudAs a matter of fact, it is common to sell by spoofing its effectiveness and side effects, and it is considered to be a serious and repetitive crime.[26]..In recent years, the illegal sale of medicines in the United States has set new maximum fines for each pharmaceutical company, reaching billions of dollars at a time.[27].

Access to medicines

World Health OrganizationWHO Essential Drug Model ListHas been established,Essential medicinesDemands that it be easily available and used in any nation.But especiallyDeveloping countryThis requirement is often not met in[28]..This is because the government's drug regulations are not working, especially in developing countries, and the problems of high drug prices and low quality drugs have not been solved, and more drugs for developed countries are manufactured than for developing countries. Has been, "Neglected Tropical DiseasesDue to the delay in the development of therapeutic agents for diseases that are widespread in developing countries.[29]..One of the causes of the problem is that patent protection protects the rights of pharmaceutical companies that develop new drugs and limits the production of cheap generic drugs.Agreement on Trade-related Aspects of Intellectual Property RightsAlthough the drug patent is protected for 20 years under the (TRIPS, Trips Agreement), the so-called compulsory license to manufacture and import the drug is granted within the agreement, ignoring this patent in the event of a national emergency. Ori, ThailandIndiaHas been implemented several times in several countries[30][31].

In Japan, the delay in approval of new drugs launched overseas, so-calledDrag lagIn the 2000s, the period from the first sale overseas to the domestic sale in Japan reached 2010 years on average in 4.7.[32]..This was the slowest number in the 12 developed countries, more than double the shortest time in the United States.[33]..In response to this, the Japanese government promoted international joint clinical trials.[34]By strengthening the examination system, the delay at the time of examination was eliminated in 2012, and the drug lag as a whole was shortened to 0.3 years.[35]..Since then, drug lag has increased slightly but has maintained a small number, reaching 2018 years in FY0.9.[36].

Soaring prices

In addition, rising drug prices, especially some drugs, have become a global problem.Due to soaring R & D costs, some epoch-making new drugs have become extremely expensive, and in 2019, some drugs exceeding 1 million yen per dose appeared in Japan.[37]..In the same year in AmericaZorgensumaWas approved, and the price was 212 dollars, which exceeded 5000 million yen in Japanese yen.[38]..In Japan, the drug price of Zolgensuma was 2020 million yen when the insurance was applied in 1, making it the first drug to exceed 6707 million yen.[39].

The soaring price of this drug is particularly problematic in the United States.The country has the highest drug prices in the world, and the per capita drug spending is also the highest.[40]..Since there is no drug price standard system in the United States, it is easy to raise prices, and not only new drugs but also drugs that have been used in the past may be significantly increased. In 2015Martin ShkreliIs an AIDS drugDalaprimThe price was raised 55 times at a stretch, and it received strong criticism not only from the United States but also from all over the world.In addition to this, in the latter half of the 2010s, the rise in drug prices accelerated further, and each company raised the price significantly.[41]..For this reason, drug price cuts have become one of the political focal points, and in 2019 the Democratic Party will show a move to submit a drug price cut bill.[42]Also, in 2020, President Donald Trump signed a presidential directive to reduce drug prices, but it seems unlikely to be feasible.[40].

Japanesemedical insuranceIn the system, there is a drug price standard system, and soaring drug prices are regulated.[43]..The patient's own expenseDrug price3% (handicapped,Senior citizensIn the case of, it will be reduced to 2% or 1%), and the remaining 7% will be paid from medical insurance.[44]..However, even in Japan, the financial burden on the medical insurance system due to the application of high-priced drug insurance is becoming a problem.[45]..Therefore, as a measure to improve the medical insurance finance, the national government has a lower drug price than the original drug and has the same effect.Generic drugWith measures to promote the use of (generic drugs)[46], Over-the-counter drugs (over-the-counter drugs) that you choose and purchase at pharmacies or drug storesOTCWe are working on measures to promote the use of medicines).

Veterinary medicine

In Japan, "exclusivelyAnimalIt is defined as "a drug intended to be used for"Minister of Agriculture, Forestry and FisheriesRefers to what is defined by.

footnote

[How to use footnotes]

Source

  1. ^ "Act on ensuring the quality, effectiveness and safety of pharmaceuticals, medical equipment, etc.". e-Gov Law Search.Administrative Management Bureau, Ministry of Internal Affairs and Communications. April 2013, 6Browse.
  2. ^ a b c d "Medicine and Health Week About Over-the-Counter Medicine”. Fukushima Pharmacist Association. As of October 2014, 10original[Broken link]More archives.April 2017, 2Browse.
  3. ^ Handling of labeling items and brand names of pharmaceutical products to prevent medical accidents Notification No. 935, Director General of Pharmaceutical Safety Bureau, Ministry of Health and Welfare (September 2000, 9) (PDF)
  4. ^ a b "The latest industry common sense, well-understood pharmaceutical industry" p21 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  5. ^ Handling of prescription drugs, etc. Notification of Director General of Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare No. 0330016 (March 2005, 3), Partial Amendment 30 No. 0331 (March 17, 2011) (PDF)
  6. ^ https://www.daiichisankyo-hc.co.jp/health/knowledge/otc/type.html "Classification of OTC drugs" Daiichi Sankyo Healthcare Retrieved September 2020, 9
  7. ^ "The latest industry common sense, well-understood pharmaceutical industry" p234 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  8. ^ "The latest industry common sense, well-understood pharmaceutical industry" p126-127 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  9. ^ a b c "The latest industry common sense, well-understood pharmaceutical industry" p127 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  10. ^ "Guidance crackdown on unauthorized drugs". Ministry of Health, Labor and Welfare laws and regulations database serviceMinistry of Health, Labor and Welfare (March 1971, 6). April 2016, 5Browse.
  11. ^ a b c d e f g h i j Drug sales systems in foreign countries Retrieved February 2017, 2, Ministry of Health, Labor and Welfare.
  12. ^ http://www.jpma.or.jp/medicine/med_qa/info_qa55/q33.html "Q33 How long does it take to develop one medicine?" JPMA August 1, 2020
  13. ^ "The latest industry common sense, well-understood pharmaceutical industry" p76 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  14. ^ http://jasmo.org/ja/business/flow/index.html "Until you can take medicine" Japan SMO Association, viewed August 2020, 8
  15. ^ a b "Global Pharmaceutical Policy in Charts How are Pharmaceutical Prices Determined in the Global Market?" P52 OECDEdited by Hiroyuki Sakamaki Translated by Hiroyuki Sakamaki Akashi Shoten June 2009, 6 First Edition First Edition
  16. ^ "The latest industry common sense, well-understood pharmaceutical industry" p78 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  17. ^ "Global Pharmaceutical Policy in Charts How are Pharmaceutical Prices Determined in the Global Market?" P56 OECDEdited by Hiroyuki Sakamaki Translated by Hiroyuki Sakamaki Akashi Shoten June 2009, 6 First Edition First Edition
  18. ^ "Global Pharmaceutical Policy in Charts How are Pharmaceutical Prices Determined in the Global Market?" P62 OECDEdited by Hiroyuki Sakamaki Translated by Hiroyuki Sakamaki Akashi Shoten June 2009, 6 First Edition First Edition
  19. ^ "Global Pharmaceutical Policy in Charts How are Pharmaceutical Prices Determined in the Global Market?" P57 OECDEdited by Hiroyuki Sakamaki Translated by Hiroyuki Sakamaki Akashi Shoten June 2009, 6 First Edition First Edition
  20. ^ "Global Pharmaceutical Policy in Charts How are Pharmaceutical Prices Determined in the Global Market?" P28 OECDEdited by Hiroyuki Sakamaki Translated by Hiroyuki Sakamaki Akashi Shoten June 2009, 6 First Edition First Edition
  21. ^ "Global Pharmaceutical Policy in Charts How are Pharmaceutical Prices Determined in the Global Market?" P30 OECDEdited by Hiroyuki Sakamaki Translated by Hiroyuki Sakamaki Akashi Shoten June 2009, 6 First Edition First Edition
  22. ^ "Global Pharmaceutical Policy in Charts How are Pharmaceutical Prices Determined in the Global Market?" P40-42 OECDEdited by Hiroyuki Sakamaki Translated by Hiroyuki Sakamaki Akashi Shoten June 2009, 6 First Edition First Edition
  23. ^ "The latest industry common sense, well-understood pharmaceutical industry" p20-21 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  24. ^ International Pharmaceutical Information Magazine Association 2005, p. 7.
  25. ^ International Pharmaceutical Information Magazine Association 2005, p. 11.
  26. ^ Peter C. Gotzsche (14 Dec 2012) (pdf). Corporate crime in the pharmaceutical industry is common, serious and repetitive (Report). Nordic Cochrane Center. http://www.cochrane.dk/research/corporatecrime/Corporate-crime-long-version.pdf April 2014, 6Browse.. , A shortened version of this is:Gotzsche, PC (2012). “Big pharma often commits corporate crime, and this must be stopped”. BMJ 345 (dec14 3): e8462–e8462. two:10.1136 / bmj.e8462. PMID 23241451. 
  27. ^ Maia Szalavitz Sept (September 2012, 9). “Top 10 Drug Company Settlements”.TIME.com. http://healthland.time.com/2012/09/17/pharma-behaving-badly-top-10-drug-company-settlements/ April 2013, 2Browse. 
  28. ^ "Humanity and Disease" p191-193 Kayo Takuma Chuko Shinsho April 2020, 4 First Edition
  29. ^ "Humanity and Disease" p193-197 Kayo Takuma Chuko Shinsho April 2020, 4 First Edition
  30. ^ "Humanity and Disease" p200-202 Kayo Takuma Chuko Shinsho April 2020, 4 First Edition
  31. ^ Invoking compulsory license for the first time under the current patent law-A sense of crisis in the pharmaceutical business of Japanese companies- (India) --JETRO March 2012, 03 Retrieved September 19, 2020
  32. ^ Q39 What is "drag lag"?What are the national and pharmaceutical industries doing? --JPMA, viewed September 2020, 9
  33. ^ "Global Pharmaceutical Policy in Charts How are Pharmaceutical Prices Determined in the Global Market?" P134 OECDEdited by Hiroyuki Sakamaki Translated by Hiroyuki Sakamaki Akashi Shoten June 2009, 6 First Edition First Edition
  34. ^ "The latest industry common sense, well-understood pharmaceutical industry" p226 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  35. ^ Estimated drag and lag (24-28) --Pharmaceuticals and Medical Devices Agency, September 2020, 9
  36. ^ Estimated drag and lag (26-30) --Pharmaceuticals and Medical Devices Agency, September 2020, 9
  37. ^ XNUMX yen each time ... Ultra-high-priced drug Kimria, covered by insurance from XNUMXnd One stone on how drug prices should be, patients have expectations --Sankei Shimbun 2019.5.21 Retrieved September 2020, 9
  38. ^ The highest price ever, a drug with a drug price of 2 million yen appears in the United States --Nikkei Biotech 2019.05.29 Retrieved September 2020, 9
  39. ^ Medical insurance Yusaburu high-priced drug 1 million yen, 6707-day insurance coverage --Nihon Keizai Shimbun 2020/5/13 Retrieved September 2020, 9
  40. ^ a b Mr. Trump appeals to presidential directive election to reduce drug prices --Nihon Keizai Shimbun 2020/7/25 Retrieved September 2020, 9
  41. ^ "55 times at a stretch ... Is it only corporate ethics that the drug prices in the United States are being questioned one after another?" THE PAGE 2016/9/4 Retrieved September 2020, 9
  42. ^ U.S. House Speaker Calls on President to Announce Bill to Reduce Drug Prices --Reuters September 2019, 9 Retrieved September 20, 2020
  43. ^ "The latest industry common sense, well-understood pharmaceutical industry" p38-39 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  44. ^ "The latest industry common sense, well-understood pharmaceutical industry" p39 Takeshi Nagao Nihon Jitsugyo Publishing Co., Ltd. July 2018, 7 Published the latest 1 editions
  45. ^ 1 million yen at a time ... Ultra-high-priced drug Kimria, covered by insurance from 3349nd One stone for drug prices, patients have expectations --Sankei Shimbun 2019.5.21 Retrieved September 2020, 9
  46. ^ Promotion of use of generic drugs --Ministry of Health, Labor and Welfare, Japan, viewed September 2020, 9

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