Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector最新文献_第5页

An overview on the various pricing policies of health-related products and incentivizing the innovation during the health emergency situations 突发卫生事件中与健康相关产品的各种定价政策及激励创新综述

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-08-11 DOI: 10.1177/17411343211065583

Abdul Fasi Mohammed

引用次数: 0

Adherence to a generic medicine policy: A developing country's experience 坚持仿制药政策:一个发展中国家的经验

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-08-03 DOI: 10.1177/17411343211030672

Samuel Nkansah, F. C. Bearden, Faustina Frempong-Ainguah, F. Nkansah

{"title":"Adherence to a generic medicine policy: A developing country's experience","authors":"Samuel Nkansah, F. C. Bearden, Faustina Frempong-Ainguah, F. Nkansah","doi":"10.1177/17411343211030672","DOIUrl":"https://doi.org/10.1177/17411343211030672","url":null,"abstract":"Escalating pharmaceutical expenditure is a global phenomenon, and Ghana has not been spared. To attend to the increasing cost of healthcare resulting from the high cost of drugs, the government of Ghana took a strategic decision to reduce its expenditure on healthcare without compromising the quality of care. The government directed that all medicines be prescribed by their generic names only at all health facilities. The purpose of this study is to assess the extent to which physicians adhere to the policy by assessing physicians' generic medicine prescribing patterns across the healthcare system in selected facilities in the Greater Accra Region. Questionnaires were administered to 87 physicians in 13 selected health facilities in Ghana. The results were analyzed using SPSS. The study's findings revealed that 74.7% of physicians adhere to the policy, and there is a likely relationship between knowledge of the policy and its implementation. Also, there is no significant relationship between health facility, physician's experience, disease diagnosis stage, and the prescribing of generic medicines. There is a need for regular review of the policy with aggressive and wellstructured in-service training on the subject and the introduction of pharmacists' substitution rights.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"8 1","pages":"99 - 109"},"PeriodicalIF":0.0,"publicationDate":"2021-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90211912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Brand drug companies impeding generic drug company access to product samples: Estimated prevalence and impact on drug costs 品牌药公司阻碍仿制药公司获取产品样品:估计流行程度及其对药品成本的影响

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-07-26 DOI: 10.1177/17411343211035168

P. Grootendorst

{"title":"Brand drug companies impeding generic drug company access to product samples: Estimated prevalence and impact on drug costs","authors":"P. Grootendorst","doi":"10.1177/17411343211035168","DOIUrl":"https://doi.org/10.1177/17411343211035168","url":null,"abstract":"Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"20 1","pages":"10 - 20"},"PeriodicalIF":0.0,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87425141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

A review and analysis of product recall for pharmaceutical drug product 药品召回事件的回顾与分析

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-07-22 DOI: 10.1177/17411343211033887

Ashish Miglani, Chandan Saini, P. Musyuni, G. Aggarwal

引用次数: 3

Comparison of generic drug registration strategies between health Canada and Gulf Cooperation Council 加拿大卫生部与海湾合作委员会仿制药注册战略的比较

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-07-04 DOI: 10.1177/17411343211029995

N. Charyulu, Anoop Narayanan, A. Shetty

{"title":"Comparison of generic drug registration strategies between health Canada and Gulf Cooperation Council","authors":"N. Charyulu, Anoop Narayanan, A. Shetty","doi":"10.1177/17411343211029995","DOIUrl":"https://doi.org/10.1177/17411343211029995","url":null,"abstract":"Recently, generic drug products have played an increasingly important role in the health care system globally, especially in the developing world, as they provide for an effective and more affordable alternative for healthcare professional. Generic drug products are proven therapeutically equivalent to the corresponding innovator’s product, and hence can be substituted in clinical practice. The Gulf Cooperation Council’s pharmaceutical market is known to be semi-regulated market when compared with Health Canada and the United States of America drug regulatory market. Product regulation in Gulf Cooperation Council and Health Canada are challenging task in comparison to EU and USA. This study aimed to understand the generic drug registration comparison of Health Canada and Gulf Cooperation Council’s. The aim of this study was achieved by review of the Health Canada and Gulf Cooperation council guidelines and publications. Health Canada and Gulf Cooperation council follows Common Technical Document format and also emphasizes on safety, quality and efficacy of the drug. In summary Gulf Cooperation council and Health Canada offers lucrative market for Indian pharmaceutical manufacturer and the process of registration has been simplified by centralized procedure.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"77 1","pages":"82 - 87"},"PeriodicalIF":0.0,"publicationDate":"2021-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79053279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The anatomy of CUSMA’s patent: Does it still reflect an equipoise? CUSMA专利的剖析:它是否仍然反映了一种平衡?

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-06-23 DOI: 10.1177/17411343211008589

Z. Boru

{"title":"The anatomy of CUSMA’s patent: Does it still reflect an equipoise?","authors":"Z. Boru","doi":"10.1177/17411343211008589","DOIUrl":"https://doi.org/10.1177/17411343211008589","url":null,"abstract":"The Protocol of Amendment to the Agreement between the United States of America, Canada and the United Mexican States erased many of the TRIPS-plus provisions inserted earlier into the Canada- United States of America-Mexico Agreement (hereafter, CUSMA) signed on 30 November 2018. While the erasure of the provisions shows the contributions made to promote access to medicines, the Agreement still retains TRIPS-plus provisions, including the provisions on patent term extensions. Thus seen, irrespective of the changes introduced by the Protocol of Amendment, patent term extensions may have a negative implication on access to cost-cutting medicines (biosimilars and generics). Against this backdrop, this paper focuses on patent term extensions, as contained in the CUSMA’s Intellectual Property Rights (IPRs) chapter. The paper investigates if & how the patent term extension has the potential to impede access to affordable medicines (biologics and chemically synthesized medicines). In so doing, the paper provides possible responses to the question, do the provisions on patent term extensions hinder the timely access to affordable medicines? As such, the first part of the paper succinctly looks at CUSMA. Section “Patent protection under the TRIPS agreement” examines the TRIPS patent regime. While “The CUSMA’s rules on patent term extension” section discusses the nature of obligations included in the CUSMA’s IPRs chapter, the Section “The CUSMA’s rules on patent term extension vis-à-vis access to medicines” analyzes the potential implications of patent term extensions on access to affordable medicines. The final section concludes the paper.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"16 1","pages":"21 - 31"},"PeriodicalIF":0.0,"publicationDate":"2021-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89885770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA 美国食品药品监督管理局(USFDA)向药品制造商发出的483表格和警告信的审查

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-06-12 DOI: 10.1177/17411343211023539

Chandan Saini, Ashish Miglani, P. Musyuni, G. Aggarwal

{"title":"Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA","authors":"Chandan Saini, Ashish Miglani, P. Musyuni, G. Aggarwal","doi":"10.1177/17411343211023539","DOIUrl":"https://doi.org/10.1177/17411343211023539","url":null,"abstract":"Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"2012 1","pages":"32 - 41"},"PeriodicalIF":0.0,"publicationDate":"2021-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72747760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

GlaxoSmithKline v. Teva: Federal circuit broadens induced infringement to preclude marketing generics for off-patent indications 葛兰素史克诉梯瓦:联邦巡回法院扩大诱导侵权以排除非专利适应症的仿制药销售

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-06-01 DOI: 10.1177/1741134321999698

Paul A. Braier

引用次数: 0

Idenix v. Gilead: The enablement and written description limits of a genus claim Idenix诉Gilead:属权利要求的使能关系和书面描述限制

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-06-01 DOI: 10.1177/17411343211013572

Keith A Zullow, Ci-Wen Chang, S. Anderson

引用次数: 0

Journal of Generic Medicine – Editorial June 2021 仿制药杂志-社论2021年6月

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-06-01 DOI: 10.1177/17411343211020525

B. Tempest

引用次数: 0