Pharmaceuticals, policy and law最新文献_第5页

The prevention and detection of corruption in pharmaceutical companies 预防及侦测制药公司的贪污

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-170451

Dominic Peltier-Rivest

引用次数: 8

HTAs and access to rare diseases therapies: How can clinicians assist in the healthcare assessment of treatments for patients with primary immune deficiencies? hta与罕见病治疗的可及性:临床医生如何协助对原发性免疫缺陷患者的治疗进行保健评估?

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2011-0325

H. Chapel

{"title":"HTAs and access to rare diseases therapies: How can clinicians assist in the healthcare assessment of treatments for patients with primary immune deficiencies?","authors":"H. Chapel","doi":"10.3233/PPL-2011-0325","DOIUrl":"https://doi.org/10.3233/PPL-2011-0325","url":null,"abstract":"1. Background Health Technology Assessments (HTA) in terms of therapies depend on established treatments for defined conditionswith provenoutcomes; the various treatment regimes can be compared with each other or with outcomes in the absence of treatment, in various healthcare settings. For example in the UK, the National Institute for Health Research – NIHR states that “The HTA programmeproducesindependent research about the effectiveness of different healthcare treatments ...for those who use, manage and provide care in the NHS”. Given limited financial resources, it is appropriate that HTA agencies are increasingly involved in assessment of the cost effectiveness of well -established therapies, includingthose for rare diseases. Ultimately HTAs are mechanismsthat help funders and governments to control healthcare budget expenditure. An excellent example is therecentdecisionoftheIrishAuthority’sHealthTechnologyAssessmentDirectorate “not to introduce a new technology to screen donated blood for Creutzfeldt-Jakob disease because it would not be cost effective to do so”. Such tools are widely used, though for rare diseases the background is often poorly understood. However their popularity is exemplified in the Journal Citation Reports for 2009, which shows that \"Health Technology Assessment\", the journal of the HTA programme, has seen a significant rise in its impact factor rising from 5.01 last year, to 6.91. In the current world-wide economic climate, clinicians, patients, healthcare providers and those with the budgets need to understand the economic strategy of HTAs. This is particularly true for those involved with rare diseases, such as primary immune deficiencies (PIDs), and applies in countries with good access to PID centres of excellence that may be at risk, as well as in those in which therapies are restricted for financial reasons. The role of HTAs in assessing the efficacy and cost effectiveness treatments for patientswithPIDsisdifficultforavarietyofreasons: difficultiesinsettingupclinical","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"48 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116752213","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

Understanding the pharmaceutical value chain 了解制药价值链

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-160432

Murray L. Aitken

引用次数: 26

Pharmacologic-technical progress and the economics of growth 药理学——技术进步与经济增长

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-130365

Christoph Heible

{"title":"Pharmacologic-technical progress and the economics of growth","authors":"Christoph Heible","doi":"10.3233/PPL-130365","DOIUrl":"https://doi.org/10.3233/PPL-130365","url":null,"abstract":"Over the past 200 years, the real GDP in western industrialized countries rose continuously. The decisive factor of long-term economic growth is technical progress. Beside its macroeconomic importance it is the key vehicle of competition between research-based pharmaceutical companies. Further innovative drugs are an integral part of national health care systems in most industrialized countries. Innovative medicines contribute to the increase in life expectancy and an improved quality of life. To evaluate the share of pharmacologic-technical progress in the increase in life expectancy at the microand macroeconomic level it is initially helpful to clarify the economic relevance of technical progress in general. This will be the purpose of chapter two. Furthermore, the discussion encompasses the different approaches to define pharmacological innovations and the associated difficulties to discriminate between the different types of innovation. The focus of chapter three is the description of incentive mechanisms, which are fundamental to the Research and Development (R&D) activities leading to innovative pharmaceuticals. Beyond that, the microand macroeconomic positive effects of pharmaceutical innovations will be represented and interpreted with the help of existing results stemming from selected empirical studies. The last chapter gives a detailed overview on the current empirical results, which illustrate the versatile interdependencies on macroeconomic level between health and growth. It demonstrates the channels through which better health can have growth-enhancing effects.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125625425","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: 2

The European Innovative Medicines Initiative 欧洲创新药物倡议

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0259

G. Ruberti

引用次数: 0

The new Spanish regulation of the medicinal industry 西班牙对医药行业的新规定

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0302

J. Gillard, C. Escudero

{"title":"The new Spanish regulation of the medicinal industry","authors":"J. Gillard, C. Escudero","doi":"10.3233/PPL-2010-0302","DOIUrl":"https://doi.org/10.3233/PPL-2010-0302","url":null,"abstract":"The Spanish legislator has finally decided to approve Royal Decree 824/2010 concerning pharmaceutical laboratories, manufacturers of pharmaceutical active ingredients and foreign trade in medicines. We say ‘finally’ because this is an area of regulation that is obviously primordial in the pharmaceutical sector and which, nevertheless, has been waiting for regulatory development to give operators minimal security and to clarify numerous underlying conflicts. Therefore, since the approval of Act 29/2006 of July 26th on Guarantees and the Rational Use of Medicine and Health Products – LGURM, in Spanish –, the current framework law in Spain, four long years have passed in which many of the mandates set out in article 63 and following were in need of greater specification. Some questions were even in direct conflict with Royal Decree 1564/1992 of December 18th, regulating the authorisation system of Pharmaceutical Laboratories and Medicine Importers and the guarantee of quality in their industrial manufacture, which was developed by the previous Law of Medicines of 1990, and which remained in force in the absence of legal replacement. To give but one example, in this time there have been numerous headers of the former authorisations such as “Commercialising laboratory”, whose administrative recognition was revoked without their being legalised with any alternative formula, leaving them in an unacceptable legal limbo. With such lacunae, it was difficult to encourage domestic, and above all foreign, operators to invest in Spain without a sufficiently predictable entrepreneurial ecosystem.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"72 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122626622","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

Specific requirements for somatic cell therapy medicinal products and tissue engineered products 体细胞治疗药品和组织工程产品的特殊要求

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-140413

R. H. Martín, Eduardo L. Mariño Hernández, J. L. Pedraz Muñoz, Antonio M. Rabasco Álvarez

{"title":"Specific requirements for somatic cell therapy medicinal products and tissue engineered products","authors":"R. H. Martín, Eduardo L. Mariño Hernández, J. L. Pedraz Muñoz, Antonio M. Rabasco Álvarez","doi":"10.3233/PPL-140413","DOIUrl":"https://doi.org/10.3233/PPL-140413","url":null,"abstract":"Advanced-therapymedicinal products (ATMPs) are medicines for human use that are based on genes (gene therapy), cells (somatic-cell therapy) or tissues (tissue engineering) and include autologous, allogeneic, or xenogenic origin products. They are new therapeutic strategies and their development will contribute to providing opportunities for some diseases that so far lack effective treatments. The main objective of the pharmaceutical industry is to introduce on the market effective medications that increase hope and quality of life of the population, not to mention the safety criteria. To do this, it is important to know well the existing advanced therapies regulation allowing you to more easily perform the translation of basic research carried out in research laboratories and that decision making is quality. Definitions from a point of view regulatory of these medications are in the Regulation (EC) N◦ 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy (Chapter 1, article 2) drugs and the Directive 2001/83/CE of the European Parliament and of the Council of 6 November 2001 by establishing a community relating to medicinal products for human use code (annex I part IV, according to its last modification).","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121233678","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

What is the evidence produced so far by the application of HTA to haemophilia care 到目前为止，HTA在血友病治疗中的应用有哪些证据

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2011-0326

K. Berger, D. Schopohl, W. Schramm

引用次数: 1

Latin American pharmaceutical overview 拉丁美洲制药概述

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-140384

J. Valverde

{"title":"Latin American pharmaceutical overview","authors":"J. Valverde","doi":"10.3233/PPL-140384","DOIUrl":"https://doi.org/10.3233/PPL-140384","url":null,"abstract":"Latin America is a diverse, multi-coloured and dynamic region; boast the highest life expectancy among developing regions. In Latin America persistent social exclusion and inequities in wealth distribution and in access and use of services are reflected in health outcomes. With its population reaching 600 million people in 2011, Latin American pharmaceutical sales were at $62.9 billion. LA’s pharmaceutical market represents approximately 25% of global pharmaceutical sales. As a developing market, Latin America is quite complicated and diverse in terms of regulatory, reimbursement, market, demographic, and political characteristics. The harmonization of pharmaceutical regulation has been initiated in conjunction with the creation of regional free trade zones. Five main free trade zones are developing: North American Free Trade Agreement (NAFTA); MERCOSUR; Central America; Andean Area; and The Caribbean Community. Regulatory frameworks overall have improved as a result of free trade and intellectual property agreements. Regulatory enforcement bodies, quality investigators, proactive Good Clinical Practice (GCP) and policy development, have been cited as contributing to Latin America’s explosive growth. Latin American countries are currently moving policies to support productive development and innovation. The local biotechnology industry is developing rapidly.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"54 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132618379","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: 5

Health Technology Assessment and patients' rights: Assess versus access? 卫生技术评估与患者权利:评估与获取?

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2011-0335

F. Houÿez, Y. Cam, F. Bignami, F. Macchia, F. Faurisson

{"title":"Health Technology Assessment and patients' rights: Assess versus access?","authors":"F. Houÿez, Y. Cam, F. Bignami, F. Macchia, F. Faurisson","doi":"10.3233/PPL-2011-0335","DOIUrl":"https://doi.org/10.3233/PPL-2011-0335","url":null,"abstract":"Patients’ organisations call for an assessment of the clinical added value of orphan drugs at the time of the marketing authorisation evaluation. The European Commission has commissioned Ernst & Young to explore the feasibility of a new Committee at the European Medicines Agency1. A new drug candidate faces a number of hurdles on its journey to reach the patient. Regulators are the first, and right after are the Health Technology Agencies and payers. Things can turn sour, from a political point of view, when that second scenario happens, when the regulators say “yes this drug is safe and effective” and the payers say “Oh well but we won’t reimburse it”. Regulators and health technology assessment experts have recently started to harmonise their respective methodologies to avoid some degree of redundancy and contradictions in their respective opinions. Patients are participating in the decision making at the European Medicines Agency, and work closely with some national regulatory agencies. More systematic involvement with health technology assessment agencies is only beginning. This paper illustrates some of the issues patients are discussing with health technology assessment bodies.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"71 10","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131874729","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