The single market for pharmaceuticals in the European Union in light of European Court of Justice rulings

This article analyses the likely implications for the European pharmaceutical market of 2 European Court rulings (Kohll and Decker) and addresses whether these will contribute to the completion of the single European market. In doing so, the Kohll and Decker cases are discussed and the likely implications of these cases for key stakeholders (patients, providers, payers and the industry) are investigated. Of the 2 cases, the latter has direct application to pharmaceuticals as tradable goods. The article argues that the short term implications for the stakeholders, relating to the freedom of providing goods, may lead to a re-thinking of how pharmaceutical products are financed and provided in European Union (EU) countries in the long term. A key corollary of the Decker case is that it leads to greater transparency and awareness of pharmaceutical price differentials across the member states. As part of this transparency, consumers may benefit directly by gaining access to a product that may not be available in their country of residence, or may be available but at a higher cost. Consumers may also benefit indirectly through greater transparency and efficiency in the long term. Providers may wish to increase their procurement from cheaper sources of the same product and much will depend on their future procurement strategies. Manufacturers will in this case face an increase in parallel trade streams and may respond by not marketing or producing in 'low-price' countries. The rulings add a further supranational dimension to a national policy issue and may have far reaching implications for the EU pharmaceutical market and industry.     

Deterrence of Drunk Driving in Massachusetts: Criminal Justice System Impacts

This paper examines the extent to which a “toughened” drunk driving law in Massachusetts has deterred drunk driving and the law's impact on criminal justice system operations. Included are analyses of pre- to postlaw trends in: alcohol-related highway fatalities and arrests, drunk driving arraignments and convictions, and jail sentences served by drunk driving offenders. Many of the positive trends found since the implementation of the law (increased arrests, reduced fatalities, and increased conviction rates) actually began before the law took effect. Moreover, the law has exacerbated existing problems in the criminal justice system such as overcrowded jails.     

欧盟新法规下的药物警戒制度简介

通过对于欧盟药物警戒法规修订情况的介绍,进一步了解欧盟药物警戒制度框架的组成,并且清晰了欧盟药物警戒系统和质量体系、药物警戒系统主文件、药物警戒检查、风险管理系统等制度形式的具体内容,为完善和发展我国药品不良反应报告和监测体系提供借鉴和参考。     

Differences in vaccinations in European Union

The European Union (EU) currently has 27 Member States, each with its own history, characteristics and habits. The National Health Services of most of these countries have different vaccination systems, different vaccine recommendations and different schedules of vaccine administration, which means that immunization is not considered in the same way and, at least for some antigens, vaccination coverage does not always meet changing medical needs. Together with a lack of political will concerning prevention in childhood, a poor understanding or false perceptions on the part of the general public (and even healthcare workers), and the inadequacies and heterogeneity of the vaccination systems can all be considered barriers to vaccinations in Europe. The most important limitations are those relating to the evaluation of vaccination coverage, the lack of active reminder systems to pick up patients who miss appointments, and the monitoring of adverse events. A common programme designed to overcome these limitations could be beneficial in promoting vaccinations everywhere, above all because active measures by the Health Authorities to demonstrate the importance they attribute to vaccination could convince still uncertain parents to have their children vaccinated.     

Parallel imports of pharmaceuticals in the European Union

Parallel importing has existed on a small scale in Europe for many years and has been upheld by the European Court of Justice as consistent with standard principles of free trade. However, the potential impact of parallel trade has increased significantly with the launch of the European Medicines Evaluation Agency in 1995, the accession to the European Union (EU) of countries with traditionally low prices, such as Spain, and the possible accession of Eastern European countries. This article examines the current state of parallel trade in medicines in the EU (different modalities and the medicines affected), analyses some policy implications associated with parallel trade (who gains and who loses) and explores the effects of several policy scenarios affecting parallel trade. The main conclusion is that a single European price is probably not the best solution from a European welfare point of view. A solution to the present situation could be achieved by separating the market price (at which any agent is allowed to buy a product either for consumption or for resale) and the price actually paid by a final consumer. Discounts and reference pricing may present two of the most feasible options.     

Three years of paediatric regulation in the European Union

Purpose  

To investigate whether the Paediatric Regulation has already succeeded in addressing the needs of the paediatric population both quantitatively with respect to paediatric development plans and trials, and qualitatively with respect to the content of the plans. The Paediatric Regulation No 1901/2006 entered into force in Europe on 26 January 2007, with the aim to improve the development of medicinal products, to address the lack of age-appropriate formulations and to provide information on efficacy, safety and dosing for the paediatric population. The Regulation requires applications for marketing authorisations to be accompanied by either a product-specific waiver or a paediatric investigation plan, to be agreed by the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).     

The regulatory framework of biosimilars in the European Union

In the European Union (EU), the regulatory policy for biosimilars has enabled different biosimilar products to be marketed through an abridged application, which allows the applicant to submit a reduced dossier. Nevertheless, some manufacturers of biological products that share some characteristics with copies have opted for a full application; therefore, the number and extent of clinical studies required in these cases is increased. Here, we focus on a comparison of recombinant human erythropoietin medicinal products. We analyse and discuss clinical studies submitted to the European Medicines Agency that relate to available biosimilars and biological medicinal products that are authorised with a full dossier. We also discuss the issues of interchangeability and substitution, given that the EU allows each Member State to set their own substitution policies.     

Bioequivalence Requirements in the European Union: Critical Discussion

The aim of the present paper is to summarize the revised European Union (EU) Guideline on the Investigation of Bioequivalence and to discuss critically with respect to previous European requirements and present US Food and Drug Administration guidelines its more relevant novelties such as the following: in order to facilitate the development of generic medicinal products, the EU guideline includes the eligibility for Biopharmaceutics Classification System (BCS)-based biowaivers not only for BCS class I drugs but also for class III drugs with tighter requirements for dissolution and excipient composition. The permeability criterion of BCS classification has been substituted with human absorbability, as per the Biopharmaceutical Drug Disposition Classification System. The widening of the acceptance range for C _max is possible only for highly variable reference products with an additional clinical justification. This scaled widening is carried out with a proportionality constant of 0.760 which is more conservative than the FDA approach and maintains the consumer risk at a 5% level when the intra-subject CV is close to 30%, due to the smooth transition between the scaled and the constant criteria. The guideline allows for the possibility of two-stage designs to obtain the necessary information on formulation differences and variability from interim analyses as a part of the pivotal bioequivalence study, instead of undertaking pilot studies. The guideline also specifies that the statistical analyses should be performed considering all factors as fixed, which has implications in the case of replicate designs.     

Predictors of orphan drug approval in the European Union

Objective To encourage the development of drugs for rare diseases, orphan drug legislation has been introduced in the USA (1983) and in the EU (2000). Recent literature discusses factors that may influence the development of new orphan medicinal products in the EU. This study aims to identify predictors for successful marketing authorisation of potential orphan drugs in the EU. Methods A comparison between randomly selected authorised and a matched sample of not-yet-authorised orphan drug designations has been performed. Determinants in the study included characteristics of the indication, of the product and of the sponsor. Data were collected from the public domain only. Results Orphan drug approval was strongly associated with previous experience of the sponsor in obtaining approval for another orphan drug (OR = 17.3, 95% CI = 5.6–53.1). Furthermore, existing synthetic entities compared to biotechnology products tended to have a higher likelihood of reaching approval status (OR = 3.9, 95% CI = 0.9–16.6). Conclusion This study showed that experience of a company in developing orphan drugs is an important predictor for subsequent authorisation of other orphan drugs. The same applies for existing (synthetic) molecules, for which much knowledge is available. Further research should be directed towards studying the quality of the clinical development program of those designated orphan medicinal products not reaching approval status.     

欧盟药物警戒检查制度简介

文章旨在了解欧盟药物警戒检查制度的背景与实施,为我国开展检查工作提供借鉴和参考。根据欧盟法规,欧洲药品管理局建立了一套包括检查程序、检查内容在内的完整体系。建立检查制度对于监督和促进生产企业开展药品不良反应报告和监测工作具有重要作用,我国《药品不良反应报告和监测管理办法》已为此奠定了实施基础,但尚缺乏具体实施的程序与规范,值得今后深入研究和实践。     

欧盟有关生物技术通用名药法规进展

随着第一代生物技术药物接近专利保护期满,欧盟发布了一系列针对生物技术通用名药的法规,针对该类药物的复杂性,力争将应该进行的试验减至最少.现综述欧盟有关生物技术通用名药的法规,包括欧盟人用药品2001/83/EC和2004/27/EC法令、生物技术蛋白质为活性成分的药品等效性指导方针、生物技术药物/生物制品制造过程中的变化的指导方针说明.     

欧盟药物审评程序及要求

药品作为一种特殊商品，直接影响人们的身体健康及生命安全，所以各个国家对其都有专门的管理制度和管理体系，以确保其安全、有效。本文详细介绍欧盟的药物审评机构及立法体系，着重说明审评的程序和要求。     

Food packaging regulation in the United States and the European Union

The regulation of food packaging has, indeed, become a global subject as the world's commercial channels have broadened since World War II. The first comprehensive regulatory statute governing the area was the Food Additives Amendment of 1958 in the United States, a modification of the 1938 Federal Food, Drug, and Cosmetic Act. Germany, Italy, The Netherlands, and Belgium began regulatory activity in the early 1960s and the European Community set in motion its own work in this direction beginning in 1976. Companies in the United States and the Europe have been struggling with each of the laws since then. The regulatory systems employed on the two continents are superficially similar but this is far from the truth in actual practice. Each has its own special history and set of exemptions; they vary tremendously. Each has its cadre of supporters as well but a considerable lack of understanding afflicts regulators and the regulated on both sides of the Atlantic. This three part report first discusses the history of the United States system and its characteristics; Book II covers the history of European Union regulations and their salient features; and Book III highlights the commonalities and differences in the systems, discusses their scientific basing points, and makes some recommendations as to how they can be brought closer together in the interests of harmonization and the removal of unnecessary trade barriers.     

Enhancing the role of science in the decision-making of the European Union

Used well, science provides effective ways of identifying potential risks, protecting citizens, and using resources wisely. It enables government decisions to be based on evidence and provides a foundation for a rule-based framework that supports global trade. To ensure that the best available science becomes a key input in the decisions made by EU institutions, this abridged version of a working paper produced for the European Policy Centre, a leading, independent think tank, considers how science is currently used in the policy and decision-making processes of the EU, what the limitations of scientific evidence are, and how a risk assessment process based on scientific 'good practices' can be advantageous. Finally, the paper makes recommendations on how to improve the use of science by EU institutions.     

Pharmaceutical biotechnology products approved within the European Union.

The manufacture of therapeutic proteins represented the first true industrial application of recombinant DNA technology. Thus far some 88 recombinant proteins/monoclonal antibody-based products have gained marketing approval within the European Union (EU). This represents 36% of all new drug approvals since the introduction of the new centralized European drug approval system in 1995. More recently, an increasing proportion of approved proteins are engineered, tailored to display altered pharmacokinetic profiles or reduced immunogenicity in man. Currently no nucleic acid-based products are approved in the EU. Technical innovations/milestones likely characterizing the biopharmaceutical industry within the next decade include approval of some products produced in transgenic systems, approval of some products administered by non-parenteral means, approval of at least some nucleic acid-based products and the identification of novel biopharmaceuticals/biopharmaceutical targets through discoveries in functional genomics and proteomics.     

The Criminal Justice Experience of African American Cocaine Users in Arkansas

Background: African Americans are incarcerated at rates much higher than other racial and ethnic groups in the United States. Objectives: We sought to qualitatively explore the relationships between ongoing involvement in the criminal justice system and continued drug use in a population of urban and rural African American cocaine users in a southern state. Methods: Semi-structured qualitative interviews were conducted among African American cocaine users in Arkansas between 2010 and 2012. Participants resided in both rural (two counties located in the eastern Arkansas Mississippi delta region) and urban (the county including the capital city of Little Rock) areas. Results: Numerous important themes emerged from participants’ narratives, including chronic involvement with the criminal justice system (being a “career criminal”), continued access to drugs while incarcerated, relapse, and reincarceration and lack of access to effective drug treatment. Conclusion/Importance: The themes which emerged from our data speak to the collective experience that many substance using populations in the United States face in dealing with the criminal justice system. Our findings highlight the need to better, more holistic ways of engaging African American substance users in community based substance use treatment and supportive services.     

欧盟、美国和日本的药物警戒信号管理体系比较研究

目的:比较欧盟、美国和日本的药物警戒信号管理体系,为建立和完善我国药物警戒信号管理体系提供参考.方法:采用文献研究分析法,系统对比欧盟、美国和日本的相关监管机构在药物警戒信号定义、来源、检测方法和管理流程等方面的异同,并对我国药物警戒管理工作提出建议.结果与结论:欧盟、美国和日本的监管机构对于信号的定义并不统一,欧盟药...