European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population

This document has been developed by the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the European Commission. The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood. This will contribute to the protection of all children who are the subject of clinical trials. As the approval of clinical trials, including ethical approval, is performed by the Member States, any recommendations on ethical aspects of clinical trials in children will also facilitate a harmonised approach to the application of the clinical trials directive across the EU, thereby facilitating the conduct of clinical trials in the EU and in whichever country the paediatric trial occurs. The protection against the risks of research in such a vulnerable population is paramount whilst this should not lead to denying them the benefits of research. Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent (in the legal sense) but their assent should be sought using age appropriate information. Ethics Committees need paediatric expertise to balance the benefits and risks of research in children. The lack of legal ability to consent has implications on the design, analysis and the choice of comparators used in trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The neonate represents the most vulnerable of all paediatric age groups and requires even more careful review. Finally, various other aspects relating to the performance of trials in children are discussed.     

The European Agency for the Evaluation of Medicines and European Regulation of Pharmaceuticals

Abstract: The new European Agency for the Evaluation of Medicinal Products is the focus of the EC's new regulatory framework for approval of pharmaceuticals for human and veterinary use. This article considers past efforts at European pharmaceutical regulation, discusses the new 'centralised' and 'decentralised' procedures, and offers a functional analysis of the new system. It addresses European regulation of biotechnology, including Parliament's 1995 rejection of the proposed biotechnology directive using its codecision powers. It also reviews European case law and suggests that the Court of Justice's decision in Keck provides a useful way to analyse pharmaceuticals' place in the free movement of goods. While the new framework will likely improve approval of pharmaceuticals and over time lead to greater centralisation of the process, Member States will still retain some autonomy over the actual use of approved drugs, particularly through their continued control of conditions of reimbursement in national health systems.     

Overview of clinical forensic services in various countries of the European Union

Examination of a person who has been a victim of a physical or sexual assault may be very important for upcoming legal proceedings.In the context of a clinical ...     

Data transfer to third countries: Transfers of personal data to third countries: the role of binding corporate rules

This article explores an EU Working Party report that examines the role of contractual solutions, such as binding corporate rules, on transfers of personal data to third countries.     

Commentary about the paper:"Overview of clinical forensic services in various countries of European Union"

The article about theOverview of clinical forensic services in various countries of European Union[1] is an important milestone in the field of clinical foren...     

Participation of children in clinical trials: UK, European and international legal perspectives on consent

The Declaration of Helsinki was, until recently, the leading international code on the conduct of clinical trials on human subjects. The Council of Europe's Convention on Human Rights and Biomedicine (1997) and the ICH guidelines for Good Clinical Practice (1996) represent a significant step towards increased harmonization of standards in the conduct of medical experiments on human subjects. But in spite of emerging areas of consensus, there remain important areas of unclarity and divergence. Medical practitioners involved in paediatric research in the UK are concerned about the lack of certainty in the law, particularly on the application of consent rules to emergency research. This paper examines UK, European and International norms on the participation of children in medical research and compares the circumstances under which consent rules may be waived under each normative regime.     

Legal prerequisites for clinical trials under the revised Declaration of Helsinki and the European Convention on Human Rights and Biomedicine.

Biomedical research is a perennially controversial subject. While the provisions of the Revised Declaration of Helsinki enjoy world-wide acceptance, they are increasingly placed in question--not least by the Council of Europe's Bioethics Convention, which allows non-therapeutic research in restricted cases on those incapable of giving informed consent. Taking as its starting-point the fundamental conflict between the general interest in research and the individual interests of the patients concerned, this article analyses the conditions under which medical experimentation on human beings is permissible. The article recognises the model of risk/benefit analysis and the doctrine of informed consent as equally valid core principles which do not conflict with restricted, non-therapeutic research, whether on patients who lack the capacity to consent or in placebo-controlled trials.     

Topics in macro-modelling of East European countries in the period of transition

Central and European former Centrally Planned Economies (CPEs) entered a period of transition towards market economies. The evolution is marked by a transition from shortage- to demand-determined economies, associated with the abandonment of price control and the introduction of tight wage control. Stabilization programmes (in Poland from 1990), implementing tough deflationary fiscal and monetary policies, brought about the suppression of hyperinflation. The high adjustment costs — deep recession, high rates of unemployment — are characteristics of the early '90s. The deregulation of the public sector and the building of the private one commenced, and will be a long-lasting process. To meet the changes in economic regimes and mechanisms, the existing models had to be adequately respecified and new models constructed. The large W-5 macromodel for Poland, which covers the final and intermediate demands, had to be extended to introduce the market adjustment mechanisms and, more broadly, the financial flows. To meet the needs of short-term financial policies, new quarterly models had to be built, as, for instance, the WK macromodel for the Polish economy. The paper discusses the major problems of the models' specification under the data constraints.     

欧盟国家地方税立法权问题初探

对一个主权国家而言,地方税立法权是一个既重要又复杂的问题。一个国家的地方税立法权制度不仅在很大程度上取决于其宪政体制,而且与该国的历史与传统也紧密相关。欧盟国家的地方税立法权体制因各国的国情不同而不尽一致,德国、英国、西班牙和法国所采行的模式颇具代表性,基本囊括了目前世界各国实行的主要几种模式。对欧盟这几个主要国家,特别是法国的地方税立法权进行考察,有利于对中国在构建本国的地方税立法权体制时将其作为参考借鉴的资讯。     

Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.