Directive

About: Directive is a research topic. Over the lifetime, 5695 publications have been published within this topic receiving 56084 citations.

The European Biotech Directive: Past as Prologue

Abstract: The directive on the legal protection of biotechnological inventions (the ‘Biotech Directive’) represents the end of a decade-long dialogue on how best to encourage biotechnology innovation in Europe while addressing ethical concerns. The Biotech Directive represents an interesting compromise between Parliament, Commission, and Council based on divergent policy concerns, treaty limitations, and international trade rules. In this article, the authors explore the meaning and implication of the Biotech Directive by examining its contentious history, its provisions, and its jurisdictional foundations. Drawing on this base, the authors examine questions left unanswered by the Biotech Directive and analyse how the Biotech Directive fits in with existing international law.

Code of Ethics and Conduct for European Nursing

Abstract: A main identifying factor of professions is professionals' willingness to comply with ethical and professional standards, often defined in a code of ethics and conduct. In a period of intense nursing mobility, if the public are aware that health professionals have committed themselves to the drawing up of a code of ethics and conduct, they will have more trust in the health professional they choose, especially if this person comes from another European Member State. The Code of Ethics and Conduct for European Nursing is a programmatic document for the nursing profession constructed by the FEPI (European Federation of Nursing Regulators) according to Directive 2005/36/EC On recognition of professional qualifications , and Directive 2006/123/EC On services in the internal market, set out by the European Commission. This article describes the construction of the Code and gives an overview of some specific areas of importance. The main text of the Code is reproduced in Appendix 1.

Behind the European Works Councils Directive: The European Commission's Legislative Strategy

Abstract: The aim of the draft European works councils Directive is to bridge the gap between increasingly transnational corporate decision-making and employees' nationally-defined information and consultation rights. The proposal seeks to accommodate existing national systems of employee representation, but in the UK auxiliary measures would be needed to designate employee representatives in the absence of voluntary trade union recognition by employers. Although the Directive is strongly opposed by the UK government, the Maastricht social policy protocol has boosted its prospects of being adopted by the other 11 EC countries, with important repercussions for UK-based multinationals.

The new European directive on in vitro diagnostics.

Abstract: The Directive on in vitro Diagnostic Medical Devices (IVDD 98/79/EC) was officially adopted by the European Union (EU) on December 7, 1998. The IVDD aims to supplement the legal framework of the European Community, which governs the conditions for the placing on the market of medical devices, by extending the already implemented legislation to the category of in vitro diagnostic medical devices (IVDs). They consist of those devices, including reagents and reagent products, calibrator materials or instruments, as well as specimen receptacles, intended by the manufacturer for the in vitro analysis of specimens derived from the human body. This directive has introduced at the European level common regulatory requirements across Europe for the safety, quality and performance of in vitro diagnostics (IVDs), incorporating them into medical device legislation. It harmonizes the conformity assessment procedures to be applied by manufacturers before they place IVDs on the market. For certain products expressly specified in the directive, of which the most important are used for the evaluation of the safety of blood supply and patient testing, the manufacturer will have to take into account in their performance evaluation the so-called "Common Technical Specifications" (CTS). These are needed to establish the performance characteristics of the IVDs in evaluation and have the same status as harmonized standards. In the meantime, the IVD directive has been transposed into national law in all EU countries. During a transitional period ending in December 2003, manufacturers will have the option of following pre-existing national regulatory processes or taking their IVDs through the new procedures as specified in the directive. Following this, starting from 7th December 2003, adherence to the directive regulations will become mandatory, and only IVDs bearing the "Communautes Europeennes (CE) mark" can then be sold in the EU.