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  Bio-Science Law Review   (United Kingdom)
  Volume 8, Issue 4, 2005/2006
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  • EDITORIAL
  • THE GOWERS' REVIEW: IMPLICATIONS FOR THE BIOSCIENCE INDUSTRY
        NIGEL JONES
        p.143                                                                                      +cite        

  • ARTICLES
  • LEVELLING THE GENETIC FIELD? OECD GUIDELINES FOR THE LICENSING OF GENETIC INVENTIONS
        JONATHAN BALL AND ANDREW SKUDDER
        p.147                                                                                      +cite        
        After extensive negotiation, the Organisation for Economic Co-operation and Development (OECD) has published guidelines for the licensing of genetic inventions used in human healthcare. This article explores the way in which these guidelines aim to achieve a balance between the dissemination of vital knowledge on the one hand, and the intellectual property rights of inventors (and those that fund them) on the other. The authors highlight the main provisions of the guidelines and discuss some of the legal and commercial implications for players in this field.
  • RISK MANAGEMENT AND TRANSPARENCY IN PRE-CLINICAL RESEARCH AND EARLY CLINICAL TRIALS: LESSONS LEARNT FROM TGN1412
        CARLA SCHOONDERBEEK
        p.151                                                                                      +cite        
        On 13 March 2006 a Phase I trial of new drug TGΝ1412 was suspended in London, after all six healthy volunteers who took the drug experienced a massive immune response to the treatment and were admitted to intensive care. TGN1412 is a new class of monoclonal antibody, new biological medicines that are becoming increasingly important in the treatment of autoimmune and immunodeficiency diseases. What happened seems to be in sharp contrast to the large increase in international guidelines and EU legislation over the past years in respect to clinical trials. The question is whether the legislative framework needs to be adapted to prevent near disasters like this. Historically, European marketing authorisation legislation was written with 'chemical' medicinal products in mind: products whose active substance can easily be characterised and where animal data can reasonably predict human results. Are the current regulations appropriate and sufficiently rigerous for the new wave of biological medicines? The outcome of the TGΝ1412 trial stresses the need to review the risk management and assessment principles following pre-clinical tests and the safety of first-time-in-man trials of novel compounds. A new requirement in the law to present and execute a structured risk management and risk assessment plan to improve the safety of the transition from animal studies to first-time-in-man studies as a condition for approval of Phase I trials should be considered. Equally important is a requirement for more transparency by the principal investigators and centres that conduct Phase I trials.
  • REGULATION OF THE USE OF GENETICALLY MODIFIED ORGANISMS IN THE EU
        GARETH MORGAN
        p.157                                                                                      +cite        
        The use of genetically modified organisms ("GMOs") is an area in which there has been much legislative activity in the past few years in the EU and, in particular, agricultural biotechnology is a hot topic. This article reviews the manner in which the approval of GM crops can be authorised for release into the environment via this regulatory system (known as a "Deliberate Release"). First, this is illustrative of the way in which the EU currently legislates for the release of GMOs into the environment in general and second, because GM crops represent the main form in which GMOs are released in the EU.

  • NEWS
  • AUSTRALIA - Cloning and Embryo Research - Proposed Amendment of Laws Concerning Therapeutic Cloning and Human Embryo Research - GERMANY - Patents - Patentability of Human Embryonic Stem Cells - THE NETHERLANDS - Patents - Conor Medsystems Inc. v Angiotech Pharmaceuticals - UNITED KINGDOM - News - Companies Targeted Via False Companies House Fillings News - The New DOH/ABPI Model Clinical Trial Agreement Patents - European Stent Wars Validity and Infringement
        p.163                                                                                      +cite    

  • BOOK REVIEW
  • A GUIDE TO UK AND EU PLANT VARIETY RIGHTS
        p.172                                                                                      +cite