House of Lords

Session 2005-06 Publications on the internet European Union Committee Publications

European Union - Twentieth Report Here you can browse the report together with the Proceedings of the Committee. The published report was ordered by the House of Lords to be printed 17 January 2006. CONTENTS Terms of Reference REPORT ABSTRACT CHAPTER 1: INTRODUCTION Why are we carrying out this Inquiry? Background CHAPTER 2: THE COMMISSION PROPOSAL Approvals Procedure Authorisation Procedures: Rewards and Incentives Product Identification Review Procedures Legal Base Justification for the Proposal Consultation by the Commission Impact Assessment CHAPTER 3: THE NEED FOR THE REGULATION CHAPTER 4: ETHICAL CONSIDERATIONS The Clinical Trials Directive Consent Ages of Children Other Aspects of the Guidelines CHAPTER 5: INFORMATION Access to the Database Product Information CHAPTER 6: MECHANISM FOR IMPLEMENTING THE REGULATION European Medicines Agency (EMEA) Paediatric Committee Research CHAPTER 7: REWARDS AND INCENTIVES Assessing Benefits and Costs Off-Label Prescribing Cost/Benefit Assumptions Benefits for Industry Costs EMEA Innovative Pharmaceutical Industry Generics Sector Costs to the National Drugs Bill/NHS CHAPTER 8: LEGAL BASE CHAPTER 9: PARLIAMENTARY SCRUTINY CHAPTER 10: CONCLUSIONS AND RECOMMENDATIONS Chapter 3 - The Need for the Regulation Chapter 4 - Ethical Considerations Chapter 5 - Information Chapter 6 - Mechanism for Implementing the Regulation Chapter 7 - Rewards and Incentives Chapter 8 - Legal Base APPENDIX 1: Sub-Committee G (Social and Consumer Affairs) APPENDIX 2: List of Witnesses APPENDIX 3: Guidelines for the ethical conduct of medical research involving children APPENDIX 4: Recent Reports MINUTES OF EVIDENCE Thursday 27 October 2005 Thursday 10 November 2005 WRITTEN EVIDENCE Oral Evidence Professor Sir Cyril Chantler Written Evidence Oral Evidence, 27 October 2005    Department of Health Written Evidence Oral Evidence, 10 November 2005 Supplementary Written Evidence    Written Evidence Association of the British Pharmaceutical Industry British Medical Association European Federation of Pharmaceutical Industries and Associations Royal College of Nursing Royal College of Paediatrics and Child Health Royal College of Physicians of Edinburgh Royal Pharmaceutical Society of Great Britain    Correspondence between the Chairman of the European Union Select Committee and the Department of Health    NOTE: References in the text of the report are as follows: (Q) refers to a question in oral evidence (p) refers to a page of written evidence

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