The Experts below are selected from a list of 3657 Experts worldwide ranked by ideXlab platform

John Abraham - One of the best experts on this subject based on the ideXlab platform.

  • from evidence to theory neo liberal corporate bias as a framework for understanding uk Pharmaceuticals Regulation response to alison edgley
    Social Theory and Health, 2007
    Co-Authors: John Abraham
    Abstract:

    This paper elaborates on Abraham's thesis of 'neo-liberal corporate bias' as an account and explanation of UK medicines Regulation. It is argued that Edgley is wrong to represent the thesis as explaining regulatory change solely by reference to the interests of the pharmaceutical industry. On the contrary, it is demonstrated that the theory incorporates the role of the interests of the state, particularly in connection with budgetary savings within the national health-care system. Following on from this, it is shown that, far from disproving the thesis, as Edgley contends, the case of statins switching in the UK is actually entirely predictable from the theory, although not necessarily because Edgley's account of statins switching is correct.

  • trading risks for markets the international harmonisation of Pharmaceuticals Regulation
    Health Risk & Society, 2001
    Co-Authors: John Abraham, Tim Reed
    Abstract:

    Drawing on interviews and documentary research, this paper explores the nature of international harmonisation of pharmaceutical Regulation. The relationships between international harmonisation, trade interests in market expansion and the regulatory state are examined. Particular attention is given to the implications of this harmonisation for drug safety, risk assessment and public health. It is argued that this process is lowering regulatory standards regarding drug safety and is making the regulatory state more vulnerable to capture by industrial interests. This is accentuated by the misrepresentation of societal and political judgements as technical calculations and a concomitant lack of public accountability.

Tim Reed - One of the best experts on this subject based on the ideXlab platform.

  • trading risks for markets the international harmonisation of Pharmaceuticals Regulation
    Health Risk & Society, 2001
    Co-Authors: John Abraham, Tim Reed
    Abstract:

    Drawing on interviews and documentary research, this paper explores the nature of international harmonisation of pharmaceutical Regulation. The relationships between international harmonisation, trade interests in market expansion and the regulatory state are examined. Particular attention is given to the implications of this harmonisation for drug safety, risk assessment and public health. It is argued that this process is lowering regulatory standards regarding drug safety and is making the regulatory state more vulnerable to capture by industrial interests. This is accentuated by the misrepresentation of societal and political judgements as technical calculations and a concomitant lack of public accountability.

Barbel R Dorbeckjung - One of the best experts on this subject based on the ideXlab platform.

  • challenges to the legitimacy of international Regulation the case of Pharmaceuticals standardisation
    Multilevel regulation and the EU. The interplay between global European and national normative processes, 2008
    Co-Authors: Barbel R Dorbeckjung
    Abstract:

    In Pharmaceuticals Regulation the standardisation activities of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceutical for Human use (ICH) is an interesting example of multilevel Regulation. This chapter describes the regulatory activities of the ICH and deals with the evaluation of these activities in light of the requirements of legitimacy. In legal and social theory the notion of legitimacy connotes the acceptability and acceptance of collective action. Ideas about the acceptability of human action cover the normative aspects of legitimacy, while the conception of acceptance refers to empirical aspects. The necessity for international regulatory guidance with regard to Pharmaceuticals was recognised in the 1980s, with the successful single market created by the European Community at that time setting an example of what could be achieved. Keywords:ICH; international regulatory; multilevel Regulation; pharmaceutical industry

James Raftery - One of the best experts on this subject based on the ideXlab platform.

  • Paying for costly Pharmaceuticals: Regulation of new drugs in Australia, England and New Zealand.
    The Medical Journal of Australia, 2008
    Co-Authors: James Raftery
    Abstract:

    The United Kingdom, Australia and New Zealand use different criteria for public funding of Pharmaceuticals, but all include estimates of clinical effectiveness and cost-effectiveness. Drug appraisal is done through the National Institute for Health and Clinical Excellence (NICE) in the UK, the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the Pharmaceutical Management Agency (PHARMAC) in NZ. Of the 10 drugs deemed least cost-effective by NICE between 1996 and 2005, all were approved for funding in the UK, six were approved in Australia and five were approved in NZ. Australia and NZ refused funding for drugs for obesity, influenza and growth deficiency. All three countries made exceptions in order to fund drugs of poor cost-effectiveness for some “dread” diseases, but some drugs for less alarming conditions were either not funded or heavily restricted.