PubMed · 15515475
The source did not provide an abstract. Follow the original record for more information.
Explore connections, maps & timelines
Jytte Lyngvig. 2004-10-04. [Nothing wrong with generic preparations].. https://pubmed.ncbi.nlm.nih.gov/15515475/
Cite the original work for its findings. Save a collection to share your selection of sources.
KEEP EXPLORING
The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long-term focus on defining benefit in the regulatory system, considerable uncertainty remains about the methods of defining benefit and how to operationalize this knowledge. In this 'think tank,' part of a larger series on risk management, issues were divided into those that can be identified before a study is initiated, those that commonly arise after a study is completed, biomarkers and surrogates, use of benefit findings in defining quality and performance indicators, implementation of findings into health systems and formularies, and methods of comparative trials. Key categories for the establishment of a research agenda to fill in gaps in our understanding of assessing benefit were developed by the group.
This paper examines the economic, political and legal characteristics of the Greek pharmaceutical market, which is largely affected by the paradox of state intervention: while pharmaceutical regulation is mainly directed towards a rationalisation of total pharmaceutical expenditure, all measures taken to date aim at exhaustive pricing controls, i.e. interventions on the supply side alone, disregarding the "balloon" effect of shrinking prices on the expanding volume of consumption. As a result, pharmaceutical expenditure has been steadily rising, adding a disproportional burden on both social insurance and private income. The "unconstitutionality" of current pricing regulations exerted further pressure for a comprehensive reform. The paper proposes an alternative regulatory paradigm, which is loosely founded on European experience with regulating pharmaceutical markets. The conclusions of the economic, political and constitutional analysis help formulate a proposal for a comprehensive pharmaceutical policy that could assure the financial viability of the system as well as adhere to the principle of "legality", as the latter is constitutionally defined.
Explore the source record for details and available documents.