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The UK government conditions the pharmaceutical environment with a combination of micro and macro policies and pressures. Drug profits have been controlled since 1969 but it was only in May 1996 that the first report on these regulations were made available by government. The pharmaceutical price regulation scheme (PPRS) is obviously complex, synthesising price cap and profit regulation for example, but what makes matters more difficult is that the regulation has serious problems. The paper identifies and discusses the problems with PPRS regulation. The problems are: a lack of impact analysis; a lack of accountability; no agreement on what is meant by ‘reasonable profits’; problems in apportioning R&D costs to UK sales; disincentives for international trade; whether the drug companies' accounts submitted to government are true and fair; and whether or not the regulation is legal according to EU law. By identifying and discussing these problems this paper aims to open the debate and provide an opportunity for improvements in the regulations.
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