A European proposal to regulate off-label prescription in China
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A European proposal to regulate off-label prescription in China Vera Lúcia Raposo 1 Received: 24 June 2018 / Revised: 12 November 2019 / Accepted: 12 February 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Off-label prescription – that is, the use of a medicine for unlicensed uses – is a practice spread worldwide. Therefore, many countries issued specific regulation to establish its requisites, promote safer off-label practices and punish reckless prescriptions. However, China still lacks a proper juridical framework for off-label prescription. This legal void may turn out to be very dangerous for patients, that in this scenario are at greater risk of injury; but also for physicians, whose likelihood of being suited and effectively convicted is also higher. In addition, it discourages pharmaceutical companies to invest in more research in order to turn those offlabel uses in on-label ones, since this practice became an easy source of profit without much effort to them. This article intends to propose some legal measures to help China dealing with off-label prescription, inspired by European law, by national legislations from European countries and by guidelines from European scientific associations and regulatory authorities. Keywords Off-label prescription . Europe . China . Drugs . Patient safety . Medical liability
Off-label prescription: definition of the concept Drug prescription is usually grounded on a Marketing Authorisation (MA), granted by competent authorities, after careful analysis of the clinical trials results submitted by the producer, i.e. the pharmaceutical company (Working Group of NSW Tag Inc 2003). For that purpose, the drug is submitted to a very strict evaluation by the competent authority – the European Medicines Agency (EMA, http://www.ema.europa.eu/ema/) in the European Union and the China Food and Drug Administration (CFDA, http://eng.cfda.gov.cn/WS03/CL0755/) in China – in order to evaluate if the product is safe and efficient for the specific purpose aimed by the drug.
* Vera Lúcia Raposo [email protected]; [email protected]
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Room 2043, Faculty of Law, University of Macao, E32, Avenida da Universidade, Taipa, Macao, China
V. L. Raposo
Subsequently, the MA provides the ground for the Summary of Product Characteristics (SmPC), the label that accompanies the product and which provides useful information to patients and physicians. Both of them define the clinical conditions, the dosage, the frequency, the posology and the group of patients for which the drug is intended. In this sense, the MA and the SmPC operate as a kind of road map for the doctor. But occasionally, doctors prescribe medications for another medical condition, using a different method of administration or a different dosage, or to a group of patients not specified in the label. In other words, doctors issue prescriptions that extrapolate the label. These various scenarios in which the drug is prescribed to be used in different terms from those set forth in the MA and in the SmPC are called
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