A European proposal to regulate off-label prescription in China

Vera Lúcia Raposo ()
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Vera Lúcia Raposo: University of Macao

Asia Europe Journal, 2020, vol. 18, issue 4, No 7, 527 pages

Abstract: 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 off-label 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 (search for similar items in EconPapers)
Date: 2020
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DOI: 10.1007/s10308-020-00569-0

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