Abstract

In the European Parliament right now, the author is working with a small team of authors and shadow Members of the European Parliament (MEPs) on the proposed Advanced Therapy Directive(1). The directive deals with the regulation of cell, gene and tissue therapies. Though this is not the everyday work of radiology, it is an area in which radiology will play a part. It is the new frontier of medicine and for this reason it is the context in which the author, as a legislator with particular interest in people and health, works and in which it is arguably, easiest to see where ethics is going. In working out the details of the advanced therapy regulation, issues such as what is exempted, costs of registration, protection for small- and medium-sized enterprises (SMEs), etc., take up most of the directive. The decisions made here, for instance, about whether derogation should be granted for once-off hospital-based treatment rather than individual hospital-based treatment will have major financial implications down the line; yet this is not what is taxing the minds and hearts of the parliamentary team. It is the few words here and there that indicate ethical consideration; those that are making a usually cool socialist vice president of the parliament stamp her foot, slam down her pencil and threaten to walk out if the words are included in the directive.

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