Several limitations of the present external review

Several limitations of the present external review of legislation should be mentioned. First, legal and regulatory data were analysed on the basis of selection by key experts in each country and, in many cases, after AG 556 into English. Both incorrect translation and incomplete selection of documents might have caused incomplete or incorrect reporting of potential barriers. By training and guiding carefully selected key experts and by following a two-step method with an additional update of legal and regulatory text, the omission of data was minimised. Inconsistencies in translation were reduced as much as possible by working with a professional translation agency that specialised in the area of law and health, and through dissemination of the results to the ATOME country teams with the explicit request to provide feedback on errors in translation. Second, since the methods of this study consisted of an analysis of legal text, variation in the interpretation of legal terminology and text might have occurred. By involving three reviewers and determining the general interpretation of the assessment instrument, the possibility of different interpretations was minimised.