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In that context, the applicant, supported by the intervener, submits that: – where access to documents held by the EMA is sought in an economic or regulatory context to which specific legislation pursuing different objectives applies, the Court must endeavour to ensure that all the legislation is applied coherently, unless the relevant measures contain a provision expressly giving one body of measures primacy over the other; – where the specific sectoral legislation sets out its own disclosure regime, a ‘general presumption’ arises to the effect that documents should only be disclosed pursuant to and in the circumstances envisaged by that legislation and are otherwise to be treated as confidential for the purposes of both Article 4(2) and Article 4(3) of Regulation No°1049/2001, subject to the possibility of demonstrating, by reference to the particular circumstances of the case, that a particular document falls outside the presumption, or that disclosure under Article 4(2) of Regulation No 1049/2001 is nonetheless justified by a relevant ‘overriding public interest’; – such an approach has already been recognised in the case-law; – in the present case, Regulation No 726/2004 contains, in conjunction with other relevant regulations, specific and detailed provisions as to the information held by the EMA which is or is not to be made publicly available; – in the context of the highly competitive and innovative pharmaceutical industry, characterised by expensive investment, Regulation No 726/2004 and the other relevant legislation strike a very careful balance between, on the one hand, the interests of transparency, legitimate public interest considerations, and the desirability of avoiding duplicative research, and, on the other hand, the need to give companies a proper incentive to invest in research and development without fear that competitors will be able to free-ride on their innovation, the interests of stimulating multiple lines of research, and the proper and open functioning of a system for the assessment of MA applications under which companies are not discouraged from providing full and frank disclosure of all relevant information; – it is also of the very essence of the MA regime that all documents submitted as part of an MA application dossier, and in particular the studies and trial reports, including the report at issue, are entitled to the protection of a general presumption of confidentiality for the purposes of Article 4(2) or (3) of Regulation No 1049/2001; – the general presumption of confidentiality must apply throughout the period of marketing data exclusivity and even beyond, rather than expiring once the MA decision has been made: any other interpretation would not be in accordance with the effet utile of the EMA Regulation; – moreover, in the present case, only a conditional MA has been granted; that means that the decision-making process concerning the grant of a full MA has not yet been concluded; consequently, all study documents (periodic safety update reports) should be kept secret at least until the grant of a full MA or final refusal of an ongoing conditional MA, so that the EMA can conduct its investigation into the safety and efficacy of the medicinal product in question without outside interference; – Regulations Nos 1049/2001, 726/2004, 141/2000 and 507/2006 must be interpreted in light of the requirements of the TRIPS Agreement, and in particular Article 39(3), which reinforces the conclusion that the report at issue is covered by a general presumption of confidentiality; – the extremely administratively burdensome nature of the line-by-line redaction task contemplated by the EMA provides yet further support for the view that on a proper interpretation of Regulation No 726/2004 preserving its useful effect the EMA would be able to rely on a general presumption of confidentiality in respect of documents submitted to it as part of MA application dossiers, including clinical study reports; – the EMA’s reasons for rejecting the application of a general presumption of confidentiality to the report at issue are inadequate.