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The present paper explores what role the principles of inclusivity, access to justice and participation in decision-making are playing in the Genetically Modified Organisms (GMO) authorization in the European Union. The introductory chapter highlights the concerns as reasons behind the delimitation of this scope: above all, the difficulties stemming from the risk regulation in agricultural biotechnology (scientific uncertainty, conflicting interests etc.) and the need to promote participation and representation of different stakeholders in processes related to global environmental and Sustainable Development assessment and decision-making. In the following pages, after having framed the main criticisms regarding the GMO authorization process, the paper will analyze the praxis and the Court of Justice of the European Union case-law after the approval of EU Regulation no. 1367/2006. This implemented the Aarhus Convention on access to information, public participation in decision-making, and access to justice in environmental matters into the European legal framework. As it will be discussed in the conclusion, neither the previously adopted Aarhus Convention nor the EU regulation have led, so far, to a satisfactory implementation of inclusivity, access to justice and participation in decision-making in the GMO field. Given that these principles echo some of the pivotal aims of Sustainable Development Goal 16 of the 2030 Agenda, the paper reflects on the possibility that the Sustainable Development debate could promote further steps towards a greater implementation of the above mentioned principles in the GMO authorization process ; Il presente contributo indaga in che misura i principi di inclusività, accesso alla giustizia e partecipazione nei processi decisionali trovano attuazione all'interno della procedura di autorizzazione degli organismi geneticamente modificati (OGM) dell'Unione Europea. Il paragrafo introduttivo mette in luce le principali problematiche sottese allo studio di questo argomento: in particolare, le difficoltà derivanti dalla regolamentazione del rischio in relazione alle biotecnologie applicate all'agricoltura (incertezza scientifica, conflitti d'interesse etc), nonché la necessità di garantire ampia partecipazione e rappresentanza dei diversi portatori d'interessi nei processi decisionali che incidono sull'ambiente globale e sulla realizzazione dello Sviluppo Sostenibile. Nei paragrafi successivi, dopo aver illustrato le principali lacune della procedura di autorizzazione degli OGM, l'articolo analizza la prassi e la giurisprudenza della Corte GUE successiveall'approvazione del Regolamento UE n. 1367/2006. Quest'ultimo implementa a livello Europeo la Convenzione di Aarhus sull'accesso alle informazioni, la partecipazione del pubblico ai processi decisionali e l'accesso alla giustizia in materia ambientale. Come emerge dalle conclusioni, nè la sottoscrizione della Convenzione di Aarhus, prima, nè la sua implementazione tramite Regolamento, poi, hanno condotto ad oggi ad una soddisfacente attuazione dei principi di inclusività, accesso alla giustizia e partecipazione nei processi decisionali nell'ambito degli OGM. Dal momento che tali principi riecheggiano alcuni degli obiettivi stabiliti dal Goal 16 dell'Agenda 2030, l'articolo riflette da ultimo sulla possibilità che il dibattito sullo Sviluppo Sostenibile possa portare a passi ulteriori nella direzione di una maggiore implentazione dei principi menzionati nel processo di autorizzazione degli OGM in Europa.

Under European Union (EU) law, genetically modified organisms (GMOs) for consumption require authorizations for cultivation, for use in human food, and for use in animal feed. The recast of the legislative framework in 2003 introduced the "one-door-one-key principle." This principle links and integrates the procedures to acquire these three authorizations partly in a mandatory and partly in an optional manner. Even though the EU legislature perceives the three authorizations as intrinsically linked, in practice considerable differences can be observed in the presence of GMOs on the EU market for cultivation, for feed use, and for food use. Partly these differences are reflected in differences in authorization. This Article traces the one-door-one-key principle in EU GMO food law; its content is an application. Based on literature and a few interviews, it attempts to explain the gap between legal theory and business practice.

Despite the early access procedures for marketing authorization (MA) valid throughout the European Union still in the most of the Member states patient access to innovative medicines depends on cost-effectiveness, budget impact assessment and negotiations for price discount with the public payers. Retrospective analysis on the availability and time to market access of medicines authorized under the European medicines agency's specific procedures for early access shows that despite the shortening of the time to market access after 2013, for most medicines still exceeds 365 days. This is due to the fact that requirements for pricing and reimbursement across EU is fixed to some degree and medicines with MA for early access are subject to the same legal requirements as the medicines with standard centralized marketing authorization. Some specific national legal requirements for pricing and reimbursement decisions, population of interest and manufactures intentions to enter certain markets should also be considered.

Despite the early access procedures for marketing authorization (MA) valid throughout the European Union still in the most of the Member states patient access to innovative medicines depends on cost-effectiveness, budget impact assessment and negotiations for price discount with the public payers. Retrospective analysis on the availability and time to market access of medicines authorized under the European medicines agency's specific procedures for early access shows that despite the shortening of the time to market access after 2013, for most medicines still exceeds 365 days. This is due to the fact that requirements for pricing and reimbursement across EU is fixed to some degree and medicines with MA for early access are subject to the same legal requirements as the medicines with standard centralized marketing authorization. Some specific national legal requirements for pricing and reimbursement decisions, population of interest and manufactures intentions to enter certain markets should also be considered.

Background : The past decades have seen advances in cancer treatments in terms of toxicity and side effects but progress in the treatment of advanced cancer has been modest. New drugs have emerged improving progression free survival but with little impact on overall survival, raising questions about the criteria on which to base decisions to grant marketing authorizations and about the authorization procedure itself. For decisions to be fair, transparent and accountable, it is necessary to consider the views of those with relevant expertise and experience. Methods : We conducted a Q-study to explore the views of a range of stakeholders in France, involving: 54 patients (18 months after diagnosis); 50 members of the general population; 27 oncologists; 19 healthcare decision makers; and 2 individuals from the pharmaceutical industry. Results : Three viewpoints emerged, focussing on different dimensions entitled: 1) 'Quality of life (QoL), opportunity cost and participative democracy'; 2)'QoL and patient-centeredness'; and 3) 'Length of life'. Respondents from all groups were associated with each viewpoint, except for healthcare decision makers, who were only associated with the first one. Conclusion: Our results highlight plurality in the views of stakeholders, emphasize the need for transparency in decision making processes, and illustrate the importance of a re-evaluation of treatments for all 3 viewpoints. In the context of advanced cancer, our results suggest that QoL should be more prominent amongst authorization criteria, as it is a concern for 2 of the 3 viewpoints.

There are various methods proposed in the literature to provide authorization control in workows and in-formation systems. Authorization implementations have deficiencies based on procedural scope. Basic login mechanisms grant system-wide access; the provided margins are broad. Access control lists provide limited definition on access restrictions; the authorization is bounded by these definitions. Role based authorizations do not cover regulations in institutions where the regulations describe specific operations and their operational procedures in institutional work-ows. The proposed multilayer authorization model depicts the attributes of authorization mechanisms and analyzes the methods according to their authorization capabilities and contributions to the reliability of documents in the workow. The layered structure provides comparative and integrated analysis of the authorization mechanisms. The incremental authorization structure would be a guide for implementations in that each layer presents the scope of authorization by providing analysis on deficiencies and the methods of solution. An institutional authorization mechanism on documents is also proposed. The proposed mechanism suggests and implements an authorization mechanism to enclose authorization restrictions in institutional regulations. © TÜBITAK.

There are various methods proposed in the literature to provide authorization control in workows and in-formation systems. Authorization implementations have deficiencies based on procedural scope. Basic login mechanisms grant system-wide access; the provided margins are broad. Access control lists provide limited definition on access restrictions; the authorization is bounded by these definitions. Role based authorizations do not cover regulations in institutions where the regulations describe specific operations and their operational procedures in institutional work-flows. The proposed multilayer authorization model depicts the attributes of authorization mechanisms and analyzes the methods according to their authorization capabilities and contributions to the reliability of documents in the workflow. The layered structure provides comparative and integrated analysis of the authorization mechanisms. The incremental authorization structure would be a guide for implementations in that each layer presents the scope of authorization by providing analysis on deficiencies and the methods of solution. An institutional authorization mechanism on documents is also proposed. The proposed mechanism suggests and implements an authorization mechanism to enclose authorization restrictions in institutional regulations.

There are various methods proposed in the literature to provide authorization control in workows and in-formation systems. Authorization implementations have deficiencies based on procedural scope. Basic login mechanisms grant system-wide access; the provided margins are broad. Access control lists provide limited definition on access restrictions; the authorization is bounded by these definitions. Role based authorizations do not cover regulations in institutions where the regulations describe specific operations and their operational procedures in institutional work-flows. The proposed multilayer authorization model depicts the attributes of authorization mechanisms and analyzes the methods according to their authorization capabilities and contributions to the reliability of documents in the workflow. The layered structure provides comparative and integrated analysis of the authorization mechanisms. The incremental authorization structure would be a guide for implementations in that each layer presents the scope of authorization by providing analysis on deficiencies and the methods of solution. An institutional authorization mechanism on documents is also proposed. The proposed mechanism suggests and implements an authorization mechanism to enclose authorization restrictions in institutional regulations.