This article evaluates two proposals that the Organs Directive along with the commission’s Action Plan 2009-2015 can be viewed as a form of hybrid governance. The Organs Directive is the first legally-binding supranational risk regulation devised in the field of organ donation and transplantation. The Directive is modelled on the earlier Directive dealing with blood, tissue, and cells. The Action Plan, which is soft law, will complement the Directive. The Directive and Action Plan requires additional administration procedures from the Member States with the EU Commission regularly monitoring the implementation of the work programme to ensure it is manageable for them.

Before probing the Directive, the Impact Assessment (IA) undertaken by the EU Commission on organ donations, which is used to determine the rationale behind the adoption of the stringent Directive with the Action Plan, will be examined. The social, economic, and health impacts of the four regulatory options available to the Commission will be considered. The Directive and the Action Plan, which are finally adopted, will be discussed in detail, before the arguments are placed highlighting the fact that the Directive and Action Plan display a mode of hybrid governance. Next, the advantages and disadvantages of hybrid governance are laid out and conclusions are drawn as to whether the hybrid model was the best form of action in EU healthcare. In the conclusion, the article proposes the emergence of an “integrated model” within the Organs Directive, which is based on the fusion of the three governance structures: the OMC, comitology, and agencies.