Academic journal article Journal of Law and Health

A Leap to Hybrid Governance for European Union Healthcare on Organ Donations

Academic journal article Journal of Law and Health

A Leap to Hybrid Governance for European Union Healthcare on Organ Donations

Article excerpt

I. INTRODUCTION                                              119 II. EU GOVERNANCE IN ORGANS                                  120 III. ACTION PLAN (2009-2015) AND ORGANS DIRECTIVE            130 IV. IS NEW GOVERNANCE THE RIGHT WAY FORWARD IN THE ORGANS     CASE?                                                    133 V. HYBRID FORM OF REGULATION AND THE CASE OF THE ORGANS    DIRECTIVE                                                 135 VI. PROPOSAL OF THE INTEGRATED MODEL: A FUSION OF THE THREE     GOVERNANCE STRUCTURES                                    141 VII. CONCLUSION                                              143 


Over the last decade, the use of 'soft law' has extended the boundaries of European Union (EU) involvement in healthcare, thereby pushing the Europeanization process to involve learning and adoption rather than institution-building. Radaelli describes the process as "generating indirect pressures for adaption at national level via non-binding instruments". (1) However, the problem with soft law is that there are significant variations in its outcomes. This seems to produce better results in areas where actors share similar objectives, best practices are easily practiced and cultural sensitivities are low. Hence, this article asserts that soft law on its own merits may not be sufficient for Europeanization and that an element of hard law is required to ensure optimum outcomes. Therefore, the best solution would be to apply a hybrid model. The existence of soft law as the only mechanism for law making in the field of EU healthcare is fairly unlikely. Nevertheless, Hervey notes that "law and soft modes of health governance are becoming increasingly interwoven, thereby opening the door for hybrid EU policy instruments". (2)

Accordingly, this article will evaluate two proposals that the Organs Directive along with the Commission's Action Plan 2009-2015 can be viewed as a form of hybrid governance. (3) 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, 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 will be laid out and conclusions will be drawn to whether the hybrid model was the best form of action in EU healthcare. Lastly, in conclusion, the article will propose the emergence of an "integrated model" within the Organs Directive. This is based on the fusion of the three governance structures, namely the OMC, comitology and agencies.


The EU has competence to legislate in the area of organ transplantation. Notably, Article 168(4) (a) of the Treaty on the Functioning of the European Union ("TEFU") has empowered the Community to take "Measures setting high standards of quality and safety of organs and substances of human origin blood and blood derivatives." (4) In accordance with Article 168(7) TFEU: 'The measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood'. …

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