A LEAP TO HYBRID GOVERNANCE FOR EUROPEAN UNION HEALTHCARE ON ORGAN DONATIONS.

• Author: Ahmed, Tasnim
• Position: AHMED, A LEAP TO HYBRID GOVERNANCE FOR EUROPEAN UNION HEALTHCARE ON ORGAN DONATIONS

1. 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 I. INTRODUCTION

   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.

2. EU GOVERNANCE IN ORGANS

   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'. (5)

   The term 'national provisions' highlights the differences in the national legal approaches to concerning donor consent. The term 'medical use' refers to organ donations for transplantation. (6) The sub Article stating 'The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them' highlights the special status of organ transplantation. (7)

   The EU Commission justified European-wide action by pointing out that unified European action would result in European-wide diversity. The EU Commission claimed the advantages of Union action as follows: The EU facilitation of consensus-building allowing quicker implementation: economies of scale, lower transition costs in establishing the New Quality and Safety system and reduced running costs; greater fairness and contribution to solidarity; enhanced donor and recipient confidence stemming from legal clarity. (8)

   However, it is noted that the requirement for a similar quality and safety regime from each EU Member State may require various adjustments to be successful at the local hospital level. On the positive side, it would ensure that it if quality and standards are standardized at the European level, then it would guarantee equal access for all European citizens. The EU Commission's first publication looked at the policy options and set objectives to promote enhanced coordination between Member States. (9) Here, the EU Commission highlighted that the Community needed to react under Article 168(4) (a) TFEU to deal with the challenges facing organ transplantation: The transfer of organs can lead to transmission of diseases such as Hepatitis B and C, HIV, various parasites and cancer. Although, there are a number of cross-border treatments the legal quality and safety requirements differ between Member States. Thus there was a need for the system to a standardisation of the system to ensure patients are being protected throughout Europe. (10) The EU Commission urged that measures needed to be introduced throughout the procedure to improve the quality and safety of organs, from pre-transplant evaluation procedures set for donors, to setting procedures for procurement and requirements for organ preservation and transport. (11) A system needed to be in place, which allowed donors to be traced in case of complications. National authorities were also encouraged to take active roles and establish authorized centres in Europe that would monitor safety and quality criteria. The EU Commission concluded that it would 'define the precise, balanced scope of the EU legal framework on quality and safety for human organs taking in account the dialogue it has had so far with the Member States on the issues'. (12)

   Due to a shortage of donors, the Commission suggested that the EU Member States may be able to create a system by which donors could be identified, as after their death donors are lost due to lack of referral, or because the option was not presented to their relations. (13) If healthcare professionals were trained to identify potential donors, donor rates could be increased. Moreover, providing information to the healthcare professionals on transplantation may affect the donors' willingness to donate. Eighty-one per cent of Europeans agreed that the use of a donor card would facilitate organ donations after their death. (14) Given the need to establish adequate national transplant systems; good organisational and technical support is essential. (15) The document stated that a "flexible system combining a decentralized network formed by local organisations mainly focused on organ procurement, and the promotion of donation with large organisations focused on promoting organ sharing and cooperation seems to be the most effective organisational approach". (16) This would give rise to the formation of networks and experimental governance, as experimentalist tools such as open consultations would be utilized to achieve the goals of promoting organ donation.

   The EU Commission emphasized the need to share best practices among the Member States to increase the number of donors and educate health care professionals. It would also encourage action at the EU level for the interchange of organs between national levels. (17) The EU Commission also proposed an Action Plan that would include qualitative, and quantative indicators, and regular reporting in order to promote greater coordination. It restated the preference for the use of the OMC type methodology utilising the Directly Deliberative Polyarchy theory (so called DDP theory) and signalled the shift away from the traditional command and control mechanisms of governance used in blood and to a lesser extent, in tissues and cells regulation. (18) Thereafter the EU Commission conducted a series of meetings with stakeholders and experts to receive feedback on the proposed Action Plan, as well as input on the drafting of the proposal for a Directive in this area. The adoption of the OMC within this area raised issues with certain stakeholders, who felt that this method would divert personnel and resources away from the actual strategies and thus was unnecessary. (19) It was also felt that there was a greater need for flexibility to be built into any EU regulation regime. This meant that clinicians and patients needed to be granted adequate freedoms to make decisions about associated risks of the use organ transplantation, given factors such as waiting lists and organ shortage. (20)

   In reaction to stakeholders' participation in organ donation and transplantation policies, DG Sanco launched an open consultation in 2006. The Commission received 73 contributions from regulators, medical and patient organisations and created a key stakeholder group from around 16 European Associations. (21) The group met in 2008 and shared information, which was then incorporated within the definitions of the policy options. The EU Commission since 2007 has held various meetings with national experts of all Member States, including Eurotransplant and Scandiatransplant, and discussed key priorities. (22)

   Arguably, the EU Commission's interactions with the stakeholders and experts for feedback, along with its efforts to...