The role of European agencies in global health standards from global to EU to national level

This paper will analyze the role of European Agencies in the setting of global standards, focusing on the regulatory area of health (pharmaceuticals, foods, chemicals). In all these fields, European Agencies participate in the setting of standards on the global level e.g. in the ICH, the Codex and the OECD. They also play an important role in the implementation of the global standards and their enforcement on EU as well as Member State level. Therefore, this paper will examine the role of European Agencies in global standard-setting in-between the global, EU and national level. It will compare the role of EU Agencies in the setting of pharmaceutical, chemical and food standards and which role these bodies play in the implementation of global standards on the EU level. It will also examine how the EU implemented global standards affect the Member States and the role that EU agencies play in this regard.

Private Implementation of Global Standards in EU Law: The Case of Certification

Under the influence of WTO law, a private infrastructure for the implementation of international standards has emerged. The paper identifies its development out of independent conformity assessment bodies, called certifiers. The basis for the conduct of certification are International Standardization Organization (ISO) standards. The EU has intervened in different ways to integrate these global implementation structures into EU law. The paper discusses many examples from the fields of general product, as well as organic production certification, and emission reduction certification. It moreover develops a typology of the ways of interaction between global, EU and domestic law in the field of certification. The ultimate goal of the employment of the private infrastructure by the EU is the implementation of global–ISO, IFOAM, etc..–standards and international law into domestic law. This raises important issues of the legitimacy of private implementation in EU law.

The EU’s compliance with environmental law standards established in the Aarhus Convention: coming together or drifting apart?

The EU is a Party to the Aarhus Convention (the Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters), which establishes a set of environmental law standards in those areas. While implementing the Convention, the EU sometimes went beyond but other times has fallen short of the standards established. Any member of the public can bring a communication before the Aarhus Compliance Committee concerning the EU’s compliance with the Convention. After a communication regarding the «individual concern» standing criteria for individuals and NGOs to challenge decisions of EU institutions, the Committee found that the EU failed to comply with its obligations with regard to access to justice by members of the public, a decision that is still under appreciation by the MoP. The paper will focus on the EU’s compliance with the environmental standards established and the role of the Committee (an external body) in controlling it.

Incorporation and endorsement: the EU, transnational networks, and private financial standards

Transnational regulatory networks (such as the Basel Committee, the Financial Stability Board (FSB) and the Iosco) and private actors (such as the International Accounting Standards Board (IASB)) have long been setting global financial standards, lacking formal binding force, but often perceived as having a hard impact. The implementation of financial standards coming from transnational networks through incorporation in binding acts has been criticized as a “mere copycat exercise” of the norms set in the network of experts, leading the EU Parliament to criticize the accountability deficit resulting from this process. Private standards set by the IASB, on the contrary, are the object of an endorsement procedure, in which the EU retains some veto powers. How can different implementation models be explained? Can the EU’s participation in global decision making process – for which the EP is advocating – compensate for the lack of accountability of the incorporation process?