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Whereas some harmonisation networks tend to emulate the format of a club with a limited number of participants, others tend to be more inclusive. For example, the ICH, has in recent years set up a Global Cooperation Group and a Regulators Forum in order to cooperate with other regional harmonisation networks and drug regulatory authorities, respectively. The Basel Committee, originally founded by the G industrial economies, and comprised of central bankers, has also expanded and now includes significant emerging economies such as China and Brazil.

Unless authorized by the State, they will, as a rule, not conclude treaties on behalf of the State. Often, cooperation takes place in the form of informal initiatives without any sort of MOU between the regulators involved. These documents, while informal, often have a constitutional nature. The organizational framework in which harmonization networks operate Harmonisation networks operate in different contexts. Some operate within the framework of an IO, whereas others operate independently of any traditional framework.

It is comprised of regulatory authorities that have responsibility for the regulation of blood products, and whose activities take place under the auspices of the WHO. Internal structure and governance Trans-governmental regulatory networks may operate at different levels of institutionalisation. While some may be extremely unstructured, some have become more institutionalised. The ICH, for instance, is composed of a permanent steering committee and working groups, has a secretariat and organizes public conferences. Having said that, the level of institutionalisation of harmonisation networks is still relatively light in comparison to traditional IOs: their secretariats tend to be rotating amongst members such as in GHTF , or they are too small and thus rely on a secretariat of an IO or an industry association.

They have few employees, if any, and other than regular meeting schedules, they have no permanent presence. They feature either a small budget or no budget at all, with each member usually covering their own costs.


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Finally, many harmonisation networks have developed administrative features that are traditionally marked as features of democratically governed domestic systems of administrative law. The guideline- development procedures include elements similar to notices and comments as well as instructions regarding transparency and consultations with stakeholders. Their websites make many of their meeting minutes, framework documents, and so forth available to the public.

The Basel Committee has similar administrative features, too. The output The documents issued by harmonisation networks are typically considered not legally binding. Nevertheless, members are expected to implement the guidelines in their domestic legal system. And indeed, in practice the guidelines enjoy widespread compliance and considerable normative force, which puts their non-legally binding character into perspective. The normative effect of the guidelines extends beyond the member regions. In practice, the guidelines are often adopted by non-members. For example, more than States have implemented the Basel Accords to a greater or lesser degree.

Cassese et al. International agencies 1. That is, international bodies that are neither based on a treaty nor on a bottom-up cooperation between national regulators, but on a decision by an IO. According to some observers, these international agencies even outnumber conventional organisations. Here also, the tendency towards functional specialisation because of the technical expertise required in many areas may be a reason for the proliferation of such bodies and for their interaction with other IOs and agencies, which sometimes leads to the creation of common bodies.

International regulatory cooperation is often conducted between these non- conventional international bodies. Since these bodies are usually not based on a treaty, they would traditionally not qualify as IOs themselves. These bodies are usually referred to as subsidiary organs47, or as quasi-autonomous 42 See C. Shanks et al. Schermers and N. Dupuy ed. A second group of bodies is created by two or more IOs in areas where the problems they face transcend their individual competences.

International Courts and Informal International Law

It is not even exceptional for the above-mentioned subsidiary organs to, in turn, act as a parent organisation for the newly created bodies thus leading to what could be termed third-level international bodies. Characteristics of International Agencies Irrespective of our use of the term international agencies for public law bodies established by IOs, there seems to be a great deal of differentiation among the institutional designs and practices of various agencies.

The question is whether it is possible to identify some 48 P. See Martini, op. Most examples used in this section are drawn from her survey. See on the interesting example of the GEF also L. Wolfrum and V. Does the label simply refer to second generation international bodies, established by one or more IOs? Or it is possible to distinguish a more articulated regulatory structure, based on a number of shared legal features? The aim of the present section is to identify the nature of these bodies by attempting to define them on the basis of possible common characteristics. Membership The membership of most International Agencies is usually strictly linked to the membership of the establishing organizations.

At the same time, non- governmental organizations and IOs that are not members of the establishing institutions may usually join the International Agency as observers, in accordance with the relevant provisions of the parent organization. Internal structure Though not always but quite often provided with legal personality, international agencies usually share a structure centred around four pillars, reflecting the mainstream of the establishing IOs: a main collegiate body composed of representatives of all members; an executive committee made up of representatives of a limited number of members; several subsidiary bodies responsible for specific tasks and usually composed of representatives of a limited number of members; and an administrative secretariat made up of officials serving the international agency.

Relations with member States Member states participate in international agencies in two main regards. All other offices have a plenary or selective transnational composition. Member States participate not only in the internal structure, but also in the administrative proceedings taking place within international agencies themselves. As a matter of fact, international regulation lays down a number of administrative proceedings that require the intervention not only of the relevant international agency, but also of national and composite 52 This section is largely based on E.

Chiti and R. White and R. Collins Eds. That contribution also offers a number of examples of International Agencies. Credit is due to Edoardo Chiti. Administrative proceedings involving international agencies do not usually result from the introduction of new, international layers of procedure on top of pre-existing national procedures. Yet, they are composite administrative proceedings and may involve and integrate a number of international, national, and mixed authorities. Such composite administrative proceedings allow for a different form of participation of member States in the activities of international agencies.

Whereas the voice of member States is usually expressed in collegiate bodies in which several strategies may be developed, composite administrative proceedings stabilize the cooperation between a number of national, international, and mixed competent authorities. Relations with other international institutions The relationship between international agencies and other global and regional institutions may differ from the one between the parent organization and other institutions.

In this case, the relevant global regulatory system participates in the international agency in the same way member States do. Most commonly, however, global regulatory systems do not become members of an international agency, but acquire an observer status or establish other forms of cooperation that are not necessarily formalized in an agreement. In both cases, the parent organizations exercises a strict control over the relations between the established agency and other international organisations.

Involvement of private parties International agencies are public law bodies established by IOs and, presumably, subject to public law institutes and rules. Although some authors point to the hybrid private-public regime of some important International Agencies, such as CAC, usually the interaction of private parties does not lead to any kind of hybrid nature of the international agency. In a more limited number of cases, private parties have a formal representation within the internal structure of the relevant international agency, in particular in a collegiate body provided with advisory power.

Powers and administrative law mechanisms Finally, international agencies tend to converge as far as their powers are concerned. Again, we see a mixed picture. And yet, such powers tend in practice to go well beyond mere coordination and gain a genuinely binding regulatory character.

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Kingsbury, N. Krisch and R. For a different view, see A. Joerges, I. See on these bodies recently L. Lindsay, International Domain Name Law. Such mechanisms vary considerably from case to case. Yet, in all cases they respond to the exigency of strengthening control over the functioning and operations of international agencies through the provision of a number of administrative principles and rules applying to decision-making. Their sources include treaties and general principles of public international law. More often, however, administrative law mechanisms are established by non-treaty law-making of the parent organisations as well as of international agencies per se, including soft law measures.

As for their content, the emerging administrative law principles and rules tend to converge around decisional transparency, procedural participation and reasoned decisions, while review by a court or other independent tribunal is normally excluded. In particular, international agencies develop a practice of transparency by releasing, generally on their websites, administrative decisions, information on which they are based and material on internal decision- making.

Moreover, participation in decision-making proceedings has been promoted. Notably, procedural guarantees are designed as rights of States and are granted to all member States, not only to those directly affected by regulatory decisions. Procedural guarantees are extended to civil society and private actors, although their effective role in the decision-making process is contested and their formal rights are often more limited than those granted to States.

The autonomy of international agencies IOs usually do much more with their authority than their creators intended and are even forced to do so. And, indeed, States have created IOs also in cases where they themselves lack the necessary expertise. And it is exactly their expertise that may form a source of the exercise of public authority of international agencies. Barnet and M. A similar line of reasoning may be found in I. After all, the very reason to establish an agency is that the organisation wishes to outsource certain technical or operational tasks.

The autonomy of the agency is thus related to its relative independent position as a bureaucracy from the parent organisation, and thus, from the member States of that organisation. In practice, however, the picture is, at best, mixed. Research reveals that International Agencies continue to be dependent on member States, in so far as their internal architecture has an intergovernmental or multinational nature, and they operate through administrative proceedings to which national authorities are called to participate in.

In functional terms, irrespective of their bureaucratic character, many international agencies can even be seen as mechanisms of administrative cooperation and integration among domestic authorities. Ironically, it may very well be their pivotal position in the global regulatory network — with tentacles that reach within domestic legal orders as well as towards global and regional institutions — that allows them to be key actors in IN-LAW.

The international legal status of harmonisation networks and international agencies 1. The traditional approach under international law In this section we examine the traditional definitions in public international law of international legal personality and intergovernmental organization, and how harmonisation networks or more generally, Trans-governmental Regulatory Networks and International Agencies fit in, if at all.

While there is no formal definition of an IO under international law, there is a common understanding based on practice, scholars, etc. These criteria are 1 some form of international agreement, 2 between states, 3 autonomy or will of its own, and 4 international legal personality.

See for an extensive assessment of the notion of legal personality: R. Reports Harmonisation networks Trans-governmental Regulatory Networks in general, and harmonization networks as a particular case, do not constitute IOs and lack international legal personality under the traditional definitions in public international law. As such, they express the consolidated will of the State parties, rather than an independent and distinct will of the network. The secretariat, too, will usually not have independent powers. Moreover, autonomy is often understood as meaning the capacity to conduct external relations.

Indeed, harmonization networks may have extensive external relations with other networks, IOs, NGOs, or the private sector. However, all of these relations are informal in the sense that they are not based on legally-binding agreements. These are, therefore, not external relations in the traditional sense.

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Finally, harmonisation networks cannot be equated with the creation of a new international legal person, which would enjoy an independent status under public international law. Schermers and Niels M. Nijhoff, The Hague and Boston Wolfrum ed. As a result, harmonisation networks, being composed of regulatory authorities, are not considered as capable of possessing international legal personality. International agencies The situation may be somewhat ambiguous with regard to international agencies. Established by IOs, these agencies may have been granted a separate status under international law and may even be seen as a special type of IO.

As we have seen, the autonomy of international agencies is restricted, either because of their strong link with the parent organisation, or because of the dominant role played by member States. The contemporary approach The fact that trans-governmental regulatory networks are globally active and have significant normative effects on countries, companies, and individuals, but do not have an apparent place in international law has left legal scholars at unease. This has generated contemporary legal approaches to addressing them.

International agencies have received less scholarly attention, but the contemporary approaches described below are partly relevant in assessing our approach to other IN-LAW bodies too. Carl Heymans Verlag, para. Schermers, N. Nevertheless, it seems to us that their twilight existence, albeit for different reasons, may be comparable to soft organizations in the sense that their status is somewhere between an international organisation and a TRN.

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Stretching the definition of IO There have been developments in the literature that have sought to accommodate, on the basis of liberal and broad interpretation methods, certain informal entities within the traditional definition if an IO. The IPU is an organisation of parliaments from around the world which is not treaty-based. Indeed, for many TRNs that State consent is implicit if not explicit. For example, the Transatlantic Economic Partnership between the US and EU makes the removal of third generation trade barriers, that is, the removal of technical regulatory differences between the US and EU, a priority, and expects this work to be done between regulators.

While politicians are not involved in the important aspects and practical details of harmonisation, the regulators report to the political level about their transnational activities and harmonisation efforts, and the latter are, hence, well aware of such activities. International organizations may include as members, in addition to states, other entities. Also with regard to the condition that an IO be based on a treaty, most writers acknowledge that there may be exceptions and that there may be alternative modes of creation.

White, The Law of International Organizations , Dekker and R. However, regulators certainly enjoy autonomy from the political level to harmonise regulation. Looked at from this perspective, the functional criteria is fulfilled, and harmonisation TRNs could be considered as being international legal persons, or even IOs. With regard to international agencies it has been noted that the picture is, at best, mixed. The examples reveal that international agencies continue to be dependent on member States, in so far as their internal architecture has an intergovernmental or multinational nature and they operate through administrative proceedings to which national authorities are called to participate.

This is not to ignore that certain forms of autonomy towards member States are emerging, in particular in cases where scientific expertise plays a large role. But even there the picture is mixed as is for instance illustrated by the CAC. In short, the strong links which exist between an international agency and the parent organisation, on the one hand, and the member States, on the other hand, may put the autonomy of such agencies into perspective.

The most progressive approach has been to call for the recognition of trans-governmental regulatory networks as subjects of international law that would be directly and independently subject to international legal obligations.

Generally, the need to include new legal subjects when times are changing has been acknowledged by many. And indeed, international law has seen a proliferation in the number of subjects added during the twentieth century. Our tendency is to be cautiously positive towards the recognition of the legal personality of at least some IN-LAW bodies.

We will explain this. The question of legal personality is primarily to be found at two levels. First, whether the body, rather than its component parts, possesses international rights and obligations. Second, when something has gone wrong, and responsibility is sought, whether the body or its component parts can be held responsible. The situation for IN-LAW bodies, under the traditional accounts, is that they are not directly subject to international law, and may not be held directly responsible or accountable for wrongful acts.

Lauterpacht ed. Sticking to the traditional approaches hence runs the risk of creating injustice. One possible way to approach this would be to determine that whenever an international body exercises significant international public authority as defined above , it should be directly subject to the relevant international legal rules as well as be directly responsible for any breaches of international law. Indeed, this would imply a separate legal status for these bodies. Following this approach, IN-LAW bodies that have significant public authority would be directly subject to international law and directly responsible for breaches of international law.

We acknowledge that this approach requires further consideration, and the consequences, advantages, and disadvantages need to be carefully considered. For example, a possible drawback of such independent status may be that it enhances the power of the IN-LAW body and may, in turn, make it more difficult rather than easier to hold the IN-LAW actors accountable.

Participating national actors may, for example, hide behind the body when it comes to responsibility; or independent international status may reduce the need for domestic implementation and the domestic control that comes with it.


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