LOTF2011 | Ayelet Berman

Ayelet Berman Informal International Law-making in the Pharmaceutical Field

The International Conference on Harmonization(ICH)
In 1990, ICH started out as a of network drug regulatory authorities (FDA, EC, EMA, JPMDA) and research based industry association (PhRMA, EFPIA, JPMA) from the US, EU and Japan, with Canada, EFTA and WHO as observers.
Copied European harmonization governance model rather than work within the WHO.
Harmonization of technical requirements (quality, safety, efficacy, multidisciplinary) for drug registration. So far, about 50 non-binding guidelines have been issued. These are adopted as domestic non-binding guidelines (FDA guidance documents, EMA guidelines). De facto global standards.
Model was copied to other health fields: GHTF, VICH, ICCR
Reflects the two legal trends in the global legal environment: (i) Move from national standards to internationally converged standards, (ii) Move from public legal regime to public-private regime

Example of Informal International Law-making
Informal Actors : Drug regulatory authorities and industry associations
Informal process : network
Informal output : Legally non-binding guidelines

HiiL ’s Tender Document
Networks of regulators are beyond the reach of international and domestic law: what is the consequence for accountability?

International Level
The network lacks international legal personality as understood under traditional international law, but:
1. The regulatory authorities are bound by international law under the Articles on State Responsibility (Art. 4, Art.47);
2.In any event, difficult to say that there is an international law on good administrative procedure

Accountability Measures at the International (i.e. network) Level
1. Consultative nature of the rule-making procedure -> Linked back to domestic legal requirements (US) and practice (EU)
2. Gradual increase in participation of new countries : Regional Harmonization Networks and Drug Regulatory Authorities -- Global Cooperation Group (2003) / Regulators Forum (2008)
--Steering Committee/ Expert Working Groups (Gradual expansion)
-> May be linked back to the needs of all parties due to the globalization of the pharmaceutical market.
3. ->Certain ”Accountability promoting measures” exist at the global level.

The Role of Domestic Administrative Law
Example: US FDA
1. DAL and the Network : De Jure application to regulators, De facto application of domestic administrative law on the network (imposed by powerful network member): may determine good administrative practices of the network.
2. DAL and Internal Accountability
US: “ Parity ” of accountability measures overseeing domestic and international activities of regulators:
a. Domestic oversight : FDA ’s international activities are formally part of its mandate so all of the oversight mechanisms that apply to purely domestic activities, apply to its international activities too (Congress, OMB, courts etc.)
b. Domestic consultation :
FDA Good Guidance Practices (notice and comment)
EMA Procedure for European Union Guidelines and Related Documents within the Pharmaceutical Legislative Framework (broad consultation)

Conclusion and the Future
While networks are not subjects of international or domestic law, accountability measures at both the international and domestic level exist and should be further developed.
The Future :
The “National Law makers” should consider putting domestic measures in place regarding:
i) administrative procedures to be followed in the international activities of their regulators;
ii) administrative procedures and domestic overview mechanisms to be followed before adoption of internationally developed standards (“parity” or “parity plus” approach).
National law makers should come together to :
i) Develop best practices on administrative procedures to be followed in international regulatory cooperation (OECD).
.

Future Trends
Will we witness continued internationalisation of rules and institutions ?
Yes, but we will also see an expansion and broader participation, by more countries , in the existing institutions.
Will private governance mechanisms further expand or will state connected institutions and legal regimes retain their position?
The state will remain important, but will adapt its role: We will see continued reliance on private actors for information and expertise , but the state will remain an important gateway, in particular where it is perceived as having a role in protecting the public interest.

Scenarios
Legal Internet : growth in international rules and institutions, and growing dominance of public-private collaboration.

LOTF2011 | Ayelet Berman

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