The International Conference on Harmonisation ICH) has announced the planned creation of a worldwide Agency for Drug Reconciliation (ADR), which will most likely be headquartered in Monaco.

This plan aims to reduce the cost of pharmaceutical research, most notably by avoiding the proliferation of multiple clinical trials required for applications for marketing authorisation (MA). Starting in 2015, the ADR will become the one and only avenue for marketing authorisation for new drugs in every country in the world, with the exception of Monaco.

The ICH member states support this plan as a way of better managing their human and financial resources in a time of economic crisis. The World Health Organization (WHO) and World Trade Organization (WTO) have expressed, respectively, their praise for "an opportunity to move forward on the normative aspects of regulatory science", and for "the achievement of a worldwide market ruled by free and fair competition of goods and capital".

Pharmaceutical companies have emphasised the plan's added value from an ethical point of view: at last, just one clinical trial will be sufficient to gain access to the worldwide market, "minimising the anxiety and suffering of the participants in the clinical trials that are usually required by lily-livered bureaucrats". And numerous patients' groups and learned societies have praised the plan, in the name of history and of economic realism.

Only the (de)Medication in Europe Forum has raised its voice in disagreement. According to this group, ADR would sound the death knell for national drug regulatory agencies, and would threaten certain fundamental rights of citizens. In the face of this dissenting position, Prescrire has announced its intention to "dodge the question", in order to avoid disrupting the revolution of historical proportions represented by the creation of the ADR.

> Read Prescrire's analysis of this important news

©Prescrire 1 April 2013

"ADR: a new global phenomenon, thanks to the ICH" Prescrire Int 2013; 22 (137): 88. (Pdf, free).