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Reach Letters of Access: Fun and Games
5:36 AM MDT | September 14, 2010 | By CATHERINE WELLER
by Catherine Weller, Associate with Allen & Overy
With many Reach registration dossiers now in the last stages of refinement, attention is inevitably focussing on the practicalities of joint submissions. In particular, letters of access (LoAs) need to be agreed and signed up in short order. Spare a thought for the co-ordinators of registrations of substances with large numbers of registrants.
The structure and content of letters of access vary enormously, with some just one page and others stretching to up to 10. The length will depend on whether obligations in relation to the access token mechanics and contractual protections for the lead registrant are included. Some also acknowledge that, while jointly submitting a CSR is optional, the obligation on each registrant to keep a copy available and up to date is mandatory and specify provisions in relation to this.
However, all LoAs have, as a core purpose, the aim of granting a co-registrant the right to participate in the dossier that the lead registrant will submit. Except in specific circumstances, all registrants must have legitimate possession or permission to refer to the full study reports summarised in the dossier and a registrant will have to select an option from a drop down list in IUCLID 5 to show which of these it has. The vast majority will be ticking the “data submitter has Letter of Access” box.
But does the wording of the LoA actually achieve compliance with Reach requirements? In most cases participants in the joint submissions will not get possession of the registration dossier, leaving them requiring a permission to refer. Article 10 of Reach is specific that the right to refer should relate to the full study report - not just the contents of the dossier - but not all of the LoAs floating about in the Reach stratosphere reflect this requirement. In other words, unless you get the right permission the letter of access would be insufficient to comply with a strict interpretation of Reach.