Legislation in the UK

The UK has implemented the Nagoya Protocol (Compliance) Regulations 2015 Statutory Instrument 2015 No. 821 (March 2015).

This was slightly amended by The Nagoya Protocol (Compliance) (Amendment) Regulations 2015 Statutory Instrument No 1691 (October 2015),  The amendment is only to add a very short phrase ["In   regulation   16(2)   of   the   Nagoya   Protocol   (Compliance)   Regulations   2015(c), after “regulation 13”, insert “, or regulation 14,"]; the main text is in the first of these Statutory Instruments.

The Statutory Instrument puts in place measures to implement:
• the EU Regulation;
• the Commission’s Implementing Regulation;
• elements of the Nagoya Protocol not covered by the EU Regulation.
It does not include Access requirements; the UK does not require to give PIC to anyone collecting. It does apply to the whole UK and, despite Brexit, applies until we are told otherwise!

The UK the Policy Lead is Defra (National Focal Point).

The UK Competent National Authority (& Checkpoint) is the Office for Product Safety and Standards – part of  BEIS. Further information is available here.

The Regulation requires making a Declaration of Due Diligence at two points in the project workflow. For almost all staff at the NHM this will be at the stage when utilization takes place (of GR accessed from a country that was a Party to the Nagoya Protocol at the time of access) funded by a grant (Article 7(1) of the EU Regulation). This declaration must be made after the first instalment of funding has been received and all the GR and TKaGR that are utilised in the funded research have been obtained, but no later than at the time of the final project report (or if there is no such report, at the project end). Submissions should be made using the electronic system DECLARE. To use it you will need an EU account, but you should be directed how to apply when you first try to use the system. Any problems and you can ask Regulatory Delivery [RegulatoryDelivery@public.gov.delivery.com] for assistance. The Commission has provided a set of FAQ on DECLARE, which can be found here (clicking on the link will trigger downlaod of a Word document).

Scratchpads developed and conceived by (alphabetical): Ed Baker, Katherine Bouton Alice Heaton Dimitris Koureas, Laurence Livermore, Dave Roberts, Simon Rycroft, Ben Scott, Vince Smith