Human Medicines (Amendment) Regulations 2018

The Human Medicines Regulations 2012 have been amended from the 1st April (Human Medicines (Amendment) Regulations 2018) to clarify the legal position of nuclear off-site plans that rely on the speedy distribution (or pre-distribution) of stable iodine tablets and provide advice to the public to take them. This is a useful step forward.

According to the explanatory note attached to the regulations “Regulation 12 amends Schedule 17 to the 2012 Regulations so that pharmacy medicines containing Potassium Iodide or Potassium Iodate can be supplied in the event of a radiation emergency by persons acting in accordance with an off-site emergency plan or by persons listed in Part 1 or 2 of Schedule 1 to the Civil Contingencies Act 2004.”

My understanding of the situation is now that for fixed nuclear reactor sites: (Based on Sizewell off-site plan and Highland Council’s Highsafe submarine plan).

  • The Director of Public Health determines the areas that pre-distribution of stable iodine should take place in.
  • The tablets are distributed (“supplied”) by a body such as NHS England or Navy (now permitted under the revised regulation if the radiation emergency has occurred or an event has occurred that could reasonably be expected to lead to a nuclear emergency has occurred although the legality of pre-distribution could be clearer).
  • On the day the Operator (who is likely to be the first to know that there is a serious release of radioactivity) alerts the public and advises them to take the pre-distributed tablets, having prior authorisation from the Director of Public Health to do this.
  • If tablets are indicated beyond the pre-distribution range then “PHE would be responsible for coordinating the delivery of additional tablets and NHS England would be responsible for arranging distribution to the public”.

Author: Keith Pearce

Emergency Planning and Health Physics consultant and author

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