On 15 December 2020, the Civil Contingencies Authority (CCA) agreed a set of regulations to limit the States of Guernsey liability in relation to the COVID-19 voluntary vaccination programme, while a vaccine (or vaccines) are temporarily authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Whilst the vaccination programme is entirely voluntary, the Chair of the CCA, Deputy Peter Ferbrache signed a set of regulations to limit the liability to the States of Guernsey. What this means in practice is, where a court determines in any civil proceedings that an award for damages associated with the use of a COVID-19 vaccination with temporary authorisation should be made, the maximum amount that can be awarded in respect of all losses and damages is £120,000.00 (in respect of a person who has died or suffered personal injury).
The CCA believes it is appropriate these regulations are introduced for the Bailiwick to ensure taxpayers’ money is reasonably protected against the extremely unlikely event that such a claim for damages would be made. It should not be seen as a reflection of the process by which any vaccine may be authorised for emergency use, which in respect of the Pfizer-BioNTech vaccine has been thorough and presents no safety concerns.
These regulations, known as The Emergency Powers (Coronavirus) (Vaccine) (Limitation of Liability) (Bailiwick of Guernsey) Regulations, 2020 are only a temporary measure but it may be expected that similar arrangements will be in place until a designated vaccine/s are given a marketing authorisation from the MHRA or the European Medicines Agency, as required by regulations 12 and 13(1), respectively, of the Medicines (Human) (Exemptions and Recognition of the Marketing Authorisations) (Bailiwick of Guernsey) Regulations, 2009. Once full marketing authorisations are in place, claims for damages would be made in the usual way through the States of Guernsey insurers.
The regulations came into force on 15th December 2020 and were laid before the States, in accordance with the provisions of Rule 18 of the Rules of Procedures for the States of Deliberation and their Committees, at their December 2020 Ordinary Meeting.
Regulation 174 of The Human Medicines Regulations 2012, which applies in England, Wales, Scotland and Northern Ireland, makes provision for the Secretary of State for Health and Social Care to waive the usual requirements for a full marketing authorisation from the regulatory body – the Medicines and Healthcare products Regulatory Agency (MHRA) - in a number of emergency-like situations, including in response to a suspected or confirmed pathogenic agent. The reference to the spread of pathogenic agents in Regulation 174 means the powers are available in a pandemic situation.
On 2nd December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) temporarily authorised the Pfizer-BioNTech COVID-19 vaccine under the provisions of Regulation 174.
In August 2020, the States of Deliberation approved the Prescription Only Medicines (Human) (Bailiwick of Guernsey) (Amendment) Ordinance, 2020, which enables a vaccine/s with temporary authorisation to be used in the Bailiwick. This Ordinance firstly requires the Committee for Health & Social Care to designate a named vaccine for COVID-19 by regulations, having consulted with the Policy & Resources Committee, the Policy and Finance Committee of the States of Alderney and the Medical & Emergency Services Committee of the Chief Pleas. The CfHSC is also advised by the Medicines Committee, established under sections 2 and 3 of the Medicines (Human and Veterinary) (Bailiwick of Guernsey) Law, 2008. The Committee agreed designate the Pfizer-BioNTech vaccine on 8th December 2020, thereby permitting its use in the Bailiwick.
If/when a vaccine or vaccines for COVID-19 receive a full marketing authorisation from the MHRA or European Medicines Agency, it is expected that any potential issues or risks associated with their use would be insurable by the States of Guernsey in the normal way.
At this stage, only the Pfizer-BioNTech COVID-19 vaccine has been approved for use in the Bailiwick however these regulations would apply to any COVID-19 vaccine given similar temporary authorisation and designated for use in the Bailiwick.
