Regulation 5 Amendment of regulation 12 (safe care and treatment)

In regulation 12, after paragraph (2), insert—

“(3)

For the purposes of paragraph (2)(h), a registered person (“A”) in respect of a regulated activity specified in paragraph 2 of Schedule 1 (accommodation for persons who require nursing or personal care) in a care home must secure that a person (“B”) does not enter the premises used by A unless—

(a)

B is a service user residing in the premises used by A;

(b)

B has provided A with evidence that satisfies A that either—

(i)

B has been vaccinated with the complete course of doses of an authorised vaccine; or

(ii)

that for clinical reasons B should not be vaccinated with any authorised vaccine;

(c)

it is reasonably necessary for B to provide emergency assistance in the premises used by A;

(d)

it is reasonably necessary for B to provide urgent maintenance assistance with respect to the premises used by A;

(e)

B is attending the premises used by A in the execution of B’s duties as a member of the emergency services;

(f)

B is a friend or relative of a service user and that service user is or has been residing in the premises used by A;

(g)

B is visiting a service user who is dying;

(h)

it is reasonably necessary for B to provide comfort or support to a service user in relation to a service user’s bereavement following the death of a friend or relative; or

(i)

B is under the age of 18.

(4)

A registered person provided with information as evidence in accordance with paragraph (3) may process that information.

(5)

Nothing in this regulation authorises the processing of personal data in a manner inconsistent with any provision of data protection legislation.

(6)

In this regulation—

• “authorised vaccine” means a medicinal product—

  1. (a)

     authorised for supply in the United Kingdom in accordance with a marketing authorisation; or

  2. (b)

     authorised by the licensing authority on a temporary basis under regulation 174 (supply in response to spread of pathogenic agents etc) of the Human Medicines Regulations 2012^f1

  for vaccination against coronavirus;

• “care home” has the meaning given in section 3 (care homes in England) of the Care Standards Act 2000^f2;

• “complete course of doses” means the complete course of doses specified—

  1. (a)

     in the summary of product characteristics approved as part of the marketing authorisation for the authorised vaccine; or

  2. (b)

     in the instructions for usage approved as part of the authorisation by the licensing authority on a temporary basis under regulation 174 of the Human Medicines Regulations 2012 for the authorised vaccine;

• “coronavirus” means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

• “data protection legislation” and “personal data” have the meaning given in section 3 (terms relating to the processing of personal data) of the Data Protection Act 2018;

• “marketing authorisation” has the meaning given in regulation 8(1) (general interpretation) of the Human Medicines Regulations 2012;

• “medicinal product” has the meaning given in regulation 2 (medicinal products) of the Human Medicines Regulations 2012; and

• “the licensing authority” has the meaning given in regulation 6(2) (the licensing authority and the Ministers) of the Human Medicines Regulations 2012.”.