SCHEDULE 2Amendment of the National Health Service (Personal Medical Services Agreements) Regulations 2015

PART 5Certificates

Patients who should not be tested for, or vaccinated against, coronavirus

12.  After regulation 15 insert—

Patients who should not be tested for, or vaccinated against, coronavirus: confirmation of exemption

15A.(1) Subject to paragraph (6), a contract must contain a term which requires the contractor to respond to a valid exemption confirmation request.

(2) An exemption confirmation request—

(a)is a request to confirm whether a relevant patient (“P”), for clinical reasons—

(i)should neither be tested for coronavirus nor vaccinated with an authorised vaccine, or

(ii)should not be vaccinated with an authorised vaccine, and

(b)is valid if it is made in accordance with the process approved by the Secretary of State(1).

(3) An exemption confirmation request may be made by—

(a)P, or

(b)where P is a person to whom paragraph (4) applies, an appropriate person acting on behalf of P.

(4) This paragraph applies to a person if they—

(a)are a child, or

(b)lack the capacity to make a request under paragraph (1).

(5) The contractor must respond to a valid exemption confirmation request—

(a)free of charge to P or the appropriate person, and

(b)by recording its response on an information hub using a method approved by the Secretary of State.

(6) A contractor is not required to respond to a valid exemption confirmation request if—

(a)for the medical condition which may mean that P should neither be tested for coronavirus nor vaccinated with an authorised vaccine, or should not be vaccinated with an authorised vaccine, P is being attended by a medical practitioner who is not—

(i)engaged or employed by the contractor,

(ii)in the case of a contract with two or more persons practising in partnership, one of those persons, or

(iii)in the case of a contract with a company limited by shares, one of the persons legally or beneficially owning shares in that company, and

(b)that medical condition is not one to which paragraph (7) applies.

(7) This paragraph applies to a medical condition if no person with that condition should be—

(a)tested for coronavirus or vaccinated with an authorised vaccine, or

(b)vaccinated with an authorised vaccine.

(8) In this regulation—

authorised vaccine” means a medicinal product—

(a)

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

(b)

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

for vaccination against coronavirus;

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

licensing authority”, “marketing authorisation” and “medicinal product” have the meanings given in the Human Medicines Regulations 2012 (see regulations 6, 8 and 2, respectively, of those Regulations);

relevant patient” means—

(a)

a registered patient, or

(b)

a temporary resident..

(1)

Full details of the process will be made available on www.gov.uk before 1st October 2021.