Citation, commencement and application

1. —(1) These Regulations may be cited as the National Health Service (Prescribing and Charging Amendments Relating to Pandemic Influenza) Regulations 2009 and come into force on 21st August 2009.

(2) These Regulations apply in relation to England.

Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000

2. In the National Health Service (Charges for Drugs and Appliances) Regulations 2000( 2 ), after regulation 7B( 3 ), insert the following regulation—

“ Exemption from charges in respect of listed medicines

7C. —(1) No patient shall be liable to pay a charge under these Regulations in respect of the following medicines—

(a) oseltamivir (marketed as Tamiflu);

(b) zanamivir (marketed as Relenza),

in the circumstances set out in paragraph (2).

(2) Those circumstances are that—

(a) the Secretary of State has made arrangements for supplying the medicine to patients free of charge; or

(b) the NHS body that is responsible for the arrangements under which the medicine is supplied has made arrangements, with the approval of the Secretary of State, for supplying the medicine to patients free of charge,

and the patient is supplied with the medicine under those arrangements. ” .

Amendment of the National Health Service (General Medical Services Contracts) Regulations 2004

3. In the National Health Service (General Medical Services Contracts) Regulations 2004( 4 )—

(a) in regulation 2( 5 ) (interpretation), in paragraph (1), after the definition of “limited partnership” insert the following definitions—

“ “listed medicine” means a medicine mentioned in regulation 7C(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2000;

“listed medicines voucher” means a form provided by a Primary Care Trust for use for the purpose of ordering a listed medicine; ” ;

(b) in paragraph 38( 6 ) of Schedule 6 (other contractual terms – prescribing)—

(i) in sub-paragraph (a), omit “and”,

(ii) in sub-paragraph (b), for “professional,” substitute “professional, and”, and

(iii) after sub-paragraph (b), insert the following sub-paragraph—

“ (c) any listed medicines voucher issued by a prescriber or any other person acting under the contract, ” ;

(c) in paragraph 39( 7 ) of Schedule 6 (other contractual terms – prescribing)—

(i) in sub-paragraph (1), after “sub-paragraph (1A)” insert “and (1B)”, and

(ii) after sub-paragraph (1A), insert the following sub-paragraphs—

“ (1B) During an outbreak of an illness for which a listed medicine may be used for treatment or for prophylaxis, if—

(a) the Secretary of State or the Primary Care Trust has made arrangements for the distribution of a listed medicine in the area of the Primary Care Trust free of charge; and

(b) that listed medicine is needed for treatment or prophylaxis of any patient who is receiving treatment under the contract,

a prescriber may, or if the patient has not attained the age of 13 years must, order that listed medicine by using a listed medicines voucher, which the prescriber must sign.

(1C) During an outbreak of an illness for which a listed medicine may be used for treatment or for prophylaxis, if—

(a) the Secretary of State or the Primary Care Trust has made arrangements for the distribution of a listed medicine in the area of the Primary Care Trust free of charge;

(b) those arrangements contain criteria set out in a protocol which enable persons who are not prescribers to identify the symptoms of, and whether there is a need for treatment or prophylaxis of, that disease;

(c) a person acting on behalf of the contractor, who is not a prescriber but who is authorised to order listed medicines by the Primary Care Trust, has applied the criteria referred to in paragraph (b) to any patient who is receiving treatment under the contract; and

(d) having applied the criteria, the person acting on behalf of the contractor has concluded that the listed medicine is needed for treatment or prophylaxis of that patient,

the person acting on behalf of the contractor must order that listed medicine by using a listed medicines voucher, which the person ordering the listed medicine must sign. ” ;

(d) in paragraph 42( 8 ) of Schedule 6 (other contractual terms – restrictions on prescribing by medical practitioners)—

(i) in sub-paragraph (1), after “shall not order on” insert “a listed medicines voucher,”, and

(ii) in sub-paragraph (2)—

(aa) after “shall not order on” insert “a listed medicines voucher,”,

(bb) for paragraph (c) substitute the following paragraph—

“ (c) if the order is on a prescription form, the practitioner includes—

(i) the reference “SLS”, or

(ii) if the order is under arrangements made by the Secretary of State or the Primary Care Trust for the distribution of a listed medicine free of charge, the reference “ACP”, ” ; and

(e) in paragraph 43( 9 ) of Schedule 6 (other contractual terms – restrictions on prescribing by supplementary prescribers), in sub-paragraph (2)(d)(iii), for “prescription, he includes on the prescription form the reference “SLS”” substitute “prescription on a prescription form, the prescriber includes on the form the reference “SLS” or, in the case of a listed medicine ordered under arrangements made by the Secretary of State or the Primary Care Trust for the medicine’s distribution free of charge, the reference “ACP””.

Amendment of the National Health Service (Personal Medical Services Agreements) Regulations 2004

4. In the National Health Service (Personal Medical Services Agreements) Regulations 2004( 10 )—

(a) in regulation 2( 11 ) (interpretation), in paragraph (1), after the definition of “licensing body” insert the following definitions—

“ “listed medicine” means a medicine mentioned in regulation 7C(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2000;

“listed medicines voucher” means a form provided by a Primary Care Trust for use for the purpose of ordering a listed medicine; ” ;

(b) in paragraph 37( 12 ) of Schedule 5 (other contractual terms – prescribing), in sub-paragraph (1)—

(i) at the end of paragraph (a), omit “and”,

(ii) in paragraph (b), for “professional,” substitute “professional; and”, and

(iii) after paragraph (b), insert the following paragraph—

“ (c) any listed medicines voucher issued by a prescriber or any other person acting under the contract, ” ;

(c) in paragraph 38( 13 ) of Schedule 5 (other contractual terms – prescribing)—

(i) in sub-paragraph (1), after “sub-paragraph (1A)” insert “and (1B)”, and

(ii) after sub-paragraph (1A), insert the following sub-paragraphs—

“ (1B) During an outbreak of an illness for which a listed medicine may be used for treatment or for prophylaxis, if—

(a) the Secretary of State or the Primary Care Trust has made arrangements for the distribution of a listed medicine in the area of the Primary Care Trust free of charge; and

(b) that listed medicine is needed for treatment or prophylaxis of any patient who is receiving treatment under the contract,

a prescriber may, or if the patient has not attained the age of 13 years must, order that listed medicine by using a listed medicines voucher, which the prescriber must sign.

(1C) During an outbreak of an illness for which a listed medicine may be used for treatment or for prophylaxis, if—

(a) the Secretary of State or the Primary Care Trust has made arrangements for the distribution of a listed medicine in the area of the Primary Care Trust free of charge;

(b) those arrangements contain criteria set out in a protocol which enable persons who are not prescribers to identify the symptoms of, and whether there is a need for treatment or prophylaxis of, that disease;

(c) a person acting on behalf of the contractor, who is not a prescriber but who is authorised to order listed medicines by the Primary Care Trust, has applied the criteria referred to in paragraph (b) to any patient who is receiving treatment under the contract; and

(d) having applied the criteria, the person acting on behalf of the contractor has concluded that the listed medicine is needed for treatment or prophylaxis of that patient,

the person acting on behalf of the contractor must order that listed medicine by using a listed medicines voucher, which the person ordering the listed medicine must sign. ” ;

(d) in paragraph 41( 14 ) of Schedule 5 (other contractual terms – restrictions on prescribing by medical practitioners)—

(i) in sub-paragraph (1), after “shall not order on” insert “a listed medicines voucher,”, and

(ii) in sub-paragraph (2)—

(aa) after “shall not order on” insert “a listed medicines voucher,”, and

(bb) for paragraph (c) substitute the following paragraph—

“ (c) if the order is on a prescription form, the practitioner includes—

(i) the reference “SLS”, or

(ii) if the order is under arrangements made by the Secretary of State or the Primary Care Trust for the distribution of a listed medicine free of charge, the reference “ACP”, ” ; and

(e) in paragraph 42( 15 ) of Schedule 5 (other contractual terms – restrictions on prescribing by supplementary prescribers), in sub-paragraph (2)(d)(iii), for “prescription, he includes on the prescription form the reference “SLS”” substitute “prescription on a prescription form, the prescriber includes on the form the reference “SLS” or, in the case of a listed medicine ordered under arrangements made by the Secretary of State or the Primary Care Trust for the medicine’s distribution free of charge, the reference “ACP””.

Amendment of the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc. ) Regulations 2004

5. In Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004( 16 ) (drugs, medicines and other substances that may only be ordered in certain circumstances)—

(a) in the entry for “Oseltamivir (Tamiflu)”—

(i) in the part which relates to “treatment of influenza” (as mentioned in column 3), in column 2, after paragraph (1) insert—

“ (1A) Any patient suffering from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Secretary of State or are part of a Primary Care Trust’s antivirals distribution service ( 17 ) . ” , and

(ii) in the part which relates to “prophylaxis of influenza” (as mentioned in column 3), in column 2, after paragraph (2) insert—

“ (2A) Any patient at risk from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Secretary of State or are part of a Primary Care Trust’s antivirals distribution service. ” ; and

(b) in the entry for “Zanamivir (Relenza)”—

(i) number the current paragraph for the entry in column 2 as “(1)”, and then after that paragraph add the following paragraph—

“ (2) Any patient at risk of or suffering from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Secretary of State or are part of a Primary Care Trust’s antivirals distribution service. ” , and

(ii) in column 3, opposite paragraph (2) in column 2, insert—

“ Prophylaxis or treatment of influenza. ” .