Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the National Health Service (General Medical and Pharmaceutical Services) (Miscellaneous Amendments) Regulations 1991 and shall come into force on 1st April 1991.

(2) In these Regulations, “the principal Regulations” means the National Health Service (General Medical and Pharmaceutical Services) Regulations 1974(2).

Amendment of regulation 2 of the principal Regulations

2.  In regulation 2 of the principal Regulations (interpretation), after paragraph (8) there shall be added the following paragraph:—

“(9) Where, by virtue of directions given under section 13 of the National Health Service Act 1977, or by virtue of any arrangements made pursuant to regulations made under that Act, a function of the Secretary of State is exercisable by some other person or body(3), a reference in these Regulations to the Secretary of State in relation to that function includes a reference to the person or body exercising that function on behalf of the Secretary of State.”.

Amendment of regulation 26 of the principal Regulations

3.  In regulation 26 of the principal Regulations (pharmaceutical list), in paragraph (6), for the words “make a decision under paragraph (3), (4) or (4A) above” there shall be substituted the words “include the appellant in the relevant pharmaceutical list”.

Amendment of regulation 26C of the principal Regulations

4.  In regulation 26C of the principal Regulations (effect of preliminary consent), in paragraph (2)—

(a)at the end of sub-paragraph (a) the word “and” shall be omitted;

(b)sub-paragraph (b) shall be omitted.

Amendment of regulation 29 of the principal Regulations

5.  In regulation 29 of the principal Regulations (schemes for securing proper pharmaceutical services), in paragraph (4A)—

(a)for the words “or person may appeal to the Committee”, there shall be substituted the words “or person may appeal to the Secretary of State”;

(b)for sub-paragraph (a), there shall be substituted the following sub-paragraph:—

“(a)shall be sent to the Secretary of State within one month from the date on which the Family Health Services Authority’s decision was sent to the Local Committee or to that person;”;

(c)in sub-paragraph (b), for the words “paragraph 4(3) to (6) and paragraphs 13 and 14”, there shall be substituted the words “paragraph 4(3) to (12)”.

Amendment of regulation 30D of the principal Regulations

6.  In regulation 30D of the principal Regulations (determination of controlled locality)—

(a)after paragraph (4), there shall be inserted the following new paragraph:—

“(4A) Where the Family Health Services Authority—

(a)determines that any area or part of an area is or is not rural in character; and

(b)considers that the provision of general medical services by any doctor, or pharmaceutical services by any pharmacist, is likely to be adversely affected in consequence of that determination;

it shall require such measures as in the opinion of the Family Health Services Authority are likely to reduce, so far as practicable, over such period as it thinks fit, such adverse effects.”;

(b)after paragraph (10), there shall be added the following new paragraph:—

“(11) For the purposes of this regulation, “measures” means the postponement of the making of arrangements under regulation 30 for the provision by a doctor of pharmaceutical services for patients of his, or the postponement of the termination of such arrangements.”.

Substitution of regulations 3OF and 3OG of the principal Regulations

7.  For regulations 3OF and 3OG of the principal Regulations (appeals or applications to the Rural Dispensing Committee relating to rurality of an area, and appeals to the Secretary of State), there shall be substituted the following regulations:—

“Appeals relating to rurality of an area

3OF.—(1) Where a Family Health Services Authority—

(a)has determined pursuant to regulation 30D that an area is, or is not, rural in character;

(b)has refused to consider that question on the ground that it is not satisfied as mentioned in paragraph (10) of that regulation; or

(c)has determined that measures are, or are not, required as mentioned in paragraph (4A) of that regulation,

the Local Medical Committee or the Local Pharmaceutical Committee may appeal to the Secretary of State against any such determination or, as the case may be, refusal by giving notice of appeal in accordance with paragraph (2).

(2) Any notice of appeal under paragraph (1) shall be sent to the Secretary of State, within one month from the date on which the decision of the Family Health Services Authority was sent to the Local Medical Committee or the Local Pharmaceutical Committee making the appeal and shall contain a concise statement of the facts and contentions on which the appellant intends to rely.

(3) The Secretary of State shall, on receipt of any notice of appeal under this regulation, send copies thereof to the Family Health Services Authority and all the persons to whom the Family Health Services Authority has given notice of its determination under regulation 3OD(8).

(4) The Family Health Services Authority, the Local Medical Committee and the Local Pharmaceutical Committee may, within one month from the date on which the Secretary of State sent copies to them of the notice of appeal under this regulation, submit representations in writing to him on the appeal.

(5) The Secretary of State may determine an appeal under this regulation in such manner as he thinks fit, and his decision in respect of that appeal shall be final.

(6) On determining an appeal under this regulation, the Secretary of State—

(a)shall, where he allows an appeal against a refusal mentioned in paragraph (1)(b), also determine the question whether or not the relevant area is rural in character;

(b)may, in a case where the Family Health Services Authority on determining the application considered the question of the measures to be carried out pursuant to regulation 3OD(4A), himself require such measures to be carried out by the Family Health Services Authority as will, in his opinion, be likely to reduce, so far as practicable, any adverse consequences to any pharmacist or doctor over such period as he thinks fit;

(c)shall, in a case where that question was not considered by the Family Health Services Authority when it determined the application, remit that question to the Family Health Services Authority for determination.

(7) The Secretary of State shall, upon the determination by him of an appeal under this regulation, give his decision in writing and shall send a copy of the decision and the statement of his reasons for it to all the persons to whom the notice of appeal was sent under paragraph (3).

(8) For the purposes of this regulation, “measures” means the postponement of the making of arrangements under regulation 30 for the provision by a doctor of pharmaceutical services for patients of his, or the postponement of the termination of such arrangements.

Appeals in connection with applications determined under regulation 30E

3OG.—(1) Where—

(a)an application has been determined by the Family Health Services Authority under regulation 3OE; or

(b)the Family Health Services Authority has refused to consider an application under regulation 30E on the ground that it is not satisfied as mentioned in paragraph (1 1) of that regulation,

an appeal to the Secretary of State may be made in accordance with paragraph (4) against that determination or, as the case may be, against that refusal, by any person specified in paragraph (2).

(2) The persons who may make an appeal under this regulation are—

(a)in the case of an appeal against a determination under regulation 3OE, the applicant or any person whose name is included in the medical list or a pharmaceutical list of—

(i)the Family Health Services Authority, or

(ii)any other Family Health Services Authority to which the application was sent under regulation 3OE(1)(c),

and who submitted evidence pursuant to paragraph I of Schedule 4B in connection with the application.

(b)in the case of an appeal against a refusal mentioned in paragraph (1)(b), the applicant.

(3) Where, in determining any application, the Family Health Services Authority has, pursuant to regulation 3OE(5), considered that application together with one or more other applications, any of the applicants may appeal against the determination of any of the applications, and where the Secretary of State receives appeals against two or more of the determinations, those appeals shall be considered together.

(4) An appeal shall be made in writing within one month from the date on which notice of the decision was sent to the appellant or within such further time as the Secretary of State may, for reasonable cause, allow and shall contain a concise statement of the facts and the contentions upon which the appellant relies.

(5) If, after considering the particulars of the statement furnished by the appellant, the Secretary of State is of the opinion that they do not disclose any reasonable grounds of appeal or that the appeal is otherwise vexatious or frivolous, he may determine the appeal forthwith by dismissing it.

(6) Subject to paragraph (5), where an appeal is received, the Secretary of State shall send a copy of the notice of appeal to the Family Health Services Authority whose determination is appealed against and to those persons mentioned in paragraph (2)(a).

(7) Any person to whom a copy of the notice of appeal is sent pursuant to paragraph (6) may, within one month from the date the notice was sent to him, make representations in writing on the appeal to the Secretary of State.

(8) The Secretary of State may require an oral hearing of an appeal before he determines it.

(9) Where the appeal is against the determination of a Family Health Services Authority whose locality is situated in Wales, the Secretary of State shall, where he requires an oral hearing, appoint one or more persons to hear the appeal who shall report to him thereon stating the relevant findings of fact and conclusions.

(10) The procedure at any oral hearing shall be determined by the Secretary of State, except that where paragraph (9) applies it shall be determined by the person or persons hearing the appeal.

(11) An oral hearing shall take place at such time and place as the Secretary of State may direct, and notice of the hearing shall be sent, not less than ten days before the date fixed for the hearing, to the appellant, the Family Health Services Authority, the Local Medical Committee, the Local Pharmaceutical Committee and any other person or body who gave evidence to the Family Health Services Authority in connection with the application.

(12) The appellant and any of the persons to whom notice of the hearing is required to be sent may attend and be heard in person or by Counsel, solicitor or other representative and the Family Health Services Authority may be represented at the hearing by any duly authorised officer or member, or by Counsel or solicitor.

(13) On an appeal under this regulation, the Secretary of State—

(a)may grant the application;

(b)may grant the application subject to such conditions as he may see fit to impose;

(c)shall, where he allows an appeal against a refusal of the Family Health Services Authority as mentioned in paragraph (1)(b), remit the application to the Family Health Services Authority and direct that regulation 3OE(10) shall not apply; or

(d)may dismiss the application.

(14) The decision of the Secretary of State shall be given in writing and shall—

(a)include a statement of the reasons for the decision and findings of fact material thereto, and

(b)as soon as practicable, be sent to the persons and bodies mentioned in paragraph (11).

(15) For the purposes of this regulation, “conditions” means the postponement of the making of arrangements under regulation 30 for the provision by a doctor of pharmaceutical services for patients of his, or the postponement of the termination of such arrangements.”.

Insertion of regulation 33C in the principal Regulations

8.  After regulation 33B of the principal Regulations, there shall be inserted the following new regulation:—

“Determination of question whether a substance is a drug, and recovery of cost

33C.—(1) Any question whether a substance supplied by a doctor, or by a chemist on the order of a doctor, was a drug forming part of pharmaceutical services provided under the Act shall be determined under the provisions of this regulation.

(2) Where it appears to the Family Health Services Authority that a question arises under sub-paragraph (1), the Family Health Services Authority shall, in writing—

(a)notify the doctor who ordered the substance of the nature of the question arising; and

(b)invite him to state in writing, within one month from the date on which the notice was sent to him, whether he wishes the question to be referred to the Local Medical Committee (in this regulation referred to as “the Local Committee”) for its opinion.

(3) The Family Health Services Authority—

(a)shall, where the doctor states that he wishes the question to be referred to the Local Committee for its opinion, refer the question accordingly;

(b)in any other case, may refer the question to the Local Committee for its opinion; and

(c)may, in any event, seek such medical or pharmaceutical opinion as it thinks fit otherwise than from the Local Committee.

(4) Where the question is referred to the Local Committee under the provisions of paragraph (3), the Local Committee shall—

(a)furnish the doctor concerned with a statement indicating the nature of the question referred to it by the Family Health Services Authority; and

(b)give the doctor concerned a reasonable opportunity to—

(i)submit to it any statement in writing; and

(ii)appear before it and be heard by it,

in connection with the question so referred.

(5) The Local Committee shall—

(a)in forming its opinion under this regulation, have regard to any information or evidence provided by the Family Health Services Authority in connection with the question referred to it; and

(b)inform the doctor and the Family Health Services Authority, in writing, of its opinion, its findings of fact and its reasons for its opinion.

(6) The Family Health Services Authority shall—

(a)send notice of the question, in writing, to the doctor who ordered the substance, to the person to whom the order was given and to any other person who, in the opinion of the Family Health Services Authority, has an interest in the determination of the question; and

(b)invite any such person to submit to the Family Health Services Authority his comments in writing on that question within one month or within such further period as the Family Health Services Authority may for reasonable cause allow.

(7) The Family Health Services Authority shall, in determining the question, have regard to any opinion obtained by it under any of the provisions of paragraphs (3) to (5), and shall—

(a)send notice of its decision in writing to—

(i)the doctor concerned,

(ii)the Local Committee, and paragraph (6); and

(iii)any person who submitted comments under paragraph (6) and

(b)where it determines that the substance in question is not a drug forming part of pharmaceutical services, inform the doctor of his right of appeal to the Secretary of State.

(8) Where the Family Health Services Authority has determined that the substance in question is not a drug forming part of pharmaceutical services, the doctor may appeal to the Secretary of State by giving notice of appeal, within one month from the date on which the notice of the decision was sent to him or within such longer period as the Secretary of State may, for reasonable cause, allow.

(9) Any appeal made under this regulation shall be made in writing and shall contain a concise statement of the facts and contentions upon which the appellant intends to rely.

(10) The Secretary of State shall send a copy of the notice of appeal to the Family Health Services Authority whose determination is appealed against and to any person who submitted comments to the Family Health Services Authority under paragraph (6).

(11) Any person to whom a copy of the notice of appeal is sent pursuant to paragraph (10) may, within one month from the date on which the notice was sent to him, make representations in writing to the Secretary of State on the appeal.

(12) The Secretary of State shall require an oral hearing of the appeal before he determines it.

(13) An oral hearing shall take place at such time and place as the Secretary of State may direct, and notice of the hearing shall be sent, not less than 14 days before the date fixed for the hearing, to the persons mentioned in paragraph (10).

(14) The appellant and any person mentioned in paragraph (10) may attend and be heard in person or by Counsel, solicitor or other representative and the Family Health Services Authority may be represented at the hearing by any duly authorised officer or member, or by Counsel or solicitor.

(15) The Secretary of State shall determine the procedure at the oral hearing as he sees fit.

(16) The Secretary of State shall, as soon as practicable, send to the appellant and to any person mentioned in paragraph (10) of this regulation notice in writing of his decision on the appeal and shall include in the notice a statement of his reasons for the decision and of his findings of fact.

(17) Where a Family Health Services Authority or, on appeal, the Secretary of State has determined under these Regulations that any substance supplied to a person was not a drug forming part of pharmaceutical services provided under the National Health Service Act 1977(4), the Family Health Services Authority shall recover from the doctor who ordered the substance, by deduction from his remuneration or otherwise, an amount calculated in accordance with paragraph (19) of this regulation.

(18) Any amount determined as being recoverable under this regulation shall be a debt owing by the doctor to the Family Health Services Authority by which it is recoverable.

(19) For the purposes of paragraph (17), the amount to be recovered in respect of the supply of any substance shall be the cost of that substance to the Family Health Services Authority including the dispensing fee payable in respect of the supply of the preparation, and where the substance was an ingredient in a preparation of which other ingredients were drugs, the amount to be recovered shall be the cost of that substance to the Family Health Services Authority together with one-half of the amount of the dispensing fee payable in respect of the supply of the preparation.”.

Amendment of Schedule 3A to the principal Regulations

9.  In Schedule 3A to the principal Regulations (drugs and other substances not to be prescribed for supply under pharmaceutical services)(5)—

(a)the following entries shall be omitted:—

“Adexolin Vitamin Drops

Normacol Antispasmodic”;

(b)the following entries shall be inserted at the appropriate places in the alphabetical order:—

“Acarosan Foam

Acarosan Moist Powder

Acnaveen Bar

Altelave Liquid

Aveeno Baby

Aveenobar

Beecham CoughCaps

Biocare GLA Complex Tablets

Biocare Efaplex Linseed/GLA Blend Capsules

Buttercup Syrup Honey and Lemon

Colgate Dental Cream with MFP Fluoride

Cupanol Over Six Paracetamol Suspension

Disprin Solmin Tablets

Efamolia Night Cream

Emulave

EPOC Capsules

Flurex Bedtime Cold Remedy

Flurex Capsules

Flurex Decongestant Inhalant Capsules

Flurex Hot Lemon Concentrate

Flurex Tablets

Gale’s Honey

Galloway’s Bronchial Cough Care

GF Brand English Style Mustard

Kenco Instant Decaffeinated Coffee

Lamberts Evening Primrose 011 250mg Capsules

Lamberts Evening Primrose 011 500mg Capsules

Lamberts Evening Primrose Oil 1000mg Capsules

Lyons Ground Coffee Beans

Macleans Toothpaste

Micaveen

Mitchell’s Wool Fat Soap

Nescafe Instant Coffee

Nestlé Nativa HA

Oilatum Soap

Power GLA 65 (Borage Oil) Capsules

Progress Powder

Rite-Diet Diabetic Cherry Cake

Robitussin Expectorant

Robitussin Expectorant Plus

Schar Gluten Free Sponge Cakes

SR Toothpaste (Gibbs)

Unichem Cold Relief Capsules”.

Amendment of Schedule 4B to the principal Regulations

10.  In Schedule 4B to the principal Regulations (procedure for determination of application under regulation 3OE), after paragraph 3 there shall be inserted the following paragraph:—

“3A.  The applicant and any person mentioned in paragraph 1 or 2 shall be entitled to be represented at any oral hearing in the presentation of his case by some other person who is not a barrister, solicitor or any member of the Family Health Services Authority or any of its committees or sub-committees.”.

Amendment to Schedule 4C to the principal Regulations

11.  In Schedule 4C to the principal Regulations (provisions further to regulation 26)—

(a)in Part I (procedure on, and determination of, applications to which regulation 26(3) or (4) applies), for paragraph 4 (appeals) there shall be substituted the following paragraph:—

“4.—(1) In a case to which regulation 26(3) applied—

(a)the applicant or any person, except the Community Health Council, mentioned in paragraph I of this Schedule may, if he is aggrieved by the decision, appeal to the Secretary of State; and

(b)any such appeal shall be sent to the Secretary of State within one month from the date on which the Family Health Services Authority sent its decision to the appellant or within such further time as the Secretary of State may, for reasonable cause, allow.

(2) In a case to which regulation 26(4) applied—

(a)the applicant or any person, except the Community Health Council who submitted representations to the Family Health Services Authority in accordance with paragraph 1 of this Schedule may, if he is aggrieved by the decision, appeal to the Secretary of State; and

(b)any such appeal shall be sent to the Secretary of State within one month from the date on which the Family Health Services Authority sent its decision to the appellant or within such further time as the Secretary of State may, for reasonable cause, allow.

(3) Any appeal made under this paragraph shall contain a concise statement of the facts and contentions upon which the appellant intends to rely.

(4) If the Secretary of State, after considering the notice of appeal, is of the opinion that it discloses no reasonable grounds of appeal or that the appeal is otherwise vexatious or frivolous, he may determine the appeal by dismissing it.

(5) The Secretary of State shall send a copy of the notice of appeal to the Family Health Services Authority whose determination is appealed against and to any person who submitted representations to the Family Health Services Authority under paragraph I of this Schedule.

(6) Any person to whom a copy of the notice of appeal is sent pursuant to sub-paragraph (5) of this paragraph may, within one month from the date on which the notice was sent to him, make representations in writing to the Secretary of State on the appeal.

(7) The Secretary of State may require an oral hearing before he determines the appeal.

(8) Where the appeal is against the determination of a Family Health Services Authority whose locality is situated in Wales, the Secretary of State shall, where he requires an oral hearing, appoint one or more persons to hear the appeal who shall report thereon to him stating the relevant findings of fact.

(9) The procedure at any oral hearing shall be determined by the Secretary of State, except that where sub-paragraph (8) of this paragraph applies it shall be determined by the person or persons hearing the appeal.

(10) An oral hearing shall take place at such time and place as the Secretary of State may direct, and notice of the hearing shall be sent, not less than ten days before the date fixed for the hearing, to the persons mentioned in sub-paragraph (5) of this paragraph.

(11) The appellant and any person mentioned in sub-paragraph (5) of this paragraph may attend the hearing and be heard in person or by Counsel, solicitor or other representative, and the Family Health Services Authority may be represented at the hearing by any duly authorised officer or member, or by Counsel or solicitor.

(12) The Secretary of State shall, as soon as practicable, send to the appellant and to any person mentioned in sub-paragraph (5) of this paragraph notice in writing of his decision on the appeal and shall include in the notice a statement of his reasons for the decision and of his findings of fact.”;

(b)Part IV (appeals) shall be omitted.

Amendment of the National Health Service (Service Committees and Tribunal) Regulations 1974

12.  In the National Health Service (Service Committees and Tribunal) Regulations 1974(6)—

(a)regulation 20 (determination of question whether a substance was a drug, and recovery of cost) shall be omitted;

(b)in regulation 53 (power of Secretary of State to extend time for appeals), the figure “20,” shall be omitted.

Transitional arrangements

13.—(1) Where, prior to 1st April 1991—

(a)any appeal has been made or question referred to—

(i)the Rural Dispensing Committee for determination under regulation 3OF of the principal Regulations as then in force,

(ii)an Appeal Panel for determination under Part IV of Schedule 4C to the principal Regulations as then in force,

(iii)the Secretary of State for determination under any provision of the principal Regulations as then in force, or

(iv)a Local Medical Committee or the Secretary of State for determination under regulation 20 of the National Health Service (Service Committees and Tribunal) Regulations 1974 as then in force; and

(b)that appeal or question has not been determined by the Rural Dispensing Committee, the Appeal Panel, the Local Medical Committee or the Secretary of State, as the case may be,

the principal Regulations shall, in relation to the determination of that appeal or question, have effect as if these Regulations had not come into force.

(2) Where, by virtue of paragraph (1)(a)(iv) of this regulation, any Local Medical Committee determines, on or after I st April 1991, a question which was referred to it before that date, that determination shall be treated for the purposes of regulation 33C(8) of the principal Regulations as if it were a determination of the Family Health Services Authority under paragraph (7) of that regulation.

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the National Health Service (General Medical and Pharmaceutical Services) Regulations 1974 (“the principal Regulations”) which govern the arrangements to be made by Family Health Services Authorities for the provision in their locality of general medical services and pharmaceutical services under the National Health Service Act 1977 (“the Act”).

These Regulations amend regulations 26 and 26C of the principal Regulations to enable an application by a chemist for preliminary consent to provide pharmaceutical services, which may be made in respect of any locality whether determined to be rural in character or not, to be determined by the Family Health Services Authority concurrently with an application to be included in the pharmaceutical list (regulations 3 and 4), and regulation 29 of the principal Regulations, is amended to make provision for appeals to the Secretary of State in relation to the preparation of schemes by Family Health Services Authorities for securing proper pharmaceutical services (regulation 5).

Amendments are also made to the principal Regulations by regulation 6 to enable Family Health Services Authorities to take steps to reduce adverse consequences to a doctor or a pharmacist where it has been determined that an area is or is not rural in character.

These Regulations also amend the principal Regulations to provide for appeals to the Secretary of State from determinations of Family Health Services Authorities in respect of the question whether an area is rural in character and to make further provision for appeals to the Secretary of State from the determination of those Authorities of applications by chemists and doctors relating to the provision of pharmaceutical services in an area which is determined to be rural in character (regulation 7).

A new regulation 33C is inserted in the principal Regulations to provide in particular for the determination by Family Health Services Authorities, and on appeal by the Secretary of State, of any question whether a substance which has been prescribed by a doctor is a drug forming part of pharmaceutical services (regulation 8).

Regulation 9 includes certain substances in Schedule 3A to the principal Regulations, which contains a list of drugs and other substances which may not be prescribed for supply, and which may not be dispensed, in the course of pharmaceutical services under the Act, and removes certain substances presently included in the list.

Regulation 10 amends Schedule 4B to the principal Regulations to allow any person entitled to be heard at an oral hearing of an application of preliminary consent or outline consent before Family Health Services Authorities to be represented.

Regulation 11 amends Schedule 4C to the principal Regulations to make provision for appeals to the Secretary of State from determinations of Family Health Services Authorities of applications made by chemists to be included in pharmaceutical lists, and abolishes the appeal panel which hitherto has determined such appeals.

Regulation 12 revokes regulation 20 of the National Health Service (Service Committees and Tribunal) Regulations 1974 which made provision for the determination by the Local Medical Committee, and on appeal by the Secretary of State, of the question whether a substance is a drug, and makes a consequential amendment in regulation 53 of those Regulations.

These Regulations also make transitional provision in connection with the determination of questions and appeals (regulation 13), and make other amendments which are either of a minor or consequential nature.