Source: http://www.legislation.gov.uk/uksi/2018/677/made
Timestamp: 2018-08-22 06:35:36
Document Index: 123731992

Matched Legal Cases: ['art 4', 'art 7', 'art 2', 'art 3', 'art 4', 'art 1', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 6', 'art 7', 'art 8', 'art 8', 'art 9', 'art 10']

The Secretary of State for Health and Social Care makes the following Regulations in exercise of the powers conferred by sections 264A(2), (5) and (7), 264B(1)(k) and (l) and (3)(g), 265(1), (5)(b) and (5A) and 272(7) and (8) of the National Health Service Act 2006(1).
The Secretary of State, in accordance with sections 264C(1) and 265(9) of that Act(2), has consulted the industry body and such other bodies appearing to the Secretary of State appropriate to represent UK producers.
(a)requires a person who provides primary medical services under Part 4 of the 2006 Wales Act, or any person who provides services under Part 7 of that Act, to record, keep or provide information relating to any Welsh health service products(3) which are supplied by the person in providing the services in question;
(b)requires a person who provides primary medical services under section 2C(1) of the 1978 Act, or any person who provides pharmaceutical care services under section 2CA(1) of that Act, to record, keep or provide any information relating to any Scottish health service products(4) which are supplied by the person in providing the services in question;
(c)requires a person who provides primary medical services or pharmaceutical services under Part 2 or 6 of the 1972 Order to record, keep or provide information about Northern Ireland health service products(5) which are supplied by the person in providing the services in question.
4. Nothing in these Regulations requires a UK producer(6) to record and keep, or provide, information about a product if the producer could not reasonably have known, at the time the producer purchased or supplied the product, that it was, or was to be, a UK health service product(7).
6.—(1) In these Regulations, “unbranded generic health service medicine” means a health service medicine(8) the labelling of which includes the common name of the product, but does not include an invented name.
(3) The names mentioned in paragraphs (a) to (e) of the definition of “non-proprietary name” (and their permitted variations) have the same meanings as in a list of names which has been prepared and published under regulation 318 of the 2012 Regulations and which is in force(9).
(a)in the Drug Tariff (England)(10) for the given month,
(b)in the Drug Tariff (Wales)(11) for the given month,
(c)in the Drug Tariff (Scotland)(12) for the given month, or
(d)in the Drug Tariff (Northern Ireland)(13) for the given month.
(a)a manufacturer(14), or
“special health service medicine” means a health service medicine which is a special medicinal product (within the meaning of regulation 167(15) of the 2012 Regulations).
25.—(1) If the Secretary of State requires the information for the statutory purpose, the Secretary of State may by information notice(16) require a UK producer to provide specified information in respect of any relevant costs incurred by the producer—
“notifiable presentation” means a presentation of health service medicine in respect of which a marketing authorisation has been granted other than a presentation of such medicine in respect of which a parallel distribution notice(17) with the United Kingdom as the Member State of destination has been given;
35.—(1) Until the coming into force of the repeal of section 27 of the 1978 Act by Schedule 3 to the Smoking, Health and Social Care (Scotland) Act 2005(18), any reference in these Regulations to pharmaceutical care services under section 2CA(1) of the 1978 Act is to be read as a reference to pharmaceutical services under section 27(1) of that Act.
“Scheme M” means the Scheme made by the Secretary of State and the British Generic Manufacturers Association which is dated March 2010 and known as the “Revised long-term arrangements for reimbursement of generic medicines (Scheme M)”(19);
“Scheme W” means the Scheme made by the Secretary of State, the British Association of Pharmaceutical Wholesalers and the British Association of Generic Distributors which is dated June 2005 and known as the “New long-term arrangements for reimbursement of generic medicines (Scheme W)”(20);
“the 1978 Act” means the National Health Service (Scotland) Act 1978(21);
“the 2006 Act” means the National Health Service Act 2006(22);
“the 2006 Wales Act” means the National Health Service (Wales) Act 2006(23);
“the 1972 Order” means the Health and Personal Social Services (Northern Ireland) Order 1972(24);
“the 2000 Regulations” means the Health Service Medicines (Price Control Appeals) Regulations 2000(25);
“the 2012 Regulations” means the Human Medicines Regulations 2012(26);
“the Drug Tariff (England)” means the publication known as the Drug Tariff and published by the Secretary of State under regulation 89 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013(27);
“the Drug Tariff (Northern Ireland)” means the publication known as the Drug Tariff and published by the Department of Health under regulation 9 of the Pharmaceutical Services Regulations (Northern Ireland) 1997(28);
“the Drug Tariff (Wales)” means the publication known as the Drug Tariff (“Tariff Cyffuriau”) and published under regulation 41 of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013(29);
in relation to any other UK producer, has the meaning given in section 390 of the Companies Act 2006(30);
“HSCIC” means the Health and Social Care Information Centre(31);
is mentioned in Part 3 of Schedule 1 to the Freedom of Information Act 2000(32) or in Part 4 of Schedule 1 to the Freedom of Information (Scotland) Act 2002(33); and
a bank holiday in any part of the United Kingdom under the Banking and Financial Dealings Act 1971(34).
“the 2006 Regulations” means the Public Contracts Regulations 2006(35);
“the 2012 Scotland Regulations” means the Public Contracts (Scotland) Regulations 2012(36);
“the 2015 Regulations” means the Public Contracts Regulations 2015(37);
“the 2015 Scotland Regulations” means the Public Contracts (Scotland) Regulations 2015(38);
The Regional Health and Social Care Board established under section 7 of the Health and Social Care (Reform) Act Northern Ireland 2009(39) The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(k).
Section 264A of the National Health Service Act 2006 (“the 2006 Act”) provides for the Secretary of State to make regulations to require UK producers to record and keep information which the Secretary of State may require for the purpose set out in subsection (3) of that section and to provide that information to Secretary of State (section 264A(2) of the 2006 Act).
A “UK producer” is a person who manufactures, distributes or supplies any UK health service products (section 264A(1) of the 2006 Act). “UK health service products” are medicinal products, medical supplies and other related products used for any purposes of any of the health services in England, Wales, Scotland or Northern Ireland (section 264A(10) to (15)).
Section 264B of the 2006 Act sets out the persons to whom information provided by virtue of section 264A may be disclosed. That section imposes further restrictions on the use of any such information which is commercially sensitive or confidential. The persons to whom information may be disclosed include persons prescribed in regulations by the Secretary of State under section 264B(1)(k) or (l). The Secretary of State must also prescribe in regulations the purposes for which those bodies may use any commercially sensitive or confidential information.
These Regulations make provision for the purposes of sections 264A and 264B(1)(k) and (l) of the 2006 Act.
Part 1 of the Regulations
Part 1 of the Regulations deals with citation and commencement of the Regulations (regulation 1), their application (regulation 3), exceptions (regulation 4) and presumptions which will apply if information is provided to the Secretary of State via an online gateway.
Regulation 2 and Schedule 1 are the general interpretation provisions for the Regulations. The terms defined here include “primary medical services provider”, “NHS chemist”, “importer”, “wholesaler” and “presentation of health service medicine”.
Part 2 of the Regulations deals with routine provision of information about the supply of unbranded generic health service medicines. “Unbranded generic health service medicine” is defined in regulation 6.
Manufacturers and importers of unbranded generic health service medicines must record and keep information about supplies of unbranded generic health service medicines in accordance with regulation 7. Wholesalers must record and keep information about their purchases and supply of unbranded generic health service medicines in accordance with regulation 8.
That information must be provided to the Secretary of State at quarterly intervals (regulation 9).
Part 3 of the Regulations deals with routine provision of information about the supply of made and imported special health service medicines. “Made special health service medicine” and “imported special health service medicine” are defined in regulation 10.
Manufacturers of made special health service medicines must record and keep information about their supply of those medicines in accordance with regulation 11. Wholesalers must record and keep information about their purchases and supply of made special health service medicines in accordance with regulation 12. Wholesalers and importers must record and keep information about their purchases and supply of imported special health service medicines in accordance with regulation 13.
That information must be provided to the Secretary of State at quarterly intervals (regulation 14).
Part 4 of the Regulations deals with the provision on request of general information about the supply of UK health service products. The key terms used in this Part are defined in regulation 15.
Regulations 16 to 19 set out the information about the supply of health service medicines that is to be recorded and kept by UK producers.
Regulations 20 to 22 set out the information out the information that is to be recorded and kept by UK producers about the supply of certain appliances and borderline substances.
The Secretary of State may, by written request, require a UK producer to provide any of the information recorded and kept under any of regulations 16 to 22 (regulation 23).
A UK producer who is a small producer may provide any of the requested information in the form of existing documents such as invoices (regulation 24). Whether a UK producer is a small producer is determined in accordance with Schedule 2 to the Regulations.
Part 5 of the Regulations deals with the provision of information about costs incurred by UK producers in connection with the manufacturing, distribution or supply of UK health service products.
The Secretary of State may, by information notice, require a producer to provide information about costs incurred in:
(a)the manufacturing of a particular presentation of unbranded generic health service medicine or special health service medicine,
(b)the distribution or supply of a particular presentation of health service medicine, or
(c)the manufacturing, distribution or supply of a particular appliance.
(regulation 25).
“Information notice” is defined in section 264A(6) of the 2006 Act. A producer who receives an information notice under this regulation may appeal that notice (regulation 33).
The Secretary of State may, by request in writing, require that a producer provide information about costs other than those mentioned above in accordance with regulation 26.
Part 6 of the Regulations deals with the provision of information about the price and availability of health service medicines.
Where the Secretary of State has reasonable grounds to suspect that a medicine is not available for supply to NHS chemists in England at the listed price, the Secretary of State may require manufacturers, importers or wholesalers of the medicine to provide information about the quantity available for supply in England and related prices. “The listed price” is the price listed for the medicine in Part VIII of the Drug Tariff (England) (regulation 27).
The Secretary of State may also require UK producers to provide information where the Secretary of State considers that there is a supply shortage of particular medicine (regulation 28).
Manufacturers and importers of health service medicines (other than medicines which are parallel imported or distributed) must notify the Secretary of State if:
(a)they intend to stop manufacturing or supplying a medicine and they consider this could have an impact on patients, or
(b)they consider there is likely to be a supply shortage of a medicine which could have an impact on patients.
(regulation 29).
Part 7 of the Regulations
Information that UK producers are required to provide under the Regulations may, in certain cases, be provided in the form of a reasonable estimate, rather than an actual amount. Where a producer provides information on the basis of such an estimate, regulation 30 allows the Secretary of State to require the producer to explain why an estimate has been used and also the method used to calculate that estimate.
Part 8 of the Regulations
Part 8 of the Regulations deals with enforcement and appeals.
If a UK producer does not comply with an obligation to provide information in or under the Regulations, or provides information which is incorrect or incomplete, the Secretary of State may give the producer a compliance notice (regulation 31). The notice must state the obligation that the Secretary of State considers the producer has not complied with, the information to be provided to remedy the failure and the period within which that information must be provided.
A UK producer who is given a compliance notice has a right of appeal against that notice (regulation 33).
If a UK producer does not comply with an information notice or a compliance notice, the producer becomes liable to pay a penalty to the Secretary of State (regulation 32). The amount of the penalty is to be calculated in accordance with regulation 32 and Schedule 3. There are different levels of penalty for UK producers who are small producers and those who are not. Whether a producer is a small producer is to be determined in accordance with Schedule 2.
The Secretary of State may issue a demand to a producer who is liable to pay a penalty requiring the payment of that penalty. A UK producer who is given such a demand has a right of appeal against the decision to require the payment of the penalty and also the amount of the penalty (regulation 33(6)). No daily penalty is payable for any day falling during the period for which the appeal is ongoing (regulation 32(10)).
Part 9 of the Regulations
Regulation 34 and Schedule 4 prescribe bodies for the purposes of section 264B(1)(k) and (l) of the 2006 Act. Those provisions also prescribe, in accordance with section 264B(3)(g) of the 2006 Act, the purpose for which those bodies may use any confidential or commercially sensitive information disclosed to them under section 264B of the 2006 Act.
Part 10 of the Regulations
Regulation 35 and Schedule 5 make transitional provision.
Regulation 36 provides for an annual review of the operation of the Regulations. The report setting out the first review of the Regulations must be published by 1st July 2019.
An impact assessment relating to these Regulations has been prepared and copies can be obtained from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU.
2006 c. 41; sections 264A and 264B were inserted by the Health Services Medical Supplies (Costs) Act 2017 (c. 23) (“the 2017 Act”), section 8. Section 265(5) was amended by the 2017 Act, section 10(9). Section 265(5A) was inserted by the 2017 Act, section 10(10). See section 275(1) of the National Health Service Act 2006 for the definition of “prescribed” and “regulations”.
Section 264C was inserted by the Health Services Medical Supplies (Costs) Act 2017, section 8. Section 265(9) was substituted by the Health Services Medical Supplies (Costs) Act 2017, section 10(13).
See the definition of “Welsh health service products” in section 264A(15) of the National Health Service Act 2006.
See the definition of “Scottish health service products” in section 264A(13) of the National Health Service Act 2006.
See the definition of “Northern Ireland health service products” in section 264A(12) of the National Health Service Act 2006.
See the definition of “UK producer” in section 264A(1) of the National Health Service Act 2006.
See the definition of “UK health service products” in section 264A(14) of the National Health Service Act 2006.
See section 266(6) of the National Health Service Act 2006 for the definition of “health service medicine”.
Copies of the list can be obtained from: https://www.pharmacopoeia.com/what-is-the-ban-book or The Stationery Office, PO Box 29, Norwich, NR3 1GN.
The Drug Tariff (England) is available at https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff or from NHS Business Services Authority, Stella House, Goldcrest Way, Newburn Riverside, Newcastle upon Tyne, NEI5 8NY.
The Drug Tariff (Wales) is available at https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff or from NHS Business Services Authority, Stella House, Goldcrest Way, Newburn Riverside, Newcastle upon Tyne, NEI5 8NY.
The Drug Tariff (Scotland) is available at http://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Scottish-Drug-Tariff/ or from Information Services Division, NHS National Services Scotland, Gyle Square, 1 South Gyle Crescent, Edinburgh EH12 9EB.
The Drug Tariff (Northern Ireland) is available at http://www.hscbusiness.hscni.net/services/2034.htm or from Business Services Organisation Headquarters, 2 Franklin Street Belfast, BT2 8DQ.
Regulation 167 of the 2012 Regulations was amended by S.I. 2017/715.
Scheme M is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU or online at: http://webarchive.nationalarchives.gov.uk/20130123201658/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_115260 .
Scheme W is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU or online at: http://webarchive.nationalarchives.gov.uk/20130123204650/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4114370