Skip to main content

Departmental Legislation

Volume 503: debated on Thursday 7 January 2010

To ask the Secretary of State for Health what criminal offences have been (a) created and (b) abolished by secondary legislation sponsored by his Department since 1 May 2008. (307798)

The criminal offences created by secondary legislation (a total of four statutory instruments) since 1 May 2008 are as follows:

Regulation 6 of the Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009 (S.I. 2009/660) made it a criminal offence for a person registered as a service provider to contravene or fail to comply with the provisions of regulation 5 of those regulations which set out requirements which a service provider has to meet in relation to the prevention and control of health care associated infections. This came into force on 1 April 2009.

Regulation 25 of the Care Quality Commission (Registration) Regulations 2009 (S.I. 2009/3112) makes it a criminal offence for a person to contravene or fail to comply with the provisions of these regulations which set out requirements which registered persons are required to meet in carrying out regulated activities. This will come into force on 1 April 2010.

The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936) implement directive 2007/47/EC on general medical devices and directive 90/385/EEC on active implantable devices. These will come into force on 21 March 2010. They amend the Medical Devices Regulations 2002 (SI 2002/618) by adding additional requirements, each of which is punishable as a criminal offence, if not complied with. For general medical devices:

A new regulation 8(3) of the Active Implantable Medical Devices Regulations 1992 is created, under which where a hazard exists, devices which are also machinery must also meet the essential health and safety requirements set out in annex I to directive 2006/42 to the extent to which those essential health and safety requirements are more specific than the essential requirements to directive 93/42;

Regulation 9 is amended, so that when a custom-made device is supplied to a patient, the health care professional who writes the prescription for the custom-made device must, in relation to each patient that they supply with such a device, (a) ensure that the patient is aware that they may request the statement containing the information required by sections 1 and 2 of annex VIII; and (b) ensure that the statement containing the information required by sections 1 and 2 of annex VIII is made available to the patient on request;

Regulation 14 is amended so that where a device is intended by the manufacturer to be used in conjunction with both the provisions in council directive 89/686/EEC on the approximation or the laws of the member states relating to personal protective equipment and directive 93/42, the relevant basic health and safety requirements of that directive must also be fulfilled;

Regulation 16 is amended, requiring the manufacturer, or their single authorised representative, to (a) notify the Secretary of State of the end of the clinical investigation; and (b) provide justification where premature termination has resulted.

Similar amendments are made to the provisions of the Active Implantable Medical Devices Regulations 1992 which deal with active implantable devices:

Regulation 30 is amended so that the manufacturer of an active implantable device, who under their own name places devices on the market, must provide the Secretary of State with (a) the address of their registered place of business; (b) a description of the devices concerned; and (c) details of the label and instructions for use that accompany each device. Where they do not have a registered place of business in a member state, the manufacturer must (a) designate a single authorised representative; and (b) ensure that the authorised representative has a registered place of business in a member state.

The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (SI 2008/3097) amend the Medicines for Human Use (Marketing Authorisation Etc.) Regulations (SI 1994/3144) so as to give effect to Regulation (EC) No. 1901/2006 on medicinal products for paediatric use, which establishes a scheme of obligations and incentives to encourage the development of, and improve access to, medicines for children. These came into force on 29 December 2008. They amend the 1994 regulations by imposing several additional requirements, each of which is punishable as a criminal offence:

An authorisation holder must submit an annual report to the European Medicines Agency (EMEA) as required by article 34(4) of the paediatric regulation;

A new paragraph 6BA is added, so that where the holder of a United Kingdom marketing authorisation has benefited from rewards or incentives under articles 36, 37 or 38 of the paediatric regulation in relation to the product to which the authorisation relates and the periods of protection provided pursuant to those articles have expired, he shall be guilty of an offence if he discontinues the placing of that product on the market without previously, in compliance with article 35 of the paediatric regulation (a) transferring the marketing authorisation of that product to another person who has declared his intention to continue to place that product on the market, or (b) allowing use by such a person of the pharmaceutical, pre-clinical and clinical documentation contained in the file on that product on the basis of article 10c of the directive 2001/83/EC;

A new paragraph 6BB is added, so that where the holder of a United Kingdom marketing authorisation has benefited from rewards or incentives under articles 36, 37 or 38 of the paediatric regulation in relation to the product to which the authorisation relates, and the periods of protection provided pursuant to those articles have expired, he shall be guilty of an offence if he discontinues the placing of that product on the market without informing the EMEA in compliance with article 35 of the paediatric regulation, at least six months before the discontinuation of his intention to discontinue the placing of the product on the market;

A new paragraph 6G is added, so that where any person who (a) is the holder of a United Kingdom marketing authorisation (b) obtains a paediatric indication in respect of the product to which the marketing authorisation relates following completion of an agreed paediatric investigation plan, (c) has marketed that product for other indications prior to obtaining that paediatric indication and (d) fails to place the product on the market taking account of the paediatric indication within two years of the date on which the paediatric indication is authorised as required by article 33 of the paediatric regulation, he shall be guilty of an offence;

A new paragraph 13B(1) is added, so that any person established in the United Kingdom to whom a decision by the EMEA in respect of a paediatric investigation plan is addressed shall be guilty of an offence if the plan relates to a product which does not have a Community marketing authorisation and the person fails to (a) enter into the database referred to in article 11 of the clinical trials directive within a period of six months beginning with the date that the decision was received, the details set out in that article in relation to clinical trials referred to in the paediatric investigation plan and carried out in third countries as required by article 41(1) of the paediatric regulation; or (b) submit the results of those clinical trials to the EMEA within a period of six months beginning with the date that the trial ended as required by article 41(2) of the paediatric regulation;

A new paragraph 13B(2) is added, so that where the holder of a United Kingdom marketing authorisation instigates or conducts a paediatric clinical trial in the United Kingdom in respect of the product to which the authorisation relates and the trial is not included in a paediatric investigation plan, he shall be guilty of an offence if he fails to submit the results of that trial to the EMEA within a period of six months beginning with the date that the trial ended, as required by article 41(2) of the paediatric regulation;

A new paragraph 13B(3) is added, so that where the holder of a United Kingdom marketing authorisation has instigated or conducted a paediatric clinical trial in the United Kingdom which ended on or after 26 January 2007 but before 29 December 2008 in respect of the product to which the authorisation relates and the trial is not included in a paediatric investigation plan, he shall be guilty of an offence if he fails to submit the results of that trial to the EMEA on or before 29 June 2009, as required by article 41(2) of the paediatric regulation;

A new paragraph 13B(4) is added, so that where any person who (a) is the sponsor of a paediatric clinical trial in the United Kingdom in respect of a medicinal product (i) with a United Kingdom marketing authorisation, but where the trial is not instigated by the marketing authorisation holder; or (ii) without a United Kingdom or Community marketing authorisation, where the trial is not included in a paediatric investigation plan; and (b) fails to submit the results of that trial to the EMEA within the period of six months beginning on the date that the trial ended as required by article 41(2) of the paediatric regulation, he shall be guilty of an offence;

A new paragraph 13B(5) is added, so that where any person who (a) has sponsored a paediatric clinical trial in the United Kingdom in respect of a medicinal product (i) with a United Kingdom marketing authorisation, but who is not the marketing authorisation holder; or (ii) without a United Kingdom or Community marketing authorisation, where the trial is not included in a paediatric investigation plan and ended on or after 26 January 2007 but before 29 December 2008; and (b) fails to submit the results of that trial to the EMEA on or before 29 June 2009 as required by article 41(2) of the paediatric regulation, he shall be guilty of an offence;

A new paragraph 13B(6) is added, so that any holder of a United Kingdom marketing authorisation who (a) has knowledge of a paediatric study in respect of the product to which the authorisation relates that ended on or before 25 January 2007; and (b) fails to submit that paediatric study to the licensing authority on or before 29 June 2009 as required by article 45(1) of the paediatric regulation, shall be guilty of an offence;

A new paragraph 13B(7) is added, so that any holder of a United Kingdom marketing authorisation who (a) sponsors a paediatric study in respect of the product to which the authorisation relates; and (b) fails to submit the results to the licensing authority within a period of six months beginning with the date that the trial ended as required by article 46(1) of the paediatric regulation, shall be guilty of an offence;

A new paragraph 13B(8) is added, so that any holder of a United Kingdom marketing authorisation who (a) has sponsored a paediatric study in respect of the product to which the authorisation relates which ended on or after 26 January 2007 but before 29 December 2008; and (b) fails to submit the results to the licensing authority on or before 29 June 2009 as required by article 46(1) of the paediatric regulation, shall be guilty of an offence.

No criminal offences have been abolished by secondary legislation since 1 May 2008.