Philip Davies – 2015 Parliamentary Question to the Department of Health
The below Parliamentary question was asked by Philip Davies on 2015-11-05.
To ask the Secretary of State for Health, which regulations his Department introduced as a result of EU legislation in (a) 2013, (b) 2014 and (c) 2015 to date; which regulations his Department expects to implement as a result of EU legislation in (i) 2016 and (ii) 2017; and what estimate he has made of the cost of such regulation to the (A) public purse and (B) private sector.
Jane Ellison
In the years indicated, the Department has introduced the following regulations, either wholly or partially, as a result of European Union legislation:
2013
– Statutory Instruments 2013/1855 and 2013/2593 concerning the regulation of medicines.
– Statutory Instrument 2013/2327 concerning the regulation of medical devices.
– National Health Service (Cross-Border Healthcare) Regulations 2013 (SI 2013/2269).
– The Infant Formula and Follow-on Formula (England) (Amendment) Regulations 2013 (SI 2013/3243).
– Medical Profession (Responsible Officers) (Amendment) Regulations 2013.
2014
– Statutory Instrument 2014/490 concerning the regulation of medicines.
– Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (SI 2014/1459).
– Health Care and Associated Professions (Indemnity Arrangements) Order 2014 (Order 2014/1887).
– The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2014 (SI 2014/2883).
– The Human Fertilisation and Embryology (Quality and Safety) Regulations 2014 (SI 2014/2884).
– General Medical Council (Fitness to Practise) (Amendment) Rules Order of Council 2014.
– General Medical Council (Licence to Practise and Revalidation) (Amendment) Regulations Order of Council 2014.
– General Medical Council (Restoration following Administrative Erasure) (Amendment) Regulations Order of Council 2014.
– General Medical Council (Voluntary Erasure and Restoration following Voluntary Erasure) (Amendment) Regulations Order of Council 2014.
– Medical Act 1983 (Amendment) (Knowledge of English) Order 2014.
– The Human Medicines (Amendment) Regulations 2014.
2015 to date:
– National Health Service (Cross-Border Healthcare) (Amendment) Regulations 2015 (SI 2015/139).
– General Chiropractic Council (Indemnity Arrangements) Rules Order of Council 2015.
– General Osteopathic Council (Indemnity Arrangements) Rules Order of Council 2015.
– General Medical Council (Fitness to Practise and Over-arching Objective) and the Professional Standards Authority for Health and Social Care (References to Court) Order 2015.
– Health Care and Associated Professions (Knowledge of English) Order 2015.
– Health Care and Associated Professions (Knowledge of English) Order 2015 (Commencement No 1) Order of Council 2015.
In the years indicated, the Department expects to implement the following regulations as a as a result of EU legislation:
2016
– The Human Fertilisation and Embryology (Quality and Safety) Regulations 2016.
– The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2016.
– Regulation (EU) 609/2013, concerning detailed requirements as to the composition of certain specific types of food (infant and follow-on formula; processed cereal-based foods and baby foods; foods for special medical purposes; and total diet replacement for weight control), and the nutritional information that must be provided in respect of such foods.
– The European Qualification (Health and Social Care Professions) Regulations 2016.
– The Tobacco and Related Products Regulations 2016.
2017
– Regulations implementing the EU Regulation on Clinical Trials and Regulations implementing the two EU Regulations on Medical Devices and In-vitro Medical Devices.
When the Department makes regulations that transpose EU legislation, it follows the guidance and framework set by the Better Regulation Executive. This requires the Department to prepare and publish an impact assessment only when the net costs to business are greater than £1 million per year. These would be laid with associated regulations and explanatory memorandum.
