An Audit of the impact of the Department of Health’s Regulations upon business Final Report September 2013 1 Contents Executive summary .................................................................................................................. 4 Background .............................................................................................................................. 6 DH Regulatory landscape ......................................................................................................... 7 Audit Results .......................................................................................................................... 10 Annex A - Detailed commentary on the Department of Health’s stock of regulations ............. 12 1. Care Quality .................................................................................................................... 13 1.1 Care Quality Commission (CQC) .................................................................................. 13 1.2 Mental Health and Mental Capacity .............................................................................. 18 1.3 Social Care (Isles of Scilly) ........................................................................................... 23 1.4 Social Care other .......................................................................................................... 24 2. Medicines and Healthcare products Regulatory Agency (MHRA) ................................... 25 2.1 Blood ............................................................................................................................. 26 2.2 Clinical Trials................................................................................................................. 28 2.3 Devices ......................................................................................................................... 30 2.4 Fees .............................................................................................................................. 33 2.5 Good Laboratory Practice ............................................................................................. 36 2.6 Herbals ......................................................................................................................... 37 2.7 Homeopathics ............................................................................................................... 39 2.8 Pharmaceuticals ........................................................................................................... 41 2.9 Transmissible Spongiform Encephalopathies (TSEs) ................................................... 46 3. Medicines, Pharmacy, Dental and Ophthalmic Services ................................................. 48 3.1 Charges and benefits .................................................................................................... 50 3.2 Dental ........................................................................................................................... 52 3.3 General Pharmaceutical Services, Local Pharmaceutical Services, Controlled Drugs, Responsible Pharmacist and non-medical prescribing ....................................................... 54 3.4 Ophthalmic Services ..................................................................................................... 59 4. NHS ................................................................................................................................. 63 4.1 Cost recovery ................................................................................................................ 63 4.2 NHS Litigation ............................................................................................................... 67 5. Public Health ................................................................................................................... 70 5.1 Abortion ........................................................................................................................ 70 5.2 Blood and tissue ........................................................................................................... 73 5.3 Food composition, labelling and safety ......................................................................... 76 5.4 Healthy Start and Welfare Food .................................................................................... 78 2 An Audit of the impact of the Department of Health’s Regulations upon business 5.5 Health Protection .......................................................................................................... 81 5.6 Health Protection – Port Health and Travel ................................................................... 84 5.7 Health Protection – Vaccinations .................................................................................. 86 5.8 Human Fertilisation and Embryology Authority (HFEA) ................................................ 87 5.9 HIV / Venereal Disease ................................................................................................. 90 5.10 National Child Measurement Programme (NCMP) ..................................................... 92 5.11 Radiation ..................................................................................................................... 93 5.12 Surrogacy ................................................................................................................... 96 5.13 Tobacco ...................................................................................................................... 97 5.14 Other ......................................................................................................................... 103 6. Professional Standards ................................................................................................. 105 Annex B – Professional Standards additional information .................................................... 109 List of Registered Professions .......................................................................................... 109 Full List of Professional Standards Regulations ................................................................ 110 Annex C - Research Approach ............................................................................................. 116 Overview ........................................................................................................................... 116 Research Stages .............................................................................................................. 116 Estimating costs and benefits ........................................................................................... 117 Reliability rating ................................................................................................................ 119 Annex D – NHS regulations thought to have no impact to business .................................... 120 Annex E - the Department of Health’s closing position on Statement of New Regulation Five ............................................................................................................................................. 124 Annex F – Full tables of regulations in and out of scope and potential to revoke by policy area ............................................................................................................................................. 126 Annex G – Tobacco Control Additional information on costs and benefits ........................... 132 Annex H – Deregulatory measures ...................................................................................... 136 3 Executive summary 1. The purpose of this Audit report is to provide a thorough overview of all the regulations for which DH has responsibility that are thought to have an impact to business. The Audit describes why we have the regulations, provides an assessment of their estimated costs and, where possible, benefits to business and to wider society. The Audit has been conducted with a view to identifying regulations that should be removed or consolidated to reduce the regulatory burden the Department places on business and Civil Society Organisations (hereafter “business”) as well as reducing the number and scope of our regulations. 2. The scope of the Audit covered all regulations believed to have a potential cost to business. In a Cabinet Office trawl for the Red Tape Challenge (RTC) around 1,200 regulations had been identified as the responsibility of the Department of Health, a significant subset of which was put forward for review under the RTC. Many of the regulations attributed to the Department of Health (DH) clearly only impact on the public sector or are in fact owned by Other Government Departments. These were excluded from the scope of the Audit which has focussed on just over 650 individual regulations (Statutory Instruments for the most part). 3. There are differences between the set of regulations considered in this Audit and the set examined in the Red Tape Challenge phases one (Medicines) and two (Healthy Living and Social Care) which together cover 774 regulations. This is because this Audit did not include some regulations revoked shortly after RTC phase one (214 MHRA regulations) and because we included 91 additional regulations identified by policy teams outside of these RTC processes. The derivation of the set of regulations included in scope of the Audit is set out in the annex on the Research approach (Annex C). 4.