HTA Stakeholder Group meeting

Date 13 May 2014 Time 10.30 – 13.00 Venue Mary Sumner House

24 Tufton Street Westminster London SW1P 3RB

Agenda

1. Welcome and introductions Oral

2. Minutes, actions and matters arising from the last meeting

HTA SG (01/14)

3. HTA Stakeholder Group Terms of Reference (Information)

HTA SG (02/14)

4. Review of the HTA’s codes of practice 2014 to 2016 (Discussion)

HTA SG (03/14)

5. Licence Fees (Discussion) HTA SG (04/14) 6. The Regulators’ Code (Discussion) HTA SG (05/14) 7. Proposed items for next meeting Oral 8. Any other business Oral 9. Lunch

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Minutes of the first meeting of the HTA Stakeholder and Fees Group

Date 6 November 2013

Venue Westminster Conference Centre1 Victoria StLondonSW1H 0ET

Present

Members

Gurch Randhawa (Chair)

Kamal Ahmed, HCA Healthcare (London BridgeHospital)Ian Bateman, NHS Blood and TransplantVeronica English, British Medical AssociationSteve Gaze, University of BristolDavid Haddow, RegenerysNancy Lee, Wellcome TrustJames Lowe, Royal College of PathologistsSalmah Mahmood, Anthony NolanVishy Mahadeven, Royal College of SurgeonsRachel Maxwell, Belfast Health & Social CareTrustKay Wadey, Member of public

In attendance

Shaun Griffin (Director of Communications andPublic Affairs; lead Director)Sarah Bedwell (Director of Regulation)Jo deBank (Media & Communications Officer)Nicola Fookes (Finance Manager)Sue Gallone (Director of Resources)

Apologies

Andy Hall, Northern Institute for CancerResearch

Maggie Wilcox, Independent Cancer PatientsVoice

Item 1 – Welcome and introductions

1. Gurch Randhawa (GR) welcomed everyone to the first meeting of the groupand explained that it was set up following the McCracken review. The groupwas intended as a means by which stakeholders across all licensed sectors

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and from the public to contribute to the HTA’s work. The Chair alsoconfirmed that he would report to the Authority on the group’s discussions.

Item 2 – Terms of Reference for the Fees and Stakeholder Group (FSG 0301/13)

2. The Terms of Reference were considered.

3. It was agreed that the name of the group should be changed to theStakeholder and Fees Group as this was a more accurate reflection of thegroup’s aims.

4. The Stakeholder and Fees Group is an advisory group, while it will feed in toany decision-making, it is not considered to be an alternative to formal orinformal public or stakeholder consultation.

5. It was also agreed that papers would be sent out at least a fortnight beforethe meetings.

6. It was noted that the earlier in a process stakeholders are consulted, themore effective the contribution, and that consultation with the group wouldnot be a substitute for wider consultation.

Action: Change name of group for future meetings. Update website andother communications channels to reflect change [JdB]

Action: Send papers out a fortnight before all subsequent meetings[JdB]

Item 3 – Results of the HTA public and professional survey (Oral)

7. Shaun Griffin presented the results of a survey undertaken recently on behalfof the HTA which looked at professional confidence and advocacy, as wellas public confidence.

8. The survey results will be published by the HTA in due course.

Item 4 – Progress on the McCracken recommendations (FSG 02/13)

9. Sarah Bedwell introduced a paper on the progress of recommendationsrelevant to the HTA of the recent McCracken review. This included on-goingwork on closer collaborative and joint inspections with other regulators andlooking at the HTA’s risk assessment processes.

10. There was discussion concerning the McCracken recommendation thathuman tissue legislation should be reviewed.

Item 5 – Regulation Strategy 2013-2017 (FSG 03/13)

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11. Sarah Bedwell took the group through the HTA’s Regulation Strategy. Thediscussion covered corporate drivers for our stakeholders, potential benefitsof compliance, inspections models and risk assessments. Members of thegroup discussed regulation in their particular sectors.

12. It was suggested that a review of the Preparation Process Dossier processtook place during 14/15, one year after implementation).

13. Action: The HTA will consider this as an action [SB]

Item 6 – Proposals for 2014/15 licence fees (FSG 04/14)

14. Sue Gallone introduced this paper. This included presenting the feesstructure, as well as the HTA’s process for setting fees and fundingrequirements. This year’s fees (2014/15) were still subject to board approvaland comments on the proposals were welcome. Any views on changes tothe fees structure would also be useful for consideration in the longer term(from 2015/16).

15. A 2010 consultation showed that the preference was for a stable annual fee,but other fee structures could be considered for the future. Potentialalternatives and relative costs for different sectors and various activities werediscussed by the group. The group suggested that it would be worthexploring again charging for site visits and charging less compliant or morerisky establishments more. These topics will be explored further at the nextmeeting.

Action: Alternative structure for fees model to added to the agenda forthe group’s next meeting.

Item 7 – AOB

16. The Chair reiterated that although the inaugural meeting of the Stakeholderand Fees Group had been introductory and HTA-led, it was planned thatfuture ideas would come from the group and any ideas would be welcomedby the Chair. Comments on timings and frequencies were also welcome.

Action: Ensure that group members receive contact details for Chairand admin for the group with the minutes.

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HTA SG (02/14)

HTA STAKEHOLDER GROUP

TERMS OF REFERENCE

Background and overview

1. The HTA has effective working relationships in place with those we regulate andhas consulted with our stakeholders when changes are planned. We wish tostrengthen these relationships further and provide a forum for more regularconsultation on our approach to regulatory activities, including fee setting. The aimis to provide a channel for regular dialogue with stakeholders, so that they aremore involved in regulatory changes and fee setting, can make their views knownto the Authority and for the HTA to achieve greater transparency andaccountability.

2. The HTA aims to be a “right touch” regulator. That means that we focus ourregulation on those areas which we have assessed as being at most risk of non-compliance and which would have an adverse impact on our overall aim tomaintain public confidence in the use of human tissue and organs. For thisapproach to be successful we have regular dialogue with our stakeholders,including our licence holders, so that they have confidence in our decisions andwe understand the demands they are facing. Over the last two years this hasincluded regular meetings with key opinion leader organisations and publicgroups. Our Histopathology Working Group discuss a range of issues with usfacing the post mortem sector and which has led to changes in our regulatoryapproach. In the living organ donation sector, the Transplantation Advisory Groupplays a similar role. We also held a number of workshops with the transplantsector as we implemented the European Directive on the Quality and Safety ofOrgans Intended for Transplant. Whilst the HTA Stakeholder Group will notreplace any of our existing engagement mechanisms we shall ask the Group tocontribute to the development of our thinking on new initiatives across all sectorsincluding some of the work arising from the McCracken Review.

3. Achieving best value for money through a robust fee setting process is essential toensure the costs of regulation are both proportionate and fair and that theregulated sector can operate efficiently and competitively.

4. In 2010 the HTA reviewed the way we calculate fees to link them more closely tothe resource needed for the regulation of establishments, consulting formally withstakeholders on our plans and developing a new model for fee setting. Each year

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HTA SG (02/14)

the HTA updates the model and determines the income required from fees. The HTA has reduced the amount of income we generate from fees by 35% over the 3 years from 2011/12 to 2013/14 by making efficiencies. The Authority approves fees in November of the year before they are charged and new fee levels are announced in December. Fees are charged for the year from April to March, with invoices issued in April or September depending on the sector.

5. The Group shall review fee proposals in October each year, to inform theAuthority’s approval.

Purpose and functions

6. The purpose of the Stakeholder Group shall be to consider regulatory issuesacross all sectors to inform the continued development of HTA regulation and feesetting.

7. The Group shall have four core functions:

(i) To provide an ongoing channel of communication with stakeholders (ii) To provide a forum for regular discussion of regulatory issues (iii) To consider fees proposals annually (iv) For the Chair to report back to the Authority on key issues following

meetings as necessary

Structure/Membership

8. The Group shall comprise:

(i) An Authority Member Chair (ii) Up to 13 representatives from the licensed sectors of the HTA, the public

and other stakeholders (iii) Four HTA Executive members

Chief Executive Director of Regulation Director of Resources Director of Communications and Public Affairs

9. Other HTA staff may attend to present information or hear views.

10. An observer from the Department of Health shall be invited to meetings.

Governance

11. The Group shall be advisory and accountable to the Authority.

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HTA SG (02/14)

12. The HTA shall provide administrative support and be responsible for booking thevenue, liaising with the Chair to create the agenda, inviting the members, collatingand distributing the papers relating to the meeting, taking minutes and recordingaction points.

13. The quorum for the Group shall be five, including the Chair, a relevant HTAmember and three external representatives.

Frequency and format of meetings

14. The Group shall meet twice a year (October and May) and on an ad hoc basis, asrequired. Agendas shall be set in advance and minutes and action pointsrecorded. Where necessary, members may be contacted by email to comment onpapers or review progress against actions agreed.

15. The format, frequency and outputs of the meetings and the terms of reference ofthe Group shall be reviewed annually to ensure that the Group is being effective.

Communications

16. A week before each meeting, the agenda, minutes from the last meeting and anypapers for consideration shall be distributed to the Group.

17. Within ten days of each meeting, the minutes and action points shall be sent tomembers for comment.

18. Agendas and agreed minutes shall be made available on the HTA website and onrequest to the HTA.

19. A report of the issues discussed shall be made to the next Authority meeting bythe Chair.

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HTA SG (03/14)

Stakeholder Group paper

Date 13 May 2014 Paper reference HTA SG (03/14)

Agenda item 4 Author Vicky Marshment

Review of the HTA’s codes of practice 2014 to 2016

Purpose of paper

1. This paper provides the Stakeholder Group with an overview of the HTA’s plansto review both the structure and content of its codes of practice. It also providesinformation on the interim review which is due to be completed in July 2014.

Background

2. The HTA publishes nine codes of practice. These are:

• Code of practice 1 - Consent• Code of practice 2 - Donation of solid organs for transplantation• Code of practice 3 - Post-mortem examination• Code of practice 4 - Anatomical examination• Code of practice 5 - Disposal of human tissue• Code of practice 6 - Donation of allogeneic bone marrow and peripheral

blood stem cells for transplantation• Code of practice 7 - Public display• Code of practice 8 - Import and export of human bodies, body parts and

tissue• Code of practice 9 – Research

3. Most codes of practice were last reviewed in 2008/9 and published inSeptember 2009. The exceptions to this are code of practice two which wasupdated in order to reflect legal advice the HTA had received, and code ofpractice eight which was drafted and published in 2007.

4. The HTA is required to produce codes of practice giving practical guidance andlaying down standards under section 26 of the Human Tissue Act 2004 (HT Act)

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on a range of matters. The majority of the HTA’s codes of practice must be approved by the Westminster Parliament, as well as Ministers in Wales and Northern Ireland, prior to publication. The exceptions to this are codes of practice five and eight which do not require parliamentary approval.

5. The HTA is also required to consult on the draft codes of practice.

6. The HTA has recently drafted a code of practice to provide advice and guidanceon the Human Transplantation (Wales) Act 2013. This code of practice will notbe included in the review due to the fact that it has been drafted so recently.

Interim review

7. The HTA became aware in 2012 that there were a small number of inaccuraciesin code of practice two and it was decided that steps should be taken to correctthese inaccuracies, even if this meant that for a period of time a non-Parliamentary code of practice would be in place. The decision was taken onthe balance of risks, and the conclusion was reached that there was greater riskin not taking action to remove the inaccuracies than there was in the code ofpractice not having gone through the Parliamentary process. The amendeddocument was shared with colleagues at the Westminster and WelshGovernments, as well as the Northern Ireland Assembly, prior to publication.

8. This approach worked well, and has been adopted for the remaining codes ofpractice. Updated versions of these codes of practice will be published on theHTA website in July 2014. They will be publicised through the e-newsletter, theHTA website and social media channels.

9. The updated codes of practice will not differ significantly from the currentversions. However, they will reflect guidance which has been amended sincetheir publication and clarify any areas where further legal advice has beenobtained.

10. Annotated versions of the amended codes of practice will also be available onthe website which will include the rationale for the changes.

Code of practice five – disposal

11. In light of recent discussions on the disposal of fetal tissue, a more in-depthreview of code of practice five on disposal is required and the updated version ofthis code of practice will not be published in July, but later in the business year.

12. Further information on the update of this code of practice will be made availablethrough the channels identified in paragraph eight.

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HTA SG (03/14)

Full review

13. A full review of how the HTA structures the codes of practice and the content ofthe documents will be undertaken during 2014/15 and 2015/16, with the aim thatthe updated code, or codes, be approved by Parliament and published by theend of March 2016.

14. During the spring and summer of 2014 a scoping exercise will be undertaken toestablish how the HTA will structure codes of practice in future. Options include:

a. Continue to publish nine codes of practice, of which the majority are aimedat a particular sector (e.g. research) and a minority cover an activity (e.g.disposal).

b. Publish a range of codes of practice which are either sector specific oractivity-based. For example, the HTA could decide not to publish any over-arching activity codes and include this information in a code for eachregulated sector, or could move to an activity-based model which no sectorspecific codes of practice.

c. Publish one high-level code of practice which provides a practicaltransposition of the relevant legislation. Under this would sit a number ofguidance and policy documents, which could be sector specific, activity-based or a mixture of both. (This would not include the Code of Practice onthe Human Transplantation (Wales) Act as the HTA considers this newlegislation requires a period of at least two years from full implementation inDecember 2015 to become established with a more detailed code ofpractice in place.)

15. There are benefits and detriments to each of the approaches above and theHTA will seek the views of those who use the codes of practice andstakeholders more widely to inform the decision on the structure of future codesof practice.

16. A desk based exercise will also be undertaken to establish the approach otherregulators take to publishing codes of practice and to collate the feedback theHTA has received on the existing codes of practice via various surveys andevents held in recent years.

17. Consideration will also be given as to how the codes of practice are provided inhard copy and electronically, and whether there are any improvements whichcan be made to the functionality of the website in regard to the codes ofpractice.

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HTA SG (03/14)

18. It is hoped that this full review will coincide with any amendments made to theHT Act and associated Regulations as a result of the planned Department ofHealth consultation. However, the HTA considers it vital that a review beundertaken and completed in the next two years, and accepts that subsequentrevisions may be necessary to reflect any amendments to legislation if thesehave not passed through Parliament by the time the codes of practice are laid.

Next steps

19. This meeting of the Stakeholder Group marks the beginning of engagement onthe structure of the codes of practice. A similar session will be held at the HTA’sTransplantation Advisory Group meeting.

20. Views will be sought from a wide range of stakeholders and used to develop arecommended option for the structure of the codes of practice which will beconsidered by the Authority in October 2014.

21. The full public consultation on the redrafted codes of practice is planned to takeplace in spring/summer 2015.

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HTA SG (04/14)

Stakeholder Group paper

Date 13 May 2014 Paper reference HTA SG (04/14)

Agenda item 5 Author Sue Gallone

Licence Fees

Purpose of paper

1. The purpose of this paper is to provide background about previousconsiderations on licence fees, to inform discussion during the StakeholderGroup meeting on 13 May.

Action

2. Members are asked to read this background. At the meeting, we will considerthe issues that should be explored further over the period to October 2014 aspart of fee setting for 2015/16.

Background

3. In early 2010, the HTA reviewed fundamentally the way we charge fees. Thiswas to address views such as:

Licence fees should reflect the differing sizes of establishments and reflectthe different volume and nature of regulatory activity;

Fees should bear some relationship to the regulatory risk attributed to anestablishment;

The level and complexity of site visit inspections required/undergone shouldinfluence the licence fee;

The level of fees is too high.

4. In setting fees, we are required to adhere to the Treasury’s guidelines. Theseare that fees must cover the cost of licensing and that there can be no cross-subsidy between sectors.

5. The fees review considered a long list of activities for which fees could becharged. These were reduced to a shortlist and, after consultation, a feestructure was adopted for 2011/12 onwards. Throughout, there was an aim tostrike a balance between charging appropriately for activities and what can be

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HTA SG (04/14)

implemented by the HTA without incurring more cost (which would have to be passed onto fee payers).

6. The selection criteria, which still seem relevant today, were:

Cultural fit. With the HTA and with licence holders. This includes whetherthe option supports the objectives of Better Regulation and the intent of theHuman Tissue Act;

Fairness and transparency. This includes whether the option is equitable inthe fees set between and within sectors. It also considers whether the optionis clear in the way that it relates the fee structure and levels to regulatory riskand to the regulatory activity needed;

Ease of understanding. Testing how clear and straightforward the option is; HTA implementation. This considers how manageable the option is for

implementation by the HTA, and how costly its operation would be; Licensee implementation. This considers how manageable the option is for

implementation for licence holders; Change. This includes considering the likely scale of change in fees and in

the structure for different licence holders; Financial Risk. This covers the risk to the HTA that our costs may not be

fully recovered (not the regulatory risk attributed to establishments).

7. A number of options were rejected before the consultation stage:

It was suggested that we should recover costs of suspending/revokinglicences. At the time this did not fit with the HTA’s culture and there wereimplementation and financial risk issues.

Additional fee costs would not be charged for licence variations or for theprovision of advice and guidance. This is because the HTA did not want toset up any perverse incentives that might lead to establishments not seekingadvice or avoiding mentioning changes in their licensable activities. It wouldalso introduce complexity and there would be questions on how to priceadvice not sought (e.g. that given after a site visit).

A risk-based approach to charging fees was considered but not takenforward. This is because risk is reflected in the level of activity relating toeach sector, so risk will have been taken into account when apportioningcosts across sectors (for example using previous enforcement activity topredict future levels moving forward). Within a sector it was consideredinappropriate to use a risk-based model to determine fee charges, since thismay incentivise unwanted behaviour from establishments trying tomanipulate a risk score and would introduce complex timing issues as towhen risk scores were established and fees set. In addition, anorganisation’s risk rating could change at any time and potentially manytimes throughout the year.

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8. The HTA consulted on:

Introducing an application fee for new establishments or re-application afterrevocation;

Introducing a charge for site visits, depending on the complexity (number ofdays and HTA staff involved) of the planned visit;

Changing the way establishments are charged for satellites, from the samefee for each satellite to charging in bands of numbers of satellites, to reflecteconomies of scale when dealing with a larger number of satellites;

Introducing an individual fee for temporary public displays (and continue todifferentiate the annual fee for public display establishments depending onwhether the number of exhibits is less than 20 or not);

Breaking down the annual fee for human application establishmentsaccording to licensed activity and tissue types managed;

Introducing part year payments for new applicants and the ability for allestablishments to pay the annual fee in two instalments.

9. Three consultation workshops took place in May 2010, with a total of 94attendees from 89 different establishments. A further 48 responses to theconsultation were received.

10. Following the consultation, there were three aspects of the proposals that we didnot take forward:

Implementing the proposal to charge for site visits. The strong opinion fromconsultation was that there should be a consistent annual fee to enableestablishments to make financial plans. We were told that variations in feelevels would need to be communicated at least 18 months in advance to betaken into account in budget setting timetables. We looked at retaining theconcept of site visit charges but smoothing charges so that there would beno large peak when the site visit occurs. That would require the HTA to setwith some certainty longer term plans for site visits. Early identification of theestablishments that would be visited and the HTA resource the visit wouldconsume would be required to put establishments into different site visitcategories (simple, complex etc) at a very early stage. Introducing thisconcept would also require the need for an HTA process to handleestablishments’ views about the category of visit they would receive, ifdifferent to the HTA’s, adding a layer of bureaucracy to inspection planning,at an eventual cost to licence fee payers.

Using tissue type as a determinant of the annual fee for establishments inthe human application sector. Feedback was that it is not an appropriatemeasure because the tissue types dealt with can change throughout the yearand that including it would make the fee structure too complex. Instead wedeveloped further the suggested approach for charging for licensed activities,

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HTA SG (04/14)

reflecting that this is the only measure used to differentiate fees in the human application sector.

Introducing instalments for paying fees. The overall response to theconsultation question was not supportive, predominantly with public sectororganisations not being in favour or being unsure.

11. The responses to the consultation also suggested that we look again at someareas. These were reflecting regulatory risk and linking licence fees to volumesof activity.

12. Our reasons for not reflecting risk explicitly were set out in the consultationdocument (and are summarised above) and we remained of the view that thesewere valid.

13. HM Treasury’s guidance requires us to recover costs, without crosssubsidisation, so we are only able to reflect the amount of HTA activity withestablishments, not how much activity an establishment undertakes. Some ofour charges (e.g. the charges for satellites) do take account of theestablishment’s profile, where this has a direct relationship to HTA activity.

14. In response to feedback, we also looked at incorporating some differentiation infees within the post mortem sector. Previously, establishments paid the samefee that entitled them to undertake three separate licensable activities: (in shortform) storage, removal and making of a post mortem examination. However, asmall number of establishments store post mortem blocks and slides for NHSTrusts and are not engaged in any other activities. These consume around thesame level of HTA resource as establishments in the research sector who alsostore such materials. Therefore we introduced a lower fee rate to post mortemestablishments that only store blocks and slides, the same rate as the researchsector.

Issues in 2014

15. At the last Stakeholder Group meeting, there were suggestions around chargingfor site visits and charging less compliant or more risky establishments more.

16. Members’ views on these, including whether the reasons these aspects werenot included in fees in 2010 are still valid, and any other areas to consider arewelcome.

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HTA SG (05/14)

HTA Stakeholder Group

Date 13 May 2014 Paper reference HTA SG (05/14)

Agenda item 6 Author Alan Clamp

The Regulators’ Code

Purpose of paper

1. To provide an overview of the new Regulators’ Code and the approach of theHTA to ensure compliance with the Code.

Action

2. The paper is provided for discussion and comments.

Background

3. The new Regulators’ Code is published by the Better Regulation Delivery Office(BRDO; part of the Department for Business, Innovation and Skills) and cameinto force on 6 April 2014. A copy of the Code is provided in Annex A.

4. The Code provides a framework for how regulators should engage with thosethey regulate and imposes a statutory duty for the HTA to have regard to theCode in developing policies and practices which guide our regulatory activities.

5. The foreward to the Code notes that it “seeks to promote proportionate,consistent and targeted regulatory activity through the development oftransparent and effective dialogue and understanding between regulators andthose they regulate”.

6. In addition to the Regulators’ Code, the HTA will also be assessed in terms ofhow well it meets the proposed Growth Duty for non-economic regulators. This

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duty is not yet formally in place but will form part of the Deregulation Bill, which is expected to receive royal assent in autumn 2014.

The HTA response to the Regulators’ Code

7. In Quarters 1 and 2 of 2014/15 the HTA will assess itself against the six themesin the Regulators’ Code and seek the views of stakeholders on its self-assessment. The HTA notes that it is not bound to follow all the provisions in theCode, but will set out in its self-assessment the rationale for non-compliancewith any of the provisions.

8. The six themes of the Regulators’ Code are as follows:

Regulators should carry out their activities in a way that supports those theyregulate to comply and grow

Regulators should provide simple and straightforward ways to engage withthose they regulate and hear their views

Regulators should base their regulatory activities on risk Regulators should share information about compliance and risk Regulators should ensure clear information, guidance and advice is

available to help those they regulate meet their responsibilities to comply Regulators should ensure that their approach to their regulatory activities is

transparent

9. The HTA will publish its final self-assessment report, and any associated actionplan to improve compliance with the Code, by 30 September 2014. Thesedocuments will be shared with the BRDO. Any proposed changes to HTApolicies and practices as a result of the action plan will be consulted on with theHTA Stakeholder Group and other interested parties.

10. An update on the HTA action plan will be published by the end of the 2014/15business year and again shared with the BRDO.

11. Following the passage of the Deregulation Bill, the HTA will also publish adocument that demonstrates how it complies with the Growth Duty.

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Regulators’ Code

April 2014

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Foreword

In the Autumn Statement 2012 Government announced that it would introduce a package of measures to improve the way regulation is delivered at the frontline such as the Focus on Enforcement review of appeals, the proposed Growth Duty for non-economic regulators and the Accountability for Regulator Impact measure.

This Government is committed to reducing regulatory burdens and supporting compliant business growth through the development of an open and constructive relationship between regulators and those they regulate. The Regulators’ Code provides a flexible, principles based framework for regulatory delivery that supports and enables regulators to design their service and enforcement policies in a manner that best suits the needs of businesses and other regulated entities.

Our expectation is that by clarifying the provisions contained in the previous Regulators’ Compliance Code, in a shorter and accessible format, regulators and those they regulate will have a clear understanding of the services that can be expected and will feel able to challenge if these are not being fulfilled.

Regulators within scope of the Regulators' Code are diverse but they share a common primary purpose – to regulate for the protection of the vulnerable, the environment, social or other objective. This Code does not detract from these core purposes but seeks to promote proportionate, consistent and targeted regulatory activity through the development of transparent and effective dialogue and understanding between regulators and those they regulate.

I believe the Regulators’ Code will support a positive shift in how regulation is delivered by setting clear expectations and promising open dialogue. Ultimately this will give businesses greater confidence to invest and grow.

Michael Fallon Minister of State for Business and Enterprise Department for Business, Innovation and Skills

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Regulators’ Code

This Code was laid before Parliament in accordance with section 23 of the Legislative and Regulatory Reform Act 2006 (“the Act”). Regulators whose functions are specified by order under section 24(2) of the Act must have regard to the Code when developing policies and operational procedures that guide their regulatory activities. Regulators must equally have regard to the Code when setting standards or giving guidance which will guide the regulatory activities of other regulators. If a regulator concludes, on the basis of material evidence, that a specific provision of the Code is either not applicable or is outweighed by another relevant consideration, the regulator is not bound to follow that provision, but should record that decision and the reasons for it.

1. Regulators should carry out their activities in a way that supports those theyregulate to comply and grow

1.1 Regulators should avoid imposing unnecessary regulatory burdens through their regulatory activities1 and should assess whether similar social, environmental and economic outcomes could be achieved by less burdensome means. Regulators should choose proportionate approaches to those they regulate, based on relevant factors including, for example, business size and capacity.

1.2 When designing and reviewing policies, operational procedures and practices, regulators should consider how they might support or enable economic growth for compliant businesses and other regulated entities2, for example, by considering how they can best:

understand and minimise negative economic impacts of their regulatory activities; minimising the costs of compliance for those they regulate; improve confidence in compliance for those they regulate, by providing greater

certainty; and encourage and promote compliance.

1.3 Regulators should ensure that their officers have the necessary knowledge and skills to support those they regulate, including having an understanding of those they regulate that enables them to choose proportionate and effective approaches.

1.4 Regulators should ensure that their officers understand the statutory principles of good regulation3 and of this Code, and how the regulator delivers its activities in accordance with them.

2. Regulators should provide simple and straightforward ways to engage withthose they regulate and hear their views

2.1 Regulators should have mechanisms in place to engage those they regulate, citizens and others to offer views and contribute to the development of their policies and service standards. Before changing policies, practices or service standards, regulators should consider the impact on business and engage with business representatives.

1 The term ‘regulatory activities’ refers to the whole range of regulatory options and interventions available to regulators.

2 The terms ‘business or businesses’ is used throughout this document to refer to businesses and other regulated entities.

3 The statutory principles of good regulation can be viewed in Part 2 (21) on page 12: http://www.legislation.gov.uk/ukpga/2006/51/pdfs/ukpga_20060051_en.pdf.

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2.2 In responding to non-compliance that they identify, regulators should clearly explain what the non-compliant item or activity is, the advice being given, actions required or decisions taken, and the reasons for these. Regulators should provide an opportunity for dialogue in relation to the advice, requirements or decisions, with a view to ensuring that they are acting in a way that is proportionate and consistent.

This paragraph does not apply where the regulator can demonstrate that immediate enforcement action is required to prevent or respond to a serious breach or where providing such an opportunity would be likely to defeat the purpose of the proposed enforcement action.

2.3 Regulators should provide an impartial and clearly explained route to appeal against a regulatory decision or a failure to act in accordance with this Code. Individual officers of the regulator who took the decision or action against which the appeal is being made should not be involved in considering the appeal. This route to appeal should be publicised to those who are regulated.

2.4 Regulators should provide a timely explanation in writing of any right to representation or right to appeal. This explanation should be in plain language and include practical information on the process involved.

2.5 Regulators should make available to those they regulate, clearly explained complaints procedures, allowing them to easily make a complaint about the conduct of the regulator.

2.6 Regulators should have a range of mechanisms to enable and regularly invite, receive and take on board customer feedback, including, for example, through customer satisfaction surveys of those they regulate4.

3. Regulators should base their regulatory activities on risk

3.1 Regulators should take an evidence based approach to determining the priority risks in their area of responsibility, and should allocate resources where they would be most effective in addressing those priority risks.

3.2 Regulators should consider risk at every stage of their decision-making processes, including choosing the most appropriate type of intervention or way of working with those regulated; targeting checks on compliance; and when taking enforcement action.

3.3 Regulators designing a risk assessment framework5, for their own use or for use by others, should have mechanisms in place to consult on the design with those affected, and to review it regularly.

3.4 Regulators, in making their assessment of risk, should recognise the compliance record of those they regulate, including using earned recognition approaches and should consider all available and relevant data on compliance, including evidence of relevant external verification.

3.5 Regulators should review the effectiveness of their chosen regulatory activities in delivering the desired outcomes and make any necessary adjustments accordingly.

4 The Government will discuss with national regulators a common approach to surveys to support benchmarking of their performance.

5 The term ‘risk assessment framework’ encompasses any model, scheme, methodology or risk rating approach that is used to inform risk-based targeting of regulatory activities in relation to individual businesses or other regulated entities.

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4. Regulators should share information about compliance and risk

4.1 Regulators should collectively follow the principle of “collect once, use many times” when requesting information from those they regulate.

4.2 When the law allows, regulators should agree secure mechanisms to share information with each other about businesses and other bodies they regulate, to help target resources and activities and minimise duplication.

5. Regulators should ensure clear information, guidance and advice is available tohelp those they regulate meet their responsibilities to comply

5.1 Regulators should provide advice and guidance that is focused on assisting those they regulate to understand and meet their responsibilities. When providing advice and guidance, legal requirements should be distinguished from suggested good practice and the impact of the advice or guidance should be considered so that it does not impose unnecessary burdens in itself.

5.2 Regulators should publish guidance, and information in a clear, accessible, concise format, using media appropriate to the target audience and written in plain language for the audience.

5.3 Regulators should have mechanisms in place to consult those they regulate in relation to the guidance they produce to ensure that it meets their needs.

5.4 Regulators should seek to create an environment in which those they regulate have confidence in the advice they receive and feel able to seek advice without fear of triggering enforcement action.

5.5 In responding to requests for advice, a regulator’s primary concerns should be to provide the advice necessary to support compliance, and to ensure that the advice can be relied on.

5.6 Regulators should have mechanisms to work collaboratively to assist those regulated by more than one regulator. Regulators should consider advice provided by other regulators and, where there is disagreement about the advice provided, this should be discussed with the other regulator to reach agreement.

6. Regulators should ensure that their approach to their regulatory activities istransparent

6.1 Regulators should publish a set of clear service standards, setting out what those they regulate should expect from them.

6.2 Regulators’ published service standards should include clear information on:

a) how they communicate with those they regulate and how they can be contacted;

b) their approach to providing information, guidance and advice;

c) their approach to checks on compliance6, including details of the risk assessmentframework used to target those checks as well as protocols for their conduct, clearlysetting out what those they regulate should expect;

6 Including inspections, audit, monitoring and sampling visits, and test purchases.

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Regulators’ Code 

d) their enforcement policy, explaining how they respond to non-compliance;

e) their fees and charges, if any. This information should clearly explain the basis onwhich these are calculated, and should include an explanation of whethercompliance will affect fees and charges; and

f) how to comment or complain about the service provided and routes to appeal.

6.3 Information published to meet the provisions of this Code should be easily accessible, including being available at a single point7 on the regulator’s website that is clearly signposted, and it should be kept up to date.

6.4 Regulators should have mechanisms in place to ensure that their officers act in accordance with their published service standards, including their enforcement policy.

6.5 Regulators should publish, on a regular basis, details of their performance against their service standards, including feedback received from those they regulate, such as customer satisfaction surveys, and data relating to complaints about them and appeals against their decisions.

7 This requirement may be satisfied by providing a single web page that includes links to information published elsewhere.

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Monitoring the effectiveness of the Regulators’ Code

The Government is committed to making sure the Regulators’ Code is effective. To make sure that the Code is being used effectively, we want businesses, regulated bodies and citizens to challenge regulators who they believe are not acting in accordance with their published policies and standards. It is in the wider public interest that regulators are transparent and proportionate in their approaches to regulation.

The Government will monitor published policies and standards of regulators subject to the Regulators’ Code, and will challenge regulators where there is evidence that policies and standards are not in line with the Code or are not followed.

© Crown copyright 2014

You may re-use this information (not including logos) free of charge in any format or medium, under the terms of the Open Government Licence. Visit www.nationalarchives.gov.uk/doc/open-government-licence, write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email psi@nationalarchives.gsi.gov.uk.

This publication is also available on our website at: https://www.gov.uk/government/publications/regulators-code

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Tel: 0121 345 1200

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URN: BRDO/14/705

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