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Independent healthcare in house lawyers forum 2016
Modern Slavery Act
Raymond Silverstein
Modern Slavery Act 2015Modern slavery - slavery, servitude, forced, compulsory labour and human trafficking
World’s fastest growing organised crime worth USD 38-50 billion a year
ILO estimate: 21m men, women and children work in modern slavery conditions today
Modern Slavery Act 2015Any organisation which:• is a body corporate or partnership• supply goods or services in the UK, and• has a total annual turnover of more than
£36 millionmust prepare and publish a slavery & human trafficking statement for each financial year
Modern Slavery Act 2015Slavery and Human Trafficking statementTurnover includes:• The turnover of any subsidiary wherever it is
located and excludes:• trade discounts• VAT • any other taxes based on the amounts so derived
Modern Slavery Act 2015Slavery and Human Trafficking statementPurposeTo set out the steps the organisation has taken that financial year to ensure modern slavery is not taking place in any –• of its supply chains, and• part of its own business, orto show that no such steps were taken
Modern Slavery Act 2015Slavery and Human Trafficking statementA statement may include information about:• the organisation’s structure, its business and
supply chains• its policies in relation to modern slavery• its due diligence processes in relation to
modern slavery in its business and supply chains
• the parts of its business and supply chains where there is a risk of modern slavery taking place, and
Modern Slavery Act 2015Slavery and Human Trafficking statementthe steps it has taken to assess and manage the risk• its effectiveness in ensuring that modern
slavery is not taking place in its business or supply chains, measured against such KPIs as it considers appropriate;
• the training on modern slavery available to staff
Modern Slavery Act 2015Slavery and Human Trafficking statement• must be approved by the board of
directors and • signed by a directorand• published on the organisation’s website
with a link to the slavery and human trafficking statement in a prominent place on the homepage
Modern Slavery Act 2015Slavery and Human Trafficking statementOrganisations with a year-end of 31st March 2016 are the first to be required to complyNot later than 6 months of year-endAlongside other annual or non-financial reports required to produce?
Modern Slavery Act 2015Slavery and Human Trafficking statementEnforcement• injunction compelling performance• naming and shaming• reputational risk
Modern Slavery Act 2015Slavery and Human Trafficking statementWe can help BJ MSA product – fixed price!
Persons of significant control and influence – are you ready?Clare Auty
A new company register - PSC• Who? All UK companies (non-listed) and LLPs• What? New register to identify and record PSCs
(stipulated information)• When? 6 April 2016 (internal) and 30 June 2016 (file
at Companies House)• Why? Transparency, trust, terrorist funding, tax
evasion• How? Small Business, Enterprise and Employment Act
2015 (SBEEA) plus statutory instruments and guidance
What do companies need to do?• Internal register – 6 April 2016• Reasonable steps to identify PSCs (plus
notices)• Enter required information on register &
update• Available for inspection (free) or copies (£12)• File at Companies House – 30 June 2016• Must have a PSC register – never be blank• Criminal offence if fail to comply
Who is a PSC?“Significant control conditions”• Holds, directly or indirectly, more than 25% of shares• Holds, directly or indirectly, more than 25% of voting
rights• Has the right, directly or indirectly, to appoint or
remove a majority of the board of directors• Has the right to exercise, or actually exercises,
significant influence or control (see guidance – nb minority protections)
• Exercises, or has the right to exercise, significant influence or control over a trust or firm, which itself meets any of above conditions
Indirect ownership / RLEs• Rights might be held indirectly (i.e. corporate groups)• When legal entity holds shares/rights and someone has
majority stake in that entity• Don’t need to enter that person on register unless legal
entity they held interest through is not an RLE• Majority stake: majority voting rights, appoint/remove
majority of board, right to exercise or actually exercise dominant influence
• RLE: meets one or more of four control conditions and keeps own PSC register/DTR5/listed on relevant overseas exchange
• Registrable RLE: only if first RLE in ownership chain
Examples 1. Simple 3. More complex 4. Very complex
2.
50% 50%
UK Company A
20% 20% 20% 20% 20%
P1 P2
UK Company B
PSCs = P1 + P2
100%
P1
UK Company Z
UK Company Y
UK Company X
Company Z PSC register = P1
Company Y PSC register = Company Z
30%
Company X PSC register = Company Y
70%
P1 P2
Overseas Company B (unlisted)
Overseas Company C (unlisted)
No PSC register
UK Company A
No PSC register
Company A PSC register = P2 only (majority stake)“Look through non-
RLE’s”Still need a PSC register stating no PSCs
No PSCs (unless arrangements)
100%
100%
100%
100%
What else will the SBEEA change?• Private co registers may be held at
Companies House (June 2016)• End of annual return – replaced by annual
confirmation (June 2016)• Prohibition on corporate directors (currently
October 2016 – already delayed by 12 months)
Fit and proper persons RegulationsPaul Wainwright
Fit and proper persons regulations (Regs 4-7,18 &19)People covered by the Regs :
– Staff, employees, individuals (consultants), and partnerships with varying degrees of “fit and proper” requirements
– “Registered managers” – employed (or director) supervising the management of regulated activities
– Directors under Regulation 5 – special requirements.
• Discussion: To what level of employee do you need to ensure compliance with the regulations ?
Fit and proper persons test for Directors (or “similar”)(Reg 5)
No appointment unless satisfied..(a) – (c) AND:– Not been responsible for, been privy to, contributed to or
facilitated any serious misconduct or mismanagement in the course of carrying on a regulated activity
– Not have any of the grounds of “unfitness” apply to him/her
Bankruptcy Children or adults’ barred list Legal impediment
• Discussion : what methods are used to gather evidence to satisfy the above criteria?
Fit and proper persons test for Directors (or “similar”)(Reg 5)• Ongoing duty:
– Regulation 5(6): “when an individual no longer meets the requirements of sub para (3)”
• Remedial action– Regulation 5(6)(a)“necessary and
proportionate steps” to ensure the office/position is held by someone who meets the requirements
– Notify the regulator• Impact – regularity of checks?
Measures to satisfy compliance - Actions for clients• Availability and provision of Schedule 3 evidence• Good governance :appropriate systems and
processes (incl. record keeping) are in place to ensure that all new and existing directors are & continue to be fit
• Make every effort to assure itself about an individual ‘by all means available’
• Make specified information about registered persons available to the CQC (generally 28 days from request)
• be aware of guidelines and best practice & possible changes
5YFV and New Models of CareJonathan Hayden
Five Year Forward View• Published October 2014• Looks at the challenges facing the NHS and
how delivery of healthcare needs to change – including through “New Care Models”
• Acknowledgement that not “one size fits all” and that we shouldn’t let “a thousand flowers bloom”
• Various care models were outlined
Five Year Forward View
• Various supplements / updates have followed the main 5YFV publication – for example:– The forward view into action: planning for
2015/16– Five Year Forward View: Time to Deliver– New Care Model support packages released
July 2015 December 2015
New Care Models• Five New Care Models:
– Primary and Acute Care Systems (PACS)– Multi-specialty Community Provider (MCP)– Enhanced Health in Care Homes– Urgent and Emergency Care (UEC)– Acute Care Collaborations (ACC)
• Supplement the Integrated Care Pioneers
New Care Models (2)• Vanguard programme launched to select sites
to test / implement the New Care Models – three waves:– 1) PACS, MCP and Care Homes
29 sites announced March 2015– 2) UECs
8 sites announced July 2015– 3) ACCs
13 sites announced September 2015
New Care Models team• Central New Care Models team created during
2015• Largely based within NHS England but is
designed as a programme across: NHSE, CQC, NHS Improvement (Monitor/TDA), Public Health England, Health Education England
• Support across workstreams and care models
New Care Models support
PACS• Primary and Acute Care Systems (PACS)
– Responsible for health and care needs of a population (built from GP lists – so needs to include primary medical care)
– Likely to cover larger populations than an MCP, and slightly wider range of services
– Potentially covering all health and social care services, including in-hospital care
– Capitated budget (or meaningful steps toward it)
MCP• Multi-specialty Community Provider (MCP)
– Responsible for health and care needs of a population (built from GP lists – so, as for PACS, needs to include primary medical care)
– Likely to cover smaller populations than an a PACS, and slightly narrower range of services
– Potentially covering all health and social care services, except those that need to be delivered as a hospital-based service
Care Homes & UECs• Enhanced Health in Care Homes
– Focus on how older people can be offered better, and more joined-up health, care and rehabilitation services
• Urgent and Emergency Care Systems (UEC)– Focus on better and more coordinated urgent
and emergency care, especially through implementation of recommendations of the Keogh review
ACCs• Acute Care Collaborations – actually a
collection of various quite different models – for example:– Hospital groups / chains – eg Royal Free– “Franchises” – eg Moorfields– Accountable clinical networks – eg for cancer
services (Royal Marsden) or for smaller services like radiology (EMRAD)
MCPs & PACS development• MCPs and PACS were in the first wave of
vanguards and have been a key area of focus so far
• These models present some particularly challenging issues – for example:– Organisational form they may take– Contractual model / terms– Pricing / capitation (or similar)– Technical issues - indemnity cover, VAT, NHS
pensions access etc
MCPs & PACS development (2)• NCM team are actively exploring these areas
and providing guidance• Many of the issues are linked, so can be
difficult to resolve areas in isolation• Care model frameworks are being prepared -
MCP framework is likely to be the first and may be released this month
MCPs & PACS development (3)• Intention for some MCP / PACS sites to be
operational from April 2017• Key deliverable is a new MCP contract, which
should be available for use from April 2017 (PACS contract likely to also be available)
• Being developed in the NCM spirit of “co-creation” with the vanguards
MCP / PACS Contracts• Currently, specific contractual terms must be
used for primary medical services – the “GMS”, “PMS” and “APMS” contracting arrangements - and the NHS Standard Contract must be used for most non-primary care services
• Recent versions of the NHS Standard Contract have enabled single contracts for a combination of primary care and other services
MCP / PACS Contracts (2)• The NHS Standard Contract includes an
“APMS plug-in” schedule that enables that contract to be both an NHS Standard Contract and an APMS contract
• In theory this could capture MCP / PACS arrangements now, but there’s a desire to create something more tailored for MCPs and PACS
NCM, Devo and STPs • NCM programme deliberately ambitious• Some geographical areas have added
complexity:– Several vanguards– Vanguards combined with devolution plans (eg
NW)• Sustainability and Transformation Plan (STP)
process underway – 44 “footprints” each developing STPs showing their plans for the next five years
General Practice Forward View • 5YFV also noted the pressure on primary care• GP Forward View published in late April 2016• Main aims:
– Increased investment (inc exploring new funding formula, indemnity costs etc)
– Increased workforce – increase in GP / clinical staff
– Relieve workload– Infrastructure – Care redesign
Questions & Answers
Health Care Procurement 2016Peter WarePartner, Government and Infrastructure
Who is responsible for commissioning?• The Health and Social Care Act 2012
– Abolished the strategic health authorities and primary care trusts;
– Created: Clinical Commissioning Groups; and The National Health Service Commissioning
Board (NHS England)
Who is responsible for commissioning?• CCGs are responsible for commissioning the majority of NHS
services this includes:– elective hospital care;– community health services; and– Urgent and emergency care
• NHS England is responsible for:– Specialised commissioning;– Certain services which are at a national level; and– Primary care services;
• Local authorities note they assumed responsibilities for public health services and thus they will be commissioning those types of services.
The Legal Framework• EU Directives on public procurement• Public Contracts Regulations 2006 (for pre 18th April 2016)
• Public Contracts Regulations 2015 (for post 18th April 2016)
• Principals on the Functioning of the Functioning of the European Union (general treaty Principles)
EU Public Procureme
nt Law
• the National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013 (Patient Choice Regs)
• Guidance issued by Monitor to accompany such regulations
NHS specific English rules
The European Bit:(Light Touch Regime) • Light Touch Regime (LTR) applies to service
contract types set out in Schedule 3 of the PCR 2015 which have a value in excess of £589,148
• Applies to all contracting authorities (e.g. CCGs, NHSE and Local Authorities)
• Applies to all procurements commenced after 18th April 2016.
Light Touch Regime • Regulation 75 requires advertisement in the OJEU
either by way of a Contract Notice or a Prior Information Notice (PIN)
• Reg 76(7) No particular procedure to follow, but must state clearly how the process will be conducted at the start
• Reg 76(2) Must comply with General Treaty Principles (transparency and equal treatment)
• This means that objective criteria must be published and adhered to
• Time limits must be long enough to allow undertakings to make a meaningful assessment and prepare their offer.
• Standstill Period?
Derogations from the LTR• Reg 32 sets out the situations in which negotiations can take
place without prior publication of a Contract Notice:(a) where no tenders, no suitable tenders, no requests to participate or no suitable requests to participate have been submitted in response to an open procedure or a restricted procedure, provided that the initial conditions of the contract are not substantially altered and that a report is sent to the Commission where it so requests;(b) where the works, supplies or services can be supplied only by a particular economic operator for any of the following reasons:—
(i) the aim of the procurement is the creation or acquisition of a unique work of art or artistic performance,(ii) competition is absent for technical reasons,(iii) the protection of exclusive rights, including intellectual property rights,
but only, in the case of paragraphs (ii) and (iii), where no reasonable alternative or substitute exists and the absence of competition is not the result of an artificial narrowing down of the parameters of the procurement;(c) insofar as is strictly necessary where, for reasons of extreme urgency brought about by events unforeseeable by the contracting authority, the time limits for the open or restricted procedures or competitive procedures with negotiation cannot be complied with.
Public to Public Cooperation • The Teckal Exemption and Regulation 12
– Control– Activity test– No private sector involvement
• Hamburg Waste principle and public to public cooperation – Cooperation between contracting authorities with
aim of securing public service obligation they both have
– Governed solely by public law considerations – The bodies perform less than 20% of such activities
on the open market.
Patient Choice Regulations• Apply only to NHS bodies so CCGs and NHSE• Apply to all contracts for healthcare services
regardless of value• Are subject to the jurisdiction of Monitor and
the courts in England• There is still much disagreement over what
they actually require• The key regulation (for competition purposes)
are regulations 2,3 and 5.
Regulation 2 2. Procurement: objectiveWhen procuring health care services for the purposes of the NHS (including taking a decision referred to in regulation 7(2)), a relevant body must act with a view to—(a) securing the needs of the people who use the services,(b) improving the quality of the services, and(c) improving efficiency in the provision of the services,including through the services being provided in an integrated way (including with other health care services, health-related services, or social care services).
Regulation 3 (2) The relevant body must—
(a) act in a transparent and proportionate way, and(b) treat providers equally and in a non-discriminatory way, including
by not treating a provider, or type of provider, more favourably than any other provider, in particular on the basis of ownership.(3) The relevant body must procure the services from one or more providers that—
(a) are most capable of delivering the objective referred to in regulation 2 in relation to the services, and
(b) provide best value for money in doing so.(4) In acting with a view to improving quality and efficiency in the provision of the services the relevant body must consider appropriate means of making such improvements, including through—
(a) the services being provided in a more integrated way (including with other health care services, health-related services, or social care services),
(b) enabling providers to compete to provide the services, and(c) allowing patients a choice of provider of the services.
Regulation 5 5.— Award of a new contract without a competition(1) A relevant body may award a new contract for the provision of health care services for the purposes of the NHS to a single provider without advertising an intention to seek offers from providers in relation to that contract where the relevant body is satisfied that the services to which the contract relates are capable of being provided only by that provider.
What does that all mean? • Strict interpretation would mean that unless there is
only one capable provider then all contracts must be competed.
• That is not what Monitor and DoH say in their guidance or notes.
• They confirm that regulation 2 is the starting and overriding point
• When there is “only one capable provider” is only one of a number of situations where competition is not required.
• Their view is that there should be a balanced judgement
• Whilst it is only guidance case law suggests that the courts will give it considerable weight
How does the LTR and Patient Choice regulations sit together? • Conflict:
– LTR requires competition for above threshold contracts
– Patient Choice Regs arguably do not.• The Reg 32 derogation from LTR is much more
limited • EU law will take precedence • We await the Monitor guidance!
Remedies
Remedies under EU Law
Remedies under the Patient Choice Regulations
Alternative Remedies
EU Remedies: Pre contract • Regulation 95: Automatic Suspension
– Awareness – Linked to standstill?
• Regulation 96 Interim orders– Ending standstill– Modifying standstill– suspending the procedure
• Regulation 97: Before Contract– Setting aside the contract – Order an amendment to any document– Award damages
• Pre action disclosure and Pre action protocol
EU Remedies: Post Contract • Ineffectiveness?
– Probably not for the vast majority of cases• If ineffectiveness applies civil financial
penalty and/or shortening of the contract • Damages
Remedies: Patient Choice Regulations • Monitor can investigate:
– As a result of a complaint;– On its own initiative;
• No guarantee that Monitor will investigate (see enforcement guidance on their approach)
• No Control over the process• But they have wide ranging investigative
powers • Power to do a number of things including
declare a contract ineffective
Remedies: Patient Choice Regulations • Breach of statutory duty and complaint to
court?• What should you do?
– Think about limitation – Monitor first and then court action?– Can’t pursue a dual track
• Judicial review of Monitor?
Other Remedies etc • Complaint to the Commission
– Try to solve it through structured dialogue with member state;
– Then infringement proceedings: Letter of formal Notice Reasoned opinion Referral to CJEU Judgement
Other Remedies etc. • Judicial Review
– Must have standing – You must not have an alternative remedy or must
have exhausted that first – There must be a “public Law” element – Grounds include:
Illegality Irrationality Procedural unfairness Breach of legitimate expectation
• Below Threshold?
Speak to us…
Paul Wainwright| 0121 237 [email protected]
Clare Auty| 0121 237 3943 [email protected]
Raymond Silverstein| 020 7337 [email protected]
