ABHI and MediWales Briefing and MediWales... · 2012-05-17 · ABHI Advancing access to medical...
Transcript of ABHI and MediWales Briefing and MediWales... · 2012-05-17 · ABHI Advancing access to medical...
ABHI and MediWales Briefing Event
21 February 2012
ABHI
Advancing access to medical technology
Our mission
To champion the benefits and use of safe and
effective medical technologies in delivering high
quality patient outcomes
Who we are
1
What we do
2
STRATEGY
Advocating policies that allow members to operate in
a favourable business environment
UK MARKET
Policies that support the
rapid evaluation,
reimbursement and
adoption of medical
technologies by UK
healthcare systems
INTERNATIONAL
MARKETS
Policies to provide an
effective gateway to
foreign markets
REGULATION &
STANDARDS
Policies for simple and
smart regulation,
providing patients with
safe, effective, high
quality and innovative
medical technologies
ETHICS & PRINCIPLES
Policies to ensure
business is conducted in
the right manner
ABHI 2012 Priorities
UK Market
Create industry position on procurement and gain NHS agreement
Establish clear and structured relationship with NHS Commissioning Board
Adopt industry leadership role on implementation of IHAW key recommendations
International Develop industry position on trade support mechanisms and influence Government
Minimise barriers to trade with China, Brazil and India
Regulatory &
Standards
Ensure industry positions on MDD Revision reflected in UK input to “Formal Proposal”
Establish clear and structured relationship with MHRA Devices Division
Ethics &
Compliance
Establish ABHI CoBP as standard for all NHS interactions with suppliers
Develop member employee accreditation system for interaction with NHS
The Regulatory Landscape
Mike Kreuzer OBE
Executive Director, Technical & Regulatory
Medical Device Regulation and ABHI’s role
• ABHI founded 1989 to address the Medical Devices
Directives
• Today regulation is one of ABHI‟s four strategic pillars
• The system is under review - Some say under threat
Regulatory Activity in ABHI
• European dimension to all MD regulation
• Monitor developments in the medical device regulatory
system
• Provide a limited advisory role to members
• Influence the regulators both in the UK and at
European level
European Commission
MHRA /
Notified Bodies
UK Rep
UK Industry
(ABHI)
Eucomed
The Virtuous Circle
Top line regulatory issues today
• The Revision of the MDDs (was Recast)
–UDI (Unique Device Identification)
• MHRA Organisation / Capability / Funding
• Standardisation
• Environmental Legislation
The Revision (The future of device regulation)
• The regulatory regime has served society well over 20 years
• Patients have benefitted from products which are
– both safe and innovative
• Like all legislation the system needs periodic revision
• Will that revision be „industry friendly‟ or not?
• The Exploratory Process (Commission consults) suggests „YES‟
EU Council Conclusion - June 2011
The Conclusion signed by all 27 member States says:
„that innovation in medical devices should contribute to the
continued improvement of patient and user safety‟
And that there is a need to:
„...adapt EU medical device legislation to the needs of tomorrow
so as to achieve a suitable, robust, transparent and sustainable
regulatory framework, which is central to fostering the
development of safe, effective and innovative medical devices for
the benefit of European patients and healthcare professionals‟
The Recast – key issues
• The debate revolves around the following five key areas:
1. Novel Innovative Technologies – A speedy and effective system needs to be designed and agreed.
2. Notified Bodies (NBs) – Tighter control of designation and oversight essential. Intentional side effect: less NBs
3. PMS / Vigilance – Central reporting and coordination across the EU needed
4. Transparency – Central EU database with open access. Eliminate local databases (the „UDI effect‟?)
5. Management of the system. – Broad agreement for greater centralisation and therefore more administration. The options
are either EMA or JRC with „enhanced member state involvement‟
So is everything rosy?
• The „Establishment‟ agrees with Industry
• BUT some want a more prescriptive regime
–That „cause‟ has been greatly helped by PIP (and Hip)
• This could stifle an innovative industry and
–make the EU less attractive for innovation and investment
• Our advocacy work focuses on resisting this (particularly
centralised PMA) AND on keeping to a sensible reform
agenda
L’Affaire PIP
• The PIP scandal allegedly caused by criminal action
• Cosmetic Surgery „industry‟ under fire
• Regulators and regulatory system easy to blame
• Not good news when Revision proposal due
• Extensive „bad press‟ for MDs and the system
• BUT Commission and UK authorities standing firm on basic
direction
– ....while tightening up process in short term
The PIP Effect
Short term measures announced by the Commission
(February 2012)
• Reviewing NB designation and encouraging unannounced
inspections
• Reminding authorities of available powers in market
surveillance including making spot checks for certain types of
devices
• Enforcing the vigilance system, in particular on incident
reporting, analysis and action
• Taking steps to improve the traceability and monitoring of
medical devices using UDI and implant registers
UDI – A (rapidly) Emerging Issue
• UDI is cross-discipline – patient safety / supply chain
• New legislation likely in 2012
– FDA and EU (Recast)
• „All devices‟ to carry a machine-readable identifier
• Main purpose: patient safety (traceability)
• But will be used for „commercial‟ purposes
• ABHI can influence development through Eucomed & GHTF
• Programme will accelerate after PIP
• BUT key concerns are:
– Proliferation of systems
– „reciprocity‟ – will healthcare authorities and providers be equipped
to interact with industry?
The Recast of the MDD
How it will affect you
• High Risk Products – more evidence
– Pre market
– Post market
• Lower Risk Products
– More Notified Body involvement?
– Up classification?
• Fees payable to MHRA?
• Cost of UDI
• Enhanced control of imports & distribution (market surveillance)
• MDA merged with MCA to form MHRA in 2003
• Concern at lack of device focus 2003 – 2011
• Today a Device Division has been created
• This is good news but there are on-going concerns
MHRA
Standardisation
• Horizontal harmonised standards support the Directives
• ABHI has always had a specific involvement in Standards
– Standards management – visibility and control
• ABHI currently provides
– Chair and rapporteur of ABHS and chairs Eucomed SFG
• The Formal Objection
• Standards system remains key to EU 2020 objectives
Environmental Issues
• Packaging & Packaging Waste Directive
• Waste Electrical & Electronic Equipment (WEEE) Directive
• Restriction on use of Hazardous Substances (RoHS)
Directive
• Registration, Evaluation and Authorisation of Chemicals
(REACH)
And finally an up to the minute concern...
CMC Decision 3
• This requires all product to be labelled with manufacturers full
postal address
• Changes required by September 2012
• One major company has estimated a cost of € 2 million to
comply
• Not in line with EN 1041
• Possible Legal Challenge
• Possible compromise?
ABHI Code of Business Practice
Background
• Need for a Code recognised years ago but proved
difficult to achieve
• Prosecutions in the US and elsewhere forced the
issue
• ABHI Code developed in 2007/08
• In 2008 became a condition of membership for the
first time
The Code
Developed by Eucomed, adopted by ABHI
Covers: – Quality & Regulatory Compliance
– Interactions with Healthcare Professionals
– Advertising & Promotion
– Unlawful Payments & Practices
– Competition/Antitrust Procurement Laws – Dos & Dont‟s
– Export Controls Sanctions
– Environmental Issues
– Data Privacy
– Compliance & Enforcement – Dealt with by CoP Complaints Panel
Interactions with Health Care Professionals
• Addressed through
– Guidelines
– Q&A section
• Aim was to provide a practical document
• Q&A subject to periodic updating – latest September
2011
Future Developments
• Annex on Advertising and Promotional Materials – April
2012/January 2013
• Logo Scheme Pilot – from 29th September 2011
• Broadening „reach‟ of the code
• Continue publicising the code to the wider community –
HCPs, regulators, government etc
The “Logo Scheme”
Nishan Sunthares
Commercial and Market Access Director
NHS Procurement
21 February 2012
2011 activity
‒ NHS Supply Chain Direct From Manufacturer – Choice
for Health initiative
‒ Procurement intermediaries‟ Activity Based Income
business model
2012 focus
‒ NHS Procurement Strategy
Discussion points
28
All activity governed by Commercial Policy Group
Our focus:
‒ NHS Supply Chain Direct From Manufacturer
Choice for Health initiative
‒ Procurement intermediaries‟ Activity Based
Income business model
2011 Activity
29
Choice for Health (CfH):
‒ The provision of an “own-brand” product offering by NHS Supply Chain
Ongoing activity augmented by targeted legal analysis
Outcome: CfH now halted
Next steps: Continued engagement with DH to
ascertain future incarnation of “own-brand”
NHS Supply Chain Direct From Manufacturer – Choice for Health
30
Targeted legal analysis:
‒ Would the business model be construed as a facilitation
payment?
‒ Whether US legislation has any relevance in the UK?
‒ The aspects of public procurement law that have to be
observed?
‒ Whether there are any anti-competitive practices in the
service offering?
Procurement intermediaries‟ Activity Based Income business model
31
Conflict of interest
‒ De-facto commission or value-added service?
‒ Is the business model aligned to that of Trusts?
Exclusivity
‒ How would this generate value for money?
Operational risks to Trusts
‒ Most economically advantageous tender
32
Activity Based Income business model ABHI response
NHS “Procurement Strategy” – March 2012
Why?
‒ National Audit Office: “Procurement of consumables by NHS
Acute and Foundation Trusts”
‒ Public Accounts Committee tasked Sir David Nicholson
2012 Activity
33
The NHS Procurement Strategy Findings of the Public Accounts Committee
34
There is a need for clarity from the Department about how it will deliver
the necessary improvements in procurement by NHS hospitals when
trusts are independent of its control.
It is not clear how trusts will be motivated to deliver collectively the £1.2
billion savings required from procurement under the Quality, Innovation,
Productivity and Prevention (QIPP) programme.
Information on what products trusts buy and the prices they pay is poor.
NHS Supply Chain is not demonstrating its value to the NHS.
Regional purchasing structures are confused and lack transparency.
There is a risk that, faced with the need to make savings, trusts will not
identify procurement savings and will instead cut elsewhere.
There is a need for clarity from the Department about how it will deliver
the necessary improvements in procurement by NHS hospitals when
trusts are independent of its control.
It is not clear how trusts will be motivated to deliver collectively the £1.2
billion savings required from procurement under the Quality, Innovation,
Productivity and Prevention (QIPP) programme.
Information on what products trusts buy and the prices they pay is poor.
NHS Supply Chain is not demonstrating its value to the NHS.
Regional purchasing structures are confused and lack transparency.
There is a risk that, faced with the need to make savings, trusts will not
identify procurement savings and will instead cut elsewhere.
The bigger prize
Currently has an acute sector slant
Needs to be wider:
‒ shift of care
‒ clinical decision making (quality & outcomes)
‒ long term
ABHI feedback
35
Role of the Centre
‒ Performance benchmarking
‒ Consistent approach to data collection and information
management
‒ one size fits all?
‒ procurement channels?
‒ oversight (vis a vis intermediaries)
ABHI feedback
36
Effective local procurement
NHS Standards of Excellence
‒ People
‒ Process
‒ Leadership
‒ Partnerships
ABHI feedback
37
2011 activity
‒ NHS Supply Chain Direct From Manufacturer – Choice
for Health initiative
‒ Procurement intermediaries‟ Activity Based Income
business model
2012 focus
‒ NHS Procurement Strategy
Summary
38
Andy Taylor – Executive Director, Healthcare Policy
21 February 2012
Changes in the NHS – things to watch out for
“The NHS needs to plan for making huge efficiency savings”
NHS expenditure by year
70,000
80,000
90,000
100,000
110,000
120,000
130,000
2006
/07
2007
/08
2008
/09
2009
/10
2010
/11
2011
/12
2012
/13
2013
/14
£m
illio
ns
demand, pay & price
pressures
scenario with "flat cash"
from 2011/12
actual and planned spend
£15-20bn
productivity
challenge
•Money is tight in the NHS...
•„demographic pressures‟
•Ageing population, long term conditions
•Also expectations – private spend is down
•In Wales, Scotland, Northern Ireland – the NHS is still „of
the state‟
•In England, turbulence – leadership clear?
•Different responses to pressure on the service?
•Waiting times, activity
Wherever you are in the UK...
41
An emphasis on - economic/growth policy in each
administration and especially on „life sciences‟
•Some „UK‟, but also quite competitive across the UK
•Weakness or strength?
Potential for a different relationship:
"We need to establish new relationships with industry,
based on partnerships that deliver mutual value, rather
than simple transactional business."
....but also...
42
•Through the services it provides: a healthy population is more
productive, and more economically active
•By adopting innovation to improve its own productivity, it can deliver
more health benefit for a given public resource
•By accelerating adoption and diffusion of innovation throughout the
NHS it supports growth in the life sciences industry
•By exporting innovation, ideas and expertise, working in partnership
with UK industry, it provides new business opportunities abroad for
UK-based companies.
Health and the Economy: the NHS contributes to the UK economy in four important ways:
43 Innovation, Health & Wealth – December 2011
What is said at the centre of government(s) and what actually
happens on the ground
„It‟s like the wild west out there‟(Sir John Bell, Government life
sciences adviser )
NHS cash limits trump all other cards historically: the NHS balances
its budget (usually)
•tends to reinforce the silos
Is this time any different?
Though gulf persists between theory and practice
44
Move the dial on:
• adoption – role of NICE, learning from NTAC
• incentives – how to shift the point of care?
• in England, tariff
•Investment and silo budgets
“Developing and introducing a shared savings formula
to break down silo budgeting and encourage cross
boundary working”
• Is this a lost cause?
• Senior NHS leaders in England appear to believe it is not.....
Key objective for ABHI in 2012 is to shift the focus this time
45
Procurement
•Targeting 5% of the budget for what proportion of savings?
Regulatory changes in the spotlight
•But also: excessive variation in practice and in outcomes
•Need for more rational introduction/commissioning of specialised services
-issues for clinician skill development as much as for device
technology. This is a natural focus for innovation....
•England national commissioning likely to spotlight this. Audit Scotland
has...
Big challenges
46
Thank you!