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Slide1
The Falsified Medicines Directive
Slide2The
HDA (formerly BAPW)
Who we are
Good Distribution Practice
HDA is a UK-wide representative trade association whose mission is to advance the interests and values of those member companies who provide
comprehensive
medicines wholesaling, distribution and associated services to all UK pharmacies, hospitals, and dispensing doctors.
Patient safety is
the
priority of all members.
The HDA
Gold Standard of GDP
provides:
resilience & certainty across 4 countries of the UK
7-day, 24 hour emergency service
a service integrated into NHS primary & secondary care
NHS preparedness
community pharmacy support
MHRA membership of HDA RP Committee
HDA membership of MHRA anti-counterfeiting stakeholder group
HDA membership of DH Supply Chain Forum
HDA membership of EU Stakeholder Group for Falsified Medicines
HDA membership of GS1
Slide3The UK businesses we represent
Slide4.. In volume market HDA share is ~87%
10/20/16
HDA
Report
All Charts for MAT Jun’16
Data Labels show – % share
Total Market Volume (Retail + Doctor)
Source: DSGREP
Slide5The backbone of NHS medicines supply
54 MHRA fully validated cold & ambient warehouse locations, with CD stores
Delivering 85% of NHS medicines – 2.4billion
Full range of products – 25,000
250,000 deliveries per week across the UK
All sites fully audited and compliant to GDP
24-hour emergency supply
Dedicated account management
Bespoke customer service teamsOn-line management & ordering functionalities
Full e-commerce capabilities Single packet to full pallet capabilitiesUndertake medicine recalls on behalf of MHRA‘End-to-end regulation’
Slide614,256 pharmacies + 327 hospitals
+ 2,098 disp. doctors’ practices
9 HDA distributors
1250
manufacturers
Slide7Adding value to the NHS
‘wholesaling’ provides efficiencies by:
consolidating transactions (manufacturer to pharmacy) to provide individual orders
providing working capital of £1.4billion
providing frequent deliveries and stock control
m
anaging customer
accounts
providing resilience:
medicine recalls & anti-counterfeit surveillance (on behalf of MHRA)
NHS pandemic preparedness/buffer stockssupport for NHS community pharmacy servicesemergency supply services
Slide8Our challenge
– to
explain value at a time of change
While fixed cost base is growing
wholesale needs volume and value
Wholesale margins are at an all-time low
volume
business is not enough to sustain
comprehensive end-to-end supply chain development, required by patients and pharmaA broader range of products in wholesale is needed to sustain developmentand to maintain the order consolidation platform for community pharmacy, hospital pharmacy and dispensing doctorsto get medicines to patients at the right time, in the right place and at the right price
Slide9a
nd now changing hats
…..on behalf of SecurMed The UK implementation of FMD(in spite of Brexit)
Slide10What are
falsified
medicines?
Growing threat to public health and safety in Europe
Involving nearly 2500
cases,
EU Customs seized 27.4 million doses of falsified medicines at EU borders in 2011- an almost seven-
fold
increase from 2007MHRA seized £8.6m in May 2014 from organised crime, who are now infiltrating the NHS drugs and medical devices supply chains and diverting medicines to street drug dealers and illegal websites…...in order to make money
Falsified medicines may:Contain low quality ingredients or the wrong dosesHave their identity or source deliberately mislabelledHave fake packaging or the wrong ingredients
Slide11Recent Examples in UK
April
2013 - Remicade from Romania (packaging falsified)September
2013 - Symbicort
Turbohaler
from Lithuania (packaging falsified)
April
2014
- Herceptin from Italy (tampered and refilled vials contained liquid instead of lyophilised powder) June 2014 - Kaletra from Latvia (packaging falsified) November 2014 - Symbicort Turbohaler from Bulgaria (packaging falsified)
June 2015 - Kaletra from Latvia (packaging falsified)
Slide12Falsified Medicines Directive (FMD) 20011/62/EU
Directive published 1 July 2011
Entered into force 1 January 2013
Contains measures to increase security of the medicinal supply chain in Europe
Strengthen Good Manufacturing and Good Distribution Practices including the sourcing of active ingredients
Improve supervision of actors in the distribution chain (e.g. wholesalers, parallel distributors...)
Ensure product integrity and authentication of medicines (safety features and product serialisation)
Slide13Delegated
Regulation to the FMD13
European Medicines Verification System
Adopted on 2
nd
October 2015
Published on 9
th
February 2016Enacting terms: Safety Features
Characteristics and technical specifications of the unique identifierModalities for the verification of the safety featuresEstablishment, management and accessibility of the repository systemsList of RX medicines exempted from carrying the safety featuresNotification procedure for exceptions by Member StatesProcedure for rapid assessment of notifications
Slide14Implementation
of the Delegated Regulation – Required in Member States 3 years after publication
Objective:
Protection
of patients from falsified medicines in the legal distribution chain
Content:
Pan-European system to verify the authenticity of medicinal products
2011
2018 (2015+3)
Complete
Implementation
9 February 2016
Publication of
Delegated Regulation
July 2011
Publication of FMD
36 Mon.
2019
2016
Non-compliance puts supply and sales at risk
2013
Jan 2013
FMD except Safety Features implemented
*Italy,
Belgium
, Greece have 6 years longer for implementation
Slide15Safety Features
Marketing Authorisation Holders obliged to add safety features on all
prescribable medicines, except excluded medicines
Introduced to enable
wholesale distributors and those who supply to patients:
to verify the authenticity of the medicinal product,
to identify individual packs,
to
verify whether the outer packaging has been tampered with
FMD SF
Slide16Requirements for safety features
Code (‘safety feature’)
+
Tamper evidence
Unique identifier
Data-Matrix Code
Randomised serial number
Product #:
09876543210982
Batch:
A1C2E3G4I5 Expiry: 140531S/N:
12345AZRQF1234567890
Slide17Verification of authenticity
Medicine authenticity will be guaranteed by an end-to-end verification system.
verification
scanning before
dispensing
supplemented by
‘risk-based’ verification
by wholesale distributors.
medicines at higher risk of falsification additionally checked at wholesalers (eg
: returns)VERIFICATION
FMD SF
Slide18Stakeholders in distribution chain are obliged to build the pan-European verification systems
System set up and governed by stakeholders under supervision of authorities
Slide19Pan-European Structure
National
System
Pharmacy
Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
National
System
National
System
National
System
National
System
National
System
European
Hub
Required by Delegated Regulation
Slide20Fundamental principles for medicines verification in the EU
Unique identifier with randomised serial number
Check of pack’s authenticity at point of dispense
SAFETY FEATURES
Transactional data belongs to stakeholder that generated it, e.g. pharmacists for dispensing data
No access to data of other stakeholders except for verification purposes
DATA
Systems governed by non-profit organisations, established and managed by relevant stakeholders
Systems supervised by EU and/or national authorities
Quality supervision by EDQM (
tbd)GOVERNANCE
Flexible to implement national solutions within an EU technical framework (according to User Requirement Specifications)
Interoperable between different national systems through European Hub
SYSTEM DESIGN
Slide21Costs are incurred by all stakeholders
Each stakeholder pays for costs of own installations
Manufacturers pay for cost of verification system
Manufacturers
and Marketing Authorisation Holders
Manufacturers and Marketing
Authorisation
Holders –
contact EMVO to sign up for European Hub testing
Dispensing & Verification Entities e.g. Pharmacies and WholesalersInstallation for pack codingVerification system (hub & national systems)Installations for pack verification
Pharmacy
Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
European
Hub
Slide22What are the actions/tasks at national level?
Agreement between stakeholders
Principles for cooperation (
MoU
blueprint)
Establish stakeholder implementation project
Foundation of
National Medicines Verification Organization (NMVO)
Definition of technical requirements
Select IT provider (if blueprint out of the EMVO selection)
Provide funding
Cooperation with competent authority
System
implementation
System complete in 2019 !
Slide23Stakeholders in distribution chain are obliged to build the ‘national’ verification systems
System set up and governed by stakeholders under supervision of national competent authorities
Slide24Where Are We Now in the UK?
2016
Monthly meetings of UK Stakeholders, representing the 5 ’constituencies’Framework
MOU/Articles agreed and signed off
Incorporation of NMVO as
SecurMed
UK
Full engagement with Competent Authorities
MHRA letters to all MAHs and WDA holders regarding obligationsStakeholder membership of DH/MHRA FMD Implementation Advisory Board & associated workstreamsMHRA Impact Assessment work currentlyMHRA/DH consultation due in early 2017 Statutory Instruments (SIs) due in UK Parliament in 2018
Slide25Flexibilities under Article
23 - of key interest
“Member States may require
, where necessary to accommodate the particular characteristics of the supply chain on their territory, that a wholesaler verifies the safety features and decommissions the unique identifier of a medicinal product before he supplies that medicinal product to any of the following persons or institutions
:
(
a) persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;
(
b) veterinarians and retailers of veterinary medicinal products; (c) dental practitioners; (d) optometrists and opticians; (e) paramedics and emergency medical practitioners; (f) armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;(g) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions; (h) prisons;
(i) schools; (j) hospices; (k) nursing homes.”
Slide26T
he
train has finally left the station (in spite of Brexit!)
UK
MVO has issued consultation, on 2 issues:
p
rinciples
of establishment
of a UKMVO (MOU)User Requirement Specification (URS) for the Blueprint Service Provider (BSP) model….....and then ‘user testing scenarios’ in 2017Recent milestones:Incorporation of SecurMed UK and Board establishment during August 2016 Tendering and
BSP selection during August/September 2016 – with ‘Preferred Provider’ selected by Autumn 2016Recruitment for full-tme SecurMed General Manager underway
Slide27Where are YOU now?