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Impressions Kaiseraugst
A global view from the Pharmaceutical Industry Mathieu Aman
F. Hoffmann-La Roche Ltd, Basel (Switzerland) SETRM2016
Rastreabilidade de Medicamento
Sao Paulo, Jun 2016
Agenda
Worldwide, the Pharma
Industry is taking action
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What matters when
implementing a Drug
Traceability system
Suggested path forward in
Brazil
10’ 10’ 10’
Agenda
Worldwide, the Pharma
Industry is taking action
3
What matters when
implementing a Drug
Traceability system
Suggested path forward in
Brazil
10’ 10’ 10’
Supply chain complexity and lack of control facilitate criminal
activities, lead to medication error and ultimately harm patients
and healthcare systems
Counterfeiting
Manufacturer Distribution Center Wholesaler Patient
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Product Diversion
Point of dispensing
Re-imbursement fraud
Dispensing errors
Lack of accountability / supply chain visibility
Inefficient recall/return procedures
Under MAH control
Outside MAH control
Drug shortages / stock-outs
Criminal activities
Inefficiencies
5
A sustainable regulatory trend, as supply chain integrity and
patient safety are key concerns for the Healthcare community
With the courtesy of
…AND NOW
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Patients Healthcare
Professionals
Healthcare
Systems
Relying more on a system organized
around modern principles of patient
safety than on individual performance
Fighting criminal activities
Removing inefficiencies between
trading partners
Digitization of transactions
Barcoding, Serialization and Traceability technologies can help to
improve Healthcare to the benefit of…
Today, Mass Serialization & Traceability is a reality across the globe
And is continuing to mature
Argentina 2013
USA 2017
Brazil 2016
EU 2019
Market Response: There has been a rigorous international response to counterfeiting and supply chain integrity threats (in general) from governments, law
enforcement agencies, healthcare organizations and pharmaceutical companies.
Ukraine
Turkey 2010
Draft or In preparation
Published
Jordan 2018
China 2015
Korea 2016
Saudi Arabia
2015 Egypt
Taiwan 2018
Nigeria 2015
India
Russia 2017
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Pakistan Colombia
Philippines 2016
Singapore
UAE
Algeria
Early Adopter Experiences Very positive feedback and strong interest
Turkey • Combatted successfully re-imbursement fraud
• Supply Chain Visibility, including identification of re-export
Argentina • Roche reduced counterfeit related recall to 0 (4-7/year in previous years)
Korea • Successful collaboration with health authorities by shaping regulations and
timelines
US • Increased collaboration Industry – Distributors to the benefit of the Healthcare
Supply Chain
Germany • Ongoing dialog with key Healthcare actors on product security, supply chain
integrity and patient safety
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Agenda
Worldwide, the Pharma
Industry is taking action
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What matters when
implementing a Drug
Traceability system
Suggested path forward in
Brazil
10’ 10’ 10’
• Item level drug traceability is a
standard by 2020
• Assume 2D Barcoding
enabling/accelerating e/m-health
Strategic thinking & a long-term vision is required
2009
Vision ideal
state
2
3
1
Vision + backward planning
What we didn’ t want:
«Classical» Incremental approach
Sc
ala
bil
ity
Proof-of-concept
Ramp-Up
Maximize Biz.
Value
2010
2013
2016
French Coding
E-pedigree
Korea SER
EU VPD
Brazil T&T
TE …
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What are the trends/ commonalities ?
What do we think the future will bring us ?
Where do we want to be in 10 years from now ?
A cross functional effort
Strategic thinking & a long-term vision What Roche’s approach is from beginning
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Scale FAST Start SMALL Think BIG
• Ensure standardization, interoperability and integration
• Based on global standards
Develop and implement an
adaptable/scalable technical
standard solution
Work together with all
stakeholders &
Accept a Win-Win situation
• Co-develop and mature
• A constant mix of prototyping, conceptual design and
operational implementation
• Associations, peers, trading partners, vendors
• Regulators, standard bodies, Health Authorities
• Patients…
Lessons learned Sticking to international standards is crucial, to ensure maximum interoperability…
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GTIN + S/N + required
variable data
SSCC
GTIN + S/N + required
variable data
GS1: the Global standard in Healthcare now
2D DataMatrix ECC200
Linear GS1 128
2D DataMatrix ECC200
Linear GS1 128
… even the design of the product/shipping labels has to be adapted
Agenda
Worldwide, the Pharma
Industry is taking action
13
What matters when
implementing a Drug
Traceability system
Suggested path forward in
Brazil
10’ 10’ 10’
There is something in it for everybody
Allowing for opportunities (for everybody) will ease implementation
1. PharmaCo
More real world data / live-
studies
Less counterfeits and fakes
Easier recalls and root-cause
analysis
Higher supply chain integrity
Reduce inventories using
advanced analytics S&OP
WIP
Better understand usage
pattern
2. Payer/Insurer
3. Physician/hospital
pharmacists 4. Patient 5. Authority
Less reimbursement fraud
Easier personalized
reimbursement
Less administrative work (e.g.
paperless reimbursement)
Less patient compliance
issues (i.e. not taking but
reimbursing drug)
Better diagnostics &
treatment link improve
outcomes
Innovative contracting (e.g.
claw backs)
Value based pricing
More safety (counterfeits,
expiry date, recalls)
Better (vendor-) managed
inventory
Easier patient history
monitoring
Driving better diagnostics &
outcomes with transactional
data
Guidance for complex
administration &
e-leaflet/customer services
Less administrative work (e.g.
paperless reimbursement)
Higher product safety
(counterfeits, expiry date,
recalls)
Safer application (e.g.
adherence programs, online
coaching to support patient
behavior)
Better information (e.g. link
with prescription, e-leaflet)
Faster reimbursement (e.g.
automated)
More effective adverse event
reporting
Higher safety (better recalls,
less fakes)
Better control over
prescription/usage patterns
Faster access to emerging
markets
improved safety improved time/response improved costs/earnings
To the benefit of
the entire Healthcare system and ultimately
the Patient
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What the Industry’s approach should be
• It is in the ultimate interest of our Patients
• We can contribute to make our Healthcare systems more secure and efficient
• A nice opportunity for Healthcare Innovation Digitization
Not sure if, as an Industry, we can be successful
in fighting against such a strong need for more
Supply Chain integrity
We should welcome Health Authorities efforts
to secure drug supply chains
Why ?
Instead,
What we
should
NOT do
• Top 30 companies invest 2 Billion USD in Mass Serialization*
• We have gained a lot of experience worldwide
• We want to leverage the investments & adhere to
internationally recognized GS1 standards
Because we have to comply without endangering our ability to supply
while keeping a level of complexity which is still manageable
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Why the Industry wants to be part of the definition
• We should jointly exploit opportunities beyond anti-
counterfeiting or traceability only e.g.
– Patient information, bedside scanning, e-leaflet, link to e-
prescription
– More operational efficiency in drug dispensing process
– A win/win situation for all Healthcare actors
* According to a Serialization benchmark 2015 performed by 4XScience
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Invite national stakeholders to open dialogue
Clearly articulate the long-term expectations
Provide clear positions
as a reliable basis for planning
Establish common principles
as a basis for cooperation
How we believe Brazilian Health Authorities can drive implementation
of a traceability regulation to the next step
What needs to be DEFINED
Standard Data Carrier *
Standard Data Construct *
Access to Data
Reporting needs
National database
Implementation Timelines
* Stick to the data carrier/construct standards you have defined so far
A joint work and shared effort between all stakeholders to
increase patient safety
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Manufacturers Stakeholder coalition Pharmacies / Wholesalers,
respectively
Installation for pack
coding
Repository system
(National database)
Installations for pack
verification
r
What’s next ? E-leaflet ? Adverse Event Reporting ?
App for patient verification
The example of Turkey nicely illustrates the transformational
effect mass serialization can trigger on Healthcare systems
In scope
40’000 Stakeholders (Hospitals, Health Centers, Family Physician Centers, Pharmacies and Pharmacy Warehouses,
Manufacturers, Importers, Reimbursement Institutions)
Figures & Facts today
Number of drug types in İTS: 18 900
Number of drug unıts in İTS: 7 000 000 000
Number of daily operations in İTS: 45 000 000
Number of operations per second in İTS: 520
Response time of system: < 1 sec
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E-prescription / e-invoicing
Tracking & Tracing / Chain of Custody
Verification at dispensing + scanning based
Re-imbursement
Barcoding & Item
Serialization
All Health providers
Patients
Pharmacists
Wholesalers
Pharma Industry
???
2013
2014
2011
2012
2010
2015+ ?
Apply 2D Barcode / Technical features
MoH builds infrastructure & Database
Onboard & Connect
Onboard & Connect
Reach out to public
Equivalent developments can be observed whenever a
country decides to implement mass serialization
Healthcare engaged now in increased digitization A strong focus in hospitals, aiming for a higher process efficiency and patient safety
• Enabled by use of 2D-barcoding technology
• Development cannot be stopped
• Greatest risk is to be unprepared, hesitant and too
timid to act
B2C
tracking & tracing
B2B
advance shipping notification
e-leaflet
e-prescription
serial-Nr. based adverse event reporting
e-invoicing
Patient information
HCP interaction
bed-side scanning
RIGHT Patient
RIGHT Product
RIGHT Dose
RIGHT Time
RIGHT Channel
Ultimately it is our all’s shared goal to ensure 5 Patient’s Rights are
secured…
RIGHT (e-) Information
RELIABLE Supply Chain
And tomorrow… 7 Patients’s Rights…
With Barcoding, Mass serialization and Traceability Techniques. At sales unit level.
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