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

2

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

8

Agenda

Worldwide, the Pharma

Industry is taking action

9

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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Doing now what patients need next