the falsified medicines directive - regulation driving digitisation
DESCRIPTION
"The Falsified Medicines Directive - Regulation Driving Digitisation" by Graham Smith of Aegate. Presented at The European Generic Medicines Association’s Annual Conference, Madrid June 25-27th 2014TRANSCRIPT
"The Falsified Medicines Directive- Regulation Driving Digitisation"
by Graham Smith of Aegate25th June 2014
Agenda
1. About Aegate
2. Falsified Medicines Directive
3. The Way Forward
2
The largest dedicated medicine verification company
Operational since 2006
Work in multiple European markets
Checked 3 billion medicines to date
200,000 transactions an hour
Robust secure systems (ISO 27001 & 9001 certified)
Protect patients
3www.aegate.com
The largest dedicated medicine verification company
For Manufacturers
Check your medicines
Secure the supply chain
Bring you closer to the pharmacist
For Pharmacy
Provide a service that is fully integrated into workflow
Fast response time of 250 milliseconds
Provide information & messaging that enhances pharmacists professional role
4www.aegate.com
Aegate Service Measurement
5
Falsified Medicines Directive
What's Your View?
a) Another piece of European legislation?
b) Just a Cost?
c) Imposition or Opportunity?
6
Another piece of European legislation?
Targeted at protecting patients from the threat of counterfeit or falsified medicines:-
Counterfeit medicines – the threat is growing
Stolen Herceptin in Italy (May 2014)
Counterfeit Aspirin in France (May 2013)
Counterfeit Omeprazole in Germany (April 2013)
Delegated Acts are being used to ensure uniformity across the EU
Ultimately the legislation will improve patient care & wellbeing
7
Just a Cost?
There are costs for manufacturers associated with the legislation:
Tamper Evidence
Serialisation
Authentication System
However, it will also create a digitised network connecting manufactures, wholesalers, pharmacy and patients.
8
Imposition or Opportunity?
The digitisation of the pharmaceutical supply chain should not be looked at as a “cost” or “unnecessary legislation”
Opportunity
Step change in Patient Safety
A lot tougher for the counterfeiter
Efficiency improvements in pharmaceutical supply chain
Closer to the pharmacist
9
Technology
What is important is how you use it:
10
It is not
Information is changing our World
The way we work
The way we see things
The ability to influence real time activities
Our ability to make informed decisions
Our ability to make a difference
11
The Falsified Medicines Directive will change how we deliver healthcare
It will establish the network
1212
The Falsified Medicines Directive will link
1313
manufacturers
10 billion prescription medicine packs across Europe
500 million people
150,000 pharmacies
2,500 manufacturers
Transform how we do business
14
Pharmaceutical
Companies
Patient(Consumer)
ProductsPharmacy
AlertPreventing:
Expired
Recalled
Suspicious
medicines from being dispensed to patients
15
InformExperience & Expertise in the delivery of information to both pharmacy & indirectly the patient
16
Imaginol
Message Inform the patient
Provide materials
Ask questions
Get feedback
Sign-up to services
17
Imaginol
Using messaging at the point of dispense you can use the pharmacist to sign up patients to innovative reminder services
18
Pan European adherence services
Deliver market research messages and capture patient responses
19
Market research services
Imaginol
Inform the pharmacist about the benefits of complementary products
20
Cross selling services
Imaginol
Imaginol
Imaginol
Pharmacy messaging works
A recent Pneumococcal vaccination campaign ran in Belgium gave a ROI of 267% based upon increased dispensing against a control group
A message targeting osteoporosis patients improved compliance by 9%
A recent launch campaign message with a link to instruction materials got a 95% response rate from pharmacists
21
The Way Forward
22
Aegate positioning
Aegate advocates one verification system per country, run on a standard platform
Aegate are supportive of the ESM joint stakeholder model
Aegate agree with the Commission’s requirement for an end to end system to verify medicine authenticity
23
Common User Interface
Embedded Security Features
Simple Integration
Offline Storage Device Identification
Embedded Support +
Configuration
PharmacyManufacturer Supply chain
Common User Interface
Embedded Security Features
Simple Integration
Offline Storage Device Identification
Embedded Support +
Configuration
1
The EGA have an important role
Aegate Other Approaches
To ensure the best system is chosen:
24
• Safe
• Reliable
• Low Cost
• Proven
• Efficient
• Conceptual
• Complex
• Expensive
• Unproven
• Wasteful
vs
Aegate are here to help• Verification & patient safety is our core business
• Decade of experience, proven technology
• Experienced team with ecosystem partners
• We work with manufacturers to help them resolve serialisation data transfer issues
• We have the scale and ability to roll-out National Systems on a market by market basis
• Users have the opportunity to benefit from other services using the digital network
• High levels of system availability 99.98%
• ISO Certified, secure, proven and expandable system
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