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Falsified Medicines Directive
Stuart Hurst
A little bit about me……
• Worked in Brussels for eight years for Pfizer and Lilly
• Former chair of the EFPIA Coding & Serialisation Group
• Founder board member of the EAASM
• Just set up The Policy House
The Issue
A counterfeit manufacturing lab in Columbia A counterfeit manufacturing lab in China
Source: EC Annual Report on Customs Actions to enforce IPRs
Photos from WHO, IMPACT
Pharmaceutical GMP, Turkish style!!
Pharmaceutical GMP, Egypt.
Incredible though it may seem, this cement mixer was not
always used to make fake drugs……….
……… sometimes, it was used to make cement
Storage
Counterfeiters are frequently more concerned with the appearance of their product than their efficacy.
The counterfeit Ponstan tablets, which look similar to the original, contain none of Ponstan’s API. Instead,
they contain boric acid, which can cause kidney failure and even death, brick dust and road paint.
And the Profits?
Towards the end of the 20th Century, street
prices of narcotics began to fall in real terms.
It is a harsh reality of life in the 21st Century
that the profit margin on fake Viagra is
approximately 2000 times the profit margin on
real cocaine.
The Global Dimension
•
1957 The Treaty of Rome is signed, establishing the framework for the EU
Article 2 – Establishes Common Market
Article 3(a) – Eliminates Customs duties in the EC
Article 3(c) – Abolishes obstacles to free movement of goods,
services, people and capital within the internal market
Article 9 – Prohibits the introduction of Customs duties
Article 10.1 – if an import from a third country enters any
Member State, it enters free movement
Article 85 – Prohibits actions to limit or control free trade
Article 95 – Prohibits any Member State from introducing
preferential taxing
The Falsified Medicines Directive
• New EU legislation on the prevention of the entry into the legal supply chain of ‘falsified medicines’
• Directive 2011/62/EC amending Directive 2001/83/EC
• Applicable from 2 January 2013
Timeline
14
2012 2013 2014 2015 2016
July 1, 2011
Publication of Directive in official journal of EU
January 2, 2013
EU Member States to convert Directive to national law
2014-2017
Introduction of medicines verification systems in EU Member States
Provision of coded products
Q2 2012
EU public consultation on ‘Delegated Acts’ preparation ended
2014 (est.)
Publication of ‘Delegated Acts’
Falsified medicine
• Any medicinal product with a false representation of:
• (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
• (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
• (c) its history, including the records and documents relating to the distribution channels used.
Falsified medicine
• This definition does not include unintentional
quality defects
• and is without prejudice to infringements of
intellectual property rights.
The World did not end
January
2nd came
and went.
No-one
even
noticed.
FMD Summary • Introduces concept of brokering for finished medicinal products and provides a new definition for brokering
medicinal products
• Introduces requirement that brokers have to register with the Competent Authority of the EEA Member
State in which they are established
• Extends the requirement for a wholesale dealer's licence for export of medicines to third countries
• Extends existing obligations for wholesale dealers and provides new obligations, in particular reporting
any suspected falsified medicines
• Manufacturers to audit suppliers of active substances for compliance with the GMP and GDP
• Manufacturers will verify the authenticity and quality of the active substances and excipients
• Manufacturers to inform the Competent Authority and marketing authorisation holder should they get
information that products may be falsified
• Each shipment of active substance imported into the EEA to be accompanied by a written confirmation
that the standards of manufacture are equivalent to EU GMP
• Manufacturers, importers and distributors of active substances to be registered with the Competent
Authority of the Member State in which they are established
• Companies selling medicines at a distance to members of the public to be registered and a requirement
for a common internet logo on their website
•New rules for import of API:
Written confirmation on GMP or
country is listed by the Commission
•In the EU: registration of activity
•Safety
features
•Audit of API
manufacturers
•Obligation of reporting incidents
•Authorisation in EU database
•Common trust mark
•Awareness campaign
Manufacturers
of active
substances
Manufacturers
of medicines Distributors
Online
pharmacies
New measures for all actors in the supply chain
Safety features
Internet sales
Actors in the supply
chain
Active substances
Directive 2011/62/EU on falsified medicinal products
Wholesale distributors:
already regulated under EU rules
will henceforth be listed in a EU database
will be subject to Good Distribution Practices (GDP) for all activities performed on the EU territory
will have to report any suspicion of falsification.
Brokers:
i.e. persons who are trading in medicines without physically handling them
so far, not regulated under EU rules
will have to be registered
will have obligations similar to those of wholesale distributors.
Actors in the
supply chain
Safety features
The ‘safety features' introduced by Directive 2011/62/EU will enable wholesale distributors and
pharmacists:
to verify the authenticity of the medicinal product,
to identify individual packs,
to verify, by means of a device, whether the outer packaging has been tampered with.
'Safety features' will be compulsory for prescription-only medicines and for some non-prescription
medicines, to be determined through implementing measures.
The characteristics and technical specifications of the 'safety features‘, such as the unique identifier
for individual packs, will be laid down in implementing measures.
Active substances
All APIs:
Whether manufactured, imported or distributed in the EU (including those intended for export from
the EU).
Must comply with Good Manufacturing Practices and Good Distribution Practices for APIs.
Mandatory audits performed by medicines manufacturers or third party contractor.
„Written confirmation“ from the manufacturer on GMP compliance becomes legally part of the
application with:
a reference to the time of the audit,
a declaration that the outcome of the audit confirms the compliance with GMP.
All operators (manufacturers, importers, distributors of APIs) must be registered with the competent
authority where they are established 60 days prior to commencement of activity (to allow for
inspection).
Member State will continue to legislate autonomously on the supply of medicines at retail level
MS will continue to be responsible for the classification of a medicinal product as OTC or
prescription medicinal product.
Restrictions / bans of online sales of prescription medicines still possible
Total ban of OTC no longer possible, but a restriction on the grounds of public health is
Online pharmacies/retailers will have:
• to be authorised by the Member State of establishment,
• to display the ‘common logo’
• to supply medicines authorised in the Member State of destination, where the patient is
located (package and language)
Internet sales
Role of the EU Commission will be limited to the establishment of the Common EU logo
The logo will have to allow identification of the country where the retailer/pharmacy is located.
Public consultation over
Implementing act prepared during 2013
Each EU Member State to establish a website to provide information on:
national legislation governing the sales of medicines over the internet,
common logo,
online pharmacies operating legally on their territory.
Rules on online pharmacies/retailer will be applicable 1 year after the publication of the
implementing act on the common logo.
Commission together with MS and EMA will have to organise public information campaigns
Internet sales
In Summary
The FMD is alive and well and in its Implementing Acts phase
It presents great opportunities for those willing to look beyond
the initial requirements
The battleground will move increasingly online
Voluntary, collaborative, multi-stakeholder action will be
infinitely more effective than disparate Member State laws,
which will only drive low standards.
• Established in 2007 as a not-for-profit multi-sectoral organisation
• Campaigns for action to ensure that the legitimate supply chain for medicines is
better secured
• Targets the illegitimate supply chain
• Campaigns for legislative change to the regulatory environment, to target
counterfeiters
• Strives to raise awareness amongst patients through pan-EU activities, supported
by media campaigns
• Only independent, pan-EU patient safety organisation solely championing access to
safe medicines
• A new initiative to address the problem of illegal online pharmacies.
• Inclusive, collaborative, determined
The European Stakeholder Model
• Securing the legal supply chain is key to tackle the growing threat of falsified medicines
• MAHs will have to bear the cost of the future system
• EFPIA with key supply chain partners is proactively engaged in setting up a harmonised,
cost-effective, and stakeholder-governed system to comply with the legislation and
ensure patient safety
• Technical specifications are expected to be announced in 2014
The Directive – Safety Features
What Does the Directive
Mandate?
• Safety features that enable
relevant persons to
• “verify…authenticity”
• “identify individual packs”
• Tamper evidence
• Rx included, all OTCs excluded
Some exceptions based on a risk
assessment
• Govts can use the system for
reimbursement and/or
pharmacovigilance purposes
• MAHs will pay for the
‘repositories systems’
What Will Be Decided by Implementing Measures?
• Characteristics & technical
specifications of the ‘unique
identifier’
• Criteria for the risk
assessments & process for
notification of products included
• “Extent and modalities of
verification of the safety
features” to “ensure the
verification of authenticity of each
dispensed pack”
• Establishment (including
accessibility) of the
‘repositories’
The European Stakeholder Model
• A cost-effective solution for medicines verification
• Run on a non-profit basis
• A pan-European system called the EMVS (European Medicines Verification System) enabling medicines to be verified at point of dispensing
• Developed by the stakeholders who will use it on a day-to-day
• Immediate verification of the pack
• Ensures safe access to medicines
• Is interoperable solution
• EFPIA is one of the 4
stakeholders developing
the ESM solution
• The ESM solution is
being developed by the
stakeholders who will use
it day-to-day
• Talks ongoing with
AESGP, EAHP, EGA and
HOPE
AESGP Association of the European Self-Medication Industry EAHP European Association of Hospital Pharmacists EGA European Generic Medicines Association GIRP European Association of Pharmaceutical Full-line Wholesalers HOPE European Hospital and Healthcare Federation PGEU European Association Representing Community Pharmacists
ESM view on implementation of the FMD
• Combine tamper-evident packaging and a unique randomised serial number
• Verify product authenticity by checking each pack against a central database at the point of dispensing
Safety Features
• Manufacturers do not seek, and will not have access to, individual patient / prescribing profile information
• Transactional data belongs to stakeholder that created it e.g. pharmacists for dispensing data
Data
• Systems should be established and managed by the stakeholders that will use them day-to-day
• Systems governed by independent non-profit organisations jointly managed by relevant stakeholders
Governance
• Harmonised standard coding system across the EU that allows national codes to be incorporated as necessary
• Sufficient flexibility to implement national or multi-country solutions within an overall EU technical framework
System Design
• The ESM uses a 2D barcode, developed to internationally recognised standards
• Four key data elements:
• 14 digit Manufacturer Product Code
• Randomised Unique Serial Number
• Expiry Date
• Batch Number (up to 20 alpha-numeric characters)
• Example:
Product #: (01)09876543210982
Batch: (10)A1C2E3G4I5
Expiry: (17)140531
S/N: (21)12345AZRQF1234567890
Manufacturers to choose from Variety of tamper-evident Packaging Solutions
• Diverse solutions for tamper-evident closure
of original manufacturer’s package exist e.g.
• Glued cartons with/without perforation
• Security seals
• Wrap with foil
• Bottles with tamper-evident screw caps
• Cost-effectiveness and technical
feasibility need to be considered
• Selection should be left at each manufacturer’s
discretion
Operation and governance
• The ESM will be operated by a not-for-profit independent organisation called the European Medicines Verification Organisation (EMVO)
• Governance of the EMVO will include representatives from the stakeholder organisations in an EU Stakeholder Board
• EMVO will
• Develop and control EMVS policies and processes
• Communicate with authorities and the broader public
• Establish relationships (and contracts) with national stakeholder organisations (NMVO)
• Oversee development of European Hub and Blueprint Template
• Provide reports to stakeholders
• Manages the operation of the Hub and national Blueprint System(s)
Why Point of Dispensing rather than Track and Trace?
Point of dispensing verification
The product is verified by the pharmacist
immediately before being handed to the
patient
Cost-effective solution to patient
protection
Integrates best with existing distribution
chain practices
A simple and robust solution that can be
readily implemented across Europe
Why not Track and Trace?
Does not offer any significant patient
safety advantages over point of
dispensing verification
Demands significantly greater
investment by all supply chain
stakeholders.
Requires aggregation, which is error
prone and complex to implement
Untested on the scale that would be
required for Europe-wide implementation
Any benefits that Track &Trace can provide over a simpler Point of
Dispensing system are negated by complexity, time and cost of
implementation
Testing and evolution • Swedish pilot project (Sep 09 - Feb 10)
• 25 pharmacies in greater Stockholm.180 dispensing points
• 25 products. 110,000 packs. 14 manufacturers
• Key findings
• Allows pharmacists to work at normal pace
• Is customised to existing workflows
• Is integrated into existing pharmacy software
• Pharmacists and wholesalers are keen to get expiry date and batch number in machine-readable form
38
Sweden exceeded expectations
and proved the concept in practice
June 2012
ESM officially launched (MoU in
place)
Jan 2013
EU Members transpose Directive
into national law
2009 – 10
Sweden Pilot
July 2011
Publication of the FMD
2010 EFPIA, GIPR and
PGEU issue a joint position paper
2013 Q2 Vendor selected and
ESM Hub development started
Key milestone to date
Q4 2013 ESM Hub
targeted to be complete
Q1 2014 ESM Hub
Link to securPharm national system
Next major milestones
2014 Publication die of FMD – Delegated
Acts
2017 Expected mandatory
application of medicines verification
in EU
Q4 2013 Establish
EMVO
ESM fully addresses the FMD
The key stakeholders all support the Point-of-Dispensing verification concept
Verification upon
Dispense to
Patient
Patient Pharmaceutical
Manufacturer
Unique Serialisation
with Random
Numbers
Upload Number
Medicines Verification Repository
Pharmacist Wholesaler
Product Flow
Wholesaler
Voluntary
Verification
GTIN
Batch
Expiry
S/N Authenticate Number
The European architecture
National System n
Wholesaler
Pharmacy
National System 1
Pharmacy
Wholesaler
Parallel
Distributor Pharmaceutical
Manufacturer
European Hub
National Blueprint System n
Wholesaler
Pharmacy
National Blueprint System 1
Wholesaler
Pharmacy
Pharmacy: mandatory verification
Manufacturer: data upload + voluntary verification
Wholesaler: voluntary verification
Parallel Distributor: mandatory verification + data upload
Periodic cross-region update
Avoiding 27 Interfaces
Parallel distributor
Manufacturer
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
National system
Serialisation in the Pharmaceutical Supply Chain
Why ESM?
• Shared stakeholders vision for a pan-EU product verification system
• Ensure product and patient safety
• Provide interoperability between regional systems
• Be accepted and supported by many stakeholders organisations
• Be based on same principles in different regions (e.g. harmonised coding system,
standardised work flows, etc)
• Accommodate different needs in different regions (building on existing national
systems)
• Be scalable to be extended over time
• Be cost effective
