Outline
o Definition: Falsified medicines
o Scope of the problem
o EU laws on falsified medicines: Directive 2011/62/EU
o Role of the European Medicines Agency
Introduction
1. What are falsified medicines?
 « Falsified medicines are fake medicines that pass themselves
off as real, authorised medicines. »
 Those products usually
contain sub-standard or falsified ingredients or no
ingredients or ingredients, including active substances, in
the wrong dosage
 be deliberately and fraudulently mislabelled with respect
to their identity or source;
 have fake packaging
2. Scope of the problem
 Recent years: medicines were the leading counterfeit products
seized by European customs, ahead of counterfeit cigarettes
(Pharmaceutical Security Institute “2011 situation report”)
 Alarming increase of falsified medicinal products in the Union
(identity, history or source)
 Falsified medicines: do not pass through the usual evaluation
of quality, safety and efficacy ..
 Particular threat to human health
 Lack of trust of the patient in the legal supply chain.
2. Scope of the problem
o Until recently: in wealthy countries  expensive 'lifestyle'
medicines (hormones, steroids and antihistamines)
o In developing countries  life-threatening treatments (
malaria, tuberculosis and HIV / AIDS)
o Phenomenon on the increase: expensive medicines ++
(anticancer medicines), high demand (antivirals)
 Falsified cancer medicine
 Substandard heart medicine
• Bevacizumab (unknown origin)
• More than 125 people died in
• The falsified product closely
Pakistan of bone marrow suppression
medicine, but tests indicate that it
contains starch and acetone
instead of active ingredient.
• The fakes were trafficked on a
complex supply chain, through
Turkey,
Switzerland,
and
Denmark to US, in part by a
after a public cardiology pharmacy
BMJ | 24 NOVEMBER 2012 | VOLUME 345
matches the appearance of the real
provided
generic
isosorbide-5-
mononitrate tablets adulterated with
a toxic overdose of pyrimethamine,
an antimalarial drug.
• Result of a manufacturing error,
although police allege that company,
officials learnt of the error and sold
the medicine anyway.
Canadian firm and its offshore
• If the allegation proves true, the
affiliates => The extent of harm to
medicine would be reclassified as
patients is unknown.
falsified.
3. EU laws on falsified medicines
o Directive 2001/83/EC of the European Parliament and of the
Council lays down the rules for, inter alia, manufacturing,
importing, placing on the market, and the wholesale distribution
of medicinal products in the Union as well as rules relating to active
substances.
o Directive 2001/83/EC should be amended in order to respond to
this increasing threat.
 EC: Directive 2011/62/EU of the european parliament and of the
council of 8 june 2011
Directive 2011/62/EU
• The Directive came into force on 21 July 2011.
• Member States had to start applying its measures in January
2013.
• This Directive aims to prevent falsified medicines entering the
legal supply chain and reaching patients.
It introduces harmonised safety and strengthened control
measures across Europe by applying new measures
1. AFFIXING OF SECURITY AND TRACEABILITY DEVICES
•
Verify authenticity and identification of individual boxes of medicines
•
Verify whether the outer packaging has been violated
The Directive provides for affixing devices for security and inviolability

On 9 February 2016, the European Commission published a delegated
regulation (Commission Delegated Regulation (EU) 2016/161): safety
features to be placed on the packaging of most human medicines:
a unique identifier (a 2-dimension barcode) and an anti-tampering
device.

The annexes of the regulation: list of medicines subject to the new
requirement

Application: no later than 9 February 2019
2. IMPROVED CONTROL OF THE DISTRIBUTION CHAIN

New requirements for improving the distribution chain

New player: the broker who takes part in transactions but without
entering into physical contact with the medicines.

Directive: new responsibilities for wholesalers , definition of
brokering activities as well as new responsibilities for brokers

Agency: revision of good-distribution-practice guideline (2013/C
68/01) => specific provisions for brokering activities

The EudraGMDP database now also includes information on good
distribution practice (GDP).
3. NEW REQUIREMENTS CONCERNING
RAW MATERIALS AND EXCIPIENTS

Upgrading the requirements on verifications applicable to the
manufacturers of medicines  guaranteeing their authenticity
and quality

From July 2013, all active substances manufactured outside the
EU and imported into the EU have had to be accompanied by a
written confirmation from the regulatory authority of the
exporting country.
NEW REQUIREMENTS CONCERNING
RAW MATERIALS AND EXCIPIENTS
Statements isued /manufacturing site /active substance
ensure that standards of good manufacurting practice
(GMP) equivalent to those in force in the EU are upheld.

Regular controls, repeated and unexpected inspections
during which certificates of good practices for active
substances can be issued
4. CONTROL AND HARMONISATION OF THE SALE OF MEDICINES
ONLINE

at any given moment, over 400 criminal websites with a
.eu
suffix, are online, targeting and selling falsified medicines into
the EU

Falsified medicines may reach the public in this way

The Directive includes the minimal conditions to be met by
online pharmacies to be authorized so as to engage in distance
selling
Counter the illegal sale of medicines to the public through the
Internet
• Since July 2014: Obligatory logo that will appear on the websites of
legally operating online pharmacies and approved retailers in the EU.
• Link to the national regulatory authority websites, where all legally
operating online pharmacies and approved retailers in their respective
countries will be listed.
• Member States: conduct campaigns to raise awareness of the logo and
the dangers of falsified medicines
.
www.fightthefakes.org
4. Role of the EMA
 Cooperation+ EC + Member States
 Implement the Directive 2011/62/EU
 European Directorate for the Quality of Medicines and Healthcare
(EDQM)
 and the World Health Organization's International Medical Products
Anti-Counterfeiting Taskforce (IMPACT).
 The Heads of Medicines Agencies
• have identified falsified medicines as being a key issue facing the
European regulatory network for the five years to 2015.
• enforcement of this legislation is the competency of Member States
• But: coordination between the national and international bodies
involved in fighting falsified medicines is necessary
Role of the EMA
A strategy for the Heads of Medicines Agencies, 2011-

15
The Agency is also cooperating with international anti-
counterfeiting
trade
agreements
and
other
criminal-law
instruments:
 the Council of Europe's Medicrime convention
 The Organisation for Economic Co-operation and Development
(OECD) project on counterfeiting and piracy
Penalties for Falsifying Medicine
« Effective, proportionate and dissuasive penalties »
*Additional penalties and fines may be associated with specific infractions
Conclusion
The Falsified Medicines Directive will not stop this crimes
 What it will do – through the identification of medicines at the pack level,
stricter regulation and stiffer penalties – => Traditional supply chain
more secure => less attractive to the criminal.
 Identifying financial impact of falsified medicines across the EU:
extremely difficult.
*Peter Pitts (et al) : by 2010 the global trade in falsified medicines would
reach $75bn.
And this does not of course take into account the human cost !
 EMA: working closely with its partners on the implementation of these
law  Making progress but a long road to travel