a WHO initiative to combat counterfeit

medical products

Dr V. ReggiWorld Health Organization

Combating counterfeit medical products

Define the problem

What is ‘counterfeiting medicines’? (1)

To manufacture and give unaware patients ‘medicines’ that . . . are not medicines:

Counterfeits do not cure but may endanger healthArbitrary and unpredictable composition: no active ingredient, another active ingredient, wrong amounts, bad quality

Jeopardizing the credibility of our health care delivery and

pharmaceutical supply systems!

What is ‘counterfeiting medicines’? (2)

Being among the richest, most industrially &

technologically advanced is little consolation if people cannot be sure that their

medicines are … medicines!

It is not an IP problem! It is a public health problem!

What is ‘counterfeiting medicines’? (3)

Aren’t medicines different things to bags, watches or T-shirts?

Do you know anyone who would deliberately buy a counterfeit medicine?

What is ‘counterfeiting medicines’? (4)

It is a problem that has consequences becoming evident at the national level …… … …but with international dimensions, transactions and ramifications

It affects products of all kinds

Expensive, prescriptio

n

Inexpensive, OTC

Inexpensive, generic

Nobody knows!We know it is there and growing!If we don’t act, it will continue to grow!

Number of incidents (PSI 2006)

2004 2004 update 2005 (as of 31/12/2004) (as of 31/12/2005) (as of 31/12/2005)

Counterfeit 390 557 781 Diversion 113 151 124 Theft 50 57 68 Total 553 765 973

How big is it?

FAKEDRUGBOMB

Continuing Increase in the Detection of Counterfeit Medicines (PSI, 2006)

Top Ten Ranked by Counterfeits Seized/Discovered

Country Seizures/Discoveries

1 Russian Federation

93

2 China 87

3 Korea 66

4 Peru 54

5 Colombia 50

6 USA 42

7 UK 39

8 Ukraine 28

9 Germany 25

10 Israel 25

- No single average figure! A single figure blurs the real picture and misleads the public

- Range: from <1% of sales in developed countries (but growing), to >10% in some areas of some developing countries

- Internet sites that conceal their actual physical address sell counterfeits in over 50% of cases

- counterfeiting is greatest in those areas where regulatory and legal oversight are weakest

WHO, OECD, IFPMA, PSI estimates

How are counterfeits How are counterfeits distributed?distributed?

Regulated Chain

Patient

Manufacturer(May be licensed)

Trader / Broker(Can be many steps and across borders)

Wholesaler Internet(Unlicensed)

Grey Market

Pharmacy

Unregulated Chain

Informal Market

U.S. Federal Criminal CodeTrafficking in Counterfeit Goods or Services, 18 U.S.C. § 2320

1st offence: 10-year prison; $2 million maximum fine

Federal Food Drug and Cosmetic ActCounterfeit Drugs, 21 U.S.C. § 331(i)1st offence: 1-year misdemeanor & significant fines

Are we serious about it?

Fake T-shirt

You know, I’m not thaat bad...

Fake medicine

What should we do?

Que devrions-Que devrions-nous faire?nous faire?

Define the Define the problemproblem

Combating counterfeit medicines

What should we do?

International Conference: 16-18 February 2006 – Rome

160 participants: 57 national authorities, 7 international organisations, 12 international associations representing patients, health professionals, manufacturers, wholesalersIMPACT: International Medical Products

Anti-Counterfeiting Taskforce

IMPACT is a taskforce launched by WHO to gather all the most important international actors in the fight against the counterfeiting of medical products

IMPACT aims at coordinating global action in order to promote and protect

public health.

What is IMPACT ?

Globalization of economies is helping to ‘globalize’ the problem

Increased commercial use of the Internet contributes to the expansion of the problem

Criminals are not stopped by borders, regulation and enforcement must be able to effectively act internationally

Why do we need strengthened international collaboration?

All 193 WHO Member States and all major international stakeholders, such as:

Who is/should be in IMPACT ?

European Commission

“IMPACT approach”: collaboration among all those concerned is

essential

OTHER PUBLIC SECTOR

INSTITUTIONS

MANUFACTURERSDISTRIBUTION

CHANNEL

PATIENTS

PERIPHERAL PUBLIC SECTOR INSTITUTIONS

BORDER CONTROL BODIES

POLICE & OTHER ENFORCEMENT BODIES

HEALTH PROFESSIONALS

DRUG REGULATORY AUTHORITIES

JUDICIARY

MEDIA

How does IMPACT work?

Secretariat: WHO

5 working groups, focusing on the areas where weaknesses have been identified and action needs to be taken at national and international level:

legislative and regulatory infrastructure regulatory implementation enforcementtechnologycommunication

AIM: agreed set of principles underpinning national legislation

• Meeting of jurists from different legal systems: draft principles July 2007 Brussels

• Meeting of jurists and MPs to finalise endorse principles 10-11 December 2007 Lisbon

• One parliament debates and pass national legislation based on agreed principles TBD 2008

LEGISLATIVE & REGULATORY INFRASTRUCTURE

REGULATORY IMPLEMENTATIONApril 2007 – Washington DC, final drafts of:• Revised GDP and GPP with emphasis on

counterfeit medical products; • Check lists and decision trees on action

upon cases/signals; • Amendments/Improvements to 1999 WHO

guidelines on measures to combat CMP;• Data Collection Tool on assessment of

national situations• Action to be taken by NRA, health

professionals

Finalised drafts to be discussed/finalized at coming IMPACT General Meeting –

December 2007

ENFORCEMENT

• Coordination of operations among participating countries

• Internet monitoring and purchases• Training materials and manuals to

improve skills of enforcement officers• Data/reports on issues/gaps hindering

action at national level

ENFORCEMENT

Strengthened Interpol-WHO collaboration

“ASEAN+” Conference - November 2007, JakartaASEAN Secreatriat, 10 ASEAN Member Countries, China

Invited: NRAs, police and other enforcement bodies, associations representing health professionals, manufacturers, wholesalers, NGOs.

Expected result: improved coordination among autorities, specific operations launched (e.g. Jupiter), analysis of situation in ASEAN with recommendations for action to be taken ar level of Member Countries, ASEAN Secretariat and beyond

COMMUNICATION

• Agreed ‘IMPACT messages’• IMPACT web site• Event organization/participation strategy• Model materials addressing different

audiences (health professionals, distribution system, patients, enforcement officials, media, etc.)

• Short films

IMPACT toolkit

•Experience from different countries;

•Model legislation & regulations;

•Training materials and methodologies;

•Tools and manuals to assist national authorities in implementing activities;

•Tools and methodologies for the assessment of national/regional situations.

- Report and help investigating cases- Increase security and transparency of

distribution systems- In many countries pharmacists’

monopoly is an illusion: if you do not organize informal networks others will take care of it

PROTECT YOUR

REPUTATION

Thank

you