Conference under the Danish Presidency of the Council of the European Union
SLIDES
COMBATTING FALSIFIED MEDICAL PRODUCTS
AND SIMILAR CRIMES THROUGH LEGAL INSTRUMENTS AND PRACTICAL MEASURES
Copenhagen (Denmark) 16 May 2012
Hotel Scandic Copenhagen Vester Soegade 6
1601 Copenhagen, Denmark
Combating falsified and illegal medicines – challenges and counter-strategies
Gerald HeddellDirector Inspection, Enforcement & Standards Medicines and Healthcare products Regulatory Agency
MEDICRIME CONFERENCE 16 MAY 2012COPENHAGEN, DENMARK
Outline
• Falsified medical product situation – Global
• Falsified medical product situation – UK
• The Risks
• Legal frameworks to combat
• MHRA Falsified Medical Products Strategy
• Conclusion
Falsified Medical Products Situation - Global
West Africa
Europe
North America
Eur-Asia
South East Asia
Middle East
Falsified Medical Products Situation - Global
• Nigeria (Jan): Smuggler arrested by Customs Service - 10m naira-worth (£40,293) of counterfeit medicines (Feed Fine cyproheptadine, antihistamine, vitamin tablets) concealed in textile materials.
• Switzerland-Denmark-UK-USA (Jan): Avastin and Altuzan cancer medicines – hundreds of counterfeit packs originating in Turkey moved through Europe to the USA where they reached patients.
• Russia (March):a Moscow police officers seized a large quantity of counterfeit Arbidol antiviral medicine (containing starch) distributed through a pharmacy chain. The flu remedy was produced in the Moscow region where 700 boxes were purchased by police in a covert operation.
• USA (March): A former South Korean law enforcement officer was arrested at a US airport for trafficking in counterfeit goods, following the discovery of nearly 40,000 counterfeit Viagra, Cialis and Levitra pills in his luggage.
• Armenia (April): Counterfeit medicines discovered within the licensed supply chain, listed as Actovegin Forte and Concor. It is thought that the medicines were within pharmacies for up to two weeks before the discovery.
• China (April): Fake and expired medicines valued at more thank 100,000 yuan (£9,985) were seized by authorities from 18 rural pharmacies in Changsha. Separately a drug producer in east China was stripped of its licence and fined on charges of making counterfeit medicines - several oral liquids and syrups without authorization under a forged consigned manufacturing document.
• Vietnam (April): Ho Chi Min City Department of Health seized quantities of fake or low quality oriental medicines circulating on the market - products were said to be contaminated with bacteria, illegally mixed with fresh medicine or had become mouldy.
• Niger (April): A husband and wife were arrested following being found in possession of 25kg bags of Gelosyle, and large quantities of Paracetamol, Piriton and Flagyl tablets - suspected that they were using the raw pharmaceutical ingredients to manufacture counterfeit medicines.
• Jordan (May): A Jordanian doctor has been referred to court for selling smuggled and counterfeit medicine - mainly sexual enhancers and psychotropic drugs in his own apartment.
2012 (all reported in the Press):
Falsified Medical Products Situation - UK
• Vast majority of counterfeits discovered in the UK are supplied over the internet
• 10 instances of counterfeit medicines in the legitimate supply chain that reached pharmacies and led to recall since 2004
• 850 million+ prescriptions written annually
• Counterfeit medicines in the legitimate supply chain are rare
• Obtaining medicines from unregulated sources significantly exposes the risk of receiving counterfeit medicines
0
1
2
3
4
5
6
1994
-200
320
0420
0520
0620
0720
0820
0920
1020
11
Wholesale level
Clinical Trial
Pharmacy level
Falsified Medical Products Situation - UK
Wholesale - Anti- cholesterol, Anti- inflammatory, Anti-platelet,Alopecia, Erectile Dysfunction, Rheumatoid Arthritis, HIV.
Pharmacy - Anti-cholesterol, Anti-platelet, Anti-psychotic, Erectile dysfunction,Prostate cancer, Appetite suppressants, Chronic asthma.
Clinical Trial - Anti - platelet
The Risks
To public health:
• The products are sub standard in terms of their method of production and/or pharmaceutical ingredients/impurities and/or contamination
• Consumers and patients deserve to have a high degree of confidence when obtaining their medical products especially with a prescription from a pharmacy
• Counterfeit medical products undermine that level of trust, and lead to recalls, further damaging consumer confidence
• A number of fatalities and serious adverse reactions have been seen around the world
To industry/trade:
• public health as above
• reputational damage
• financial impact
Legal Frameworks to Combat - EU Falsified Medicines Directive
Safetyfeatures
Internetsales
Actors in the supply chain
Activesubstances
Directive2011/62/EUon falsifiedmedicinalproducts
Legal Frameworks to Combat – CoE Medicrime Convention
MHRA Falsified Medical Products Strategy
Download from:www.mhra.gov.uk
MHRA Falsified Medical Products Strategy
Objective:
The aim of the strategy is to:
• reduce the risks to patients
and consumers
• increase the risk to those
behind the illegal activity
Strategy key themes:
MHRA Falsified Medical Products Strategy
• Prevention
• Incident handling
• Investigation
Use of Social Media:
• Engagement
• Accessibility
• Targeted
• Mass audience
MHRA Falsified Medical Products Strategy
Impact (last 5 years):
• No of counterfeit incidents significantly reduced
• No of individuals convicted – 24
• No of years sentenced: – 30 yrs 2 months imprisonment– 5 yrs 9.5 months suspended– 930 hours Community Service– £1,300 fines
• Total costs awarded – £66,000
• Total amount of proceeds of crime ordered to be confiscated from criminals - £15.3m
MHRA Falsified Medical Products Strategy
Conclusion
• No supply chain is impenetrable
• No room for complacency
• Collaborative effort from all key stakeholders is the only way to successfully tackle this issue
• Legal frameworks and/or a national strategy can be very helpful to combat this issue and act as a deterrent
• Protecting public health is the overarching aim
© Crown Copyright 2012About copyrightAll material created by the Medicines and Healthcare products Regulatory Agency, including materials featured within these MHRA presentation notes and delegate pack, is subject to Crown copyright protection. We control the copyright to our work (which includes all information, database rights, logos and visual images), under a delegation of authority from the Controller of Her Majesty’s Stationery Office (HMSO).
The MHRA authorises you to make one free copy, by downloading to printer or to electronic, magnetic or optical storage media, of these presentations (excluding Agency logos) for the purposes of private research, study and reference. Any other copy or use of Crown copyright materials featured on this site, in any form or medium is subject to the prior approval of the MHRA.
Further information, including an application form for requests to reproduce our material can be found at www.mhra.gov.uk/crowncopyright
Material from other organisationsThe permission to reproduce Crown copyright protected material does not extend to any material in this pack which is subject to a separate licence or is the copyright of a third party. Authorisation to reproduce such material must be obtained from the copyright holders concerned.
Safeguarding public health
Thank youAll Enforcement enquiries and potential referrals to:
MHRA Case Referrals Centre [email protected] or tel +44 (0)20 3080 6330
Gerald Heddell
Director
Inspection, Enforcement and Standards
Medicines and Healthcare products Regulatory Agency
+44 (0) 203 080 6500
The European Union’s Directive on falsified medicines
MediCrime Convention
Combatting Falsified Medical Products and Similar Crimes Through Legal Instruments and Practical Measures
Copenhagen, 16 May 2012
Fabio D‘AtriUnit D6 „Medicinal products – quality, safety and efficacy“
Directorate-General „Health and Consumers“European Commission
Disclaimer
The views and opinions expressed in the following slides are those of the presenter.
They should not be understood or quoted as being made on behalf of the European Commission.
Speaker: Fabio D'Atri 2
Legislation
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
Speaker: Fabio D'Atri 3
New measures for all actors in the supply chain
•New rules for import of API:Written confirmation on GMP orcountry 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
substancesManufacturers
of medicines DistributorsOnline
pharmacies
Speaker: Fabio D'Atri 4
Implementation: Work on track
• 14 tasks for the European Commission
• 3 concept papers already published
Speaker: Fabio D'Atri 5
Implementation: 3 concept papers
1. 1. Establishment of unique identifiers for medicinal products
• 2. Assessment of the equivalence of Good Manufacturing Practices (GMP) rules for the manufacturing of active substances in third countries
• 3.Principles of GMP for active substances
Speaker: Fabio D'Atri 6
1. Safety feature / unique identifier
Safety feature = unique identifier +
anti- tampering device
to verify the authenticity of the medicinal product and identify individual packs
a device allowing verification of whether the outer packaging has been tampered with.
Speaker: Fabio D'Atri 7
1. Safety feature / unique identifier
• Characteristics of the unique identifier. Linear or 2D barcode ?
• Who checks the serialisation number. Wholesalers? Frequency of checks?
• Establishment, management and accessibility of the repositories system
• Lists of exceptions/inclusions
• Notification of products at risk
Speaker: Fabio D'Atri 8
1. Safety feature / unique identifier
• Consultation closed
• Analysis of responses
• Impact assessment in 2013
• Delegated act in 2014
• Application 3 years after its publication
Speaker: Fabio D'Atri 9
2. assessment of the equivalence of GMP rules for the manufacturing of active
substances in third countries
From July 2013, new requirements on import of API active substances into the EU:
- written confirmation from the competent authority of the third country demonstrating:
- manufacturing site is in compliance with GMP equivalent to EU GMP
- is subject to controls including site inspections.
Speaker: Fabio D'Atri 10
2. assessment of the equivalence of GMP rules for the manufacturing of active
substances in third countries
Written confirmation:
-Template published for public consultation
http://ec.europa.eu/health/files/counterf_par_trade/2012_04_16_pc_en.pdf
- contacts with third countries trade partners.
Speaker: Fabio D'Atri 11
2. assessment of the equivalence of GMP rules for the manufacturing of active
substances in third countries
From July 2013, new requirements on import of API active substances into the EU:
- -the country is listed in a EU list (upon request of the third country)
Speaker: Fabio D'Atri 12
2. assessment of the equivalence of GMP rules for the manufacturing of active
substances in third countries
Countries in the EU list have been assessed for:
• GMP rules equivalent to EU rules
• Regularity of inspections
• Effectiveness of enforcement of GMP
• Rapid alert system for non-compliant producers
Speaker: Fabio D'Atri 13
3. rules of GMP for active substances
Proposal to expand the scope of the current Directive 2003/94/EC on GMP to API
Speaker: Fabio D'Atri 14
Other implementing measures
• Delegated act on the introduction of medicines in the EU
• Implementing act on a “ trust mark” for online pharmacies
• 4 guidelines (excipients, GDPs for APIs, Rules for “brokers”, inspections)
• 1 awareness campaign (illegal online-offers of medicines)
Speaker: Fabio D'Atri 15
Rules and penalties
Member States have to:
- Lay down rules and penalties
- Take measures to ensure that penalties are implemented
Penalties must be effective, proportionate and dissuasive.
Where relevant penalties shall take into account the risk to public health presented by falsified products.
Speaker: Fabio D'Atri 16
Rules and penalties
Member States have to notify the Commission:
- national provisions on rules and penalties by 2 January 2013
- future amendments.
Commission will submit by January 2018 to the EP and the Council a report:
- on those transpositions by Member States
- on the effectiveness of those measures.
Speaker: Fabio D'Atri 17
Thank you!
Speaker: Fabio D'Atri 18
UK Largest Counterfeit Case in the legitimate supply chain 2007 –Operation Singapore
Nimo AhmedHead of Enforcement (Acting) Medicines and Healthcare products Regulatory Agency
MEDICRIME CONFERENCE 16 MAY 2012COPENHAGEN, DENMARK
Outline
• Case overview
• Public Health v Investigation
• Case in detail
• Lessons learned
• Conclusion
• Most serious known case of Counterfeit Medicines penetrating the UK Supply Chain
• 72,000 packs of counterfeit medicine (Over 2 million doses) penetrated the UK supply chain between December 2006 and May 2007 (Retail value 2007 £4.7m)
• Medicines were for the treatment of Psychosis, Prostate Cancer and Heart Disease
• Seven batches of three medicines were subject of a class 1 recall from the market in May and June 2007
Case overview
Public Health v Investigation
• Quarantine/SeizeIMMEDIATE ACTION to prevent further product reaching the public
• SampleObtain samples of suspicious product and any other medicines supplied with it
• AnalyseAsk genuine manufacturer to test the product AND your own Government laboratory – obtain medical assessment from both
• RecallRecall the product from the market if there is evidence that it has reached pharmacies or patients, make use of press
• MHRA seized 1.3m doses before reaching pharmacies
• Further 7000 packs recovered following recalls
• 25,000 packs (700,000 doses) reached pharmacies and patients
• Products contained between 50% - 80% of Active pharmaceutical ingredient together with unknown impurities
• No known fatalities or adverse reactions
• Counterfeits indistinguishable from genuine through visual identification alone
Case in detail
Singapore
BelgiumUK
Hong Kong
Tianjin
Case in detail – movement of counterfeits
Case in detail – the counterfeit medicines ‘as sold’
The counterfeit medicines ‘as sold’:
UK
Mauritius
Case in detail - movement of money
China
Luxembourg
Case in detail - scale
• 72,000 packs, 2.1 million doses• 3 medicines, 7 separate batches• 4 Class 1 recalls in May and June 2007• Retail value £4.7m• 3 ½ year investigation• 13 countries involved• 17,000 pages of evidence• 4000 exhibits• 40 Computers and phones forensically examined• 93 witnesses gave evidence at trial from 6 countries • 205 witnesses made written statements• 4 month Crown Court Trial
Case in detail – ‘convicts’
USA
• Lu (Kevin) XU (Chinese)• 6 ½ years imprisonment• Trafficking counterfeit medicine• MHRA investigators gave evidence
UK
• Peter Gillespie (British)• 8 years imprisonment• Conspiracy to defraud, TM, MA• US officers gave evidence
Lessons learned
• Priority is public health
• Act quickly, first 72 hours most important
• Develop investigation strategy: computer forensics document all decisions financial investigation media strategy
• Collaboration: national: customs and police international: engage partners at earliest
opportunity
• Look for ‘victims’!!
Conclusion
• Public health always priority
• First 72 hours vital for investigation
• International collaboration essential
• Legal frameworks ensure crucial and timely international cooperation
Safeguarding public health
Thank youAll Enforcement enquiries and potential referrals to:
MHRA Case Referrals Centre [email protected] or tel +44 (0)20 3080 6330
Nimo Ahmed
Acting Head of Enforcement
Enforcement Group
Medicines and Healthcare products Regulatory Agency
+44 (0) 203 080 6576
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARK
Anita Filipović Sučić
Agency for Medicinal Products and Medical Devices
Head of Regulatory Affairs Department
Challenges for Croatian Medicines Agency as regards networking at both the national and international levels
COUNTERFEIT MEDICINES AND CROATIA
-in Croatia no cases of counterfeit medicines have been detected so far in licensed pharmacies or in wholesale chains (legal supply chain)
-well regulated system of medicines quality control
-medicines without marketing authorisation in Croatia found on the illegal market: • “lifestyle” medicines for erectile dysfunction, treatment of
obesity• anabolic steroids• medicines for oncological diseases • diuretics
2Speaker: Anita Filipović Sučić
CASES FROM CROATIA-ILLEGAL SUPPLY CHAIN
3Speaker: Anita Filipović Sučić
CASES FROM CROATIA-ILLEGAL SUPPLY CHAIN
4Speaker: Anita Filipović Sučić
-so far about 10 cases recorded
-medicines were seized by customs or police
-Croatian Medicines Agency: testing and classification
-persons prosecuted for the illegal import of medicines (import without wholesales licences and import of unauthorised medicines)
Example 1. Analytical results of 23 seized illegal samples
(12 samples did not comply with the quality specification)
COMBATING COUNTERFEITS1) INTERNATIONAL CO-OPERATION
-Croatian Medicines Agency member of the OMCL network (sharing the latest counterfeit information)
-representative in the Committee of Experts on Minimising the Public Health Risks Posed by Counterfeiting of Medical Products and Related Crimes
-representative in the Ad hoc Committee on Counterfeiting of Medical products and Similar Crimes Involving Threats to Public Health
-representative in HMA Working Group of Enforcement Officers (WGEO)
-Co-operation with national medicines agencies in the EU
5Speaker: Anita Filipović Sučić
COMBATING COUNTERFEITS
2) CO-OPERATION BETWEEN RELEVANT INSTITUTIONS IN CROATIA (police, customs, pharmaceutical inspection, medicines agency)
• good cooperation and communication but SPOC model (Single Point of Contact) has not been established yet
• workshop in Zagreb in December 2012 for countries in region to facilitate establishment of SPOCs network in Croatia and surrounding countries
3) RAISING PUBLIC AWARENESS
6Speaker: Anita Filipović Sučić
RAISING PUBLIC AWARENESS
7Speaker: Anita Filipović Sučić
BROCHURE: MEDICINAL PRODUCTS AND THE INTERNET MASS MEDIA
PUBLIC CAMPAIGNS AND ADVERTISEMENTS
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARK
“UKRAINIAN PROGRESS IN COMBATTING FALSIFIED MEDICINES”State Administration of Ukraine on Medicinal ProductsMr. DUBOVYTSKYI Sergii – Director of Department for State Quality ControlMr. POGREBNIAK Yurii – Informational-analytical Division
Ukraine was one of the first who joined to the Council of Europe Convention on Counterfeiting of medicinal products and similar crimes involving threats to public health (MEDICRIME Convention), which complements EU Directive 2011/62 on falsified medicines.
Moreover, falsification of medicines in Ukraine and related crimes became seriously punished according to the approved in 2011 amendments to the Criminal Law of Ukraine, which provides severe imprisonment and fines.
2Speaker: Mr. DUBOVYTSKYI Sergii and Mr. POGREBNIAK Yurii
As for today MEDICRIME Convention is in process of ratification. The following Authorities have signed Ukrainian translation of Convention:
• Ministry of Health;
• Ministry of Foreign Affairs;
• Ministry of Internal Affairs (Police);
• Ministry of Finance;
• State Customs Service;
• State Tax Service;
• Security Service;
The next step is to prepare list of regulations which need to be amended in accordance with the Convention. After that Convention will be signed in the Ministry of Justice and the Bill will be submitted to the Government for approval. Adopted Bill will be the final stage of ratification procedure.
3Speaker: Mr. DUBOVYTSKYI Sergii and Mr. POGREBNIAK Yurii
In parallel, serious efforts were paid in order to develop modern laboratory network, using the OMCL’s structure and experience. SAUMP Central Laboratory was successfully prequalified by the WHO.During the last two years number of scheduled and unscheduled inspections was significantly increased, as well as their quality. Medical devices have also been reviewed for protection against counterfeiting.The communication strategy is crucial for the State Administration of Ukraine on Medicinal Products. SAUMP supports continuous exchange of information with the EMEA, WHO, EDQM and interested European Agencies. SAUMP also supports constant cooperation with the representatives of Ukrainian law enforcement bodies and customs; a permanent working group was established and it works.Ukrainian authorities and pharmaceutical industry are now discussing the implementation of systems for protection against falsification, as well as implementation of Track & Trace System, and this point was highlighted by the respective Prime-Minister’s Resolution two weeks ago.
4Speaker: Mr. DUBOVYTSKYI Sergii and Mr. POGREBNIAK Yurii
The problems that remain:- Lack of effective cooperation with the law enforcement authorities and importance of control over the Internet;- Lack of informational exchange with the Customs Service in Ukraine in regard to medical products, need in legal binding instruments;- The complexity of purchasing procedure for equipment, need in modernization of laboratories and services;- Lack of preparedness of Ukrainian legislation to impose new requirements and standards;- Difficulties in cooperation with some regions and countries, lack of established network of single points of contacts.
5Speaker: Mr. DUBOVYTSKYI Sergii and Mr. POGREBNIAK Yurii
• As far Department on Organization the State Quality Control already performs SPOC determined functions in Ukrainian drug regulatory authority and reports to the interested parties about counterfeit cases in accordance with a set procedure, we propose:
• to include SAUMP details in the list of all SPOC’s for each country;
• to develop the concept of a SPOC network;
• to emphasize cooperation on the national level and to establish SPOC’s for Customs, Police and Justice.
6Speaker: Mr. DUBOVYTSKYI Sergii and Mr. POGREBNIAK Yurii
INTERNET COMMUNICATION
Dr. Monika Johansson
Medical Products Agency, Sweden
Communication today
• Information on the website, www.mpa.seproduct names
responsible company (if known and action being taken)
content found (identity and concentration)
pictures of the products
risk communication (medical information)
• Information to healthcare professionals about counterfeited products and food supplements containing active pharmaceutical ingredients
2Speaker: Monika Johansson
Internet warnings 20113
Sibutramin, 8 July
Sildenafil and tadalafil, 13 May
Tadalafil, 14 June
Growth hormone, 11 January
Sildenafil,13 January (2012)Corticosteroid
7 Mars
Speaker: Monika Johansson
Who should be the target for information?
Public surveys in 2011 gives (1500 responders, 15-65 years old and 2100 young people, 15-24 years old):Consumers of weight-reduction products
Consumers who use products for exercise
Patient/consumers of medicines to combat physical pain
Patient/consumers of medicines for mental disorders/illness or for products that help them sleep
Young people, healthcare professionals, general public
4
How to reach the target audience?
Speaker: Monika Johansson
5Speaker: Monika Johansson
Crimemedicine, information given
• Production of falsified medical products – factory south of Stockholm• Professional information (police/custom/medical authority)• Cases, information from hospital, 3 cases• Interview with a women who had bought weight loss pills over the
internet• Industry representative, quality failure of falsified medical products• Economic crimes • How do homepages look like selling falsified medical products
Result• Increased awareness of the risk of buying medicines over the internet
(from 0 to 50%). • Message needs to be repeated
6Speaker: Monika Johansson
Future projects
• New website for information regarding regulations and falsified medical products
• Update www.crimemedicine.com with Q&A?
• Blogs? /Twitter?
• New information campaign?
7Speaker: Monika Johansson
13/06/2012
1
Captain Laurent [email protected]
Tel. :+331 56 28 71 75Cel. :+336 31 89 07 97
OCLAESP supports MediCrime Convention
Copenhagen, 16 may 2012
OCLAESP Supports MediCrime Convention
Interest for international cooperation
Pharmaceutical crimes as an international tool in the field of criminal law
Signature extended to non-Member States
Harmonization of legislation
Obligation to cooperate
Possibility of seizure and confiscation
13/06/2012
2
Convention Medicrime : indispensable tool
Specialised criminal investigation
Including financial investigations
Covert operations
Controlled delivery
Special investigative techniques
Multidisciplinary and multisectoral approach
OCLAESP : an example to follow?
National territorial competence
interministerial
Specialized
NCB France
National and international Networks
Protocols between police forces/customs and French Health Products Safety Agency
National and international training
Public-private partnership
13/06/2012
3
PANGEA IV
FRENCH RESULTS
- 171 Illegal websites identified- 12 established in France- 170 000 pills seized- 1 Illegal laboratory dismantled- 49 criminal investigations initiated
PANGEA IV
Global resultsOver 13 000 websites closed
606 auction sites removed
Over 500 websites under investigation
checks in postal hubs
66 505 packages inspected
8 695 packages seized
55 individuals arrested/ under investigationOver 2.5 million units seizedEstimated value: 6.8 million USD
13/06/2012
4
Thank you
OCLAESP6 avenue de Stalingrad94110 ARCUEIL – France
[email protected]+331 56 28 71 75
MEDICRIME CONFERENCE16 MAY 2012,
COPENHAGEN, DENMARK
Mr. Ashley How,Director EMEA,Pharmaceutical Security Institute, PSI
Successfully combating illegal medicines on the Internet.
Topics for discussion…..
• What is the key challenge?
• What is required to combat the challenge?
• How to achieve success.
2Speaker: Mr. Ashley How, PSI
What is the key challenge?
• The international complexity of the organised crime networks responsible for exploiting the public…
3Speaker: Mr. Ashley How, PSI
Speaker: Mr. Ashley How, PSI
‘Drop-shipping’ and ‘Fulfilment’ operations
C/F Meds manufacturer
Illegal Meds manufacturer
Distributor / Shipper /
Seller
Customer
Drop-Shipping operation
Fulfilment operation
© Copyright PSI
What is required to combat the challenge?
• Identify & map the Organised Crime Groups’ Affiliatenetworks
• Identify the OCGs & the facilitators/enablers
• Remove their infrastructures
• Review & Monitor
5Speaker: Mr. Ashley How, PSI
How to achieve success….
• A sustained and coordinated international programme involving the key stakeholders.
• Utilise international treaties and legislation - The MedicrimeConvention provides measures, tools & sanctions to assist, for example Articles 9, 10, 12 & 17.
• A real commitment to cooperate & collaborate .
6Speaker: Mr. Ashley How, PSI
Thank you….
Speaker: XXXXX 7
Ashley HOW
Director EMEAPharmaceutical Security Institute, PSI
Office: +44 (0) 1903 779955Mobile: +44 (0) 7795 345600Email: [email protected]: www.psi-inc.org
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARK
MICKEY ARIELI-RPh.
DIRECTOR –PHARMACEUTICAL CRIME UNIT
MOH ISRAEL
MEDICRIME CONVENTION-ISRAELI EXPERIENCE
TRAUMA OF GENEVA –SSFI Working Group” of Member States onSubstandard/spurious/falsely-labelled/falsified/
counterfeit medical products
• POLITICALLY CORRECT
• ‘BE LENIENT ON QUALITY ’ –AVAILABILITY AND PRICE IS WHAT IS IMPORTANT
• NEVER USE THE :
• E WORD- THIS IS NOT THE MANDATE OF WHO criminalization and WHO no connection
• C WORD-
• WHERE WAS THE CONCERN FOR THE VICTIMS?
• WHAT IS EFFCT OF PHARMACY LAW WITHOUT PUNISHMENT CLAUSE?
2Speaker: MICKEY ARIELI-RPh
PRE-MEDICRIME ISRAEL
•PHARMACY LAW OF ISRAEL:
1. BASED UPON LAWS AND ORDINANCES OF BRITISH MANDATE
2. NO CONCEPT OF PHARMACEUTICAL CRIME
3. PUNISHMENT CLAUSE?
• 6 MONTHS PRISON (NOBODY EVER RECEIVED IT)
• $3000 FINE
3Speaker: MICKEY ARIELI-RPh
APPROVAL PROCESS ISRAEL
• TOTAL SUPPORT OF MOH (MANAGEMENT AND LEGAL DIVISION)
• MINISTRY OF FOREIGN AFFAIRS AND MINISTRY OF JUSTICE :WHAT ARE LEGAL AND FINANCIAL OBLIGATIONS?
• COMBINED LOBBY OF DIRECTOR GENERAL OF MOH (WITH OUR PRESSURE)
4SpeakerMICKEY ARIELI RPh.
IMMEDIATE BENEFITS OF MEDICRIME
1. CHANGE IN PHARMACY LAW :• RECOGNITION OF ‘PHARMACEUTICAL CRIME AS
DANGER TO PUBLIC HEALTH’
• DEFINE ‘COUNTERFEIT ‘the term “counterfeit” shall mean a false representation as regards identity and/or source- utilized convention definition
• Criminalization of MEDICRIME OFFENCES WITH PUNISHMENT CLAUSE AMENDED TO 3 YEAR SENTENCE WITH HEAVY FINANCIAL FINE
• RECOGNITION OF RIGHT OF VICTIMS
5Speaker:mickeyarieli RPh
FUTURE BENEFITS AND EFFECTS OF MEDICRIME
• LEGAL COUNTER TO IMPOTENCE OF SSFI
• OUR EMPHASIS IN ISRAELI COURTS OF INTERNATIONAL CONVENTION AND CRIMINALIZATION OF PHARMACEUTICAL CRIME
• CONCERN FOR VICTIMS: SIGNALS OF HARM
6Speaker: Mickey Arieli RPh
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARK
Einar Magnússon, Icelandic Ministry of Welfare, Director of Pharmaceutical Affairs
Iceland´s signature of the Medicrime Convention
2
Benefits expected from the Medicrime Convention
• Better control over the whole market, included the internet sale of medicines.
• Less falsified and counterfeit medicines on the market.
• Less fraud and other crimes conducted concerning prescriptions and medicines in general.
3
Issues raised under the preparation
• It was a challenge to convince three ministers to accept with rather short notice a convention which they were not too well familiar with.
• Ministries in Iceland were mostly concerned about possible legal and financial obligations as well as the time pressure for the signature. There were however no legal obstacles for signing the convention.
• There have also been concerns about the cost of pharmaceutical expertise needed for control on the border, should this cost be paid by the custom or the medicine agency?
Next practical steps to progress with ratification
• http://www.velferdarraduneyti.is/frettir-vel/nr/33070
4
Next practical steps for ratification
• Next step is to adapt our legislation to the convention in cooperation with other European countries, the European Union and the Council of Europe.
• Look for solution for financing inspection and border control of pharmaceuticals.
5
Thank you0
6Speaker: XXXXX
Thank you
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARKRuth Mosimann, Swissmedic, Head of Control illegal MedicinesMatthias Stacchetti, Swissmedic, Head of Penal Division
Signing and Ratifying the MEDICRIME convention: experiences made in Switzerland
Benefits expected from implementing the MEDICRIME convention
• Higher awareness of the phenomenon
• Improvement of the procedural tools
• More severe sanctions
• Formalisation and visibility of SPOCs network in Switzerland
• International collaboration with robust network of points of contact
• Better communication between industry and authorities
2Speaker: Mosimann, Swissmedic
Experiences
Issues raised:
• Costs: estimation of additional costs after ratification
• Roles of the different stakeholders, differing priorities
Positive experiences:
• Awareness amongst various authorities
• Good collaboration between Ministries, initial invitation done by medicines agency
3Speaker: Mosimann, Swissmedic
Practical steps for signature
• Working group Ministry of Health, Ministry of Justice, Swissmedic (Drug Regulatory Agency)
• Identification of articles to modify in Swiss Law of Therapeutic Products and in other laws
• Consultation of federal authorities
• Submission for signature
• Decision for signature by Federal Council
• Switzerland signed 28th october 2011
4Speaker: Mosimann, Swissmedic
Next practical steps for ratification
• Ratification process started 2011, lead by Ministry of Health
• Draft for a decision by Parliament
• 1st consultation of federal authorities (January 2012) > consolidation
• Consultation of public stakeholders > consolidation
• 2nd consultation of federal authorities > consolidation
• Submission to the Parliament
• Parlamentary debates and decision
• If positive > ratification
5Speaker: Mosimann, Swissmedic
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARK
Helder Mota Filipe Vice-President of the Executive BoardInfarmed,I.P.
Ratification Procedure In Portugal ‐ State Of Play
Regulatory Framework
• Art.282 Portuguese Penal Code (corruption of medical substances)
• Foresees crime of manufacture and commercialisation of medical substances punishable with 1-8 years imprisonment
• ONLY if evidence can sustain that the corruption of a medical substance has caused danger to the life of a person
• Crime only if cause effect is proven in court
• Very wide scope of application
• Undefined concepts
2Speaker: HMF
Benefits
• Reinforcement/clarification of legislative framework• Definition of pharmaceutical crime
• Criminalization of conducts
• Legal certainty
• Better prosecution of cases
• Legal basis for national and international cooperation• Better coordination/communication
• Formal SPOC network
• Reference for portuguese speaking countries
3Speaker: HMF
Ratification Procedure
• Joint inter-ministerial taskforce to analyse legislation and propose changes
• Foreign Affairs (team leader), Justice, Health
• Parliamentary Approval
• Publication in Official Journal as Parliamentary Resolution
4Speaker: HMF
State of Play
• Political priorities focused on economic and financial situation
• Internal reorganisation of Foreign Affairs & public service in general• Replacement of identified contact points
• Loss of information flow – whole dossier to be resumed from the start
• Delay in setting up taskforce
5Speaker: HMF
Conclusions
• Expectation of quick ratification frustrated
• New regulatory framework awaited with anticipation by all regulatory authorities
• Political Support to move forward expected in the coming months
6Speaker: XXXXX
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARK
Deputy Public Prosecutor Henrik Helmer Steen, The Public Prosecutor for Serious Economic Crime in Denmark.
Benefits expected from the MEDICRIME Convention.
• Political awareness
• Legal harmonization
• Mutual recognition
• Common understanding
2Speaker: XXXXX
Substantive criminal law:
• Defined the crime(s)
• Defined the necessary criminal terms
• Defined the necessary terms as far as sanctions and other measures are concerned
3Speaker: XXXXX
Procedural criminal law:
• Jurisdiction
• Extradition
• Domestic procedural criminal law
4Speaker: XXXXX
Measures to ensure an effective criminal investigation and prosecution
• Locating necessary recourses
• Exchange of information
• Co-operation between competent authorities
• Protection of the rights and interests of the victims
5Speaker: XXXXX
6Speaker: XXXXX
MEDICRIME CONFERENCE 16 MAY 2012, COPENHAGEN, DENMARK
Strategic approach towards implementation
Hugo K. Bonar,
Irish Medicines Board
Getting there
Pathway to successful
implementation
Strategic changes in
attitude
Cooperation designed
strategically today
Strategic Networks identified
+
SPOCs created
Know what makes success
– follow it through
implementation
Speaker: H.K. Bonar 2
Strategic changes
Make Medicrime Convention a living approach driven by the need to
protect public health
Stakeholders must drive implementation together – it is an
opportunity, not a burden
Involve police, customs and health authorities in designing practical
implementation steps
Medicrime Convention promotes prevention (Art 18)
Holistic approach
No one agency has all the resources to implement Medicrime
No single focus will work
All stakeholders have a role in protecting the public health (Art 17)
Strategic changes in attitude required –
not just another economic crime
Speaker: H.K. Bonar 3
Develop Communication Mechanisms
TaskObjectiveMechanismCommunication
Two-way process
SPOCs
Art 17, 22)
National –coordination, not control
Develop a national
committee by consensus
International –Know whom to
contact
Agree nationally, promote
internationally
Overcomes conflict – many SPOC models
Networks
Art 17, 22
Increase resource potential
Interagecy support facility
Improve information flow
and quality
Resolve competition opportunties
Better decision making
increased support for coordinated
action
Speaker: H.K. Bonar 4
Cooperation before implementation = results after implementation
Share
Traditional areas of
competence
Resources• Expertise• People• Legal powers
Requires a high level of
prepararationEngage
Mutual reliances
Interagency strategic goal
setting
Speaker: H.K. Bonar 5
Recognise success as a pathway
• Don’t wait until it is signed before you act• Optimise implementation by preparing the groundwork today
• Prepare strategic initiatives that facilitate implementation (Art 17)• Interdepartmental discussions on sharing implementation• Developing formal agreements (e.g. Memorandum of Undersanding)
• Facilitate interagency joint actions (Art17, 18)• Cooperative training – share what each has to offer (Art 16)• Decision making needs information – share it now – start building the trust
• Be prepared to support other agency agenda in support of Medicrime Convention
Speaker: H.K. Bonar 6
Indicators of success to implement Medicrime Convention
Success follows actions
Recognising and altering attitudes and
systems
Risingconfidence that we can
face thischallenge
Organisational maturity to be a partner with other agencies
Sharing resources,
not the blame
Realisation on need to
work on preparation
before implementati
on
7Speaker: H.K. Bonar
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARKJesper HjortenbergNational Member for Denmark, EurojustVice-Chairman of CDPC (Council of Europe)Approaches to support the effective implementation of the Medicrime Convention- Criminal Law focus
Criminal Law on dangers and damages
• Criminalization of offences causing (general (and more specific)) danger or damage to the public
• Development in society – new challenges/threats
• From tampering with foodstuffs and drinking water over interferences with electricity and trains and now….
• Medicrime !
• Not a whole new issue, but due to growing demands for health care, the costs of health care and globalization a more and more pertinent problem on a local and global scale
• Motivation behind medicrime: to make money/org. crime
2Speaker: XXXXX
From exotic speciality to main stream
• Medicrime ( Offences) often regulated in very specialisedlaws
• Limited awareness in society and among law enforcementbodies and judiciary
• Are criminal law regulations really up to date ?
• Criminal law provisions in specific laws – In the CriminalCode ?
• Can states really cope with new threats and challenges within existing rules and regulations ?
• The Medicrime Convention opens a window of opportunity
3Speaker: XXXXX
The Medicrime Convention offers….
• A chance to have a look at the relevant criminal lawprovisions
• Wellprepared rules and structures to be implemented in national law (without having to start from almost zero in each individual state)
• An opportunity to raise awareness of problems and solutions during the whole implementing process amongall relevant sectors and groups (general public, politiciansand practitioners)
4Speaker: XXXXX
Stakeholders in implementing
• Start the implementing process early and do not forgetthat the law or the ammendments to existing regulationsdo not necessarily produce results in themselves
• Do not forget the groups that should work with the specificviolations of the rules !
• Training issues, specialization, co-operation structures
• Making health care authorities and law enforcement worktogether in an efficient and trustful way
• The expertise from different partners joining forces provides the overall good results !
5Speaker: XXXXX
Thanks for your attention
6Speaker: XXXXX
MEDICRIME CONFERENCE 16 MAY2012, COPENHAGEN, DENMARK
Bart WIJNBERG, Netherlands
Practical Suggestions
HOW TO… Step 1: Make an analysis
1. What’s in it for me?
2. What are the stakeholders’ vested interest in my country/authority?
(what’s in it for ‘them’)
3. Where can you expect resistanceand how will you deal with it?
2Speaker: Bart WIJNBERG
How to… Step 2: implementation scenarios/strategies.
Map the next practical steps for ratification
• ‘Walk through’ the text of the Convention
3Speaker: Bart WIJNBERG
Thank you.
• Bart [email protected]
4Speaker: Bart WIJNBERG