Slides Medicrime

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 counterstrategies

Gerald Heddell Director Inspection, Enforcement & Standards Medicines and Healthcare products Regulatory Agency MEDICRIME CONFERENCE 16 MAY 2012 COPENHAGEN, 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

Europe Eur-Asia
North America
West Africa Middle East
South East Asia
Falsified Medical Products Situation - Global

2012 (all reported in the Press):
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.
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
Falsified Medical Products Situation - UK

6 5 4 3 2 1 0
19 94 -2 00 3 20 04 20 05 20 06 20 07 20 08 20 09 20 10 20 11
Wholesale level Clinical Trial Pharmacy level
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
Safety features
Actors in the supply chain
Directive 2011/62/EU on falsified medicinal products
Internet sales
Active substances
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: Prevention Incident handling Investigation

Use of Social Media:
Engagement
Accessibility Targeted Mass audience

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
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 2012

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Safeguarding public health
Thank you
All Enforcement enquiries and potential referrals to: MHRA Case Referrals Centre casereferrals@mhra.gsi.gov.uk 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 gerald.heddell@mhra.gsi.gov.uk
The European Unions Directive on falsified medicines

MediCrime Convention Combatting Falsified Medical Products and Similar Crimes Through Legal Instruments and Practical Measures Copenhagen, 16 May 2012 Fabio DAtri Unit D6 Medicinal products quality, safety and efficacy Directorate-General Health and Consumers European Commission
Speaker: Fabio D'Atri
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.
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
New measures for all actors in the supply chain
Manufacturers of active substances
Manufacturers of medicines
Distributors
Online pharmacies
New rules for import of API:

Written confirmation on GMP or country is listed by the Commission
Safety features Audit of API manufacturers
Obligation of reporting incidents Authorisation in EU database
Common trust mark Awareness campaign
In the EU: registration of activity
Implementation: Work on track

14 tasks for the European Commission 3 concept papers already published
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
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.

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

Consultation closed Analysis of responses Impact assessment in 2013 Delegated act in 2014 Application 3 years after its publication
10
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.
11
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.
12
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)
13
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
14
3. rules of GMP for active substances
Proposal to expand the scope of the current Directive 2003/94/EC on GMP to API
15
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)
16
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.
17
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.
18
Thank you!
UK Largest Counterfeit Case in the legitimate supply chain 2007 Operation Singapore
Nimo Ahmed Head of Enforcement (Acting) Medicines and Healthcare products Regulatory Agency MEDICRIME CONFERENCE 16 MAY 2012 COPENHAGEN, DENMARK
Outline

Case overview Public Health v Investigation Case in detail Lessons learned Conclusion
Case overview
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
Public Health v Investigation

Quarantine/Seize IMMEDIATE ACTION to prevent further product reaching the public Sample Obtain samples of suspicious product and any other medicines supplied with it Analyse Ask genuine manufacturer to test the product AND your own Government laboratory obtain medical assessment from both Recall Recall the product from the market if there is evidence that it has reached pharmacies or patients, make use of press
Case in detail
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 movement of counterfeits
UK
Belgium
Tianjin Hong Kong Singapore
Case in detail the counterfeit medicines as purchased
Case in detail UK licensed wholesaler
Case in detail Vignette evidence
Case in detail the counterfeit medicines as sold

The counterfeit medicines as sold:
Case in detail - movement of money
UK
Luxembourg China
Mauritius
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 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

UK

Lu (Kevin) XU (Chinese) 6 years imprisonment Trafficking counterfeit medicine MHRA investigators gave evidence
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 you
All Enforcement enquiries and potential referrals to: MHRA Case Referrals Centre casereferrals@mhra.gsi.gov.uk 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 nimo.ahmed@mhra.gsi.gov.uk
MEDICRIME CONFERENCE 16 MAY 2012, COPENHAGEN, DENMARK

Anita Filipovi Sui 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
Speaker: Anita Filipovi Sui
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
CASES FROM CROATIA-ILLEGAL SUPPLY CHAIN
CASES FROM CROATIA-ILLEGAL SUPPLY CHAIN

-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 COUNTERFEITS
1) 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
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
RAISING PUBLIC AWARENESS

PUBLIC CAMPAIGNS AND ADVERTISEMENTS BROCHURE: MEDICINAL PRODUCTS AND THE INTERNET MASS MEDIA

UKRAINIAN PROGRESS IN COMBATTING FALSIFIED MEDICINES State Administration of Ukraine on Medicinal Products Mr. DUBOVYTSKYI Sergii Director of Department for State Quality Control Mr. POGREBNIAK Yurii Informational-analytical Division
Speaker: Mr. DUBOVYTSKYI Sergii and Mr. POGREBNIAK Yurii
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.
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.
In parallel, serious efforts were paid in order to develop modern laboratory network, using the OMCLs 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-Ministers Resolution two weeks ago.
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.
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 SPOCs for each country; to develop the concept of a SPOC network; to emphasize cooperation on the national level and to establish SPOCs for Customs, Police and Justice.
INTERNET COMMUNICATION
Dr. Monika Johansson Medical Products Agency, Sweden
Speaker: Monika Johansson
Communication today
Information on the website, www.mpa.se product 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
Internet warnings 2011

Sildenafil and tadalafil, 13 May Tadalafil, 14 June
Growth hormone, 11 January
Sildenafil,13 January (2012) Corticosteroid 7 Mars
Sibutramin, 8 July
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
How to reach the target audience?

4
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
Future projects
New website for information regarding regulations and
falsified medical products Update www.crimemedicine.com with Q&A? Blogs? /Twitter? New information campaign?
13/06/2012
OCLAESP supports MediCrime Convention

Copenhagen, 16 may 2012
Captain Laurent Ruff oclaesp@gendarmerie.interieur.gouv.fr Tel. :+331 56 28 71 75 Cel. :+336 31 89 07 97
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
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
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 results Over 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 investigation Over 2.5 million units seized Estimated value: 6.8 million USD
13/06/2012
Thank you
OCLAESP 6 avenue de Stalingrad 94110 ARCUEIL France oclaesp@gendarmerie.interieur.gouv.fr +331 56 28 71 75

Successfully combating illegal medicines on the Internet.
Mr. Ashley How, Director EMEA, Pharmaceutical Security Institute, PSI
Speaker: Mr. Ashley How, PSI
Topics for discussion..

What is the key challenge? What is required to combat the challenge? How to achieve success.
What is the key challenge?

The international complexity of the organised crime
networks responsible for exploiting the public
Drop-shipping and Fulfilment operations

Drop-Shipping operation
C/F Meds manufacturer
Customer
Distributor / Shipper / Seller
Fulfilment operation
Copyright PSI
Illegal Meds manufacturer
What is required to combat the challenge?

Identify & map the Organised Crime Groups Affiliate
networks
Identify the OCGs & the facilitators/enablers Remove their infrastructures Review & Monitor
How to achieve success.

A sustained and coordinated international programme
involving the key stakeholders.

Utilise international treaties and legislation - The Medicrime
Convention provides measures, tools & sanctions to assist, for example Articles 9, 10, 12 & 17.
A real commitment to cooperate & collaborate .
Speaker: XXXXX
Thank you.
Ashley HOW Director EMEA Pharmaceutical Security Institute, PSI Office: Mobile: Email: Website: +44 (0) 1903 779955 +44 (0) 7795 345600 ahow@psi-inc.org www.psi-inc.org

MICKEY ARIELI-RPh. DIRECTOR PHARMACEUTICAL CRIME UNIT MOH ISRAEL MEDICRIME CONVENTION-ISRAELI EXPERIENCE
Speaker: MICKEY ARIELI-RPh
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?
Speaker: 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
SpeakerMICKEY 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)
Speaker:mickeyarieli 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
Speaker: Mickey Arieli 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

Einar Magnsson, Icelandic Ministry of Welfare, Director of Pharmaceutical Affairs Icelands signature of the Medicrime Convention
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.
2
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?
3
Next practical steps to progress with ratification

http://www.velferdarraduneyti.is/frettir-vel/nr/33070
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.
Speaker: XXXXX
Thank you Thank you0

Ruth Mosimann, Swissmedic, Head of Control illegal Medicines Matthias Stacchetti, Swissmedic, Head of Penal Division
Signing and Ratifying the MEDICRIME convention: experiences made in Switzerland
Speaker: Mosimann, Swissmedic
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
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
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
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

Helder Mota Filipe Vice-President of the Executive Board Infarmed,I.P. RatificationProcedureInPortugal StateOfPlay
Speaker: HMF
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
Speaker: 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
Speaker: 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
Speaker: 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
Speaker: XXXXX
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
Speaker: HMF
Thank You for your attention

Deputy Public Prosecutor Henrik Helmer Steen, The Public Prosecutor for Serious Economic Crime in Denmark. Benefits expected from the MEDICRIME Convention.
Speaker: XXXXX
Political awareness Legal harmonization Mutual recognition Common understanding
Speaker: 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
Speaker: XXXXX
Procedural criminal law:
Jurisdiction Extradition Domestic procedural criminal law
Speaker: 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
Speaker: XXXXX

Strategic approach towards implementation
Hugo K. Bonar, Irish Medicines Board
Speaker: H.K. Bonar
Getting there
Strategic changes in attitude
Know what makes success follow it through implementation
Pathway to successful implementation
Cooperation designed strategically today
Strategic Networks identified + SPOCs created
Speaker: H.K. Bonar
Strategic changes
Stakeholders must drive implementation together it is an opportunity, not a burden Involve police, customs and health authorities in designing practical implementation steps
Make Medicrime Convention a living approach driven by the need to protect public health
Strategic changes in attitude required not just another economic crime 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)
Medicrime Convention promotes prevention (Art 18)
Speaker: H.K. Bonar
Develop Communication Mechanisms
Communication
Mechanism
Objective
Task
National coordination, not control SPOCs Art 17, 22) International Know whom to contact
Develop a national committee by consensus Agree nationally, promote internationally Overcomes conflict many SPOC models Interagecy support facility Resolve competition opportunties increased support for coordinated action
Two-way process
Increase resource potential Networks Art 17, 22 Improve information flow and quality Better decision making
Speaker: H.K. Bonar
Cooperation before implementation = results after implementation
Share
Requires a high level of prepararation
Engage
Traditional areas of competence Resources

Expertise People Legal powers
Mutual reliances
Interagency strategic goal setting
Speaker: H.K. Bonar
Recognise success as a pathway

Dont 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
Indicators of success to implement Medicrime Convention

Recognising and altering attitudes and systems
Realisation on need to work on preparation before implementati on
Success follows actions
Rising confidence that we can face this challenge
Sharing resources, not the blame
Organisation al maturity to be a partner with other agencies

Jesper Hjortenberg National Member for Denmark, Eurojust Vice-Chairman of CDPC (Council of Europe) Approaches to support the effective implementation of the Medicrime Convention- Criminal Law focus
Speaker: XXXXX
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
Speaker: XXXXX
From exotic speciality to main stream

Medicrime ( Offences) often regulated in very specialised
laws Limited awareness in society and among law enforcement bodies and judiciary Are criminal law regulations really up to date ? Criminal law provisions in specific laws In the Criminal Code ? Can states really cope with new threats and challenges within existing rules and regulations ? The Medicrime Convention opens a window of opportunity
Speaker: XXXXX
The Medicrime Convention offers.

A chance to have a look at the relevant criminal law
provisions 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 among all relevant sectors and groups (general public, politicians and practitioners)
Speaker: XXXXX
Stakeholders in implementing
Start the implementing process early and do not forget
that the law or the ammendments to existing regulations do not necessarily produce results in themselves Do not forget the groups that should work with the specific violations of the rules ! Training issues, specialization, co-operation structures Making health care authorities and law enforcement work together in an efficient and trustful way The expertise from different partners joining forces provides the overall good results !
Speaker: XXXXX
Thanks for your attention

Bart WIJNBERG, Netherlands Practical Suggestions
Speaker: Bart WIJNBERG
HOW TO Step 1: Make an analysis

1. Whats in it for me? 2. What are the stakeholders vested interest in my country/authority? (whats in it for them) 3. Where can you expect resistance and how will you deal with it?
How to Step 2: implementation scenarios/strategies.
Map the next practical steps for ratification
Walk through the text of the Convention
Thank you.
Bart Wijnberg
bartwijnberg@gmail.com

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Conference under the Danish Presidency of the Council of the European Union

Copenhagen (Denmark) 16 May 2012

Hotel Scandic Copenhagen Vester Soegade 6 1601 Copenhagen, Denmark

Combating falsified and illegal medicines challenges and counterstrategies

Falsified Medical Products Situation - Global

West Africa Middle East

South East Asia

Falsified Medical Products Situation - Global

Falsified Medical Products Situation - UK

Falsified Medical Products Situation - UK

Wholesale level Clinical Trial Pharmacy level

production and/or pharmaceutical ingredients/impurities and/or contamination

and lead to recalls, further damaging consumer confidence

have been seen around the world

Legal Frameworks to Combat - EU Falsified Medicines Directive

Actors in the supply chain

Directive 2011/62/EU on falsified medicinal products

Legal Frameworks to Combat CoE Medicrime Convention

MHRA Falsified Medical Products Strategy

Download from: www.mhra.gov.uk

MHRA Falsified Medical Products Strategy Objective:

behind the illegal activity

MHRA Falsified Medical Products Strategy

Strategy key themes: Prevention Incident handling Investigation

MHRA Falsified Medical Products Strategy

MHRA Falsified Medical Products Strategy

No of counterfeit incidents significantly reduced No of individuals convicted 24 No of years sentenced:

Crown Copyright 2012

Safeguarding public health

+44 (0) 203 080 6500 gerald.heddell@mhra.gsi.gov.uk

The European Unions Directive on falsified medicines

Speaker: Fabio D'Atri

Speaker: Fabio D'Atri

Applicable from 2 January 2013

Speaker: Fabio D'Atri

New measures for all actors in the supply chain

Manufacturers of active substances

New rules for import of API:

Safety features Audit of API manufacturers

Obligation of reporting incidents Authorisation in EU database

Common trust mark Awareness campaign

In the EU: registration of activity

Speaker: Fabio D'Atri

Implementation: Work on track

Speaker: Fabio D'Atri

Implementation: 3 concept papers

Speaker: Fabio D'Atri

1. Safety feature / unique identifier

Speaker: Fabio D'Atri

1. Safety feature / unique identifier

Speaker: Fabio D'Atri

1. Safety feature / unique identifier

Speaker: Fabio D'Atri

Speaker: Fabio D'Atri

Speaker: Fabio D'Atri

Speaker: Fabio D'Atri

Speaker: Fabio D'Atri

3. rules of GMP for active substances

Speaker: Fabio D'Atri

Other implementing measures

Speaker: Fabio D'Atri

Rules and penalties

Speaker: Fabio D'Atri