COMBATTING FALSIFIED MEDICAL PRODUCTS AND … · COMBATTING FALSIFIED MEDICAL PRODUCTS AND SIMILAR CRIMES THROUGH LEGAL INSTRUMENTS AND PRACTICAL MEASURES Copenhagen (Denmark) 16

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


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

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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

[email protected]

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


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


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


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.




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.




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)




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


3. rules of GMP for active substances

Proposal to expand the scope of the current Directive 2003/94/EC on GMP to API


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)


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.


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.


Thank you!


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 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’:

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

[email protected]

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


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 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


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


BROCHURE: MEDICINAL PRODUCTS AND THE INTERNET MASS MEDIA

PUBLIC CAMPAIGNS AND ADVERTISEMENTS


“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.


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.


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 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.


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


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

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…


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


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 .


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


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


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


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 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

Thank You for your attention

Speaker: HMF 7


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


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


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


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


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


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


Thank you.

• Bart [email protected]


Documents

COMBATTING FALSIFIED MEDICAL PRODUCTS AND … · COMBATTING FALSIFIED MEDICAL PRODUCTS AND SIMILAR CRIMES THROUGH LEGAL INSTRUMENTS AND PRACTICAL MEASURES Copenhagen (Denmark) 16