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MONITORING OF COUNTERFEIT MEDICINES IN MALAYSIA :
PUBLIC-PRIVATE SECTOR COOPERATION
DR. SALMAH BINTI BAHRI, R.Ph.
Director of Pharmacy Enforcement
Pharmaceutical Services Division
Ministry of Health Malaysia
Lot 36, Jalan Universiti,
46730 Petaling Jaya, Selangor,
Malaysia
Outline of Presentation
• Introduction
• Control of Pharmaceutical Products in Malaysia
• Control & Monitoring of Counterfeit Medicines
• Implementation of Meditag Hologram
• Consumer Awareness Activities
• Impact and Outcome
• The Way Forward
• Collaboration With Other Stakeholders
• Knowledge Sharing
• Conclusion
3
COUNTRY PROFILE
Total Land Area 329,961.22 km2
Population (2015) 30.7 million (Urban: 71%)
Life expectancy (2013) Male: 72.6 yrs Female: 77.2 yrs
Age ≥ 60 years 10.3%
GDP per capita MYR 34,126 (USD10,902.87)
Estimated labour force (2013) 12.9M
(44% of the total population)
Total Expenditure on Health2011 (Public & Private) (in million)
MYR 37,542 (USD 11,994)
Total Expenditure on Health as a Percentage of GDP (current prices) (2011)
4.3%
COUNTRY PROFILE - MALAYSIA
Source : 1. Department of Statistics, Malaysia,
2. Economic Planning Unit, Prime Minister’s Department and Malaysian Economy 4th Quarter Document, MOF
4
Malaysian National Medicines Policy (MNMP)
Quality Use of Medicines
Access to Medicines
Governance in Medicines
Quality, Safety and Efficacy of
Medicines
Partnership & Collaboration for Healthcare
Industry
5
To improve health outcomes of Malaysians through:
Promoting equitable access to essential medicines
Ensuring availability of safe, effective and affordable medicines of good quality
Promoting quality use of medicines by healthcare providers and consumers
Objectives of MNMP
CONTROL OF
PHARMACEUTICAL PRODUCTS
IN MALAYSIA
7
• 4617 license issued to pharmacists practising in 2766 pharmacies • 2086 license issued to importers and wholesalers of controlled items
148 Public Hospitals
2765 Public Clinics
6,801 GP Clinics 1686 Dental Clinics
Control of Pharmaceutical Products in Supply Chain
214 Private Hospitals
2015/3/43/4/2015 8
POLICY Good governance, practices, conduct and professionalism shall be
emphasised within the healthcare industry towards achieving optimal health outcomes
Policy 1: Governance in Medicines
STRATEGIES
• Health professional bodies and relevant
stakeholders shall have codes of conduct
and be responsible for ensuring
compliance by its members with the code.
• Stakeholders shall perform in accordance
with the standards of practice developed by
appropriate authorities or relevant
professional bodies.
• Compliance with the standards shall be
supported by legislation where appropriate.
• Relevant legislation/
regulations shall be
developed and reviewed
regularly to ensure an
efficient supply chain
network and integrated
medicines management to
safeguard the public
2015/3/43/4/2015 9 9
POLICY Only safe, efficacious and quality medicines that meet
approved standards and specifications shall be registered and made available for sale and use by the consumers in Malaysia
Policy 2: Quality, Safety and Efficacy of Medicines
STRATEGIES
LEGISLATION AND REGULATIONS
• National Pharmaceutical Control Bureau (NPCB)
• Regulating Premises that supply medicines
• Effective Enforcement
• Medicines Advertisement and Promotion
• Counterfeit Medicines
PHARMACEUTICAL QUALITY ASSURANCE
• Post-Marketing Surveillance
• Management of Complaints about Medicines
2015/3/43/4/2015 10 10
POLICY Partnerships and collaboration in the implementation and
strengthening of relevant areas in the healthcare industry shall be established among various stakeholders at the national, regional and international levels
Policy 5: Partnership and Collaboration for the Healthcare Industry
STRATEGY 5.2.3: Technical Collaboration & Partnership
• Technical collaboration and partnership shall include all areas in regulatory practices, training and human resource development, medicines accessibility, quality use, and research and development
• Effective networking shall be established to provide a framework for exchange and sharing of information.
• Referencing against best practices and standards shall be established and reviewed regularly.
• Partnerships, coordination & cooperation with all relevant stakeholders shall be strengthened.
PENCAPAIAN LEGISLATIONS
(ACTS & REGULATIONS)
11
1. Registration of Pharmacists Act 1951 (revised 1989) & Regulations 2. Poisons Act 1952 (revised 1989) & Regulations 3. Sale of Drugs Act 1952 (revised 1989) & Control of Drugs and Cosmetics Regulations 1984 (revised 2006) 4. Dangerous Drugs Act 1952 (revised 1980) & Regulations 5. Medicines (Advertisement and Sale) Act 1956 (revised 1983) & Regulations
12
PHARMACY ENFORCEMENT DIVISION
Legislation, Inspection & Prosecution
Licensing, Inspection & Entry Point Control
Intelligence, Surveillance & Operation
Advertisement & Innovation
Prevention & Consumer Awareness
Consists of 5 Branches in HQ and 15 State Offices •450 Pharmacy Enforcement Officers
14 14
• Adulterations
• Counterfeit medicines • Illegal activities
Manufacturing
Importation
Sale
• Online trading & cyber crime
• Medicines & chemicals abuse
• Control of psychotropics
Precursors
Diversions
• Intelligence gathering
• Legislation
Current Scenarios & Challenges
CONTROL & MONITORING OF COUNTERFEIT MEDICINES :
PUBLIC-PRIVATE SECTOR COOPERATION
2015/3/43/4/2015 16 16
POLICY Only safe, efficacious and quality medicines that meet approved
standards and specifications shall be registered and made available for sale and use by the consumers in Malaysia
Policy 2: Quality, Safety and Efficacy of Medicines
STRATEGY 2.2.1.5 Counterfeit Medicines
• Appropriate legal and technical framework for concerted efforts in the enforcement of laws and regulations by the Ministry of Health and other relevant authorities relating to market surveillance shall be further enhanced to overcome the problem of counterfeit medicines.
• Suitable security measures for authentication, traceability of counterfeit medicines and public education shall be implemented and continuously enhanced.
Counterfeit Medicinal Products Definition (WHO) 1992
A product that is deliberately and fraudulently mislabeled with respect to identity or source to make it appears to be a genuine product
May include products with Correct or wrong ingredients, without active ingredients, with incorrect quantity of active ingredients or with fake packaging
Counterfeiting can apply to both branded and generic
product and sold under product name without proper authorization
Counterfeit Medicines
Substandard/Spurious/ Falsely-labelled / Falsified/ Counterfeit
(SSFFC)
Medicinal Products
18
New Terminology by WHO (2011)
SSFFC Medicinal Products
Substandard Below the usual or required standard
Spurious Not being what it claim to be; false or fake
Falsely-labelled
Declaring what is untrue, tending to deceive or mislead, not genuine
Falsified Incorrect or false- especially to deceive i.e pass themselves off as real
Counterfeit Imitate fraudulently, fake
• All pharmaceutical products have to be registered with the Drug Control Authority (DCA) before it is marketed and sold to consumers.
• Assessment of safety, quality and efficacy based on adequate and scientific data is the prerequisite for registration
• Any products that passed the evaluation and approved by the DCA will be given a unique registration number starting with ‘MAL’
• SSFFC medicinal products are currently deal as unregistered products under Sale of Drugs Act 1952
Control of Pharmaceutical Products in Malaysia
MAL 12095678 A, X, T OR N
A Controlled Medicine Only dispensed by doctors & pharmacist
Eg: Antibiotics, Anti-Hypertensive
X General/Over the counter Medicine Eg: Fever medicines, Antacids
T Traditional Medicine Eg: Jamu, Liniments, Minyak Gamat
N Health Supplement Eg: Cod Liver Oil, Multivitamins.
‘MAL’ Registration Number:
Product Registration 1985-2014
Product Category Total Registered Currently
Registered
Control Medicines (Prescriptions)
14,140 7,101
Non-prescriptions (OTC)
10,144 4,172
Natural Products (Traditional Medicines)
22,867 12,052
Veterinary Products 385 509
Health Supplement 509 385
Total 48,045 24,219
(50.39%)
Limitation of ‘MAL’ Registration Number
• Through market surveillance, Pharmacy Enforcement Officers detected the existence of pharmaceutical products using fake registration numbers or registration numbers that belong to other products.
• The registration numbers are easily copied and consumers are finding it hard to verify its authenticity in the market
• The huge number of products registered make it difficult for consumers to determine the exact status of the pharmaceutical products at the point of sales
IMPLEMENTATION
OF
Meditagtm Hologram
Malaysia is the first country in the world who implements the
use of a single security hologram label for all
pharmaceutical products sold in the country.
25
All registered products are required to display their product registration number and Meditag hologram
security label on its packaging. Any products that do not carry both of these
features will be considered as unregistered products
Registration Number MeditagTM Hologram
Implementation of Hologram Technology
• An additional safety measure was adopted on the 1st May
2005 with the introduction of the Meditag hologram sticker
on all pharmaceutical products.
• This first Meditag hologram reflects our commitment and
seriousness in controlling the medicinal products in
Malaysia. • The implementation of the Meditag scheme shows how modern technology can be a key
to curbing fake drugs. • The Meditag hologram can help reduce sale of counterfeits and aid in the prosecution of
offences against adulterated and fake drugs.
28
The characteristics
that can be seen with
naked eye of
consumers
Features of the First MEDITAG® HOLOGRAM
29
MeditagTM II (2006)
MeditagTM III (2012)
Upgrading security features
in the hologram to keep
abreast with rapid
advancement in technology
IMPROVING CURRENT SECURITY FEATURES
30
Control on MeditagTM Hologram
•Only supplied to importers and manufacturers licensed by MOH Malaysia.
•Meditag holds 10 digits alphanumeric serial code, each hologram is serialized and the serial number is recorded in a computerized system - MTOS.
•Meditag can be related to a particular manufacturer or importer base on its serial number. They will be held responsible on how the labels are kept and used.
•Enforcement officers can login into the system and identify the rightful owner of any genuine Meditag Hologram.
Formats of Meditag™ Hologram
• Sheets
–100pcs Meditag™ labels
per sheet
• Rolls
–15,000pcs Meditag™ labels
per roll
Meditag™ Security Concept
• Public
– Immediate visual identification
– Point of sale verification with decoder
• Inspectors
– Tool kits
• Forensic personnels
– 100% certainty/Nanograph®
3 levels authentication and control
Visual Aid Device – Meditag Decoder
1st Edition 3rd Edition 2nd Edition
34
PLACEMENT 0F MEDITAG DECORDER
• Available at all pharmacy
throughout the country
• Encourages the public to check
the authenticity of their medicinal
products.
• Promotes and encourages the
public to obtain medicines from
licensed Pharmacist
•Encourages the Pharmacist to
check the product sold in their
premises.
35
Using Meditag Decorder
35
Click to edit Master title style
Polapen® Enhanced Tool
•Mediharta has developed a Polapen® as a tool to identify the Polarigraph feature of the genuine Meditag™ label.
•The Polapen® is distributed to all Pharmacy Enforcement Officer
37
Example – Fake Hologram
ORIGINAL COUNTERFEIT
Example – Fake Hologram
Effectiveness – Moving In The Right Direction
• The implementation of Meditag hologram is an added advantage and has certainly facilitated in enforcement activities particularly with respect to product authentication.
• Easier to identify and differentiate the genuine from fake medicinal product
– It serves as a deterrent to the counterfeiters.
40
SEIZURES & RAIDS
40
Detection of Counterfeit/Unregistered Medicines
42
BEFORE
AFTER
Meditag Hologram
facilitate detection of
counterfeit drugs and their
removal from the market
44
Consumer Awareness
CONVENTIONAL METHOD :
•Informative Poster/postcard/leaflet/pen
•Informative Calendar
•Lectures – students, NGOs, enforcement officers
•Exhibitions – school, office, shopping complex, etc
•Dialogues – target groups
•Roadshows and Carnival
•Announcement/article in media – newspaper, tv, etc
•Advertisement in media & public transport
•TV & Radio talks
•Billboard and bunting
45
Awareness and Public Education Activities
46
Campaign at Hypermarkets
Tesco
Selayang
Seremban
Kulai
Tebrau
Prai
Mergong
Sungai Petani
Puchong
Tanjung Pinang
Mydin Subang Jaya
Mydin Meru Raya
Various location throughout the country
Educating the Industry
• Dialogues and briefing sessions with the associations.
• Training the pharmacists, wholesalers and retailers on how to identify genuine holograms and how to verify using the decoder.
• Meditag decoders were given free to all pharmacies, wholesalers and certain retails outlets dealing with medicinal products.
• The decoders must be placed visibly on the counter for easy access to the public
Consumers & Industry Awareness Activities
2009 – 2014
49
Innovation – in line with the new era
Enhancement of Awareness Activities using various new means and channel :
•Dissemination of Information through :-
– Official Websites
– Social Media
•Smartphone App – Meditag Checker
•Online verification of registration number
•Informational videos on Youtube
•Submission of complaints or information through :
– Official Website
50 50
Official Website
51
Social Media – Online Awareness Platforms
IMPACT & OUTCOME
53
Seizure of Unregistered Products
Year
No of Items
seized (a)
No of counterfeit
items seized (b)
No of unregistered
items seized (c)
% of counterfeit items seized (d) (c/a x 100= d) %
2009 10,478 234 10,244
2.23%
2010 11,934 362 11,572 3.03%
2011 17,768 344 17,424 1.94%
2012
27,836 116 27,720 0.42%
2013 26,567 52 26,515 0.20%
Malaysia was awarded the “GLOBAL ANTI-COUNTERFEITING AWARD 2013” by The Global Anti-counterfeiting Group Network (GACG) presented during the World Anti-Counterfeiting Day in Paris, France on the 28th of May 2013
54
The Way Forward
56
• Enactment of the new Pharmacy Bill to address the issues and lacunae in the existing legislation and stiffer penalties:
Clearly define counterfeit medicinal products
Impose up to 10 times higher penalty -imprisonment of not less than 4 years but not exceeding 15 years and will be fine up to RM 2 million
• Close collaboration with other stakeholders (National, Regional and International)
– Operation Pangea
– Operation Storm
• Review and study of new security features/ safety mechanism to further improve the current safety label on medicinal products
The Way Forward - Malaysia
New Pharmacy Bill supported by the Government – political will
57
Collaboration
with other
Stakeholders
59
Collaboration with other Stakeholders
PANGEA :
‘An International Internet Week of Action (IIWA) involving Law Enforcement Agencies and Medicine Regulators targeting the illegal on-line supply of medicines including counterfeit and unlicensed products to the public’
60
Objectives
•Safeguard public health
•Raise public awareness of the risk of buying medicines from fraudulent websites
•Seize counterfeit & illicits medicines and medical products and remove them from the market
•Close down fraudulent websites & remove advertisements
•Identify the producers & distributors of counterfeit and illicit pharmaceuticals and medical products.
Operation PANGEA
–Pharmacy Enforcement Division, MOH
–15 State Pharmacy Enforcement Offices
–Royal Malaysia Customs
–Malaysian Communications and
Multimedia Commission
61
Local Collaboration
1. INTERPOL
2. WORLD CUSTOMS ORGANIZATION
3. Permanent Forum of International Pharmaceutical crime (PFIPC)
4. Working Group on Enforcement Officers (WGEO)
5. EUROPOL
6. Pharmaceutical Security Institute (PSI)
7. Center for Safe Internet Pharmacies (CSIP)
INTERNATIONAL COOPERATIONS
• Monitoring at Entry Points
– Airports (Cargo and Passenger)
– Postal & Courier Hubs
– Border Checkpoints
– Ferry Terminals
• Monitoring 0f Websites and Social Medias
• Inspections and Raids
• Consumer Awareness Activities
63
Activities Conducted In Malaysia
64
Activity Pangea V Pangea VI Pangea VII
2014 (113 countries)
Websites monitored/ investigated
96 134
236
Social media monitored/ investigated
97
Parcels inspected 1,260 888 9,014
Parcels seized 67 21 204
Value (RM) 49,830 76,600 259,346
Consumer Awareness Activities
2 2 28
Results & Achievements (Malaysia)
65 65
Collaboration With Other Stakeholders
No Activities Conducted
1 Inspection on licensed & unlicensed premise (pharmacies, clinics, drug store, sundry shops, etc)
2 Comprehensive entry point monitoring on all entry points into Malaysia.
3 Surveillance and raiding on premises involved in illegal sale of medicine
4 Monitoring of websites / social media selling medicines online
5 Monitoring of advertisement
6 Intelligent Sampling and test on medicine / food with medical claims.
7 Awareness Campaign and dissemination on information through all channel (websites, facebook, etc)
Operation Storm V (13 countries) in 2014
• Premises inspected
• Pharmacies
• Clinics and Hospitals
• Pharmaceutical Manufacturers and Wholesalers
• Traditional Medicine Shops
• Sundry shops, Mini markets
• Business Kiosks, Stalls and Night Markets
• Beauty Saloons
• Other premises dealing with pharmaceuticals 66
STORM V : Malaysia
67
No. of Entry Points 30
No. of Parcels inspected 23,767
No. of premises inspected 559
No. of cases investigated 17
No. of Parcels seized 190
No. of items seized 865
Value of item seized at Entry Points
RM 45,359 (USD 13,820)
Results & Achievements
68 68
Other Activities Quantity
Products sent for analysis 252
Consumer Awareness Activities
89
Dissemination of information through Social Media
76 new postings
Websites investigated 29
Results & Achievements
69 69
Total Seizures
Quantity of Item Seized (pill, vial, tablet, etc.…)
851,500
Value of item seized :
RM 1,204,441
(USD 363,627)
70
Knowledge Sharing
KNOWLEDGE SHARING : Case Study 1
Modus Operandi
1. Ordering done by a company in Singapore.
2. Products sent from India to Kuala Lumpur International Airport International Hub.
3. Products sold online through various websites.
4. SMMR will receive customer info and re-pack the products
5. Products delivered to customer through courier services.
Seized Items
2 premises related to the business were raided
•181 medicinal products (mostly generic Erectile Dysfunction and antihypertensive drugs and antibiotics,) were found and seized
•Total value = RM 7.5 million ≈ USD 2.34 million
Seized Items
FILAGRA 100 (Sildenafil)
AVANA & SUPER AVANA
(Avanafil)
TADALIST (Tadalafil)
Seized Items
POST MORTEM & OBSERVATION
• Products were kept in transit and stored inside the
airport compound, declarations with customs are not
required.
• Products delivered to other countries as health
supplements without its original packaging/ information
about its identity.
• Difficulty to trace or gather evidence (unregistered,
counterfeits, adulterated food supplements) to
successfully prosecute the offenders as the actual
transactions were done in other countries
COLLABORATION WITH PHARMACEUTICAL INDUSTRY
s • Pharmacy Enforcement Division also work closely
with Pharmaceutical Security Institute (PSI) and Pharmaceutical companies (Pfizer, Eli Lilly, etc.) to further enhance our control mechanisms.
• Pharmaceutical companies do provide assistance with test purchases and surveillance activities while the Enforcement Division will follow up with raids and prosecutions.
78
CONCLUSION • Implementation of the security hologram has proven to
be a practical and effective tool to facilitate enforcement activities particularly with respect to product authentication.
• Enforcement agencies must keep vigilant on the continuous change of tactics. R&D on enforcement activities should be strengthened together with new strategies to educate and empower the consumers.
• New invention and advancement in the security label technologies should be considered and integrated to further improve the current system.
• Structured local, regional and global public-private collaboration is the way forward.
79
TERIMA KASIH Thank You