role of the business sector in countering...
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2010/SOM3/ACT-ABAC/RT/007
Role of the Business Sector in Countering Corruption
Submitted by: PhRMA
ACT-ABAC Roundtable Meeting on Fighting Corruption and Strengthening Market Integrity
Sendai, Japan17 September 2010
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Role of the Business Sector in Countering Corruption
ACT‐ABAC Roundtable Meeting on Fighting Corruption and Strengthening Market Integrity
September, 2010
ACT ABAC Roundtable Meeting on Fighting Corruption and Strengthening Market Integrity
Anthony B. Cino, Associate Vice President, PhRMA
Sendai, Japan
Content
1. Introduction of PhRMA
2. Nature of the Problem
3. International Response and Examples of R&D‐Based Industry Efforts
4 Conclusion
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4. Conclusion
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• PhRMA represents approximately 30 global leading pharmaceutical research and biotechnology companies
About PhRMA
biotechnology companies
• Our companies are devoted to discovering new medicines that allow patients to live longer, healthier, and more productive lives.
• In 2009 alone PhRMA members invested an estimated total of $45.8 billion in discovering and developing new medicines
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• PhRMA members are committed to helping ensure that all patients have access to the medicines they need.
• For more information, you can visit our website at www.phrma.org.
Source: Pharmaceutical Research and Manufacturers of America, PhRMA Annual Membership Survey, 2009.
Counterfeit medicines are a Public Health Threat
• Defraud consumers
• Deny patients therapies that can alleviate suffering and save livesDeny patients therapies that can alleviate suffering and save lives
• Can cause great harm and fatalities
• Allergic reactions
• Heavy metal poisoning
• Promote drug resistance strains of diseases
• Not limited to brand-name, prescription lifestyle drug
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• Fake versions of generic and over-the-counter (OTC) drugs
• Global issues with widespread health challenges
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PSI Situation Report, 2009
Key findings by the Pharmaceutical Security Institute (PSI) for 2009
2 003 Incidents up 9 2% 2,003 Incidents – up 9.2% 1,693 Counterfeit incidents – up 6.8% 118 countries impacted 808 different drugs – up 36% 1,468 arrests – up 60% 48% of seizures are 1,000+ dosage units (commercial size) Counterfeit medicines are a threat to the health and well‐being of
people around the world
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Each PSI Member reported/experienced a counterfeit, theft or illegal diversion incident
Total incidents include reports by PSI members plus those identified by PSI analysts using open source information
Total Incident Trends
PSI Situation Report, 2009
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PSI Situation Report, 2009
Most arrests took place in Asia and Latin America
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Example of one trade route for counterfeit drugs
Multinational Operations
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Source: “Counterfeit Drugs’ Path Eased by Free Trade Zones,” New York Times, December 17, 2007
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Examples of how counterfeits are produced
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“… The layout and design of premises must aim to (…) permit effective cleaning and maintenance in order to avoid cross‐contamination, build‐up of dust or dirt, and, in general, any adverse effect on the quality of
products…”
WHO’s Good Manufacturing Practices for Pharmaceutical Products
Picture courtesy of PSI. Operation Cross Ocean, China.
International Responses Outside of APEC
• WHO International Medical Products Anti‐Counterfeiting Taskforce (IMPACT),
o Created in 2006, has been active in forging international collaboration to seek solutions and raise awareness
• WHO South East Asia regional office passed a resolution on counterfeits at a meeting 2009
• Interpol
o Adopted a resolution aimed at enhancing regulatory authorities and the police cooperation
o In 2009 created unit working specifically in counterfeit medicines
o Various operations and training programs
• Universal Postal Union
o A resolution adopted in 2008 urged Posts within the framework of their national laws to assist customs to
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o A resolution adopted in 2008 urged Posts, within the framework of their national laws, to assist customs to identify counterfeit or pirated articles sent through the postal network.
• World Customs Organization ‐WCO
o Launched a new group, “Counterfeiting and Piracy (CAP)” to focus on health and safety that will be limited to dialogue and exchanges of national experiences and discussions on WCO capacity building activities.
• World Intellectual Property Organization ‐WIPO
o Inactive; co‐organizes Global Congress on Piracy and Counterfeiting with ICC’s BASCAP WCO and Interpol
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The Pharmaceutical Security Institute (PSI)
• PSI collects, analyses and disseminates information concerning counterfeiting incidentscounterfeiting incidents.
• Begun by security directors in 1992 it began rigorous collection of data in 2002 after a major reorganization.
• Central point of contact for multi-national enforcement efforts
• Provides strategic reporting and regional reporting through the Counterfeit Incident System
• PSI conducts briefings and training for drug regulators, law
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PSI conducts briefings and training for drug regulators, law enforcement and customs authorities around the world.
Examples of Association Engagement in the APEC Region
Pharmaceutical associations around the world are engaged in positive dialogue with Governments and other partners. Some examples:
I th US PhRMA k ith th P t hi f S f M di i• In the US, PhRMA works with the Partnership for Safe Medicines.
• The Japanese Association, JPMA, provided capacity building and technology transfer to Cambodia’s National Laboratory for Drug Quality Control in order to address issues related to the quality of pharmaceuticals, including counterfeiting.
• In Hong Kong, HKAPI provides direct counseling to patients for checking suspected products via a partnership with pharmacists. They also sponsor a reward scheme aimed at encouraging reporting of suspected counterfeits to
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g g p g pthe Government’s appropriate organizations via a Hotline.
• In Taiwan, IRPMA has put in place a “counterfeit drug data sharing platform” (website for their members) to help track suspect cases, and also has created an “investigator brochure” for investigators, containing the picture and identification information of medicines commonly counterfeited.
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The IFPMA
• The IFPMA has been an active partner of the WHO in anti‐counterfeiting activities since the 1980’scounterfeiting activities since the 1980 s.
• Provided support to IMPACT’s technical groups through IFPMA members’ expertise in legislation, technology, regulation, enforcement and communications.
• Advocacy and communication events for Geneva delegates.
• Advocacy and communications in international/regional events of the industry.
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• Support to communications activities of IFPMA members in anti‐counterfeiting.
Partnership for Safe Medicines Members
Academy of Managed Care Pharmacy
The ALS Association
American Association for Homecare
American Pharmacists Association
Institute of Health Law Studies
Institute for Safe Medication Practices
Interamerican College of Physicians and Surgeons
Nevada Board of Pharmacy
New York State Council of Health‐system Pharmacists (NYSCHP)
North Carolina Association of PharmacistsAmerican Pharmacists Association
American Society of Health System Pharmacists
Amerinet GPO
Arizona Pharmacy Alliance (AzPA)
Biotechnology Industry Organization
California Healthcare Institute
California Pharmacists Association
California Society of Health‐System Pharmacists (CSHP)
Colorado Biotechnology Association
The Council for Affordable Health Insurance
International Anti‐Counterfeiting Coalition
Iowa Pharmacy Association
Kidney Cancer Association
The Latino Coalition
Maryland Pharmacists Association
Missouri Pharmacy Association
National Alliance for Hispanic Health
National Alliance on Mentally Illness
National Association for Uniformed Services
National Association of Boards of Pharmacy
National Association of Drug Diversion
Oklahoma Pharmacists Association
Pharmaceutical Industry Labor Management Association (PILMA)
Pharmaceutical Security Institute
Pharmacists Planning Services, Inc.
Pharmaceutical Research and Manufacturers of America (PhRMA)
Product Surety Center
RetireSafe
Spina Bifida Association of America
Texas Pharmacists Association
Title II Community AIDS National Network
United States Chamber of Commerce
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drugstore.com, inc.
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Healthcare Distribution Management Association
HealthCare Institute of New Jersey
Healthcare Leadership Council
Hispanic Business Roundtable
The Hispanic Institute
Illinois Pharmacists Association
Investigators
National Association of Manufacturers
National Biopharmaceutical Security Council
National Coalition for Women with Heart Disease
National Latina Health Network
NeedyMeds
United States Chamber of Commerce
University of Texas Pharmacy School
Vietnam Veterans of America
Virginia Pharmacists Association
Vermont Pharmacists Association
Wisconsin Biotechnology Association
World Health Organization
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PSM Web Resources for Every Audience
• Consumers: “SAFE DRUG checklist” and “SAFE SAVINGS” brochures in 5 languages
• Policymakers and Media: “Counterfeit Drug Incident Encyclopedia” and “Principles for Drug Safety” to provide policy guidance
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• Healthcare Professionals: “LEADERS guide for Pharmacists” and “Safely Sourcing Medication” handouts
PSM Consumer handouts like SAFE DRUG are available in English, Spanish, Tagalog, Chinese, and Vietnamese
Every day the PSM team produces a daily summary of counterfeit drug news and distributes it through the website, RSS, and on Twitter
International Principles for Drug Safety
U if i th Fi ht A i t• Unify in the Fight Against Counterfeit or Spurious Drugs
• Secure and Protect the Supply Chain
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• Regulate Online Drug Sellers
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How to Start a Partnership for Safe Medicines
• Eight step process to begin a g p p gSafe Medicines affiliate in your country
• Benchmark matrix to provide guidance and progress reporting
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reporting
• Cost sharing on behalf of PSM
Recent Outreach and Progress in India
• Conducted more than 30 meetings during the last 18 months, over three trips in both Delhi and Bombaythree trips, in both Delhi and Bombay
• Outreach efforts range across all segments and interested parties:
o Consumer organizations
o Pharmaceutical Industry (brand and generic) and broader industry associations
o Patient Advocacy Organizations (including cancer and diabetes)
P id (I di M di l A i i )
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o Providers (Indian Medical Association)
o Government (such as Drugs Controller‐General of India and Department of Pharmaceuticals)
o Academic and Research (All India Institute of Medical Sciences)
o Public health organizations
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Partnership for Safe Medicines in India
• Hosted a brainstorming session last May with interested parties (“Founders” event)( Founders event)
o Model for success: Public Private Partnership (PPP), modeled after PSM in the United States
o Principles in development; intellectual property issues are explicitly not to be addressed
o Government and Indian Pharma Industry (largely generic) are important partners in the PPP
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• Named a prominent consumer advocate as Executive Director and a retired senior government official as Chairman of PSM‐India
• Public launch of PSM‐India scheduled later this month
Key Messages
• The counterfeit medicines issue is a safe medicines issue that threatens the health of our citizensthreatens the health of our citizens
• The problem seems to be getting worse
• Further coalition building will be critical to making progress
• Multi‐economy forums like APEC provide and important opportunity to strengthen the fight against counterfeiters
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• The pharmaceutical industry has a long history and a strong interest in partnering with Governments to combat counterfeit medicines
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Thank You
Anthony B. Cino, Associate Vice President
Pharmaceutical Research and Manufacturers of America (PhRMA)Pharmaceutical Research and Manufacturers of America (PhRMA)
950 F Street NW
Washington, DC 20004
+1-202-250-9529
www.phrma.org
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