1. ©2014 First Conference of Regulatory Authorities in Sudan and Neighbouring Countries Khartoum, 6-8 December 2014 Dr Lembit Rägo Head, Regulation of Medicines and other Health Technologies Essential Medicines and Health Products First Conference of Regulatory Authorities in Sudan and Neighbouring Countries Khartoum, 6-8 December 2014 Dr Lembit Rägo Head, Regulation of Medicines and other Health Technologies Essential Medicines and Health Products

2. ©2014 WHO Member State Mechanism WHA Resolution 65.19 Established Member State Mechanism World Health Assembly 1 st Meeting Argentina 2012 2 nd Meeting Geneva 2013 3 rd Meeting Geneva 2014 Member State Mechanism Rotating chair, Currently Americas 2 vice chairs from 6 WHO regions Chair and Steering Committee 8 Point work plan adopted by WHA in May 2014 Working groups have commenced Work Plan

3. ©2014 Member State Mechanism – Work Plan Capacity Strengthening, Regulators and Laboratories Co-operation and collaboration amongst National Authorities Communication, education and awareness raising Consult, cooperate and collaborate with relevant stakeholders Identify actions, activities and behaviours resulting in SSFFC medical products Strengthen national and regional capacities to secure supply chains Collaborate on surveillance and monitoring of SSFFC medical products Collaborate on access to Quality, safe, efficacious and affordable medicines

4. ©2014 A Global Issue Contaminated Active Pharmaceutical Ingredient (API) produced in one country Exported to 6 other countries on three continents Used to manufacture finished medicines Caused loss of life and hospitalizations in two countries International drug alerts issued, medicines and API seized

5. ©2014 African Customs Seizure 2012 Coartem – Anti malarial 1.383,528 packs Artemether /Lumefantrine Postinor 2 – Emergency Contraceptive 4930 packs Levongestrel Vermox – Worming treatment 1534 packs Mebendazole Clomid – Fertility treatment 36,550 packs Clomiphene Clamoxyl - Antibiotic 744 packs Amoxicillin

6. ©2014 Rationale Global Picture Understand the Global Picture through validated evidence Identify vulnerabilities Identify vulnerabilities in Health Systems and influence change Provide technical support and build capacity PROTECT PUBLIC HEALTH

7. ©2014 WHO S URVEILLANCE AND M ONITORING S YSTEM O BJECTIVES S CALE Quantity Value S COPE Medicines Vaccines Diagnostics E XTENT Geographic coverage H ARM Public Health

8. ©2014 SSFFC I NCIDENTS R EPORTED TO WHO 90 Member States trained in 9 workshops 250 Regulatory personnel trained 18 large procurement agencies trained Over 530 Suspect Products Reported Incidents occurred in 65 countries

9. ©2014 West Africa 2012-14

10. ©2014 D ATABASE H IGH LEVEL S TATISTICS  Over 530 medicines, vaccines and devices reported  285 (53%) medical products reported are listed as WHO Essential Medicines  Over 50 reports refer to WHO PreQualified Medicines  10% of reports involved attributable serious adverse reactions  8 WHO International Drug Alerts issued

11. ©2014 S USPECT PRODUCTS REPORTED BY WHO R EGION

12. ©2014 T HERAPEUTIC C ATEGORIES BY S USPECT RECORDS

13. ©2014 F ALSIFIED A NTIBIOTICS BY API FOCUS ON AMOXICILLIN DISTRIBUTION BY REGION

14. ©2014 P ATIENT H ARM

15. ©2014 CLASSIFICATION PRODUCT RECORDS

16. ©2014 Criteria for WHO Medical Product Alert (Drug Alert) Extended geographic risk Extended geographic risk Significant threat to public health Product in recent circulation Validated Report (eg. Lab analysis) Validated Report (eg. Lab analysis)

17. ©2014 G LOBAL V ULNERABILITIES Pharmacists and hospitals purchase products from unlicensed sources Poor procurement practice Unregulated supply chains Stock shortages and Storage difficulties Price differentials Lack of awareness Difficult access to quality and safe products Lack of deterrents Porous Borders High levels of corruption Lack of effective law and criminal justice system

18. ©2014 Prevention, Detection and Response

19. ©2014 Collaboration is the key! Thank you