International Medical Products Anti-Counterfeiting Taskforce

1. International Medical Products Anti-Counterfeiting Taskforce

2. Map of Seychelles

3. Introduction • Seychelles consists of about 115 islands situated in the western Indian ocean • The major islands of Seychelles are located 1000 miles (1600 km) east of Kenya • The main islands are Mahe, Praslin and La Digue. The capital is Victoria • Seychelles has a population of about 85000

4. Introduction Cont., • The total area of Seychelles islands are 175 square miles (453 square km) • The climate is tropical oceanic with little temperature variation during the year. Education • School system is free for the nine year of primary and secondary education

5. Health System • Health is free • Seven private doctors with dispensing facilities • Four private pharmacies and few health care shops • Majority of medicines are distributed by Government pharmacies • Medicines imported by Ministry of Health (MOH) are tested during pre-marketing and post marketing surveillance by National Drug Quality Control Laboratory (NDQCL) • The NDQCL was established in 2001

6. Health System Cont., • Medicines imported by MOH are mainly generic items whereas private pharmacies mostly target branded items • MOH buys its medicines directly from the manufacturers for export • There is only one International Air port and most medicines imported by MOH comes via air • Private pharmacies target parallel market • Medicines imported by Private or NGO’s are not tested at NDQCL due to lack of Legislations

7. Definition of counterfeit medical product used in Seychelles • In the past years there were no seizure of counterfeit medicines • No Legislation in place • Inadequate drug registration system • Absence of CM in the country Seychelles is not aware of the WHO’s Rapid Alert System

8. Our National Legislation • Seychelles Pharmacy Act is outdated • Currently we are in the process of getting the WHO’s consultants to review the National Medicine Legislation and Regulatory Framework • In the new Pharmacy Legislations, the following be in cooperated: Definition of CM, Cooperation between national authorities and stake holders, Regional and International cooperation, Strengthening the operational capacity of the medicines regulatory authority, Criminalizing the trade of CM and more severe sanctions for crimes related to CM

9. National coordination • There is a Medicines Regulatory Authority (MRA) unit within the Pharmaceutical Services under the MOH • Only issues permits for private and NGO’s for importing medicines • Inspection of Pharmacy premises together with licensing authority • No registration of medicines • Public sector uses open permit system for importing medicines and its renewed annually • For the year 2007, MRA issued • 655 permits to private sectors • 5 permits to NGO’s

10. Free Trade Zone • In Seychelles the free trade zone is only for export market • The free trade zone are under the supervision of MRA but inadequate human resources makes it difficult to supervise frequently • The National Pharmaceutical Legislations is applicable for the free trade zone • In 2008, there were two pharmaceutical inspections carried out

11. Market Control • In 2007, the total number of samples collected from public sector were 313 • All the 313 samples were tested at NDQCL • There are no informal market for medicines in Seychelles

12. Number of cases How where these cases detected?

13. Conclusion • So far MOH has not encountered with Counterfeit Medicines • Possibly in private sectors counterfeit medicines may exist • Nothing could be done until the National Medicine Legislation and Regulatory Framework is established • Seychelles will support any proposal that will help to combat counterfeit medicines