International Medical Products Anti-CounterfeitingTaskforce

Map of Seychelles

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

Introduction Cont., The total area of Seychelles islands are 175 square miles (453 square km)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.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 educationSchool system is free for the nine year of primary and secondary education

Health System Health is freeHealth is free Seven private doctors with dispensing facilitiesSeven private doctors with dispensing facilities Four private pharmacies and few health care shopsFour private pharmacies and few health care shops Majority of medicines are distributed by Government pharmaciesMajority 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)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 2001The NDQCL was established in 2001

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

In the past years there were no seizure of counterfeit medicinesIn 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 WHOs Rapid Alert System Definition of counterfeit medical product used in Seychelles

Seychelles Pharmacy Act is outdatedSeychelles Pharmacy Act is outdated Currently we are in the process of getting the WHOs consultants to review the National Medicine Legislation and Regulatory FrameworkCurrently we are in the process of getting the WHOs 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 CMIn 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 Our National Legislation

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

Free Trade Zone In Seychelles the free trade zone is only for export marketIn 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 frequentlyThe 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 zoneThe National Pharmaceutical Legislations is applicable for the free trade zone In 2008, there were two pharmaceutical inspections carried outIn 2008, there were two pharmaceutical inspections carried out

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

Number of cases SuspectedConfirmedImported / DomesticVital Medicines How where these cases detected? number of cases Patients complaints Health professionals reports Enforcement/investigation work Routine checks Reported by affected manufacturer/importer Other

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