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BIIB-GEN Meeting August 2009

BIIB-GEN Meeting August 2009. prepared for. about us…. Our Partners. Pr oduct L icensing & B usiness D evelopment - 1. Marketed. P roduct l icensing & B usiness d evelopment - 2. Pipeline. P roduct l icensing & B usiness d evelopment - 2. Pipeline. Offices.

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BIIB-GEN Meeting August 2009

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  1. BIIB-GEN Meeting August 2009

  2. preparedfor

  3. about us…

  4. OurPartners

  5. ProductLicensing & BusinessDevelopment - 1 Marketed

  6. Product licensing & Business development - 2 Pipeline

  7. Product licensing & Business development - 2 Pipeline

  8. Offices

  9. RegulatoryTimeline

  10. RegulatoryTimeline • After the submission of the registration dossier,registration approval will be in 18 to 24 months. • FDA or EMEA files are accepted. • As of January 1st 2006, only CTD format is accepted byTurkish MOH.

  11. Registrationtimelinesandprocedures 2-2,5 years

  12. Pharmaceuticalspricingformula

  13. Pharmaceuticalspricingformula The cheapest ex-factory price (hospital price if ex-factory is not available) in reference countries(France, Italy, Portugal, Spain, Greece) and country of origin will be accepted as Turkish ex-factory price.

  14. Reimbursement

  15. Reimbursement • SGK (SosyalGuvenlikKurumu-Social Security Organisation) is a state controlled organisation which acts independently. Of course has close ties with the MOH and MOF(finance) and MOL (labour). MOH is responsible for registration of pharmaceuticals and SGK is the main body for reimbursement. Almost 2/3 of the population has State controlled social security coverage. Private insurance companies control 3-4% of the population.

  16. Reimbursement For all reimbursed products 24% reimbursement discount is by law. Additional discount may be asked in some cases. Registered products may apply for reimbursement (fully or partly) which is a very difficult process. It takes time and huge effort is necessary.

  17. Reimbursement • MOH, MOF and SGK decides the product to be reimbursed (fully/partly) or not. There may be a indication limitation. Company applies for the reimbursement after getting the registration. If there is any competitor (as a generic) which is already registered, the new product’s reimbursement price must be lower than the competitor’s. If there is a registered therapeutic competitor, than the company should prove that the new product is more efficacious or has less side effects in order to get a higher, same or lower reimbursement price. • Pharmaco-economical data is required.

  18. IP situation& Data protection

  19. IP situation & Data protection • IP situation • Turkey accepted the patent law and there is no generic or biosimilar risk for the patented products until patent expiry. • Data protection • Data protection is not valid in Turkey yet. Expected time for validity in 2011.

  20. ThankYou

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