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Ensuring generic competition for effective price reduction in
UkraineOlga StefanyshynaExecutive director CF «Patients of Ukraine»
24th of July 2014
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Charitable Foundation«Patients of Ukraine»
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OUR MISSION - TREATMENT IS AVAIBLE FOR ALL
What we do?
• We unite more than 100 patients organisations from all parts of Ukraine
• We ensure full funding of state treatment programs
• We fight against corruption at in the Ministry of Health
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10 years dynamics
2004 year 2014 year560
56000
•Number of patients on treatment
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10 years dynamics
2004 year 2014 year
10000
100
•Cost of treatment, $ USD
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10 years dynamics: people&prices
2004 year 2014 year
10000 100
560
56000
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Background
• In 2001 the first initiative on price reduction in Ukraine under Accelerated Access Initiative/UNAIDS
• Negotiations with leading originator companies: GSK, BMS, MSD
• GSK decreases price for Combivir to 1300 USD/patient/year
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Access to generic competiton
• In 2003 12 generic ARVs (Cipla and Ranbaxy) registered in Ukraine under MSF-Ukraine initiative
• Competition from the side of pre-qualified ARVs effective price reduction: Combivir price dropped to 154 USD/year/patient
• By 2004 the price for first-line ARV combination in Ukraine became less than 300 USD/ patient/year
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Accessing WTO – new challenge
• 2008 – Ukraine is at risk of loosing its status of “generic country”
• 2010 – Merck sends official letter to GFATM Principal Recipient in Ukraine
STOP EFV generic use and switch to brand formMerck suggested “reduced price” of 240
USD/year/patient
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EFV case
Tough talk of PLHIV community and Merck
• EFV is a key medicine in first-line combination for 90% of patients on ARV in Ukraine
• Both government and Principal Recipient have been using generic EFV since 2003 (96 USD/patient/year)
Risk of treatment interruptions for thousands of ARV patients
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EFV case
• In 2 weeks: official letter from Merck confirming “not to block access to life-saving treatment”.
• The court case has been lasting for a year and Merck office in Ukraine was continuing undercover game.
• “Patients of Ukraine” organized meeting with Merck and demanded written confirmation that court case will be immediately terminated in the presence of media and international community leaders.
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Tenofovir/Emtricitabine case
• Immediately started to work on access to pre-qualified generic versions
• First negotiations with Gilead on TDF access pricing have been started in 2007
• Ukrainian activists managed to get access price of 324 USD/patient/year (GFATM only)
• Treatment activists provided technical assistance to Truvada registration in Ukraine
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Tenofovir/Emtricitabine case
• In 2013 price increased to 540 USD/year
• Government procures generic versions on 243 USD/year
• Our goal is to get optimal price of pre-qualified generics/CHAI of 76 USD/year
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Key factors for the availability of generics in Ukraine
• Developing local ART production
• 90% of generics are registered in Ukraine
• Compulsory licensing is ensured in national legislation of the country
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Active position of patient organizations ensures
• Lobbying for increased national funding for treatment
• Negotiations with the Big Pharma to reduce the cost of ARVs and/or for voluntary licening
• Lobbying for registration of generics
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Key messages
• We should not rest on our achievement and overcome new challenges
• WTO/FTA agreements carry new risks for generic competition
• We should not stop our efforts on ensuring access to innovative, safe and user-friendly medicines
Active role of the patients’ community is a KEY
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Our aim
The lowest price for upcoming new antiretrovirals in the region of Eastern Europe is in Ukraine!
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www.patients.org.ua