Ensuring generic competition for effective price reduction in Ukraine Olga Stefanyshyna Executive director CF «Patients of Ukraine» 24 th of July 2014

Charitable Foundation «Patients of Ukraine»

OUR MISSION - TREATMENT IS AVAIBLE FOR ALL 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

10 years dynamics Number of patients on treatment

10 years dynamics Cost of treatment, $ USD

10 years dynamics: people&prices

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

Access to generic competiton In 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

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 form Merck suggested “reduced price” of 240 USD/year/patient

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

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.

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

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

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

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

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

Our aim The lowest price for upcoming new antiretrovirals in the region of Eastern Europe is in Ukraine!