Ensuring generic competition for effective price reduction in Ukraine Olga Stefanyshyna

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

2. Charitable Foundation «Patients of Ukraine»

3. What we do? • OUR MISSION - • TREATMENT IS AVAIBLE FOR ALL • 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

4. 10 years dynamics • Number of patients on treatment

5. 10 years dynamics • Cost of treatment, $ USD

6. 10 years dynamics: people&prices

7. 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 decreasesprice for Combivir to 1300 USD/patient/year

8. 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

9. 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

10. EFV case • 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 • Tough talk of PLHIV community and Merck

11. 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.

12. Tenofovir/Emtricitabine case • First negotiations with Gilead on TDF access pricing have been started in 2007 • Ukrainian activists managed to get access price of 324USD/patient/year(GFATM only) • Treatment activists provided technical assistance to Truvada registration in Ukraine • Immediately started to work on access to pre-qualified generic versions

13. Tenofovir/Emtricitabine case • In 2013 price increased to 540USD/year • Government procures generic versions on 243USD/year • Our goal is to get optimal price of pre-qualified generics/CHAI of 76USD/year

14. 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

15. Active position of patient organizations ensures • Lobbying for increased national funding for treatment • Negotiations with the BigPharma to reduce the cost of ARVs and/or for voluntary licening • Lobbying for registration of generics

16. 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

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

18. www.patients.org.ua