BARRIERS TO GENERICS IN CENTRAL&EASTERN EUROPE

1. BARRIERS TO GENERICS IN CENTRAL&EASTERN EUROPE SPRING GOMBE HEALTH ACTION INTERNATIONAL-EUROPE

2. THE CEE COUNTRIES CENTRAL EUROPE • Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia THE BALTICS • Estonia, Latvia, Lithuania RUSSIA, UKRAINE AND THE NIS • Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyz Republic, Moldova, Tajikistan, Turkmenistan, Uzbekistan (the CIS-7) + Belarus SOUTHEAST EUROPE • Albania, Bosnia-Herzegovina, FYR Macedonia, FedYR (Serbia/Montenegro)

3. THE CEE COUNTRIES EU ACCESSION COUNTRIES & RUSSIA MEDIUM INCOME CIS-7 COUNTRIES, BALTIC COUNTRIES, THE UKRAINE LOW INCOME

4. THE EU ACCESSION COUNTRIES BULGARIA CZECH REPUBLIC HUNGARY POLAND ROMANIA SLOVAKIA SLOVENIA ESTONIA LATVIA LITHUANIA

6. GENERICS: EXTERNAL ISSUES ACCESS Interpretation of Multilateral trade and IP agreements: WTO - TRIPS WIPO – Patent Treaties The associated pressures: EU ACCESSION BILATERAL AGREEMENTS WITH USA

7. GENERICS: INTERNAL ISSUES QUALITY STANDARD • chemical equivalence & bioequivalence • WHO prequalification ACCEPTANCE • Professional and public awareness, education PRICE INFRASTRUCTURE

8. GENERICS: OUTSTANDING ISSUES • December TRIPS Council Meeting • Resolve par. 6 of Doha, “We recognise that WTO Members with insufficient or no manufacturing capacities … could face difficulties in making effective use of compulsory licensing…”

9. GENERICS: OUTSTANDING ISSUES • EU, USA want to exclude CEE countries from resolution of Doha issues

10. GENERICS: INTERNAL ISSUES QUALITY STANDARD • chemical equivalence & bioequivalence • WHO prequalification INFRASTRUCTURE PRICE ACCEPTANCE • Professional and public awareness, education

11. GENERICS: QUALITYLOCAL PRODUCTION vs IMPORT • Theoretically no difference • medicines produced in Hungary vs medicines produced in India • Need good regulatory processes • Local production needs economies of scale & large-scale investment • need to determine if this is the best use of limited healthcare resources

12. Infrastructure: Rational Drug Use INFRASTRUCTURE: RATIONAL DRUG USE • Right medicine for the right condition for a specific patient based on evidence • evidence comes from literature, not from folklore, empirical experience • Post-marketing surveillance – not enough to fight for early registration of products. Need good patient-inclusive monitoring systems for side-effects, including feedback with good information

13. INFRASTRUCTURE: PROCUREMENT & DELIVERY • Medications (incl. ARVs) should be part of a well-run system (not parallel) • Procurement should be rationalised • NOT donations, private systems, unreliable sources • Delivery should be through a sustainable, context-appropriate system • specialised centres? • health clinics? • general practitioners?

14. INFRASTRUCTURE: TRAINING AND PROFESSIONALISM Infrastructure: Training & Professionalism • Healthcare workers need training • technical: how to treat • attitudes: acceptance & integration • Healthcare workers need to be compensated properly for the work they do • incentive • prevent “brain drain” • prevent corruption

15. GENERICS:PRICE: IMPORT TARIFFS • Monetary Tariffs • essential drugs should be exempt from import taxes • Restrictions • essential drugs should be exempt from import restrictions

16. INFRASTRUCTURE: REGULATION Infrastructure: Regulation • What? • Professions • Drug registration • Quality • Import • How? • public awareness • political will

17. GENERICS:PRICE: SALES TAX AND MARGINS • Sales Tax • some governments charge VAT on medicines • make no distinction between essential medicines and others • can add up to 20% more to the cost • Margins • pharmacies should charge a flat fee, not margins

18. GENERICS:PRICE: REGULATORY FEES • Registration • Regulatory agencies should be able to charge a fair price for their services • Annual registration fees are unnecessary and simply increase prices • Quality • no need to repeat quality tests already performed by recognised agencies • Professionals • unnecessary registration fees should be avoided • entry to professions should be based on competence

19. INFRASTRUCTURE: MEDICINE EXPENDITURE Expenditure per person in US $source: The European Health Report, WHO

20. GENERICS: EXTERNAL ISSUES ACCESS • Interpretation of Multilateral Trade and IP agreements: • WTO TRIPS • WIPO Patent Treaties • The associated pressures: • EU ACCESSION • BILATERAL AGREEMENTS WITH USA

21. INTERPRETATION WTO TRIPS ISSUES

22. MULTILATERAL TREATIES - THE EU • Data exclusivity - TRIPS 39.3 • Data exclusivity vs. Bolar exception

23. DATA EXCLUSIVITY Data Exclusivity guarantees market protection for branded pharmaceuticals by preventing health authorities, during a given period (6 or 10 years), from accepting applications for generic medicines.

24. DATA EXCLUSIVITY The effective period of market protection is the given period of data exclusivity plus the period to register and market the generic medicine (i.e. a further 2-3 years).

25. DATA EXCLUSIVITY Ten-year periods of data exclusivity are in operation in eight EU countries: [Belgium, France, Italy, Germany, Netherlands, Sweden and UK]. Ten-year period of data exclusivity is granted for all approvals under the Centralised Procedure.

26. MULTILATERAL TREATIES - THE EU The European Commission proposes to • Extend overall periods of exclusivity to up to 11 years, potentially preventing the marketing of generics until well after the expiry of the patent; • Eliminate the right to prevent the data exclusivity from running beyond the patent • Further increase extension provision by allowing already patent protected second indications to be used as a justification for adding one year to the first indication, the 10+1 (11-year)

27. MULTILATERAL TREATIES - THE EU • Further increase extension provision by allowing already patent protected second indications to be used as a justification for adding one year to the first indication, the 10+1 (11-year) • Use the Bolar exception as a ‘balance’ for data exclusivity

28. MULTILATERAL TREATIES - THE EU • Registration of generics allowed as long as testing is done outside EU member states – will push generic industry right out

29. BILATERAL TREATIES - THE USA • Change in International Development Policy • The New USAID • Expenditure on WTO Agreements • SEGIR Indefinite Quantity Contracts • The experts used • Pressure for strong data exclusivity provisions • The use of threat – Special 301 – Sanction can be based on TRIPS+ provisions

30. PROPRIETARY INDUSTRY • Corruption of US and EU Policy spreads rapidly • Disproportionate Influence • Ever-expanding involvement in development policy • Examples SEGIR Consortia USA • UK Diplomatic Corps

31. INTERPRETATION WIPO ISSUES

32. WIPO WIPO’s assessment of its role TRIPs+ advice Patent Law Treaty Conditions Entry into effect (ratification by 10 of 177 member countries)

33. OTHER ISSUES

34. OTHER ISSUES - THE EU • Other exclusivities (formulation, uses, etc...) • Strategic changes and uncertainties of reference products • Patent “evergreening” and non uniform extensions • Lengthy and complex authorisation system for generics • Absence of a true pan-EU Registration system for generics

35. OTHER ISSUES: INDUSTRY Continued use of delaying tactics Litigation  Reformulation  New isomeric forms Change in manufacturing process Anticompetitive practices own generics cosy voluntary licensing

36. BEHIND IT ALL CIVIL SOCIETY • weak, unable to demand that government adequately regulate industry, and respond to societal needs • Very technical issues - unaware of problems • disperse, unfamiliar with lobbying • ‘that won’t work here’

37. ACTIVISTS’ ROLES • Fight for Access WITHIN an operational system • fight to address both immediate and system problems • Unite with consumer groups/ networks • especially those with a health focus • Practice enlightened self-interest

38. SPECIFICS Lobby for • more funding in health care • equity based insurance schemes • effective and independent regulation of professions / pharmaceuticals • for use of generics and against counterfeits (differentiate between the two) • health-positive interpretation of patent laws (including TRIPS) • appropriate development assistance

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