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


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


THE EU ACCESSION COUNTRIES: THE EU ACCESSION COUNTRIES CZECH REPUBLIC HUNGARY POLAND SLOVAKIA SLOVENIA ESTONIA LATVIA LITHUANIA


GENERICS: EXTERNAL ISSUES: 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


GENERICS: INTERNAL ISSUES: GENERICS: INTERNAL ISSUES QUALITY STANDARD LOCAL PRODUCTION vs IMPORT ACCEPTANCE PRICE INFRASTRUCTURE


GENERICS: OUTSTANDING ISSUES: 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…”


INTERNAL BARRIERS : INTERNAL BARRIERS


Infrastructure: Rational Drug Use: Infrastructure: Rational Drug Use RATIONAL DRUG USE PROCUREMENT TRAINING AND PROFESSIONALISM REGULATION INFRASTRUCTURE


PRICE: PRICE IMPORT TARIFFS Monetary Tariffs : essential drugs should be exempt from import taxes RESTRICTIONS essential drugs should be exempt from import restrictions 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 professional fee, not margins REGULATORY FEES Registration, Quality Tests and Professional


INTERPRETATION WTO TRIPS ISSUES : INTERPRETATION WTO TRIPS ISSUES


DOHA OUTSTANDING ISSUES: DOHA OUTSTANDING ISSUES EU, USA want to exclude CEE countries from resolution of Doha issues


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


DATA EXCLUSIVITY: 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.


DATA EXCLUSIVITY: 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).


DATA EXCLUSIVITY: 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.


MULTILATERAL TREATIES - THE EU: 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)


MULTILATERAL TREATIES - THE EU: 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


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


BILATERAL TREATIES - THE USA: 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


PROPRIETARY INDUSTRY: 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


INTERPRETATION WIPO ISSUES : INTERPRETATION WIPO ISSUES


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


OTHER ISSUES : OTHER ISSUES


OTHER ISSUES - THE EU: OTHER ISSUES - THE EU Exclusivities (formulation, uses, etc...) Patent “evergreening” and non uniform extensions Lengthy and complex authorisation system for generics Absence of a true pan-EU Registration system for generics


OTHER ISSUES - THE USA: OTHER ISSUES - THE USA


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


BEHIND IT ALL: 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’


ACTIVISTS’ ROLES: 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


SPECIFICS: 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


MORE INFORMATION? HAI WEBSITEWWW.HAIWEB.ORG: MORE INFORMATION? HAI WEBSITE WWW.HAIWEB.ORG