BARRIERS TO GENERICS IN CENTRAL&EASTERN
EUROPE
SPRING GOMBE
HEALTH ACTION INTERNATIONAL-EUROPE
THE CEE COUNTRIESCENTRAL 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)
THE CEE COUNTRIES
EU ACCESSION COUNTRIES & RUSSIA
MEDIUM INCOME
CIS-7 COUNTRIES, BALTIC COUNTRIES, THE UKRAINE
LOW INCOME
THE EU ACCESSION COUNTRIES
BULGARIACZECH REPUBLIC
HUNGARYPOLAND
ROMANIASLOVAKIA SLOVENIAESTONIALATVIA
LITHUANIA
GENERICS: EXTERNAL ISSUESACCESS
Interpretation of Multilateral trade and IP agreements:
WTO - TRIPS WIPO – Patent Treaties
The associated pressures:EU ACCESSION
BILATERAL AGREEMENTS WITH USA
GENERICS: INTERNAL ISSUES
QUALITY STANDARD– chemical equivalence & bioequivalence– WHO prequalification
ACCEPTANCE– Professional and public awareness,
education
PRICE
INFRASTRUCTURE
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…”
GENERICS: OUTSTANDING ISSUES
•EU, USA want to exclude CEE countries from resolution of Doha issues
GENERICS: INTERNAL ISSUES
QUALITY STANDARD– chemical equivalence &
bioequivalence– WHO prequalification
INFRASTRUCTUREPRICE ACCEPTANCE
– Professional and public awareness, education
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
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
INFRASTRUCTURE: RATIONAL DRUG USE
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?
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
INFRASTRUCTURE: TRAINING AND
PROFESSIONALISM
GENERICS:PRICE: IMPORT TARIFFS
• Monetary Tariffs– essential drugs should be exempt
from import taxes
• Restrictions– essential drugs should be exempt
from import restrictions
Infrastructure: Regulation
• What?– Professions – Drug registration– Quality– Import
• How?– public awareness– political will
INFRASTRUCTURE: REGULATION
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
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
INFRASTRUCTURE: MEDICINE EXPENDITURE
0
50
100
150
200
250
300
High Low
Western EuropeCCEENIS
Expenditure per person in US $source: The European Health Report, WHO
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
INTERPRETATION WTO TRIPS ISSUES
MULTILATERAL TREATIES - THE EU
Data exclusivity - TRIPS 39.3
Data exclusivity vs. Bolar exception
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
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
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
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
• 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
•Registration of generics allowed as long as testing is done outside EU member states – will push generic industry right out
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
• 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
WIPO
WIPO’s assessment of its role
TRIPs+ advice
Patent Law Treaty Conditions
Entry into effect (ratification by10 of 177 member countries)
OTHER ISSUES
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
OTHER ISSUES: INDUSTRY
Continued use of delaying tactics
Litigation Reformulation New isomeric formsChange in manufacturing process
Anticompetitive practicesown genericscosy voluntary licensing
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
• 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
SPECIFICSLobby 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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