Transcript Barriers to Generics in Eastern Europe

BARRIERS TO GENERICS IN
CENTRAL&EASTERN EUROPE
SPRING GOMBE
HEALTH ACTION INTERNATIONAL-EUROPE
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)
THE CEE COUNTRIES
EU ACCESSION COUNTRIES & RUSSIA
MEDIUM INCOME
CIS-7 COUNTRIES, BALTIC
COUNTRIES, THE UKRAINE
LOW INCOME
THE EU ACCESSION COUNTRIES
BULGARIA
CZECH REPUBLIC
HUNGARY
POLAND
ROMANIA
SLOVAKIA
SLOVENIA
ESTONIA
LATVIA
LITHUANIA
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
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
INFRASTRUCTURE
PRICE
ACCEPTANCE
– Professional and public awareness,
education
GENERICS: QUALITY
LOCAL 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
INFRASTRUCTURE:
Use
RATIONALDrug
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:
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 &
INFRASTRUCTURE:
TRAINING ANDProfessionalism
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
GENERICS:
PRICE: IMPORT TARIFFS
• Monetary Tariffs
– essential drugs should be exempt from
import taxes
• Restrictions
– essential drugs should be exempt from
import restrictions
INFRASTRUCTURE:
Infrastructure: Regulation
REGULATION
• What?
–
–
–
–
Professions
Drug registration
Quality
Import
• How?
– public awareness
– political will
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
300
250
200
Western Europe
CCEE
NIS
150
100
50
0
High
Low
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 (11year)
• 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 by
10 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 forms
Change in manufacturing process
Anticompetitive practices
own generics
cosy 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
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?
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