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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