EU/ EC Acquis caum m unautaire: perspectives from a m em ber state - - PowerPoint PPT Presentation

EU/ EC Acquis caum m unautaire: perspectives from a m em ber state

Jasmina Mircheva, MD PhD

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BG Pharm a Sector before 1 9 8 9

• Fully centralized
• One state owned pharmaceutical holding –

PHARMACHI M (the only BG producer, wholesaler, importer, exporter, distributor of MPs and MDs)

• Institute for State Control of Drugs

(laboratories for analyses + PhVG + Commission for Registration of MPs)

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Harmonisation Activities before 1989

BULGARI A BULGARI A WHO

COMECON COMECON

Council for Mutual Econom ic Assistance Council for Mutual Econom ic Assistance

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9 Novem ber 1 9 8 9

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Bulgaria Bulgaria Romania Romania Hungary Hungary Slovenia Slovenia Czech Czech.Rep Rep Poland Poland Slovakia Slovakia Lithuania Lithuania Latvia Latvia Estonia Estonia

European borders between CEE and EU were removed but divergences

appeared

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Divergences between EU and CEE

• Inadequate political instruments
• Feeble civic culture
• Different institutional and capacity development
• Week administrative capacity
• Incoherence in standards
• Disharmony in regulations and procedures

No influence on the Acquis caummunautaire according to country preferences and action capacities

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PHARE BG Project 1993-1996

Targets

• Capacity building
• Institutional building
• Implementation of A.C. in national

pharmaceutical law

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PHARE BG Project 1993-1996

Instruments

• Study tours to the EU DRAs
• Experts visits from EU DRAs
• Seminars in Bulgaria (with the

industry)

Contributing countries – At, Be, De, Dk, Es, Fi, Fr, Nl, Pt, UK

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PHARE BG Project 1993-1996

Achievem ents

• New Drug Law (1995) + 32 bylaws based on

10 EU directives / ICH guidelines

• Transformation of I nstitute for State Control
• f Drugs into Natl. regulatory body = Agency
• Implementation of EU regulatory requirements

in dossier assessment (Q+ S+ E), GMP, GCP, GLP, GDP, Pharmacovigilance, Telematics, etc.

Presentation title (to edit, click View > Header and Footer) 11 Bulgaria Czech Republic Cyprus Estonia Hungary Latvia Lithuania Poland Romania Slovakia Slovenia Russia* Turkey* Ukraine* Belarus*

Harm onization Activities after 1 9 9 7

EU EU

BULGARI A BULGARI A

WHO I CH I CH

CADREAC

Sofia, 1997

PERF

1999

Bulgaria Czech Republic Estonia Hungary Latvia Lithuania Poland Romania Slovakia Slovenia

* - Observers

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CADREAC

I nitiated in 1 9 9 7 in Sofia and renew ed on 1 May 2 0 0 6

• Simplified EU centralized procedure

introduced for the CADREAC members

• Exchange of safety and pharmacovigilance

data

• Set-up of regulatory networking with MSs

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PERF

Boosted m utual understanding and confidence betw een EU and CEE

• Inter-agency training (joint activities,

exchange of scientific information and staff, attendance at EU regulatory W. Party meetings, case studies)

• Expanded networking between EU/ CEE

Drug Regulatory Authorities

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Achievements

Regulatory environment

• Regulatory system - improved overall

consistency and visibility

• Regulatory standards - open, visible,

predictable and time-controlled

• Regulatory authority – transparent,

efficient, flexible and independent in decision-making

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Achievements

Harmonized Regulatory Practices

• Quality management systems -
• Defined performance indicators
• Transparent cost-effective procedures
• Dossier assessment - high standards + consistent in

methodology and criteria

• Telematics
• secure, sound and reliable network
• usage of appropriate and compatible technology

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BG Drug Law in 2 0 0 3

• Administrative procedure – less burden
• “Competent person”
• Data exclusivity – 10 + 1 yr for new indication
• Test and trials of generic not contrary to patent

rights or to SPC – (Bolar)

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BG Drug Law in 2 0 0 7

• No transition period, no closed doors

– New format of applications – Feb 07 – DMF for API introduced – CTD format for all new submissions and renewals – New registration procedure for national application – CP – all national registrations terminated – CTA format introduced for clinical trials – Bioequivalence – GLP requirements

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Bulgarian Drug Agency

I nst. f. State I nst. f. State Control of Drugs Control of Drugs

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Bulgarian Drug Market

46 50 56 68 78 210 240 313 332 390 320 367 492 533 624 256 293 369 400 468 39 42 45 54 65 193 115 118 100 92 100 200 300 400 500 600 700 2001 2002 2003 2004 2005 Reimbursed BG Drugs (value) Reimbursed Import Drugs (value) Total BG Market (value) Total Subsidized Market (value) Total Import on BG Market (volume) Total Local Drugs (volume)

Source: BDA/ABPhM EUR millions

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Pressure on Health Care Budget

New EU-10, EUR per capita, 400 Bulgaria, EUR per capita, 150 EU-15, EUR per capita, 1600 EUR per capita EU-15 New EU-10 Bulgaria

Gap in Health Care Budget

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Outcom es for the Patients

• Quicker access to new therapeutic alternatives
• Enhance quality of life
• Better for patients information on MP
• Regulatory information – public available
• Compulsory order + readability of PILs
• Braille

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Outcom es for the BG Pharm a Business

• Around 8 0 private

m anufacturers

• Over 3 0 0 private

im porters/ distributors

• Over 4 0 0 0 private

pharm acies

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Local Manufacturers under the EU Regulatory Rules

• Consolidation of the local business - big companies

have become bigger, small ones have disappeared

• Companies’ portfolio have been shortened,
• ptimized and prioritized
• New generic molecules were developed or in-

sourced from attractive suppliers

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Local Manufacturers Managem ent

• Operations management – building new production

facilities and maintaining GMP and other quality assurance standards

• Human resources management – cutting costs and

raising the standard of professional expertise

• Financial management – raising the value for

shareholders

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Other Opportunities

• Geographical expansion & pipeline development

and growth through penetration in new markets, acquisitions at national and above national level, Outsourcing R&D and production

• Cross-licensing and partnerships with EU based

companies

• Community registration procedures

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• Technological modernization

Technological modernization

• Increased technical expertise

Increased technical expertise

• Strengthened competitiveness and

Strengthened competitiveness and research capacity research capacity

• Minimized political pressure

Minimized political pressure

Outcom es for the Local I ndustry