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) 3 Presentation title (to edit, click View > Header and Footer)
Harmonisation Activities before 1989 COMECON COMECON Council for Mutual Econom ic Assistance Council for Mutual Econom ic Assistance BULGARI A BULGARI A WHO 4 Presentation title (to edit, click View > Header and Footer)
9 Novem ber 1 9 8 9 5 Presentation title (to edit, click View > Header and Footer)
European borders between CEE and EU were removed but divergences appeared Estonia Estonia Latvia Latvia Lithuania Lithuania Poland Poland Czech . Rep Rep Czech Slovakia Slovakia Hungary Hungary Slovenia Slovenia Romania Romania Bulgaria Bulgaria 6 Presentation title (to edit, click View > Header and Footer)
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 7 Presentation title (to edit, click View > Header and Footer)
PHARE BG Project 1993-1996 Targets • Capacity building • Institutional building • Implementation of A.C. in national pharmaceutical law 8 Presentation title (to edit, click View > Header and Footer)
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 9 Presentation title (to edit, click View > Header and Footer)
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 of Drugs into Natl. regulatory body = Agency • Implementation of EU regulatory requirements in dossier assessment (Q+ S+ E), GMP, GCP, GLP, GDP, Pharmacovigilance, Telematics, etc. 10 Presentation title (to edit, click View > Header and Footer)
Harm onization Activities after 1 9 9 7 CADREAC PERF EU EU Sofia, 1997 1999 I CH I CH BULGARI A BULGARI A Bulgaria Bulgaria Czech Republic Czech Republic Cyprus Estonia Estonia Hungary Hungary Latvia Latvia Lithuania Lithuania Poland Poland Romania WHO Romania Slovakia Slovakia Slovenia Slovenia Russia* Turkey* Ukraine* Belarus* * - Observers 11 Presentation title (to edit, click View > Header and Footer)
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 12 Presentation title (to edit, click View > Header and Footer)
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 13 Presentation title (to edit, click View > Header and Footer)
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 14 Presentation title (to edit, click View > Header and Footer)
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 15 Presentation title (to edit, click View > Header and Footer)
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) 16 Presentation title (to edit, click View > Header and Footer)
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 17 Presentation title (to edit, click View > Header and Footer)
Bulgarian Drug Agency I nst. f. State I nst. f. State Control of Drugs Control of Drugs 18 Presentation title (to edit, click View > Header and Footer)
Bulgarian Drug Market 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) 700 EUR 624 millions 600 533 492 500 468 390 367 400 400 369 332 320 313 300 293 240 256 210 200 193 118 115 78 68 100 100 56 92 50 46 65 54 45 42 39 0 2001 2002 2003 2004 2005 Source: BDA/ABPhM 19 Presentation title (to edit, click View > Header and Footer)
Pressure on Health Care Budget EU-15, EUR per capita, 1600 Gap in Health EU-15 New EU-10 Care Bulgaria Budget New EU-10, EUR per capita, 400 Bulgaria, EUR per capita, 150 EUR per capita 20 Presentation title (to edit, click View > Header and Footer)
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 21 Presentation title (to edit, click View > Header and Footer)
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 22 Presentation title (to edit, click View > Header and Footer)
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, optimized and prioritized • New generic molecules were developed or in- sourced from attractive suppliers 23 Presentation title (to edit, click View > Header and Footer)
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 24 Presentation title (to edit, click View > Header and Footer)
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 25 Presentation title (to edit, click View > Header and Footer)
Outcom es for the Local I ndustry • 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 • 26 Presentation title (to edit, click View > Header and Footer)
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