Collaboration among the regulatory authorities in the EU: a micro-agency s perspective Alar Irs, Estonia
EU? 27 countries 23 languages 497 198 740 citizens GDP per capita: $28,213.00
EU? Member states (MS) of 0,4 to 82 million GDP per capita EUR PPP 10 000 64 000 Close collaboration with EEA countries Austria Belgium Bulgaria Cyprus The Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta The Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden The United Kingdom
Medicines in EU EU was not formed to take care of health, rather to foster coal and steel trade Medicines have been regulated at the EU level as goods, not as an aspect of health policy Recent move of the medicines area from the DG Enterprise to the health directorate of the European Commission may or may not make a difference
Some history: EU drug regulation as regional collaboration First EU directive 1965, amended in 1975 and later Several agencies founded/re-shaped around that time Multi-state procedure ( 75) same dossier, 1 initial assessment, CPMP discussions, different outcomes possible, incl indications Concertation procedure ( 87) out of necessity when biologicals appeared in greater number, common decision-making Single market concept, 1985-1992 European central scientific agency, 1993-1995 From 6 to 27 member states, issues of logistics and trust
Big, medium-size and micro-agencies Any national agency with staff <100 in human medicines regulation in European Union is critically small if one tries to keep minimal competence in all major areas of regulation and contribute to the EU network Even if 10 people, still the only agency in the Member State concerned, with important tasks in the national health system, not least the credible mediation of the output of the EU regulatory network to the society
Survival strategies
Estonia? 45 226 km² 1.3 mill people GDP per capita 1993 $PPP 6 000 2009 $PPP 20 000 National drug regulatory authority 1991, 80 staff Joined the EU in 2004 (together with 9 others)
Minimal tasks of a EU national agency Marketing authorisation related assessment Drug information + advertising control Pharmacovigilance Clinical trial oversight GXP inspection OMCL Market control (import + full supply chain) Regulatory and scientific advice and training + other national tasks + possibly cells, tissues, organs
Volume differs, e.g. in the 4th smallest MS: 500 MA applications (+ renewals, ~10 000 variations) ~ 100 ADR reports / million + efforts to this PSURs, safety variations 80-90 clinical trial applications, + amendments Around 20 GMP establishments, incl 4 blood centres 40+ wholesalers, 500 retail outlets Laboratory control, incl non-ma medicines
Collaboration networks in drug regulation Those based on mutual affection, sincere admiration of each others work, love and passion Those driven by dire necessity
Collaboration networks in drug regulation Those based on mutual affection, sincere admiration of each others work, love and passion Those driven by dire necessity
Collaboration networks in drug regulation Those based on mutual affection, sincere admiration of each others work, love and passion Those driven by dire necessity No agreement on (or possibility of) complete centralisation No option to be totally self-standing and not care
EU drug regulatory network Roles and responsibilities legislated: at the EU and national level Gradual enlargement from 6 to 27 MS-s
Whatever you thought you knew about Singapore, there s always a surprise around the corner Lonely Planet Singapore City Guide, 8th ed, 2009
Would be interesting to see what it looks like when ready Whatever you thought you knew about Singapore, there s always a surprise around the corner Lonely Planet Singapore City Guide, 8th ed, 2009
EU drug regulatory network Roles and responsibilities legislated: at the EU and national level Gradual enlargement from 6 to 27 MS-s 40+ national human and veterinary regulatory agencies, huge expert pool Inter-agency co-ordination by Heads of Medicines Agencies (HMA) group 1 central scientific co-ordinating agency
40+ national human and veterinary drug regulatory agencies of <50 >1100 staff, 10 000 in total
Not (entirely) introvert
40+ national human and veterinary drug regulatory agencies of <50 >1100 staff, 10 000 in total
Technical standards Central and decentral marketing authorisation Inspections Training Quality systems IT systems Clinical trials Quality control Sub-regional initiatives Informal help to each other
Technical standards Central and decentral marketing authorisation Inspections Training Quality systems IT systems Clinical trials Quality control Sub-regional initiatives Informal help to each other
Challenges of being small in EU co-operation Inability to contribute badly tolerated Being there is a problem, not being is an even bigger problem around 130 must go meetings per year + at least equal number of very exciting gatherings national agency represents the network in its home country
62 Contribution to the system: decentralised procedures completed 01.01.-30.06.2010 Population, millions 16 6 82 11 9 64 8 1 10 11 0,32 60 38 45 22
Typical thinking pre EU accession From now on everything would be decided at the EU level The national regulatory function would shrink i.e. resources would be saved One insetad discovers that all the available resources will be put to good use and more will be asked for
Some benefits of being part of the network Necessary level of protection of public health ensured even when one needs to entirely rely on others in one or another function Work-load (somewhat) distributes itself Peer review helps to avoid fatal mistakes Friendly punch in the ribs stimulates Scientific help is at hand in a formal or informal way
E.g. authorisation output of a very small EU country 400-500 marketing authorisations annually 10-20% full national assessment, to be possibly recognised by other EU countries 80-90% some form of mutual recognition 1-3 new product (AB, CV) assessments + a few generics for the EU centralised procedure
Strengths, and strengths, of the EU system Greater strengths reasonable common standards + adhered to competence and peer review relative political independence offers reliable protection of public health right weight category to talk to industry industrial interests duely taken into account Lesser strengths unable and sometimes unwilling to deal with diversity of MS-s struggle between ratio and national interests/emotion relative self-centeredness dependence on MS contribution inefficient in many of its functions (effective, but unnecessarily resource consuming): unable to risk the risk-based approach unable to set clear priorities progressively ivory tower
Strengths, and strengths, of the EU system Greater strengths reasonable common standards + adhered to competence and peer review relative political independence offers reliable protection of public health right weight category to talk to industry industrial interests duly taken into account Lesser strengths unable and sometimes unwilling to deal with diversity of MS-s struggle between ration and national interests relative self-centeredness dependence on MS contribution inefficient in many of its functions (effective, but unnecessarily resource consuming): unable to risk the risk-based approach unable to set clear priorities progressively ivory tower
Thank you!