Perspectives from a new Mem ber State Accession preparation I Reinforcing patient safety in Europe Romaldas Maciulaitis and Gintautas Barcys State Medicines Control Agency
Topics • Phasing-in Lithuanian national competent authority (SMCA) to EU network • Main safety activities • Lessons learned 2 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Lithuanian NCA: Sm all Agency in a Sm all Country Population (in millions): ~ 3.0 (in 2011) from ~ 3.7 in 1990) Experts’ monthly salaries (netto) ~ $1000 (in 2010) from ~ $100 (in 1995) 3 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Populations and em ployees per Agencies 4 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
State Medicines Control Agency ( SMCA) and regulatory fram ew ork Food Medical Medicines Veterinary ( including inspections) supplem ents devices Accreditation Veterinary SMCA Agency Agency Ministry of Health Lithuanian Governm ent 5 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
SMCA ~ 1 0 0 internal em ployees ~ 1 3 0 before crisis + 8 external contractors + 2 external experts 6 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Challenges during “Phasing-in” and im plem enting ACQUI S ( 1 / 2 ) • Continuously changing ACQUIS – (2 Pharma laws → 1 Consolidated law + Orders) • Challenges with SOPs, deadlines, communication with applicants => Do not intent to be ideal everywhere from the very beginning => Do not just simply copy CRP practices for NRP purposes • Too limited number of priorities from the activities expected by upper government bodies 7 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Challenges during “Phasing-in” and im plem enting ACQUI S ( 2 / 2 ) • Too long time for MA procedures and sometimes just minimal quality in performances • Too big turnover of experts makes additional burdens to keep constant national competence • Need for competence development for active participation in EU regulatory framework 8 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
I m pact on national authorizations • Conversion of numbers of herbal and “medical purpose” products based on revised benefit/ risk assessments • Not-upgraded dossiers => Do not mix regulatory pharma science with economic politics => Do not assume that applicants always know what they are doing => Learn how to translate scientific judgment into legal language • Authorization of “ex-concertation” type of products • Availability problems, including limited consistency in supplies to pharmacies 9 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
After 5 years w e finally confirm ed a status of food supplem ent for popular MP Validolis – ne vaistas, o m aisto papildas 2009-07-21 Valstybin ė visuomen ė s sveikatos prie ž i ū ros tarnyba prie Sveikatos apsaugos ministerijos (VVSPT) informuoja, kad nuo š. m. liepos 1 dienos validoliu prekiaujama kaip maisto papildu. VVSPT atkreipia d ė mes į į tai, kad maisto papildas yra ne vaistas, o maisto produktas, neturintis gydomojo poveikio ir nevartotinas jokioms ligoms gydyti. Lietuvoje validolis nebepriskiriamas vaistams nuo 2003 m. Valstybin ė vaist ų kontrol ė s tarnyba atsisak ė j į registruoti kaip vaist ą , nes n ė ra į rodyta, kad jis pad ė t ų sergant kokia nors liga. 2004-aisiais validolis buvo į trauktas į medicinin ė s paskirties produkt ų s ą raš ą , kuris š. m. liepos 1 dien ą panaikintas. Ilg ą laik ą validolis vartotas esant širdies veiklos sutrikimams. 10 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Food supplem ent I ron Medicinal products product 11 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
I m pact on National MA procedures Evolution of MA in Lithuania Evolution of Marketing Autorisations in Lithuania (including all strengths and forms) ( including all strengths and form s) 6000 Dramatically changed profile of procedures: 5000 4 7 9 3 4 6 0 1 2 0 1 7 4000 - decrease in NRPs Post Accession MRP/DCP MRP 3000 Post Accession NRP DCP - constant increase in Pre Accession NRP 1 4 4 MRP/ DCP 2 4 4 0 New 2000 NRP - introduction of CRPs 1000 NRP NRP 0 2 0 1 0 -1 1 -0 1 2 0 0 4 -0 4 -3 0 2004 2010 12 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Tendencies in procedures Medicinal products in national registry Proportions TOTAL NRP NRP 2007 2008 2009 2010 2007 2008 2009 2010 13 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Tendencies in procedures Authorisations Renewals 14 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Availability problem s used to be observed once upon a tim e…. As a consequence, medicines availability is not always sufficient: the absence of essential ones, such as: • Anticoagulants – heparinum • Hormones – hydrocortisonum • Antibiotics – izoniazidum, amphotericinum, tazocinum • Cardiovasculars – nitroglycerinum, clonidinum, labetololum, prazosinum, norepinephrinum, digoxinum inj., verapamilum inj. • Immunosuppressants: tacrolimus (all formulations) , MMF i/v, ciclosporinum i/v • Other – 40% glucosum, calcium i/v , and various antidotes 15 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Em ployed solutions to availability problem s in Lithuania Different additional measures have to be introduced to overcome the shortages putting with an additional burden to all stakeholders: – Patient named supply chains – Special hospital supply arrangements – Prioritizations in MA procedures, including the for variations 16 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Topics • Phasing-in Lithuanian national competent authority (SMCA) to EU network • Main safety activities – Safe, or not safe: that is a very relative question… like beauty… • Lessons learned 17 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Main regulatory activities for safety • Pre-m arketing safety evaluations • NRP • MRP/ DCP • CRP • Pre-m arketing clinical trials • Post-m arketing safety evaluations • ADR reporting and proceedings • PSUR, including EU W orksharing • PhW system s • DHCP, “Dear Patient” letters, teaching m aterials • Post-m arketing safety trials • Quality inspections in pharm acies 18 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
ADR reporting Serious Total 19 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Applications for Clinical trials 20 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Reports about quality defects ( in 2 0 1 0 ) n= 6 4 Productions in pharmacy 9 (14%) Reports from Labeling 24 (38%) manufacturers 9 (14%) SMCA laboratory reports 55 (86%) Quality defects 22 (34%) 21 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Quality inspections and defects Medicines Extemporal production Pure/Water for injection Active substances n n n n Labeling n Non-compliant 22 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Topics • Phasing-in Lithuanian national competent authority (SMCA) to EU network • Main safety activities • Lessons learned 23 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Lessons learned: 1 0 “DOs” (1)Strategic positioning of NCA in Big EU => Do not limit NCA to national competences only (2) Follow examples of those NCAs that do control flow of their budgets (3) Invest into key national scientific competences (4) Make use of administrative support available from EU, including IT developments ( 5 ) Utilize w orksharing opportunities of EU regulatory fram ew ork 24 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
.. Firstly, negotiate the strategic balance betw een Mano galva, nuolatin ė nepriklausomos Lietuvos vyriausybi ų ir VVKT administravimo kaita neleido national and EU priorities suformuoti ilgalaik ė s strategijos ekspert ų kompetencijos ir motyvacijos atžvilgiu 2 0 1 0 1 5 ( stabilisation in EU) 2 ( + 2 ) Appointm ents 1 4 Governem tns of HoA 1 3 EU 2 0 0 4 1 2 1 1 1 0 2 0 0 0 9 4 ( + 1 ) 8 7 = > Do not 6 5 4 experim ent in key 3 2 1 1 9 9 0 areas 25 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Budgetary Conditions of the Agency 12 ↑ 80% of incomes are from MA 10,2 10 9,1 Total Budget (in Mln Litas; 1 Euro = 3.45 Lt) 7,8 8 7,3 7,1 Suma, mln. Lt 5,9 6 4 2 0 2005 2006 2007 2008 2009 2010 Years Metai 26 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
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