“Phasing-in” issues in Marketing authorizations – Lithuanian perspectives Romaldas Maciulaitis and Gintautas Barcys State Medicines Control Agency
Topics • Introduction of Lithuanian national competent authority SMCA • Challenges in implementation of ACQUIS • Lessons learned 2 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Lithuanian NCA: Sm all Agency in a Sm all Country Population (in millions): from 3.7 (in 1990) to ~ 3.3 (in 2010) Monthly salaries (netto): from ~ $100 (in 1995) to ~ $1000 (in 2010) 3 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
GDP per capita evolution in LT and EU ( € ) 40000 UK: ~27’000 35000 EU15: ~27’000 EU15: ~23’000 30000 UK: ~25’000 25000 ~ 7x 20000 ~ 3x 15000 10000 LT: ~3’500 LT: ~8’000 5000 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 United Kingdom Germany (including ex-GDR from 1991) European Union (27 countries) European Union (15 countries) Italy Greece Portugal Slovenia Poland Lithuania 4 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In Eurostat 2010
Populations and em ployees per Agencies 5 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 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 • 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
Lietuvos Centrini ų vaist ų registracij ų evoliucija Confirmed 6 th and 7th Lithuanian Agency in EU Fram ew ork CRP ( Renal area, 2 nd Rap ) CADREAC 1 Lithuanian Current 3 ir 4 Lithuanian & CRP CRP PERF ( Advagraf ) ( Transplantation and Renal area ) Lithuanian Pharmoclogy Start of 2 Lithuanian CRP Committee EC & CHMP ( Modigraf ) Started 5th Lithuania CRP ( Antiemetic – 1 st Rap ) 1991 2004 2006/7 2010/11 1997 Foreseen First constant European constant Contracts First annual and incomes competitive European of 2-5 CRP maintenance European Contracts Contracts and incomes and incomes 9 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Count of m em bers and alternates in the CHMP and W Ps Total num ber of m em bers and alternates 50 45 45 40 37 Total of members and alternates 34 34 35 29 30 23 25 18 18 18 18 20 15 14 14 14 14 15 12 11 11 10 10 10 10 10 9 9 10 7 4 5 0 DE UK BE NL FR IT SE ES NO FI HU DK IE EL AT PT IS CZ EE CY SL PL MT LV LU SK LT Country Note: CHMP, BW P, BPW P, EW P, GTW P, QW P, PEG, PgW P, PhVG, SW P, SAW P, VW P, BMW P, CPW P 10 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 10
Concept papers / Guidelines developed by the CHMP in 2 0 0 7 11 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 • Authorization of ex-concertation type of products • Availability problems, including limited consistency in supplies to pharmacies 12 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. 13 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Food supplem ent I ron Medicinal products product 14 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 15 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
~ 30 % 16 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 with 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 17 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 18 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Lessons learned: 1 0 “DON’Ts” (1) Do not mix regulatory pharma science with economic politics (2) Do not limit NCA to national competences only (3) Do not spend too much on not essential activities (4) Do not just simply copy CRP practices for NRP purposes (5) Do not delegate national expert(s) to EMA without clear objectives 19 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Lessons learned: 1 0 “DON’Ts” (6) Do not experiment in key areas (7) Do not assume that applicants know always what they are doing (8) Do not intent to be ideal everywhere from the very beginning (9) Learn how to translate scientific judgment into legal language (10) and… 20 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
1 0 . Do not m iss opportunity to build / Mano galva, nuolatin ė nepriklausomos Lietuvos vyriausybi ų ir VVKT administravimo kaita neleido negotiate the Strategy on NCA Evolution suformuoti ilgalaik ė s strategijos ekspert ų kompetencijos ir motyvacijos atžvilgiu Stabilization In EU 21 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Lessons learned: 1 0 “DOs” (1) Strategic positioning of NCA in Big EU (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 worksharing opportunities of EU regulatory framework 22 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
Lessons learned: 1 0 “DOs” (6) Start contributing to EU network asap (7) Employ regional initiatives (multilingual packages) (8) Initiate pro-active agreements with other stakeholders, including the applicants (9) Select 4 – 5 persons for key areas and motivate them to do long-term commitments (10) and… 23 Maciulaitis & Barcys Lithuanian Challenges during Phasing-In
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