Phasing-in issues in Marketing authorizations Lithuanian - - PowerPoint PPT Presentation

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phasing in issues in marketing authorizations lithuanian
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Phasing-in issues in Marketing authorizations Lithuanian - - PowerPoint PPT Presentation

Oct 18, 2023 1.4k likes •1.69k views

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

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“Phasing-in” issues in Marketing authorizations – Lithuanian perspectives

Romaldas Maciulaitis and Gintautas Barcys State Medicines Control Agency

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 2

Topics

  • Introduction of Lithuanian national competent

authority SMCA

  • Challenges in implementation of ACQUIS
  • Lessons learned
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 3

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)

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 4

5000 10000 15000 20000 25000 30000 35000 40000 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

EU15: ~27’000 UK: ~25’000 LT: ~8’000 EU15: ~23’000 UK: ~27’000 LT: ~3’500

Eurostat 2010

~ 7x ~ 3x

GDP per capita evolution in LT and EU ( € )

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 5

Populations and em ployees per Agencies

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 6 7,1 7,3 9,1 10,2 7,8 5,9 2 4 6 8 10 12 2005 2006 2007 2008 2009 2010

Metai

Suma, mln. Lt

Budgetary Conditions of the Agency

Years Total Budget (in Mln Litas; 1 Euro = 3.45 Lt)

↑80% of Incomes are from MA

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 7

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

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 8

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

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 9

Lietuvos Centrinių vaistų registracijų evoliucija

1991 2004 2006/7 2010/11

1 Lithuanian CRP (Advagraf) Start of EC & CHMP First constant annual European Contracts and incomes Foreseen constant European Contracts and incomes

  • f 2-5 CRP maintenance

CADREAC & PERF Lithuanian Pharmoclogy Committee First competitive European Contracts and incomes

1997

2 Lithuanian CRP (Modigraf) Confirmed 6th and 7th Lithuanian CRP (Renal area, 2nd Rap) Started 5th Lithuania CRP (Antiemetic – 1st Rap) Current 3 ir 4 Lithuanian CRP (Transplantation and Renal area)

Agency in EU Fram ew ork

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 10

10

Total num ber of m em bers and alternates 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

Count of m em bers and alternates in the CHMP and W Ps

45 37 34 34 29 23 18 18 18 18 15 14 14 14 14 12 11 11 10 10 10 10 10 9 9 7 4 5 10 15 20 25 30 35 40 45 50 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 Total of members and alternates

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 11

Concept papers / Guidelines developed by the CHMP in 2 0 0 7

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 12

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

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 13

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 Valstybinė visuomenės sveikatos priežiūros tarnyba prie Sveikatos apsaugos ministerijos (VVSPT) informuoja, kad nuo š. m. liepos 1 dienos validoliu prekiaujama kaip maisto papildu. VVSPT atkreipia dėmesį 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. Valstybinė vaistų kontrolės tarnyba atsisakė jį registruoti kaip vaistą, nes nėra įrodyta, kad jis padėtų sergant kokia nors liga. 2004-aisiais validolis buvo įtrauktas į medicininės paskirties produktų sąrašą, kuris š. m. liepos 1 dieną panaikintas. Ilgą laiką validolis vartotas esant širdies veiklos sutrikimams.

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 14

I ron products Food supplem ent Medicinal product

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 15

I m pact on National MA procedures

Dramatically changed profile

  • f procedures:
  • decrease in NRPs
  • constant increase in

MRP/ DCP

  • introduction of CRPs

Evolution of Marketing Autorisations in Lithuania (including all strengths and forms)

1000 2000 3000 4000 5000 6000 2004 2010 Post Accession MRP/DCP Post Accession NRP Pre Accession NRP

2 0 0 4 -0 4 -3 0 2 0 1 0 -1 1 -0 1 4 7 9 3

4 6 0 1

2 0 1 7 1 4 4 2 4 4 0

Evolution of MA in Lithuania ( including all strengths and form s) NRP NRP MRP DCP

New NRP

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 16

~ 30 %

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 17

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

Availability problem s used to be observed

  • nce upon a tim e….
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 18

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

Em ployed solutions to availability problem s in Lithuania

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 19

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

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 20

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…

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 21

Mano galva, nuolatinė nepriklausomos Lietuvos vyriausybių ir VVKT administravimo kaita neleido suformuoti ilgalaikės strategijos ekspertų kompetencijos ir motyvacijos atžvilgiu

1 0 . Do not m iss opportunity to build / negotiate the Strategy on NCA Evolution

Stabilization In EU

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 22

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

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 23

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…

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 24

1 0 . Arrange consultations w ithin a EU regulatory fram ew ork

Thus, You are welcome to meet the experts of The State Medicines Control Agency GintautasBarcys@vvkt.lt RomaldasMaciulaitis@vvkt.lt

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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 25

Conclusions

  • Small NCA will not necessary get smaller
  • Learn from mistakes of others
  • Invest into local competences and explore EU
  • pportunities
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 26

Special thanks to:

  • Dr Sif Ormarsdóttir, Islandic MCA, CHMP London
  • Dr Truus (G.M.) Janse-de Hoog, Chair CMD (h), London
  • Dr Daniel Brasseur, Former Chair of CHMP, London
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Maciulaitis & Barcys Lithuanian Challenges during Phasing-In 27

Let’s do all to m eet in EU Thank you