Fee system of the European Medicines Agency Ensuring long-term - - PowerPoint PPT Presentation

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Fee system of the European Medicines Agency Ensuring long-term - - PowerPoint PPT Presentation

Apr 25, 2023 44 likes •289 views

Fee system of the European Medicines Agency Ensuring long-term sustainability Presented by: Ulrike Nagl On behalf of the Project Team An agency of the European Union Scope of the presentation To present the reasons for changing the

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An agency of the European Union

Presented by: Ulrike Nagl On behalf of the Project Team

Fee system of the European Medicines Agency

Ensuring long-term sustainability

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  • To present the reasons for changing the current

fee system

  • To propose a model which takes account the
  • bjectives identified by the EMA
  • To discuss the objectives for a future fee

system

Scope of the presentation

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Drivers for change Drivers for change

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  • 1. Result of Ernst & Young Evaluation on fees
  • 2. Fee regulation requires evaluation of its

implementation

  • 3. Recent and anticipated changes in

legislative and regulatory environment

Drivers for change Drivers for change

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  • Stakeholders recognise the economic interest of

centralised procedure

  • Overall the fees compare favourably with other

regulatory agencies

  • EMA’s income is vulnerability due to its high

dependency on fees from applications

  • 1. Result of Ernst & Young Evaluation on

fees

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  • Stakeholders consider that:

– Fee structure could be simplified – Certain applicants and product groups require special attention

  • Sustainability of resources from the European

network questioned as certain procedures are currently non-fee attracting

  • 1. Result of Ernst & Young Evaluation on

fees (cont.)

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The 3rd paragraph of Article 12 states: “By 24 November 2010, the Commission shall present a report on its [ the Fee Regulations] implementation to the Council … ”

  • 2. Fee regulation requires evaluation of

implementation

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  • New tasks resulting from changes in

pharmaceutical legislation since 2005

  • Legislative proposals under discussion include

introduction of new types of fees

  • 3. Recent and anticipated changes in

legislative and regulatory environment

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  • 3. Recent and anticipated changes in

legislative and regulatory environment (cont.)

2 0 0 4

Revision of Founding Regulation EU enlargement 15 + 10

2 0 0 5

I nvestigational Medicinal Products Directive

Revision of Fee Regulation

SME Regulation

2 0 0 6

Conditional MA Regulation Paediatric Regulation

2 0 0 7 2 0 0 8

Financial Penalties Regulation Advanced Therapies Regulation EU enlargement 25 + 2

2 0 0 9

Variations Regulation MRL Regulation Certification

  • f ATMP

“Pharm a package” Future EU enlargement

…

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EMA’s reflection on current fee system

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  • Overall fees and EU contribution finance EMA’s

activities

  • Balance between fee and level of service for certain

activities no longer provided

  • Complexity of fees has increased over the years

leading to high administrative burden for the pharmaceutical industry, NCAs and EMA (currently 131 different types of fees)

  • Limited flexibility in introducing and adapting fees

to a changing legislative and regulatory environment

EMA’s reflection on current fee system

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EMA’s reflection on current fee system (cont.)

Medicinal products for hum an use

PI P/ deferral PI P/ deferral Scientific advice Scientific advice Eligibility & nam e review Eligibility & nam e review Assessm ent W orking party contribution SAG I nspection Assessm ent W orking party contribution SAG I nspection Re- exam ination SAG Re- exam ination SAG SME status SME status Designation Designation Review of designation Review of designation Classification recom m endation Classification recom m endation SME applicants Orphan products Advanced therapy products Paediatric…...Advice……Pre-subm ission……Evaluation…… Paediatric…...Advice……Pre-subm ission……Evaluation…… CAT draft

  • pinion

CAT draft

  • pinion

I ncreasing com plexity and cost

  • f procedures

I ncrease in fee incentives and w aivers I ncreasing com plexity and cost

  • f procedures

I ncrease in fee incentives and w aivers Certification

  • f data ( for

SMEs) Certification

  • f data ( for

SMEs) Protocol assistance Protocol assistance

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Model – overall concept

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  • To allow compensation for services provided by

the NCAs, including for those that are currently not remunerated

  • To maintain lower fee levels and incentives for

certain types of applicants and products

  • To allow cost of future additional activities to be

incorporated

  • To simplify the EMA’s fee structure

Model – overall concept

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Certificates Com passionate Use ( H)

Proposed model Proposed model Current model Current model

Annual Fee Transfer Renew al Post - I nspection Type I Variation Type I I Variation Parallel Distribution Medical Device Consultation ( H) VAMF ( H) PMF ( H) Article 5 8 Opinion ( H) Herbals ( H) Paediatric Article 2 9 ( H) Article 5 8 Opinion ( H) Referral Extension of MA Com passionate Use ( H) Paediatric Article 2 9 ( H) Referral MRL ( V) MRL ( V) Marketing Authorisation Application Pre-I nspection Advanced Therapies Certification Marketing Authorisation Application Scientific Advice

Pre- authorisation Post- authorisation Services Referrals

Parallel Distribution Medical Device Consultation ( H) VAMF ( H) PMF ( H) Herbals ( H) Annual Fee Type I I ( Extension of I ndications) Extension of MA w ith Clinical Data Scientific Advice

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Article 5 8 Opinion ( H) Article 5 8 Opinion ( H) MRL ( V) MRL ( V) Marketing Authorisation Application ( H,V) Marketing Authorisation Application ( H,V) Scientific Advice ( H,V) Pre-I nspection ( H,V)

Pre Pre-

  • authorisation

authorisation

Current model Current model Proposed model Proposed model

Advanced Therapies Certification ( H) Scientific Advice ( H,V)

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Application for Marketing Authorisation Article 13(1), (3), 13c Veterinary medicines Application for Marketing Authorisation Article 10 (1), 10(3), 10c Medicines for human use Additional presentation to MAA (Art. 10(1), 10(3), 10c ..) Additional presentation to MA (Article 13 (1), (3), 13c ..) Additional strength to MA (Article 13 (1), (3), 13c ..) Application for MA (Article 13 (1), (3), 13c ..) Additional presentation to MA (Article 13(4) ..) Additional strength to MA (Article 13(4) ..) Application for MA (Article 13(4) 2001/ 82/ EC) Additional presentation to MAA (full dossier) Additional strength to MAA (full dossier) Application for MA (Full dossier) Consecutive pre-authorisation inspection Pre-authorisation inspection Additional strength to MAA (Art. 10(1), 10(3), 10c ..) Application for MA (Article 10(1), 10(3), 10c ..) Additional presentation to MAA (Article 10(4) ..) Additional strength to MAA (Article 10(4) ..) Application for MA (Article 10(4) 2001/ 83/ EC) Additional presentation to MAA (full dossier) Additional strength to MAA (full dossier) Application for MA (full dossier) Advanced Therapies Certification Consecutive pre-authorisation inspection Pre-authorisation inspection

Current model Proposed model

Application for Marketing Authorisation Article 10 (4) Medicines for human use Application for Marketing Authorisation Article 13(4) Veterinary medicines Application for Marketing Authorisation Full dossier Medicines for human use Application for Marketing Authorisation Full dossier Veterinary medicines

Medicinal products for human use Veterinary medicines

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Objectives for a future fee system Objectives for a future fee system

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  • Ensure sustainability
  • Introduce adaptability
  • Reduce complexity

Objectives for a future fee system

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  • Provide for realistic funding and take account of

all EMA public health responsibilities

  • Compensate for differences in procedures due

to their inherent variability

  • Maintain fee system as major source of income

for EMA

Sustainability

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  • Adaptability to a changing environment

including ongoing or new pharmaceutical legislation

  • Model remains flexible enough to accommodate

different product types

Adaptability

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  • Potential 3-fold-reduction in total number of fee

types:

– Administrative simplification for all involved parties – Increased transparency

  • Simplify fee incentives whilst maintaining
  • verall value of incentives for pharmaceutical

industry

Complexity

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In conclusion …

What do we seek to achieve?

  • A better system for the partners in the network
  • A better system for the pharmaceutical industry
  • A better system for the European Medicines Agency
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Thank you very much for your attention