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 current fee system • To propose a model which takes account the objectives identified by the EMA • To discuss the objectives for a future fee system 2
Drivers for change Drivers for change 3
Drivers for change Drivers for change 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 4
1. Result of Ernst & Young Evaluation on fees • 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 5
1. Result of Ernst & Young Evaluation on fees (cont.) • 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 6
2. Fee regulation requires evaluation of implementation 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 … ” 7
3. Recent and anticipated changes in legislative and regulatory environment • New tasks resulting from changes in pharmaceutical legislation since 2005 • Legislative proposals under discussion include introduction of new types of fees 8
3. Recent and anticipated changes in legislative and regulatory environment (cont.) Revision of Fee Regulation … 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 “Pharm a Revision of I nvestigational Conditional Financial Variations MRL package” Founding Medicinal MA Penalties Regulation Regulation Regulation Products Regulation Regulation Directive SME Paediatric Advanced Certification Regulation Regulation Therapies of ATMP Regulation EU EU Future EU enlargement enlargement enlargement 15 + 10 25 + 2 9
EMA’s reflection on current fee system 10
EMA’s reflection on current fee system • 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 11
EMA’s reflection on current fee system (cont.) Paediatric…...Advice……Pre-subm ission……Evaluation…… Paediatric…...Advice……Pre-subm ission……Evaluation…… Medicinal products for hum an use Assessm ent Assessm ent W orking W orking Eligibility & Re- Re- Eligibility & party PI P/ Scientific party PI P/ Scientific nam e exam ination nam e exam ination contribution deferral advice contribution deferral advice review SAG review SAG SAG SAG I nspection I nspection I ncreasing com plexity and cost I ncrease in fee incentives and I ncreasing com plexity and cost SME I ncrease in fee incentives and SME SME status applicants status of procedures of procedures w aivers Review of w aivers Review of Protocol Orphan Protocol designation Designation designation assistance Designation products assistance Advanced Certification Classification Certification CAT draft therapy Classification CAT draft of data ( for recom m endation of data ( for opinion products recom m endation opinion SMEs) SMEs) 12
Model – overall concept 13
Model – overall concept • 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 14
Current model Current model Proposed model Proposed model Scientific Advice Scientific Advice authorisation Advanced Therapies Certification Pre-I nspection Marketing Authorisation Pre- Application Marketing Authorisation Application MRL ( V) MRL ( V) Article 5 8 Opinion ( H) Article 5 8 Opinion ( H) Extension of MA Extension of MA w ith Clinical Data Type I I Variation Type I I ( Extension of I ndications) authorisation Type I Variation Post- Post - I nspection Renew al Annual Fee Transfer Annual Fee Certificates Referral Referral Referrals Paediatric Article 2 9 ( H) Paediatric Article 2 9 ( H) Herbals ( H) Herbals ( H) Services PMF ( H) PMF ( H) VAMF ( H) VAMF ( H) Medical Device Consultation ( H) Medical Device Consultation ( H) Parallel Distribution Parallel Distribution 15 Com passionate Use ( H) Com passionate Use ( H)
Pre- - authorisation authorisation Pre Proposed model Current model Proposed model Current model Scientific Advice ( H,V) Scientific Advice ( H,V) Advanced Therapies Certification ( H) Marketing Authorisation Application ( H,V) Pre-I nspection ( H,V) Marketing Authorisation Application ( H,V) MRL ( V) MRL ( V) Article 5 8 Opinion ( H) Article 5 8 Opinion ( H) 16
Current model Proposed model Medicinal products for human use Pre-authorisation inspection Consecutive pre-authorisation inspection Application for Marketing Authorisation Advanced Therapies Certification Full dossier Application for MA (full dossier) Medicines for human use Additional strength to MAA (full dossier) Application for Marketing Authorisation Additional presentation to MAA (full dossier) Article 10 (4) Medicines for human use Application for MA (Article 10(4) 2001/ 83/ EC) Additional strength to MAA (Article 10(4) ..) Application for Marketing Authorisation Article 10 (1), 10(3), 10c Additional presentation to MAA (Article 10(4) ..) Medicines for human use Application for MA (Article 10(1), 10(3), 10c ..) Additional strength to MAA (Art. 10(1), 10(3), 10c ..) Additional presentation to MAA (Art. 10(1), 10(3), 10c ..) Pre-authorisation inspection Application for Marketing Authorisation Consecutive pre-authorisation inspection Veterinary medicines Full dossier Application for MA (Full dossier) Veterinary medicines Additional strength to MAA (full dossier) Application for Marketing Authorisation Additional presentation to MAA (full dossier) Article 13(4) Application for MA (Article 13(4) 2001/ 82/ EC) Veterinary medicines Additional strength to MA (Article 13(4) ..) Application for Marketing Authorisation Additional presentation to MA (Article 13(4) ..) Article 13(1), (3), 13c Application for MA (Article 13 (1), (3), 13c ..) Veterinary medicines Additional strength to MA (Article 13 (1), (3), 13c ..) 17 Additional presentation to MA (Article 13 (1), (3), 13c ..)
Objectives for a future fee system Objectives for a future fee system 18
Objectives for a future fee system • Ensure sustainability • Introduce adaptability • Reduce complexity 19
Sustainability • 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 20
Adaptability • Adaptability to a changing environment including ongoing or new pharmaceutical legislation • Model remains flexible enough to accommodate different product types 21
Complexity • Potential 3-fold-reduction in total number of fee types: – Administrative simplification for all involved parties – Increased transparency • Simplify fee incentives whilst maintaining overall value of incentives for pharmaceutical industry 22
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 23
Thank you very much for your attention 24
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