A gyógyszerek nemzetközi referenciaárazása és az EURIPID...
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A gyógyszerek nemzetközi referenciaárazása és az
EURIPID Együttműködés
META ülés 2017. 04. 11
Németh Gergely
664317 – EURIPID – HP-PJ-2014 Ref. Ares (2015)2197859 – 27/05/2015
National Institute
of Health
Insurance Fund
Management
Disclaimer
“The content of this presentation represents the views of the author only and is his/her sole responsibility; it can not be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.”
Tartalom
1. Nemzetközi referencia árazás
2. Az EURIPID Együttműködés bemutatása
3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása
4. Nyitott kérdések
5. EU Parlamenti riport
Tartalom
1. Nemzetközi referencia árazás
2. Az EURIPID Együttműködés bemutatása
3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása
4. Nyitott kérdések
5. EU Parlamenti riport
1.1 Mi a nemzetközi referenciaárazás?
Használt rövidítések: IPR, ERP, EPR
Használt fogalmak: International price comparison, External reference pricing, External price referencing
The practice of using the price(s) of a medicine in one or several countries in order to derive a benchmark or reference price for the purposes of setting or negotiating the price of the product in a given country.
Forrás: WHO-PPRI glossary:
http://whocc.goeg.at/Glossary/PreferredTerms/External%20price%20referencing
Nemzetközi referencia árazás Európában
Sabine Vogler, CAPR meeting, 2017.03.15.
Nemzetközi referencia árazás a világban
Espi, Rovira, Labry: WHO/HAI Project on Medicines Prices and Availability, 2011:
http://haiweb.org/mwg-internal/de5fs23hu73ds/progress?id=xostTqdF9Rl2FHX9YUnItsFCUOAbW8CvBslY84atde4,
A nemzetközi referenciaárazás kritikája
Piaci sajátosságok figyelmen kívül hagyása Marginok, adók, szabadalmi jogok, indikációk, fogyás stb.
Részben nehezen értelmezhetőek, részben figyelembe vannak véve
Kockázatok Késedelmes bevezetés, korlátozott hozzáférés
Nincsenek elfogadható bizonyítékok
Más árazási modellek value based pricing, differential pricing
Az egyéb árazási modelleket is súlyos kritikával lehet illetni*
Módszertani problémák Kiszerelések, árfolyam, eljárások transzparenciája Egyszerű eljárás, nemzeti szinten kezelve
vannak a problémák
*http://www.msfaccess.org/sites/default/files/MSF_assets/Vaccines/Do
cs/VAC_report_TheRightShot2ndEd_ENG_2015.pdf
http://www.efpia.eu/uploads/Principles_for_application_of_international
_reference_pricing_systems_June_2014_Position_Paper.pdf
Tartalom
1. Nemzetközi referencia árazás
2. Az EURIPID Együttműködés bemutatása
3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása
4. Nyitott kérdések
5. EU Parlamenti riport
1.1 What is the EURIPID undertaking?
A voluntary non-profit COLLABORATION of the European P&R authorities for the mutual sharing of price information of medicinal products
A TECHNICAL TOOL to make prices of pharmaceuticals more transparent in Europe
An attempt to create a comprehensive, continuously maintained, easy-to-use online DATABASE of prices of reimbursed pharmaceuticals
1.2 History
CEDD pilot project
OEP
EURIPID project
DG ENTR, OEP,
GÖG/ÖBIG
EURIPID Collaborati
on
national P&R
authorities
EURIPID Collaboration & DG SANTÉ
grant
national P&R authorities
Cooperation with
EUROSTAT
2008-2010 2010-2013
2014-2015
2015 2017
1.3 The EURIPID Collaboration
• Framework Partnership Agreement
• General Terms and Conditions
• Terms and Conditions of Use of the Website Legal issues
• Founders, Partners, Associated Partners, European Commission
• Board of Participants (BoP) (one delegate per country + EC)
• Executive Committee (3 delegates of the BoP + NEAK + GÖG/ÖBIG + EC repr.)
• project team (NEAK & GÖG/ÖBIG)
Organisation
• non-profit
• annual contribution fee equally shared
• the budget depends on the number of participants Finances
1.4 Operational model
Information provision by the national authorities
• Only publicly available information
Data standardisation by the project team
• In line with the data standardisation manual
easy to use web platform
• Standard structure
• Relevant clustering of products
1.5 Status of recruitment
Participating countries in 2017:
Austria Italy Belgium Latvia Bulgaria Lithuania Croatia Netherlands Czech Republic Norway Cyprus Poland Denmark Portugal Estonia Slovakia Finland Slovenia France Spain Greece Sweden Hungary Switzerland Ireland United Kingdom Israel
Potential participants for the future: Russian
Federation, FYRM Not participants but data available: Iceland, Romania Former participant: Albania
T W S
O
8 years of experience
Successful operational model
Most EU Member States are participants
Limited in scope (non-reimbursed products, hospital products are not in the focus)
Only official prices
Access is restricted
Bringing together the experts on pricing
Extension of the dataset
Cooperation with other databases/projects (e.g. EMVS)
Geographic extension of the collaboration
Confidential pricing
Managed Entry Agreements
2. SWOT analysis of the EURIPID Collaboration
Tartalom
1. Nemzetközi referencia árazás
2. Az EURIPID Együttműködés bemutatása
3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása
4. Nyitott kérdések
5. EU Parlamenti riport
3.1 DG SANTE call proposal - objectives
SO.1
Determining an optimised dataset and
data lay-out (in collaboration with the stakeholders)
SO.2
Providing the necessary (additional) information
SO.3
Developing a Guidance Document on external
reference pricing (in collaboration with the stakeholders)
Dissemination of information to the public
http://ec.europa.eu/chafea/news/news492.html
Formal collaboration with the stakeholders
EC is member in the Board of Participants and in the Executive Committee
3.3 Novelties under the grant for the EURIPID Collaboration
Optimised dataset and –layout in the EURIPID website and database
Continuous information provision for the national authorities in a sustainable way
Guidance Document
3.4 Expected outcomes
3.5 Grant activities
Tartalom
1. Nemzetközi referencia árazás
2. Az EURIPID Együttműködés bemutatása
3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása
4. Nyitott kérdések
5. EU Parlamenti riport
• Qualitative information on managed entry agreements, patient access schemes, risk sharing agreements
MEA
• Information on volumes/availability
• Potential cooperation with EMVO/NMVOs Volumes
• Hospital only products
• Non-reimbursed but controlled priced products
Product scope
• Who can get access to the website? Access
4.1 Open questions
Preventing free riding
Data ownership issues
Concerns about parallel trade
Concerns about the misinterpretation of prices (sales volumes, pricing structures matters, real prices vs. list
prices)
Incalculable effect on pricing and access to medicines on a global level
The stakeholders have not yet expressed their explicit interest for accessing the EURIPID website
6. Reasons of access restrictions
The Board of
Participants
has the right
to decide
about the
access policy
Tartalom
1. Nemzetközi referencia árazás
2. Az EURIPID Együttműködés bemutatása
3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása
4. Nyitott kérdések
5. EU Parlamenti riport
36. Notes that the EURIPID project needs more transparency from Members States to include the real prices paid by them;
5.1 European Parliament INI Report
Report – EU options for improving access medicines – A8-0040/2017 – Committee on the Environment, Public Health and Food Safety
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A8-2017-
0040&format=XML&language=EN
5.2 How real prices could be shared?
Uncoordinated ERP between MS Voluntary agreement with industry on the principles of fair pricing
Wish of full transparency Limited transparency (full transparency for those who agree on the principles)
Focus on prices Prices + contractual conditions
Focus on new MEAs Is fair pricing principles applied for the existing MEAs?
BARRIERS SOLUTIONS
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