A gyógyszerek nemzetközi referenciaárazása és az EURIPID Együttműködés

National Institute of Health Insurance Fund Management 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

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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 http://www.efpia.eu/uploads/principles_for_application_of_international _reference_pricing_systems_june_2014_position_paper.pdf 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

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 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 OEP 2008-2010 2010-2013 2014-2015 2015 2017

1.3 The EURIPID Collaboration Legal issues Framework Partnership Agreement General Terms and Conditions Terms and Conditions of Use of the Website Organisation 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) Finances non-profit annual contribution fee equally shared the budget depends on the number of participants

1.4 Operational model Information provision by the national authorities Data standardisation by the project team easy to use web platform Only publicly available information In line with the data standardisation manual Standard structure Relevant clustering of products

1.5 Status of recruitment Participating countries in 2017: Austria Belgium Bulgaria Croatia Czech Republic Cyprus Denmark Estonia Finland France Greece Hungary Ireland Israel Italy Latvia Lithuania Netherlands Norway Poland Portugal Slovakia Slovenia Spain Sweden Switzerland United Kingdom Potential participants for the future: Russian Federation, FYRM Not participants but data available: Iceland, Romania Former participant: Albania

2. SWOT analysis of the EURIPID Collaboration 8 years S of experience Successful operational model Most EU Member States are participants Bringing together O the experts on pricing Extension of the dataset Cooperation with other databases/projects (e.g. EMVS) Geographic extension of the collaboration Limited W in scope (non-reimbursed products, hospital products are not in the focus) Only official prices Access is restricted T Confidential pricing Managed Entry Agreements

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)

3.3 Novelties under the grant for the EURIPID Collaboration 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

3.4 Expected outcomes Optimised dataset and layout in the EURIPID website and database Continuous information provision for the national authorities in a sustainable way Guidance Document

3.5 Grant activities

4.1 Open questions MEA Volumes Product scope Access Qualitative information on managed entry agreements, patient access schemes, risk sharing agreements Information on volumes/availability Potential cooperation with EMVO/NMVOs Hospital only products Non-reimbursed but controlled priced products Who can get access to the website?

6. Reasons of access restrictions Preventing free riding The Board of Participants has the right to decide about the access policy 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

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 36. Notes that the EURIPID project needs more transparency from Members States to include the real prices paid by them; 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? BARRIERS SOLUTIONS 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?

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