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Extraordinary General Meeting of SFEE Re-pricing & New Products Nikos Kefalas, Vice President of SFEE Wednesday, November 27, 2013
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Main views of SFEE for pricing Respect of the patents in force for original medicinal products The lowest price limit for original medicinal products is the average of the three lower prices in the EU. Sources saving from off-patent medicinal products/generics Approval of the price of new medicinal products based on the provisions of the national and European legislation Clear and predictable framework/pricing procedure Avoidance of any impact of Greek prices to foreign countries Protection of domestic production of medicinal products
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Newer developments (1/2) Filing of the Bill on November 15, in relation to pricing issues. Main points: – Revision of the price of off-patent products (active substance), in case a generic is marketed (50% on the last on-patent price/average of the three lower prices in the EU) – Revision of the price of generics at 65% of the price of the original/dynamic pricing – Horizontal decreases of prices for cases of off-patent/generic products before 01/01/2012 – Ability of voluntary decrease of prices – No increase of prices, save in the case of errors – Re-pricing twice per year – Revision of the profit margins of pharmacists/wholesalers, for the products included in the list of Law 3816 which are sold by private pharmacies After the enactment of the Bill, the Ministerial Decisions regulating in detail the above will be issued.
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Newer developments (2/2) Pricing of new pharmaceutical products in August 2013, after 2.5 years (reimbursement of their cost is still pending …) Commitment of the Ministry of Health /EOF for the pricing of new medicines for which the approval of their price is pending (application filed until 30/9/13), until the end of the year Creation of a Prices Department in EOF Saving achieved by the prices field in 2013 compared to 2012, is calculated at Euro 400 mil.
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Review of SFEE’s actions for 2013 Intensive efforts/continuous contacts with agencies for the issue of Prices Bulletins with the new pharmaceutical products Respect of the patents in force for the original pharmaceutical products, through the relevant Legislation/Ministerial Decisions Continuous and intensive efforts for the correction of errors in prices, via the issue of Corrective Prices Bulletins Substantial number of contacts with agencies, for the establishment of a predictability/stability/smoothness in the field of pricing
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Suggestive actions/goals for 2014 Fixed request for the development of infrastructure and procedures for the issue of a Prices Bulletin by the Competent Department of EOF. Co-operation with EOF for: – Formation of a prices observatory for medicinal products – use of a web application – Support of EOF’s computerisation – Adaptation of specific communication procedures/procedures for dealing with prices issues with the competent services – Minimisation of errors in prices calculation Reinforcement of the role of the Medicinal Products Prices Committee Approval of the price of new medicinal products based on the provisions of the national and European legislation
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