Extraordinary General Meeting of SFEE

Re-pricing & New ProductsNikos Kefalas, Vice President of SFEE

Wednesday, November 27, 2013

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

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.

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.

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

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