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September 25, 2012 PowerPoint Presentation
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September 25, 2012

September 25, 2012

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September 25, 2012

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  1. SfEE’sExtraordinary General Assembly“SfEE’s Actions and Positions regarding the critical issues faced by the companies of our sector” September25, 2012

  2. Agenda • Claw Back, Rebates: EOPYY’s Expenditure • Outstanding Debts – PSI - Offsettings • “September” Re-pricing – New Medicinal Products • Reimbursement System (Reimbursement Price & Brand name) • Stability Pact 2012-2014 Government – Pharma industry

  3. Pharma Industry:Contribution to Savings: €2,5 bio in 3 years! (Additionally:€1.8 bio Oustanding Debts & €1 bio bonds’ “haircut”) bio € Outpatient Pharmaceutical Expenditure - 45% €- 2,5bio ??? VAT Expenditure * GDP 2012/2009 ≥ -20%!

  4. SfEE’s Position onClaw Back • SfEE is totally opposed to the payment of the legislated clawback, because: • It is a serious disincentive for the implementation of structural reforms and therefore any excess must be calculated after all measures and reforms have been implemented following the deadlines provided by the MoU and applied to all partners of the pharma sector • The calculation must be based on the sales reimbursed by SSFs in ex-factory prices • The hospital use only products distributed by EOPYY (L.3816)must be exempted by the calculation • VAT should not be calculated as public expenditure! • Whatever the excess, this should be calculated on a yearly basis • Companies should be allowed to offset the clawback with debts of the State

  5. Sfee’s Positions – Actions on Outstanding Debts • Payment of the entire amount of outstanding debts owed by the State to the pharmaceutical companies within 2012 • Determine α concrete plan of payments of the outstanding debts of public hospitals and social security funds to the pharmaceutical companies • If the “bridge” loan is granted within September or October (EOPYY + Hospitals) debts Q1 2012 should be paid

  6. SfEE’s Positions – Actions on Off-setting Within the next 2-4 weeks establish an offsetting mechanism of all public outstanding debtstowards the pharma companies with debts of the latter towards the State SfEE has already sent the Ministry of Finance a concrete legislative and regulatory proposal for the expansion of the offsetting mechanism of outstanding debts of pharma companies towards the State with outstanding debts of the latter to them

  7. SfEE’s Positions – Actions on PSI • In the context of the upcoming recapitalisation of the Greek Banks a provision must be foreseen for the pre-PSI bonds, which were offered by pharmaceutical companies as collateral to secure their borrowing from banks • Immediate payment by EOPPY and public hospitals of their debts to pharmaceutical companies for amounts up to the equivalent of the haircut on the pre-PSI bonds they held • Prompt payment of reimbursed medicinal products under Law 3816/2010 within one month from their supply

  8. SfEE’s Positions – Actions on PSI • Ways to address the negative net balance sheet position: • Exemption of these pharmaceutical companies from any rebates and claw backs up to the amount of the haircut • Offsetting the amounts of monthly VAT due against the amount of VAT included in the haircut of 53.5%, which, having already been paid to the State through regular monthly VAT returns, it was paid once again indirectly, through the PSI; this double payment is totally unfair and unreasonable • Offsetting allowed with income tax liabilities • Calculation of the net worth of pharmaceutical companies without taking into account the impact of the haircut • Carrying forward, for tax purposes, the losses caused by the 53,5% haircut in the context of the PSI, so that they can be offset in any year starting from 2011 and up to the maturity of the new bonds issued during the exchange • Offsetting the loss likely to result from the sale of the new bonds against tax liabilities until the loss is fully offset

  9. Pricing of Medicines: September Re-pricing • Reliable, fair and transparent pricing system – Publication of all data on the internet and publication of the draft Price Bulletin • On patent: Re-pricing based on the average of the 3 lowest prices in the EU (provision for the exclusion of several countries and of re-pricing of several categories of medicinal products: orphans, vaccines, blood derivatives, antiretroviral,OTC, products of the negative list) • Off-patent/Generics/On-patent with Retail Price<10 Euro:Horizontal cuts& set as the lowest limit the average of the 3 lowest prices in the EU • Submit verification sheet & prices crosscheck of all products by the companies, excluding orphans, vaccines, blood derivatives, OTC, antiretroviral medicines, based on the IDIKA and negative list file • No publication of the hospital price in the Price Bulletin • Implementation of Legislation on the profit of pharmacists regarding medicinal products of L.3816

  10. SfEE’s Positions - Actions:Price Bulletin with New Medicinal Products • A Price Bulletin including all new medicinal products should be immediately issued, according to the EU Directive 89/105 based on which Price Bulletins should be issued every 90 days • SFEE has already proceeded with legal actions against the non issuance of the Price Bulletin • SFEE constantly demands the immediate issuance of a Price Bulletin with new medicinal products to all relevant stakeholders, in order to achieve patient access to new treatments • Remove from the Price Bulletin all medicinal products introduced arbitrarily in the April 2012 Bulletin • Deliberations between SFEE and the Government for the gradual reimbursement of new medicinal products that are priced, based on specific criteria

  11. Expansion of the existing pilot reimbursement system (Reimbursement Price) In collaboration with PEF, SFEE is in deliberations with the Government to immediately expand the pilot reimbursement system that will secure: • Prescription by brand name with the responsibility of the doctor • A specific and fair reimbursement price

  12. Immediate Implementation of Structural ReformsE-prescribing & Therapeutic Protocols • Full implementation of e-prescribing will contributein: • Saving of resources • Reaching targets and improving the functioning of the system • Reliable monitoring of allocation of pharmaceutical expenditure, in order to obtain substantiated data as a tool for developing and setting sound health and pharmaceutical policy • Combat of illegal trafficking of fake prescriptions • Full computerization and technological modernization is the only effective and safe solution for: • Rationalization of health expenditure and volume reduction • Control of supplies and expenditure by government • Objective and substantiated calculation of the expenditure throughout the supply chain from the insurance funds • Implementation of Diagnostic & Therapeutic Protocols of DRGs and the patients’ co-payment rates • Full Implementation of measures that have been instituted and are not being implemented

  13. What is immediately required: • YES to structural and implementable reformsNO to horizontal measures likeclawback • The most important reform:e-prescription = Transparency • All partners and cost centers in the health sector should contribute in the savings in order to secure their viability • EOPYY’s Financement to secure payments within 2012 • A Stability Pact for 2012-2014 (Government-Pharma Industry) with commitments and obligations from both parties, within October 2012

  14. BACK UP

  15. Rebate 9% - Legal actions • SFEE has already filed before the Council of State an application for the annulment of the Ministerial Decision which determines the procedure and the payment method of the 9% rebate, the discussion of which has not yet been determined • In case a company ascertains that the calculation of the 9% rebate is erroneous, it can submit an appeal before the competent authority which issued the relevant act, i.e. before EOPYY, asking for the correct re-calculation • It is clarified that pharmaceutical companies, which have claims against EOPYY from the supply of their products they can offset the amounts due with the 9% rebate according to the Ministerial Decision No F.42000/8809/1081/4-5-2012 (OJ 1504/B/4-5-12

  16. Escalated Rebate – Legal actions • SFEE has already filed before the Council of State an application for the annulment of the Ministerial Decision establishing the additional escalated rebate. • In case a company ascertains that the calculation of the escalated rebate is erroneous, it can submit an appeal before the competent authority which issued the relevant act, i.e. before EOPYY, asking for the correct re-calculation • The companies can also challenge the note before the Administrative Court of First Instance within 60 days starting from the day they received the note. In calculating the 60 days the month of August is not taken into account. • At the same time companies can submit an application for the suspension of the enforcement of the note imposing the allocated amount. The application may be accepted by the Administrative Court, only if the company concerned is able to prove that, in case the amount imposed is paid, it will cause irreparable financial damage to the latter. • In case the companies challenge the note imposing the additional escalated rebate before the Administrative Court and their application is rejected, they have the right to submit an appeal before the Court of Appeal. Prerequisite for the admission of the appeal is the payment of 50% of the amount imposedaccording to the decision of the Administrative Court of First Instance (article 93 of the Code of Administrative Procedure).

  17. Clawback– Legal actions • SFEE has already challenged before the Council of State the Ministerial Decision introducingthe clawback mechanism but so far the discussion of the case has not been determined yet. • The pharmaceutical companies have the following options to legally challenge the imposed clawback amount: • To submit before the Council of State an application for the annulment of the note imposing the clawback within 60 days starting form the day they received the note. In calculating the 60 days the month of August is not taken into account. • At the same time companies can submit before the Council of State an application for the suspension of the enforcement of the note imposing the allocated amount until the ruling of the supreme court on the above mentioned application for annulment is published. • In case the companies do not settle the clawback amount on time and the procedure described by the Code on the Collection of Public Revenues (KEDE) is applied, the treasury will send to the companies notes imposing the allocated clawback amounts. • In this case, companies can challenge the clawback notes before the competent Administrative Court of First Instancewithin 60 days. In calculating the 60 days the month of August is not taken into account. In case their application is rejected, they have the right to submit an appeal. Prerequisite for the admission of the appeal is the payment of 50% of the amount imposedaccording to the decision of the Administrative Court of First Instance (article 93 of the Code of Administrative Procedure). • At the same time companies can submit an application for the suspension of the enforcement of the note imposing the allocated amount. The application may be accepted by the Administrative Court, only if the company concerned is able to prove that, in case the amount imposed is paid, it will cause irreparable economic damage to the latter.