SeptemberSeptember 25, 25, 20122012

1.1. Claw Back, RebatesClaw Back, Rebates: : EOPYY’s ExpenditureEOPYY’s Expenditure

2.2. Outstanding Debts – PSI - OffsettingsOutstanding Debts – PSI - Offsettings

3.3. ““September” Re-pricingSeptember” Re-pricing – – New Medicinal ProductsNew Medicinal Products

4.4. Reimbursement SystemReimbursement System ( (Reimbursement PriceReimbursement Price & & Brand Brand

namename) )

5.5. Stability PactStability Pact 2012-2014 2012-2014 Government Government – Pharma industry– Pharma industry

5,6

4,3 3,8< 2,9

0,2

0

1

2

3

4

5

6

2009 2010 2011 Rebates deducted 2012 Projection

<3,1

bio €

% GDP

2,4% 1,9% 1.7% 1.5%

* GDP 2012/2009 ≥ -20%!

- 45%

Outpatient Pharmaceutical Expenditure

VATVAT

Expenditure

€- 2,5bio

??????

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

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

Within the next 2-4 weeks establish an offsetting mechanism of all public outstanding debts towards the pharma

companies with debts of the latter towards the State

SfEE has already sent the Ministry of Finance a concrete SfEE has already sent the Ministry of Finance a concrete legislative and regulatory proposal for the expansion of the legislative and regulatory proposal for the expansion of the

offsetting mechanism of outstanding debts of pharma companies offsetting mechanism of outstanding debts of pharma companies towards the State with outstanding debts of the latter to themtowards the State with outstanding debts of the latter to them

SfEE has already sent the Ministry of Finance a concrete SfEE has already sent the Ministry of Finance a concrete legislative and regulatory proposal for the expansion of the legislative and regulatory proposal for the expansion of the

offsetting mechanism of outstanding debts of pharma companies offsetting mechanism of outstanding debts of pharma companies towards the State with outstanding debts of the latter to themtowards the State with outstanding debts of the latter to them

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

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

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

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

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

Full implementation of e-prescribing will contribute in:

◦ 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

YES to structural and implementable reforms NO to horizontal measures like clawback

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

BACK UPBACK UP

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

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 imposed according to the decision of

the Administrative Court of First Instance (article 93 of the Code of Administrative

Procedure).

SFEE has already challenged before the Council of State the Ministerial Decision introducing the 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 Instance within 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 imposed according 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.