Pharma Maket Access - Southeast Europe & Turkey

Member of regulanet®© 2013 Farmavita Regulanet Ltd. 1
Zdravko Mauko, Farmavita Regulanet
for Pharma Market Access Conference, Opatija, 5th – 7th June 2013
Pharmaceutical Market Access
Across Southeast Europe &
Turkey

Southeast Europe & Turkey
 Croatia – 4,5 mn
 Serbia – 7,2 mn
 Bosnia &
Herzegovina
– 4,1 mn
 Macedonia – 2,1
 Montenegro-0,6
 Kosovo – 2,3mn
 Albania – 2,8 mn
 Bulgaria – 7,6
 Romania – 22,4
 Turkey - 79,75
Total market of about
130 million citizens.

Croatia
Marketing Authoristions
- ICH Guidelines, CTD format
- From 1st July harmonized with EU
- NP, CP, MRP,
- EU MAH , EU QPPV, local PV
support
Unauthorised Imports
- Compassionate use
- Named patient list
- Clinical trials, research
- Urgent general population
need
Healthcare Expenditure
- Population 4.5 million citizens, GDP 80.33 bill. USD
- HE was 7.8 % of GDP in 2010
- Croatian pharmaceutical market size is comparable to
Bulgaria
- Drug expenditure per capita (DEPC) is 128€ , similar to
that of Poland
- Market growth is hindered by economic crisis
- Phramaceuticals sales projection for 2012 is 1.26bn
USD, -5.8% from 2011

Croatia – P & R
Wholesale Price
• sum of manufacturing price and custom service price, without VAT
• Wholesale margin up to 8.5%
Criteria for wholesale price determination are:
• level of comparative wholesale price
• pharmacoeconomic study
• reference price (Italy, France, Slovenia / Czech, Spain)
Retail Price
- Retail margin is 10 to 35%, except for AIDS, cancer , long lasting
treatments and epidemics (may be 2%)
- 5% VAT
Reimbursement List – Croatian Health Insurance Institute (HZZO)
- Pharmacoeconomic study – Innovative medicines
- Budget impact analysis – first generics, without innovative
- Price determination – generics

Serbia
- Population 7,2 million citizens, GDP 28.01 bill. EUR
- HE was 9.6% of GDP in 2007
- approximately at the level of Denmark (9.8%), Greece
(9.6%), and Iceland (9.3%)
- 63.8% public health care exp.
- Total expeniture per capita – 348 €
- per capita consumption of drugs EUR 179 per capita in
2012
Marketing Authorizations
- ALIMS
- MA from other country – not accepted
- NP – standard regulatory pathway
- Local MAH , local QPPV
Unauthorized Imports
- Compassionate use
- Urgent general population need
- On request of insititution

Serbia – P & R
Wholesale Price
• + wholesale margin up to 6 % proposed to RZZO
• reference price (Italy, Croatia, Slovenia)
Retail Price
- Retail margin is 12 % + VAT
Reimbursement List - Serbian Health Insurance Institute (RZZO)
- Pharmacoeconomic study – Innovative medicines
- Price determination – generics (Regulation on the Criteria for
Establishing Medicinal Products Prices (Official Gazette No. 87/2010))
- Determined onece a year, updated qurterly

Bosnia and Herzegovina
- ALMBIH
- NP – standard, generic regulatory
pathway
- Compassionate use
- Clinical trial, research
- Population 4,35 million citizens, GDP 24.80 bill. USD
- Pharmaceutical market 125mill. EUR
- Prescription drugs expenditure: 32 mill.$ (9 USD per
capita)
- 60% hospital / 40 % non-hospital sales
- large amounts of money are spent on prescription drugs
which, in fact, have no appropriate value for therapy

Bosnia & Herzegovina – Pricing
Pricing - controled by ALMBIH
Price is controlled by the Agency for Medicinal Products and Medical Devices of
Bosnia and Herzegovina:
• Article 84. of Medicinal Products and Medical Devices Act
• Calculating and Reporting the Prices of Medicinal Products (Official Gazette of
the Bosnia and Herzegovina No. 82/11)
Wholesale Price
• + wholesale margin up to 8 % proposed to ALMBIH
• reference price (Serbia, Croatia and Slovenia / Austria or Italy)
Retail Price
- Retail margin is 10 – 25 % + VAT

Bosnia & Herzegovina – Reimbursement
Reimbursement Lists – 10 cantons
• two federal essential lists in two Entities of B&H
(R. Srpska and BiH Federation)
• Other cantonal essetial lists
Specific creiteria:
• The obligatory including of domestic
pharmaceutical industries;
• Experience in the therapeutic use of drug in
FB&H;
• Manufacturer’s declarations of acceptance of
drug prices established by the Federal list of
essential drugs.
Health care services are not transferable between the two entities. Persons insured in
the various cantons have a different rights and different approach health care
services, especially in tertiary care. Fragmented health care system limits the
equitable access to health services for all citizens in FB&H.

Macedonia
- REGLEK
- MA from EU – priority reviuwe
- standard, generic, hybrid, established
- Compassionate use
- On request of insititution
- Population 2.04 million citizens, GDP 20.35 bn. USD
- drug consumption is not monitored closely
- Estimate of pharmaceutical market vary from US$ 40
million to US$ 300 million
- 3 local manufacturers provide an estimated 25 % of
market and are able to provide the full range of essential
drugs needed

Macedonia – P & R
Pricing
• reference price (Croatia, Serbia, Slovenia, and Bulgaria)
• 100 % for first gneric
• 78% for following generics
• Lowest defined price at Macedonian market
• Therapeutic group
Legal frame: Regulation on Establishing the Criteria for Determining the
Reference Price of Medicine (Official gazette No. 158/09); New Draft
Reimbursement List – HCI Fund
- Referent prices are determined at least once a year. The date of the calculation
of the reference price is January 10th every year
Tenders
• Law on Public Procurement (Official gazette No. 136/07)
• Bureau of public procurements

Kosovo
- KMA
- MA from EU – priority review 30d
- standard regulatory pathway
- Local Authorised person required
- Compassionate use
- Population 2.1 million citizens, GDP 13,56 bn USD
- HE was 3 % of GDP
- The annual per capita government expenditure in health
care is only 35 € (the lowest in Europe)
- Health insurance system has not yet been established.
- The private sector in health care has grown in the recent
years and is predominantly focused on diagnosis and
treatment.

Kosovo – P & R
Pricing
• There is no price control and price registration in place
Reimbursement List
• There is not yet established a reimbursement system.
• It has been drafted some proposition of legislation but not yet approved by the parliament.
• Every year the MOH formulate an Essential Drug List based on the need of the regional
hospitals. After that list is formed, the tender is published.
• Usually there are not enough drugs procured by tender so patients have to by everything
themselves.
Tenders
• Usually tenders are announced centrally. MOH distributes medicines among healthcare
institutions.
• Additionally every healthcare institution has its own budget and allowed to open the local
decentralized tenders.
• list of medicinal products allowed for purchasing by funds of Kosovo State Budget is
provided in official website of the MOH of Kosovo called as Essential Drug List.
• Any person or company (resident and non-resident) can participate in state tender.

Albania
- QKKB
- Local Guidelines, CTD format
- standard, abbreviated reg. pathway
- 30d abbreviated, 210d standard
- Authorised representative, local QPPV
- Compassionate use / donation
- Population 2.8 million citizens, GDP 23,12 bn USD
- HE was 2.6 % of GDP in 2010, 8.9% of national budget
- The health system in Albania is mainly public but the
private sector is expanding rapidly.
- The Albanian pharmaceutical market is estimated to be
around 130 million Euro.
- Domestic pharmaceutical manufacturing in Albania is
rather underdeveloped.

Albania – Pricing
Pricing
• Controled by Drug Pricing Commission, a unit located at the Ministry
of Health
• This commission approves every year the „CIF prices” for the
imported drugs and the fabrication prices for the domestic drugs. The
prices are declared every year, within the 30 September.
• requirements for the preparation of the letter on CIF price declaration
is available in the website of the Ministry of health
• CIF prices in Albania are be compared to CIF prices of reference
countries: Italy, Greece and Macedonia. The reference price is the
lowest price among the three states.
• "CIF" prices are officially notified to the National Center for Drug
Control, Health Insurance Institute, the General Customs Directorate
and the General Directorate of Taxation.
• Wholesaler and pharmacy margines are also regulated

Albania – Reimbursment
• Reimbursement list is compiled by the Commission of Composition
and Review of the Reimbursement List of Medicinal Products in the
Ministry of Health
• Reimbursement provided by Health Insurance Institute (HII)
• Each year, the alternatives in reimbursement list may be proposed by
associations of doctors or pharmacists, pharmaceutical
manufacturers, representatives of pharmaceutical
companies, physicians of the primary service, clinics of the University
Hospital Center of Tirana, Drug Nomenclature Commission (DNC), or
National Center for the Control of Drugs (QKKB) according to a format
determined by the Pharmaceutical Department of the MoH.
• Legal frame : Order No 185/1 by the Minister of Health of 4 June 2012
on Approval of the Regulation on Methodology of Determination of
Drug Prices and Administration Way of Price Declarations in the
Republic of Albania

Bulgaria
- BDA
- ICH Guidelines, eCTD adn NeeS format
- Stadard, abbreviated, literature
- NP, CP, MRP, DCP
- Local liason and PV person
- Treatment of patient requested
by hospital
- Product authorised in Eum but
not in Bulgaria
- Hospital supply by “international
and national programs”
- Population 7.6 million citizens, GDP 103 bn USD
(2012est)
- HE was 4 % of GDP in 2011, DEPC 85 €
- National Health Fund pays EUR 34 per person each year
(average figure in Europe circulates around EUR 200)
- Only 1/3 of Rx medicines are reimbursed
- Currently 10 companies in Bulgaria hold nearly 55% of
the total medicine market
- Pharma market was EUR 1 billion in 2012

Bulgaria – Pricing
National Council on Pricing and Reimbursement is established by the Minister of
Health. It regulates „limit prices”.
The limit price is determined for:
• For medicinal products included in the Positive List is the retail price
• For medicinal products not included in the Positive list is the highest price on
which one medicinal product is sold on the market.
• For OTC medicinal products the limit price is the highest retail price
determinated by the MAH and the Council.
The price for Positive List of Medicine is calculated as sum of:
1. lowest price for the same product paid by public health insurance funds of the
Romania, France, Estonia, Greece, Slovakia, Lithuania, Portugal, Italy,
Denmark, Finland, Slovenia or Spain
2. a wholesaler margin in size 7 %, 6% and 4 % percent of the stated price
respectively for prices up to 10.00 leva, for price from 10 to 30 leva and for
prices up to 30 leva
3. a retail margin in size 20%, 18% or 16% percent of the stated price
respectively for same prices
SUM 1+2+3+20% VAT= „limit price”

Bulgaria – Reimbursement by NHIF
Positive List is 100% reimbursed by the state budget, there is no retail margin
calculated
Special inclusion criteria:
- INN belonging to the medicinal product, which is paid by the public health
insurance fund of one of the following countries:
Romania, France, Estonia, Greece, Slovakia, Lithuania, Portugal, Italy, Denmark
, Finland, Slovenia, Spain, Belgium, Hungary, Poland and Check Republic.
- There is shortage or alternative treatment
- a criteria for efficacy and benefit of the medicinal product
- A criteria for safety
- Pharmaco-economic indexes
- The medicinal product will be used for a treatment of disease with high risk
to the society
The list of the reimbursed drugs is published on the Ministry of Health (Positive
list) and on the web page of the NHIF. The Positive list update is twice monthly.

Romania
- ANM
- stadard, abbreviated, hybrid, estab.
- NP, CP, MRP, DCP
- Local liason person
(2012est)
- HE was 5.6 % of GDP in 2010, DEPC 88€
- Pharmaceutical market was 1,55 bn EUR in 2006
- Only 1/3 of Rx medicines are reimbursed
- Rx drug market is 83%, of which 80% is reimbursed by
public healatcare system
- The drug market is growing mainly due to the
introduction of new, expensive drugs
- Compassionate use is an order
placed at physician's initiative,
with the consent of the patient;
- When equivalent is not
authorized
- Through authorized distributor

Romania – P & R
Pricing
The Pharmaceutical department in the Ministry of Public Health is in
charge with the price approval.
Criteria for price determination are:
• reference price = lowest price ffrom
Czech, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lit
huania, Spain, Greece, Germany
Reimbursement – NHIH
• Genric medicines 65% of originnator proice
• Innovative medicines – not more than 35% more expensive than
gnerics at refrence country list.
• List of reimbursable drugs contains 3748 products 100%
reimbursable, 1513 products 90% and 1032 products 50%
• HC system still encounters massive delays in reimbursement.
• In order to change the reimbursement system, doctors might receive
the right to manage reimbursement funds

Turkey
- IEGM
- NP – standard regulatory pathway
(2012est)
- HE was 6.7 % of GDP in 2010, DEPC 96 €
- Rx market has reached 6,54 billion Euros in 2009
- Original drugs has realized as 4,1 billion US$ in 2009
- 90% of the drugs consumed are manufactured
domestically
- foreign companies run 80% of this manufacturing
- Compassionate use is an order
placed at physician's initiative,
with the consent of the patient;
- When equivalent is not
authorized

Turkey – P & R
Pricing
• Ex-factory prices of pharmaceuticals are determined by applying the
lowest ex-factory price in the reference countries -
Spain, France, Italy, Greece and Portugal
• The reference price is lowest official "sale price to
wholesalers", excluding discounts
• Wholesale margin 2% to 9%, depending on product price
• Retail price 12 to 25%, depending price of product
• Generics – max. 66% of originator refrence price
• Innovative medicines- PhEc Studies for first application globaly or
lowest refrence price
Reimbursement – Social Security Institution (SSI)
• The reimbursement price of a product is the registered price of the
product by the Turkish Drug and Medical Device Institution.
• Application (Reimbursement Dossier) should be submited to SSI

Thank you !
Zdravko Mauko
Farmavita Regulanet d.o.o.
Okicka desni odvojak 2
10430 Samobor
Phone: +385-1-3377 058
Mail:
zdravko.mauko@farmavitar.com
Skype: zdravko.mauko

Pharma Maket Access - Southeast Europe & Turkey

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