Ban of Advertising

of Community Pharmacies

in Poland

Piotr BohaterInternational Affairs Coordinator

Polish Pharmaceutical Chamber

The self-government

of the pharmaceutical profession

is is independent andindependent andsubordinated only to legislationsubordinated only to legislation,,especially to:especially to:

- - the Law on Pharmaceutical Chambersthe Law on Pharmaceutical Chambers

- - the Pharmaceutical Lawthe Pharmaceutical Law

There are about There are about 27.00027.000 members of the members of the pharmaceutical self-government in Polandpharmaceutical self-government in Poland

The Polish Pharmaceutical Chamber

and its organs have and its organs have their seat in the their seat in the capital city of capital city of WarsaWarsaww

Regional Pharmaceutical Chambers

The area of operation of each particular The area of operation of each particular regional pharmaceutical chamber and its seat regional pharmaceutical chamber and its seat is determined by the Polish Pharmaceutical is determined by the Polish Pharmaceutical Chamber, taking into account the basic Chamber, taking into account the basic administrative territorial division of the stateadministrative territorial division of the state

- different magnitude of area of operation- different magnitude of area of operation

- different number of members- different number of members

20 Regional Pharmaceutical Chambers

Number of Pharmacies per CountryNumber of Pharmacies per Country

86 278 322 442 573 802 875 978 1200 13941580 1692 1825

23482775

4445

5196

11204

12948

17206

20745

21558

23197

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

22000

24000

number of pharmacies

Lu

xe

mb

ou

rg

Slo

ve

nia

De

nm

ark

Cy

pru

s

No

rwa

y

Fin

lan

d

Sw

ed

en

Cro

ati

a

Au

str

ia

Ire

lan

d

Slo

va

kia

Sw

itze

rla

nd

Ne

the

rla

nd

s

Cze

ch

Re

p

Po

rtu

ga

l

Bu

lga

ria

Be

lgiu

m

Po

lan

d

UK

Ita

ly

Sp

ain

Ge

rma

ny

Fra

nc

e

5

One of the most liberal pharmacy systemin Europe

ownership of the community pharmacy is not limited to pharmacists

there are neither demographic nor geographical criteria for establishing a pharmacy

pharmacies cannot by owned by the pharmaceutical wholesalers only theoretically

the rules that prohibit establishing big pharmacy chains (more than 1% of pharmacies in the province) are not enforced

there are maximum prices for the prescripion-only medicines

community pharmacy can resign from the patient’s co-payment

a great number of OTC medicines can be sold outside pharmacies online sales of non-prescription medicines

Act on the Reimbursement of Medicines,Food for Particular Nutritional Uses

and Medical Devices

The Polish Parliament on 12 May 2011 voted for the Act on the Reimbursement of Medicines, Food for Particular Nutritional Uses and Medical Devices, approving most amendments proposed by the Senate. The new law was signed by the President on 25 May 2011.

Main provisions of the Reimbursement Act came into force on the 1st of January 2012.

The new bill governing the reimbursement of pharmaceuticals is a part of the „health-care package”

The act led to a radical change in the rules on the Polish pharmaceutical market, affecting pharmaceutical manufacturers, wholesale companies and community pharmacies.

Functioning of the reimbursement systemin Poland until 1st of January 2012

The functioning of the reimbursement system was marked by cumulated pathologies leading to irrational management of public funds.

Fierce competition between pharmacies, with infamous Drugs for a Penny and Wholesale Prices.

Aggressive marketing, promotions, offering gifts for purchasing reimbursed medicines led to the unnatural creation of demand which resulted in medically unjustified expenditure, both on the part of the National Health Fund, and on the part of patients themselves.

The Polish Pharmaceutical Chamber pointed out for many years that the pathologies were very destructive for community pharmacies and the whole pharmaceutical market.

On the basis of long term experience, it was legitimate to say that the Polish reimbursement system required thorough changes.

It could not be cheaper

Wholesale prices

Medical pharma

cy

Big opening

Stop overpaying!

First patients

will receive

the money

The end of expensive

medicines in Głogów

Manufacturer prices

Pharmacy of cheap

medicines

Style Pharmacies –queens of low

prices

1226th of June 2010, Sofia

Don’t let milk you dry

Buy here the

cheapest

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s for everyone

Do not overpay!!!Buy cheap

medicines inyour town

The Ban of Bonus and Loyalty Systems

The Reimbursement act introduced the ban of bonus systems, lotteries, offering gifts, loyalty systems for purchasing of reimbursed medicinal products.

A MAJOR STEP FORWARD IN RESTORINGTHE RIGHT PLACE OF POLISH PHARMACIES

IN THE HEALTH CARE SYSTEM

AAfter many years of liberalisation of pharmaceutical distribution the fter many years of liberalisation of pharmaceutical distribution the Polish government decided Polish government decided to stop the negative trendto stop the negative trend because because practical experiences proved that it was unfavourable for both the public practical experiences proved that it was unfavourable for both the public interest and for the state’s complex medication policyinterest and for the state’s complex medication policy.

The Polish parliament made a major step in this direction by enacting Article 94a of the Pharmaceutical Law that has introduced

the ban of advertising of community pharmacies in Poland.

Fixed prices and margins

One of the most important provision introduced by the Reimbursement Act

Introduction of fixed manufacturer prices, wholesale margins and retail margins for reimbursed medicines

Prices are set during the negotiation process between the Ministry of Health and a pharmaceutical manufacturer

Introduction of limit groups based on criteria such as similar indications and similar effectiveness. The base of the reimbursement limit will be the highest among the lowest wholesale prices, which cover at least 15% of monthly turnover in terms of value in a given category.

Retail margin calculated only to the reimbursement limit that is, in most cases, much lower than the wholesale price

Obligation to complying with the priceand co-payment

Pharmacies are obliged to comply with the price and patient’sco-payment established for medicines included on the official reimbursement list.

Penalties are imposed on pharmacies not complying with the prices and patients co-payments.

Measures that ban any bonus systems, lotteries, discounts, gifts, loyalty systems etc. offered to patients for purchase of reimbursed medicinal products.

Ban of Advertisingof Community Pharmacies

The provisions on the prohibition of advertising of community pharmacies are simple and clear. In accordance to the Pharmaceutical LawArticle 94a:

"1. It is forbidden to advertise community pharmacies and pharmaceutical dispensaries and their activities. The information about the location and opening hours of the community pharmacy and pharmaceutical dispensary is not advertising.

1a. Advertising of non-pharmacy turnover units and their activities concerning medicinal products or medical products is prohibited”

Ban of AdvertisingStandard for Liberal Professions in Poland

There are much the same restrictions concerning other liberal professions in Poland:

medical doctors, dentists, veterinarians, midwives, lawyers or legal advisers.

That means the ban of advertising of community pharmacies constitutes a standard for liberal professions in Poland.

Supervision over the Ban of Advertisingof Community Pharmacies

Supervision over the ban of advertising of community pharmacies in Poland hold Voivodeship Pharmaceutical Inspectorsaccording to the Article 94a of the Pharmaceutical Law.

In case of breaking the law with regard to the ban of advertising of community pharmacies the Voivodeship Pharmaceutical inspector orders to stop the advertising immediately and may fine the owner of the community pharmacy up to 50,000 zł (12,000 Euro).

The owner of the community pharmacy may appeal to the Main Pharmaceutical Inspector and then to the Administrative Court in Warsaw.

But the order to stop the advertising immediately will be in force until the decision of the Main Pharmaceutical Inspector and possibly the ruling of the Administrative Court in Warsaw.

Ban of Advertisingof Community Pharmacies

It is one of the the most important guarantee of proper functioning of pharmacies as public health practitioners and pharmacists as representatives of public health profession.

Particularly that there are neither ownership nor establishment (demographic and/or geographic) criteria for opening new community pharmacies in Poland.

Therefore, when any company owned by non-pharmacists may own and run community pharmacies in Poland, introducing the ban of advertising of community pharmacies has been the only way to stop very aggressive marketing campaigns performed by many chain pharmacies that were contrary to pharmaceutical deontological code.

Lobbying Campaigns Againstthe Ban of Advertising

of Community Pharmacies

Non-pharmaceutical business associations operating on the Polish pharmacy market have been continuing lobbying campaign against the ban of advertising of community pharmacies for many months.

They have attacked members of the Polish Pharmaceutical Council and have been putting the Polish government under pressure.

But Polish pharmacists strongly support the position of the Polish Pharmaceutical Chamber of no change in the rules prohibiting advertising of pharmacies.

The letter on these matter signed by nearly five thousand Polish pharmacists was sent to the Ministry of Health.

The Polish government refused to change the Article 94a

The Polish government has rejected proposals to make any change of the Article 94a of the Pharmaceutical Law because after two years evidences proved that the effects of the ban are very positive for patients and the National Health Fund.

The Polish Pharmaceutical Association representing the pharmaceutical profession and many pharmacists working as scientists at pharmaceutical faculties at ten medical universities in Poland has supported the position of the Polish Pharmaceutical Chamber and the Polish government concerning the ban of advertising of community pharmacies.

Complaint of the Polish Confederation Lewiatanto the European Commission

The Polish Confederation Lewiatan (the business association) representing owners of biggest pharmacy chains in Poland lodged a complaint against Article 94a of the Pharmaceutical Law that introduced the ban of advertising of community pharmacies in Poland to the European Commission in October 2013.

We do not know the detailed text of the complaint but we know that Lewiatan has referenced:

Article 3 and 4 of The Treaty of European Union,

Article 34, 49 and 101 of The Treaty on the Functioning of the European Union and

The Title VIII of The Directive 2001/83/EC of the European Parliament and of the Council

The Role of Pharmacists in the Health Care System

Experiences of most European countries show explicitly that the main direction of development of pharmacies in Europe should be desire to advance pharmacy profession and community pharmacy services.

Pharmaceutical care focused on patient performed by committed health care professionals creating multidisciplinary team benefits patients and health care systems much more than marketing strategies with the aim to achieve only business goals.

Medicines should not be treated like ordinary articles of commerce and community pharmacies should not be treated like “shops with medicines” because in this case it would not be possible to perform the complex pharmaceutical care that should be an important element of the state’s medication policy.

Thank you for your attention

Piotr BohaterInternational Affairs Coordinator

Polish Pharmaceutical Chamber