Ban of Advertising of Community Pharmacies in Poland Piotr Bohater International Affairs Coordinator Polish Pharmaceutical Chamber

The self-government of the pharmaceutical profession is independent and subordinated only to legislation, especially to: - the Law on Pharmaceutical Chambers - the Pharmaceutical Law There are about members of the pharmaceutical self-government in Poland

The Polish Pharmaceutical Chamber and its organs have their seat in the capital city of Warsaw Regional Pharmaceutical Chambers The area of operation of each particular regional pharmaceutical chamber and its seat is determined by the Polish Pharmaceutical Chamber, taking into account the basic administrative territorial division of the state

- different magnitude of area of operation - different number of members 20 Regional Pharmaceutical Chambers

Number of Pharmacies per Country 5

One of the most liberal pharmacy system in 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 Main provisions of the Reimbursement Act came into force on the 1st of January 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 system in 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.

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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 RESTORING THE RIGHT PLACE OF POLISH PHARMACIES IN THE HEALTH CARE SYSTEM After many years of liberalisation of pharmaceutical distribution the Polish government decided to stop the negative trend because practical experiences proved that it was unfavourable for both the public interest and for the state’s complex medication policy After many years of liberalisation of pharmaceutical distribution the Polish government decided to stop the negative trend because practical experiences proved that it was unfavourable for both the public interest 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 price and co-payment Pharmacies are obliged to comply with the price and patient’s co-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 Advertising of Community Pharmacies The provisions on the prohibition of advertising of community pharmacies are simple and clear. In accordance to the Pharmaceutical Law Article 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 Advertising Standard 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 Advertising of Community Pharmacies Supervision over the ban of advertising of community pharmacies in Poland hold Voivodeship Pharmaceutical Inspectors according 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 Advertising of 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 Against the 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 Lewiatan to 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 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 Bohater International Affairs Coordinator Polish Pharmaceutical Chamber