Przegląd regulacji rynków farmaceutycznych wybranych krajów Unii Europejskiej

Katarzyna Pogorzelczyk1, Joanna Synoweć2, Marlena Robakowska3, Daniel Ślęzak1, Piotr Holajn1,
Piotr Robakowski4, Przemysław Żuratyński1, Klaudiusz Nadolny5

1DEPARTMENT OF EMERGENCY, MEDICINE FACULTY OF HEALTH, MEDICAL UNIVERSITY OF GDAŃSK, GDANSK, POLSKA

2UNIVERSITY CLINICAL CENTRE, GDANSK, POLSKA

3DEPARTMENT OF PUBLIC HEALTH & SOCIAL MEDICINE,MEDICINE FACULTY OF HEALTH, MEDICAL UNIVERSITY OF GDAŃSK, GDANSK, POLSKA

4UNIVERSITY OF GDAŃSK, GDANSK, POLSKA

5DEPARTMENT OF EMERGENCY, MEDICINE FACULTY OF HEALTH, MEDICAL UNIVERSITY OF BIAŁYSTOK, BIALYSTOK, POLSKA

 

Abstract

Introduction: Pharmacy markets, operating in the European Union are regulated by national laws. In many of them, the main restrictions concern the process of creating a new pharmacy institutions. They are basic criteria for entities that can carry out this form of business, as well as demographic and geographic factors regulating the possible location of a new pharmacy. In Poland, the Act of from the 7th of April 2017 has changed the pharmaceutical law and introduced new legal restrictions so far unknown on the Polish market.

The aim: To analyze the main changes in the Polish legal requirements focused on opening process of new pharmacies and review of regulations on European markets.

Materials and methods: The materials used in the study were concentrating on legal acts regulating the pharmacy markets of the European Community countries, as well as EU directives issued by the European Union Parliament. The analysis of the Polish market took place on the basis of the adopted amendment to the Pharmaceutical Law in the Act from April 7th 2017 (Journal of Laws 2017, No. 0, item 1015)

Conclusions: The amendment to the Pharmaceutical Law, brings the Polish pharmaceutical market standard to European conditions. The introduction of the restrictions on the pharmaceutical market in Polish will contribute to the fulfillment of the obligation to guarantee permanent and equal access to benefits for all citizens.

 

Streszczenie

Wstęp: Funkcjonowanie rynków farmaceutycznych prowadzących działalność w Unii Europejskiej jest uregulowane przez prawo poszczególnych krajów. W wielu z nich główne ograniczenia dotyczą procedur związanych z powstawaniem nowych aptek. One to, obok czynników demograficznych i geograficznych regulujących możliwą lokalizację nowej apteki, stanowią główne kryteria dla podmiotów rozpoczynających działalność. W Polsce ustawa z 7 kwietnia 2017 zmieniła prawo farmaceutyczne i wprowadziła nowe prawne ograniczenia, do tej pory nieznane na polskim rynku.

Cel pracy: Analiza głównych zmian w polskich wymaganiach prawnych dotyczących procesu otwierania nowych aptek oraz przeglądu regulacji na rynkach europejskich.

Materiał i metody: Materiał stanowiły akty prawne regulujące rynki farmaceutyczne w krajach Wspólnoty Europejskiej, a także dyrektywy UE wydane przez Parlament Europejski. Analiza polskiego rynku została przeprowadzona na podstawie przyjętej nowelizacji prawa farmaceutycznego w ustawie z kwietnia 7 th 2017 (Dz.U. 2017, Nr 0, poz 1015)

Wnioski: Nowelizacja prawa farmaceutycznego dostosowuje polski rynek farmaceutyczny do standardów europejskich. Wprowadzenie ograniczeń prawnych przyczyni się do obowiązkowego zagwarantowania stałego i równego dostępu do świadczeń dla wszystkich obywateli.

 

Wiad Lek 2018, 71, 7, -1408

 

INTRODUCTION

Striving the guarantee of proper and unrestricted access to medical services and medicines is a duty of the state. In Poland, the role of authority in this area is for example.: providing medical care financed from public funds, which is defined in the art. 68 of the Polish Constitution [1]. However, their reachability is limited by many economic and demographic factors.

Pharmaceutical laws are interdisciplinary, legal and organizational activities carried out as one of the basic tasks of the Ministry of Health. Ensuring that citizens have adequate access to safe and effective medicines while minimizing the financial contribution of patients during treatment is the fulfilment of the statutory obligation [2]. The Ministry of Finance and above all, the Ministry of Health, are standing for the current shape and principles behind Polish Pharmaceutical Law. The initiator and coordinator who is supervising the drug market is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, cooperating directly with the Minister of Health and the National Health Fund. The results of joint decisions made by the above mentioned bodies, are to provide patients with access to information, as well as optimization of medical costs, taking into account the accompanying socio-economic situation of the state.

In most of European countries, the pharmaceutical market is, as well as the one in Poland, regulated by governments [3]. The restrictions there are primarily those arising from the demographic or geographical criteria imposed. The attention is also paid to the pharmacy manager, in most cases they are pharmacists or companies where the majority of shares belong to them. Each country, according to EU Directive No. 2005/36 / EC from the 7th of September 2005 on the recognition of professional qualifications (Journal of Laws No. L 255, p. 22) [4], sets individual norms and rules for the creation of new pharmacies and patient access to medicines within its boundaries. Since the entry into force of the Pharmaceutical Law Act from September 6th, 2001 (Journal of Laws 2001, No. 126, item 1381)2, this document has been amended several times over the past 17 years. Change, known as Pharmacy for the Pharmacists, passed April 7, 2017 (Journal of Laws 2017, No. 0, item 1015) [5], this update assumes the introduction of legal and formal legal unknowns on the Polish pharmaceutical market so far.

THE AIM OF THE STUDY

The aim of the study is to analyze the juristic regulations in European countries on the basis of legal acts that constitute the pharmaceutical law in each of the countries included in the work, i.e.: selected countries belonging to the European Union. The comparison has been subject to regulations regarding the creation of new pharmacies, the requirements for their deployment – including size of the town and the total number of population, the minimum number of patients per one branch and the minimum distance between two pharmacies. Also taken into account are the provisions regarding entities that may operate such a branch.

METHODS AND MATERIALS

The material analyzed in the work were legal acts constituting on pharmaceutical law dedicated to EU countries.

The work is also focusing on the EU directives issued by the European Parliament regarding standards, decisions that states can take individually, as well as the rules for harmonizing legislative acts in line with the achievement of Community objectives.

In the course of the paper , publications were also used on the pharmaceutical markets characteristic of given countries and related to their amendments, transformations – socio-economic or legal problems.

KEY FINDINGS.
LIMITATIONS OF THE POLISH MARKET

After Poland’s accession to the European Union, national legislation constituting the appearance and operation of Polish Pharmaceutical Law had to undergo a wide scale of changes. For almost 14 years, the acts regulating health policy and, consequently, the pharmaceutical market have undergone transformations that bring them closer to the standards that accompany European Union Members [6]. The last update of this document, known as Pharmacy for the Apothecary, passed on the 7th of April 2017 (Journal of Laws 2017, No. 0, item 1015), assumes many changes, that so far were unparalleled with the solutions at the level of the power-legislation-pharmacy.

One of the main changes is the introduction of provisions regarding entities that may run a business like pharmacy. Under the new regulations, only people with higher education, a pharmacist with an important right to practice as a sole proprietor (bearing professional and financial liability) or pharmacists in the form of selected types of partnerships (general partnership and partner company) are allowed to open the pharmacy. The only exception will be the situation of acquiring the pharmacy from the heir in its entirety (the address remains unchanged) [5].

The amendment to the act, also contributes to the introduction of legal restrictions in the form of demographic and geographical regulations. In the process of locating a new pharmacy, it will be necessary to properly justify the selection of a place for a new pharmacy. The law update assumes that at least 3,000 residents will belong to the new institution. It does not at the same time specify the division into cities, smaller towns or villages. This number is fixed. An additional aspect is also the need to comply with the requirement to maintain a distance of at least 500m from an already existing pharmacy. The only exceptions to this rule is the purchase of the institution from the heir in its entirety with the current address, or if the distance from the selected place to locate a new pharmacy point to an already existing pharmacy is at least 1000m in straight line on the day of submitting the application for the permit to conduct this type of activity.

Restrictions on European markets

In the European Union, there is no uniform or even dominant model of the pharmacy market7. However, according to the four basic types of practicing pharmaceutical / pharmacy policy can be distinguished:

• countries which acts constituting pharmaceutical law are defined by many standards and limitations; the authorities’ approach is defined as restrictive, examples are: Austria, Cyprus, Denmark, Finland, Iceland, Luxembourg, Liechtenstein, Slovenia or Germany,

• countries which approach to activity on the discussed market is liberal, with the intention to start a business − there are no restrictions; examples are: the Czech Republic, the Netherlands, Ireland, Sweden, Norway, the United Kingdom and Switzerland,

• countries which defined as their policy the mix of features of the two above models; mixed model; Examples include Italy, Portugal, Spain, France, Greece, Croatia, Bulgaria, Latvia, Slovakia and Malta,

• countries which pharmacy policy is undergoing transformation, the so-called model in transformation, which occurs in Belgium, Estonia, Romania or Hungary [8].

The analysis of legal acts regulating the pharmaceutical law of the European Union countries makes it possible to notice the lack of unambiguous tendency when introducing or applying restrictions or exacerbations of running a pharmacy institutions, or on the other hand, the pharmaceutical production. However, one can distinguish four, most frequently occurring, restrictions of this area [9]. For 17 of the 32 analyzed countries, a common regulation is the limitation of the number of pharmacies owned by one entity to a maximum of four branches. The identification of an entity that can run such an economic activity using the pharmacy for a pharmacist principle is present in 14 countries (excluding Poland). Geographical and demographical complications, respectively 10 and 15 analyzed countries, turned out to be other barriers encountered in the files.

Limited number of pharmacies
/ pharmacy for a pharmacist

Limiting the maximum number of pharmacies (in most cases up to four branches), which may be owned by one entity, applies primarily in Estonia, Hungary, Denmark, Finland, Austria, Spain, as well as in France or Germany. Currently, over 60% of Europeans live in a country where the pharmacy can only be run by a pharmacist or pharmacists’ company. This phenomenon has often been subject to legal review by the Court of Justice of the European Union. The problem here was the reduction of the establishment freedom. The restriction of this zone of the pharmaceutical market led to the introduction of restrictions on the necessity of a pharmacist practicing professionally as the owner of a pharmacy in France. In addition, at least 51% of shares in this type of facility must belong to pharmacists. The same situation occurs in Spain, Hungary (since 2011) and Estonia (since 2014). Another range of restrictions is recorded in Latvia. In this country, in the case of the desire to run a pharmacy, there are two types of solutions. Similarly to the ones discussed above, the owner, should be a pharmacist (there is no requirement to maintain professional practice) or the need to have qualified managers in human resources (50% of people holding this position).

Demographical
and geographical criterion

Demographical limitations – constituting a minimum number of patients, which a given pharmacy institution can supply with drugs, as well as geographical, which determines the minimum distance that should be between successive pharmacies, are one of the most common in European legislation. For each country, these are individual regulations, such exacerbations occur in Great Britain, Spain, Slovenia, Portugal, Luxembourg, Finland, France, Estonia, Croatia, Denmark, Belgium, Austria, Lithuania, Italy and Malta. The characteristics of the discussed limitations for selected countries are presented in Table 1.

DISCUSSION

The Polish pharmaceutical market is a regulated market. As Krążyńska says in her work, this market can also be described as largely closed [10]. The drug policy implemented by the authorities, as well as the pharmaceutical law resulting from it directly affects the model of shaping the domestic market [11]. Regulations, which are determined by subsequent amendments, affect not only the drugs prices and the level of payment for them, but are also introducing the set of new restrictions in the case of opening a new pharmacy. The latest amendment to the Pharmaceutical Law Act from the 7th of April 2017 introduces a number of legal regulations unknown to the Polish pharmaceutical market [5]. As presented by the Supreme Pharmaceutical Chamber, more than 0.5 million people working in the so-called white staff, support the solutions contained in the latest statutory update [12]. The solutions that the latest amendment to the Pharmaceutical Law brought, is not new to the European markets. Poland is also not the only country that has recently taken a step towards increasing the level of legal regulations in this area or is planning to introduce them in the near future. As it is evident from the Gross and Volmer study carried out in Estonia, the use of just such changes as specifying requirements in relation to the potential owner of a pharmacy establishment, and the exacerbation of the location of such activities is a very good idea [13]. Importantly, these changes, work in favor of mini companies and pharmacies, which would be located in the villages. The same issue was recalled by the Supreme Pharmaceutical Chamber. He estimates that the Act on the amendment is a salvation for equals 4,500 Polish microenterprises. NIA talks about the consequences of adopting new provisions. Currently, nearly 60% of the pharmacy sector belongs to the pharmacy network [12]. The restrictions regarding the creation of new ones will therefore be, to some extent, helping to the family pharmacies, small outlets run in small towns, as well as those operating with a long tradition in a large urban agglomerations. However, this situation also has a second issue. These legal changes meet with constant negation on the part of representatives of pharmacy chains. The requirement that such activity, should be carried out by a pharmacist or restrictions to the legal form that may lead a pharmacy – a partnership or partner company also does not support the further expansion of the pharmaceutical market by the giants of this industry.

With the structures development of pharmaceutical markets in Europe – the introduction of subsequent changes to the pharmaceutical industry, there were many discrepancies in the interpretation of the law. Referring to the expansion of pharmaceutical networks, in recent years, in accordance with the publications of subsequent amendments to the pharmaceutical law of EU member countries, many complaints and opinions issued by the European governing states. The main topic turned out to be the aforementioned choice of the pharmacy owner. Similarly to Poland, in Germany, this function can only be performed by a pharmacist [13]. In this case, a caveat for infringement of the freedom of establishment guaranteed by community law has been referred to the Court of Justice of the European Union. As can be read from the justification of the TS, a qualified specialist pharmacist has the ability to run a pharmacy not only for profit but also to perform professional duties [13]. The CJ also indicates that the private interest of the pharmacist is directly connected with his education, professional experience and the responsibility he bears for any violation of legal provisions or professional ethics (judgment of the Grand Chamber from the 19th of May 2009 in C 171 cases) / 07 and C 172/07; Apothekerkammer des Saarlandes) [13].

As presented in the amendment of the Pharmaceutical Law, the introduction of such solutions on the Polish market will result in the market ordering being started and will limit the violations that have occurred so far.

Another aspect that was often discussed was demographical and geographical limitations. Each country defines them individually, but such decisions are to be consistent with Community law – the Treaty on the Functioning of the European Union. Spain, specifying the requirements to be met in the case of setting up a new pharmacy establishment, also took into account areas that are not characterized by the same or similar demographic conditions as metropolitan areas. In spite of the dispute that arose around this decision, the TSEU issued a judgment on the rational action of the Spanish government. As can be read in the judgment of 1 June 2010 in cases C570 / 07 and C571 / 07, health and life have a higher significance than good and interests protected by the Treaty. Worth noting is also the position of the SE saying about the voluntary level of ensuring public health protection and the form of obtaining this level. The Supreme Chamber of Pharmacists has a similar position with regard to the latest update of Polish law. As the chamber points out, the main objective of the Act is to restore the availability of medicines and services of pharmacists also in rural areas. The introduced obligation of demographical and geographical criteria will allow patients to have easier and more convenient access to pharmacies.

CONCLUSIONS

The amendment of the Pharmaceutical Law Act, in spite of many extreme opinions, brings the Polish market of the pharmaceutical industry closer to the standards prevailing for decades in the area of the European Union community. Determined but also strict restrictions directed to entrepreneurs of the pharmaceutical market and contributes to the systematization of the process of increasing the number of pharmaceutical outlets in the country. The introduction of legal barriers standing in the way of locating new ones, will have a positive impact on the processes accompanying the guarantee of equal access to pharmaceutical care services for the society.

REFERENCES

1. The Constitution of the Republic of Poland of April 2, 1997. (Journal of Laws of 1997 No. 78 item 483),

2. Act of 6 September 2001, Pharmaceutical Law (Journal of Laws of 2001 No. 126 item 1381),

3. Nojszewska E. The Health Care System in Poland. Warsaw: Wolters Kluwer, 2011.

4. Directive 2005/36 / EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications,

5. Pharmaceutical Law Act of April 7, 2017 (Journal of Laws 2017, No. 0, item 1015),

7. Michalik M, Mruk H, Pilarczyk B. Strategic marketing on the pharmaceutical market, Warsaw: Wolters Kluwer, 2011,

8. Szalonek K. New directions for marketing in the pharmaceutical market. In: Marketing and Management. Szczecin: University of Szczecin Publishing House, 2013, 77-86,

9. Pharmanet Pharmaceutical Employers’ Association, Report on restrictions on the pharmacy market in the European Union, Warsaw, 2015

10. Krążyńska K. Pharmaceutical pharmaceutical market and drug consumption in Poland. Consump Develop. 2013;2(5):109-119.

11. Czech M, Jasiński Z, Zięba P. Drug policy in the field of biological and biosimilar medicines. From the specificity of the molecule to the market situation – analysis in selected European Union countries. Med News 2013;82(4):277-287,

12. Supreme Pharmaceutical Chamber, Amendment to the Pharmaceutical Law Act (so-called “Apteka for the Apothecary”), http://www.nia.org.pl/2017/06/26/nowelizacja-ustawy-prawo-farmaceutyczne-tzw-apteka -dla-aptekarza / (access 12/03/2018),

13. Gross M, Volmer D. Restrictions to Pharmacy Ownership and Vertical Integration in Estonia-Perception of Different Stakeholders, Tallinn, 2013

Conflict of interest:

The Authors declare no conflict of interest.

CORRESPONDING AUTHOR

Daniel Ślęzak

Chair and Clinic of Emergency Medicine,

Medical Emergency Laboratory,

Faculty of Health Sciences with the Division of Nursing

and Institute of Maritime and Tropical Medicine,

Medical University of Gdańsk,

ul. Smoluchowskiego 17, 80-214 Gdańsk

e-mail: daniel.slezak@gumed.edu.pl

Table 1. Demographical and geographical limitations − characteristics of selected European countries

Country

Demographical limitation

(number of inhabitants /

one pharmacy)

Geographical limitation (minimum distance between two pharmacies)

Spain

min. 2.800, except for the town

with specific demographics

min. 250 m

France

In cities over 30,000 Residents – 3.000,

smaller towns + villages − 2.500

Estonia

3.000 residents

min. 500m

Austria

5.500 residents

min. 500m

Italy

In cities over
12.500 residents – 5.000 residents,
in smaller cities – 3.000 residents

min. 200m

Hungary

Cities over 50.000 residents – 4.000 people, smaller cities and villages – 4.500 people

min. 250m