Many countries in the WHO European Region have legal provisions governing the establishment of new pharmacies. They are usually based on demographic and geographical criteria and are generally the same throughout the country, although sometimes adjusted to the specifics of a particular territory. For example, this is the case in Spain, where autonomous communities (regions) are allowed to adapt the criteria established at the national level and thus bring them in line with their specifics. Planning for the infrastructure of community pharmacies can also be done at a more local level, as in Italy, where these functions are transferred to the level of the city, which is responsible for Pianta organica.
These restrictions often serve as regulatory mechanisms through which the state plans the pharmacy infrastructure. In Finland, the law stipulates that the number of pharmacies must be sufficient to ensure that the population has access to pharmaceutical products without difficulty, thus defining the goal of pharmacy network planning. Thus, the license for an out-of-hospital pharmacy is often tied to its location or territorial unit, as mentioned, for example, in France.
To ensure fairness and enable transparent decision-making (and the possibility of appeal), in countries with pharmacy infrastructure planning, the legal and regulatory framework usually contains detailed criteria for the establishment and location of out-of-hospital pharmacies, as in Belgium, Malta and France. In some countries, such as Turkey and Finland, it is publicly announced that an out-of-hospital pharmacy license is available.
Countries with pharmacy infrastructure planning also have specific criteria for relocating an existing pharmacy. For example, in Malta, a pharmacy can only be relocated within the same town or village if there is a site with better facilities and if the new pharmacy is not less than 300 m m from any existing pharmacy or not more than 50 m m m from the premises where it is currently located. Similarly, in Portugal, when relocating an out-of-hospital pharmacy, it is necessary to “guarantee citizens’ access to medicines, take into account their convenience and also the economic viability of the pharmacy whose location the owner intends to change”.
In countries attempting to stabilize or reduce the number of out-of-hospital pharmacies, there are some rules and regulations that facilitate mergers and, in parallel, prevent potential imbalances in access to medicines as a result of such mergers. For example, in Belgium, after a merger of out-of-hospital pharmacies, it is not possible to open (or relocate) a new pharmacy within 1.5 km of the pharmacy that remains. Moreover, according to this regulation, the number of pharmacies cannot be increased for 20 years – from December 8 1999 on.
If a pharmacy license has to be revoked for pharmacy infrastructure planning purposes, the regulations may establish compensation to the pharmacy owner, as in Denmark.
Demographic and geographic constraints
In some countries in the WHO European Region, the granting of a license to open a new pharmacy may be conditioned on specific demographic criteria. The most common of these is the size of the population in a city, district or administrative region. Demographic criteria are usually based on state census data. However, the criteria for establishing a new pharmacy and additional pharmacies may differ.
However, demographic criteria do not always reflect the pharmaceutical care needs of transit passengers (e.g. airports). In France, special rules have been established at the regulatory level to calculate the number of out-of-hospital pharmacies that may be allowed to operate at an airport, based on the number of passengers per year. Thus, the first out-of-hospital pharmacy can be opened when annual passenger traffic exceeds 3 million and an additional pharmacy for every 20 million additional passengers.
In some countries, geographical criteria are used to decide whether to grant or deny a license. This avoids the concentration of pharmacies in one area. One widely used criterion is the distance between the planned new pharmacy and existing pharmacies. Sometimes the methodology for calculating this distance is clearly stated (e.g., it is calculated as the length of a straight line from the entrance to an existing pharmacy or walking distance). This distance ranges from 100 m in Northern Macedonia to 5 km in Belgium and Slovenia.
In many countries, such as Belgium, Hungary and Croatia, the allowable distance between pharmacies is adjusted according to the size of the city. For example, in Croatia, the minimum distance in large cities (more than 500 000 inhabitants) is 200 m, while in smaller cities it increases to 500 m.
Sometimes another criterion used in regulation is the territorial unit. For example, it may be a small town or village or also a unit specifically established for planning the infrastructure of out-of-hospital pharmacies. In Finland, a license for an out-of-hospital pharmacy is issued for a specific assigned area, usually a municipality. Large municipalities and cities may be subdivided into several such pharmacy sites with several pharmacies in each.
Some criteria may be set to prevent monopoly in each village. In particular, they are stipulated in Malta’s regulatory framework, which states that “within one town or village, the number of pharmacies for which a license may be issued shall not be less than two”. And finally in Portugal it is not allowed to locate out-of-hospital pharmacies closer than 100 m from a hospital or health center, except in municipalities with a population of less than 4000.
No restrictions
In some countries, there are no restrictions on the location of a new pharmacy, provided that other legal requirements are met. This is the case, for example, in Bulgaria, the Czech Republic, Germany, Ireland, the Netherlands, Norway and the Czech Republic, as well as in Albania, Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Tajikistan and Uzbekistan. Some countries have never had these restrictions (as in the Netherlands), while others have abolished them: for example, in Ireland, rules for the establishment of new pharmacies were introduced in the 1990s, but eventually abolished in 2002. In Norway, the criteria for establishing a new pharmacy were abolished in conjunction with the entry into force of a new law on March 1, 2001. Such liberalization usually leads to an increase in the number of out-of-hospital pharmacies. However, new pharmacies are mainly established in urban areas where there are already good conditions for access to medicines and pharmacists’ advice, while they are rarely opened in rural areas where there are no pharmacies at all.
Shutterstock/FOTODOM UKRAINE photos were used
