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Pharmacy Models in European Union Member States

INTRODUCTION

This report, which has been drawn up by the General Spanish Council of Pharmacists, principally aims to objectively analyse the various pharmacy models that exist in Europe. The information has been gathered from the fifteen European Union member states, as well as from several European Commission reports.

The chapters of this document have been structured in accordance with the pharmacy models in European Union member states. The planning criteria needed to open a pharmacy in each of the countries are analysed, as is the system of ownership, practice and transfer of these. The dispensing of medicines is another aspect that is studied, along with the various services provided in pharmacies in the different European countries.

The functions and responsibilities of the professionals who work in pharmacies is another issue that is covered, as well as whether or not this job is compatible with other professions.

Certain medicines can be bought outside the confines of the pharmacy channel in several European countries, and this feature is highlighted throughout the document in the countries where this occurs. Likewise the advertising of medicines and its regulation is another aspect of the profession, which is discussed.

Contents

German Pharmacy Model

In Germany, the pharmacy owner must be a qualified pharmacist. Joint ownership of pharmacies is prohibited and the pharmacist can only own one pharmacy.

Authorisation to open a pharmacy is issued by the competent authority of the regional government (Länder). There are no geographical distribution criteria in Germany to regulate the opening of pharmacies. Neither are there any restrictions with respect to the sale of pharmacies, thus the transfer is unrestricted, the only condition being that the buyer is another qualified pharmacist.

With respect to the transfer of the pharmacy in the event of the death of the owner, German law allows the spouse to keep the pharmacy for economic reasons, until he or she remarries. The children can keep the pharmacy until they reach the age of 23. If the youngest child studies pharmacy, the transfer period can be extended until he or she has completed his or her studies.

German regulations include the obligation for the pharmacist to be present in the pharmacy, where they assume final responsibility. Only in exceptional circumstances (illness, holidays, etc.) may the pharmacist be absent for a three-month period every year. Likewise, the pharmacist who takes final responsibility has the right to undertake additional activities, as long as this does not prevent them from fulfilling their obligations in the pharmacy. They are prohibited from undertaking any other activity that is incompatible with the standards of the profession.

Pharmacists working in pharmacies can only conduct certain types of simple analyses in their pharmacy. Every pharmacist must have a laboratory in which products are monitored. The following are some of the analyses that can be conducted in the pharmacy: pregnancy tests, blood pressure, the taking of blood samples, albumin and blood analysis, among others.

In Germany, pharmacies can dispense medicines and other health-related products. They do not however have the exclusive rights to dispense medicines, as vets can also sell medicines for animals under their treatment, and certain medicines can be sold in centres other than pharmacies.

The advertising of prescribed medicines and pharmacies is strictly forbidden. On the other hand, the advertising of pharmaceutical specialities is permitted in all communication media, as long as a series of indications concerning the risks involved in their use and the contraindications are specified, or the phrase "consult your doctor or pharmacist" is present.

The opening and closing hours of pharmacies are regulated, as are the emergency night services, which stipulate that one pharmacy out of every 20 should be open.

There are no restrictions on pharmacy owners transferring their business to another place. Neither is there any compulsory retirement age for the pharmacist.

There are two types of medicine in Germany: those with prescription, which depend on their active principle and are classified in accordance with their dosage, presentation or applications; and those available without a prescription which, in some cases, can be sold in places other than the pharmacy.

Remote selling or teleshopping is authorised for the products that can be sold in premises other than pharmacies.

Austrian Pharmacy Model

In Austria, the pharmacy owner must be a qualified pharmacist. Permission to run a pharmacy can only be given to a pharmacist. The latter must run the pharmacy as the sole proprietor, or in the form of a company in which he or she must hold the majority of shares. Only a pharmacist can be the owner of pharmacy and manage it, which they should do in person.

A study, based on geographical (distances from existing pharmacies) and demographic criteria (maintenance of the sales' potential of the existing pharmacies), is carried out in order to assess the need for opening a new pharmacy.

Austrian regulations stipulate a minimum distance of 500 metres from the nearest pharmacy (geographical criterion) and a remaining population of 5,500 consumers for existing pharmacies (demographic criterion) for opening a pharmacy.

The sale of a pharmacy in Austria is permitted only after five years have elapsed since authorisation was granted for its opening.

With respect to the transfer of a pharmacy as a result of the death of its owner, Austrian legislation allows the spouse to lease the pharmacy to another pharmacist for a period of five years, with the lessee working on a self-employed basis. The children of the deceased can likewise lease it to another pharmacist, until they reach the age of 24. If one of the children is studying pharmacy, or is already a qualified pharmacist, the pharmacy can be leased until he or she reaches the age of 35. When the rights of the inheritors have expired, if they do not meet the conditions required to run a pharmacy, the business should be sold or a company created with a pharmacist, who should be the majority shareholder.

Austrian regulations include the obligation for the pharmacist to be present in the pharmacy, where they assume final responsibility. The pharmacist must serve in the pharmacy for which he or she is responsible, and must run it personally. Should the pharmacist be unable to be present in the pharmacy for more than a six-week period (due to illness or leave) he or she must contract a replacement and inform the competent authority of this person's name. If the pharmacist is unable to work for more than a six-week period, they and their replacement manager must receive special permission.

Furthermore, the pharmacist responsible for a pharmacy cannot undertake any other activity that might interfere with their personal management of the pharmacy. The Austrian pharmacist cannot undertake any type of analysis in their pharmacy.

In general, only pharmacists can dispense medicines, although in some cases other health professionals can sell medicines. This applies to some doctors who, when treating their patients, can obtain permission to set up a pharmacy for internal use, if the surgery is over six kilometres from the nearest pharmacy. Veterinary clinics can have a pharmacy without the need for authorisation in order to meet clinical needs. Likewise, some pharmaceutical products, specified by the relevant regulations, can be sold in some retail outlets. Pharmacies can dispense medicines and other health-related products.

As far as advertising is concerned, the regulations permit advertising outside the pharmacy and the advertising of other pharmaceutical products within strict limits.

Belgian Pharmacy Model

There are no regulations governing pharmacy ownership. Any natural person or legal entity can own a pharmacy in Belgium. The only condition is that there should always be a pharmacist in charge of the pharmacy. According to 1998 data, 83% of the pharmacies are privately owned, while the remaining 17% belong to cooperatives. A pharmacist, or any natural person or legal entity, can own several pharmacies in the same state; however, only one pharmacist can manage and be at the head of one pharmacy. Belgian regulations lay down a combination of demographic and geographical criteria, which include distances and density of population, for opening a new pharmacy.

Belgian law allows two pharmacies to merge, as along as both are in the same population centre, there are at least two other pharmacies apart from the one that has merged, and the number of pharmacists is at least the same as were working in the previous two. Authorisation for the transfer or merging of pharmacies must be issued by the Ministry of Health.

The sale or transfer of the pharmacy is allowed if it has been open for at least five years. Pharmacies can be freely transferred and are not subject to any regulatory conditions to impede their inheritance, as long as the rules for the determination and valuation of the transfer have been observed. The price paid for the pharmacy cannot exceed the value of the following elements: fittings and technical equipment, product stock and 150% of the average gross profit obtained over the last five years.

A pharmacist is obliged to be in the pharmacy, but may be replaced by another pharmacist, who then assumes ultimate responsibility. The pharmacist who works in a pharmacy cannot conduct any other medicine-related business, nor can he or she trade in non-pharmaceutical products; neither can the pharmacist work in the industry, nor as a pharmaceutical product wholesaler. The pharmacist who does not work in the pharmacy can undertake any activity that is compatible with the honour and dignity of the profession. Pharmacists cannot run a pharmacy and carry out clinical analyses at the same time. However, an assistant pharmacist can carry out these analyses in the pharmacy.

Medicines must be dispensed by pharmacists. Doctors and veterinary clinics authorised to store medicines can also sell them to patients (or for animals) under their care. Doctors and veterinary clinics are obliged to purchase medicines in a pharmacy that is open to the public. Only medicines and health-related products, such as dietetic products, can be sold in pharmacies.

Distance selling, Internet selling and the teleshopping of non-prescriptive medicines are prohibited in Belgium. Only parapharmaceutical products can be sold by post. Prescriptive medicines cannot be advertised. Pharmacists cannot advertise their pharmacies. Comparative advertising or medical claims for health products is also forbidden.

There is no stipulated age at which the Belgian pharmacist is obliged to retire. The opening and closing hours of pharmacies and emergency services are established by the local pharmaceutical associations. Pharmacists receive a professional fee for duty services and the preparation of magistral formulae.

Danish Pharmacy Model

In Denmark, the pharmacy owner must be a qualified pharmacist. The pharmacist can only own one pharmacy and cannot be responsible for more than one.

The Ministry of Health is the body that grants authorisation for the opening of pharmacies. Authorisation is only given to those pharmacies that have applied for it. Danish legislation does not impose any demographic or geographical criteria for opening a pharmacy. Nevertheless, the administrative authority attempts to ensure that patients do not have to travel more than 15 kilometres to reach a pharmacy.

The sale of pharmacies is prohibited. The property license expires when the owner reaches 70 years of age and is granted to another pharmacist following an application to the Ministry of Health.

When the pharmacy is transferred as a result of the death of the owner, Danish law allows the inheritors to retain the property for a period of six months, or until the license is granted to another pharmacist by the Ministry of Health.

There must be a pharmacist present at opening time, who assumes ultimate responsibility for the pharmacy. If the pharmacist is unable to be present on account of illness, they can be replaced by another pharmacist for a year.

Any pharmacist who assumes the ultimate responsibility for a pharmacy may not practice any other profession. More specifically, Danish regulations specify that he or she may not practice medicine, odontology or veterinary medicine. Moreover, the pharmacist is prohibited from having financial interests in the production or wholesale of pharmaceutical products.

Pharmacists working in pharmacists can only undertake certain types of simple analysis in their pharmacy. Very few biological medical analyses are conducted: pregnancy, blood pressure and cholesterol tests. Pharmacists do not have exclusive rights for the sale of animal medicines. Furthermore, veterinary group medical products and brand name pharmaceutical specialist medicines can be sold in centres by means of a special permit or license from the Danish Medicines Agency.

Pharmacies can sell medicines and other health-related products. Danish law does not prohibit pharmacies, or other interested parties, from advertising their medicinal products.

Spanish Pharmacy Model

In Spain, the owner of a pharmacy must be a Pharmacy graduate, either alone or in partnership with other pharmacists, and each one of them can only own one pharmacy. The pharmacist can only own and run one pharmacy. The authorisation procedure to open a new pharmacy is based on advertising and transparency principles, by means of a competitive examination based on professional and academic merit.

The planning of pharmacies is provided for in Article 2.2 of the Act 16/1997, of 25th April, relating to the Regulation of Services in Pharmacies, which states that they will be opened in accordance with demographic and geographical criteria. The criteria are based on the number of inhabitants and the distances between pharmacies. The competent Autonomous Regional Administrations are those that, on the basis of the planning criteria set forth in the aforementioned State Act 16/97, lay down the population modules required to open pharmacies such that concentrations of pharmacies are avoided in densely populated areas, thus neglecting the health services available in less popular areas.

The sale of a pharmacy in Spain is permitted only after a certain period of time has elapsed since authorisation was granted for its opening.

On the transfer of a pharmacy owing to the death of the owner, Spanish law generally permits the inheritors to retain ownership if they have the requisite qualifications, or are studying to obtain them. Autonomous Regions regulate the ways, conditions, deadlines and all other transfer requirements. Therefore, some regional laws prohibit and/or limit the transfer of pharmacies under particular circumstances. In Spain, the presence and professional activity of the pharmacist is an essential condition and requirement for the dispensation of medicines to the public. The qualified pharmacist assumes ultimate responsibility and has to ensure that users are provided with the service. The replacement of a pharmacist is only permitted in exceptional circumstances and for a limited period of time.

The clinical practice of medicine, odontology and veterinary medicine are incompatible with the ownership of a pharmacy. Likewise, professional practice in a pharmacy is incompatible with any type of financial interest in the pharmaceutical industry.

Pharmacists can carry out clinical analyses, as specialist studies can be pursued in this field. In general, pharmacists are exclusively entitled to dispense medicines. The storage, safekeeping and supply of medicinal products can only be undertaken by legally authorised pharmacies and hospitals, primary care health centres for internal use, or wherever the monitoring, supervision and inspection of multidisciplinary health equipment are required. Veterinary medicinal products can only be dispensed by pharmacists or livestock entity pharmacy services and authorised business concerns.

In addition to medicines, Spanish pharmacies can sell a wide range of products including parapharmacy products. Pharmacists are not allowed to advertise their pharmacy.

Finnish Pharmacy Model

In Finland, the pharmacy owner must be a qualified pharmacist. A pharmacist can only own one pharmacy. Nevertheless, a pharmacist can manage a small pharmaceutical outlet in an area with a small population, as long as they have a license from the National Agency for Medicines. A pharmacist who own s a pharmacy can hold three licenses at most. The licenses to open a pharmacy are granted by means of an open competition system between candidates.

Finnish legislation does not impose any demographic or geographical criteria to open a pharmacy. Nevertheless, in practice, factors such as population and local health services are taken into account. The sale of pharmacies is restricted, but these restrictions have nothing to do with how long the pharmacy in question has been open since its authorisation.

The regulations make the presence of the pharmacist in the pharmacy compulsory. However, the presence the licensed pharmacist is not obligatory. The pharmacist-owner can transfer the management to another pharmacist for a total period of three months per year.

Any pharmacist who assumes ultimate responsibility for a pharmacy may not practice any other profession. Moreover, it is explicitly stated that the pharmacist who owns the pharmacy cannot act as the manager of pharmaceutical laboratory or a wholesale store.

Pharmacists can undertake biological medical analyses in pharmacies. Although legally the conducting of this type of analysis is not prohibited, it does not occur often in practice. During some campaigns, such as for heart disease prevention, other health professionals can take blood pressure readings in the pharmacies. Pharmacists do not hold the exclusive rights over the sale of medicines, given that veterinary doctors are authorised to sell medicinal products for animal use.

Finnish pharmacies can sell a wide range of products in addition to medicines. Non-medicinal products or products which are not health-related represent only a small share of the total turnover. The sale of non-medicinal products, which might interfere with the sale of medicinal products, is prohibited.

Whenever advertising any medicinal product in Finland, the pharmacist who owns a pharmacy must observe the regulations concerning the commercialisation of medicines.

French Pharmacy Model

In France, the pharmacy owner must be a qualified pharmacist. The pharmacist can only own one pharmacy and must run it personally. The law permits joint ownership. Several pharmacists can become joint owners of a pharmacy (with a maximum of 25% of the capital, for a single pharmacy), however, the same pharmacist can never own more than one pharmacy. Apart from these privately owned pharmacies, there are other outlets such as the mutual pharmacies, which are owned by a mutual society and run by a salaried pharmacist. There are other special cases, such as airport pharmacies, which are owned by the airport in question.

The application for a license to open a pharmacy is made individually, without the need for a public notice. The Ministry of Health is the body responsible for issuing the authorization.

Pharmaceutical planning criteria are set in accordance with population figures. The number of inhabitants assigned to each pharmacy is fixed by the law is as follows: one pharmacy for every 2,500 inhabitants if the population is below 5,000; one pharmacy for every 3,000 inhabitants if the population is between 5,000 and 30,000 people; or one pharmacy for every 3,500 inhabitants if the population is over 30,000. However, no criteria have been fixed with respect to the distance between pharmacies, or the size. Opening and closing hours are unrestricted. There are 24-hour emergency service pharmacies, but not many.

Except in the event of force majeure, pharmacies cannot be sold until they have been operating for five years. As provided for by the Public Health Code, only one qualified French pharmacist can set up or buy a pharmacy that has been open for less than three years.

In the event of transfer of the pharmacy as a result of the death of the owner, French law enables a family member to retain ownership on condition that they are a qualified pharmacist. Should the owner die, the pharmacy can contract a manager for a period of no longer than two years, which is the maximum time allowed to sell the pharmacy.

French regulations oblige the pharmacist to work in the pharmacy, although he or she can be replaced in certain circumstances. There are no age limits with respect to exercising the profession. When the pharmacist retires he or she is obliged to sell his or her pharmacy.

Any pharmacist who assumes ultimate responsibility for a pharmacy may not practice any other profession. The Public Health Code allows the pharmacist to run an internal use pharmacy as part of a private or public health establishment with less than 500 beds. Likewise, this regulation permits the creation of an annexe to the pharmacy to make pharmaceutical products.

Pharmacists can carry out some types of simple analyses in their pharmacies, such as glucose and urea tests. All specialist pharmaceutical medicines, be they advertised or not, as well as magistral formulae are sold exclusively in pharmacies. Likewise, homeopathic medicines are dispensed by the pharmacy, given that they are medicines financed by the Social Security system. In France, pharmacies can sell medicines and other health-related products. Dietetic, orthopaedic, cosmetic, optical, infant food, etc. products are not sold exclusively in pharmacies. The pharmacist can only open an optician's if he or she has obtained the relevant degree, and is prohibited from practicing optometry if he or she owns a pharmacy.

In France, a pharmacist can use communication media to inform the general public about the activities of their pharmacy; likewise, the pharmacist can use the telephone directories to provide practical information (opening times, etc.) The Advertising Control Committee forms part of the French Medicines Agency and is responsible for monitoring and fixing the guidelines that must be observed when advertising medicines.

Greek Pharmacy Model

The owner of a pharmacy in Greece must be a qualified pharmacist, who should also have obtained authorisation to work as a pharmacist. The pharmacist can only own one pharmacy. The application for a license to open a pharmacy is made individually, without the need for a public notice. The regional delegations of the Ministry of Health are responsible for issuing the authorisation. There are certain demographic and geographical criteria that must be observed in order to open a pharmacy in Greece. These criteria are based on the distance between pharmacies and the population to be provided with the service. There are no regulations in Greece with respect to the sale of pharmacies.

In the event of transfer of the pharmacy owing to the death of the owner, Greek law permits the surviving spouse to retain ownership for a maximum of five years and the children to do so until they reach the age of 18. There must be a pharmacist present, who assumes ultimate responsibility for the pharmacy. Permission for absence may be authorised on important occasions for a specific period of time. During the owner's absence, they should be replaced by another pharmacist. A pharmacist who has received permission to open a pharmacy is obliged to run it personally, and cannot have any other paid employment, in either the municipal or public administration or private sectors. Furthermore, pharmacists are forbidden from carrying out any types of clinical analysis in their pharmacies. Pharmacists hold the exclusive rights to dispense medicines. In addition to medicines, other health-related products can be sold in pharmacies.

The advertising of specialist pharmaceutical medicines and other non-medicinal products is permitted. Advertising the pharmacy is prohibited outside its confines.

Dutch Pharmacy Model

The law does not provide for the concept of ownership. A pharmacist cannot be responsible for more than one pharmacy, where they assume ultimate responsibility for the services it provides. Likewise, the pharmacist can be replaced by another pharmacist, who then assumes ultimate responsibility. In the Netherlands, the authorisation required to open a shop (including pharmacies) is granted by the local authorities. Applications to open a pharmacy are submitted individually. Furthermore, there are no restrictions on the sale of pharmacies. Dutch law does not take into account geographical or demographic criteria for opening a pharmacy.

In the event of transfer of a pharmacy owing to the death of the pharmacist, the heirs can, under certain conditions, keep the pharmacy. The pharmacist who assumes ultimate responsibility for a pharmacy cannot exercise any other profession, and is specifically prohibited from practicing medicine, even though they are qualified to do so.

The pharmacist can carry out clinical analyses in the pharmacy. With the exception of some rural areas, pharmacists hold the exclusive rights to dispense medicines. Family doctors in rural areas are authorised to dispense medicine to their patients if the nearest pharmacy is over five kilometres away. Furthermore, there are other outlets apart from pharmacies where, under license, a limited number of medicinal products can be sold. Veterinary doctors can also supply medicinal products for animals that are under their care.

In addition to dispensing medicines in pharmacies, other health-related products are also sold. Pharmacists cannot advertise outside their pharmacy, given that this type of advertising is banned by the profession's code of ethics. The advertising of brand name pharmaceutical specialities is permitted.

Irish Pharmacy Model

In Ireland, the pharmacy owner can be a pharmacist, a pharmaceutical company, any legal entity or the legal representative of a pharmacist who is standing in for them after their death, for a period of five years. A pharmacist in this country can own several pharmacies, given that there are no restrictions governing this. The pharmacy must always be run personally by a pharmacist, who can either be the owner or a pharmacist employed to do so. The preparation of medical prescriptions must be personally supervised by the relevant pharmacist.

In order to dispense refundable prescriptions, a "Pharmacy Contractor Agreement" must be obtained, which has to be applied for from the local health authority, and a public notice issued. Objections may be presented and appeals made against the local authority decision. There are a number of criteria laid down for opening a pharmacy, including distance and population density.

There are no restrictions on the sale of pharmacies in Ireland, as long as the buyer fulfils all the requirements to become the owner of the pharmacy. However, a pharmacist who has obtained a degree in another member state can only take on responsibility for a pharmacy that has been operating for three years. This does not apply to the management and supervision of the pharmacy.

In the event that a pharmacist is managing their own pharmacy at their time of death, Irish law permits their legal representative, normally the spouse, to retain ownership for a period of not more than five years. During this time the pharmacy must be managed by a qualified pharmacist. Before the five-year period has ended, the pharmacy must be closed, sold or turned into a pharmaceutical company by the legal representative, who must contract a pharmacist as its manager.

Pharmacists who assume ultimate responsibility for a pharmacy are not restricted from exercising other professions, as long as the pharmacy is personally run by a qualified pharmacist and both the dispensing and preparation of prescriptions are supervised by them. Pharmacists can carry out certain types of simple analyses, although in practice very few are done (pregnancy and cholesterol tests).

Pharmacists do not hold exclusive rights for the retail sale of medicines, given that there are other outlets that can sell medicinal products, described collectively as medicines in the "general sales list". In pharmacies, medicines are dispensed and a wide range of health-related and other products are also sold. As a professional rule, pharmacies are not permitted to advertise outside the confines of their premises.

Italian Pharmacy Model

In Italy the owner of the pharmacy must be a qualified pharmacist, who must also have passed the State exam, and whose name has been entered in the registry of pharmacists for the province in which the pharmacy is located. Pharmacists can also form entities and companies in order to operate a pharmacy. A pharmacist can only own one pharmacy. Pharmacy chains are forbidden.

The pharmacist can become the manager of a pharmacy by buying or acquiring it, either through a public auction by competition or after having worked a period of training, or through inheritance. In order to acquire authorisation to open a pharmacy, a system of open competitions is conducted at the national level. The competition consists in an exam which includes a practical test (laboratory) and an oral exam consisting of 300 test-type questions. The candidate who passes the tests can apply for authorisation to open a pharmacy. If the pharmacist is training, he must spend two years working in a pharmacy in order to be able to buy a pharmacy put up for sale by another pharmacist. Authorisation to open a pharmacy requires the possession of two licenses: one from the competent health authority for each territory and a commercial license, which is issued by the Town Council.

The Italian pharmaceutical system is a regulated model, which uses distances between pharmacies and population criteria. The number of pharmacies is proportional to the number of inhabitants. Towns with a population of less than 12,500 inhabitants have a pharmacy for every 5,000 inhabitants; in other towns or cities there is a pharmacy for every 4,000 inhabitants. There must be a minimum distance of 200 metres between two pharmacies.

Pharmacies can be sold as long as three years have elapsed since the date when authorisation for its opening was granted. In the event of the transfer of a pharmacy following the death of the pharmacist, the heirs should sell the pharmacy within three years. If one of the heirs is studying pharmacy, or decides to begin studying pharmacy, this period can be extended to ten years. The law permits pharmacist who own pharmacies to be replaced in certain circumstances, such as illness, holidays, pregnancy or military service. Furthermore, any pharmacist who assumes ultimate responsibility for a pharmacy may not practice any other profession.

Pharmacists are not permitted to carry out any type of analysis in their pharmacies. In practice, measuring instruments are available for customers to weigh themselves and to take their blood pressure. Pharmacists hold the exclusive rights to sell medicines, and only pharmacies can sell pharmaceutical products. All pharmaceutical products are exclusively dispensed in pharmacies, including health-medical-surgical products and baby foods. Likewise, pharmacies can sell all types of health-related products (parapharmacy, cosmetics, etc.). The distance selling and teleshopping of both prescriptive and non-prescriptive medicines is prohibited.

The pharmacist has the capacity to replace a medicine, as long as it involves generic medicines or magistral formulae. Pharmacists may replace pharmaceutical specialities in the event of need or shortage, subject to the patient's consent. Pharmacists cannot advertise their pharmacies outside its premises. The advertising of pharmacies and medicines is regulated by law. Only the "medicinali di automedicazione" can be advertised to the general public through all communication media.

The opening times are restricted to eight hours and are regulated regionally. There are emergency service pharmacies, which are regulated in accordance with the number of inhabitants in each region. It is possible to run a 24-hour pharmacy if permission has been received from the Pharmaceutical Association. There are no legal restrictions on the transfer of the pharmacy. A pharmacy can be physically transferred as long as it stays within the same area. If the transfer involves moving to another area, a selection process has to be passed. The law does not fix a compulsory retirement age for pharmacists.

Luxembourg Pharmacy Model

In Luxembourg, the pharmacy owner must be a qualified pharmacist. Only a pharmacist can obtain a transferable or non-transferrable concession ("concession réelle" or "concession personnelle"). A pharmacist cannot own more than one pharmacy, and they assume ultimate responsibility for the services provided there. The authorisation procedure for a new pharmacy is based on an open competition system for non-transferrable concessions ("concessions personnelles") under the authority of the Ministry of Health.

The law in Luxembourg stipulates the requirement for Government authorisation to open a pharmacy, for which it should seek the opinion of both the health and local authorities. However, there are no geographical or demographic criteria for setting up a pharmacy.

Only the sale of transferable concession pharmacies is allowed ("concessions réelles"). The non-transferrable concessions belong to the State. In the event of transfer of the pharmacy following the death of the owner, the law permits the heirs (spouse or minor children) to retain transferable concession pharmacies, but they must be managed by a qualified pharmacist.

The presence of the pharmacist who owns the pharmacy, and who assumes ultimate responsibility, is compulsory. They can be replaced for one month upon receiving prior authorisation. The pharmacist who is ultimately responsible for the pharmacy can carry out an additional activity, as long as this does not impede him or her fulfilling his or her pharmacy duties in person, even if it is undertaken outside pharmacy opening hours.

Pharmacists are not permitted to carry out any type of analysis in their pharmacies. Pharmacists also have the exclusive right to dispense medicines. Nevertheless, veterinary clinics can supply medicinal products, which they should buy in a pharmacy that is open to the general public. Medicines are dispensed in pharmacies, which may also sell other health-related products, such as parapharmaceutical products.

Pharmacists cannot advertise their pharmacies outside its premises. Luxembourg law permits the advertising of pharmaceutical specialities and other non-medicinal products.

Portuguese Pharmacy Model

In Portugal, the ownership of pharmacies is restricted to qualified pharmacists, who can only own one pharmacy. Pharmacies may also be owned by pharmacy companies and by private limited companies. A pharmacist can only own or jointly own one pharmacy. The pharmacist must offer guarantees of civic and professional ethics, and he or she must be entered in the register of pharmacists. Chains of pharmacies are prohibited.

The authorisation procedure for a new pharmacy is based on an open competition system. The competitions to open a new pharmacy are conducted at the national level, under the authorisation of the Ministry of Health, the National Institute of Pharmacy and Medicines, at the request of the local health authorities. New pharmacies are opened in accordance with a competition for pharmacists in the area where they want to open a pharmacy. The selection criterion is based on a points system, up to a maximum of ten, and which takes into account the number of years the candidate has worked in a pharmacy or hospital, their place of residence, age and academic record. Pharmacists or companies formed by pharmacists who already own a pharmacy at the time of the competition cannot take part in it, neither can pharmacists who have owned a pharmacy in the previous ten years. Companies with one or more partners who fulfil the previous conditions are also prohibited from taking part.

The Portuguese pharmaceutical system is a regulated model, in which distance and population criteria are set. The criteria are as follows: one pharmacy for every 6,000 inhabitants in towns with a population of 6,000 people or more. There must be a minimum distance of 250 metres between pharmacies. A pharmacy can be authorised, regardless of the number of inhabitants, in areas without any, if local population needs justify it:

If there is a hospital or medical centre and the nearest pharmacy is over 3 km away
If the distance is over 5km
In areas where there is a shopping centre, which serves a town that, complies with a series of conditions, etc.

The sale or transfer of a pharmacy can only take place after a period of two years has elapsed since it was opened. In the event of the transfer of a pharmacy following the death of the owner, the law states that if one of the heirs is a pharmacist or a pharmacy student, he or she can take over the ownership. In the latter case, a qualified pharmacist will have to be employed in the interim. If the heirs are not pharmacists, they have two years within which to sell the pharmacy or transfer it to another pharmacist for a period of ten years. The pharmacy must be sold at the end of this period.

The regulation obliges the presence of the pharmacist who owns the pharmacy or a company, otherwise no pharmacy can remain open. The regulations also stipulate the conditions concerning the contracting of a replacement, who must always be a qualified pharmacist. The pharmacist who has ultimate responsibility can carry out an additional activity, as long as this does not prevent them from fulfilling their pharmacy duties in person, even if it takes place pharmacy opening hours. It is prohibited to undertake any other business that is incompatible with the standards of the profession. Pharmacists can only carry out pregnancy and glycaemia tests in the pharmacy. Pharmacies are the only outlets authorised to dispense medicines. Only veterinary clinics can sell medicines when conducting emergency operations. Vitamin supplements and herbal products can also be sold in supermarkets. Apart from dispensing medicines, pharmacies also sell a wide range of products such as cosmetics, orthopaedic, phytopharmaceutical and optometric products, homeopathic and dietary products, etc.

In Portugal the advertising of prescriptive medicines is prohibited. However, other medicines can be advertised as long as they include a series of instructions on dosage, contraindications, etc. The distance selling and teleshopping of medicines, and any other sales method brought about by new information technologies, are prohibited. Pharmacists cannot advertise their pharmacies outside its premises. The advertising of non-medicinal products, as well as other activities carried out at the pharmacy, is permitted, as long as general advertising rules and the profession's Code of Ethics are observed. Portuguese pharmacies have no special opening-hours and are governed by the same system as general trade. There are two types of special opening hours: supplementary hours (until 10.00 p.m.) or duty service (24 hours). Pharmacists can continue to practice in pharmacies after retirement at 65.

UK Pharmacy Model

In the United Kingdom, a pharmacy may be owned by a pharmacist, a company whose partners are pharmacists, or a private limited company managed by a qualified pharmacist. Only pharmacy association members can manage a pharmacy. A pharmacist can only manage one pharmacy. However, a pharmacist or a company can own several pharmacies. Chains of pharmacies are permitted in the United Kingdom. However, there has to be a pharmacist in charge of the pharmacy and discounts on medicines are prohibited.

In Scotland, both pharmaceutical and non-pharmaceutical companies are permitted. A license from the Royal Pharmaceutical Society of Great Britain is needed to open a pharmacy. Moreover, permission must also be received from the local health authorities to dispense National Health Service (NHS) prescriptions. This permit is notified to the owners of other pharmacies in the same area and to several other organisations. Objections may be presented and there is a right of appeal against the local health authority's decision.

There are no geographical or demographic distribution criteria regulating the opening of pharmacies in the United Kingdom. Nevertheless, in order to issue a new National Health Service contract, the applicant must show that a new contract is necessary or desirable for the provision of a pharmaceutical service under the National Health to the residents of that area.

There are no restrictions on the sale of a pharmacy, as long as the new owner meets the stipulated conditions for ownership. In the United Kingdom, the "new pharmacies" derogation is applied in accordance with article 2 of the EU Directive 85/433/EEC. Thus a pharmacist from another EU member state can only take responsibility for a pharmacy that has been operating for over three years. The derogation applies to the running of the pharmacy, not to its ownership.

In the event of transfer of a pharmacy following the death of the owner, if the heirs are not pharmacists, in England and Wales a private limited company has to be set up with a qualified pharmacist employed as its manager. In Scotland, the unqualified heir has to enter into partnership with one or more pharmacists.
The pharmacist who assumes ultimate responsibility for the pharmacy can be replaced. In order to dispense medicines, the company must be under the personal supervision of a pharmacist. All prescriptions and medicines that can only be sold in pharmacies have to be dispensed under the direct supervision of a pharmacist. Apart from the dispensing of medicines, UK pharmacies sell a wide range of products, some of which are health-related.
The pharmacist who assumes ultimate responsibility for the pharmacy can practice other compatible professions for which they are qualified, such as optometry and chiropody. Pharmacists can conduct biological medical analyses in pharmacies.

Medicines are divided in three categories in the United Kingdom:

Prescription Only Medicines (POMs): These cannot be advertised to the public and their active principles are registered on the list of the 1997 Prescription Only Medicines (for human use) Amendment Order. Only pharmacies with the NHS contract can dispense prescriptions in the United Kingdom (community pharmacies).

General Sale List Medicines or GSLs: This category includes small packets of analgesics that contain aspirins/paracetamol, the majority of antacids, antiseptics, tablets for coughs and colds, etc.). GSL products are sold mainly in supermarkets, chemist's and other establishments. GSL medicines are those that the competent authorities consider can be sold, with reasonable security, without the supervision of a pharmacist.

Pharmacy medicines (Ps). These can only be dispensed in pharmacies under the supervision of a qualified pharmacist. This category includes analgesics, medicines for colds that contain suppressants, antihistamines or decongestants, and products that have recently been released from prescription control.

Pharmacists do not posses exclusive rights to dispense medicines as doctors can sell medicines to their patients, pursuant to the 1968 Medicines Act. Under the National Health Service Acts, only rural doctors, who are specifically authorised to dispense, can supply medicines to their patients.

Dentists can sell medicines for dental treatment, but only to patients who are not being treated under the National Health Service. General Sale List (GSL) medicines can be sold in any shop, as long as the shops can be locked; for example, their sale is not permitted from market stalls. Veterinary clinics can sell medicines to treat animals that are under their care. Some medicines for horses can be sold by saddlers and a specific range of medicines can be sold by agricultural salesmen.

The owner of a pharmacy can advertise any product that is sold in the pharmacy, along with the pharmacy itself, subject to observance of the profession's Code of Ethics and advertising rules. All advertisements must comply with the self-regulatory Codes of Practice. The Code prohibits the offering of any medicine samples to the general public for commercial purposes. The products that appear on the television, radio, press, Internet and other points of sale must carry the following sentence "Always read the label" and the name of the active principle if the medicine has only one. Distance selling and teleshopping is accepted for GSL products and foods, but is not a widespread practice.

Swedish Pharmacy Model

In Sweden, the retailing of medicines can only be managed by the Government, or a legal entity controlled by it. The National Corporation of Swedish Pharmacies (Apoteket AB), in accordance with an agreement signed with the Government, has taken over the management of pharmaceutical product retailing, for which it has exclusive rights. Apoteket AB manages a policy, which states that a pharmacy manager must be a qualified pharmacist or a person who has graduated as a "prescriber" (lower grade university degree).

There are no governmental criteria for geographical and demographic distribution in the Sweden to regulate the opening of pharmacies. The National Corporation of Swedish Pharmacies determines the areas in which pharmacies, or other points of sale for medicines, will be situated. In setting-up pharmacies, Apoteket AB's policy aims to guarantee that there are pharmacies near places in which medicines can be prescribed and also where there is a large flow of patients. Apoteket AB pursues a systematic policy of setting-up pharmacies in health centres. On average, there is one pharmacy for every 10,000 people in Sweden.

All Swedish pharmacies belong to Apoteket AB and, therefore, all pharmacy workers are employees. As a result, there are no transfers due to inheritance. The sales restrictions that prevail arise from the exclusive rights of pharmacies. The Government and Parliament are able to decide on the matters concerning the sale of an individual pharmacy, or the whole company. Only Apoteket AB can own a pharmacy, and these are organised as a chain.

In accordance with the Medicinal Products Agency rules, they can only dispense medicines prescribed by doctors and prescribers. Brand name pharmaceutical specialities can be sold by pharmacy assistants. Pharmacists and the personnel who work in a pharmacy, cannot practice any other profession during working hours, but outside these hours there are no special rules.

Pharmacists can carry out biological medical analyses in pharmacies, but not many analyses are currently undertaken. As stated previously, pharmacists are not the only professionals that can dispense medicines. OTC brand name pharmaceutical specialities can be sold by Apoteket AB pharmacy assistants.

In addition to dispensing medicines, pharmacies also sell other health-related products. Prescription only medicines are not advertised, except in publications for doctors, dentists and other health professionals and in a Code of Ethics. Non-prescription medicines can be advertised.