Regulatory, Pricing and Reimbursement
A legal intro to the situation regarding regulation, pricing and reimbursement in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
The National Organization for Medicines (hereinafter referred to as E.O.F.) which was established in 1983 as a public entity of the Ministry of Health by virtue of Law 1316/1983, constitutes the main national regulatory authority with regard to medicinal products for human and veterinary use, drugs, foodstuffs intended for particular nutritional uses and food supplements, biocides, cosmetics and medical devices in Greece.
Within the framework of its mission to ensure public health and safety, E.O.F., in co-operation with the European Union, is endowed with the following powers:
- Evaluates and authorizes new, safe and efficient health – related products.
- Monitors the post-marketing product quality, safety and efficacy.
- Monitors product manufacturing procedures, clinical studies and the marketing of products, in order to ensure compliance with good manufacturing, laboratory and clinical practice, as well as with the existing legislation regarding the marketing, distribution, commercialization and advertising of the products.
- Develops and promotes medical and pharmaceutical research.
- Provides health scientists, competent authorities, and the general public with objective and useful information regarding medicines (for human or veterinary use) and other products, in order to ensure their rational use and provide an assessment of their cost-effectiveness.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
The regulatory framework for the authorization of pharmaceutical products is mainly governed by Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B 1049/2013 issued in application of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as in force and amended by Directive 2011/62/EU as regards the prevention of the entry into the legal supply chain of falsified medicinal products read together with Legislative Decree 96/1973, as currently in force.
Furthermore, pricing and reimbursement of pharmaceutical products falls within the scope of Ministerial Decision No. G5(a) 90552/Government Gazette B 3890/2016 on the setting of pharmaceutical prices, as amended by Ministerial Decisions G5(a) 97012/Government Gazette B 4215/2016 and G5(a) 11601/Government Gazette B 445/2017. It should be noted that in light of provision 17 of Legislative Decree 96/1973, the maximum retail, wholesale, hospital and ex-factory price, as well as any other special sale price of medicinal products – with the exception of non-prescription medicinal products- are defined by the relevant Price Bulletins, issued twice a year by the Minister of Health and uploaded to the official website of the Ministry of Health, following an opinion provided by E.O.F.
The field of medical devices is mainly regulated by Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009, issued in application of Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directives 98/79/EC, 2000/70/EC, 2001/104/EC, 2007/47/EC and Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003.
The general standards for the good production and control of medical devices are laid down in Decision 6209 of E.O.F.’s Board of Directors (published on Government Gazette B’/199/06.02.2009).
Several Interministerial and Ministerial Decisions in force govern specific types of Medical Devices, such as, indicatively, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 issued in application of Directive
90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Interministerial Decision DY8d/G.P. 3607/Government Gazette B’ 1060/2001 issued in application of Directive 98/79/EC on in vitro diagnostic medical devices.
However, it should be noted that on 5 April 2017, two new European Regulations on medical devices were adopted and entered into force on 25 May 2017. These Regulations will eventually replace the existing Directives as on medical devices. More specifically:
- Regulation (EU) 2017/745of the European Parliament and of the Council of 5 April 2017 on medical devices, was adopted in substitution of Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, also repealing Council Directives 90/385/EEC and 93/42/EEC and
- Regulation (EU) 2017/746of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices repeals Directive 98/79/EC as well as Commission Decision 2010/227/EU.
The above mentioned new European legislation will become effective after a transitional period, namely 3 years following entry into force of the Regulation on medical devices (26.05.2020) and 5 years following entry into force of the Regulation on in vitro diagnostic medical devices (26.05.2022). It may be noted that the new Regulations provide for the validity of existing certificates issued under the Directives and Interministerial Decisions currently in force for a term following the progressive entry into force of the EU Regulations, as provided therein..
3. What are the steps to obtain authorization to develop, test, and market a product?
The specific procedure to be followed is mainly laid down in Interministerial Decision D.YG3α/G.P.32221/Government Gazette B’ 1049/2013 on the manufacture and marketing of medicinal products for human use. More specifically, the process of manufacture of medicinal products is stipulated under section IV of the aforesaid Interministerial Decision. By virtue of article 57 thereof, the manufacture of medicinal products in Greece is subject to a relevant authorization granted by E.O.F.
According to the same provision this manufacturing authorization shall be required notwithstanding that the medicinal products manufactured are intended for export. The minimum requirements to be met by the applicant are listed in article 58, which provides that the applicant must in particular:
- Specify the medicinal products and pharmaceutical forms to be manufactured or imported and also the place of manufacture and the necessary controls;
- Have at their disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements as regards both manufacture and control as well as storage of medicinal products;
- Have at their disposal the services of at least one qualified person within the meaning of Article 68. Attention must be paid to the fact that the applicant shall provide particulars in support of the above in the application.
Pursuant to article 57(3) of said Interministerial Decision, authorization referred to in the above paragraph is also required as regards imports coming from third countries into Greece.
A specific prior authorization process must also be strictly followed in view of testing, namely in order to conduct a clinical trial of the medicinal product. In accordance with the provisions of Chapter II of Regulation (EU) No 536/2014 on Clinical Trials, as well as those of Greek Interministerial Decision No. G5α/59676/Government Gazette B’ 4131/2016 on clinical trials conducted on humans, clinical trials are subject to a specific procedure of review and authorization performed by E.O.F., as described under article 3 thereof (and below under question 18 of Preclinical and Clinical Trial Requirements).
In line with EU legislation, four different procedures may alternatively be followed in view of obtaining marketing authorization in Greece, namely:
- The Centralized Procedure. Marketing authorizations granted under the “centralized procedure” allow the marketing-authorization holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorization. Such authorization is granted by the European Commission following the scientific assessment of the application by the European Medicines Agency. The centralized procedure is laid down in Regulation (EC) No 726/2004
- The mutual recognition process. This process is stipulated under articles 45-46 of the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013. To be eligible for the mutual recognition procedure, a medicinal product must have already received a marketing authorization at least in one EU country. In this case an application for mutual recognition may be addressed to one or more EU countries. The applications submitted must be identical, and all EU countries notified accordingly. The country charged with evaluating the application or Reference Member State notifies the other Concerned Member States. The Reference Member State is then charged with deciding on the product.
This evaluation process may take up to 210 days, and ends with the granting of a marketing authorization in the EU country of application. The Concerned Member States then have 90 days to acknowledge the decision of the Reference Member State, including the summary of product characteristics, labelling and packaging. National marketing authorizations are granted within 30 days.
- The decentralized procedure. This procedure introduced by Directive 2004/27 is provided for under article 47 et seq. of Interministerial Decision D.YG3α/G.P. 32221. It allows the common assessment of an application submitted simultaneously to several Member States. One of the Member States will take the lead in evaluating the application as reference Member State. At the end of the procedure, the draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved by the other (concerned) Member States.
- The National authorization. According to article 7 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, authorization to placea medicinal product on the market may also be obtained by virtue of an application to E.O.F. as national regulating authority. Said public entity is charged with ensuring all appropriate measures are taken in order for the procedure to be finalized within 210 days of the submission of a valid application (article 29 of the named Interministerial Decision).
The application shall be accompanied by a list of particulars and documents concerning the specific medicinal product, including –but not limited to- (a) name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer, (b) name of the medicinal product, (c) qualitative and quantitative particulars of all the constituents of the medicinal product, with mention of the international non-proprietary name recommended by the World Health Organization where such name exists or reference to the relevant chemical name, (d) description of the manufacturing method, (e) therapeutic indications, contra-indications and adverse reactions, (f) Posology, pharmaceutical form, method and route of administration and expected shelf life, (g) If applicable, reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients, as well as for the disposal of waste products, together with an indication of any potential risks to the environment associated with the medicinal product, (h) Description of the control methods employed by the manufacturer (i) Results of physico-chemical, biological or microbiological tests, toxicological and pharmacological tests of the product under examination etc.
4. What are the approximate fees for each authorization?
Pursuant to article 1 of Interministerial Decision DYG3(a)/171107/Government Gazette B’/2689/2008, the relevant payable fee depends on the type of application and necessarily of the concerned medicinal product.
A complete file of scientific documents must be submitted along with the respective fee:
- For a new or known active substance (complete file) – €20,000;
- If the license is based on related literature combined with the applicant’s studies – €20,000; and
- If the license is founded upon well-established medicinal use – €18,000.
A complete file of scientific documents is not required to be submitted (simplified application) if:
- The application for marketing authorization does not fall within the definition of a ‘generic’, with reference as opposed to the so-called product reference product – €20,000;
- The application for marketing authorization for a generic product has the same pharmaceutical form and content to the reference product and only a bio-equal potentiality study is required – €14,000;
- The application for marketing authorization for a generic product has the same pharmaceutical form and content to the reference product without requiring a bio-equal potentiality study – €9,000;
- The request for authorization is submitted following concession for the use of the data of an already approved drug – €5,000.
- The payable fee for a marketing authorization if the application is based on a combination of known active substances is €20,000.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
According to article 40 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, as a general rule a marketing authorization is valid for five years and may be renewed , on application by the holder and upon new risk-benefit assessment by E.O.F. following the submission of a dossier containing the particulars listed under paragraph 2 of the same article at least nine months before the initial expiry date. After its renewal, the authorization is in principle rendered unlimited, unless otherwise justifiably decided by E.O.F.
Attention must be paid to the fact that paragraphs 4 and 5 of the same article introduce a double exception to the above general rule. These exceptions provide that the authorization is no longer valid and is ipso jure recalled by virtue of a relevant confirmatory act of E.O.F in the following circumstances, i.e. (a) if the authorized medicinal product is not placed on the market within a three-year period after the grant of its authorization or (b) if a medicinal product having been placed on the market following its authorization becomes unavailable for a consecutive three-year period.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
Regarding generic products, the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 provides for a procedure slightly different from the standard authorization process as described above. More specifically, in derogation of article 9 (3) (i) and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of preclinical and clinical trials if he can demonstrate that the product is generic of a reference product which was granted marketing authorization within the EU at least 8 years ago. However, the generic product is not authorized to be marketed before the lapse of a ten-year period as of the authorization date of the reference product.
The definitions of both generic and reference products are provided by the Interministerial Decision itself. If a product does not fall within the scope of the respective stipulated definition in light of the bioequivalence study data available and required to be submitted in support of the application, the applicant must prove bioequivalence on the basis of data obtained through appropriate preclinical and clinical trials.
The marketing authorization process does not differ between local and foreign-owned manufacturers as long as they are established in the European Union. More specifically, according to article 9(2) of the above Interministerial Decision, marketing authorization may only be granted to an applicant established in the European Community.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug +biologic + device) regulated?
According to Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 the definition of medicinal product covers any substance or combination of substances suitable for treating or preventing disease in human beings. Furthermore, the definition of substance refers to any matter irrespective of origin which may be either human, e.g. human blood and human blood products; animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts or chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.
Given the wide scope of the above definitions, the combination products of drug + drug and drug + biologic are governed by the aforesaid Interministerial Decision D.YG3α/G.P. 32221. Moreover, the combination products that include medical devices are in addition regulated by the above mentioned Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009 on medical devices, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 on active implantable medical devices and Interministerial Decision DY8d/G.P. 3607/Government Gazette B’ 1060/2001 on in vitro diagnostic medical devices.
8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
As Greece constitutes an EU Member State, the Greek regulatory regime is expected to meet the requirements of the European Medicines Agency. E.O.F. as the competent national regulatory authority is entrusted with a significant amount of powers in order to ensure that the legal requirements governing medicinal products are constantly met and to promote the post-marketing product quality, safety and efficacy.
Each pharmaceutical company is required to monitor the safety of all medicines that it markets. In addition, pursuant to article 162 et seq. of the Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013, E.O.F. is competent to perform a wide range of inspections, such as, indicatively (a) inspections of manufacturing or commercial establishments and of any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out controls of third-country imported drugs pursuant to Article 32, (b) take samples, (c) examine any documents relating to the object of the inspection and (d) inspect the establishments, archives, documents, as well as the main archives of the pharmacovigilance system of the marketing authorization holder.
Moreover, E.O.F. is charged with taking all appropriate steps to ensure that (a) the manufacturing processes adopted in view of the manufacture of immunological products are properly validated and attain batch-to-batch consistency and (b) the holder of the marketing authorization for a medicinal product and, where appropriate, the holder of the manufacturing authorization, furnish proof of the controls carried out on the medicinal product and/or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down in Article 9(3)(h).
Lastly, according to articles 168-169 of the aforesaid Interministerial Decision, E.O.F. is entitled (a) to suspend or revoke or modify an authorization to place a medicinal product on the market and (b) to prohibit the supply of a medicinal product and withdraw a medicinal product from the market under the specific conditions alternatively stipulated therein.
9. What is the potential range of penalties for noncompliance?
Apart from the civil and criminal liability established by the legislation in force, any infringement of the provisions of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 on medicinal products for human use may lead to the imposition of administrative fines up to a maximum amount of 100,000 €, in accordance with the provisions of Legislative Decree 96/1973.
Moreover, specific provisions imposing administrative fines are laid down in Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009 on medical devices, Interministerial Decision DY8d/130644/Government Gazette B’ 2197/2009 on active implantable medical devices, as well as Interministerial Decision DY8d/G.P. 3607/Government Gazette B’ 1060/2001 on in vitro diagnostic medical devices.
10. Is there a national healthcare system? If so, how is it administered and funded?
The Greek national health system was intended to guarantee the provision of healthcare services through a network of public/state providers and contracted private providers of primary, hospital and ambulatory health care with the aim to ensure disease prevention and the promotion, preservation, improvement, recovery and protection of citizens’ health. The presence of private providers is stronger in primary health care, especially as regards the provision of diagnostic services, but also as regards the provision of medical services by independent physicians and private clinics, either contracted by the National Healthcare Services Provider (EOPYY) or not.
The system is co-financed by means of the State, social insurance contributions and private payments. EOPYY (Greek acronym for National Organization for the Provision of Healthcare Services) was established in 2012 by virtue of Law 3918/2011 (article 17) and is under the control of the Greek Ministry of Health. EOPYY is exclusively responsible for negotiating, contracting and remunerating public/state and private contracted healthcare providers, covering the healthcare costs for over 95% of the population including the vulnerable social groups such as the unemployed and uninsured, refugees etc.
Additionally, EOPYY holds a number of statutory designations at EU level, namely, as the Greek liaison body for the reimbursement of sickness benefits in kind according to the Regulation (EC) 883/2004, the competent institution of the place of stay or residence, is a member of the European Healthcare Fraud and Corruption Network (EHFCN) and works closely with EU agencies and authorities on various health issues.
Primary Healthcare is provided by:
- EOPYY-contracted private healthcare providers (doctors, diagnostic centers, private clinics, chronic hemodialysis units)
- PEDΙ (National Primary Healthcare Network) Units
- State hospitals, health centers, rural and regional medical units of the National Health System (Greek acronym: ESY)
- Purely private healthcare professionals, not contracted with EOPYY but paid entirely by patients.
Hospital Healthcare is provided by:
- EOPYY – contracted private clinics.
- State hospitals of the National Healthcare System (ESY), free of charge as regards healthcare services within the national health benefits basket.
- Private hospitals and clinics.
11. How does the government (or public) healthcare system function with private sector healthcare?
The National Organization for the Provision of Healthcare Services (Greek acronym: EOPYY) negotiates contracts and remunerates healthcare professionals on the basis of a Health Benefits Regulation (Greek acronym EKPY) prescribing the benefits basket for the beneficiaries of the system.
The healthcare benefits basket includes, under various specific conditions:
- medical treatment
- diagnostic/laboratory/clinical tests
- dental treatment
- physiotherapy, occupational therapy, speech therapy, psychotherapy
- medication, consumables, dietary supplements, medical devices
- hospital treatment
- supplementary healthcare (orthopedics, eyeglasses, hearing aids, prosthetics etc)
- long-term care
- obstetric care and ivf
- healthcare abroad
- vaccination programs
Contracted private doctors must respect a limit of 200 patients’ visits per month, which may be remunerated by EOPYY, so one will be required to pay privately when visiting a contracted doctor who has reached the 200-consultation ceiling for the particular month.
Any doctor may provide referral for hospital treatment. Although healthcare within the framework of the national healthcare benefits basket is provided free of charge by the public/state providers, the insured patient is expected to participate in the charge, paying for a certain varying percentage of the total cost when opting for contracted private hospital healthcare providers.
12. Are prices of drugs and devices regulated and, if so, how?
Prescription Medicinal Products
Pricing and reimbursement of pharmaceutical products falls within the scope of Ministerial Decision No. G5 (a) 90552/Government Gazette B 3890/2016 on the setting of pharmaceutical prices, as amended by Ministerial Decisions G5 (a) 97012/Government Gazette B 4215/2016 and G5(a) 11601/Government Gazette B 445/2017. According to Article 5 of MD 90552/2016 prices of all medicinal products are revised twice a year and the price bulletins are issued in May and November of each year. Such price bulletins setting the maximum prices of medicinal products, are issued by the Minister of Health, following the recommendation of E.O.F.
Prior to its recommendation to the Minister of Health, EOF posts the Price Bulletin on its website. Anyone having legitimate interest may submit comments on the Price Bulletin before EOF in the event of a manifest error, within 3 business days as of the following day of the post of the Price Bulletin on EOF’s website. Following this, EOF conducts a 5-day consultation and finally submits its proposal to the Minister of Health. The Price Bulletin is issued by the Minister of Health and posted on the website of the Ministry of Health. Anyone having legitimate interest may appeal the decision of the Minister of Health within 5 days as of the following day of the issuance of said decision and its post on the Ministry’s website. Such an appeal is submitted before EOF. By virtue of a Ministerial Decision, following EOF’s opinion, the appeals submitted are rejected or accepted and a revised Price Bulletin is issued, which is posted on the Ministry’s website and enters into force as of the day of its post, as regards its amended part.
OTC Medicinal Products
Unlike prescription medicines, the pricing of the non-prescription medicines or the so-called “over-the-counter medicinal products” (hereinafter referred to as “OTC medicinal products”) has recently been released to a certain extent. More specifically, according to article 2(3) of Interministerial Decision G5(a) 38152/Government Gazette B 1761/2017, the indicative retail price of OTC medicines, determined on the basis of the average of the three lowest prices of the same medicinal product in three EU member states, is not compulsory for those entitled to market the OTC product. As a result, the latter can freely determine their pricing policy as to the OTC medicinal products, despite the fact that the indicative –but non-compulsory- retail price is determined according to the above criteria. For the determination of prices for reference medicinal products, EOF’s competent department conducts a research with EU member states’ competent authorities, or other official and reputable State or European institutions providing similar data,. Moreover, it should be noted that pursuant to article 5(5) of Law 4558/2018 which recently entered into force, the indicative retail price of OTC medicinal products should no longer appear on the packaging of the product∙ this measure may be regarded as a further step towards the liberalization of OTC medicinal products’ prices.
Pricing of medical devices is accordingly regulated pursuant to article 108 of Law 4461/2017, as amended by Law 4472/2017. More specifically, according to said provision, the maximum price of the medicinal product is determined on the basis of the average of the three lowest prices in EU member states. The importer-manufacturer-representative of each medicinal product must submit a statement with E.O.F. solemnly declaring the above.
13. How are drugs and devices used by patients paid for? What roles do public and private payers play?
As a general note, pursuant to article 38 of Law 4025/2011 patient undertakes a participation of 25% price of the medicinal product, when the latter is prescribed by EOPYY – contracted private doctors or hospitals.
However, certain patients’ groups, such as –indicatively- the chronically ill, pregnant women, vulnerable groups, patients with a maximum taxable income of 1,200 € are entitled to receive medicines free of charge or pay a reduced participation. Pursuant to article 26 of Law 4549/2018 the contribution of patients belonging to the above –mentioned vulnerable groups may be reduced to none if the patient is supplied with a generic product.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
With the exception of OTC medicinal products, prescription medicinal products and medical devices may be prescribed to patients by either EOPYY – contracted private doctors, private doctors or hospital doctors and they are dispensed through pharmacies, pursuant to article 4(1) of Law 1963/1991. The retail sale of medicinal products by pharmacies is also governed by Legislative Decree 312/1992 which regulates the organization and constitution of pharmacies at national level.
In this regard, it should also be noted that:
- The retail sale through pharmacies of medicinal products and medical devices other than those exclusively listed in article 1(1) and 1(2) of the above Legislative Decree or in any other specific provisions of law and/or Ministerial Decisions is strictly prohibited.
- In line with Ministerial Decision D3(a) 46627/Government Gazette B 2285/2018 every pharmacy should possess stock of at least one package of generic product per each therapeutic class containing the active substances listed at the beginning of each year by IDIKA S.A.
As regards the dispensation of OTC medicinal products and of the so-called Products of General Dispensation (which constitute a sub-category of OTC products – Greek Acronym: ΓΕΔΙΦΑ) – see the section Traditional Medicines and OTC products.
Furthermore, the pharmacies’ reimbursement is covered partly by the patients’ contribution of (as a general rule) 25% of the product’s price and partly by the competent Social Insurance Institution covering the patients’ insurance, also contracted with the pharmacy, according to Law 3918/2011.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
The Hellenic Code of Pharmaceutical Ethics provides for numerous professional and legal responsibilities borne by pharmacists. Among others, according to article 21 thereof a pharmacist must check whether the prescribed product to be dispensed meets legal specifications. Furthermore, while dispensing a medicinal product a pharmacist must provide the patient with clear directions for its use and reassure the avoidance of possible errors throughout its use, in line with article 20 of said Code.
It is acknowledged that dispensing patients with medicinal products alone does not suffice in order to achieve the goals of the adopted treatment. To address these medication – related needs, pharmacists must embrace their key role behind a successful treatment, as well as their responsibility in providing patients with enhanced services. According to the Code of Pharmaceutical Ethics, a pharmacist must provide any patient with assistance to the extent of his/her knowledge∙ it is therefore clear that the pharmacist’s contribution in guaranteeing high public health standards is of great importance.
In the event of non – compliance a pharmacist’s disciplinary liability may be established pursuant to article 34 of said Code of Ethics. Moreover, according to the same article a pharmacist may also be liable at civil, administrative and criminal level, in accordance with the legislation in force.