FOOD SUPPLEMENTS
What rules govern the sale of food supplements?
Food supplements are regulated in Greece mainly by the provisions of the MD Nr.
Γ5α/53625/2017 which implemented into the Greek law the European Directive 2002/46/ EC “on food supplements”. Said MD provides that any import and supply of the Greek market with food supplements, which is not consistent with its provisions, is prohibited. In this context, in order to market a food supplement in Greece no license is needed, yet a notification must be made to this effect to the EOF, which has the discretion to prohibit the product’s circulation in the Greek market, if non-compliance to the MD is established. The law imposes rules both as to the possible components of food supplements and also as to their presentation, marketing, nutritional labeling and advertising. According to art. 6 of the aforementioned MD the labeling, presentation and advertising of food supplements must not attach to these products properties equal to the prevention, treatment or cure of a human disease, must always be drafted in Greek and in a way that is obvious and clear to the general public. Due to the excessive advertising of food supplements that has been observed to take place in the Media lately, attributing “miraculous” properties to said products, National Organization For Medicines (EOF) has published an official announcement reiterating and emphasizing the rules that govern advertising of food supplements and to this end has also requested for the contribution of the National Council for Radio and Television and the National and Local Telecommunication Channels as well, in order to restrict the exaggerating and unlawful practices followed by the companies, The sale of food supplements to the general public may be effected either through pharmacies or through other vendors that may legitimately sell packaged foods.
VACCINES
Are vaccines treated in a different way than other pharmaceutical products under Greek law?
Albeit in principle vaccines are not treated as a distinctive category under Greek law, due to their unique nature and purpose, they are frequently treated differently in practice, especially when part of the National Vaccination Plan. According to art. 6 par. 2 of L.1316/1983 it falls within EOF’s competency to secure protection of the public health where the national interest dictates it and therefore to provide the relevant guidance, on a case by case basis, with regards to the supply and provision of vaccines to the public.
For example, in accordance to the provisions of EOF Circular Nr. 43631/14-6-2012, although the general rule is that the promotion of pharmaceutical products to the general public is prohibited, this prohibition is lifted vis-à-vis vaccination campaigns which are conducted by the pharma industry and have been approved by the EOF. The reason for this exception to the general rule is to raise public awareness which will result to an increase in the vaccination coverage of the public. Exceptions to the treatment of vaccines may also be found in other areas, such as, indicatively, in the context of pricing and clawbacks, where vaccines are excluded from price revisions and where the 10% growth criterion which is taken into account for clawback calculation, is not applied to vaccines which are part of the National Vaccination Plan.
MEDICAL EQUIPMENT
Advertising of medical devices
The advertising of medical devices in Greece is governed, at a legislative level, on one hand, by the Greek Law 2251/1994, which is the main legislative framework for the protection of consumers, and, on the other hand, by Ministerial Decisions Nr. 130648/2009 and Nr. 130644/2009, implementing Directive 2007/47/EC. At a regulatory level, the advertising of medical devices is regulated by EOF Circular Nr.18158/2010 as well as the Code of Ethics of the Hellenic Association of Scientific and Medical Equipment Suppliers (“SEP Code”), which contains general principles and is the equivalent of the EUCOMED Code in Greece.
On the basis of Law 2251/1994, in principle, there is no general prohibition to advertise medical devices, so long as the advertising and/or promotional material corresponds with accuracy to the intended use of the medical device. Any advertising, presentation or announcement which attributes or suggests, directly or indirectly, misleading capacities, not related to the capacity of the medical device, is prohibited.
In addition, according to art. 16 and 22 of MD Nr. 130644/2009 and Nr. 130648/2009 respectively, with the former specifically regulating implantable medical devices, the advertising and promotional material must correspond to the intended use of the product. The direct or indirect promotion of misleading indications and the promotion of inaccurate or undocumented claims are prohibited. The pertinent material (printed, audio-visual etc) is, according to said MD, subject to the monitoring powers of EOF - the same authority responsible for pharmaceutical products.
Overall, considering that the regulatory and monitoring authority in Greece for medical devices is the same as for pharmaceuticals and that, roughly, the same operating principles apply, the viewpoint of EOF on advertising is also very important in order to draw analogies with pharmaceuticals’ regulation. EOF has not so far published any guiding principles/rules specifically for the advertising of medical devices. Nonetheless, according to Circular Nr. 43631/2012 of EOF, there is a reservation so far as the advertisement of prescribed medicines (and by analogy prescribed medical devices) is concerned; on the basis of this reservation, the promotion/advert of prescribed medicines is prohibited with the exception of: (i) the package leaflet instructions (operating manual in the case of medical devices) and (ii) information campaigns that have already been approved by EOF. In the latter case, and simultaneously with an authorization by EOF, the following apply:
- Any information, claims or comparisons must be scientifically documented;
- Should the promotion refer to published studies, clear bibliographical references must be provided. In case the promotional material refers to data included in the product file, the corresponding section referring to the said data, must be provided, upon request, without delay;
- Information leaflets cannot bear presentations which are misleading or which imply any vague indications of the product;
- Information and claims with respect to adverse reactions must reflect available data or must be verifiable by clinical experience. The term “safe” must not be used without detailed justification;
- No exaggerated or generalized claims must be made and the superlative must not be used, except in restricted cases where there is a reference to clear facts about a specific product. Claims must not imply that a product has a specific advantage, quality or property except in cases where this can be verified;
- The world “new”must not be used for the description of a product or package and form which is already marketed or for a therapeutic indication which has been promoted for more than 12 months.
Finally, it should be pointed out, though, that same restrictions are not applicable in the case of OTC medical devices (implantable or not).
CLINICAL TRIALS
Approval of interventional clinical trials and Good Clinical Practice
Albeit a new European Regulation, namely Regulation 536/2014 has been introduced, which aims to remedy existing loopholes of the current regime governing the conduct of clinical trials, this is anticipated to come into force in 2019. Until then the current regime continues to apply, as follows. Ministerial Decision Nr. 89292/2003 as amended and in force today, which has implemented in Greece the Directive 2001/20/EC “on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use”, regulates the conduct of clinical trials to human subjects in Greece, in order to ensure compliance and application of the good clinical practice principles.
Good clinical practice is a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good clinical practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. The principles of good clinical practice and detailed guidelines in line with those principles shall be adopted and, if necessary, revised to take account of technical and scientific progress.
In order to conduct an interventional clinical trial in a Greek investigational site, the prior written approval of the National Ethics Committee (henceforth “NEC”), which is the competent authority to oversee clinical trials in Greece, must be obtained. NEC’s written approval must be given within a 60-day period, at the most, following the relevant application and submission of the completed file by the study sponsor. Following an amendment of the aforesaid MD in 2013 (by virtue of MD Nr.18910/2013) a national template agreement has been adopted, which needs to be used in all cases of interventional clinical studies. Any deviation or amendment of the said template is strongly discouraged yet if made, any such modification will need to be previously approved by NEC.
NEC is an independent body, consisting of healthcare professionals and nonmedical members, whose responsibility is to protect the rights, safety and wellbeing of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent. Part of the process of approval are also the Scientific Boards and Administrations of the Health Region Administrations (“YPEs”) of the
relative hospitals, which have the obligation, within 30 days from the application and submission of the completed file, to inform NEC with regards to any problems as to the adequacy of the investigator and sub-investigators and the suitability of the hospital’s facilities where the clinical trial is to take place.
In the context of said legislation and in order to ensure good clinical practice, two databases are also in operation; namely Eudract (European Clinical Trials Database) and Eudravigilance. Eudract is a database in which the sponsor inputs basic data of the clinical trial, so as to ensure transparency as to the conduct of clinical trials and control of the data that result therefrom and are to be published. The Eudravigilance database has been created so as to allow electronic report of serious adverse events that may become apparent during the trial.
SUPPLY OF PUBLIC HOSPITALS AND PHARMACIES
How is the continuous supply of pharmaceutical products ensured vis-à-vis the domestic market?
Ensuring the continuous pharmaceutical supply so as to safeguard patient access to medicines involves the active participation and involvement of all key parties to the supply chain. Such involvement may entail various actions, from the MAHs supplying pharmacies directly as a means of addressing an unexpected shortage, to more fundamental solutions like the adoption of controlling measures by the EOF such as the imposition of bans on exports in order to ensure that adequate quantities of pharmaceutical products are circulated in the domestic market.
To this end, the imposition of sanctions for breaches of the key stakeholders’ regulatory obligations has a deterring effect and includes, mainly, the following:
- Article 29 of Law 1316/1983 imposes an obligation to the MAHs to regularly supply the domestic market with its products. In case of inability to do so, or where it is anticipated that the ordinary supply of the market may be in any way obstructed, the MAH must notify the EOF at least three months in advance.
- In the same spirit, article 12A of the Legislative Decree Nr. 96/1973 requires wholesalers to ensure the appropriate and adequate supply of pharmaceutical products to the market so as to meet the national needs, at all times. Same article 12A provides for a financial penalty on wholesalers or MAHs, ranging from € 30,000 to €1 million, if there is a breach of any regulatory obligation leading to a supply shortage;
- Additionally, in cases of bans on exports due to shortages, the wholesalers are obliged to declare at the EOF’s website any stock of these products and to make them available for sale to the market on demand. Whoever, despite the aforesaid ban, exports or accumulates products for export, is subject to a fine ranging from € 100,000 to one € 1 million depending on the gravity of the infringement, and in combination with any other available sanctions.
- Likewise, in paragraph 2 of same article 12A it is provided that the barcodes and authenticity stickers of the exported products must be submitted electronically by the wholesalers to the EOF’s database in real time. No batch may be released unless this procedure has been followed and hence in cases of violation a fine between € 100,000 and €1 million may be imposed.
- Finally a similar, as above sanction is foreseen in article 27 of Law 1316/1983 which requires MAHs to declare the data of the inventory sheets of the authenticity stickers in 526 the EOF’s database in real time. Violation of this provision incurs a fine ranging between € 30,000 and € 300,000.
PARALLEL TRADING OF PHARMACEUTICAL PRODUCTS
Medicine shortages and parallel trading
The Greek pharmaceutical market is one of the most complex in Europe today, especially due to the impact of the financial crisis and the imposition of austerity programs. Despite efforts to harmonise pricing across EU member states, individual countries –and Greece alike- remain free to set their own pricing policies and laws with regard to medicinal products. The combination of the right of each country to regulate the prices of pharmaceutical products that are marketed in the local market and simultaneously their ability to trade them freely within the EU supports largely the phenomenon of parallel trading, i.e. the lawful repackaging and reselling of pharmaceuticals in other, more expensive EU markets, on the basis of low repackaging and transport costs against huge profit margins.
This parallel trading practice has caused supply problems for patients in low-price countries, such as Greece in numerous occasions. Parallel traders will buy the cheaper Greek stock with a view to repackaging and selling it thereafter to countries where prices are higher, thereby drastically reducing supplies for patients in Greece. Hence, parallel trading, and specifically for Greece, parallel exports, are often named as the main cause for shortages in medicines for which there is no possibility for substitution. Information about pharmaceutical shortages may be recovered through the website of the EOF, which, if shortages
are deemed to be posing a risk for the public health, it can apply either of the following measures; a temporary ban on parallel exports for medicines with short supply and in some cases fines on the MAHs for not covering the domestic market with a 3-months’stock, as required by article 29 of Law 1316/1983 and MD 88979/2015.
The pharmaceutical industry’s response to parallel trading has been for the major manufacturers to resort to constructive methods to prevent or minimize it. Manufacturers now commonly adjust the delivery of their stock, to match national prescription needs, yet not the demands of parallel traders. The argument usually invoked in such a case is that a restriction of supply by a dominant pharmaceutical company in order to limit parallel trading may sometimes be justified, as a reasonable and proportionate way of defending the company’s commercial interests.
INTERNET
Are there any special rules governing websites of pharmaceutical companies?
A pharmaceutical company may create and administer various types of websites, which may be categorized in two big groups, namely, those intended for the general public and those addressed exclusively to HCPs.
Corporate websites which are accessible by the public may include general information about the company, such as corporate profile and social responsibility, history and latest news and other information of a non-promotional nature. A list of the company’s products along with the respective patient information leaflets (PIL) may also be included, and so can strictly informative texts on health issues. The pharma company must safeguard that any information provided therein is non-promotional, either directly or indirectly, and in this context, that no references to trade names or to therapeutic options connected to general
pharmacological groups are made. Any informative text should be neutrally quoted in an objective manner, with precise and updated reference sources. A disclaimer to the effect that the information provided is intended for general information purposes and does not substitute an HCP’s advice must also be included. For the aforesaid purpose, any educational or informative material included in websites addressed to the general public must have been previously approved by the competent department of the company in accordance and in compliance with EOF’s Circular Nr. 43631/14-6-2012.
In relation to websites which are addressed exclusively to HCPs, the pharmaceutical companies must ensure that the access of an HCP can only be effected via an assigned user name and password. All material included in such websites must comply with the provisions on the promotion of medicinal products, in accordance to MD Nr. 32221/2013, be approved in advance by the company’s scientific department and, if applicable, be notified to EOF. The approved SPC of the products must be accessible, posted in a visible place on the website and updated after every revision. Companies must also respect data privacy
obligations and pharmacovigilance and adverse reaction reporting. If links to other (third party) websites are included, the user must be clearly informed that s/he is leaving the protected website of the company and that s/he is entering a third-party website.
