PROMOTION OF PHARMACEUTICAL

ADVERTISING OF MEDICINAL PRODUCTS IN GREECE

 

INTRODUCTION

Promotion of pharmaceutical products in Greece is highly regulated. The Association of Pharmaceutical Companies in Greece ( SFEE ) is a member of EFPIA and follows its Code of Conduct. In parallel the National Organization of Pharmacies ( EOF ) issues regularly circulars which put rules for the promotion of pharmaceutical products.

The present deals with some usual topics that the pharmaceutical companies face when advertising their products and includes the relevant provisions of the Code of Deontology of SFEE.

  1. To whom is advertising of medicinal products allowed?

The advertising of medicinal products depends on the kind of the medicinal product which is advertised.

For prescription medicines the advertising is allowed only to health care professionals.

For  non-prescription medicines the advertising is allowed also to the public.

  1. Which are the prerequisites of advertising prescription medicines?

For the prescription medicines, the Advertisements may only appear in professional publications, namely publications sent or delivered exclusively to health care professionals.

Generally, Advertisements are not permitted in audiovisual material or on the Internet, including online journals. However, they are allowed when the access is restricted by the use of a password to HCPs.

In every advertisement the prescribing information of the product ( SPC ) must be included. However, abbreviated advertisements are exempted from this obligation.

All information and claims must be correct, accurate, objective and unambiguous and must be based on relevant and comparable aspects of the medicinal products, as well as on an up-to-date evaluation of all the evidence, reflecting that evidence clearly. They must not be directly or indirectly misleading and they must not distort the scientific facts.

Direct or indirect promotion of misleading indications of the medicinal product, reference to outdated scientific data, putting forward inaccurate or unsubstantiated claims, misleading comparison with other medicinal products and generalization of isolated observations are prohibited.

Any information, claims or comparisons must be capable of scientific substantiation .(art. 5,6 of chapter A of Code of SFEE)

 

  1. Is the comparative advertising of medicinal products allowed?

In general, the comparison is allowed but it must be capable of scientific substantiation.

Comparative claims of superiority or non-inferiority and the like are only permitted if they are risen from the level of statistical significance in Head to Head, specially designed randomised comparative trials, published in peer-reviewed scientific journals, aimed at comparing the safety/efficacy parameters and other properties of the medicinal product (primary or secondary end points of the trial).

Hanging comparisons such as “it is better”, “better safety profile”, etc. without stating what the medicinal product is compared with are not allowed.

Along with comparisons and/or statistical data, the following must always be stated:

  1. the statistical significance level (P/P value or confidence intervals) must be stated for data that are statistically non-significant;
  2. further statistical data analysis, when such data have not been published (i.e. extrapolation of results by the company), is not allowed.

Where the clinical significance is not known, this must be stated on the same page.

All factors under comparison must be stated, accompanied by clarifications where and as necessary.

Data from patient registries must not be used as a basis for comparative claims. When such data are presented, the identity of the registry must be indicated and a clarifying notice to the following effect must be added:

“The results shown here have been derived from a patient registry and not from a randomised trial involving direct comparison of therapeutic factors, therefore they do not suggest such comparison” (art. 6 of chapter A of Code of SFEE)

 

  1. Is the publishing of press releases for medicinal products allowed?

There is a general prohibition regarding the publishing of any kind of information concerning unauthorized medicines (prior to the grant of marketing authorization by the National Organization of Medicines), however a press release can be published under the strict condition that it is informative and does not include any promotional references to specific unauthorized medicine.

  1. Is the provision of gifts to the health care professionals allowed?

It is permitted to offer item medical/educational devices/applications of insignificant value, up to EUR 15 (per item) VAT included, closely associated with daily HCP practice.

All the above informational and educational material for medical use is considered promotional and must therefore be notified to EOF. Such material must not use the product brand name and/or include a direct or indirect advertising message, but only the company’s logo.

Any other donation, sponsorship or benefit in kind to HCPs is prohibited.

  1. Is the provision of hospitality to health care professionals allowed and if yes under which prerequisites?

Pharmaceutical companies are permitted to cover the participation costs of HCPs, including travel, registration, accommodation and meals, subject to approval from EOF and from their employers.

HCPs are entitled to participate only in conferences related to their specialty or similar specialties and of course the participation of any accompanying persons in any activity organized by a pharmaceutical company is banned.

The choice of venue must be very careful and it is not allowed to use venues that are renowned for their entertainment facilities or are extravagant (e.g. spas, resorts, casinos, etc.).

Scientific events cannot be held in touristic destinations during the respective high seasons, i.e. during the summer season (20/6 to 15/9) and during the winter season (15/12 to 15/1), and under no circumstances in skiing destinations for the period from 15/12 to 15/3.

The venue must be suitable for professional events and a conference hall for these events is complulsory. For conferences held in Greece, the accommodation of HCPs in, 5-star hotels is prohibited. It is permitted to hold a conference:

  1. in all 5-star hotels located in the capitals in the prefectures of Greece, which have a conference hall, provided they meet the cost requirement under the Code as to the daily cost of accommodation (including VAT and breakfast) and subject to the provisions of seasonality;
  2. in all 4-star hotels which fulfil the cost requirement under the Code and have a conference hall, subject to the provisions on seasonality.
  3. in exceptional cases, hotels located outside the capital of a prefecture, if they meet the needs of the conference and following the positive opinion of the Conferences Committee of SFEE.

 

Entertainment events (excursions etc.) in connection with a scientific event are not allowed.

EOF has put limits to the number of participation that a HCP  can have to conferences per year however these limits do not apply for HCPs with an active role in the conference ( speaker etc. )

For air travel, economy class tickets must be offered, and business class tickets may be offered only if flights exceed 4 hours.

The cost of meals per participant should not exceed EUR 70 (excluding VAT) per day abroad and EUR 70 (including VAT) per day in Greece. The same cost of meal applies also for foreign HCPs who participate in scientific events held in Greece. Accommodation costs must not exceed EUR 250 (excluding VAT) per day in 4-star hotels abroad and EUR 140 (including VAT) in Greece. In this price (EUR 140) breakfast is included. The above mentioned meals’ and accommodation limits apply also for foreign HCPs who participate in scientific events held in Greece. The hospitality cost (meals and accommodation) of scientific events held abroad, should follow the limits of the hosting country of the event, on the condition that the cost of meals does not exceed 70€ (excluding VAT) per day and the cost of accommodation does not exceed 250€ (excluding VAT) per day in 4*star hotels.

EOF categorizes the scientific events in four categories and imposes limits to the amounts that a pharmaceutical company may give for the sponshorship of the event according to its category. (art. 19 of Chapter A of Code of SFEE)

  1. It is allowed to have a business meal with an HCP ?

It is permitted to organise business meals outside the scope of scientific events in places appropriate for the purpose of the meeting. In any case, the daily cost per meal and per person cannot exceed EUR 70, including VAT. (art. 19 of Chapter A of Code of SFEE)

 

  1. Are there in Greece disclosure obligations for the payments to HCPs?

According  to the Code of SFEE each Member company shall document and disclose on their website and on the EOF website platform, within six months’ by the end of each calendar year at the latest, individually by name all Transfers of Value it makes, directly or indirectly, to or for the benefit of a Recipient.  Except as expressly provided, transfers of value shall be disclosed on an individual basis. Each Member Company shall disclose, on an individual basis for each clearly identifiable recipient (name, surname, Tax Registration No) the amounts of transfers of value  to such recipient in each Reporting Period which may be reasonably allocated to one  of the following categories: 1/. Transfers of value to HCOs related to:  Donations and grants, Sponsorship of events, Fees for service and consultancy, 2/ Transfers of value to HCPs related to: Events such as registration fee, travel and accommodation expenses (to the extent permitted by Article 19, Chapter A of Code of SFEE),  Fees for Service and Consultancy.

Disclosures shall be made on an annual basis and each reporting period shall cover a full calendar year. Disclosures shall be made by each Member Company within 6 months after the end of the relevant Reporting Period and the information disclosed shall remain available in the public domain for a minimum of 3 years, unless the Law or the Hellenic Data Protection Authority defines a shorter or longer period after the time such information is first disclosed.  Disclosures shall mandatorily be made in the Greek language.

Non-compliance with such provisions shall entail the imposition of sanctions. (Chapter B of Code of SFEE)