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Direct or indirect promotion of misleading indications of the medicinal product, reference to outdated scientific data, putting forward inaccurate or unsubstantiated claims, misleading comparison with other medicinal products and generalization of isolated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

6. 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)

 

LAW DIGEST Article on divorce 

INTRODUCTION

Greek Law recognizes various type of marriages (civil or religious ) as well as various ways for the dissolution of a marriage.

The present deals with the types of divorce and their conditions as well as with the relations between the spouses and the children after a divorce.

A/What types of marriage are there in Greece?

Marriage is conducted by means of a statement given by both persons simultaneously before the Mayor that they consent to the marriage (civil marriage) or by means of a religious ceremony (religious marriage). Both types of marriage generate the same legal effects.

Β/How can a marriage be dissolved in Greece?

B1/Divorce:

Regardless of the type of marriage, a divorce can be issued by means of an irrevocable court decision which cannot be contested by any legal means.  (Section 1438 CC)

B2/Types of divorce:

Β2.1/Mutual consent divorce:

Mutual consent divorce relies on a common agreement of the spouses that they consent to the dissolution of their marriage (Section 1441 CC). The spouses may dissolve their marriage by means of a written agreement, provided that the marriage had a minimum duration of six months before the execution of such agreement. Such agreement is signed by the contracting parties and their authorised attorneys or only by the latter, if duly authorised by special power of attorney executed during the month precedent to the date the agreement is executed.

If there are minor children, the marriage is validly dissolved if the agreement is accompanied by a written arrangement of the spouses regulating the children’s custody and parent-child communication details.

Mutual consent divorce is a much less costly and time consuming process than the contested divorce, and it is generally recommended.

B2.2/ Contested divorce:

A contested divorce procedure is initiated where the spouses failed to reach a common agreement on the dissolution of their marriage and one of them sues the other demanding the dissolution of the marriage.

Whether a divorce suit will be eventually accepted by the court depends on whether any of the following statutory grounds for divorce – restrictively set out in the law – is duly met:

1. A) According to Section 1439 CC, either spouse may file a petition for divorce if there has been an irretrievable breakdown of the marriage, for reasons attributable to the Respondent or both spouses, so that the continuation of the marriage has become intolerable for the Petitioner.  It is therefore evident that such breakdown of the marriage may not be attributable exclusively to the Petitioner. If so, the petition is dismissed as inadmissible.  By way of indication, the Greek case law mentions the following events as solid causes of such irretrievable breakdown of a marriage: abandonment of the spousal residence, disregard of either spouse towards the other, emotional detachment of the spouses, insult to the personality of either spouse by the other, immorality or dishonesty of either spouse,
2. B) Unless refuted by the Respondent, such irretrievable breakdown of the marriage is presumed in case of bigamy or adultery, abandonment of the Petitioner or attack against his/her life by the Respondent, as well as in case of domestic violence.
3. C) If the spouses have been living separately for a period of two consecutive years, then the irretrievable breakdown of the marriage is presumed and a petition for divorce may be filed even if the causes of such breakdown are attributable exclusively to the Petitioner. The two-year separation period is not suspended by any minor cessations that took place in an effort of the spouses to restore their relations. “Separation” means both the physical and emotional detachment of the spouses along with a wish to no longer live together. Separation also exists where the spousal relationship has been so severely undermined that it is no longer tolerable to the spouses. In case of physical separation of the spouses for a term of two years, the irretrievable breakdown of the marriage, as a solid ground for a divorce, is irrefutably presumed. This practically means that the spouses may be separated even while they are still living together.

 

C/ What are the spousal relations after the divorce?

C1/ Alimony

The legal term “alimony” refers to the amount of money required by a person to meet their basic needs, e.g. food, accommodation, lighting, heating, clothing, entertainment and medical care as well as their upbringing and education. C1a) Who is entitled to receive alimony? Entitled to receive alimony is any person who is unable to live on his/her own resources or from an employment appropriate to his/her age, medical condition or other living standards also in view of also to any educational needs.

 

According to Section 1486 CC, a minor child is entitled to a alimony allowance from his/her parents, even if he/she owns assets, provided that the income generated from his/her assets or employment is insufficient to cover his/her living expenses. It has also been upheld by the courts that a minor child is under no obligation to make use of its own assets before claiming alimony from his/her parents, yet he/she must have used up any such resources before claiming alimony from his/her ascendants.

 

A person who is unable to provide alimony without jeopardising his/her ability to meet his own living expenses, taking into account any other obligations he/she may have, is under no obligation to provide it.

The parents are liable to provide for their children in proportion to their financial capacity.

C1b)How is alimony awarded by the Greek courts?

The amount of alimony is determined based on the needs of the beneficiary, as same arise from his/her living standards. “Living standards” are the specific living conditions, which vary based on the age, place of residence, need for supervision or education and medical condition of the beneficiary, in conjunction with the financial situation of the person liable to provide alimony. Any extravagant wishes or irrational demands of the beneficiary (e.g. extravagant hobbies) are not considered as eligible needs.

 

The obligation to provide alimony includes anything which is essentially required for the beneficiary’s alimony, including any money required to cover his/her upbringing and professional or general education.

The amount of alimony required is determined based primarily on the income of the parents deriving from any sources. Then, the needs of the minor child are determined, based on his/her living standards, namely on his/her living conditions, without regard to any irrational demands. The parent assigned with the custody of a minor child may include in his/her alimony claim any actual expenditures incurred to meet the child’s needs, including any personal care and support services offered, which can be valued in pecuniary terms, and any other contributions in kind arising from his/her cohabitation with the child, which can be valued and included in the obligor’s child support obligation.

From the provisions of Sections 1389, 1390, 1391 and 1493 CC it emerges that spouses have a mutual obligation to maintain each other, each based on his/her financial capacity, there being no requirement for one spouse to be wealthy and the other poor. The amount of alimony is determined based on the beneficiary’s needs, which are in turn determined based on his/her family and living conditions.

 

It is important to note that if any changes in alimony terms occur after the issue of a court order defining the amount of alimony payable, the court may adjust its alimony order or order the obligor to cease alimony payments.

 

D/ What are the parent-child relations after a separation or divorce?

D1/Parental responsibility:

Parental responsibility over a minor child is a duty and a right of both parents and exercised by them jointly.

Parental responsibility includes the personal care of the minor, the management of his/her assets and his/her representation in any affairs, transactions or proceedings concerning the minor or his/her assets.

In assigning parental responsibility to either parent the Greek courts take primarily into account the appropriateness of each parent to carry out the upbringing and care of the minor child as well as the child’s relationship with each of his/her parents and siblings. In doing so, the Court evaluates each parent’s personality and ability to raise a child, as well as their living conditions and financial standing.

In case spousal cohabitation has been discontinued, i.e. the regular living conditions of the family have changed radically as there is no longer a spousal residence and each spouse lives separately from the other, then a matter arises as to whether the minor children of the family should be living with their father or mother, in which case parental responsibility is determined by the courts.

 

As guidance for the granting of parental responsibility, in case of disagreement between the parents and the children and referral of the case to the courts, and also as a core criterion for such assignment, the Court assesses the real interest of the child, namely seeks to ensure his/her development as an independent, responsible person.

In case of disagreement between the parents, if it is to the interest of the child for a decision to be adopted, the matter is referred to court.

According to section 1513 CC, in case of a divorce or dissolution of the marriage, then, provided that both parents are alive, parental responsibility is regulated by the court. It may be assigned to either parent or, if the parents agree and they have jointly determined the child’s residence, to both parents jointly.

In making its decision the court takes into consideration the child’s relations with his/her parents and siblings up to that point as well as any arrangements made by the parents in respect of the child’s custody and the management of his/her assets.

The parent deprived of parental responsibility has the right to request the other to provide information about the child’s personality and assets.

D2/Custody:

Child custody consists primarily in the child’s maintenance, supervision and education as well as the decision as to his/her place of residence.

The court awards custody taking into account primarily the child’s best interest. In determining the child’s best interest,

the court takes into account and evaluates all terms and conditions that are beneficial to the child. The child’s opinion is not decisive or substantially important, as in several cases the child’s views are influenced or merely temporary and inconsistent with his/her best interest. The responsibility of a parent in the divorce or discontinuance of the spousal cohabitation is of no importance, save where the parent’s behaviour has an impact on the exercise of parental responsibility and the severity or the extent of such behaviour is harmful to the interests of the child and at the same time indicative of the parent’s character and personality in general, so that the parent is expected to demonstrate equivalent behaviour also towards the child.

 

The parent who is not sharing premises with the child has the right to have personal contact with him/her.

The parents have no right to deprive the child of any communication with his/her grandparents, save for a serious reason. The terms of parent-child communication are determined by the court with due regard to the child’s age, obligations (educational / extra-curricular activities) and the obligations of the parents. Normally, such terms include a weekly communication for a few hours and some weekends during the month. They also include certain days during the summer and during the Christmas and Easter vacations.

E/ What are the financial effects of the dissolution of marriage?

In case a marriage is dissolved or annulled, then, if either spouse’s fortune has increased after the marriage took place and the other spouse has contributed to such increase in any manner, the latter may claim to receive a value equivalent to his/her contribution to the increase. Such contribution presumably equals one third of the increase, unless proven to be smaller, greater or zero, as per Section 1400 CC.

 

The spousal contribution of the claimant may consist not only in the supply of funds in any form, but also in the provision of services which can be evaluated in pecuniary terms, including services provided in the spousal residence for the care and upbringing of the children, where and insofar such services do not fall within each spouse’s obligation to contribute to family expenses.

 

Such services may be valued based on the pecuniary value of the income which the beneficiary could have drawn from a certain professional activity, had he/she not engaged in the supply of such services, provided that the spouse could have engaged in such activity but opted to provide his/her services to the family instead.

 

In particular, such increase in the spouse’s fortune is determined based on the entirety of his/her assets, namely, his/her financial situation as at the time the marriage took place (original fortune) is compared against his/her financial situation as at the time the relevant claim arises (eventual fortune).