Collaboration between two companies to market the same medicinal product may take two forms: co-marketing and co-promotion.

In the case of co-marketing, two companies market the same medicinal product, but under a different name / trademark each, so they are in direct competition with each other.

In the case of co-promotion, two companies market the same product under the same name, price and marketing strategy. Usually, one company is the Marketing Authorisation Holder, manufacturer and owner of the medicinal product and the other company receives it based on an agreement and is authorised to market it.

Co-promotion of a pharmaceutical product is permitted under Article 130 of Ministerial Decision 32221/2013, which specifies the terms of collaboration between the two companies. The terms and conditions of said collaboration have been set out in detail in Ministerial Decision ΔΥΓ3α/Γ.Π.οικ. 50510 (Government Gazette 1478/B/06.06.2014).

However, such agreements must be drafted with extreme care in terms of the competition law, so that they are not deemed illegal.

Our law firm has long experience in pharmaceutical law and can support you in negotiating and drafting such agreements, to ensure that all legal conditions are met and to safeguard your long-term interests in the best possible manner.

Lawyer Stefanos Economou has extensive experience in issues involving pharmaceutical companies and in similar collaborations, and can offer you advice and guidance both in terms of the legal and the business part of the agreement.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

During the latest amendment of Article 11 of Law 4052/2012, paragraph g was added to the Article, which specifies that the total amount of clawback for an EOPYY pharmaceutical expense and the hospital pharmaceutical expenditure paid by Marketing Authorisation Holders of pharmaceutical products or pharmaceutical companies may be offset, pursuant to the provisions of Articles 22A and 23 of Law 4172/2013 (167/A), against the amount that corresponds to: i. the percentage over the research and development expenses, including the expenses for clinical trials, which are directly linked to research and development activities of a specific scope and nature, ii. the percentage over the expenses that correspond to investment plans for development of products, services or production lines.

This option strengthens Greek research and production, and by extension the Greek pharmaceutical industry, and is undoubtedly a positive development.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

With Decision No. 1785/2019, the 4th Section of the Council of State deemed unconstitutional the imposition of clawback on a pharmaceutical company for a specific category of medicinal products, the so-called orphan drugs, i.e. drugs used for rare conditions.

The Court ruled that the imposition of clawback on orphan drugs violates the constitutionally established principles of proportionality and equality due to the fact that, as arising from the provisions of the European regulations and national legislation on orphan drugs and rare diseases, these medicinal products constitute an entirely different category, on the one hand because they are used to manage and treat rare diseases and on the other because they pertain to an extremely limited number of patients across the country and per hospital that can easily be established and estimated compared to the drugs used to treat other, just as grave, diseases.

According to Article 9(1) of Regulation (EC) No 141/2000, the EU member states must offer incentives that encourage the circulation of these drugs. However, the national legislation on clawback does not provide for any form of special treatment (e.g. either in the form of a higher discount from the start or with their mandatory inclusion in the legal process of negotiations ending up in the drafting of fixed budgets for the State and National Organization for the Provision of Health Services [EOPYY]). As a result, the consequences from the imposition of the clawback measure are disproportionate to the intended legitimate, in principle, purpose of this restriction in hospital expenditure, and, therefore, constitute an excessive restriction at the expense of the companies that distribute these drugs.

This new decision paves the way for the courts to review the legality of the clawback measure. To date, all the Council of State decisions have deemed the clawback as a temporary measure in view of the severe fiscal crisis plaguing the country. However, the fact that it is being continuously extended proves that it can no longer be considered temporary. Moreover, with the country having exited the memorandums, describing the fiscal crisis as severe can no longer be justified.

In this light, it is possible for the Council of State to rule the imposition of clawback unconstitutional in any other future decisions.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

Pharmaceutical companies in Greece are unable to set the prices for their medicinal products themselves, as these are set directly by the State, which issues a medicinal product pricing bulletin. As a matter a fact, not only is the price of the medicinal product set, but also the profit margin for each level during its distribution, i.e. the profit of wholesalers and pharmacies.

The medicinal product pricing provisions have changed many times in the last years and have been challenged in administrative courts as in contravention to the Constitution. The Council of State accepted that for any established medicinal product costing and verification criteria – which set the maximum sale price – to be constitutionally tolerable, they must lead to the calculation of the medicinal product manufacturing and marketing costs over which the profit margin set by the pricing control is calculated.

According to the Ministerial Decision in force, the pricing takes into account whether the medicinal product being priced is under a data protection regime or whether this has expired, and whether it is original or generic, hybrid, biological, biosimilar, orphan, medicinal product for well-established medicinal use or a steady combination of medicinal products.

The Ministerial Decision in force on medicinal product pricing sets the maximum ex-factory price (which is the price medicinal products are sold at to the wholesalers by the Marketing Authorisation Holders), based on the maximum wholesale price, decreased by i. 4.67% for reimbursable medicinal products priced up to €200.00 and 1.48% for reimbursable medicinal products priced equal to or over €200.01, and ii. 5.12% for non-reimbursable medicinal products.

The maximum wholesale price is the price medicinal products are sold at to pharmacies. This price includes the gross profit percentage of the wholesale authorisation holder, which is calculated as a percentage of the maximum net ex-factory price.

The maximum retail price is the price the medicinal products are sold at to citizens by pharmacies and is set by the maximum wholesale price plus the pharmacy’s legal profit, as specified in the provisions of Article 5 of the aforementioned Ministerial Decision, and the value added tax (VAT).

The Ministerial Decision also sets the maximum hospital price, i.e. the price the medicinal products are sold at by the companies to the public sector, public hospitals, social care units, EOPYY pharmacies, public-law legal entities under Article 37(1) of Law 3918/2011 (31/A) and private hospitals, based on the maximum ex-factory price, decreased by 8.74%.

The prices of all medicinal products are reviewed once a year and the Reviewed Medicinal Product Pricing Bulletin is issued in April each year.

A prerequisite for a medicinal product in Greece to receive a price is for the medicinal product to have received a price in at least 3 eurozone member state (for orphan drugs, only 2 eurozone member states are sufficient) for the specific pharmaceutical form, concentration and packaging. The prices in the eurozone member states are retrieved by the National Organization for Medicines (EOF) Pricing Department using the EURIPID database, as well as from official data posted by the competent agencies within each eurozone member state.

A key rule for setting the reference medicinal product price is that the maximum ex-factory price is set based on the average of 2 different lower prices for the same medicinal product in the eurozone member states, as to its active ingredient, pharmaceutical form, concentration and packaging. For generic medicinal products, their price is set at 65% of the price of the corresponding reference medicinal product.

Stefanos Economou & Associates Law Firm has over 20 years of experience and expertise in handling cases involving pharmaceutical and medical equipment companies, and can assist you in submitting your observations and objections regarding the pricing of your products to EOF and the Greek Ministry of Health. We have handled several related cases and have appeared before the Pricing Commission to safeguard the interests of our clients, as well as before the Council of State to annul Pricing Bulletins that involved illegal pricing of pharmaceutical products.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

The legislation and the National Organization for Medicines (EOF) explicitly prohibit any advertising of medicinal products for purposes not included in their marketing authorisation.

Off-label advertising, as it is known, is quite a serious violation that has come to the attention of authorities of other countries many times and hefty fines have been imposed.

Banning of off-label advertising also includes the promotion of medicinal products at scientific conferences.

However, because the health professionals need to be updated on new developments, the presentation of the latest scientific findings at scientific conferences is permitted, provided that it is stated that the specific active ingredient has not been approved and provided that the trade name is not mentioned.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

Teasers or teaser ads pertain to the promotion of an advertising message without mentioning the name of the product, in anticipation of the launch of a new major and significant medicinal product in the coming period.

In Greece, teasers are prohibited, given that advertising a medicinal product that has not received a marketing authorisation in not permitted and teasers are essentially indirect advertising, even though they do not include the name of the product.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

According to Ministerial Decision 32221/2013, the concept of advertising/promotion of medicinal products is quite broad, so as to include any activity a pharmaceutical company carries out to promote the prescribing, supply, sale or consumption of medicinal products.

However, the compliance officers and legal advisors of pharmaceutical companies are used to arguing with the marketing departments as to whether an action is an advertisement or ordinary information, and the arguments put forward by both parties are quite sound most times.

Typical cases that create doubts are press releases, media articles and interviews given by doctors and company executives.

The limits between providing ordinary information and advertising are not always clearly distinguished, and one must take many criteria into account.

If a company issues a statement to the general public about a prescribed drug and this statement is deemed to be advertising and not just ordinary information, then it is at risk of being fined or even have legal actions brought against it by its competitors.

The European Court of Justice, but also the Greek courts have dealt with such issues on many occasions. Our firm’s lawyers who specialise in pharmaceutical law can offer you advice, either as a precaution or before the National Organization for Medicines (EOF) and the courts if an action of yours is beyond the strict limits of information and constitutes an advertising action.

The following key criteria must be taken into account:

1. the purpose of the statement, i.e. whether its aim was to boost sales or not
2. the capacity of the person making the statement

iii. the potential result of the statement in terms of the decision to buy the medicinal product

1. the type of information
2. the recipients of the statement and the medium it appeared in

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

The pharmaceutical industry has adopted codes of ethics, which are self-binding even in countries where the legislation has not set restrictions or has set inadequate restrictions and audits in medicinal product advertising.

These texts are usually called Code of Conduct or Code of Practice.

Our law firm has profound knowledge of the legislation governing the advertising and promotion of medicinal products in general, as well as the compliance of said promotion to the various codes of ethics. Managing partner Stefanos Economou has written the only book in Greek literature on the marketing of medicinal products. The book is entitled Compliance with Legislation and the Code of Ethics in Promoting Medicinal Products.

1. GREEK ETHICS CODES
2. The SFEE Code of Ethics for prescribed medicinal products

The Hellenic Association of Pharmaceutical Companies (SFEE) has been a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since 1983.

The Code of Ethics currently in effect for the promotion of prescribed medicinal products was amended and approved by the SFEE General Meeting in March 2017 and came into force on 1 June 2017. Since then, the National Organization for Medicines (EOF) has changed the landscape and, consequently, the SFEE Code needs to be updated so as to correspond to the current state of affairs.

Furthermore, the SFEE has adopted a Code of Ethics that governs the relations between pharmaceutical companies and patient associations, which is in effect today, as amended after the General Meeting of the SFEE on 20/03/2015.

1. The EFEX Code on OTC drugs

With regard to over-the-counter (OTC) drugs, the Association of the Greek Self-Medication Industry (EFEX), which is a member of the Association of the European Self-Medication Industry (AESGP), has drawn up the Code of Ethics and Advertising of OTC Drugs.

1. The Code of Medical Ethics

The Code of Medical Ethics also includes provisions that are indirectly linked to the promotion of medicinal products and the relationships of doctors with the pharmaceutical industry.

1. EUROPEAN & INTERNATIONAL ETHICS CODES
2. The EFPIA Code of Practice

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in the European Union. Its members are 36 national associations of EU member states and 34 pharmaceutical companies.

1. The IFPMA Code

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents research-based pharmaceutical companies and associations from around the world.

The IFPMA issued a Code of Ethics for the first time in 1981, which has since been amended on numerous occasions.

As of 01/01/2019, the IFPMA Code has become stricter and bans gifts to health professionals, as had already been done by the EFPIA and the SFEE.

1. The WHO decision

On 13/05/1988, the World Health Organization (WHO) decided to adopt the Ethical Criteria for Medicinal Drug Promotion.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.

Our law firm has profound knowledge of the legislation governing advertising and the promotion of medicinal products in general. Managing partner Stefanos Economou has written the only book in Greek literature on the marketing of medicinal products. The book is entitled Compliance with Legislation and the Code of Ethics in Promoting Medicinal Products.

Consequently, we can offer you advice on any legal issue relating to the promotion of your products, either pharmaceutical products or medical equipment, as well as on any compliance issue.

Regulations on promoting medicinal products appear both in European and national legislation. The main ones are:

1. Legislative Decree 96/73 on trading in pharmaceutical, dietary & cosmetic products, which includes Articles 16-19 on the main obligations and restrictions in the advertising of medicinal products.
2. Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use, which includes provisions on advertising and information for medicinal products under Articles 86-100.

It aims to accomplish free and safe marketing of medicinal products for human use and eliminate technical obstacles during the relevant transactions, while promoting the operation of the internal market and ensuring a high level of public health.

29. Ministerial Decision No. ΔΥΓ3α/Γ.Π. 32221 (Government Gazette 1049/B/29.04.2013) on the harmonisation of the Greek legislation to the relevant EU legislation in the area of manufacturing and marketing of medicinal products for human use, in compliance with Directive 2001/83/EC on the Community code relating to medicinal products for human use (Law 311/28.11.2001), as in force and amended by Directive 2011/62/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Law 174/01.07.2011).

This Joint Ministerial Decision (hereinafter JMD 32221/2013) incorporated in the Greek law Directive 2001/83/EC, as amended by Directive 2004/27/EC, and includes all the provisions on medicinal product advertising in Articles 118-132, repeating and enriching the provisions of incorporated Directive 2001/83/EC.

1. Law 4316/2014

Provisions on promoting transparency when marketing medicinal products and on the doctor/manufacturer relations are also included in Article 66(7) of Law 4316/2014, which made it mandatory for pharmaceutical companies to disclose the benefits offered to health professionals.

With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.