Need the lowdown on product liability in Greek pharma? Read on! 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 types of liability are recognized in your jurisdiction?
Several types of liability, namely civil, administrative, criminal and disciplinary liability may be established under the national legislation in force in the event of breach of pharmaceutical laws and regulations, depending both on the nature of the applicable provisions as well as on the nature of the person responsible, i.e. either private or public.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
The manufacturer’s civil liability for a defective medicinal product and/or a defective medical device may be established under articles 6 and 7 of Law 2251/1994 (consumer protection Law), the provisions of which have already been coded in a single text by virtue of Ministerial Decision 5338/2018, in conjunction with the provisions of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013. Article 6 of Law 2251/1994 in particular has been amended in line with the provisions of EU Directive 85/374/EEC on liability for defective products, permitting the consumer to seek restoration of any and all damages deriving from a defective medicinal product or medical device, including nominal damage, which is specifically stipulated under article 6(7). Attention must be paid to the fact that the manufacturer’s liability under the said Law is strictly objective in the sense that the claimant is not required to claim, let alone prove the existence of the manufacturer’s fault in order to establish his/her claims. In the alternative, a claimant may also establish his/her claims under the tort liability provisions of the Greek Civil Code (articles 914 et seq.).
It is worth noting that:
- In accordance with article 6(4) of Law 2251/1994, where the producer of the (defective) product cannot be identified, each supplier of the product is treated as its producer unless he/she informs the consumer within a reasonable time of the identity of the producer or the person who supplied him with the product. Moreover, pursuant to article 7 of said Law, as recently amended by Law 4512/2018, the obligation to market safe products, including the obligation to provide sufficient information to the consumer in order to ensure safe use of a marketed product, is incumbent upon the manufacturer. The crucial definition of the manufacturer is further laid down in article 2 of Interministerial Decision Z3/2810/Government Gazette B’/2885/2004. In accordance with the specific provision, every professional who may in the course of his business affect the safety features of the product shall be deemed to be a producer. The wide scope of the manufacturer’s definition aims at the outmost protection of the consumer.
Pursuant to article 41 of Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 the granting of an authorization for the marketing of the medicinal product does not affect the civil and criminal liability of the manufacturer.
Pursuant to article 281 of the Greek Penal Code, whoever manufactures, processes or markets medicines in such a way that their use may cause damage to the user’s health or put the user’s life at risk, is punishable by imprisonment of at least 3 months and up to five years. Criminal liability, including the obligation to pay a criminal penalty, is also incurred by the persons, either Manufacturers, Representatives, Importers marketing medicinal products or Pharmacists, Doctors, Veterinaries or any distributors dispensing medicinal products in the event of repetitive infringement of either of the provisions of article 19 of Legislative Decree 96/1973 providing, in principle, for the imposition of administrative fines in cases of marketing or dispensing of medicinal products without the required authorization or while the latter has been terminated, revoked or suspended, as therein described.
As regards disciplinary liability, the Code of Ethics of the Hellenic Association of Pharmaceutical Companies (Hellenic acronym: SFEE), a member of EFPIA, regulates various aspects of the promotion of pharmaceutical products by its members, mirroring the EFPIA HCP and Disclosure Codes. Said Code enriches the regulatory framework on medicinal products; despite the – strictly speaking – ‘soft law’ character of its provisions, pharmaceutical companies active in Greece attach a great level of importance to compliance with its content, which constitutes, as regards several aspects of their day-to-day interaction with healthcare professionals, the only legal framework available.
Finally, in the event of breach of the provisions stipulated under Interministerial Decision D.YG3α/G.P. 32221/Government Gazette B’ 1049/2013 and Interministerial Decision DY8d/G.P. 130648/Government Gazette B’ 2198/2009, the manufacturer may also be held administratively liable and as a result be subject to the imposition of the relevant administrative fines as initially provided by article 19 of Legislative Decree 96/1973 and amended by virtue of article 175 par. 2 of the Interministerial Decision 32221(see the section Regulatory, Pricing and Reimbursement).
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees and representatives?
Article 71 of the Greek Civil Code provides for joint liability of both the natural person acting as representative of a legal entity and responsible for any acts or omissions throughout the execution of their duties establishing civil liability under the Greek Civil Code provisions and said legal entity. Administrative liability, being established on the basis of the infringement of the regulatory framework relevant to the marketing of medicinal products as set by virtue of Interministerial Decision 32221, is incurred by the legal entities or natural persons falling within its scope. Similarly, disciplinary liability on the grounds of an infringement of the Code of Ethics of SFEE is incurred by the legal entity member of the Association. Finally, criminal liability is naturally exclusively incurred by the natural persons the acts or omissions of which constitute infringements of criminal provisions.
4. How can a liability claim be brought?
Any individual or legal entity having suffered harm from a defective medicinal product or medical device is entitled to bring claims before civil and criminal national courts against the liable person or legal entity.
Civil law claims for positive material damage, loss of profit and/or moral damages may be brought by way of a lawsuit filed with the competent civil court.
Where criminal liability may also be established, the persons liable may be prosecuted either ex officio or following the filling of a criminal complaint by the harmed person/legal entity or report by any competent authority, namely EOF in the case of repetitive infringement of Interministerial Decision 32221 provisions.
Administrative claims are imposed by the National Medicines Organization (EOF), competent authority as regards the application of the regulatory framework relevant to the marketing of medicinal products in Greece, either following a complaint by any affected person or entity or ex officio, where any infringements are found in the context of an audit conducted by the Organization.
5. What defenses are available?
Defenses vary depending on the type of liability incurred and the nature (civil, criminal, administrative or disciplinary) of the specific provisions applicable, they should, therefore, be examined on a case-by-case basis. Defendant may naturally be represented before both civil and criminal courts, as well as before any disciplinary body. The civil procedure permits the defendant to file pleadings either denying the facts claimed by the claimant or raising objections against the claimant. Following initiation of the criminal procedure the defendant is required to supply either an oral or a written statement in answer to the charges brought against them; during the procedure before the criminal court, the defendant is entitled to participate either represented by a lawyer or not; where the defendant is present throughout the proceedings he is also required to answer questions raised by the court, the Public Prosecutor or the attorney of the party having initiated the criminal procedure (referred to as ‘plaintiff’) and may choose to provide a final oral statement on his own behalf, although usually this is made by the defendant’s advocate. Finally, administrative fines may be challenged before the competent administrative courts.