A Q&A guide to life sciences law in Italy.
The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.
To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool.
The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.
The main regulation regulating pharmaceutical matters is Legislative Decree 219/2006, implementing:
Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive).
Directive 2003/94/EC on good manufacturing practice for medicinal products (GMP Directive).
Other important provisions include:
Legislative Decree 24 June 2003 No. 211, implementing Directive 2001/20/EC on the conduct of clinical trials (Clinical Trials Directive).
Legislative Decree 6 September 2005 No. 206 (Consumer Code).
Law Decree No. 269 of 30 September 2003 (confirmed by subsequent Law No. 326 of 24 November 2003) concerning the price and reimbursement system.
Law Decree No. 158 of 13 September 2012 (as modified by subsequent Law No. 189 of 8 November 2012). This law covers many different fields, including price and reimbursement procedures and powers of the competent authorities in relation to the clinical trials authorisations process.
The National Healthcare Service (NHS) is made up of several institutional bodies, at national and territorial level, which mutually co-ordinate their activities within their specific areas of competence. At national level the most important institutions are the:
Ministry of Health (see box, Regulator details) that directs and leads the policies of healthcare-related issues in Italy.
Italian Agency of Pharmaceutical Products (AIFA) (see box, Regulator details), which has several important powers in different fields, including granting marketing and manufacturing authorisations, and negotiating the prices of medicinal products that are reimbursed by the NHS.
The territorial level comprises the Regions, the self-governing Provinces of Trento and Bolzano, local health units and hospitals, and university institutions.
Regions have, among other things, the following powers:
Approving the local healthcare plan (in conformity with the national healthcare plan).
Granting the distribution authorisations.
Biotechnology products fall within the scope of Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (EMEA Regulation). Several cases have been brought before the courts concerning biosimilar products, where substitutability between biosimilar and originator product has been challenged, particularly within public procurement frameworks.
There is no specific regulation of combination products.
The NHS is mainly centrally funded by the government through the national income tax system. Citizens do not otherwise contribute to public health expenditure, apart from the following exceptions:
The Regions can impose a fee (ticket) on any reimbursable healthcare services in general and on Class A products in particular (see Question 3).
Fees for any non-reimbursable healthcare services.
The pricing and reimbursement of medicinal products was extensively reformed in 2003 by Law Decree No. 269 of 30 September 2003 (confirmed by subsequent Law No. 326 of 24 November 2003).
Medicinal products have been divided into two classes:
Class A includes essential products and those intended for chronic diseases. These are fully reimbursed by the NHS.
Class C includes other products, which do not have the characteristics of class A. These are not reimbursed.
There is also a sub-class H. These drugs are only reimbursed if administered in a hospital.
The price of products belonging to class C can be freely determined by the marketing authorisation holder. Class C products are fully charged to the patients/buyers. The price of medicinal products belonging to class C can only be raised during January of odd-numbered years by the marketing authorisation holder (Article 1, Law Decree 87/2005).
The price of class A products is set through negotiation between the AIFA and the marketing authorisation holder. The negotiation with AIFA is not required for marketing but, since 11 November 2012, must be started contextually to the request for reimbursement by the NHS. The negotiation process is based on the Resolution of Economic Planning Interministerial Committee of 1 February 2001.
The negotiation process can be initiated after the grant of marketing authorisation if the authorisation is national or by mutual recognition (after the final Committee for Proprietary Medicinal Products (CPMP) opinion, if the marketing authorisation is centralised) (see Question 8), and is organised in three steps:
Presentation of the dossier.
Closing of the contract.
In the discussion, the authorisation holder should support its proposals:
If the drug is innovative, by documentation showing a favourable cost-efficacy relation.
If the drug does not have a significant superiority in relation to other drugs already available, with other elements of interest for NHS (that is, lower price, lower therapy cost, and so on).
In any event, with a forecast of market share, impact on NHS cost, and so on.
The relevant regulation establishes a term of 90 days for the negotiation but this term is not mandatory. The agreement is for two years. On expiration of the term, each party can request a renegotiation. Renegotiation can be opened during the term in case of change of indications or posology influencing the usage level of the drug.
The negotiation process is web-based. The documents for the negotiation can be submitted by pharmaceutical companies electronically. AIFA's website sets out the updated list of any reimbursable products, their retail price and any information on its reimbursement.
Hospitals purchase the products directly from marketing authorisation holders or manufacturers, with a discount of no less than 50% of the public price.
Due to budget constraints in the last few years, the government repeatedly decreased the price of generics (for example see Law Decree No. 78, 31 May 2010).
The cost of class A medicinal products is reimbursed by the NHS. The reimbursement is in a direct form (the patient gets the product free of charge and the NHS pays the pharmacies).
Medicinal products manufactured in Italy must be produced on a manufacturing site covered by a manufacturer's authorisation. This authorisation is required even for partial production activity such as encapsulation and packaging.
A manufacturing authorisation is granted if the applicant complies with all the requirements in Articles 50 and ff of Legislative Decree 219/2006. In particular, among other things, the applicant must:
Provide products specifications and their pharmaceutical form to be manufactured.
Describe the place of production and applicable quality controls.
Have plant, equipment and structures adequate to produce, control and store the products.
For each plant, employ at least one qualified person, with the academic background and skills legally required to supervise the production process.
There are no specific restrictions on foreign applicants, provided domestic rules are complied with.
AIFA usually arranges a site inspection before issuing a manufacturer's licence. If the information on the application is accurate and complies with the statutory requirements, AIFA must grant the authorisation within 90 days from receipt of the application. If it is not satisfied with the documents provided, AIFA can request further information on the production facility. AIFA can also prescribe conditions to make the premises or the equipment suitable for production and set a period within which these conditions must be satisfied. If authorisation is refused, the applicant must be given reasons.
Details of the fees are set out on the AIFA website (see http://pol.aifa.gov.it/docs/tariffarioTabellareING_v114.pdf). The manufacturing authorisation fee is about EUR12,580.90 for each plant (Ministerial Decree 24 May 2004). Since 2009, the payment can be submitted electronically.
Authorisation for production is granted for an indefinite period of time.
AIFA has powers, at any time and without advance notice, to:
Inspect factories and premises where medicines are manufactured and packaged.
Collect and analyse samples of medicinal products.
View copies of documents relevant to the inspection.
AIFA can revoke, vary or suspend an authorisation when a statutory condition of the authorisation is no longer complied with. AIFA notifies the authorisation holder of its proposed action and its reasons. The authorisation holder can challenge AIFA's decision within 15 days.
Where public safety is at risk, AIFA can suspend a licence with immediate effect. Suspension or revocation orders are served on the authorisation holder and published in the Official Gazette. Revocation decisions can be appealed to the Regional Administrative Tribunal.
Producers can be fined between EUR10,000 to EUR100,000 and their legal representative can be sentenced to imprisonment (from six months to one year) if a plant operates without:
Valid and ongoing authorisation.
A qualified person.
In case of non-compliance with any of AIFA's decisions, a fine from EUR10,000 to EUR50,000 can apply, unless the breach constitutes a crime.
Directive 2001/20/EC on the conduct of clinical trials was implemented by Legislative Decree No. 211/2003, which came into force on 1 January 2004.
Other important provisions are contained in Legislative Decree 200/2007, implementing Directive 2005/28/EC on good clinical practice as regards investigational medicinal products for human use (GCP Directive) and Ministerial Decree 15 December 2011 (published in the Official Gazette on 14 January 2012), regarding the minimum requisites of the CRO (Clinical Research Organisation).
Further, in relation to data privacy issues, on 24 July 2008, the Italian Authority on Data Privacy (Garante della Privacy) issued Guidelines for Data Processing within the Framework of Clinical Drug Trials.
The clinical trial must be approved by the competent authority (Article 2, Legislative Decree No. 211 of 24 June 2003). Since 11 November 2012 (see Determination 7 January 2013 No. 1, issued by AIFA) the competent authority is:
The Ministry of Health, when the study covers biological substances or genetically modified organisms, or is conducted in relation to products for which a marketing authorisation has not yet been granted.
Starting from November 2012, the Superior Institute of Health (Istituto Superiore di Sanità) (ISS) has only consultancy duty.
The competent authority has 60 days to decide on the request for authorisation.
The sponsor can only start the trial after having obtained the approval of the ethics committee, and provided the competent authority has not raised any objection (Article 9, Decree 211/03).
Clinical trial subjects must give their informed consent. The consent must be in writing, signed and dated. For the consent to be valid, the clinical trials subject must be informed of, among others, the:
Nature, objectives, risks and conditions of the trials.
Right to not take part in the trial or to withdraw consent at any time without any consequences for the medical treatment.
Rights concerning his personal data.
This information must be provided during an interview between the doctor or a member of the research team and the clinical trial subject.
Other conditions that must be met before the trial can start are the:
Assessment of a reasonable likelihood that the targeted population stands to benefit from the results of the research.
Existence of insurance coverage for any civil liability of the investigator and sponsor.
Clinical trials are conducted in compliance with the trial protocol (which can be amended during the trial with the consent of the ethics committee), good clinical practices and GMP.
During the trial, the promoter must be immediately notified of any adverse effects and any information concerning suspect, serious and unexpected adverse reactions, which caused the death of trial subjects or threatened their lives. Notice on adverse reactions is also given to the Ministry of Health.
No medicinal product can be put on the market without either an:
AIFA authorisation (autorizzazione all’immissione in commercio) (AIC), which may be national, by mutual recognition or by decentralised procedures.
EU authorisation granted in accordance with the EMEA Regulation.
AIFA requires that the:
Application and attached documentation (registration file) demonstrate the product meets the relevant criteria and safety, quality, performance and effectiveness to be marketed in Italy.
Applicant has the services of a qualified person responsible for pharmacovigilance.
The applicant must be established in the EU and the application must include, among other information:
Identification of the person responsible for placing the product on the market and, if different, the manufacturer's name. In co-production, the co-producers must specify the addresses of their facilities and the stages of production, and controls undertaken by each of them.
Name of the medicinal product.
Composition (qualitative and quantitative) of all the drug's ingredients, expressed in standard terminology.
Therapeutic indications, contra-indications and side effects.
Posology, pharmaceutical form, method and route of administration, and expected shelf life.
Results of clinical trials.
An abridged procedure applies for generics (see Question 9).
After marketing authorisation is issued, the product must undergo a price negotiation to be reimbursable by the NHS, as well as a regional procedure for insertion in the regional list of reimbursable products.
Marketing authorisation must be granted or refused within 210 days from the filing of the application. If an authorisation procedure for the same medicinal product is pending in another member state, the AIFA does not examine the application and the process is regulated by the mutual recognition provisions. The applicant is notified of this. If the applicant challenges a refusal, AIFA renders its decision within the following 90 days.
The standard fee is EUR55,680 for each single concentration relating to the product in dosage form, payable to the Ministry of Health.
The abridged procedure fee is half the standard fee (Ministerial Decree, 24 May 2004).
National and mutual recognition authorisations last five years from the date of publication of the relevant AIFA decree in the Official Gazette. After the first renewal, they are valid indefinitely. However the authorisation lapses if the product is not marketed within three years after it is issued.
An MA holder must ensure a positive risk/benefit ratio for its authorised medicinal products, in compliance with pharmacovigilance duties set by Title XI of Legislative Decree 219/2006, reflecting Title IX of the Code for Human Medicines Directive. Italy implemented Directive 2010/84/EC on 11 December 2012 (see Law Decree No. 216, as modified by subsequent Law No. 228 of 24 December 2012).
The MA holder must:
Maintain detailed records of suspected adverse events.
Submit to AIFA periodic reports on product safety.
Establish systems to ensure that all the information on adverse events is correctly reported to AIFA and any other person or entity entitled to receive it.
Every six months for the first two years after authorisation.
Ensure requests of Aifa are properly answered.
Article 10 of Legislative Decree 219/2006 almost entirely reflects Article 10 of the Code for Human Medicines Directive, providing an abridged procedure for the authorisation of generic products. The applicant is not required to provide the results of toxicological and pharmacological tests or the results of clinical trials if it can demonstrate that the medicinal product is essentially similar to a medicinal product which has been authorised within the European Community for no less than eight years. However, the generic product, even if authorised, cannot be marketed before the tenth year of marketing of the originator (see Question 23).
Further, a full dossier is not required if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use in the EU for at least ten years, with recognised efficacy and an acceptable level of safety. The test and trial results are replaced by appropriate scientific literature.
Mutual recognition and decentralised procedures are regulated by Article 41(ff), Legislative Decree 219/06. They apply when the applicant submits the application for recognition of a marketing authorisation in one or more EU member states:
Mutual recognition procedure. When the product has already been authorised in a member state, before submitting the application for recognition of a marketing authorisation, the authorisation holder informs the member state which granted the authorisation at first and on which the application is based (Reference Member State). The competent authority of the Reference Member State prepares an assessment of evaluation of the medicinal product within 90 days of receipt of the request, and forwards the assessment report to the member state or member states concerned by the application.
Decentralised procedure. When the medicinal product has not received a marketing authorisation at the time of application, the applicant requests a member state to act as Reference Member State and to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. The Reference Member State prepares these draft documents within 120 days after receipt of a valid application, and sends them to the concerned member states and to the applicant.
The AIFA has broad powers, including to:
Inspect and ensure that the manufacturing and marketing of the product comply with all applicable rules.
Check and grant a modification of a marketing authorisation.
AIFA can also:
Suspend AICs, to gather information and decide on revocation, or if irregularities can be amended in a suitable period of time.
Revoke AICs, if the product is harmful or has a negative risk/benefits ratio under its normal conditions of use, or if the conditions concerning the granting or updating of AICs are violated.
The marketing of medicinal products without an authorisation or after the authorisation has been revoked or suspended is a criminal offence, which can be punished by imprisonment for up to one year and a fine of EUR2,000 to EUR10,000.
Parallel imports are allowed and must comply with the following conditions (Ministerial Decree of 28 September 1997):
An import marketing authorisation from the AIFA is required.
The importer must show that the product fulfils certain criteria and provide documentation in Italian, proving the product has no difference in therapeutic effect from a product authorised in Italy, or that the differences do not affect quality, safety and effectiveness. If satisfied with the application, the AIFA issues the authorisation within 45 days. A fee applies.
A sample of the imported product must be made available to the AIFA.
If the product is re-packed, notice must be given to the AIFA.
The courts follow the decisions of the EU Court of Justice as far as intellectual property rights can be used to oppose parallel imports.
The following regulations on marketing and advertising practices apply (Title VII, Decree No. 219/2006):
Any gift or promotional aid (financial or not) to practitioners or pharmacists is prohibited, unless it is inexpensive and relevant to the practice of medicine or pharmacy.
Advertising material that is not specifically related to a product can only be given in compliance with the guidelines issued by the Ministry of Health (Ministerial Decree 14 April 2008).
Free samples of medicinal products, limited to a fixed quantity per practitioner, can only be given to practitioners who can prescribe them. The sample must be delivered by representatives and only at the written request of the practitioner.
Specific provisions refer to the duties and restrictions of pharmaceutical companies organising or sponsoring meetings and conventions.
The same restrictions are set out in the Ethics Code of the Association of the Pharmaceutical Companies (Farmindustria, latest edition 23 October 2012).
Retail distribution is generally limited to pharmacies. However, since 2006, under Law Decree 223/2006, large-scale retail trade can sell over-the-counter (OTC) products and self-medicated products (provided a pharmacist is present).
The sale of medicinal products online, by e-mail or mail order is not allowed. However, e-promotion to practitioners is allowed under certain conditions (see Question 15).
The definition of advertising includes any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products (Article 113, Legislative Decree No. 219/2006).
Only OTC medicinal products can be advertised to the public. In February 2010, the Ministry of Health issued guidelines on advertising health products (including only OTC medicinal products) through media.
Advertising must be authorised by the Ministry of Health, which must consider the opinion of a committee of experts, except when advertising is:
To be published in the press or broadcast by radio, and has been approved by a competent body recognised by the Ministry of Health.
Part of an already approved message.
The authorisation is deemed granted if no refusal is issued within 45 days of filing a request with the Ministry of Health.
Promotion of prescription products to the public is prohibited. Prescription products can only be promoted to general practitioners and pharmacists in specific circumstances.
The following regulations also apply:
Representatives must have specific qualifications.
The average number of visits paid to practitioners and pharmacists must be notified to the AIFA annually.
Pharmaceutical companies must have a person responsible for the scientific service, who is different from the person responsible for pharmacovigilance.
E-promotion to practitioners is subject to the same rules. Promotional material for practitioners must be previously approved by the Ministry of Health. The website section reserved for practitioners must be protected by a personal password and have a system identifying the visitor as a doctor.
Infringement is punishable by an administrative fine.
Labelling and packaging of medicinal products is regulated by Title V of Legislative Decree 219/2006.
The variations concerning labelling or package leaflets are regulated by Regulation (EC) No. 1234/2008 on variations of marketing authorisations for medicinal products (as amended by Regulation (EC) No. 712/2012).
Further, Ministerial Decree of 2 August 2001 concerning the traceability of medicinal products marketed in Italy, and Ministerial Decree of 15 July 2004 concerning the bar code stamp for medicinal products fully reimbursed by the NHS, should also be taken into account.
The competent authority responsible for the enforcement of the laws is AIFA.
Labelling must contain all elements required by Article 73(ff) of Decree 219/2006.
If a medicinal product (authorised in accordance with the centralised procedure or the mutual recognition and decentralised procedure) is marketed with different indications in the EU, all the indications should be listed in the leaflet (Article 77, Decree 219/2006).
In addition to the name of the marketing authorisation holder, the outer packaging must also bear the name of any company responsible for marketing the medicinal product, based on an agreement with the marketing authorisation holder. The agreement should be notified to AIFA.
Reimbursable products must have a special bar code stamp identifying the product. This is bought from the governmental stationery office. When the product is dispensed, the stamp is detached by the pharmacist and affixed to a special medical prescription form for reimbursed products, for monitoring purposes.
The labelling and leaflet must be in Italian. Packaging must bear, among other elements, the name of the product and special warnings (if needed) in Braille.
There are specific requirements for the packaging of medicines containing radionuclides, and for radiopharmaceutical leaflets.
Traditional herbal medicines are subject to the same regulations applicable to medicinal products for human use, but with a simplified registration procedure.
Labels and leaflets of traditional herbal medicines must clearly indicate their nature and typical use, and invite the consumer to consult with a specialist in case of symptoms or adverse effects.
Advertising must visibly qualify the product as "medicine of traditional herbal origin to be used for specific indications based on a long term use".
Any invention with lawful implementation can be patented if the following requirements are met:
Novelty (in relation to state of the art).
An inventive step.
Capable of industrial application.
Patents are mainly regulated by Legislative Decree 10 February 2005, No.30.
Medicinal products, substances and processes can be patented if the above requirements are met (see above, Conditions and legislation).
Biotechnologies can also be patented but specific provisions apply (Article 81(ff) Legislative Decree 30/2005, as amended by Legislative Decree 131/2010). Specific provisions exclude patents of technical processes that use human embryonic cells.
Applications are made to the Italian patent and trade marks office (Ufficio Italiano Brevetti e Marchi) (UIBM).
Details of the fees are set out on the UIBM website (www.uibm.gov.it). Brief guidance to the patent procedure is available on its website.
A patent is effective from the date the application is published. An application is published either:
18 months from the date the application is filed.
90 days from the date the application is filed, if the inventor expressly requests immediate publication.
From 1 July 2008, UIBM has started to verify novelty of the invention through research conducted by the European Patent Office (EPO). This is then forwarded to UIBM and the applicant (Ministerial Decree 27 June 2008). UIBM does not examine the other substantive requirements for patentability.
Patents last for 20 years from the date of filing of the complete application. No renewal or extension is generally allowed.
For existing pharmaceutical products, a complementary protection certificate (CPC) can extend patent protection period by up to 18 years, equal to the period between the filing date of the complete patent application and the date of granting the first AIC. To harmonise the CPC with EU Supplementary Protection Certificates (SPCs), which last up to five years, the term of CPCs has been reduced by six months for every year of their original duration since 1 January 2004.
For new pharmaceutical patents, protection can be extended up to five years.
A patent cannot be revoked but can be challenged before the courts if it is void or has lapsed.
Patent rights consist of the exclusive right to put an invention into practice and draw profit from it in Italy under the conditions in the Industrial Property Code.
A patent is infringed if, without the owner's consent:
The patented product is produced, used, marketed, sold or imported.
The patented process is used or exploited to use, market, sell or import products.
A patent holder can bring an infringement action against those who infringe its exclusive rights. There are specialised sections for IP-related matters in a limited number of courts (first and second level). These sections deal with national and community trade marks, inventions and new plant varieties, utility models, pictures and models, author rights and unfair competition when this interferes with protecting industrial and intellectual property (Law No. 273 of 12 December 2002, as implemented by Legislative Decree No. 168/2003).
Remedies can include:
Preliminary relief such as injunctions.
Seizure of infringing goods.
Declarations to form evidence of the violation.
Even if authorised, the generic product cannot be marketed before the tenth year from the effective marketing of the originator (Article 10, Legislative Decree 219/2006).
To obtain registration, a trade mark must be:
Distinctive for the goods or services to which the application for registration relates.
Not deceptive or contrary to law or morality.
Not similar or identical to any earlier trade marks for the same or similar goods or services.
Trade marks are regulated by Legislative Decree of 10 February 2005 No. 30.
Medicinal product brands can be registered as a trade mark.
The following cannot be the subject of a registered trade mark:
Words, figures or signs contrary to law, public order or morals.
Coats of arms, heraldic emblems and flags.
Names of people, and signs used in the artistic, literary, scientific, political or sporting field.
Signs likely to deceive the public, particularly about the geographic origin, nature or quality of the product or service.
Trade marks applications are submitted to the UIBM.
For first applications, the fees are EUR101 for one class, and EUR34 for each additional class.
A standard application form is used. The application can only be lodged by an entity with ownership rights under trade mark law or international trade mark agreements. The application must contain a sample of the mark, and should indicate the type of product or service it will distinguish according to the international classification of products and services.
Any interested party can submit to the UIBM its observations on a trade mark, within two months of the date of publication of the application or registration, or the first day of the month following publication in the WIPO Gazette.
Within three months from the same dates, a trade mark's legitimate owner and/or exclusive licensees can challenge the trade mark's registration.
If the application is accepted, the UIBM grants the trade mark, effective from the date of its valid and complete application.
Trade mark registrations last for ten years from the date of the application, and can be renewed for an unlimited number of times for further ten-year periods.
Renewal applications are submitted to the UIBM by the trade mark's owner within 12 months before the expiry of the existing trade mark. Late submission is allowed until six months after the expiry of the trade mark, subject to an extra application fee.
A trade mark registration cannot be revoked, but can be challenged before the courts if the registration is void or has lapsed. This can happen in the following circumstances:
Non-use of the mark for a continuous period of five years.
The mark has become a common term in the trade.
The use of the mark has led to the possibility of the public being misled.
Trade mark infringement occurs if there is third-party use without the trade mark owner's consent of an identical sign, or there is the possibility of confusion about the product's origin.
A trade mark holder with exclusive rights can bring an infringement action against those who infringe its exclusive rights. The action is under the jurisdiction of the specialised sections for IP-related matters of ordinary courts.
Remedies can include:
Preliminary relief such as injunctions.
Seizure of infringing goods.
Declarations to form evidence of the violation.
There is no requirement for a patent or trade mark licence agreement and payment of royalties under it to be approved by any government or regulatory body. However, the licence agreement must not be deceptive to consumers (Article 23, Industrial Property Code).
Italy is party to the following international conventions on IP protection:
Protocol Relating to the Madrid Agreement 1989.
WIPO Madrid Agreement for the Repression of False or Deceptive Indications of Source of Goods 1891 (Madrid Agreement).
WIPO Strasbourg Convention on the Unification of Certain Points of Substantive Law on Patents for Inventions 1963.
Munich Convention on the Grant of European Patents 1973.
Patent Cooperation Treaty 1970.
WIPO Paris Convention for the Protection of Industrial Property 1883.
Strasbourg Agreement Concerning the International Patent Classification 1971.
WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS).
Product liability of a producer of medicinal products is regulated by:
Legislative Decree No. 206/2005 (Consumer Code). Protection under the Consumer Code can only be used by consumers.
The general provisions of the Civil Code on extra-contractual liability.
The Consumer Code establishes the principle of no-fault liability of the producer in cases of damage caused by a defective product. In particular, the injured person must prove the:
Defect (based on the Consumer Code's definition).
Causal relationship between the defect and damage.
Therefore, the injured person does not need to prove the producer's fault.
Under tort liability, the claimant must prove the:
Causal relationship between the defect and damage.
Negligence or fault on the part of the defendant.
If the activity carried out by the producer is considered dangerous, the burden of proof of negligence or fault is shifted. The producer must demonstrate he adopted all possible measures to avoid the damage.
Under the Consumer Code, producers are liable for the defect of the product. A producer can be any of the following:
A manufacturer or its agent.
An importer in the EU.
A natural or legal person representing himself as the manufacturer by identifying the goods or services with his own name, trade mark or other sign with a distinctive character.
Where the producer of a product cannot be identified, each supplier who distributed the product in the course of a commercial activity is treated as a producer, unless it informs the injured person, within three months from the request, of the identity and domicile of the producer or of the person who supplied the product. The same provision can be applied to a product imported into the EU if the importer cannot be identified, even if the producer is known.
Under tort law, any person who by wilful or negligent conduct causes unfair detriment to another must compensate the victim for any resulting damage suffered. Therefore, any entity can be sued for damages caused by defective or faulty products without a direct contractual relationship.
When an entity is considered to have carried out dangerous activities, it is liable for damages unless it proves it adopted all possible measures to avoid damage. Many court decisions have applied this provision to the marketing and distribution of pharmaceutical products and contaminated blood derivatives.
Limitation periods for product liability claims depend on the liability basis invoked by the claimant. In particular:
Under the Consumer Code, consumers can file an action against the producer within three years from the time when they have (or should reasonably have) become aware of the damage, the defect of the product and the identity of the producer. In any case, the action is time-barred after ten years from the time when the manufacturer (or the importer into the EU) placed the product on the market.
Under tort law, the damaged person can bring an action within five years, running from the time when he could exercise his rights. However, the time limit can be extended if the tort is considered a criminal offence.
Individual rights granted to consumers by the Consumer Code, when homogeneous, can be enforced through class actions (Article 2, Law No. 244 of 24 December 2007, as amended by Article 49, Law No. 99 of 23 July 2009).
Any part of the class, including associations or a committee an individual is party to, can claim for a declaration of liability, damages or restitutions, on behalf of the whole class. By joining a class action, a consumer waives his right to any individual compensation or restitution action based on the same claim.
Class actions are not common.
The defendant can avoid liability by showing one of the following defences (Consumer Code):
The producer did not put the product into circulation.
The defect causing the damage came into being after the product was put into circulation by the producer.
The product was not manufactured for profit-making sale or distribution, or the product was neither manufactured nor distributed in the course of the business of the producer.
The defect is due to compliance of the product with mandatory regulations or with binding measures.
The state of scientific and technical knowledge at the time the product was put into circulation was not such to enable the product to be considered defective.
In the case of a manufacturer of a component or a raw material, the defect is attributable to the design of the final product in which it has been incorporated, or to compliance with the producer's instructions.
Further, a producer can only be liable for damages if the product is considered defective in relation to its intended use (Consumer Code).
No damages can be awarded if the victim could have avoided the injury by acting with ordinary diligence and care.
Compliance with existing rules is not sufficient to exclude tort or contractual liability if the defendant is found to have acted with negligence, imprudence or lack of skill (as defined by case law). If the activity carried out by the producer is considered dangerous, the producer is free from liability if he can show that he adopted all possible measures to avoid the damage.
Remedies available to the claimant include monetary compensation and injunctive relief.
Damage that can be compensated under the Consumer Code is limited to damage resulting from death or personal injury.
If the claimant is suing under tort law, recoverable damages include:
Other damage, such as moral damage and damage from an injury to constitutional rights.
If the claimant is suing under contract law, recoverable damages resulting from breach of contract include actual damage and lost profit.
Punitive damages are not contemplated or allowed.
There are currently no proposals for reform.
Main areas of responsibility. The Ministry of Health guarantees fairness in the general implementation and protection of the right to health in Italy, and carries out political and administrative guidance activities in healthcare.
Main areas of responsibility. The Superior Council acts as the technical-scientific consulting body of the Ministry of Health.
Main areas of responsibility. The Superior Institute of Health carries out research, clinical trials, inspection, advice, documentation and education activities in healthcare.
Main areas of responsibility. AIFA's main areas of responsibility include:
Description. Official website of Italian legislation, maintained by the Government. It is possible to search all legislation since 1946. Starting from 2014, it will have legislation from 1861 to 1946. Information is in Italian only.
Qualified. Italy, 2004
Areas of practice. Life sciences; corporate; commercial.
Qualified. Italy, 1974
Areas of practice. Life sciences; corporate; commercial.
Qualified. Italy, 1998
Areas of practice. Life sciences; corporate; commercial.
Qualified. Italy, 2008
Areas of practice. Life sciences; corporate; commercial.