Adverse effects of drugs and vaccines in Italy

1. Drug adverse effects: kinds of responsibility

1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?

A. Manufacturers

a) Contractual liability

Contractual liability of the drug manufacturer is rather rare, occurring only when there is evidence of direct or mediated contact with the patient. In essence, there should be evidence of participation by the manufacturer in the management of the patient's therapy.

b) Product Liability

Manufacturers are generally liable for damages caused by their defective products.

c) Tort liability

Tort liability of the drug manufacturer may be established under Article 2043 and 2050 of the Civil Code or under the Consumer Code.

Article 2043 of the civil code provides that any intentional or negligent act that causes unjust damage to another person shall oblige the person who committed the act to compensate for the damage.

Article 2050 of the Civil Code regulates the exercise of dangerous activity. According to some cases law, in fact, the activity of manufacturing and trading of specific types of drugs falls within the category of dangerous activities, i.e., an activity which, by its nature or the characteristics of the means employed, involves a significant possibility of the occurrence of damage. Article 2050 of the civil code provides that any person who causes damage to others in the exercise of a dangerous activity, by its nature or by the nature of the means employed, shall be liable to pay compensation unless he proves that he has taken all appropriate measures to avoid the damage.

In addition, drugs’ manufacturers may be liable for damages under the Consumer Code. The reference legal provision is to be found in Article 103, which regulates the characteristics that a safe product must have. These characteristics also apply to the drug placed on the market by the manufacturer.

d) Criminal liability

The manufacturer of the defective medicine may be criminally liable under Articles 440 and 443 of the Criminal Code, which punish anyone who possesses for trade, places on the market or administers defective or imperfect medicines.

B. Healthcare professionals

a) Contractual liability

The contractual liability of the healthcare professional can only arise in cases where there is a direct contractual relationship with the patient. Therefore, in most cases it occurs when the health professional operates as an independent professional. In other cases, in fact, when the professional works in healthcare facilities, the latter are contractually liable to the patient for the activity carried out by their employee.

b) Tort liability

As per tort liability of healthcare professional, it may arise under the abovementioned Article 2043 of the civil code, for any intentional or negligent act that causes unjust damage to another person.

c) Criminal liability

Criminal liability is instead governed by Article 509 sexies of the Italian Criminal Code, introduced by the so called Gelli-Bianco Law (Law n. 24/2017), which regulates the case of death or culpable injury in the exercise of medical activity. The same provision identifies the relevant criminal sanctions.

C. State

The state is not directly responsible for adverse drug events.

Generally speaking, the task of the State is to introduce the systems for monitoring and controlling adverse drug reactions that health professionals must adhere to. This is the case, for example, of the National Pharmacovigilance Network of the AIFA (Agenzia Italiana del Farmaco), which introduces the terms and procedures by which healthcare professionals must report any adverse drug event that is communicated to them.

2. Claiming compensation for damages caused by adverse drugs reactions

Which are the conditions for claiming compensation (including the burden of proof)?

2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met:

In order to claim the compensation for the damages suffered, the burden of proof rests with the injured subject, who has to demonstrate:

  1. the damage suffered;
  2. in the case of tort liability, the causal link between the damage and the conduct of the health professional or manufacturer;
  3. in the case of tort liability, the injured party must also prove malice or negligence, a subjective element not required in proof of contractual liability;
  4. in the case of contractual liability, also prove the existence of the contractual relationship.

2.2 Which are the grounds for exclusion of liability?

A. Manufacturers

Manufacturers are released from liability if they prove that they have made consumers aware, in advance and in an appropriate manner, of the risks of side effects inherent in the administration of the drug. They must demonstrate that they have taken all appropriate measures to prevent and avoid possible damage to the health of patients, with particular attention to:

  1. the industrial production phase of the drug; manufacturers shall prove to have adopted and complied with all the protocols laid down by law and AIFA (the Italian Medicines Agency), including in the testing phase, which must necessarily precede marketing;
  2. the distribution and marketing phase, manufacturers shall prove to have fully and clearly informed users, in the package leaflet, of all possible undesirable side effects that the drug could cause, even if they are very rare.

A mere information about possible side effects of the drug is, however, not sufficient to exclude liability.

B. Healthcare professionals

Healthcare professionals wishing to prove the absence of fault in their conduct must show that all the necessary measures to prevent the damage from occurring have been taken out. Therefore, they must have adopted the correct diligence and the necessary expertise in view of the type of drug administered.

The Gelli-Bianco Law lays down technical-scientific guidelines that professional must prove to have followed when administering the drug. Such guidelines provide a benchmark for demonstrating that all necessary measures have been taken, but do not a priori exclude liability for merely following them.

C.  State

Please refer to the previous answer

2.3 Which are the time limits for submitting a claim for compensation?

As to product liability, the limitation period is 3 years from the date on which the damaged party knew or could have known of the damage.

As regards tort liability, the limitation period for bringing an action for damages is five years. 

As per contractual liability, the limitation period for is set in ten years.

The day from which the time limit incepts does not correspond to the day of the drug’s administration, but rather to the moment when the adverse event is perceived or can be perceived by the injured party.

2.4 Which damages can be compensated?

Material and non-material damage could be compensated. Such damages include compensation of any medical-related expense occurred to assist and treat the damaged party as well any expense occurred because of the adverse drug reaction. Compensation may also cover non-material damages suffered by the party and, in case of death, also by the family members and affected person.

2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?

The so called Gelli – Bianco Law (Law n. 24/2017) introduced the possibility for the injured party to claim compensation directly to the insurance company of the manufacturer or healthcare professional responsible for the damage suffered.

However, the law itself provides that such provision will be definitively implemented through the issuance of government decrees identifying the minimum requirements that the policies must meet.

The decrees are still being examined by the Ministry of the Economy and have not yet been issued. Therefore, although this possibility is foreseen, direct action against the insurance company is not yet feasible by law. In this context, there are cases law that nevertheless ruled in favour of the possibility to claim compensation directly to the party responsible for the damage.

3. Compassionate use programmes

3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?

In the case of an adverse event from a drug prescribed within a compassionate use program, the answers given in the previous questions apply equally.

It is only worth pointing out, however, that in this case, in view of the greater danger involved in prescribing the drug, in order to exclude liability, more stringent proof is required that all possible measures to avoid the damage has been taken out. 

4. Off-label use

4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?

With regard to adverse events in the case of off-label drugs, the same answer as in the previous paragraph applies (3.1).

According to the prevailing cases law, a physician who prescribes medicinal products 'off-label' and who does not act on a wholly experimental basis is liable on grounds of negligence and not on grounds of wilful misconduct for the injuries suffered by the patient as a result of their administration, if he has not made a careful comparative assessment between the benefits sought and the risks connected with the particular use of the medicinal product which it was possible to foresee on the basis of the patient's clinical situation.

5. Vaccines

5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?

Adverse events from vaccines involve the same considerations made in terms of responsibility, whether contractual, tort or criminal of those involved, i.e., manufacturers, health professionals and the State.

The system for communicating adverse reactions to vaccines is in fact the same, always set up by AIFA, and therefore the National Pharmacovigilance Network (RNF).

Alternatively, the report of a suspected adverse reaction can be communicated to the Marketing Authorisation Holder (MAH) of the vaccine/drug suspected of causing the adverse reaction.

Therefore, except for the indemnities referred to in the next answer, which introduces a different form of compensation, the remaining rules discussed above for adverse drugs reaction also apply in the case of adverse reactions resulting from a vaccine.

5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?

Italian legislation provides for a mechanism of indemnification by the state for individuals who are undergone compulsory vaccination. The regulation Is set forth in Law n. 210 of 1992. The law provides that anyone who has suffered, due to compulsory vaccinations by law or by order of an Italian health authority, injury or disability, which resulted in a permanent impairment of mental and physical integrity, is entitled to receive an indemnity from the state.

This indemnity is the result of a principle of social solidarity and, therefore, different from the compensation that could be claimed from the injured party due to contractual or tort liability. 

Law n. 210 of 1992generally provides for indemnity only for mandatory vaccines. However, following an interpretation provided by the Constitutional Court, this form of compensation is also provided for certain types of vaccines which, although not compulsory, are strongly recommended by the state as being carried out in the interest of the community.

Individuals injured by compulsory vaccination, who are already beneficiaries of indemnity under Law 210/92, may submit directly to the Ministry of Health an application under Law 229/05 to obtain further compensation equal to six, five or four times the amount attributed by Law 210/92, depending on the category ascribed.

The beneficiaries of Law 229/05 may also obtain a one-off allowance equal to 50% of the further compensation provided by Law 229/05 for the period between the occurrence of the harmful event and the obtaining of compensation.

The Ministry of Health is entirely responsible for the preliminary investigation of the files and the payment of the benefits provided for by Law 229/05. The Ministerial Decree of 21 October 2009, published in the Official Gazette no. 9 of 13 January 2010, supplemented the regulations on the benefits to which persons injured by vaccinations are entitled, identifying the criteria necessary for the formation of the ranking list for the payment of benefits. The ranking list is issued by a directorial decree and expires every six months.

From the date of the report of a suspected adverse reaction to the vaccine, the injured party has three years elapse to file a claim for indemnity under Laws 210(1992 and 229/2005. Once three years have elapsed, it is no longer possible to file a claim due to the limitation period.

6. Insurance issues

6.1 Which liabilities can be insured? Is there any compulsory insurance?

The Gelli-Bianco law imposes an obligation on healthcare professional operating as independent professionals to take out a professional indemnity insurance policy covering both simple and gross negligence.

As regards healthcare workers working in a healthcare facility as an employee, professional liability insurance cover is compulsory, under the abovementioned law, only for gross negligence, due to the fact that, in this case, if liability can be ascribed with simple negligence, the public or private healthcare facility, which is also obliged to take out an insurance policy, will be liable on behalf of its employed healthcare. 

Criminal liability is not insurable. 

7. Procedural issues (litigation)

7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?

In order to lodge an appeal before the judicial authority in the event of alleged liability of the healthcare professional or healthcare facility, the plaintiff is obliged to carry out, alternatively, one of the two procedures provided for by law:

  1. procedure for prior technical assessment pursuant to art. 696 bis of the Code of Civil Procedure, with a conciliatory purpose (the so called accertamento tecnico preventivo). It is a precautionary procedure that aims to identify the objective technical causes that led to a defect, through the prior provision of a technical expert's report carried out by a technical consultant appointed by the judge, in the presence of the parties' experts. or
  2. mediation proceeding pursuant to legislative decree 28/2010.

The obligation to preliminary carry out one of the two aforementioned procedures is a condition of admissibility for bringing an appeal that gives rise to ordinary proceedings before the judge.

In the event that the mediation attempt or the procedure for a technical assessment with a conciliatory purpose is unsuccessful, the law provides for the obligation, in the event of the intention to file an appeal with the ordinary judge, to follow the summary procedure under Article 702 bis of the Code of Civil Procedure. This is a special procedure, characterised by greater speed in the evidence phase of the proceedings.

As regards the territorial jurisdiction, the judge of the place where the patient/consumer is domiciled has jurisdiction.

Portrait ofLaura Opilio
Laura Opilio
Partner
Rome
Portrait ofMaria Letizia Patania
Maria Letizia Patania
Partner
Rome
Roberto Plutino