Adverse effects of drugs and vaccines in Spain

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

Drug manufacturers can be held liable under the grounds of contractual law, tort law, criminal law, consumers law and administrative law. In the case of consumers law, there is a duty to properly inform the patient about the drugs’ risks. In the case of administrative law, in cases of operating deficiencies, the public authorities can order the suspension or withdrawal of the administrative authorisation to produce and market the drugs as well as impose economic fines.

B. Healthcare professionals 

Healthcare professionals can be held liable under the grounds of contractual law, tort law, consumers law and criminal law, and administrative law. In the case of consumers law, there is a duty to properly inform the patient of the drugs’ risks. In the case of administrative law, we note that in cases of serious negligence, the public authorities can order the suspension or withdrawal of the title (e.g. a licence) that allows the professional to practise and can impose economic fines. 

C. State

The State, or the regional public authorities, considering that Spain has a decentralized public health administration, can be held liable under the grounds of administrative law for the actions carried out by its civil servants or the competent public entity that approved a drug, through the mechanism of the administration's financial liability (Responsabilidad Patrimonial de la Administración).

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:

People claiming compensation such as patients or consumers shall give evidence of:

• the drug intake, 
• the defect in the medical product, 
• the damage produced (it can be physical, psychological, moral, etc.), and 
• the causal link between the drug and the damage produced.

We note that this last point is essential for Spanish tribunals to award compensation for damages caused by adverse drugs reactions. Failure to give evidence of the above, or not giving enough evidence, would likely mean that compensation would not be awarded and, therefore, the claim will be archived.

2.2 Which are the grounds for exclusion of liability?

In general terms, for manufacturers, healthcare professionals and the State (or the corresponding public authority, in each case) the main forms of excluding liability would be:

• Denying of the facts constituting the claim. Thus, the defendant could try to deny the action, the causal link or deny the existence of damage. 
• The fault of the injured party (e.g., not using the product as indicated, etc.) could also serve to reduce or remove liability.
• The lack of evidence proving the causality between the adverse drug reaction and the harm caused.

Additionally, for healthcare professionals we could add:

• Acting accordingly to the lex artis, which is a generally accepted good practice.
• If there is evidence that patient misused or misapplied the drug against the instructions (e.g., intake of the product when the patient should not, or disregarding the instructions (dosage, contraindications, etc.)).

As per the State (or the competent public authority in each case), we could add:

• Evidencing that the harm produced is a consequence of the normal functioning of the public administration, except in cases of force majeure or when the private individual has a legal duty to bear the harm according to the law.

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

In case of claims on the grounds of contractual law, the time limit is the one that would appear on the contract, knowing that the minimum is 5 years. We note that in case of defective products, the time limit is 3 years since the damage was caused.

In case of claims on the grounds of tort law, the time limit is 1 year since the damage was caused.

In case of claims on the grounds of criminal law, the time limit would depend on the limit provided in the Law for the prescription of crimes (e.g., injuries, manslaughter, etc.).

In cases of claims against the public authorities, the time limit would be 1 year since the damage was caused.

If the damage was hidden or is “continuous”, the time limit would start to from the moment in which it was discovered or stopped.

2.4 Which damages can be compensated?

In the case of contractual Law, the damages that can be compensated might be material, personal or even moral. The compensation may concern both the real and effective loss suffered (consequential damage) and the loss of profit (loss of earnings).

In any case, it is necessary to prove the damages caused, especially when there is loss of profit or moral damage.

Therefore, the restrictive criterion for assessing loss of profit is to prove the causal link between the unlawful act and the profit lost. The above implies that a claim based on loss of profit shall evidence a concrete, certain and accredited loss of benefits. 
Interest can be applied in cases of delay in payment, and it may be late payment or punitive interest.

As per administrative law, the public authority would be obliged to compensate for all unlawful damage caused by the activity of the public authorities, without exception. The conditions being that the alleged damage must be actual, economically assessable and individualised in relation to a person or group of persons.

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

Insurance law provides that the injured party (or their heirs) have a direct action against the insurer to claim the fulfilment of the obligation to compensate. 

The above, without prejudice to the insurer's right to repeat against the insured person, if the damage is due to a malicious conduct of the latter or if the damage or harm has been caused to a third party. 

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

The regulation of compassionate use of medicines is regulat  ed in Spain by Royal Legislative Decree 1/2015, of 24 July, approving the revised text of the Law on guarantees and rational use of medicines and health products (Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios) (“Royal Legislative Decree 1/2015”), and Royal Decree 1015/2009, of 19 June, which regulates the availability of medicines in special situations (Real Decreto 1015/2009, de 19 de junio, por el que se regula la disponibilidad de medicamentos en situaciones especiales) (“Royal Decree 1015/2009”).

Said legislation referrers to the use of a medicine prior to its authorisation in patients suffering from a chronic or severely debilitating disease or a condition considered life-threatening and who cannot be treated satisfactorily with an authorised medicine.

The medicinal product concerned must be subject to an application for marketing authorisation or must be undergoing clinical trials.

The fact that their use is legally recognised does not exempt from liability in certain cases, as is the case for the "ordinary" use of medicinal products.

The criteria that will be considered to determine if there is liability is:

a) Compliance with the requirements established in RD 1015/2009:

• the obligation to obtain consent, after informing the patient of the implications, benefits, and risks of the prescription.
• prompt communication of adverse effects.
• adequate justification of the need for the use of the medicinal product.

b) Having scientific backing for their action. It is essential to note that the acceptability of off-label practice is supported by medical literature, research, association statements and pharmaceutical reference standards.

c) Carry out a proper weighing of the benefits and risks of the chosen therapeutic option.

Additionally, compassionate use without respecting these procedural channels and safeguards would constitute an action which, if it generates harm, would be a suitable candidate suitable for liability for imprudence or negligence.

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

The regulation of off-label use of medicines is regulated in Spain by Royal Legislative Decree 1/2015 and Royal Decree 1015/2009, of 19 June, which regulates the possibility of using medicinal products under conditions different from those authorised: the use of medicinal products under conditions different from those included in the authorised label.

The fact that their use is legally recognised does not exempt from liability in certain cases, as is the case for the "ordinary" use of medicinal products.

The criteria that will be considered to determine if there is liability are:

a) Compliance with the requirements established in RD 1015/2009:

• the obligation to obtain consent, after informing the patient of the implications, benefits, and risks of the prescription.
• prompt communication of adverse effects; and
• adequate justification of the need for the use of the medicinal product.

b) Having scientific backing for their action. It is essential to note that the acceptability of off-label practice is supported by medical literature, research, association statements and pharmaceutical reference standards.

c) Carry out a proper weighing of the benefits and risks of the chosen therapeutic option.

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

In general terms, when a vaccine produces an undesirable adverse effect in the patient, the patient will be entitled to claim compensation for damages and the liability should be borne by the manufacturer or, where appropriate, by the Administration with powers to authorise and supervise medicinal products and medical devices, if the specific circumstances necessary for this are met. In Spain, said authority is the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios).

In the context of COVID-19 pandemic, the European Commission has made an exception with the coronavirus vaccine by exempting the manufacturers from compensation for possible harmful effects of the vaccine for COVID-19, due to factors such as:

• the exceptional situation of the coronavirus pandemic;
• the obligatory haste in the development of the vaccines by the pharmaceutical sector; and
• the need to have the vaccines available as soon as possible for the population.

However, it should be emphasised that the responsibility remains with the manufacturers, and the Member States rest in a position to cover financially any compensation that may be declared appropriate.

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

In Spain, there are no compulsory vaccines (not even for COVID-19).

The Public Administration can only force compulsory vaccination with prior judicial authorization and in the Contentious-Administrative proceedings. Thus, the liability of the Administration is only restricted to adverse reactions that may be caused by vaccines or to omissions or limitations of certain vaccines in the vaccination schedule. 

However, manufacturers will not be liable for damages that may be caused by a defective product if it has been previously authorized by the AEMPS and the prescription, indication and administration of the product complied with the lex artis ad hoc. 

We refer to the generic requirements for claiming damages, indicated in Section 2.

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

The liabilities that can be insured are civil (contractual law, tort law, defective products).

It is not possible, for reasons of public order, that the insurer could face the consequences of criminal liability by paying the fines imposed on the liable party. Said liability have a sanctioning or afflictive nature, the scope of which cannot be avoided by the intervention of an insurer.

Law 44/2003 of 21 November 2003 on the regulation of the health professions (Ley 44/2003, de 21 de noviembre, de ordenación de las profesiones sanitarias) establishes the obligation to ensure civil liability through an insurance policy only for professionals practising in the private branch of medicine.

However, it is becoming more and more common having professional civil liability insurance, regardless of whether the practitioner works for the Public Administration or not.

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

The EU is in favour of out-of-court settlements for the resolution of complaints and has published a document on health and consumer protection, which aims to promote out-of-court dispute resolution and which in the future will also apply to users and professionals of health services who wish to avoid court litigation.

In Spain, Health Arbitration Courts have been created recently and originate from different institutions and different starting points: Medical Associations, Bar Associations (as in Madrid and Barcelona), Consumer Arbitration Boards, Autonomous Communities, etc.  

For the time being, in practice they are not used extensively as claims are mainly discussed before courts.