The exceptional situation the country is going through due to the declaration of the state of alarm because of the COVID-19 health crisis has brought chaos due to the saturation and lack of technical and human resources in many hospitals. However, does this difficult moment we are facing automatically mean the loss of patient rights?

Patient rights in Spain are regulated by Law 14/1986, of April 25, General Health Law, and especially through Law 41/2002, of November 14, which regulates patient autonomy and rights and obligations regarding clinical information and documentation (hereinafter Patient Autonomy Law).

Among the main rights of patients, two stand out primarily: the right to health information and the right to access their clinical history.

According to Article 4 of the Patient Autonomy Law, patients have the right to know all the information available regarding any action in the field of their health.

Article 5 states that the holder of the right to information is the patient, and family members and related persons may be informed if the patient consents, indicating that this information to family members will also be provided when the patient is unable to understand it. Section 4 of this article also contemplates the possibility of limiting the information given to the patient for therapeutic necessity, that is, in cases where, for objective reasons, knowing their own situation could seriously harm their health.

Article 6 includes a very relevant case given the current situation: the right to epidemiological information. The law states that citizens have the right to know the health problems of the community when they pose a risk to public health or their individual health, and the right to have this information disseminated in truthful, understandable, and appropriate terms for health protection.

To ensure access to information, Article 8 stipulates that any medical action will require the free and voluntary consent of the affected person, and, as a general rule, consent will be verbal. However, the regulation foresees that written informed consent will be necessary in cases of surgical intervention, invasive diagnostic and therapeutic procedures, and generally, the application of procedures that pose risks or disadvantages of a notable and foreseeable negative impact on the patient’s health.

The requirements of the information included in the informed consent are regulated in Article 10, which must contain:

• The relevant or important consequences that the intervention certainly causes.
• The risks related to the patient’s personal or professional circumstances.
• The probable risks under normal conditions, according to experience and the state of science or directly related to the type of intervention.
• The contraindications.

One of the most debated issues in recent days is the limits to patient information given the terrible consequences of the coronavirus:

• Is it still necessary to inform and provide informed consent?
• Are there any limits to informed consent due to the current situation?
• If families cannot be present in the hospital and the patient is not in a condition to sign, is informed consent necessary?

Article 9 of the Patient Autonomy Law addresses the limits of informed consent. These legally regulated limits will help us understand the relationship of informed consent in the exceptional situation we are living through.

Section 2 of Article 9 states that doctors may carry out the essential clinical interventions in favor of the patient’s health without needing their consent in two specific cases:

• When there is a risk to public health due to sanitary reasons.
• When there is an immediate serious risk to the physical or mental integrity of the patient and it is not possible to obtain their authorization, consulting, when circumstances allow, with their family or people linked to them in fact.

Royal Decree 463/2020, of March 14, which declares the state of alarm for the management of the health crisis situation caused by COVID-19, expressly states its approval due to the public health emergency we are experiencing. Therefore, this risk could lead doctors to dispense with the necessary information and consent of patients given the impact on public health. We can imagine cases where medical personnel do not obtain consent due to the urgency of assistance because of the coronavirus: ICU admissions; application of techniques to improve respiratory problems; application of medication with side effects; surgical interventions; invasive diagnostic methods; etc.

However, in our opinion, the risk to public health cannot be the general rule. In cases where it is possible to inform and obtain the patient’s consent, our doctors should do so.

Another problem we now face is that in many cases there is an immediate serious risk to the integrity of patients and they are not in physical condition to authorize treatment, and their families cannot do so because they are confined at home due to the movement restrictions we are experiencing. In these cases of immediate risk, doctors may act without providing the necessary information and obtaining informed consent, although, in our opinion, where possible, they should inform the families or their legal representatives and obtain the corresponding informed consent.

In scheduled surgeries (although the vast majority have been suspended), the access to information and informed consent of patients must be respected in accordance with the Patient Autonomy Law.

The second most important right of the patient is access to their clinical history. According to Article 18, the patient has the right to access the documentation of the clinical history and to obtain a copy of the data included in it. Furthermore, Article 19 contemplates the need to have custody mechanisms in healthcare centers that allow patient access and their authorized representatives.

The Law also states that family members or authorized persons can access the clinical history of deceased patients.

Currently, the main problem in healthcare centers in our country is that the saturation and lack of personnel (including administrative staff) means they cannot handle medical documentation requests under normal conditions. However, it is true that the Patient Autonomy Law does not establish a specific deadline for delivering the clinical history. Therefore, we advise patience, understanding, and common sense for both patients and their families as well as healthcare personnel.

Ignacio Montoro Iturbe-Ormaeche | Summons Lawyers