Article “Side Effects from Vaccines – Who is Responsible?” by attorney-at-law Keijo Lindeberg
With the COVID-19 mass vaccination, the issues of adverse drug reactions and possible liability have become topical. Any vaccine is also a drug that is part of an immunological drug.
In addition, every drug always has side effects and there is nothing surprising about detecting side effects from vaccines. The purpose of this article is to analyze the question of whether and in which cases liability is possible for adverse reactions to a vaccine.
Provision of health care services
The definition of health care services is established in the Estonian Law of Obligations Act, and the health care services of a patient include:
- treating, and
- informing of his or her state of health, progress and results of treatment.
The provision of health care, including the administration of medicines, is only permitted on the basis of informed consent. However, there are special rules for the provision of health care services to unconscious, minors and people with mental health problems, as they cannot generally be guided by their will.
One of the most important principles of Estonian medical law is an informed consent. This means that the provision of any health care to a patient is subject to the patient’s consent (with the exceptions set out above). The patient’s consent is valid only if the patient has been informed of all relevant circumstances in advance.
The exact scope of the obligation to provide information on health care has not been thoroughly analyzed in Estonian case law but considering the practice of other countries, the content of the obligation to provide information is extensive and divided into:
- self-determination notification,
- lifestyle notification, and
- economic notification.
Self-determination notification is the most classic obligation for notification. This includes informing a patient about the content of health care, possible positive and negative medical consequences, etc. This is a sub-category of the obligation to provide information, which is not a problem in practice as the content of the obligation to provide information is directly related to the medical issue.
Lifestyle notification is more problematic. In general, a patient should be informed of all health-related effects on a person’s daily life, starting from the ban on lifting heavy objects and smoking or, for example, in the case of cosmetic surgery the obligation to wear support after surgery. There are a number of problems related to lifestyle notification, in particular the inconsistent implementation of the notification obligation and additionally the patient is often notified of restrictions only after the provision of health care, rather than before the service.
For example, a patient must be given an opportunity to refuse surgery on the grounds that the patient will no longer be able to pursue his or her hobbies after the operation and the patient should not be surprised by such information after the operation.
Economic notification is definitely the most problematic area in Estonia. Dental treatment is a good example, as a patient is usually informed of the cost of the treatment after the treatment has been given. In practice, however, the patient should not ask about the cost of treatment before sitting in the dentist’s chair, but the healthcare provider should explain it to the patient. A public price list cannot be considered sufficient either, as in most cases the patient is unable to assess of which components the invoice consists.
Economic notification also includes the indirect effects of health care, including the cost of subsequent rehabilitation and medicines, as well as the costs of reorganizing life (for example, upgrading a home or vehicle to accommodate a person with reduced mobility).
Additionally, it is important to emphasize that the health care provider should never assume that the patient already knows the important information. This knowledge is especially important in connection with COVID-19 vaccines, as it is easy to assume that the entire Estonian media is full of all kinds of articles about vaccines and therefore, for example, the side effects of the vaccine cannot surprise the patient. It must always be assumed that the patient lives “alone in the forest” and does not have any knowledge of the medicine, including possible side effects.
The administration of medicines, including vaccines, to a patient is part of the provision of health care services, which means that the patient must be thoroughly notified about the three types of information before they are given, and then asked for consent from the patient. Only then has the patient given an informed consent, which is a prerequisite for administering any medicine, including vaccines.
Liability for provision of health care services
In the case of vaccines, the liability of health care provider is primarily related to the failure to comply with the obligation for notification. It should be reminded that health care providers can only notify their patients about side effects that are known to the health care provider through the package leaflet or other sources. Health care providers cannot be accused of failing to inform the patient of circumstances which were not and should not have been known to the health care provider.
It can be assumed that one of the biggest problems with vaccines is the lack of thorough reporting of possible side effects. Especially in a situation where vaccination is becoming even more widespread, it means that the workload of health care providers will furthermore increase and the time resource will decrease.
For example, the side effects as stated in the package leaflet of one vaccine used in Estonia are among other:
“Rare side effects: may affect up to 1 in 1,000 people:
⦁ temporary unilateral facial nerve palsy
Unknown (cannot be estimated from the available data):
⦁ severe allergic reaction”
These are certainly possible side effects that can significantly affect a person’s daily life. Therefore, health care providers must thoroughly assess the exact content of self-determination, lifestyle notification and economic notification, including in relation to the possible side effects mentioned above.
At the same time, the characteristics of a patient must always be considered due to age, intellectual abilities, diseases affecting comprehension, etc. The obligation for notification has also not been fulfilled in a situation where the health care provider uses vocabulary that the patient does not understand. Therefore, in fulfilling the obligation to provide information, it must always be assessed whether the patient actually understands all the risks.
If the health care provider has breached the patient’s obligation to obtain informed consent, this may lead to the liability of the health care provider. In particular, it presupposes pecuniary or non-pecuniary damage caused to the patient, for which compensation must be claimed from the health care provider. If the patient does not actually suffer harm, it is generally not possible to claim compensation from the health care provider.
Liability of pharmaceutical manufacturer
By their nature, medicines are products within the meaning of Art 1063 (1) of the Estonian Law of Obligations Act, which means that the regulation of producer’s liability provided for in this Act also applies to medicines. Based on the producer’s liability, the following defects in particular are considered to be defects of the medicine:
- An error has occurred in the manufacture of the medicine;
- An error has occurred in the development of the medicine;
- An error has occurred in the marketing of the medicine (in particular shortcomings in the information contained in the package leaflet).
The manufacture of medicines is also an area regulated by a number of international regulations. For example, one important component of medicine production is research, which aims to test new medicines to ensure their safety. However, if a producer has breached, for example, the requirements for testing medicines, this may lead to the liability of the producer (in particular, the marketing authorization holder for medicines).
A separate issue is the specific regulation of agreements between pharmaceutical companies and countries purchasing vaccines. Due to the high demand for vaccines, the liability of vaccine manufacturers has also been regulated by contracts between vaccine producers and the European Commission and various countries.
Liability for potential production problems with COVID-19 vaccines is therefore an extremely complex legal issue, where the ultimate truth of liability can only be established in possible litigation. This is particularly the case with the introduction of vaccines developed and manufactured in countries where regulations significantly differ from those in force in Europe.
Vaccines are one of many types of medicines, and vaccines are subject to all medicine-related regulations. It is essential that the production of vaccines complies with international regulations and each patient has given informed consent before the vaccine is administered to the patient. Violation of these requirements may result in liability.
Attorney-at-law of Law Firm LINDEBERG
Keijo Lindeberg is a lecturer in medical law at Tallinn University of Technology. This article only reflects the personal views of the author.