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The Spanish vaccination strategy, in its seventh update, already referred to the heterologous regimen, i.e. the combination of vaccines, as a possible response to adverse events of thrombosis with thrombocytopenia associated with the vaccine AstraZeneca (Vaxzevria) and that, although very rare, they had been identified in a small number of people.
This was possible as soon as the safety and efficacy of interchangeability between vaccines was validated by the CombivacS study. Thus, it is recommended to those who had received a first dose of Vaxzevria to supplement their vaccination with that of Pfizer-BioNTech (Comirnaty), as is the case in other neighboring countries such as France and Germany.
The doubts in case of refusal prompted the Interterritorial Council of the National Health System to urgently request a (non-binding) report from the Bioethics Committee of Spain on the ethical and social acceptability of this proposal. The latter spoke in a double sense: on the one hand, to declare the impossibility of choosing a vaccine, in accordance with the information principles underlying the Strategy. On the other hand, accepting that, only in the event of refusal of treatment in Comirnaty, that of Vaxzevria would be proposed, under the formula of an informed written consent.
Finally, a particular vote from one of its members was recorded and a note was added to the seventh update.
Is informed consent ethical in the manner provided?
Informed consent, as a manifestation of the principle of autonomy, was already necessary to be inoculated. The difference is that, to date, this has been provided, in general, verbally, as established in Art. 8.2 of Law 41/2002, of 14 November, basic regulating the autonomy of the patient and the rights and obligations with regard to information and clinical documentation (LAP), supposed to be granted with the voluntary assistance of the patient at the appointment you previously requested.
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However, it is precisely the existence of “risks or inconveniences of notorious and foreseeable negative repercussions on the health of the patient” in the second paragraph which varies the method of collection, in this case, from oral to written. . From this point of view, the knowledge by the health authorities of information which was not initially available and which may be relevant in the decision of the citizens is likely to be duly explained by the responsible professional and incorporated in the file. medical. It should be remembered that the new scientific evidence available may alter the consent initially given, making it necessary to adapt it.
At the same time, the same consent could be expected not only by analogy, but by virtue of the precautionary principle, in a situation of scientific uncertainty, i.e. in the face of risks which, although foreseeable, may be more frequent when applying a vaccine other than that listed in the technical data sheet authorized by regulatory agencies. This could exceptionally be saved in terms of art. 13 of Royal Decree 1015/2009, of June 19, which regulates the availability of drugs in particular situations through the compassionate use of the vaccine, but the existence of Vaxzevria as a valid therapeutic alternative seems to prevent it.
It should also be remembered that both the European Medicines Agency (EMA) and the World Health Organization (WHO) continue to consider the benefits of Vaxzevria as greater than the risks, even more residual at the second dose (general incidence of 1.3 per million doses), pointing to the lack of data to exchange vaccines.
This absence can, precisely, vitiate the consent, since, for the decision to be free, voluntary and effectively informed, the patient should have information on the potential risks and consequences of Vaxzevria followed by Comirnaty. Therefore, the fullest possible informed consent would be expected, with medical support during the process.
Does informed consent imply an exemption from liability?
In the event of undesirable effects to drugs not expressly indicated in the technical sheet and in the vaccine leaflet, the responsibility of the pharmaceutical laboratory concerned must be considered (art. 140.3 Royal Legislative Decree 1/2007, of November 16, which approves the text. revised General Law for the Defense of Consumers and Users and other complementary laws).
However, under the supply contracts signed by the European Commission, it turned out that it will be the Member States who will face any compensation for any damage that may arise, given the haste with which the manufacturers have developed vaccines.
It is, in this scenario, that written informed consent could be seen as a way for public administrations to avoid facing future claims for the normal or abnormal functioning of public services (art. 106.2 Spanish Constitution and 32 Et seq. Law 40/2015, of 1 October on the legal regime of the public sector). This is called the patrimonial responsibility of the administration.
Although this was intended, the judgments of the Supreme Court (SSTS 645/2012, contentious-administrative chamber, of October 9; 1806/2020, of December 21; and 50/2021, of January 21) indicate that when a individual has suffered serious and permanent damage to their physical integrity that they do not legally have to endure in the interest of public health (general interest), as is the case with vaccination against covid-19, they have the right to be compensated (pooling or socialization of risk). This is due to the ethical principle of solidarity. Therefore, regardless of whether the consent is given, oral or written, the objective liability of the competent administration would persist.
Transparency as an ethical imperative
If, as has been suggested, what underlies written informed consent can be linked to Vaxzevria’s offer, it is to be expected, as when the debate was that of the scarcity of masks, a transparency of the from representatives of the public.
Fortunately, this does not appear to have affected the predisposition of the population to be vaccinated, but there is some mounting fear of side effects that should not be fed unnecessarily.
This article originally appeared on The Conversation. Read the original.
Ekain Payán Ellacuria receives funds from the Call for Contracts for the Training of Research Personnel at the UPV / EHU (2016), promoted by the Vice-Rectorate for Research of the UPV / EHU.
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