Primum non nocere

Abstract

The co-author of the Ministry of Health of Ukraine Protocol “Providing Health Care for Coronavirus Disease 2019 (COVID-19) Treatment” aimed to combat COVID-19 presented the preconditions of its creation. Ukraine was faced with COVID-19 at the start of its reforms to the secondary stage of medical care. In addition, there were no regulative documents in the country that would allow doctors to prescribe treatment to patients with COVID-19 using drugs that proved their effectiveness. Since there still no official recommendations in the world concerning the use of drugs to treat COVID-19 that would be grounded on the evidence-based medicine (such evidence will be obtained at a later stage as data is analyzed), the entire world is now using these treatments as part of clinical trials only. According to WHO, such experimental treatment is now being carried out using over 230 different means, including immunobiological drugs, while in the USA, “Extended access to compassionate use” program was approved by the US Food and Drug Administration (FDA). The Law of Ukraine “On Amending Some Legislative Acts of Ukraine Aimed at Preventing the Occurrence and Spread of Coronavirus Disease (COVID-19)” states that “coronavirus disease (COVID-19) treatment and/or prevention methods may be used to treat patients with coronavirus disease (COVID-19) confirmed by the laboratory testing if such coronavirus disease (COVID-19) prevention practices and/or treatment are allowed by the official bodies of the USA, European Union Member States, United Kingdom, Swiss Confederation, Japan, Australia, Canada, People's Republic of China, the State of Israel to treat and/or prevent COVID-19 in the respective country or the territory of the European Union based on the decision of the central executive authority responsible for shaping and implementing the state policy in the field of health care subject to the patient's consent to relevant medical intervention.