Very few studies exist of legal interventions (national laws) for essential medicines as part of universal health coverage in middle-income countries, or how the effect of these laws is measured. This study aims to critically assess whether laws related to universal health coverage use five objectives of public health law to promote medicines affordability and financing, and to understand how access to medicines achieved through these laws is measured. This comparative case study of five middle-income countries (Ecuador, Ghana, Philippines, South Africa, Ukraine) uses a public health law framework to guide the content analysis of national laws and the scoping review of empirical evidence for measuring access to medicines. Sixty laws were included. All countries write into national law: (a) health equity objectives, (b) remedies for users/patients and sanctions for some stakeholders, (c) economic policies and regulatory objectives for financing (except South Africa), pricing, and benefits selection (except South Africa), (d) information dissemination objectives (ex. for medicines prices (except Ghana)), and (e) public health infrastructure. The 17 studies included in the scoping review evaluate laws with economic policy and regulatory objectives (n = 14 articles), health equity (n = 10), information dissemination (n = 3), infrastructure (n = 2), and sanctions (n = 1) (not mutually exclusive). Cross-sectional descriptive designs (n = 8 articles) and time series analyses (n = 5) were the most frequent designs. Change in patients’ spending on medicines was the most frequent outcome measure (n = 5). Although legal interventions for pharmaceuticals in middle-income countries commonly use all objectives of public health law, the intended and unintended effects of economic policies and regulation are most frequently investigated.
10 August 2020 in Law Review of Kyiv University of Law
The article explores legal practice in the field of advertising medicines. Medicines advertising is recognized as one of the mosteffective mechanisms of medicines promotion. Factors affecting the spread of medicines advertising: the public’s attitude to advertisingas a reliable source of information about medicines, distrust of doctors and the healthcare system, and, as a consequence, the prevalenceof self-medication practices. In order to protect the interests of consumers and protect economic competition (often second prevailing),the state ensures compliance with the requirements of the legislation in the field of medicines advertising. What is important is hownational courts hear cases regarding medicines advertising.Advertising is information about a person or product, disseminated in any form and by any means and intended to generate ormaintain awareness of the consumer of the advertising and their interest in such person or product. Advertising of medicinal products,like any other advertising, must comply with: the general principles of advertising; general advertising requirements (apply to all products,regardless of their type); special advertising requirements. Specific requirements for medicines advertising are: (a) specificrequirements for the permitted and prohibited medicines advertising; (b) requirements for the content of advertising of medicines (consistingof the requirements that medicines advertising should and should not contain); (c) particularities for advertising for certain ca -tegories of persons.The mandatory content requirements for medicines advertising are almost 100% specific and evaluable, while prohibitions andrestrictions often make it impossible to assess whether this effect is present in the advertising message or how it may affect a particularconsumer. Accordingly, depending on which requirements for advertising have been violated, the public authority can assess whetherthe prohibitions and restrictions have actually been violated and consider bringing those responsible for violating advertising legislationto liability. Further, if the advertisers, producers or distributors of the advertisement do not agree with the decision of the relevant publicauthorities, they can appeal to court. Most often, the plaintiff will be the advertiser, who are the field of advertising of medicines arepharmaceutical companies, drugstores. The respondent – the relevant authority. This is how the jurisprudence in the field of medicinesadvertising is formed.Almost every case about medicines advertising is about false advertising in a form of «spreading misleading information». Caseshave been considered as to the actual dissemination of misleading information and the violation of certain special requirements for themedicines advertising. In particular, cases concerning: medicines «popularization»; «exaggeration» of medicines effect; giving theproducts features of medicines; on the use of physicians’ images in medicines advertising; medicine prices.Not all cases of «spreading misleading information» about medicines go to court. The legal practice in the field of medicinesadvertising is characterized by a certain ambiguity and depends largely on the evidence presented by the parties’ representatives. Thedecisions of the courts are based on the consideration of the circumstances of each case.
28 June 2024 in Review of European and Comparative Law
The paper focuses on surrogacy regulation, which is diverse across European countries. Four categories of rules can be identified, namely: absence of regulation, regulations allowing surrogacy , regulations that do not allow it with ongoing discussion about allowing it, and regulations under which surrogacy is strictly forbidden. Poland and Ukraine are neighboring countries with radically different regulations on surrogacy. There is no direct regulation on surrogacy in Poland and it can be stated that surrogacy agreements are not valid. IVF procedure is strictly forbidden for surrogacy. Ukraine is an example of the most liberal country when it comes to surrogacy regulation. Surrogacy agreements are regulated and requirements are formulated for surrogate mothers. Ukrainian regulation allows remuneration for surrogate mothers. After the Russian invasion, Ukrainian surrogate mothers came to Poland looking for safety. The Polish state provided extensive support for the Ukrainian people, including specific legal regulation on the right to access health care and employment opportunities. Yet, the Ukrainian surrogacy agreements are not valid in Poland, and the surrogate mothers will be approved as legal mothers.
The reform of sanitary and epidemiological surveillance and protection of the population against infectious diseases is accompanied by serious challenges and unforeseen circumstances. In Ukraine, a significant number of persons who are infected with hepatitis C and B. Ukraine is a leader in Europe in terms of HIV prevalence. In 2019, half of all measles cases in the European Region were reported in Ukraine. In the same year, the number of cases of diphtheria increased. In Ukraine, a significant number of tuberculosis patients. Coronavirus (COVID-19) is spreading worldwide today. In this article, we will focus on issues Institutional capacity on protection against infectious diseases in particular, and sanitary-epidemiological surveillance in particular. The Ministry of Health of Ukraine is the central executive authority, which provides formation and implementation of the state policy on protection of the population health against infectious diseases. The Ministry of Health of Ukraine also ensures the formation of state policy in the areas of sanitary and epidemiological well-being of the population. What executive authority implements the state policy in the sphere of sanitary and epidemiological well-being of the population, regarding the protection of the population from infectious diseases? This authority was the State Sanitary and Epidemiological Service of Ukraine (SES). In 2014, the Cabinet of Ministers of Ukraine decided to reorganize the SES. The decision on the reorganization of the SES was appealed in court and was found unlawful. In 2017, the Cabinet of Ministers of Ukraine changed its previous decision - now the SES was not subject to reorganization but liquidation. In terms of unlawfulness / lawfulness of actions (decision-making) by the Cabinet of Ministers of Ukraine were analyzed. The conclusion: Cabinet of Ministers had been acted in full compliance with the requirements of the legislation. An analysis of the history of the delegation of powers of the SES (including the results of court proceedings in this case) shows that: the functions of the implementation of state policy that belonged to the SES were entrusted to the State Service on Food Safety and Customer Protection, without functions of the implementation of state policy in the field of epidemiological surveillance. The problem is that, term what is “epidemiological surveillance”, at least at the legislative level is not set. At national legislation is enshrined and detailed in the subordinate legal acts “state sanitary and epidemiological surveillance”. It is justified that the transfer of the powers of the SES was not carried out properly and, in fact, its powers are not assigned to any of the state authorities.
1 January 2019 in Scientific notes of Taurida National V.I. Vernadsky University. Series: Juridical Sciences