scholarly journals LEGAL ASPECTS OF INTELLECTUAL PROPERTY IMPACT ON AVAILABILITY OF MEDICINES IN UKRAINE

2021 ◽  
Vol 76 (3) ◽  
pp. 39-44
Author(s):  
Dmytro Ivanenko ◽  
◽  
Nataliia Hlushchenko ◽  
Keyword(s):  
Human Rights ◽  
Intellectual Property ◽  
Access To Medicines ◽  
Legal Aspects ◽  
Trips Agreement ◽  
The European Union ◽  
Association Agreement ◽  
Compulsory Licensing ◽  
The Right ◽  
The Impact

The right of a person to access medicines is derived from the right to health. At the time of the establishment of fundamental human rights, the issue of lack of access to medical supplies was not considered a violation of human rights. The spread of pandemics has led to the gradual recognition of the right of access to medicines. The TRIPS agreement fundamentally reformatted the discussion on access to medicines. Prior to the TRIPS Agreement, states had considerable independence in the formation and implementation of state policy in the field of intellectual property. TRIPS obliges countries to provide pharmaceutical patents. The growing influence of the international patent system has aroused widespread interest and concern about the impact on access to medicines. The Doha Declaration on the TRIPS Agreement defines the importance of the implementation and interpretation of the Agreement in the most favorable way for the protection of public health by making available to the public existing medicines and creating conditions for the production of new ones. Ukraine is on the way to creating its own legislation in the field of intellectual property. Art. 219 of the Association Agreement between Ukraine and the European Union contains provisions according to which the parties recognize the importance of the Declaration on the TRIPS Agreement in the field of health care. Positive changes in the field of intellectual property include the provisions of the Law of Ukraine «On Amendments to Certain Legislative Acts of Ukraine on the Reform of Patent Legislation» № 816-IX as of 21.07.2020. This law limited the range of objects to be patented. The implementation of these legislative changes is impossible without a proper methodology for the examination of novelty. Reforming the national system of intellectual property protection has created good preconditions for the formation of a civilized pharmaceutical market in Ukraine. Among the areas of legislation in Ukraine, there is an urgent need to form an institution of compulsory licensing. A separate area is the introduction of the pre-grant and post-grant procedures of the opposition. An important area of legislative work is the formation of a favorable domestic policy for innovation and invention in the field of medicine and biotechnology.

scholarly journals THE IMPACT OF TRIPS AGREEMENT ON ACCESS TO MEDICINES IN DEVELOPING COUNTRIES: LEGAL CHALLENGES FACED BY THE PHARMACEUTICAL INDUSTRY PARTICULARLY IN INDIA

2012 ◽  
Author(s):  
Kamini Shanmugaiah
Keyword(s):  
Public Health ◽  
Developing Countries ◽  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
Intellectual Property Rights ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Compulsory Licensing ◽  
Legal Challenges ◽  
The Impact

The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specification made to India. Significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefited the developing countries in the field of public health during national emergency. The TRIPS flexibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS flexibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefit of their citizens. Further, TRIPs flexibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifically examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal

scholarly journals Medical Patents and the Right to Health – From Monopoly Control to Open Access Innovation and Provision of Medicines

2019 ◽  
Vol 61 (1) ◽  
pp. 153-182
Author(s):  
Philippe Cullet ◽  
Hu Yuanquiong
Keyword(s):  
Human Rights ◽  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Patent Protection ◽  
Access To Medicines ◽  
Right To Health ◽  
Trips Agreement ◽  
Human Right ◽  
The Right

The coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in the mid-1990s led to a massive strengthening of intellectual property rights in the global South. This was particularly controversial concerning restrictions on access to medicines and set the stage for spirited debates concerning the impacts of medical patents on the realisation of the right to health in the context of the HIV/AIDS crisis. Efforts to reconcile the right to health and medical patents led to a minor amendment of the TRIPS Agreement that has hardly had any impact on the ground while further strengthening of patent protection was obtained, for instance, through bilateral agreements. In the human rights field, attempts to strengthen the protection afforded by the right to health have been partly diluted by efforts to strengthen the claims of inventors under human rights law. At this juncture, two main elements need to be taken forward. The first is to revisit our understanding of the human right to health to ensure, for instance, that there is no compromise in the liberal promise of universality, in particular access to medicines for every person who needs them. The second element is the need to rethink the way in which legal incentives are given to innovate. In a context where patents are the only recognised legal incentive to innovate in the medical field, this discourages the development of medicines for diseases that may affect mostly poor patients, since companies need to recoup their investments. Further, it militates against giving attention to other systems of medicine whose innovations can usually not be protected under the patent system, even where treatments are effective. Keywords: TRIPS Agreement, Access to Medicines, Right to Health, ICESCR

Can public access to documents support the transparency of automated decision-making? The European Union law perspective

2020 ◽  
Author(s):  
Joanna Mazur
Keyword(s):  
Decision Making ◽  
European Union ◽  
Human Rights ◽  
Eu Law ◽  
The European Union ◽  
European Union Law ◽  
Access Information ◽  
The Right ◽  
Automated Decision Making ◽  
The Impact

ABSTRACT Due to the concerns which are raised regarding the impact of automated decision-making (ADM) on transparency and their potential discriminatory character, it is worth examining the possibility of applying legal measures which could serve to increase transparency of ADM systems. The article explores the possibility to consider algorithms used in ADM systems as documents subjected to the right to access documents in European Union (EU) law. It is focused on contrasting and comparing the approach based on the right to access public documents developed by the Court of Justice of European Union (CJEU) with the approach to the right to access public information as interpreted by the European Court of Human Rights (ECtHR). The analysis shows discrepancies in the perspectives presented by these Courts which result in a limited scope of the right to access public documents in EU law. Pointing out these differences may provide a motivation to clarify the meaning of the right to access information in EU law, the CJEU’s approach remaining as for now incoherent. The article presents the arguments for and ways of bringing together the approaches of the CJEU and the ECtHR in the light of a decreasing level of transparency resulting from the use of ADM in the public sector. It shows that in order to ensure compliance with EU law, it is necessary to rethink the role which the right to access information plays in the human rights catalogue.

scholarly journals Establishment of international standards in the field of environmental pro- tection and their impact on modern legislation of Ukraine

2021 ◽  
pp. 352-356
Author(s):  
Z.S. Brenzovich ◽  
S.A. Onufriy
Keyword(s):  
Human Rights ◽  
Environmental Protection ◽  
Marine Pollution ◽  
International Standards ◽  
Vienna Convention ◽  
The European Union ◽  
Environmental Legislation ◽  
Association Agreement ◽  
International Convention ◽  
The Right

The article examines the formation of international standards in the field of environmental protection, as well as clarifying their impact on modern environmental legislation of Ukraine.  It is established that the issue of the need to protect the environment has been actively discussed at the interna-tional level since the middle of the twentieth century. The first international environmental organization was found-ed in October 1948 in France (International Union for Conservation of Nature), which still operates today.It was found that although international instruments such as the Universal Declaration of Human Rights and the Convention for the Protection of Human Rights and Fundamental Freedoms do not contain provisions on environ-mental rights, there is still a human right to a standard of living that supports its health. It is from the standpoint of the right to life, the right to health and the right to information that the ECtHR deals with matters concerning a safe environment for humans.It is substantiated that special international acts in the field of environmental protection began to be adopted in the 70s of the last century (including: Convention on the Prevention of Marine Pollution by Discharges and Other Materials, International Convention for the Prevention of Pollution from Ships, Convention on Transboundary Air Pollution distance, the Vienna Convention for the Protection of the Ozone Layer was adopted, the European Charter on Environment and Public Health, the Basel Convention on the Control of Transboundary Movements of Hazard-ous Wastes and Their Disposal, the Convention on Environmental Impact Assessment in a Transboundary Context, etc.).These international acts have influenced the formation of legislation in the field of environmental protection of independent Ukraine, especially on the example of acts adopted in 2017-2020. The proposal of scientists on the need to adopt a new systematized act in Ukraine, in particular the Environmental Code, has been studied.It is substantiated that when reforming the environmental legislation of Ukraine it is necessary to pay special attention to the requirements of the Association Agreement with the EU, namely to implement the provisions of a number of Regulations and directives of the European Union.

The Impact of the Court of Justice of the European Union on the Israeli Legal System

2020 ◽  
pp. 265-304
Author(s):  
Arie Reich
Keyword(s):  
European Union ◽  
Legal System ◽  
Competition Law ◽  
The European Union ◽  
Coding System ◽  
Association Agreement ◽  
Court Of Justice ◽  
System P ◽  
The Right ◽  
The Impact

This chapter presents the findings of the author on the impact of the Court of Justice of the European Union (CJEU) on the Israeli legal system. After a short description of the Israeli legal system and its judiciary, including figures on the use of foreign legal sources by the courts, the chapter describes briefly the relations between the EU and Israel and notes the weak legal approximation provision in the Association Agreement. Despite the lack of obligation on Israel’s part to rely on CJEU judgments, the author has found steadily growing numbers of citations of these judgments by various Israeli courts and tribunals. The chapter presents the statistics of these citations over the years, the types of tribunals that cite the CJEU, and the fields of law where these citations are mostly found (mainly in trade marks, competition law, and labour law). It also lists the CJEU cases that are most cited by Israeli tribunals. It then assesses the impact of the citations by a coding system that allows us to observe the relative influence that the citations had in the various tribunals. After having presented a statistic overview on the citation patterns, the chapter zooms into some specific cases where the CJEU was cited in order to put the citation into context and better understand its significance. Finally, the chapter discusses instances of CJEU impact on Israeli regulation, not case law, namely in the field of competition law, sports (the Bosman case), and privacy (‘the right to be forgotten’).

Trade Rules, Intellectual Property, and the Right to Health

2007 ◽  
Vol 21 (3) ◽  
pp. 337-357 ◽  
Author(s):  
Lisa Forman
Keyword(s):  
Human Rights ◽  
Intellectual Property ◽  
Right To Health ◽  
Essential Medicines ◽  
Human Right ◽  
Poor Countries ◽  
Access To Essential Medicines ◽  
The Right ◽  
Human Rights Standards ◽  
The Impact

In perpetuating and exacerbating restricted access to essential medicines, current trade-related intellectual property rules on medicines may violate core human rights to health and medicines. In this light, their impact on the global disease burden raises serious questions about their necessity, and their justification should be critically assessed from the perspective of human rights standards. These standards require that international trade rules on medicines be justified to the fullest extent possible, and permitted only to the extent to which they can be justified. In this article I explore the impact of trade rules on medicines access, and the growing force of the human right to health. I argue that the limited justification for strong patents in poor countries suggests the need for significant reform of trade-related intellectual property rights. I argue further that human rights standards may offer both normative and practical tools for achieving this reform and for challenging trade rules on medicines at various levels.

scholarly journals Decolonising human rights: how intellectual property laws result in unequal access to the COVID-19 vaccine

2021 ◽  
Vol 6 (7) ◽  
pp. e006169
Author(s):  
Sharifah Sekalala ◽  
Lisa Forman ◽  
Timothy Hodgson ◽  
Moses Mulumba ◽  
Hadijah Namyalo-Ganafa ◽  
...  
Keyword(s):  
Human Rights ◽  
Intellectual Property ◽  
Rapid Development ◽  
Access To Medicines ◽  
Global South ◽  
Essential Medicines ◽  
Property Law ◽  
Intellectual Property Law ◽  
Marginalised Groups ◽  
The Right

The recent rapid development of COVID-19 vaccines offers hope in addressing the worst pandemic in a hundred years. However, many countries in the Global South face great difficulties in accessing vaccines, partly because of restrictive intellectual property law. These laws exacerbate both global and domestic inequalities and prevent countries from fully realising the right to health for all their people. Commodification of essential medicines, such as vaccines, pushes poorer countries into extreme debt and reproduces national inequalities that discriminate against marginalised groups. This article explains how a decolonial framing of human rights and public health could contribute to addressing this systemic injustice. We envisage a human rights and global health law framework based on solidarity and international cooperation that focuses funding on long-term goals and frees access to medicines from the restrictions of intellectual property law. This would increase domestic vaccine production, acquisition and distribution capabilities in the Global South.

Right to a name: cross-border family-legal aspects of implementation

2021 ◽  
Vol 11 (1) ◽  
pp. 43-56
Author(s):  
Elena Voytovich
Keyword(s):  
Human Rights ◽  
Legal Aspects ◽  
Coherent System ◽  
Private International Law ◽  
Family Status ◽  
The European Union ◽  
Legal Certainty ◽  
Conflict Of Laws ◽  
Cross Border ◽  
The Right

The increase of cross-border contacts of individuals has shifted the emphasis in modern studies of the right to a name in Civil and Family law to Human rights and Private International Law. The article examines the problems of cross-border implementation of the right of an individual to a name, which are a consequence of state control over the circulation of names, as well as conflicts of national laws. The author offers to get acquainted with the practice of the European Court of Human Rights and the Court of the European Union, which serves as an illustration of the peculiarities of the implementation of the right to a surname in the context of convergence of legal systems. The proposed court decisions demonstrate new approaches to protecting the right of an individual to a surname and open the way to the formation of an internally consistent, coherent system of rules governing the right to a name. The article analyzes the international private legal aspects of the implementation of the right to a surname; special attention is paid to the conflicting principles of determining the law to be applied. The author concludes that domestic practice of assigning surnames should seek to achieve legal certainty. Such practice should not interfere with the exercise of the right to respect for private and family life, freedom of movement and choice of place of residence, or discriminate. Taking into account the results of international justice, national rules on names, conflict of laws norms require revision and updating. The consistent application of lex personalis in determining the applicable law can lead to situations in which the identity of the individual will be in doubt. The solution to this problem is seen not only in improving conflict of laws approaches, but also in the mechanism of recognition of foreign administrative acts. The implementation of this proposal will eliminate lame relationships, ensure legal certainty and stability of the person’s status. The author also proposes to distinguish between conflict of laws rules governing family status and conflict of laws rules governing civil status of an individual.

The right to appeal to the European Court of Human Rights

2020 ◽  
Author(s):  
Yuliya Samovich
Keyword(s):  
Human Rights ◽  
Case Law ◽  
Legal Regulation ◽  
The European Union ◽  
Educational Organizations ◽  
European Court ◽  
Protection Of Human Rights ◽  
Judicial Procedure ◽  
The Right ◽  
Judicial Protection

The manual is devoted to making individual complaints to the European Court of human rights: peculiarities of realization of the right to appeal, conditions of admissibility and the judicial procedure of the European Court of Human Rights. The author analyses some “autonomous concepts” used in the court's case law and touches upon the possibility of limiting the right to judicial protection. The article deals with the formation and development of the individual's rights to international judicial protection, as well as the protection of human rights in universal quasi-judicial international bodies and regional judicial institutions of the European Union and the Organization of American States. This publication includes a material containing an analysis of recent changes in the legal regulation of the Institute of individual complaints. The manual is recommended for students of educational organizations of higher education, studying in the areas of bachelor's and master's degree “Jurisprudence”.

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