scholarly journals The COVID-19 Pandemic: Stress Test for Intellectual Property and Pharmaceutical Laws

2021 ◽  
Author(s):  
Andreas Oser

Abstract The COVID-19 pandemic poses a challenge to certain standards in patent law as well as in pharmaceutical law. This paper discusses questions as to whether and under what conditions government-ordered or privately claimed compulsory licensing can contribute to controlling the pandemic. The existing obstacles and conflicts under the current legal framework, such as a lack of international harmonization and a lack of coherence between patent law (compulsory licensing) and pharmaceutical law (data protection), are outlined and discussed. A possible solution could lie in a modernization of relevant legal provisions to create an internationally harmonized balance between the public interest in using important patents in the present and in future emergency situations and the interest of patent owners and data and market exclusivity holders in allowing exemptions within clearly defined limits. The article concludes with a discussion of conditions that may influence possible solutions.

Pravni zapisi ◽  
2020 ◽  
Vol 11 (2) ◽  
pp. 504-531
Author(s):  
Jelena Jerinić

Serbian Law on General Administrative Procedure (LGAP) opened a possibility for broadening the standing in administrative procedures and administrative disputes, by inclusion of subjects representing collective interests and interest of the wider public - primarily, citizen associations and similar organizations. However, by failing to regulate a series of concrete issues, the Law places the administration and the Administrative Court before a challenge, demanding from them an extensive interpretation of not only LGAP's provisions, but other legislation already recognizing such organizations as AIDS in realization of the public interest. The author analyzes relevant legislation, as well as available administrative and court caselaw in search of these answers. The lack of explicit legal provisions could be balanced by a creative approach in practice, especially by the Administrative Court. Having in mind comparative solutions, the question arises whether it is necessary to regulate this category of potential parties separately or to link it more explicitly to the already existing notion of an interested party. Instead, completely new notions have been introduced - collective interests and the wider interests of the public - which are not or not consistently defined in Serbian law. The current, not so voluminous case law, shows that the administrative bodies need a more direct indication of the rules, i.e. a more explicit definitions of these terms. However, despite the restrictive legal framework, administrative bodies should be open to understanding the specific circumstances, i.e. the motivation that an organization has when it seeks standing. In the normative sphere, one of the solutions could be to envisage the analogous application of LGAP's provisions on the interested party. Other solutions could be sought in explicitly mentioning them in the provisions on right to appeal. The current formulations of LGAP do not provide sufficient guidance to the administration and an extensive interpretation would be a great challenge for them. An active approach of the Administrative Court could show the way for the administration toward and effective application of these provisions of LGAP.


2015 ◽  
Vol 14 (1) ◽  
pp. 23-48 ◽  
Author(s):  
Thaddeus Manu

Purpose – The purpose of this paper is to examine the extent to which developing countries could build national initiatives of compulsory licences. Design/methodology/approach – The focus of this article is only on developing countries. The author reflects on the Indian patent jurisprudence regarding the operational relationship between the general principles applicable to working of patented inventions locally and the grant of compulsory licences. The discussion that follows is based on a review of the case: Bayer Corporation versus Natco Pharma with a view to presenting a model for developing countries to maintain that the public interest principle of patent law is well-founded in their domestic patent regimes. Findings – The analysis confirms that failure to work locally continues to be abusive of the patent right under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, and remains a valid condition on which to grant a compulsory licence. Thus, this reverses the often-contrary misconception that has become almost a unanimous assumption that failure to work basis for granting compulsory licensing would violate Article 27(1) of TRIPS and its enforcement provisions on patent. Originality/value – The author argues that as no member state has challenged the legality of Indian’s decision in the World Trade Organisation, under the dispute settlement understanding (DSU) system is more supportive of the contention that failure to work locally continues to be permissible under TRIPS and remains valid conditions on which member states can grant compulsory licences. This further adds weight to the understanding that nothing in the light of TRIPS would, in fact, preclude any possibility of developing countries amending their patent laws accordingly to maintain that the public interest principle underlining patent law is well-founded in their domestic patent regimes.


Laws ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. 6 ◽  
Author(s):  
Mark J. Taylor ◽  
Tess Whitton

The United Kingdom’s Data Protection Act 2018 introduces a new public interest test applicable to the research processing of personal health data. The need for interpretation and application of this new safeguard creates a further opportunity to craft a health data governance landscape deserving of public trust and confidence. At the minimum, to constitute a positive contribution, the new test must be capable of distinguishing between instances of health research that are in the public interest, from those that are not, in a meaningful, predictable and reproducible manner. In this article, we derive from the literature on theories of public interest a concept of public interest capable of supporting such a test. Its application can defend the position under data protection law that allows a legal route through to processing personal health data for research purposes that does not require individual consent. However, its adoption would also entail that the public interest test in the 2018 Act could only be met if all practicable steps are taken to maximise preservation of individual control over the use of personal health data for research purposes. This would require that consent is sought where practicable and objection respected in almost all circumstances. Importantly, we suggest that an advantage of relying upon this concept of the public interest, to ground the test introduced by the 2018 Act, is that it may work to promote the social legitimacy of data protection legislation and the research processing that it authorises without individual consent (and occasionally in the face of explicit objection).


2017 ◽  
Vol 6 (s2) ◽  
pp. 37-48
Author(s):  
Artan Spahiu

Abstract The protection of the public interest is the main principle governing the activity regulation of the administrative bodies. This activity, traditionally, has been developed through administrative acts, as an expression of the unilateral and authoritarian willpower of public authority, which creates legal consequences. The administrative act has been and remains the most important instrument for the administration bodies to accomplish their mission, but it is no longer effective. Particularly this lack of efficiency is noticed in recent years when the development of the economy and the needs of the evergrowing society have prompted the administration to adapt its activity by making use of other mechanisms “borrowed” from private law. An important part of public activity can also be achieved through the contract as a way that brings the state closer to the private, mitigating its dominant position and leaving space for the efficiency of private activity to fulfil public engagements. Such contracts today are known as “administrative contracts” or “public contracts”. The terms mentioned above are instruments that establish legal relations, for the regulation of which the principle of public interest is opposed and competes with the principle of freedom of the contractual willpower. The regulation of these types of contracts is reached through the private law, which constitutes the general normative framework of contracts (lex generalis) even for the administrative contracts. But this general arrangement will have effect for as long as it does not contradict the imperative provisions of the specific act of public law (lex specialis), which regulates the administrative procedure for the completion of these contracts. This paper aims to bring to the spotlight the way our legislation predict and regulates administrative contracts, by emphasising particularly the features of their dualistic nature. The coexistence and competition of the principles of the freedom of contractual willpower and the protection of the public interest, evidenced in administrative contracts, is presented in this paper through the legal analysis of the Albanian legal framework which regulates these contracts. Under the terms when the role of the state in providing public services tends to increase and our legislation aims the harmonization in accord with the European legislation, it is necessary to improve the administrative contract regulation and extend its scope of action.


LAW REVIEW ◽  
2018 ◽  
Vol 38 (1) ◽  
Author(s):  
Rohit P Singh ◽  
Shiv Kumar Tripathi

In view of the rapid pace of technological, scientific and medical innovations in India and abroad, the intellectual property rights i.e., copyright, patent and other neighboring rights, have been recognized in Indian and foreign jurisdiction. Moreover, its scope and content have expanded pursuant to statutory amendments over the years. Growing recognisiont, expansion and protection of IPRs needs to harmonised with the public interest. Within this backdrop, copyright law, patent law etc. have made elaborate provisions and endeavours have also been made at international level to strike a balance between protection of individual’s IPRS and social interest. The present article tries to examine the contours of protection of IPRS at national and international levels with special reference to copyright law.


Author(s):  
Carmen Lenuta Trica ◽  
Luminita Ghita

At present, legal provisions and environmental policy regulate the possibilities of using environmental considerations in the development of award criteria, as well as in the performance clauses of procurement contracts. The first part of the chapter analyzes the concept of green procurement and product categories for which green procurement can be used. The second part of the chapter presents the benefits of using green procurement. The third part of the chapter will include assessing the progress and impact of using green procurement. The fourth part of the chapter analyzes the legal framework for public procurement in Romania, as well as the capacity of the market to offer and develop products and services that include minimum environmental requirements and criteria. In the fifth part of the chapter, the authors analyze the possibility of implementing a mechanism for the operation and implementation of the legal provisions in Romania in order to improve the quality of the services and optimize the costs of the public procurement.


Author(s):  
Jef Ausloos

This chapter zooms in on Article 17 GDPR, on the right to erasure (‘right to be forgotten’). It meticulously dissects the three paragraphs of this provision. The first paragraph lists six rights-to-erasure triggers which can be summarized as: (a) purpose expiration; (b) withdrawal of consent; (c) right to object; (d) unlawful processing; (e) legal obligation; and (f) withdrawal of consent by minors in the online environment. The second paragraph comprises an odd extension of the right to erasure, enabling data subjects to request that controllers who have made the personal data public, communicate potential erasure to anyone else processing that same personal data. The third paragraph lists five exemptions to the right to erasure, summarized as: (a) freedom of expression and information; (b) legal obligation or task carried out in the public interest or official authority; (c) public interest in the area of public health; (d) public interest archiving, scientific and historical research, or statistical purposes; and (e) legal claims. What becomes clear right away is how both the right-to-erasure’s triggers and exemptions all refer to other legal provisions in and outside the GDPR. As such, the right to erasure can be seen as a central hub in the GDPR, bringing together key data protection principles from the perspective of data subject empowerment.


2021 ◽  
Author(s):  
Milica Dobričić ◽  
◽  
Milica Maksić Mulalić ◽  

The management of the national parks Tara, Fruška Gora, Djerdap and Kopaonik and the activities of the managers in Serbia are affairs of the public interest. The manner of their strategic management is defined by the legal framework in the field of nature protection and it implies the adoption and the implementation of documents, such as the nature protection strategy, management plans and spatial plans for the special purpose areas. The paper particularly emphasizes the importance of adopting management plans for national parks, as basic documents for their management, as well as their harmonization with the spatial plans for the special purpose areas, as specific instruments for the management of these areas. It points out the importance of establishing governing bodies, such as a professional alliance and a council of users of national parks, which would improve their management and incorporate the interests of local people and users of space. In accordance with the above, this paper aims to point out the importance of strategic management and strategic documents in the field of protection and management of national parks in Serbia and give suggestions for their improvement.


Author(s):  
Peter Chvosta

Purpose. The article is devoted to the legal figure of subjective public right in the context of legal protection in administrative matters. Methods. Based on the historical development of administrative jurisdiction in Austria and Germany in the 19th century, the function of the subjective public right is discussed in more detail: When the legislator grants citizens subjective public rights (and thus enforceable claims against the administration), the citizen can assert his or her individual interests before the courts by means of a right of defence against the state. At the same time, this results in an external legal control of the administration (compared to a mere internal administrative control by way of disciplinary measures) and thus promotes the rule of law of administrative action, which is in the public interest. Results. By pursuing his subjective public right, the citizen acting in his own interest indirectly contributes to the correct enforcement of the law. In a sense, he acts as an assistant to the public interest. The granting of a subjective public right also limits the group of persons who can take action against an administrative act, since otherwise anyone could challenge an administrative act. If the legislator has not expressly stipulated in the law which persons are entitled to a subjective public right in which respect, the determination of subjective public rights can be difficult in individual cases: When the law provides for a permit subject to certain conditions, the addressee of an administrative act is necessarily entitled to obtain a permit if the conditions required by law are met. The question is more complex in the case of persons who are not the addressee of an administrative act but who are affected by its effects. In this case, it must be determined by way of interpretation whether the legal provisions whose violation the citizen claims to have violated were passed not only to protect public interests but also, at least, in the interests of individual persons. Only then is there also a subjective public right of the individual to compliance with this provision. Conclusions. The legislator can avoid difficulties of interpretation by means of clear rules on the granting of subjective public rights. In particularly important administrative matters (e.g. approval of infrastructure projects), where the granting of subjective public rights is not sufficient to ensure judicial control of administrative acts, a larger group of persons can be granted party status.


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