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1

Harris, Rebecca C. "State responses to biotechnology." Politics and the Life Sciences 34, no. 1 (2015): 1–27. http://dx.doi.org/10.1017/pls.2015.2.

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This article reviews biotechnology legislation in the 50 states for 11 policy areas spanning 1990–2010, an era of immense growth in biotechnology, genetic knowledge, and significant policy development. Policies regarding health insurance, life insurance, long-term care insurance, DNA data bank collection, biotech research protection, biotech promotion and support, employment discrimination, genetic counselor licensing, human cloning, and genetic privacy each represent major policy responses arising from biotechnology and coinciding with key areas of state regulation (insurance, criminal justice, economic development, labor law, health and safety, privacy, and property rights). This analysis seeks to answer three questions regarding biotechnology legislation at the state level: who is acting (policy adoption), when is policy adopted (policy timing), and what is policy doing (policy content). Theoretical concerns examine state ideology (conservative or liberal), policy type (economic or moral), and the role of external events (federal law, news events, etc.) on state policy adoption. Findings suggest ideological patterns in adoption, timing, and content of biotech policy. Findings also suggest economic policies tend to be more uniform in content than moral policies, and findings also document a clear link between federal policy development, external events, and state policy response.
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Varela, Justo Corti. "Biotechnology." European Journal of Risk Regulation 1, no. 1 (March 2010): 63–71. http://dx.doi.org/10.1017/s1867299x00000076.

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This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.
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3

Rey Garcia, Paula. "Directive 2001 /18/EC on the Deliberate Release into the Environment of GMOs: an Overview and the Main Provisions for Placing on the Market." Journal for European Environmental & Planning Law 3, no. 1 (2006): 3–12. http://dx.doi.org/10.1163/187601006x00029.

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AbstractPublic and political views on the regulation of genetically modified organisms (GMOs) and on the role of biotechnology continue to be extremely polarised in Europe. The EU started legislating on the authorisation and use of GMOs in the early 1990s. Despite the early regulation of this complex field, agricultural applications of biotechnology continue to be very controversial. In order to address public concerns and strengthen its regulatory framework, the EU reviewed its legislation on GMOs between 1997 and 2003. The cornerstone of the regulatory framework is Directive 2001/18/EC on the deliberate release into the environment of GMOS, whose provisions for placing on the market are the main focus of this article. The implementation of the Directive to date and the difficulties encountered will be briefly analysed.
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4

Хабриева, Талия, and Taliya Khabriyeva. "Main Vectors and Problems of Development of Social Legislation." Journal of Russian Law 2, no. 8 (September 22, 2014): 5–15. http://dx.doi.org/10.12737/5271.

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The article on the guidelines for the development of social legislation of the Russian Federation predicts a rapid and accelerated development of this block of Russian law system.Among the largescale trends typical for social legislation the author includes: expanding of the scope of regulation (juridification) and the corresponding expansion of legal regulations, differentiation of social legislation on the new brunches (in particular, immigration legislation), the formation of new sub-brunches within the existing ones (for instance, labor relations in the public service) and institutions (biotechnology and so on). The article discusses some “growth problems” of social legislation: the tendency of commercialization of the sphere leads to a decrease of the quality of services, the weakening of safeguards for the most vulnerable categories of citizens (for example, cancellation of the rules on prior consent of the guardianship authorities to carry out transactions with premises where childrenlive, led to a decline of living conditions of many minors of the Russian Federation). As a result the very content of constitutional rights is expressly questioned. At the same time it is underlined that the positive aspect of social legislation juridificationis the appearance of new obligations of the state in the social sphere. To overcome the existing problems and to prevent new onesit is proposed to strengthen the role of science in determining the broad guidelines of development of social legislation in the systematization of social legislation, unification of regional legislation in the social sphere, preventing the rejection of statutory approach in the formation of the secondary legislation, reduction of by-law regulation, strengthening the greater coherence of other branches of Russian legislation with the norms of social legislation. Optimization of legislative regulation through the adoption of the Federal Law “On Normative Legal Acts” will contribute to the elimination of many defects of social legislation and greater stability of legislation of the Russian Federation in the whole.
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5

Mokhov, A. A. "The Concept of Four "Bio" in Law and Legislation." Actual Problems of Russian Law 15, no. 8 (August 30, 2020): 146–54. http://dx.doi.org/10.17803/1994-1471.2020.117.8.146-154.

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Developing biotechnologies have an impact not only on technical, technological and other economic processes, but also on industries and sectors of the economy, public relations, and change the prevailing stereotypes of behavior and habits. In this regard, new sprouts of an innovative economy, and the changing social sphere, the psychology of individual groups and communities determine the need for a unified balanced biopolitics. This policy manifests itself in the provisions of the rule of law and legislation, strategic planning documents, and in law enforcement. Due to the nontriviality of technologies, their great potential opportunities, as well as challenges, risks and threats for the population, society, biopolitics is becoming an important factor in the policy pursued in general. The author proves the need for systemic and comprehensive regulation of biotechnologies allowed for use, taking into account their biological and other types of safety, contribution (positive effects) to the developing bioeconomy and development of society. In connection with the above, the concept of the four "bio" (biotechnology — biosafety — bioeconomics — biopolitics) is proposed, which requires the development of law and legislation based on modern trends in the development of technology, economy, society and the state.
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6

Del CASTILLO Rodríguez, Carlos. "PHARMACEUTICAL LEGISLATION OR PHARMACEUTICAL LAW? ANALYSIS." Vitae 18, no. 1 (May 17, 2011): 83–87. http://dx.doi.org/10.17533/udea.vitae.8771.

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After legal enaltment in the pharmaceutical profession appear two intimately related concepts: the pharmaceutical law andt the pharmaceutical legislation that we should define and analyze. On the one hand, the pharmaceutical law is a heterogeneous group of dispositions regulating directly or indirectly the pharmaceutical activity. It cannot be considered an independent branch of the law, but it is possible for practical effects to order systematically the legal regulations. Such is the source of a new branch inside the sanitary law, the pharmaceutical legislation, that every pharmacies most know in applied to his scientific-professional activity which evolution is vertiginous. This paper will study this concept. From the beginning this study requires the most appropriate methodological tools. The most important one for investigation must be the desire to mark out the treated topics guided by the necessary documentation. The use methodology is the usually followed in the works of pharmaceutical legislation where the primary source is found in the diverse official bulletins publishing the legal disposition and the critical literature of the topics.
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7

Hristova, Vessela. "Recent Developments in EU Biotech Regulation: A Possible Solution to the Deadlock on Authorizations of GM Crops?" European Journal of Risk Regulation 1, no. 2 (June 2010): 151–52. http://dx.doi.org/10.1017/s1867299x00000234.

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This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.
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8

Varela, Justo Corti. "It’s (just) Chemistry, Stupid! Or Not?" European Journal of Risk Regulation 6, no. 3 (September 2015): 423–25. http://dx.doi.org/10.1017/s1867299x00004876.

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This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived frommodern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri–food value chain.
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9

Varela, Justo Corti. "Will Chemical Packages be the only Future for Biotechnology? Why the Bayer-Monsanto Merger Could be a Good Opportunity to Put Things in the Right Place." European Journal of Risk Regulation 7, no. 4 (December 2016): 782–83. http://dx.doi.org/10.1017/s1867299x00010199.

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AbstractThis section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.
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10

Leary, David. "Greenland's new legislation on commercial and research-related use of biological resources: implications for the International Polar Year and later." Polar Record 44, no. 2 (April 2008): 97–106. http://dx.doi.org/10.1017/s0032247407007073.

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ABSTRACTNew possibilities for economic development have been identified by the Greenland Home Rule Government in recent years. One of these is the potential for development of biotechnology based on Greenland's biodiversity. To ensure that Greenland shares in benefits derived from the exploitation of these resources the Home Rule Parliament recently enacted legislation on commercial and research-related use of biological resources that is premised on rights recognised by the 1992 Convention on Biological Diversity. This legislation represents the first law in an Arctic jurisdiction specifically to create a mechanism for access and benefit sharing in relation to Arctic genetic resources. The main area of research and commercial interest so far relates to potential developments in biotechnology from the microbial diversity of ikaite tufa columns located in the Ikka Fjord in southwest Greenland. The legislation seeks to provide a mechanism for regulating access to such biological resources and a means for Greenland to share in the potential benefits that may come from scientific research on them and subsequent commercialisation. Much research in Greenland now falls within the scope of this legislation. The purpose of this article is to explain the provisions of the legislation to the polar research community as well as to review its implications for research in the International Polar Year and later. The legislation imposes many new obligations on researchers in Greenland including obligations to obtain survey licences, obligations on reporting and the regulation of publication of scientific research. Commercially focussed research is also tightly regulated with a particular emphasis on patent rights. However, many aspects of the legislation are uncertain and it is unclear how much of the legislation will be implemented in practice.
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11

Arzamastsev, Maksim. "Criminal law guarantees of human dignity and development of biotechnology." Pravovedenie 66, no. 1 (2022): 19–42. http://dx.doi.org/10.21638/spbu25.2022.102.

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The article examines the impact of biotechnology progress on changing criminal law. The author concludes that somatic rights do not constitute a new generation of human rights but enrich the dignity of the individual. Due to the natural nature of these rights, they can only be regulated to a small extent by law, which also limits the possibility of imposing prohibitions. Criminal law must address the task of guaranteeing the dignity of the individual. There is a need for clearer regulation of circumstances that exclude the crime of an act, such as the consent of the victim and reasonable risk. Criminalization of biotechnology applications where there were no signs of abuse should be considered unreasonable. Scientific progress has created uncertainty in the application of certain rules of criminal law. This requires the improvement of sentencing rules and the calculation of the statute of limitations of criminal prosecution. The need to criminalize new types of acts against the person, to introduce responsibility for crimes against artificial organs, as well as organs and tissues separated from a person, was analyzed. Issues of criminal legal assessment of illegal acts with human embryos are considered. It was concluded that it is necessary to include genetic information in the area of privacy protected by criminal law. An analysis of the development vectors of criminal law shows the impossibility of effective deterrence by prohibitions of certain ways of self-determination of the individual. The Russian legislator in this matter shows reasonable restraint. When further improving the criminal law, it is unacceptable to use the design of formal offences. As criminal-forming signs of prohibited acts, there can be both objective characteristics (the method of medical intervention caused by harm) and subjective ones — motive, purpose (for example, performing a sex reassignment operation for unlawful purposes). This will allow criminal law not to stand in the way of biotechnological progress, helping medical legislation determine some boundaries. The article analyses the norms of criminal law, the provisions of international conventions, and the practice of constitutional proceedings.
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12

EFROYMSON, REBECCA A. "REGULATING RISK: OVERSIGHT OF MICROBIAL PRODUCTS OF BIOTECHNOLOGY UNDER THE U.S. TOXIC SUBSTANCES CONTROL ACT." Journal of Environmental Assessment Policy and Management 01, no. 03 (September 1999): 329–47. http://dx.doi.org/10.1142/s1464333299000259.

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The Toxic Substances Control Act (TSCA) is the legislation used by the U.S. Environmental Protection Agency to regulate releases of genetically engineered microorganisms. The rule defining the scope of the notification requirements for releases of microbial products of biotechnology was published in April 1997. The Environmental Protection Agency (EPA) had some latitude regarding the extent to which various categories of microorganisms would be regulated, but the agency was constrained by requirements of TSCA and an interagency agreement about how to regulate products of biotechnology. This paper investigates the extent to which the scope of oversight is based on risk. A risk-based rule is defined as one where the reporting requirements are based on potential for exposure or expected adverse effects. The evolution of the rule is described, and risk-based components are discussed. In conclusion, the scope of oversight of microbial releases is determined to be based on risk to the extent that legislation and institutional constraints permit.
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13

Stankovic, Mirjana, and Bratislav Stankovic. "Biotech Research-Tool Patents in Macedonia: Current Legal and Economic Parameters." Review of Central and East European Law 38, no. 2 (2013): 113–39. http://dx.doi.org/10.1163/092598812x13274154887385.

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One of the vigorously debated topics related to the protection of biotechnology inventions has been the issue of patents on biotechnology research tools, which usually are used in very early stages of biotechnology research. Proponents of patenting argue that the patent system acts as an incentive for biotech/pharma companies to invest in research and development which is aimed at developing biotech research tools. Opponents of patenting maintain that such patents might impede future research by creating “patent-thickets” and preventing researchers from performing experiments which rely on the patented tools without authorization and royalty payments.The Republic of Macedonia is a small, developing country that lacks specifically crafted legislation or even an articulated public policy promoting the growth of the biotechnology sector. Macedonian patent law contains rather broad exemption to patent rights, termed in “free use for personal and non commercial purposes” and “free use for research and development” of a patented invention. These provisions use obfuscating language and might generate confusion and divergent judicial practices. Also problematic are the law’s provisions which pertain to biotechnology patents and, especially, exemptions to biotechnology patents; these appear to misinterpret the mirroring provisions of the European Union Biotechnology Directive.This article argues in favor of amending the Macedonian industrial property law with a list of both specific exemptions and safeguards, which should provide clarity in future judicial practice pertaining to experimental-use exemptions of biotech research-tool patents in this country.
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14

Asmussen, Ida Helene, and Katharina Eva Ó Cathaoir. "Making Access to a Population of Bodies in the Name of Autonomy." European Journal of Health Law 25, no. 5 (November 15, 2018): 555–72. http://dx.doi.org/10.1163/15718093-12550402.

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AbstractDevelopments within biotechnology are of a pace and complexity that challenge the predictability at the foundation of legislation, i.e. the possibility for politicians to foresee pitfalls and hazards, and design legislation accordingly. The lack of predictability is not only a challenge for the legislature, but also for the citizen, who is to consent to the new biotech services offered by the health authorities. How can one give informed consent to a measure, the consequences of which is hard to predict? Does the uncertainty and lack of predictability mean that paternalism has slipped back in as a ‘self-selected’ responsiveness to the rhetoric of the health regime? Recently, Denmark has taken another step in the direction of voiding autonomy of actual value by rendering genetic analysis contingent on agreeing that the resulting data may be stored in the recently established National Genome Centre, and reused for research unless the patient opts out.
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15

Burchardi, Jan-Erik. "The proposed Amendments to the German Biotechnology Law: Progress or Setback for Biotechnology in Germany?" Journal for European Environmental & Planning Law 4, no. 6 (2007): 449–54. http://dx.doi.org/10.1163/187601007x00046.

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AbstractOn 8 August 2007 the German federal government has approved a draft legislative package introducing changes to the biotechnology laws and regulations. This is already the second time the current government has amended the rules and procedures regarding genetically modified organisms (GMOs). The new draft is aimed at fulfilling the government coalition agreement to advance research and application of biotechnology in Germany. This article will provide an overview of the proposed amendments and briefly analyse to what extend the aim of advancing biotechnology has been achieved. The author argues that the draft introduces a number of amendments with the potential of advancing biotechnology research and of appeasing the farming community on the issue of cultivation of GMOs. However, a number of fundamental policy choices regarding biotechnology have been left unaltered. The author therefore concludes that this draft does not lead to a paradigmatic change regarding biotechnology policy in Germany.
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ROMEO-CASABONA, Carlos María. "Criminal policy and legislative techniques in criminal law on biotechnology." Revue internationale de droit pénal 82, no. 1 (2011): 83. http://dx.doi.org/10.3917/ridp.821.0083.

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17

Ivanenko, Dmytro, and Nataliia Hlushchenko. "LEGAL ASPECTS OF INTELLECTUAL PROPERTY IMPACT ON AVAILABILITY OF MEDICINES IN UKRAINE." Law Journal of Donbass 76, no. 3 (2021): 39–44. http://dx.doi.org/10.32366/2523-4269-2021-76-3-39-44.

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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.
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18

Parker, David L., and Nicole Stafford. "Biotechnology and Patent Infringement in the USA." Industry and Higher Education 13, no. 3 (June 1999): 203–14. http://dx.doi.org/10.5367/000000099101294546.

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Patent systems attempt to stimulate innovation through a reward process that provides the right to exclude others from making, using, selling, or offering to sell the patented invention for a defined period of time. A critical dilemma is presented by the need to ensure at the same time that researchers have the opportunity to improve on what previous research has achieved. Patented inventions which have a significant – if not sole – usefulness in the pursuance of further research are at the centre of this dilemma. In this paper, the authors discuss this apparent conflict in the context of US biotechnology research and patent legislation. They briefly review the origins of the common law research exemption doctrine in the USA and discuss the research exemption of 35 USC Section 271(e)(1) and its judicial interpretation. They then consider a variety of proposals from commentators, and draw up their own recommendations for an approach which carefully balances the need to promote innovation through the granting of valid patents with the need to preserve research access to basic inventions which constitute valuable starting points for the furtherance of research or tools which improve researchers' ability to innovate.
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19

Belov, O. A., Yu N. Spiridonova, and A. I. Odintsov. "Genetic Engineering: Issues of Criminal Law Regulation." Penitentiary science 14, no. 4 (December 18, 2020): 479–85. http://dx.doi.org/10.46741/2686-9764-2020-14-4-479-485.

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The article analyzes modern scientific achievements in the field of genetic research, considers methods of genetic engineering as an integral part of modern biomedicine, and the issues of human cloning. We examine the differences between reproductive cloning and therapeutic cloning, emphasizing the importance of the latter for improving human life, fighting various diseases, and so on. However, along with ethical problems, there are also problems in the world of legal regulation of genetic research and manipulation of human genes. We touch upon the problems of legal regulation of genome research and human cloning in foreign countries and in the Russian Federation, and, above all, the problems of criminal law regulation of genetic engineering. Based on a comparative analysis of international legal acts, national legislation of a number of countries and regulatory legal acts of the Russian Federation, we conclude that there is insufficient legal regulation of issues related to genetic research in Russia, and, supporting the opinion of a number of scientists, we propose to introduce a number of norms in the Criminal Code of the Russian Federation on criminal liability for socially dangerous behavior in the field of modern methods of biotechnology, genetic engineering, and human cloning.
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Campbell, Angela. "Ethos and Economics: Examining the Rationale Underlying Stem Cell and Cloning Research Policies in the United States, Germany, and Japan." American Journal of Law & Medicine 31, no. 1 (March 2005): 47–86. http://dx.doi.org/10.1177/009885880503100102.

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The governance of reproductive science is fraught with controversy in nearly every jurisdiction across the globe. Worldwide, legislators and policy makers have struggled to craft meaningful and ethical parameters for the regulation of this new and evolving area of biotechnology. In most countries, it is agreed that some form of regulatory oversight over reproductive technologies is necessary. There is far less consensus, however, as to the type of regulatory structure that should be established. Recent debates over reproductive science have focused on two of the most controversial practices in this area: embryonic stem cell research and cloning technology. Specifically, interested parties have struggled over whether these practices are so egregious that they should be altogether prohibited, or whether they ought to be permitted, but subject to particular legislative limits and regulatory oversight.The difficulties that most countries have experienced in devising legislation pertaining to embryonic stem cell and cloning research emanate from the moral ambiguity that characterizes this area of science.
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Holman, Christopher M. "A Proliferation of Legislation Targeting Genetically Modified Crops." Biotechnology Law Report 34, no. 6 (December 2015): 207–12. http://dx.doi.org/10.1089/blr.2015.29019.hol.

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22

Belov, Oleg A., Yuliya N. Spiridonova, and Aleksandr I. Odintsov. "Genetic Engineering: Issues of Criminal Law Regulation." Penitentiary science 14, no. 4 (December 18, 2020): 556–59. http://dx.doi.org/10.46741/2686-9764-2020-14-4-556-560.

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The article analyzes modern scientific achievements in the field of genetic research, considers methods of genetic engineering as an integral part of modern biomedicine, and the issues of human cloning. We examine the differences between reproductive cloning and therapeutic cloning, emphasizing the importance of the latter for improving human life, fighting various diseases, and so on. However, along with ethical problems, there are also problems in the world of legal regulation of genetic research and manipulation of human genes. We touch upon the problems of legal regulation of genome research and human cloning in foreign countries and in the Russian Federation, and, above all, the problems of criminal law regulation of genetic engineering. Based on a comparative analysis of international legal acts, national legislation of a number of countries and regulatory legal acts of the Russian Federation, we conclude that there is insufficient legal regulation of issues related to genetic research in Russia, and, supporting the opinion of a number of scientists, we propose to introduce a number of norms in the Criminal Code of the Russian Federation on criminal liability for socially dangerous behavior in the field of modern methods of biotechnology, genetic engineering, and human cloning. Key words: gene; genetic research; genetic engineering; methods of genetic engineering; DNA; human cloning; criminal law regulation.
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23

Dores, Milene Therezinha das, Juliana Escarião da Nobrega, and Célia Lucia de Luces Fortes Ferreira. "Room temperature aging to guarantee microbiological safety of Brazilian artisan Canastra cheese." Food Science and Technology 33, no. 1 (February 20, 2013): 180–85. http://dx.doi.org/10.1590/s0101-20612013005000003.

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Canastra cheese is one of the oldest and most traditional cheeses made from raw milk in Brazil. However, this type of practice may have severe consequences for human health. According to the current legislation, any cheese made from raw milk must be aged for at least 60 days. Traditionally, Canastra cheese is consumed after different ripening periods, but consumers usually prefer those that are aged less than eight days. This study aimed to evaluate the effects of physicochemical and microbiological parameters, with emphasis on the pathogenic microbiota regulated by law, on cheese aged at room temperature and under refrigeration. Cheese samples were collected from eight different cheese producers located in the Serra da Canastra region twice a year (rainy and dry seasons) and analyzed with 8, 15, 22, 29, 36, and 64 days of ripening. Room temperature aging effectively reduced pathogens, reaching the total count established by law in 22 days, regardless of the season. However, ripening under refrigeration, it was ineffective in reducing the Staphylococcus aureus counts to the legislation limits, even after 64 days. Therefore, Canastra cheese should be ripened for at least 22 days at room temperature in order to fulfill the safety regulatory limits.
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Horodovenko, Viktor V., Vitalii M. Pashkov, and Larysa G. Udovyka. "INTERNATIONAL LEGAL INSTRUMENTS IN THE FIELD OF BIOETHICS AND THEIR IMPACT ON PROTECTION OF HUMAN RIGHTS." Wiadomości Lekarskie 73, no. 7 (2020): 1554–60. http://dx.doi.org/10.36740/wlek202007144.

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Introduction: A rapid development of biomedicine, genetics, pharmacology, transplantation and biotechnology has posed a number of problems to humanity, in particular, with regard to human rights protection in healthcare. These problems solution requires considering the achievements and propositions of biology, medicine, ethics and law. International legal standards in the field of bioethics are of significance in development of national states regulations on bioethics and biotic legislation. Aim: To investigate the impact of international legal instruments in the field of bioethics on protection of human rights. Materials and methods: In the research the international legal instruments and documents in the field of healthcare and bioethics were used. Civilizational, axiological, dialectical, systemic and comparative legal methods as well as systematization, analysis and synthesis were decisive in the research process. Conclusions: Legal instruments in the field of biomedical technologies (directives and regulations) are mainly advisory by nature. In many cases, the problems arising in biotechnology are resolved through establishment and involvement of national supervision bodies: councils (commissions, committees) in bioethics as well as courts. An important role in protection of human rights in the field of biotechnology is played by the ECHR the decisions of which are dynamic, based on the Convention and consideration of national legislations. At the same time, a number of problems remain unresolved because of constant development of biomedical technologies, necessity to take into account the latest achievements and discoveries as well as all types and methods of applying of genetic engineering to humans. In general, insufficient attention is paid to the problems of medical biotechnologies application both at the international and national levels.
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Rothhaar, Markus. "Spezieszugehörigkeit und Entwicklungspotential – Was impliziert ihre biotechnische Manipulierbarkeit für das Recht des Embryonenschutzes?" Jahrbuch für Recht und Ethik / Annual Review of Law and Ethics 28, no. 1 (January 1, 2020): 27–38. http://dx.doi.org/10.3790/jre.28.1.27.

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In the German legislation on embryo protection, the scope of protection is defined by its membership to the human species and by the embryo’s inherent potential to develop into a born human being. Both criteria refer to well-known bioethical arguments: the argument from species membership and the potentiality argument. With recent progresses in biotechnology it has, however, become possible manipulate the development potential of human embryos and to blur the boundaries between species. Hence, we must ask, whether both criteria (and with them the arguments) can still hold their ground in bioethics and biomedical law. In my article, I argue, that the aforementioned biotechnological techniques do not require to abandon the arguments from species membership and potentiality. There is, however, a need to clarify what the criteria of species membership and inherent potentiality actually refer to in the relevant laws, i. e. the embryo protection law and the stem cell law.
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Yu, Xiang, and Na Li. "Disclosure of Vaccine Risk and Emergency Legislation in China." Biotechnology Law Report 38, no. 3 (June 2019): 165–71. http://dx.doi.org/10.1089/blr.2019.29117.xy.

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Holman, Christopher M. "Congress Considering Legislation Aimed at Increasing Competition in Pharmaceuticals." Biotechnology Law Report 38, no. 3 (June 2019): 144–53. http://dx.doi.org/10.1089/blr.2019.29125.cmh.

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Ren, Lei, Yan Shi, and Hong Ma. "Dual Logic of Sports Violence Governance in China: A Comprehensive Survey of Law and Industry Autonomy." Journal of Healthcare Engineering 2021 (November 26, 2021): 1–11. http://dx.doi.org/10.1155/2021/4377156.

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Sports violence is a critical issue that has hindered China’s sports development. Dual logic is currently the mainstream rule of law and industrial autonomy, although it has not produced satisfactory results. In this paper, we used expert interviews, text analysis, and case analysis to investigate the flaws in the current governance process and found that the dual logic of sports violence governance has problems of varying degrees. The low degree of legislative specialization, the hazy limit of judicial intervention, and disparate law enforcement are examples of the rule of law. The clash of rights and interests between the association and the state, the association’s ineffectual control over the junior leagues, and the limited scope of governance are all examples of industry autonomy. Based on the issues mentioned above, this paper proposes dual logic strengthening measures and the notion of integrated governance. In particular, we should improve the rule of law thinking and construct a legal system for sports violence in China from legislation, justice and law enforcement, and law-abidingness to compensate for the current lack of law in sports violence. Second, we define the scope of the association’s “postdecoupling era” powers and obligations, resolve conflicts through state involvement based on the rule of law, and remove governance hurdles. Finally, we thoroughly investigate three aspects of integrated governance between the rule of law and industry autonomy: respecting industry autonomy and providing specific implementation space for industry norms, not excluding the rule of law’s intervention, and establishing an industry autonomy supervision mechanism. The rule of law and industry autonomy permeate each other and realize integration.
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Bogatyreva, Nataliya Vladimirovna, and Natalya Viktorovna Nikolaichenko. "The problem of the administrative liability for the violation of the GMO'S ban in Russia." Agrarian Scientific Journal, no. 1 (January 27, 2021): 4–7. http://dx.doi.org/10.28983/asj.y2021i1pp4-7.

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The authors analyze the Russian system of prohibitions on work with plants obtained by genomic technologies and penalties for their violation. It is prohibited in Russia to grow plants whose genetic program has been modified by humans using genome technologies. Not all plants obtained by these methods are prohibited, for example, plants obtained using DNA-free genome editing should not fall under this ban. The specialists who are planning work on growing plants obtained by genomic technologies, therefore, should correctly determine what falls under the legal ban and what is the punishment of non-compliance with it. A legislation systematic analysis has shown that there is no liability for non-compliance with this ban, which reduces the efficiency of regulatory measures and creates preconditions for violating the law. Administrative liability is provided only for the cultivation of genetically modified plants without registration. However, it is unclear when such registration should be carried out due to inconsistent amendments to the legislation. It should be stated thereby that the legal risks in growing plants obtained using genomic technologies in the Russian Federation are excessively high. Their minimization is possible by amending the legislation on genetic engineering and environmental protection, which should be preceded by the adoption and compliance at the federal level of an agreed strategy for the development of agricultural biotechnology.
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Przhilenskiy, V. I., and A. A. Vergun. "The legal regulation of genomic DNA banks in the context of social, cultural and regulatory diversity." Actual Problems of Russian Law, no. 3 (May 4, 2019): 30–38. http://dx.doi.org/10.17803/1994-1471.2019.100.3.030-038.

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The article deals with the normative regulation of genetic research and bioengineering, compares the experience of different countries in this area. The author subjects a legislative framework for the preservation of privacy in the formation of biobanks in such countries as Denmark, Israel and China to a detailed analysis. On the example of law enforcement practice in the States mentioned above, the author shows the variety of ways of development of relevant legislation, as well as the impact of legal, political and socio-cultural traditions on those ways. Special attention is paid to the connection of genetic research with the development of computer technologies that require complex legal regulation with due regard to specifics of genomic and computer knowledge. The author substantiates relevance of the thesis about a decisive role of the influence of political and administrative reasons in choosing the strategy of legislative and institutional regulation of biotechnology and bioengineering by means of a comparative review of various schemes and models emerging in Danish, Israeli and Chinese legal reality. In the article, the authors shift from the problem of development of legal support of genomic biobanks to the problem of ethical foundations of this activity, and expand the angle of view by considering protection of rights of unborn children, protection of rights of minors and those who have lost their legal capacity due to old age. The authors systematize and problematize the issues of preserving effectiveness of legal regulation in the development of precision (personalized) medicine that is based on the ontology of the unique, while law enforcement, in principle, is normative, and, therefore, based on the ontology of the universal.
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Song, Lingqiao, and Yann Joly. "After He Jianku: China's biotechnology regulation reforms." Medical Law International 21, no. 2 (February 16, 2021): 174–92. http://dx.doi.org/10.1177/0968533221993504.

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The unveiling of the world’s first gene-edited twins by biophysics researcher He Jiankui generated much discussion about Chinese legal and ethical frameworks for biotechnology. In response, the highest Chinese legislative body, the National People’s Congress, and the two responsible departments for biotechnology, the Ministry of Science and Technology and the National Health Committee, have undertaken a seemingly far-reaching regulatory reform. The most salient step of this reform is to regulate genetic research and human embryo research in the Chinese Civil Code. This article overviews recent policy developments in China and their respective importance for promoting a governance framework for biomedical research that meets the expectations of the international community. However, this regulatory reform could also set stricter administrative procedures in place for Chinese institutions and their foreign partners, which may impede scientific progress. The concrete impact of this reform on the practice of Chinese scientists will need to be closely scrutinised by Chinese authorities and the international community.
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Hernández-López, Ernesto A. "GMO Corn in México: Precaution as Law’s Decolonial Option." Law, Technology and Humans 2, no. 2 (November 21, 2020): 97–113. http://dx.doi.org/10.5204/lthj.1479.

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For over six years now, the law has been central to policy debates about genetically modified organism (GMO) corn in México, the birthplace of maíz (corn). In the lawsuit Colectividad del Maíz, the domestic courts have shaped the policy on GMO corn. Out of concern for biodiversity, the courts have suspended regulatory approval for commercial GMO corn permits needed by seed companies. This article uses decolonial theory to examine how the law can both encourage and limit the use of GMOs. Decolonial perspectives isolate how economics, legal authorities, and ideologies work in unison to shape relations between the Global South and private interests. This is accomplished by defining the subject of any such legal regulations. Different legal doctrines treat GMOs in different and distinct ways. Under the doctrines of biosecurity, intellectual property, and international trade law, markets and biotechnology benefit as the subject of the law. Such doctrines disenfranchise maíz nativo (non-GMO corn) by making it the law’s object. The article also adopts Bruno Latour’s theory of “down to earth” politics to identify important changes in GMO regulations. Collective action litigation has limited the expansion of GMO corn via the application of precautionary principle measures and motivated new legislation in México.
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Ann, Christoph. "Patents on Human Gene Sequences in Germany: On Bad Lawmaking and Ways to Deal With It." German Law Journal 7, no. 3 (March 1, 2006): 279–91. http://dx.doi.org/10.1017/s2071832200004661.

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Whether patents should be granted on human genes or gene sequences is highly controversial, both ethically and politically; not only in Germany but throughout Europe and in most parts of the world. Proof of this has been the attention created by US biotechnology company Myriad Genetics, which, in 2001, obtained European patents for human gene sequences indicating an increased risk of certain types of cancer. In Germany the Bundestag has recently addressed the issue: the core of a newly introduced provision of the German Patent Statute (PatG) is Paragraph 1a Sec. 4 PatG, which limits the scope of patent protection available for human gene sequences or parts thereof. If the subject of an invention is a human gene sequence, Paragraph 1a Sec. 4 PatG requires disclosure of not only the sequence but also at least one application. Without such disclosure a human gene sequence is not patentable under German Patent Law. This is remarkable, because under the Directive of the European Parliament and the Council on the Legal Protection of Biotechnological Inventions, the so-called Biotechnology Directive of 1998, a piece of European Union legislation, the situation is different.
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Krasnoyarova, E. V. "Institutional principles of the employment contract." Voprosy trudovogo prava (Labor law issues), no. 10 (October 29, 2022): 630–38. http://dx.doi.org/10.33920/pol-2-2210-03.

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This article considers the meaning of the principles of law, their classification, the ratio of generally recognized principles of international labor law and national. The author made an attempt to formulate the basic institutional principles of the employment contract, analyze the norms of law, judicial practice, and also formulate proposals for improving labor legislation.
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Figueira, Ricardo, Waldemar Gastoni Venturini Filho, and Carlos Ducatti. "Carbon isotope analysis in apple nectar beverages." Food Science and Technology 33, no. 1 (March 26, 2013): 32–37. http://dx.doi.org/10.1590/s0101-20612013005000026.

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The aims of this study were to use the isotope analysis method to quantify the carbon of C3 photosynthetic cycle in commercial apple nectars and to determine the legal limit to identify the beverages that do not conform to the safety standards established by the Brazilian Ministry of Agriculture, Livestock and Food Supply. These beverages (apple nectars) were produced in the laboratory according to the Brazilian legislation. Adulterated nectars were also produced with an amount of pulp juice below the permitted threshold limit value. The δ13C values of the apple nectars and their fractions (pulp and purified sugar) were measured to quantify the C3 source percentage. In order to demonstrate the existence of adulteration, the values found were compared to the limit values established by the Brazilian Law. All commercial apple nectars analyzed were within the legal limits, which enabled to identify the nectars that were in conformity with the Brazilian Law. The isotopic methodology developed proved efficient to quantify the carbon of C3 origin in commercial apple nectars.
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Maia, Guilherme Aparecido da Silva, and Lídia Maria Ribas. "Importance of Regulation in the Brazilian Intellectual Property Legal System and the Consequences of the Delay for the Development of the Country." International Journal of Advanced Engineering Research and Science 9, no. 6 (2022): 358–69. http://dx.doi.org/10.22161/ijaers.96.37.

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Intellectual property rights have their roots in the Paris Conventions (1883) and Bern (1883) and will materialize in contemporary society through TRIPS. Brazil, as a signatory country to these international agreements, sought to adapt its domestic System of knowledge protection. However, it was a relatively tardy measure, considering that implementation took place, in the late 1970s, through the Industrial Property Law (Law nº 9279/1996), which had a high cost to the country in terms of development. As if the time delay were not enough, the protection of knowledge in Brazil was born out of date, considering the advance of patent rights on biotechnology. By denying patents on genetic and modified material, the country opened its borders to patent applications requirements from developed nations, based on TRIPS. Thus, from the dialectical method combined with the hypothetical-deductive method, this work seeks to investigate the intellectual property rights of Brazil, having international treaties and national legislation as references. The results show that the country paid dearly for the negligence in protecting its knowledge, which placed it in the rear of scientific and technological development, and resulting in the expansion of the technological domain of developed nations in Brazilian territory.
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Holman, Christopher M. "Congress Considering Legislation Intended to Reverse the Recent Trend Toward Devaluation of the U.S. Patent Right." Biotechnology Law Report 37, no. 5 (October 2018): 243–54. http://dx.doi.org/10.1089/blr.2018.29083.cmh.

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38

AKHMADOVA, MARYAM. "RULES OF INTERNATIONAL LAW REGARDING APPLICATION OF THE RESULTS OF SCIENTIFIC RESEARCHES IN THE FIELD OF BIOTECHNOLOGY (ON THE EXAMPLE OF THERAPEUTIC AND REPRODUCTIVE CLONING AND HUMAN GENE EDITING) AND THEIR PATENT PROTECTION." Sociopolitical sciences 10, no. 3 (June 30, 2020): 199–209. http://dx.doi.org/10.33693/2223-0092-2020-10-3-199-209.

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The article is aimed at highlighting a number of issues in the field of legal regulation of innovative medical technologies based on interference in the human genome and cloning (therapeutic and reproductive) in the context of international law (conventions, declarations, bilateral agreements). In this format, the author examined some international acts that created the legal paradigm for regulating scientific research in the field of study, determining the limits of the admissibility of the implementation of the indicated achievements of modern science in clinical medicine, which are designed to be an effective tool in the fight against severe hereditary diseases, etc., which potentially predetermines their demand. The focus of the author’s attention is on the patentability of these biotechnologies. The relevance of such a study is due to the range of issues addressed, since in the absence of proper regulatory regulation of the studied sphere of public relations, domestic high-tech medicine will be forced to engage in “catch-up” development. In the study, such methods of scientific knowledge were used as general scientific dialectics, formal logic and comparative legal methods. At the same time, the author proceeds from both subjective and objective presetting of processes and phenomena, and their interconnection. The novelty of the study is determined by its purpose, subject and range of sources considered. Thus, the author explores the provisions of both normative acts and documents (acts of so-called “soft law”), emphasizing the peculiarities of their legal nature. In this format, the author comes the conclusion that the system of international principles and standards, formed by the considered acts and documents, does not contain explicit permission to carry out scientific research in the biotechnology field with the subsequent commercialization of its results, which can be patented as inventions, that leads to the need to create national legal frameworks by modern states wishing to advance in this field that will result in a mosaic legal map of the world. Where innovative biotechnologies will be spread in the countries -“scientific offshores” providing loyal to these kinds of scientific researches legislation. The theoretical and practical significance of the results is determined by the fact that Russian readers will be provided with up-to-date scientific information on the state of international law in the field under study, which in practical terms will contribute to the awareness of the sufficiency (or insufficiency) of the developed international legal mechanism for regulating the sphere of biotechnology, including positions of patent and legal protection of a number of“breakthrough” biotechnologies of applied nature, and will also help to establish the unification level of domestic legislation with the approaches laid down in the studied international acts and documents.
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Tarasevich, T. Y. "Principles of somatic human rights as a basis for their implementation in the development of modern biotechnology." ACTUAL PROBLEMS OF THE LEGAL DEVELOPMENT IN THE CONDITIONS OF WAR AND THE POST-WAR RECONSTRUCTION OF THE STATE, no. 13 (October 1, 2022): 318–25. http://dx.doi.org/10.33663/2524-017x-2022-13-51.

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The article emphasizes that the creation and use of new technologies have a twofold impact on human rights. Technical and technological development makes it possible to increase labor productivity, which leads to the strengthening of the economy, raising living standards. In addition, the widespread use of new medical and biotechnologies improves the quality and duration of life. The gap between the emergence and further improvement of new technologies and the pace of social change continues to widen, which is a problem for finding consensual social norms, their assessment by society and their formulation as legislation. In these circumstances, it is difficult to develop effective legal regulation of emerging social relations. At the same time, a balance must be struck between a certain breadth of regulatory boundaries for the free development of technology and research and the normative establishment of restrictions and prohibitions to prevent risks and threats to the human person, his dignity and rights. In view of this, the human rights system serves as such a legal mechanism, as it has the opportunity to offer legal approaches to regulate the use of new technologies, taking into account the traditional values of recognizing the superiority of the human person and his rights. It is concluded that the practice of using human rights remedies in the field of genetic research, features of genetic information (may belong not only to the individual but also to the community, not limited to medical issues), the possible emergence of new objects of protection (e.g. human embryo) raise the issue of the formulation of special rights, which is part of the system of constitutional human rights in Ukraine. However, not all of the above- mentioned human rights, which follow from the provisions of international legal acts regulating genomic research, are formulated in the list of current human rights in Ukraine. Key words: human rights, generation of human rights, somatic rights, principles of law, rule of law, system, hierarchy, legal regulation.
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Nkansah, Lydia. "Contributing Factors of Anemia in Pregnancy in the Twifo Atti-Morkwa District in Ghana." International Journal of Multidisciplinary Studies and Innovative Research 10, no. 1 (September 8, 2022): 1345–70. http://dx.doi.org/10.53075/ijmsirq/687899867.

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The exploding global population is presenting a new challenge of providing food for further billions of people against the backdrop of the challenges of already existing hunger and malnutrition, climate change, emerging destructive crop and animal diseases, and the pressure being exerted on arable lands by several other anthropological demands. Providing food for the world in the foreseeable future, therefore, requires the revolutionization of the agricultural sector as it stands today. Agricultural biotechnology has evolved over three decades and has presented itself as a critical avenue for addressing the perennial food production insecurity situations; particularly in Africa and other food-insecure regions of the world. This study sought to review agricultural biotechnology in Africa by assessing its current state and the future prospects of the technology on the African continent. The adoption and utilization of biotechnology in Africa have been faced with serious challenges of ethical, religious, environmental contamination, and health risks issues. Adoption of biotechnology and genetically modified (GM) products have only been achieved in a few countries in Africa on a small-scale basis and under a few selected crops. Inadequate legislation, unenhanced public education, and the spread of misconceptions by anti-GM technology activists remain a strong challenge to navigate around for the smooth adoption of the technology on the African continent. Smallholder farmers in Africa also harbor serious apprehension over seed monopoly and erosion of the traditional seed quality with neo-colonial intentions by the developers of the technology. Anti-GM sentiments based on misconceptions are deeply rooted in many African countries, heightening fear of its adoption. A stronger and more elaborate public education strategy that highlights the benefits of biotechnology and assures the people of the risk levels of the technology, and further research to alleviate public anxiety is critical for the adoption of biotechnology and GM products in Africa.
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Yao, Li. "Human Rights Legal Support in the Civil Code of the People’s Republic of China in the Context of the Development of New Technologies." Lex Russica, no. 4 (April 24, 2021): 130–41. http://dx.doi.org/10.17803/1729-5920.2021.173.4.130-141.

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The 21st century has seen the development of biotechnologies and artificial intelligence technologies leading to illegal testing of a gene and the introduction of a person’s voice, image, body movements into appropriate electronic procedures, followed by the imitation of a similar human voice, body movements, etc., which can cause a violation of personal rights. Since the establishment of the PRC, four codifications of civil legislation have been carried out: 1954, 1962, 1979 and 2001. However, none of them was implemented for various reasons. In May 28, 2020 for the first time, China has adopted the Civil Code of the People’s Republic of China entering into force on January 1, 2021. The Civil Code of the People’s Republic of China has become the basic law of the market economy in China. It consists of seven parts: "General Part", "Property law", "Contracts", "Personal rights", "Marriage and Family", "Inheritance", "Tort liability" and "Additional provisions". The paper analyzes the features of civil protection of human rights in the new Civil Code of the People’s Republic of China in the era of the development of biotechnology and artificial intelligence. The author examines the provisions on the legal protection of human rights in the illegal occupation of medical and research activities related to human genes, human embryos, and reveals ways to protect the rights to image, voice, privacy and personal information in civil law in violation of personal rights using artificial intelligence technology in China. The author also explains the regime of a preliminary injunction in civil law and ways to find a balance of different personal rights and interests in the Civil Code of the People’s Republic of China.
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Stepanyan, A. Zh, and T. S. Zaplatina. "Legal Regulation of Robots and Artificial Intelligence in Latin America, the Problem of Human Rights and AI." Lex Russica, no. 7 (July 23, 2020): 127–36. http://dx.doi.org/10.17803/1729-5920.2020.164.7.127-136.

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We are currently experiencing a new revolution, which is related to the Internet, nanotechnology, biotechnology and robotics. Artificial intelligence is based on intelligent algorithms or learning algorithms similar to human intelligence, technologies make it possible for computer systems to acquire independence, self-adaptive reconfiguration. The greater the autonomy of AI, robots, and androids, the less they depend on manufacturers, owners, and users.The fact that the new generation of robots will coexist with humans should be taken into account in legislation, it should adapt and regulate issues of great legal significance, namely: who takes responsibility for the actions or inaction of intelligent robots? What is their legal status? Should they have a special regime of rights and obligations? How to resolve ethical conflicts related to their behavior?The analysis of legislation and doctrine in Latin America has revealed some trends in the use of AI.1. The use of AI in various spheres of public life causes legal problems in terms of guaranteeing human rights, as evidenced by the analysis of the constitutions of Brazil, Mexico and Argentina. For example, article 8 of the American Convention on Human Rights states: "Everyone has the right to have his case heard, with appropriate guarantees and within a reasonable period of time, before a competent, independent and impartial court convened in advance by law in support of any criminal charge brought against him or to determine his rights or obligations of a civil, labour, financial or any other nature."2. The similarity of AI and human intelligence raises the question of legal personality of AI, granting AI rights. The civil and commercial code of Argentina departs from the category of "human person" and establishes the term "legal persons": "all persons to whom the legal system grants the ability to acquire rights are legal persons for the purpose of fulfilling their purpose and obligations".The line between things and people is becoming more blurred, technology and a more sensitive view of other living beings lead to doubt whether man is the sole subject of law.
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43

Paucar Luna, Jorge. "Vacío legal en la legislación de seguridad y salud en el trabajo, perjuicio para trabajadores y el estado peruano frente a la covid-19." REVISTA XAUXA AÑO III, NÚMERO 8 - 2022 III, no. 08 (September 30, 2022): 107–17. http://dx.doi.org/10.56374/xau.03.08.22.11.

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The objective of this research was to study the legislation issued by the Ministry of Health of Peru in the framework of the issuance of prevention regulations in the face of the COVID 19 pandemic. The methodology used is the qualitative one of the Action Research type with the purpose of to determine how the health sector solved a legal vacuum in the current labor legislation, referring to the role of the Head of the Occupational Health and Safety service at work (Law No. 29783 and complementary regulations), determining its existence, responsibility, and functions. As a conclusion, it should be pointed out the lack of presence of the State in its supervisory role and the contracting of Peruvian legislation with that of neighboring countries in industrial safety.
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О. L., Lvovа, and Ivaniv I. R. "The moral and legal foundations of bioethics in the context of human rights: legal theory and international practice." Almanac of law: The role of legal doctrine in ensuring of human rights 11, no. 11 (August 2020): 327–33. http://dx.doi.org/10.33663/2524-017x-2020-11-55.

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Modern processes of globalization taking place in the field of law are a great challenge to the idea of human nature, which is recognized in Ukraine as the highest social value, as well as to the concept and essence of law itself. In our opinion, this is a threat on a global scale and necessitates the search for an adequate response to the threat from the scientific and technical process in the field of biomedicine, both for the natural (physical) existence of man and the preservation of his moral identity. In fact, these foundations have become the prerequisites for the development of the science of bioethics. Bioethics studies controversial and ambiguous issues and proposes a humanitarian examination, which aims to assess the arguments in favor of the development of human creativity, health and prevention of premature death, and arguments in favor of preserving human identity in its spiritual and physical integrity. The purpose of the article is to study the essence of controversial bioethical problems, the reasons for their occurrence and prospects for solving these problems. human, manipulation of stem cells and others. Bioethical issues usually include the ethical issues of abortion; contraception and new reproductive technologies (artificial insemination, surrogacy); conducting experiments on humans and animals; obtaining informed consent and ensuring patients' rights; determination of death, suicide and euthanasia; problems in relation to dying patients (hospices); demographic policy and family planning; genetics (including problems of genome research, genetic engineering and gene therapy); transplantology; health equity; human cloning, manipulation of stem cells and others. These issues related to the progress of genetics, genomics, pharmacology, transplantation, biotechnology, cloning are becoming increasingly important as a direction of international law in the context of ensuring and protecting human rights. IN legal literature indicates the formation of "biolaw", "bioethical legislation", "bioethical human rights". Thus there is a combination of possibilities and purposes of medicine and law. In our article, we have explored only some of these issues, which are currently the most relevant, debatable, and therefore require detailed analysis. These include, in our view, the legal status of the embryo, therapeutic and reproductive cloning, abortion, the use of assisted reproductive technologies and organ transplantation. In order to adequately cover these issues, we compare the rules of law governing these debatable issues with the views of church representatives and scholars on these issues. We also proposed changes that need to be made to the legislation of Ukraine so that the rules of law governing these issues meet the moral and ethical principles. As a conclusion is marked, that as bioethics as science dealing with survival combines in itself biological knowledge and general human values, then it is possible to consider natural human rights, her honour and dignity morally-legal principles of bioethics, a self right and law must become on defence of that, in particular, with the aim of providing of natural (physical) existence of man, and maintenance of her moral identity. Keywords: human rights, moral, bioethics, abortion, reproductive technologies, cloning.
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Simić, Jelena. "The right to sexual and reproductive health of LGBTIQ persons and the challenges of biomedical assisted reproduction." Pravni zapisi 13, no. 1 (2022): 261–84. http://dx.doi.org/10.5937/pravzap0-37651.

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The mass application of modern medical biotechnology (BAF) and its expansion on a global level have brought numerous challenges at the individual and social level, and the very goal of reproductive technologies has exceeded the treatment of infertility. For LGBTIQ people, the use of BAF in the first place is a matter of reproductive justice that should provide everyone, without distinction, economic, social and political power and resources to make healthy decisions about their bodies, sexuality and reproduction for themselves, their families and their union. The reality, however, is that access to BAF is enjoyed by a small privileged group of people, and many medically infertile persons do not seek BAF because of the high cost of such treatment. As a result, the development of biomedical technology is increasingly becoming a subject of reconsideration and controversy, and less and less an achievement that supports life and health. In this paper, the author discusses when and why access to BAF became a matter of the LGBTIQ rights and whether access to BAF can really be equal for all, given its costs? Finally, the author refers to BAF in terms of domestic legislation and concludes the paper with a call for changes to the legal solution that prohibits the use of BAF for LGBTIQ individuals and couples in Serbia.
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Levold, Nora, Marit Svingen, and Margrethe Aune. "Stories of creation." Nordic Journal of Science and Technology Studies 7, no. 1 (May 19, 2019): 4–17. http://dx.doi.org/10.5324/njsts.v7i1.3066.

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This article discusses the Norwegian media debate on surrogacy from 2010–2013. The debate was initiated by the ‘Volden-case’ where a Norwegian woman who had travelled to India to have surrogate twins could not return to Norway because the Norwegian authorities refused to give the children passports. At that time in 2010, surrogacy was not explicitly regulated by the existing Norwegian Biotechnology Act. According to the Norwegian Child and Parents Act of 1982, the woman who physically gives birth is the mother of the child. It soon became clear that, because this case existed in regulatory limbo, it required a legislative solution. At the time there was an intense and heated media debate. This was resolved when a temporary law was passed in 2013, pending a more permanent Biotechnology Act. During the process of revising the new Biotechnology Act in 2017–2018, we anticipated a continuation of the intense debate that occurred earlier. Surprisingly, this did not happen. In this article we aim to explain why. By analyzing the original 2010–2013 media debate using Hajer’s concepts of ‘discourse coalitions’ and ‘storylines’ (Hajer 2003), we identified three discourse coalitions which gathered around three storylines: the ‘storyline of biological parenthood’, the ‘storyline of equality’ and the ‘storyline on human trafficking’. The analysis demonstrated that the ‘storyline on human trafficking’ gained strength during the 2010–2013 debate, ultimately becoming hegemonic at the end of this period. Surprisingly, the other two discourse coalitions did not appear much in the media debate prior to the new law. This article discusses the lack of these discourse coalitions and concludes that the hegemonic nature of the ‘storyline on human trafficking’ may explain why the new Biotechnology Act did not spark heated debate.
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Thomas, Vernon G., Robert H. Hanner, and Alex V. Borisenko. "DNA-based identification of invasive alien species in relation to Canadian federal policy and law, and the basis of rapid-response management." Genome 59, no. 11 (November 2016): 1023–31. http://dx.doi.org/10.1139/gen-2016-0022.

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Managing invasive alien species in Canada requires reliable taxonomic identification as the basis of rapid-response management. This can be challenging, especially when organisms are small and lack morphological diagnostic features. DNA-based techniques, such as DNA barcoding, offer a reliable, rapid, and inexpensive toolkit for taxonomic identification of individual or bulk samples, forensic remains, and even environmental DNA. Well suited for this requirement, they could be more broadly deployed and incorporated into the operating policy and practices of Canadian federal departments and should be authorized under these agencies’ articles of law. These include Fisheries and Oceans Canada, Canadian Food Inspection Agency, Transport Canada, Environment Canada, Parks Canada, and Health Canada. These efforts should be harmonized with the appropriate provisions of provincial jurisdictions, for example, the Ontario Invasive Species Act. This approach necessitates that a network of accredited, certified laboratories exists, and that updated DNA reference libraries are readily accessible. Harmonizing this approach is vital among Canadian federal agencies, and between the federal and provincial levels of government. Canadian policy and law must also be harmonized with that of the USA when detecting, and responding to, invasive species in contiguous lands and waters. Creating capacity in legislation for use of DNA-based identifications brings the authority to fund, train, deploy, and certify staff, and to refine further developments in this molecular technology.
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48

Henderson, Wendy R., and Elaine C. Murphy. "Pest or prized possession? Genetically modified biocontrol from an international perspective." Wildlife Research 34, no. 7 (2007): 578. http://dx.doi.org/10.1071/wr07062.

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This article provides an overview of current research, regulations and international issues concerning genetically modified (GM) organisms for use as biological controls of vertebrates. There is increasing interest in using biotechnology to solve vertebrate pest problems around the world. A major issue lies in the fact that individual countries focusing on internal problems of pest management may overlook the potential of transborder entry. Animals considered a pest in one country may well be prized possessions in another, and research and management strategies should consider the adverse effects of biocontrol agents entering the ‘wrong’ country. There is a wealth of guidance in the form of national and international regulations and ethics guidelines. However, current legislation and agreements may not be adequate to ensure that all risks of GM biocontrols, particularly disseminating agents, have been considered from an international perspective. Major issues include concerns of transboundary movement, non-target effects and the need for an international body to consult with and regulate the use of GM biocontrols. We live in a finite and interconnected world: it is vital that impacts of potential control strategies are assessed at a local and international level, and from social, environmental and economic perspectives.
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49

Chakrabarty, Ananda M. "Intellectual property rights and contentious legal and social issues in biotechnology." SALUTE E SOCIETÀ, no. 3 (November 2010): 183–202. http://dx.doi.org/10.3280/ses2010-003012-ing.

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It is widely recognized that scientific and technological innovations are key to industrial and economic development of a country. Innovations, however, must be protected, usually through patent or copyright laws, before they can be marketed globally. Thus sensible patent laws, and their legal enforcement, are important for the advancement of economic and industrial development. Patent laws, as mentioned here, are complex and subjective, so that patent infringement cases are plentiful and often unpredictable. Given the rapid advancements of the science of genetics and biotechnology during the last 30 years, and the propensity to create intellectual property out of a bourgeoning field of science, many interesting cases have been decided in the courts of law or have been subjects of deliberations in the legislative bodies of individual countries. This article summarizes some of the interesting court cases involving genetics and biotechnology, mainly in the United States, and points to some of the differences between the judicial systems in Europe and in the United States, concerning both intellectual property laws and the concept of morality and public order, as well as their impacts on our society.
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50

Bergkamp, Lucas. "Proposals for International Environmental Liability in Respect of Waste and Biotechnology Products." European Energy and Environmental Law Review 8, Issue 12 (December 1, 1999): 324–27. http://dx.doi.org/10.54648/eelr1999050.

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An overview of the proposed Liability Protocol under the Basel Convention on Transboundary Movements of Hazardous Wastes and their Disposal, and of the proposed rules on liability pursuant to the UN Biodiversity Convention; a short evaluation of the proposals - whether the problem is serious enough to warrant legislative intervention, balancing costs and incentives; conclusion that the proposals would require that the polluter pay twice, and need to be seriously reconsidered with a view to avoiding "overly ambitious, inefficient" schemes.
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