Relevant bibliographies by topics / Pharmaceutical biotechnology – Law and legislation

Academic literature on the topic 'Pharmaceutical biotechnology – Law and legislation'

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Published: 10 March 2023

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Journal articles on the topic "Pharmaceutical biotechnology – Law and legislation"

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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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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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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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Albolino, Sara, Tommaso Bellandi, Simone Cappelletti, Marco Di Paolo, Vittorio Fineschi, Paola Frati, Caterina Offidani, Michela Tanzini, Riccardo Tartaglia, and Emanuela Turillazzi. "New Rules on Patient’s Safety and Professional Liability for the Italian Health Service." Current Pharmaceutical Biotechnology 20, no. 8 (August 28, 2019): 615–24. http://dx.doi.org/10.2174/1389201020666190408094016.

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Background:The phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems.Methods:Over the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy. The failures of the liability system and the high cost of healthcare have led to considerable legislative activity concerning medical malpractice liability, and a law was enacted in 2012 (Law no. 189/2012), known as the “Balduzzi Law”.Results:The law tackles the mounting concern over litigation related to medical malpractice and calls for Italian physicians to follow guidelines. Briefly, the law provided for the decriminalisation of simple negligence of a physician on condition that he/she followed the guidelines and “good medical practice” while carrying out his/her duties, whilst the obligation for compensation, as defined by the Italian Civil Code, remained. Judges had to consider that the physician followed the provisions of the guidelines but nevertheless caused injury to the patient.Conclusion:However, since the emission of the law, thorny questions remain which have attracted renewed interest and criticism both in the Italian courts and legal literature. Since then, several bills have been presented on the topic and these have been merged into a single text entitled “Regulations for healthcare and patient safety and for the professional responsibility of healthcare providers”.
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SEREBRENNIKOVA, ANNA. "PHARMACEUTICAL LAW: CRIMINAL ASPECTS." Gaps in Russian Legislation 14, no. 6 (November 20, 2021): 203–9. http://dx.doi.org/10.33693/2072-3164-2021-14-6-203-209.

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The author, considering the possibility of the emergence of a new branch of law in the future - pharmaceutical law, focuses on the complexity of regulating the sphere of turnover of medicines, at the same time pointing to this as the main reason for the uncertainty of the legislator in matters of the correctness of the choice of the object and subject of legal regulation. The author, citing examples from practice, draws attention to the fact that pharmaceutical activity is gradually becoming the object of regulatory regulation of various legal institutions, where the turnover of medicines, as well as medicines and other products containing raw materials of a medicinal nature, can be subject not only to the rules of civil turnover, as well as other special acts, but also to the norms of criminal law. The purpose of the study: To analyze the criminal legislation of the Russian Federation, including articles of the Criminal Code that establish responsibility for crimes in the field of pharmaceutical criminal law. Methodology and methods: the article uses both general scientific methods of analysis, synthesis, deduction, induction, and the method of interpretation of legal norms, which together make it possible to more effectively analyze the institutions of criminal law and determine the directions of development of the norms of pharmaceutical criminal law. Conclusions: as a result of the study, the author consistently substantiated the conclusion that the scope of application of criminal legislation in the control of pharmaceutical activities is expanding, at the same time, frequent violation of established prohibitions and regulations in the turnover of medicines suggests that the dialectical component of this issue is in an active phase of development, which indicates the inevitability (regularity and expediency) of the separation of a group of norms into a relatively autonomous group, which may be called pharmaceutical criminal law.
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Malinowski, Michael J. "Pharmaceutical Medicine, Biotechnology and European Law." Journal of Legal Medicine 23, no. 1 (March 2002): 159–66. http://dx.doi.org/10.1080/019476402317276722.

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Noguera Peña, Alfonso, and Carlos del Castillo Rodríguez. "Pharmaceutical Law and Pharmaceutical Legislation in Spain and in the European Union: Concept, Evolution and Sources." Anales de la Real Academia Nacional de Farmacia 87, no. 87(03) (2021): 275–322. http://dx.doi.org/10.53519/analesranf.2021.87.03.06.

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Medicines and the professional activity of the pharmacists are the subject of study of Pharmaceutical Law and Pharmaceutical Legislation. In this paper, on the one hand, the definition of these disciplines is examined, as well as their field of study, evolution and sources. On the other hand, the development of Pharmaceutical Legislation in the European Union is analysed in three clearly differentiated periods and related to different juridic enactments of generations of norms that affect medicines. Special attention has been paid to the so–called third generation standards, as the regulatory developments at European Union level and national level have been depened in the last three decades. Finally, those areas of the pharmaceutical sector that could have a regulatory development in the coming years are detailed.
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van Wyk, Christa. "Book Review: Pharmaceutical Medicine, Biotechnology, and European Law." Maastricht Journal of European and Comparative Law 8, no. 4 (December 2001): 397–405. http://dx.doi.org/10.1177/1023263x0100800404.

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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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Brosch, Sabine, and Alessandro Spina. "International Conference on Harmonisation and Standardisation Initiatives in the Pharmaceutical Domain." European Journal of Risk Regulation 1, no. 3 (September 2010): 274–76. http://dx.doi.org/10.1017/s1867299x00000477.

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This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.
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Dissertations / Theses on the topic "Pharmaceutical biotechnology – Law and legislation"

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Babin, Dominique. "The Canadian pharmaceutical patent regime in the world trading system /." Thesis, McGill University, 1999. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=29957.

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In 1994, the members of the World Trade Organisation (WTO) adopted the Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPs Agreement") and thus committed themselves to respect certain standards for intellectual property protection. This thesis studies the scope of the standards for patent protection and their impact upon trade in medicines. The first part addresses the international dimension of the issue and explains how international trade in medicines can contribute to enhancing the level of global welfare. The first chapter argues that in order to fulfil this latter objective legislation relating to patents must be adapted to the economic and social situation of countries. The second chapter demonstrates that such adaptation is not only allowed, but is indeed encouraged by the provisions of the TRIPS Agreement. The second part of this thesis addresses the issue from a Canadian perspective, and discusses the way Canadian patent provisions applying to pharmaceuticals should be drafted so as to allow Canada to participate in---and to benefit from---international trade in medicines. Thus, I first analyse the factual, political, and legislative factors that influence the Canadian pharmaceutical industry. I then study the role of Canada as part of the integrated market for medicines, as well as the social, industrial and economic objectives underlying Canadian policies. I finally propose some modifications and adaptations to the Canadian Patent Act and suggest some orientations for future multilateral negotiations.
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Vazquez, Toro Guillermo J. "Patent Quality And Company Performance| A Sample within the USA Biotechnology and Pharmaceutical Industry." Thesis, Inter-American University of Puerto Rico (Puerto Rico), 2014. http://pqdtopen.proquest.com/#viewpdf?dispub=3577982.

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This Dissertation investigates the relationship between patent quality and company performance for a sample from the US Biotechnology and Pharmaceutical Industry. The methodology devised comprehensively examines patent worth (patent’s references), patent protection (claims and family patents) and patent quality (references, claims and family patents) to determine their implications on firm leverage (SE, TA), profits (ROE, ROA), and market value (B/M, MCap). The selected sample comprises 1,536 companies, and 285,000 patents from 1999 to 2009. The results show that total revenue just responds to changes in R&D; intensity, and patenting intensity. A 10 percent increase in patent value results in a corresponding increase rate on the market capitalization index for the full sample and a 14 percent increase for the chemicals and allied products group (SIC 28). Increases (10%) in patent protection and quality present average increases of 15 percent on market capitalization for the full sample and 8 percent for the chemicals and allied products group (SIC 28). The medical devices group (SIC 38) results suggest that Mcap increases 10 percent by the same increase in patent value index. Patent protection and quality increases (10%) suggest an average 8 percent increase in Mcap. Results suggest that profits, leverage and market indices respond differently to 10 percent increases in patent value, patent protections and patent quality. The aforementioned effects suggest that the qualitative indexes follow company related market activities and business valuations for the chemical and allied products, and medical devices industrial sectors.

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Stoddard, Damon. "A new Canadian intellectual property right : the protection of data submitted for marketing approval of pharmaceutical drugs." Thesis, McGill University, 2006. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=101828.

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In order to market and sell a new pharmaceutical drug in Canada, the Minister of Health requires the initial applicant to submit clinical test results demonstrating that the drug is safe and effective for human use. Subsequent applicants, who typically lack the resources to conduct expensive clinical trials, must refer to and rely upon the initial applicant's data in their applications to market a generic version of the drug.
On June 17, 2006, the federal government of Canada published a proposed data protection regulation, which would provide an initial applicant with eight years of protection for clinical test results submitted in a new drug submission. This protection would lead to an eight year period of market exclusivity for the drug associated with the clinical test data, regardless of whether that drug was protected by a Canadian patent.
In this thesis, the author first describes what data protection is on a practical level, and distinguishes data protection from other forms of intellectual property rights. Next, the author discusses how various jurisdictions choose to protect clinical test data submitted to their health authorities. Canada's international obligations pursuant to the NAFTA and the TRIPS Agreement are also examined. In this regard, the author argues that Canada is under no obligation to provide initial applicants with eight years of data protection. Furthermore, the author argues that exclusive time-limited property rights in clinical test data are difficult to justify from a theoretical perspective. Finally, the author prescribes certain legislative changes to Canada's proposed data protection regulation.
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Ludlow, Karinne Anne. "Which little piggy to market? : legal challenges to the commercialisation of agricultural genetically modified organisms in Australia." Monash University, Faculty of Law, 2004. http://arrow.monash.edu.au/hdl/1959.1/5489.

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Griffiths, Robert Ian. "Industrial drug development : application of the theoretical framework of Abernathy, Clark, and Kantrow (1983) in an analysis of factors which determine productivity /." Thesis, This resource online, 1988. http://scholar.lib.vt.edu/theses/available/etd-04122010-083717/.

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Zeitoun, Suzanna. "Are legislators able to meet efficiency goals? : an analysis of the pharmaceutical industry." Thesis, Linköping University, Department of Management and Economics, 2004. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-2443.

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During the last decades, legislators have tried to meet the goal of increased R&D in the pharmaceutical industry through an extension of the patent length. In parallel, an attempt to minimise ex post social costs has been made through the introduction of a shortened drug approval process for generic drugs as well as a so-called Bolar provision, giving generic producers earlier access to patented information. However, one can ask how efficient a patent extension possibility has been to meet the goal of increased R&D. Correspondingly, what effects on social costs can we expect from the introduction of an abbreviated approval process and the Bolar provision? These are questions that are dealt with in this thesis. I argue that the impact of the legislative changes have led to a decrease of ex post social cost. However, I will also show that this has lead to a detriment of ex ante R&D incentives and therefore a negative result on social welfare.

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Letsitsi, Ezekiel Tebogo. "Waste management in the pharmaceutical industry : an evaluation report of Dr Reddy's Laboratories." Thesis, Rhodes University, 2013. http://hdl.handle.net/10962/d1001872.

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The pharmaceutical industry must worry about managing pharmaceutical waste as it poses a health risk to human beings and its presence in the environment can also contribute to loss of biodiversity. Ngwuluka, Ochekpe, and Odumosu (2011: 11259) state that “Pharmaceuticals, though used to treat and manage diseases, are poisons, which justify the growing concerns about their presence in the environment.” Various forms of pharmaceutical waste exist, Ngwuluka et al. (2011) identified the following forms of pharmaceutical waste: Expired dosage forms, non-reworkable formulations, spilled pharmaceuticals, rejected active pharmaceutical ingredients, expired active pharmaceutical ingredients, and wastewater resulting from the water used for process operations during manufacturing and could come from the water used to clean equipment, pipes and floors, and would contain amongst other materials, chemicals and active pharmaceutical ingredients (APIs). A review on the pharmaceutical industry and the progress they have made in environmental management by generating health, safety and environmental programs, preventing pollution, waste minimization, recycling and reusing materials, investing in projects and facilities to ensure environmental sustainability have been established (Berry & Rondinelli, 2000). Dr. Reddy’s Laboratories is an Indian based pharmaceutical company which imports, markets and sells medicines in South Africa. Dr. Reddy’s has plans to set up a manufacturing plant in South Africa. The purpose of this study is to research waste management practices at Dr. Reddy’s plant in India and to draw parallels between India’s and South Africa’s waste legislation. This is to enable Dr. Reddy’s to review all aspects of its waste management systems, in order to revise where necessary and to improve the overall achievement of its waste management objectives in order to become a more sustainable organisation and to meet South African Waste legislation before setting up a plant in South Africa. 3 ii. Objective of the Evaluation Report The purpose of this research is to evaluate and analyse the development and implementation of a waste management system in a pharmaceutical company, specifically Dr. Reddy’s Laboratories. This is primarily to enable the company to review and analyse all aspects of waste management pertaining to pharmaceutical manufacturing and to revise or improve where necessary to ensure adherence to waste regulations as outlined by government. The following research goals have been also been identified:  To identify and describe waste management practices at Dr. Reddy’s Laboratories, on the inherent assumption by the researcher that the company has a successful waste management strategy that would need to be reviewed to identify areas of improvement before expanding manufacturing facilities into South Africa.  To evaluate, assess and compare similarities and/or differences between the identified South African Legislation for Waste Management with those identified during research conducted at Dr. Reddy’s iii. Importance of the Research Conducted Waste Management is important in that it not only removes from the environment, substances that can be harmful to humans and animals but it also enables an organisation to be more sustainable. According to Seadon (2010: i) “Integrated waste management is considered from a systems’ approach, with a particular emphasis on advancing sustainability”. The study will provide guidance to senior management, shop floor managers and employees who work in Dr. Reddy’s manufacturing plants as well as overall employees at Dr. Reddy’s on how to successfully implement a Waste Management programme to enhance sustainability at the organisation and realise the benefits to the organisation of being more sustainable. Weybrecht (2010) identified the following benefits that companies could gain by adopting sustainable waste management practices: reduced costs, resource preservation, keeping up with legislation, enhanced reputation, business differentiation from competitors, and attraction and retention of quality employees, and customer need satisfaction amongst many other benefits. This research needs to address the gap in analysing waste management practices (with more emphasis on waste treatment, waste minimisation, re-use, recycling and disposal), and implementation and understanding of waste management in the pharmaceutical industry as prior research was done mostly in other chemical industries and not to a large scale in the pharmaceutical industry. South African Waste Legislation, Indian Waste Legislation (as Dr. Reddy’s is based in India), as well as International Pharmaceutical Waste Management Guidelines, and International Pharmaceutical Good Manufacturing Practices provide a framework and benchmark of leading pharmaceutical waste management practices that can guide Dr. Reddy’s Laboratories’ leadership into integrating their waste management practices into their plans of setting up a manufacturing plant in South Africa. 5. Research Methodology This is evaluation research in the form of a case study and the data collection method employed is the conduction of a survey through questionnaires. The evaluation research also involves a document analysis of the organisation’s 2011 and 2012 annual reports, Dr. Reddy’s 2010 Sustainability Report as well as literature compiled by the organisation’s Corporate Communications Division. The research would also include review of existing literature on waste management. v. Structure of Dissertation This dissertation consists of three sections. Section 1: The Evaluation Report The section introduces the research area, provides the objectives of the research, provides contextual background information and describes the rationale for conducting the research. This section further describes Dr. Reddy’s waste management practice as outlined in relevant company documentation; it is also intended to highlight the specific waste management processes that were followed in the formulation and implementation of the waste management strategy. This section further describes the sample and presents the results of the survey, where the results are collated and reviewed in the context of the criteria set in the South African Waste Legislation, Indian Waste Legislation, as well as in International Pharmaceutical Waste Management Guidelines, and International Pharmaceutical Good Manufacturing Practices. The overall findings of this case study suggest that although management at Dr. Reddy’s are satisfied with waste management practices and results achieved at it manufacturing plant, there is however dissatisfaction amongst employees who believe the organisation has not successfully disseminated information and sufficiently trained them on waste management policies, processes and practices. There is therefore a desire amongst employees to be trained and to see the company improve on its waste management processes, this desire is a very important attribute as it indicates that employees at Dr. Reddy understand and are committed to the importance of waste management. Future research should be conducted to measure the legal impact of non-compliance to legislation governing waste management in the pharmaceutical company. Section 2: Literature Review The objective of the literature review is to provide a critical assessment and evaluation of previous research in the field of waste management in general as prior research was done mostly in other industries and not to a large scale in the pharmaceutical industry. The literature review evaluates the key elements of an effective waste management strategy implementation and is followed by a review of literature pertaining to the description of Pharmaceutical waste. Section 3: Research Methodology This section presents a description of how the work in this research was conducted. It presents the research process followed in compiling this case study, represented by the aims and objectives, research methodology and design, data collection techniques and data analysis.
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蘇柏昇. "澳門藥事法規修訂及其對公立醫院藥品供應的影響研究." Thesis, University of Macau, 2010. http://umaclib3.umac.mo/record=b2454949.

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Périé-Frey, Sarah. "Essai sur l'émergence d'un régime juridique autonome du médicament : entre bien public et bien marchand : Regards croisés en droit interne et en droit de l'Union européenne." Thesis, Perpignan, 2017. http://www.theses.fr/2017PERP0006/document.

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Comme tout corps de règles naissant et se constituant progressivement en système juridique spécifique, les règles applicables au médicament se nourrissent des régimes juridiques externes préexistants que ceux-ci relèvent du droit public ou du droit privé. Dans les systèmes juridiques reconnus, les emprunts faits, une logique d'appropriation se met en place qui aboutit à la transformation et la spécialisation de la règle empruntée à l'objet ou la situation spécifiquement abordée. Les règles applicables au médicament parviennent-elles effectivement, suivant ce processus classique, à s'approprier les règles et principes des régimes juridiques préexistants. Un système juridique ne pouvant résulter que du sens qui lui est donné. Ainsi, pour qu'il y ait système, les normes constitutives de celui-ci doivent exprimer un objet et un but uniques. La question se pose donc de l'unité des règles applicables au médicament. Ce n'est qu'alors que l'existence d'un système juridique peut être avérée
Like any set of regulations, which derives its origins from a specific legal system, the regulations for medication is based on an external, pre-existing judicial system of public and private law. Copying the approved judicial system results automatically in recognition, that - depending on the topic - entails a specific change or specification of the borrowed rule.Should the applicable regulations for medication follow the classic process and acquire the principles of the pre-existing judicial system? A judicial system can only follow one principle. Therefore, the constitutive norms of a judicial system must provide a unified objective. The question therefore arises, if the applicable regulations for medication follows this uniformity. These can only be secured by a judicial system
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Msomi, Zuziwe Nokwanda. "The protection of indigenous knowledge within the current intellectual property rights regime: a critical assessment focusing upon the Masakhane Pelargonium case." Thesis, Rhodes University, 2013. http://hdl.handle.net/10962/d1007744.

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The use of indigenous knowledge (IK) and indigenous bio-resources by pharmaceutical and herbal industries has led to concerns about the need to protect IK in order to prevent biopiracy and the misappropriation of indigenous knowledge and resources. While some commentators believe that intellectual property rights (IPR) law can effectively protect IK, others are more sceptical. In order to contribute to the growing debate on this issue, this study uses the relatively new and as yet largely critically unanalysed Masakhane Pelargonium case to address the question of whether or not IPR law can be used to effectively protect IK. It is argued here that discussion about the protection of IK is a matter that must be located within broader discussions about North-South relations and the continued struggle for economic and political freedom by indigenous people and their states. The Masakhane case suggests that IPR law in its current form cannot provide sufficient protection of IK on its own. Incompatibilities between IPR law and IK necessitate that certain factors, most important of which are land, organised representation, and what are referred as 'confidence and network resources', be present in order for IPR law to be used with any degree of success. The study also reveals various factors that undermine the possibility of using IPR law to protect IK. In particular, the study highlights the way in which local political tensions can undermine the ability of communities to effectively use IPR law to protect their knowledge. The thesis concludes with several recommendations that will enable indigenous communities and their states to benefit more substantially from the commercialisation of their bio-resources and associated IK.
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Books on the topic "Pharmaceutical biotechnology – Law and legislation"

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Cook, T. M. Pharmaceuticals, biotechnology & the law. Basingstoke: Macmillan, 1991.

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Pharmaceutical, biotechnology, and chemical inventions: World protection and exploitation. Oxford: Oxford University Press, 2011.

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Patent law in biotechnology, chemicals & pharmaceuticals. 2nd ed. New York, N.Y., USA: Stockton, 1994.

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Wegner, Harold C. Patent law in biotechnology, chemicals & pharmaceuticals. New York, N.Y., USA: Stockton Press, 1992.

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Barr, David K., and Daniel L. Reisner. Developments in pharmaceutical and biotech patent law 2013. New York, N.Y: Practising Law Institute, 2013.

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1942-, Chiu Yuan-yuan H., and Gueriguian John L, eds. Scientific and regulatory aspects of drug biotechnology. New York: M. Dekker, 1991.

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H, Chiu Yuan-yuan, and Gueriguian John L, eds. Drug biotechnology regulation: Scientific basis and practices. New York: M. Dekker, 1991.

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Barr, David K., and Daniel L. Reisner. Developments in pharmaceutical and biotech patent law 2010. New York, N.Y: Practising Law Institute, 2010.

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Barr, David K., and Daniel L. Reisner. Developments in pharmaceutical and biotech patent law 2012. New York, N.Y: Practising Law Institute, 2012.

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Barr, David K., and Daniel L. Reisner. Developments in pharmaceutical and biotech patent law 2009. New York, N.Y: Practising Law Institute, 2009.

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Book chapters on the topic "Pharmaceutical biotechnology – Law and legislation"

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"Table of treaties, European legislative instruments and national legislation." In Pharmaceutical Medicine, Biotechnology and European Law, xxvii—xxxvi. Cambridge University Press, 2001. http://dx.doi.org/10.1017/cbo9780511560125.004.

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Grubb, Philip W., Peter R. Thomsen, Tom Hoxie, and Gordon Wright. "Patents and Competition Law—United Kingdom and European Union." In Patents for Chemicals, Pharmaceuticals, and Biotechnology. Oxford University Press, 2016. http://dx.doi.org/10.1093/oso/9780199684731.003.0029.

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This chapter focuses on competition law in the UK and EU. Most countries, as well as the EU, have developed a body of competition law to provide countermeasures against what are regarded as abuses of monopoly by patentees. Abuse of monopoly is the use of a patent simply to exclude others, while not working the invention oneself. Provisions of the Paris Convention enable compulsory licences to be granted if the patent is not worked within a certain time. In the UK, they may also be granted if the patentee is preventing the working of a dependent patent by refusing to grant a licence. In the EU, competition law for the internal common market is within the exclusive competence of EU institutions; the national governments of member states only assist these institutions when it comes to implementation of the legislation. The remainder of the chapter explains EU patent licence agreements.
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Lima de Magalhães, Jorge, Marcus Vinicius Santos do Carmo, and Zulmira Hartz. "Knowledge Management in Biotechnology Drugs in Brazil as a Case Study of the National Pharmaceuticals Laboratories." In Biotechnology, 1477–96. IGI Global, 2019. http://dx.doi.org/10.4018/978-1-5225-8903-7.ch061.

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The informational age in the twenty-first century is also known as the age of knowledge. The great differential of organizations has been the strategic innovation through the best way to manage the existing knowledge. The pharmaceutical area is one of the most intensive areas in research, development, and innovation. In this century, the discovery of new drugs and biotechnology drugs has revolutionized several treatments for human health. It is estimated that in 2017 the medical prescriptions of biotech drugs will exceed US $220 billion. It was identified that by the year 2019, several biotechnological patents will be expired in the world. New structures and strategic innovations in the scientific and technological environment of the Brazilian pharmaceutical area have occurred. There is a boom in investment opportunities in the industry through strategic innovation fostered by the updating of Brazilian legislation and investments by private companies. Knowledge management in biotechnological drugs has favored scientific, technological, and market growth in Brazilian organizations.
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Goldberg, Richard, and Julian Lonbay. "Preface." In Pharmaceutical Medicine, Biotechnology and European Law, xi—xii. Cambridge University Press, 2001. http://dx.doi.org/10.1017/cbo9780511560125.001.

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Jacobs, Francis G. "Foreword by Francis G. Jacobs." In Pharmaceutical Medicine, Biotechnology and European Law, xiii—xiv. Cambridge University Press, 2001. http://dx.doi.org/10.1017/cbo9780511560125.002.

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"Editors' note." In Pharmaceutical Medicine, Biotechnology and European Law, xv. Cambridge University Press, 2001. http://dx.doi.org/10.1017/cbo9780511560125.003.

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Goldberg, Richard, and Julian Lonbay. "Introduction." In Pharmaceutical Medicine, Biotechnology and European Law, 1–8. Cambridge University Press, 2001. http://dx.doi.org/10.1017/cbo9780511560125.005.

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Cornish, W. R. "The free movement of goods I: pharmaceuticals, patents and parallel trade." In Pharmaceutical Medicine, Biotechnology and European Law, 11–24. Cambridge University Press, 2001. http://dx.doi.org/10.1017/cbo9780511560125.006.

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Isaac, Belinda. "The free movement of goods II: pharmaceuticals, trade marks and parallel imports." In Pharmaceutical Medicine, Biotechnology and European Law, 25–44. Cambridge University Press, 2001. http://dx.doi.org/10.1017/cbo9780511560125.007.

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Lonbay, Julian. "The free movement of health care professionals in the European Community." In Pharmaceutical Medicine, Biotechnology and European Law, 45–75. Cambridge University Press, 2001. http://dx.doi.org/10.1017/cbo9780511560125.008.

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Conference papers on the topic "Pharmaceutical biotechnology – Law and legislation"

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Erimia, Cristina-Luiza. "FALSIFIED MEDICINES � A PROBLEM OF REGULATING THE PHARMACEUTICAL LEGISLATION BY STANDARDIZING THE EUROPEAN LAW." In 2nd International Multidisciplinary Scientific Conference on Social Sciences and Arts SGEM2015. Stef92 Technology, 2015. http://dx.doi.org/10.5593/sgemsocial2015/b21/s5.072.

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Sovova, Olga. "ERA OF DIGITIZATION: RE-DESIGNING PRIVACY PROTECTION IN HEALTH CARE." In NORDSCI International Conference Proceedings. Saima Consult Ltd, 2019. http://dx.doi.org/10.32008/nordsci2019/b2/v2/31.

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The paper examines the issue arising when delivering healthcare in the modern information society. Throughout the past decade, the Internet has seen a significant rise of the "Web 2.0" trend, which carried on its wings a health industry trend often referred to as "Health 2.0" or "Medicine 2.0". More recently, we have also witnessed the crowning of concepts such as Health Social Media, eHealth and mHealth. European Union as well as the national states develop strategies implementing new technologies for personal and medical data sharing, including the prescription of medicals as well as their validation through websites. Healthcare data privacy and security is one of the top challenges, healthcare providers face. The huge amount of data the medical care generates holds potential for researchers, providers, pharmaceutical companies as well as for doctors, who can use it to improve care or find new treatments and insights into disease. The key issue to examine is how to balance the competing interests of privacy and data-sharing and not exclude the patient as a holder and owner of the information. The paper addresses the issue of privacy protection in digitized healthcare, using the analysis of the legislation and case-law of the Czech Republic, stressing the demands for human rights and privacy protection of a member state of the European Union. The paper introduces several proposals for providers on how to re-design digital healthcare with respect to laws and patients´ rights. The paper concludes that even modern and digitized medicine is based not only on evidence and modern technologies but also on human interaction and face-to-face approach and trust between the doctor and patient.
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