Thèses sur le sujet « Pharmaceutical biotechnology – Law and legislation »

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.

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.

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.

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.

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.

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

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.

Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, Technology and Policy Program, 2004.
Includes bibliographical references (p. 59-61).
Published findings report that it takes approximately eight years to bring a novel drug to market at an average cost of $800 million. Over the last ten years, the Food and Drug Administration (FDA) has helped to reduce the time from filing a new drug application (NDA) to granting marketing approval (i.e. the approval phase). However, there has been no alteration in the time required to progress from an investigational new drug application (IND) to an NDA filing (i.e. the clinical phase) over this same period. Since approval times began to decrease upon the initiation of the Prescription Drug User Fee Act (PDUFA), in this thesis I analyze the impact of PDUFA and calculate its benefits to companies. Due to the importance of getting new drugs to the market faster, I also investigate why there has been no significant change in the time required to test a drug clinically, and attempt to identify steps that could be taken to improve the clinical trial process. To investigate this, I evaluated ways in which the FDA and industry can work together to reduce clinical development times, without compromising safety. The results from this study show that PDUFA has had a significant impact on reducing approval times. More importantly, I determined that the direct costs of PDUFA are small in irmlparison to its benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug development has revealed potential steps both the FDA and industry can take to facilitate a more efficient process for assessing the safety and efficacy of drugs. Thus, this study represents an important step towards improving the development of medicines for the world.
by Matthew W. Strobeck.
S.M.

Un niveau élevé de protection de la santé humaine est assuré dans la définition et la mise en oeuvre de toutes les politiques et actions de l’Union européenne. L’une des politiques les plus importantes, conformément aux enjeux de santé et au développement économique, est celle des médicaments. Leur sécurité est garantie par un cadre juridique donné par une législation pharmaceutique d’envergure présidant à l’octroi de l’autorisation de mise sur le marché et au suivi post-autorisation. Ce cadre juridique est supporté par un dispositif institutionnel d’exception, caractérisé par une interaction étroite entre l’Agence européenne des médicaments, la Commission européenne et les autorités nationales compétentes. Il a récemment été réformé à travers la nouvelle législation de pharmacovigilance. Le concept de sécurité sanitaire est ainsi devenu le principe directeur de la gestion du risque pharmaceutique. Toutefois, lorsque le risque inhérent à tout produit pharmaceutique se manifeste, le dommage médicamenteux se produit ainsi que la demande de réparation. Face à la nécessité d’indemniser les victimes de tels accidents, les réponses nationales des systèmes juridiques français et italien, par les biais de la responsabilité civile de droit commun et de la responsabilité du fait des produits défectueux issue de la directive 85/374/CEE, se révèlent inefficaces, car peu respectueuses de la spécificité du médicament. Ce constat conduit à plaider en faveur d’une dissociation entre responsabilité et indemnisation, en garantissant cette dernière à travers la création d’un fonds d’indemnisation général pour les dommages médicamenteux à participation mixte public-privé. Cette solution garantit une socialisation des risques justifiée par le caractère social du risque thérapeutique. Cela constitue le contrepoids aux dangers inhérents aux innovations de la science, tout en faisant profiter les malades des bénéfices thérapeutiques de demain. En prônant une approche holistique de la politique du médicament, la proposition de ce fonds constitue un instrument d’une politique de santé publique qui ne voit dans l’indemnisation des risques médicamenteux qu’un complément et un prolongement de la garantie de sécurité à la base de la législation pharmaceutique européenne
The definition and implementation of the European Union’s policies and activities guarantee a very high level of human health protection. One of its most important policies, in accordance with the relative health and economic development issues, is that on medicinal products. Drug safety is guaranteed by a legal framework, constructed on the pharmaceutical legislation laying down rules and procedures for obtaining marketing authorisation and for post authorisation monitoring. This legal framework is supported by a special institutional system,which in particular ensures close interaction between the European Medicines Agency, the European Commission and the national competent authorities. This legal framework has recently been revised as a result of the new pharmacovigilance legislation. As such, health safety has become a key directive in managing pharmaceutical risk. Yet, whenever a risk relating directly to a particular pharmaceutical product becomes apparent, medical damages and compensation claims arise. The response of the national French and Italian legal systems to the application for compensation of the victims of such accidents, by way of the ordinary rules of civil liability and the liability for defective products as defined in Council Directive85/374/EEC, has proven ineffective: they fail to take into account the specific nature ofpharmaceutical products. Based on this observation, there is a sound case for separating liability from compensation: the latter can be guaranteed by setting up a general compensationfund for medical damages, with both public and private sector participation. This solutionwould guarantee a socialisation of risks that is justified by the social nature of therapeutic risk. It would provide a counterbalance to the dangers inherent in scientific innovation, whilst simultaneously allowing patients to benefit from future therapeutic developments. By advocating a holistic approach to drug policy, this proposed compensation fund would act as apublic health policy instrument, in the context of which compensation for medical risks would only be considered an addition to, and extension of, the security guarantee that constitutes the cornerstone of the European pharmaceutical legislation

Defence date: 26 September 2005
Examining board: Prof. Hans Ullrich (Supervisor, European University Institute) ; Prof. Christian Joerges (Co-Supervisor, European University Institute) ; Prof. David Vaver (Oxford University) ; Prof. Bernand Remiche (Université Catholique de Louvain)
PDF of thesis uploaded from the Library digitised archive of EUI PhD theses completed between 2013 and 2017
Using the example of research tools in biopharmaceutical research and innovation, this book examines the complexities of the relationship two fundamental areas of law and policy - intellectual property rights and competition law. It addresses a question that is certain to become paramount in other industries also: how to strike the balance between initial and follow-on innovation so as to ensure that access to 'essential' research tools (or other fundamental elements to follow-on innovation) is not impeded.The book concludes by suggesting how competition law could be used to complement the patent balance. "Competition Law and Patents" caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself.

During the last two decades, there have been a number of policy and legislative changes in respect of South Africa’s intellectual property (IP) and the national system of innovation (NSI). In 2012, a Ministerial Review of the Science, Technology and Innovation (STI) landscape in South Africa made recommendations to improve the STI landscape and effectively the national system of innovation. The study provides a critical review of drafts of the national IP policy published in 2013 as well as the IP Framework released in 2016 for public comment. The review of the IP and the NSI are within the context of the National Development Plan (NDP), which outlines South Africa’s desired developmental goals. South Africa is part of the BRICS group of countries (Brazil, Russia, India, China and South Africa). The South African economy is characterised by a desire to move away from being dependent on resources and commodities, to becoming a more knowledge based and innovation driven economy. It is hoped that such a move would assist the country to address some of the social and economic development challenges facing South Africa, as captured in the NDP. South Africa has a functioning IP system, but its relationship with South Africa’s development trajectory is not established. More particularly, the extent to which the IP system relates to the innovation system and how these two systems must be aligned to enable South Africa to transition successfully from a country based on the production of primary resources and associated commodity-based industries to a viable knowledge-based economy is unclear. The Trade-related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organisation (WTO) provides that IP must contribute to innovation and to transfer of technology and knowledge in a manner that is conducive to social and economic welfare. Certain provisions set out the foundations of intellectual property systems within the context of each member state. This study has thus explored the complex, complementary and sometimes contested relationships between IP and innovation, with particular emphasis on the potential of an intellectual property system to stimulate innovation and foster social and economic development. The study has also analysed the interconnectivity of IP and innovation with other WTO legal instruments, taking into account South Africa’s positioning within the globalised economy and in particular the BRICS group of countries. The research involved a critical review of South Africa’s IP and innovation policies, as well as relevant legislation, instruments, infrastructure, IP and innovation landscape, and relationship with international WTO legal instruments, in addition to its performance, given the developmental priorities and the globalised economy. The research documents patenting trends by South Africans using European Patent Office (EPO), Patent Cooperation Treaty (PCT), United States Patents and Trademarks Office (USPTO) databases over the period 1996-2015. A comparative analysis of patenting trends amongst BRICS group of countries has also been documented. The study also documents new findings, observations and insights regarding South Africa’s IP and innovation systems. Some of these, particularly in relation to higher education and research institutions, are directly attributable to the Intellectual Property Rights from Publicly Financed Research and Development Act. More particularly, the public institutions are becoming relevant players in the NSI and are responsible for growth of certain technology clusters, in particular, biotechnology. At the same time, the study makes findings of a decline of private sector participation in patenting as well as R&D investment over the 20-year period. Recommendations are included regarding specific interventions to ensure coherence between the IP and innovation systems. Such coherence and alignment should strengthen the systems’ ability to stimulate innovation and foster inclusive development and competitiveness, which are relevant for addressing South Africa’s socio-economic development priorities.
Mercantile Law
LL. D.

Patent law creates economic incentives for individuals and companies to invest in research and development, as well as to disclose publicly and commercialize new inventions. In creating these incentives, patents also impose costs on society through reduced access to new inventions. Generally, the benefits of the patent system outweigh the costs, but in new and rapidly developing industries the patent system itself can act as a barrier to the development of new technologies. This is of particular concern in the biotechnology industry where a proliferation of patents on basic and fundamental research tools risks hindering further innovation. This problem was first noted by US academics where patent rights are generally considered absolute. In contrast to the US, there are mechanisms already in place within the Canadian patent system that can be used to balance the public interest in access to technologies with the private interest promoted by patents. Two such mechanisms are studied in depth and compared: experimental use and compulsory licensing. Current conceptions of the experimental use exception to patent infringement are inadequate to deal with abuses found when research tools are patented and an expanded experimental use exception is therefore proposed to address the deficiencies found in the current law. In comparison, existing compulsory licensing provisions within the Competition and Patent Acts are generally sufficient to ensure access to needed research tools. The essential facilities doctrine developed through US antitrust laws provides assistance in determining when such compulsory licences should be granted. Compulsory licensing has certain advantages over an expanded experimental use exception: it would only be used for tools where there are no reasonable alternatives available to the scientist; and it is more likely to be compliant with Canada's international obligations. Ultimately, however, an expanded experimental use exception is preferred since it more quickly and easily puts the tools required for research into the hands of the scientists.
Law, Peter A. Allard School of
Graduate

碩士
國立臺灣大學
事業經營法務碩士在職學位學程
106
The scale of enterprises in biotechnology and pharmaceutical industries in Taiwan is too small to have competitiveness in the world. As a result, the government intends to promote cooperation and strengthen the alliance in the industries as its industrial policy, in particularly, to create a “national champion”. As a popular strategy, mergers and acquisitions may improve enterprises’ performance and thus increase competitiveness in the international market. However, mergers and acquisitions may also cause the rearrangement of market structure, resulting in competition restraints. There may be a conflict between competition policy and industrial policy. Therefore, this study focuses on harmonizing the conflict thereof as well as to investigate the application of the organic law and completion law in the mergers and acquisitions activities in biotechnology and pharmaceutical industries in Taiwan. According to the Fair Trade Act, any merger which crosses a certain threshold shall be filed with the Fair Trade Commission (FTC) in advance. However, there are ambiguities in the Principles for the Treatment of Relevant Market Definitions issued by FTC, resulting in the failing of compliance with applicable laws and regulations by the enterprises of merger. There is also no published guideline for the relevant market definitions of pharmaceuticals. FTC may consider issuing the guideline so as to help enterprises in pharmaceutical industry to ensure compliance with applicable laws and regulations. The scale of enterprises in biotechnology and pharmaceutical industries in Taiwan at present is so small that any merger of enterprises may hardly crosses the defined threshold to file with FTC. However, the enterprises of merger may need to file with FTC in the future. Considering the synergy of mergers and acquisitions and the improvement of competitiveness in the world, there is a strong possibility that the overall economic benefit of merger outweighs the disadvantages resulted from competition restraint. Besides, the competition restraint in pharmaceuticals can be controlled owing to the drug pricing system of National Health Insurance in Taiwan. Therefore, FTC may not prohibit the mergers and keep lax in the merger control practice.

Award date: 22 November 2017
Supervisor: Professor Giovanni Sartor, European University Institute
Following the U.S. Supreme Court decisions in Mayo Collaborative Services v. Prometheus Labs. Inc. and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the future of patentability of genetic material is uncertain. In the U.S., the decision in Myriad which allowed the patenting of cDNA molecules seems to have limited the force of the concerned voices from the genomic research community that had called for substantial limitations on the patenting genetic material based on the argument that these patents seriously inhibit genomic research and prevent broader provision of genetic diagnostic tests to the public. In the EU, and in markets under the EPC, the patentability issue remain unclear due to lack of judicial guidance. This status quo coincides with the ambitions of governments in both sides of the Atlantic for incentivising research and investment in personalised medicine, a field that is dependent on genetic diagnostic tests and promises radical improvement in public healthcare provision, but also potentially lots of profit and tax. In the light of all these, this paper explores social, political and more particularly legal issues surrounding developments in genomic technologies and personalised medicine, and offers an extensive overview of the limits of substantive patent law in the patenting of genetic inventions in the U.S. and Europe. The paper concludes that the approach of the Biotechnology Directive under EU law setting an over-arching industrial applicability requirement for gene patents offers a balanced response to the challenges created by these patents. Other solutions such as widening the scope of compulsory licensing or the experimental use exception, or creating a sui generis gene right are also visited. Finally, new CRISPR technology that might further challenge the existing legal frameworks is briefly introduced.

Examining Board: Professor Giovanni Sartor, Institut Universitaire Européen (directeur de thèse); Professor Serge Gutwirth, Vrije Universiteit Brussel (codirecteur de thèse); Professor Yves Poullet, Université de Namur; Professor Loïc Azoulai, Institut Universitaire Européen.
Defence date: 12 December 2012
PDF of thesis uploaded from the Library digital archive of EUI PhD theses
Grâce au développement de technologies de plus en plus complexes susceptibles de s’immiscer dans l’organisme, corps et artéfacts semblent en passe de connaître un degré d’hybridation jamais atteint jusqu’alors. Certaines technologies prothétiques émergentes - comme les bio-implants ou les puces électroniques - sont incontestablement de nature à bouleverser nos représentations du corps humain, si ce n’est notre nature anthropologique elle-même. A ce titre, ces technologies sont à la source de nombreuses inquiétudes et nourrissent, dans le champ juridique et éthique, un très vif débat qui se situe principalement sur le versant politique de la réglementation et de la gouvernance. L’objectif de la présente étude est d’élargir le champ de l’investigation consacrée aux rapports entre droit et nouvelles technologies en portant l’attention sur la pratique juridictionnelle, afin de mettre en évidence les problèmes posés par l’hybridation à partir de litiges auxquels les cours et tribunaux ont déjà été confrontés. Ceux-ci étant souvent en première ligne lorsqu’une technologie inédite affecte l’une ou l’autre sphère d’activité humaine, il est alors possible d’observer comment le droit s’adapte au changement technologique. A partir de trois cas d’étude distincts, relevant du droit travail, du droit antidiscriminatoire et du droit du sport, nous montrons d’une part comment les juges résorbent les tensions résultant d’une pluralité des manières de saisir l’hybridation entre homme et artéfacts dans le chef des protagonistes du litige. D’autre part, ous mettons l’accent sur les dispositifs et moyens - qu’ils soient externes au droit (les axinomies, les mesures, les statistiques de la biomédecine) ou internes (les standards, les atégories, les critères) - qu’utilisent les protagonistes d’un litige, et en particulier le juge, orsqu’ils sont confrontés à l’irruption d’entités problématiques, comme l’est le corps hybride, ans des situations litigieuses. Cette approche pragmatique permet de faire apparaître la ingularité du travail réalisé par les juges pour concilier l’émancipation de la personne par la echnique et son intégration et sa participation à un ordre commun.

In partial fulfilment of the degree of MSc. Med (Bioethics & Health Law) Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand (Wits), Johannesburg June 2016
It is estimated that about two billion people, one-third of the world's population, lack regular access to essential medicines (Forman & Kohler 2012: 26). The situation is worst in Africa and South East Asia, where it is reported that about half the population do not have regular access to potentially life-saving drugs (Forman & Kohler 2012:26). A normative study was undertaken to probe whether legal duties to provide affordable medicines place or ought to place limitations on the exercise of pharmaceutical patents in developing countries. I have used the bioethics theory of justice and the jurisprudence on the right-to-health, enshrined in international human rights law, as my argumentative framework. Like other pro-health equity academics (Forman & Kohler 2012, Cameron 2005, Gostin 2014) I argue that the exorbitant prices charged by the multinational pharmaceutical industry for patented drugs are a barrier to equitable access to essential medicines for the world’s poor, most of whom live in developing countries. I concur with (Forman and Kohler 2012:1) that, “access to essential medicines (should be) authoritatively interpreted to constitute a minimum core entitlement under the human right to the highest attainable standard of health (the right-to-health), placing correlative duties on a range of actors to enable and ensure access." In addition, I posit that the interests of social justice ought to justify a partial infringement of private commercial interests in the public interest – to speed up regular and affordable access to essential medicines to all who need them. My argument proceeds as follows: Firstly, nation states bear the primary responsibility to meet right-to-health responsibilities as espoused in international human rights law and applicable African regional laws. Secondly, I argue that richer states (should) have joint legal and moral responsibilities to assist poorer nations to realize access to the "highest attainable standard of health" which is the legal entitlement of "every person" (WHO 1946, African Charter of Human Rights, 1981). I conclude by arguing that the multinational pharmaceutical industry ought to assume binding right-to-health human rights obligations, with nation states.
MT2016

This dissertation is the compilation of three separate works of research revolving around the theme of regulation of biomedical technologies that are either emerging or that have undergone significant developments over the past decade or so. Each of these three research works examines a legal response to a technological development in the areas of biotechnology and/or medicine and addresses one or more challenges - ethical, constitutional, legal or one that is related to public policy - created by that response. The first work of research, which was published in the Administrative Law Review in March 2008, examines the legality of the restrictions imposed by the administration of President George W. Bush on the funding of research involving human embryonic stem cells. Reaching the conclusion that the Bush Administration's actions were outright illegal in more than one way, the research highlights existing tensions in the division of decision-making power between the President and executive agencies and between Congress and the President. The second work of research, which was published in the Columbia Science and Technology Law Review in August 2010, reviews the regulation of genetic screening and testing of donated reproductive tissue in the United States. Analyzing the regulation in the federal, state and industry level, the research highlights significant shortcomings of the regulation of this area and, drawing on the experience of other countries, advocates the regulation of this area by the FDA. The third and last work of research of which this dissertation consists is dedicated to the examination of the newly created regime of statutory exclusivities afforded to biological pharmaceuticals under the Biologics Price Competition and Innovation Act (BPCIA) as it compares to the protection afforded to such products under patent law. The research concludes that allowing biological pharmaceuticals to benefits from parallel protection under both patent law and the statutory exclusivities regime established under BPCIA does not contribute to incentivizing innovation and might have undesirable ramifications from a public policy perspective. Hence, the research proposes limiting the protection afforded to biological pharmaceutical products, namely to the protection under either patent law or BPCIA, by suspending the ability to enforce patents covering biological pharmaceuticals against generic applicants under BPCIA. In addition, the research examines the proposition that under some circumstances it would be possible to substitute patent protection for statutory exclusivities.

This dissertation consists of two separately published articles and one book chapter linked together by their investigation of the legal regulation of reproductive and genetic technologies. In "Fragmenting the Body" I explore how law is to understand the relationship between the person and the body, and the body and its parts in the context of the instrumental uses to which reproductive and genetic material can be put. Drawing on feminist and postmodernist theories, the article critiques the liberal legal conception of personhood and argues in favour of an embodied account of personhood as central to the legal metaphors and categories we should use in analyzing novel social and material arrangements. "Public Bodies, Private Parts: Genetics in a Post-Keynesian Era" analyzes the use of the new genetics and the role of geneticization in the privatization orientation of the Canadian state from 1990-2002. The chapter defines and explores the relationships among genetics, geneticization and privatization, and demonstrates how a new discourse of health is central to the privatization agenda. The chapter examines three policy/legal initiatives of the Canadian government regulating the new genetics and demonstrates how law operates to further the values and objectives of privatization. Finally, the chapter addresses the gendered impact of the relationship between the new genetics and privatization. In "Beyond Conception: Legal Determinations of Filiation in the Context of Assisted Reproductive Technologies" I argue that legal determinations of filiation are normative ideological constructions about how societal relations between children and parents should be ordered. They are based on particular understandings of the relationship between social and biological facts and operate to create asymmetrical relationships between the categories of maternity and paternity. I suggest that developments in reproductive and genetic filiation offer the potential for an expanded understanding of relatedness which does not take the two-parent -one of each sex--model of the family as its normative form.

Defence date: 29 September 2015
Examining Board: Professor Alberto Alemanno, HEC Paris; Professor Claire Kilpatrick, EUI; Professor Joana Mendes, Universiteit van Amsterdam; Professor Hans-Wolfgang Micklitz, EUI (Supervisor).
The thesis argues for a 'pedagogical' role for courts in the US and EU in ameliorating the increasingly transnational regulation of pharmaceutical product safety through complementary monitoring of the outputs of regulatory processes. The study is divided into two parts. First, the thesis explores the regulatory institutional design in the US and EU. The parallel development of the FDA and EMA suggests that both markets have achieved consolidated domestic/regional regulatory frameworks, which do however show multiple weak spots. These vulnerabilities are aggravated by a strong push towards transnationalisation of regulatory procedures: domestic systems are now permeated by potentially disruptive exogenous elements (e.g. the ratification of transnationally negotiated protocols and increasing reliance on foreign clinical trials data). The thesis explores issues of effectiveness of safety delivery and legitimacy of rule-making processes to suggest scope for improvement in both areas. The second part considers the potential contribution of the judiciary, particularly national courts in the US and EU, to investigate whether the exercise of complementary judicial governance can enhance the effectiveness and legitimacy of an otherwise essentially closed and self-perpetuating system. A selection of cases grounds the claim that, through liability litigation, courts have the capacity to improve the safety levels delivered by regulation and thereby to contribute to output-based legitimacy of the institutional design. This claim is tested in light of acknowledged strengths and limitations of court processes and with regard to differentiating elements at the national level, particularly regarding access to justice. The concluding argument reassembles the results of the study to recommend the existing tool of domestic litigation as a response to certain vulnerabilities in pharmaceutical regulation. The 'hard look' doctrine described by Sheila Jasanoff grounds the normative claim for a 'pedagogical' role for courts, enhancing regulation beyond the outcome of isolated cases – ad adiuvandum rather than contra.

Intellectual property, particularly patents, plays a major role in innovation and discovery in biotechnology. Likewise, since the passage of the Bayh-Dole Act in 1981, patents have become an increasingly important factor in U.S. university-driven basic research, especially in the life sciences where patented technologies have transformed agriculture. Specifically, this paper looks at the potential impacts of these trends on university driven research, the university researcher, the pharmaceutical industry, and the farm sector with an emphasis on recent and pending court cases and legislation. This paper examines policy and adoptions issues in biotechnology and biomedicine in depth and touches on important developments in the tech sectors as a back drop for pending legislation and recent court rulings. How policy is adopted, implemented and interpreted have profound impacts on food production, medical ethics, ecology, U.S. and international farm and innovation sectors and the competiveness of the U.S. in the global economy

Changes in the health sector in South Africa have been widespread since 1994 with restructuring ofthe public sector being the focal point of legislation. The limelight has recently shifted focus to the health sector with the Medicine and Related Substances (MRSCA) Amendment Act, 59 of 2002 in which generic substitution was finally promulgated, after disputes in the international arena about patent rights, due to the government's policy on parallel imports. Section12 ofPharmacy Act 90, which forms part of the Act is an attempt to further regulate the industry, that eventually became effective this year. This legislation addresses issues of sampling and perverse incentives and calls for the establishment of a Marketing Code for the pharmaceutical industry. The South African government has, as part of the amendment, called for input from all stakeholders including: trade associations, the pharmaceutical industry and the medical profession. All role players were invited to be part of the decisionmaking process as to what should constitute the Marketing Code and its' regulatory body. The Society of Psychiatrists (SASOP), an affiliate of the South African Medical Association (SAMA), has not yet prepared a response to SAMA for submission to government with regard to the Marketing Code, in the field of central nervous system (CNS) products. The impact of the banning of samples on psychiatric private practice is not known and there is insufficient data available about the marketing activities of drug companies and the link to the prescription habits of medical professionals. Further, to date, there has been no canvassing of opinions with regard to the impact of the legislation on the consumer. In this case study analysis, an evaluation of the impact of legislative changes in the South African pharmaceutical industry is made. Recommendations as to what should constitute a Marketing Code for the pharmaceutical industry are highlighted. restructuring ofthe public sector being the focal point of legislation. The limelight has recently shifted focus to the health sector with the Medicine and Related Substances (MRSCA) Amendment Act, 59 of 2002 in which generic substitution was finally promulgated, after disputes in the international arena about patent rights, due to the government's policy on parallel imports. Section12 ofPharmacy Act 90, which forms part of the Act is an attempt to further regulate the industry, that eventually became effective this year. This legislation addresses issues of sampling and perverse incentives and calls for the establishment of a Marketing Code for the pharmaceutical industry. The South African government has, as part of the amendment, called for input from all stakeholders including: trade associations, the pharmaceutical industry and the medical profession. All role players were invited to be part of the decisionmaking process as to what should constitute the Marketing Code and its' regulatory body. The Society of Psychiatrists (SASOP), an affiliate of the South African Medical Association (SAMA), has not yet prepared a response to SAMA for submission to government with regard to the Marketing Code, in the field of central nervous system (CNS) products. The impact of the banning of samples on psychiatric private practice is not known and there is insufficient data available about the marketing activities of drug companies and the link to the prescription habits of medical professionals. Further, to date, there has been no canvassing of opinions with regard to the impact of the legislation on the consumer. In this case study analysis, an evaluation of the impact of legislative changes in the South African pharmaceutical industry is made. Recommendations as to what should constitute a Marketing Code for the pharmaceutical industry are highlighted.
Thesis (MBA)- University of Natal, 2003.

Patent protection grants the patent holder with a market monopoly, free from market competition allowing the patentee to charge any price; therefore medicines are sold at prices much higher than the marginal cost of production and distribution. The connection between international trade and intellectual property has aggravated human rights and public health concerns surrounding the inaccessibility of essential medicines. The World Trade Organisation‘s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement is an international instrument which has greatly impacted intellectual property rights protection and access to medicine. It has globalized intellectual property law by obliging all Members to subscribe to the minimum international standards of protection for intellectual property. South Africa is an example of the issues faced whilst attempting to bring their domestic laws into compliance with the Agreement. The government had to attempt to strike a balance between creating an effective intellectual property infrastructure whilst realizing the therapeutic needs of those affected by HIV/AIDS. The South African Patents Act 57 of 1978 did not comply with the Agreement and was subsequently amended in order to bring its patent legislation in full compliance with the Agreement. Currently, South Africa grants patents for new uses or formulations of existing medicines consequently lengthening the period of patent monopoly by allowing pharmaceutical companies to obtain new patents for slight modifications to existing medicines. It is submitted that South Africa‘s patent legislation is more extensive than is necessary under international law, examples of this being disclosure standards and the process for compulsory licensing. In addition, it has not made use of provisions in its existing law to take measures to improve access to essential medicines, nor has it implemented legislative amendments consequent to the flexibilities established in the Doha Declaration. This dissertation seeks to review the steps South Africa has taken in its compliance with the TRIPS Agreement with respect to the relevant intellectual property legislation that has been enacted, including its implications for access to essential medicines. The intention behind this dissertation is to assess the efficacy of the intellectual property legislation in South Africa and its impact on access to medicines.
Thesis (LL.M.)-Univeristy of KwaZulu-Natal, Durban, 2012.

The purpose of this study was to develop a framework for provision of essential medicines for the district health services. A qualitative descriptive, exploratory and contextual action research design was followed. The data collection was conducted through site visits and semi structured interviews targeting the responsible pharmacists who were purposively selected on the basis of their expert knowledge and experiences from the eight of the nine provinces of the Republic of South Africa which is a developing country with limited resources for provision of healthcare services. The study found that there was no standardised framework for provision of essential medicines for the District Health Services. Based on the site visits and action research findings a proposed framework covering the selection, procurement, warehousing, distribution and management support components for provision of essential medicines for district health services was developed and subjected to national pharmaceutical experts and district health services managers review and critique which is finally presented, after taking into consideration the experts inputs as a proposed framework emanating from the study. The proposed framework will contribute towards improving the provisioning and availability of essential medicines within the district health services.
Health Studies
D.Litt. et Phil. (Health Studies)

Despite the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, which unequivocally affirmed WTO members’ rights to use compulsory licences and other TRIPS flexibilities to access medicines, thirteen years on, developing countries and least developed countries are still grappling with access to medicines issues and a high disease burden. Despite some well researched and eloquent arguments to the contrary, it is a trite fact that patents remain an impediment to access to medicines by encouraging monopoly prices. The WTO TRIPS Agreement gives members room to legislate in a manner that is sympathetic to access to affordable medicines by providing for exceptions to patentability and the use of patents without the authorisation of the patent holder (TRIPS flexibilities). This study focuses on access to medicines under the TRIPS Agreement from a SADC comparative perspective by interrogating the extent of the domestication of TRIPS provisions promoting access to medicines in the SADC region with specific reference to Botswana, South Africa and Zimbabwe. After establishing that all SADC members, including Seychelles which is yet to be a WTO member have intellectual property (IP) laws in their statute books, this study confirms that while most of the IP provisions may be used to override patents, they are currently not being used by SADC members due to non-IP reasons such as lack of knowledge and political will. The study also engages in comparative discussions of topical occurrences in the context of access to medicines litigation in India, Thailand and Kenya and extracts useful thematic lessons for the SADC region. The study’s overall approach is to extract useful lessons for regional access to medicines from the good experiences of SADC members and other developing country jurisdictions in the context of a south-south bias. The study draws conclusions and recommendations which if implemented will in all likelihood lead to improved access to medicines for SADC citizens, while at the same time respecting the sanctity of patent rights. The study recommends the adoption of a rights-based approach, which will ultimately elevate patient rights over patent rights and urges the region to consider using its LDCs status to issue compulsory licences in the context of TRIPS Article 31 bis while exploring the possibility of local pharmaceutical manufacturing to produce generics, inspired by the experiences of Zimbabwe and current goings on in Mozambique and the use of pooled procurement for the region. The study embraces the rewards theory of patents which should be used to spur innovation and research into diseases of the poor in the SADC region. Civil society activity in the region is also identified as a potential vehicle to drive the move towards access to affordable medicines for all in the SADC region.
Mercantile Law
LL.D.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements.
Mercantile Law
LL.D.

Defence date: 14 November 2006
Examining board: Prof. Ernst-Ulrich Petersmann (Supervisor, European University Institute) ; Prof. Francesco Francioni (European University Institute) ; Prof. Thomas Cottier (University of Bern, Switzerland) ; Dr. Graham Dutfield (Queen Mary, University of London)
PDF of thesis uploaded from the Library digitised archive of EUI PhD theses completed between 2013 and 2017