BACKGROUND: In recent years, the cannabis industry has evolved from a world defined by the simplicity and ubiquity of illegality of recreational drug cannabis to a world marked by the legal and geographic complexity of ongoing depenalisation, decriminalisation, and legalisation processes. Within this landscape where drug Cannabis plants and their many derivatives see their legal status change, Cannabis cultigens and end products are increasingly likely to becoming subject to protection by intellectual property rights. This article delves into the implications of these changes for traditional Cannabis farmers, particularly in the Global South, as they face economic and legal threats amidst global legalisation efforts. It examines the potential role of appellations of origin in protecting local Cannabis cultigens and end products, focusing on Moroccan Cannabis and hashish as a case study.
METHODS: The text resorts to the treaties and agreements regulating international property rights and plant variety protection, but also to the concepts of terroir and landrace and their definitions, in order to determine, by way of treaty interpretation and conceptual analysis, what type of legal and economic protections can apply to Cannabis landraces and terroir products. The analysis is also based on previous empirical research published by the author.
RESULTS: The text argues that appellations of origin are the best intellectual property protections possible for landraces and terroir products because what needs to be protected is not innovation and individual ownership, but tradition and collective ownership, and because appellations of origin are suitable collective intellectual property rights. It shows that appellations of origin are best suited to protect terroir products and landraces because their originality and distinctiveness are place-based originality and distinctiveness.
CONCLUSIONS: The text concludes that appellations or origin offer the only existing intellectual property protection for preserving the distinctiveness of terroir cannabis products, and for landrace conservation. It acknowledges that neither appellations of origin nor existing plant variety protection laws can be legal forms of control of third parties\' uses of landraces but that appellations of origin can help protect terroir products and landraces by way of their associated agro-ecosystems.

International openness can affect regional innovation through more export opportunities, enhanced import competition and the spillover effects of foreign direct investment. Many studies have been conducted based on different countries for capturing the determinants of regional innovation, but very little literature is available with contradictory findings for the case of China. Based on 19 years\' panel data of 31 Chinese provinces, this paper analyzes the impact of international openness on regional innovation measured by the number of patent grants. The positive effects of overall trade and a higher proportion of exports and imports to GDP are significant and robust across different model specifications, indicating that an increase in international openness can promote regional innovating activities in China. The causal relationship of all the variables depicted by path analysis matches the results of the system GMM model. Higher intellectual property protection provides each region with the opportunity to obtain economic benefits from innovation and then make a higher investment in R&D activities. Besides, the lag effect of regional innovation capability can also explain a large part of local innovating activities. In our subsample regressions, the positive effect of trade openness on innovation is majorly manifested in developed areas like eastern provinces.

In recent years, there has been increasing pressure on public health systems in high-income countries due to high medicines prices, one of the underlying causes of which are the market monopolies granted to pharmaceutical undertakings. These monopolies have been facilitated by expanded forms of intellectual property protections, including the extension of the exclusivity period after the expiration of the patent term concerning medicinal products. In the European Union such an approach lies in the Supplementary Protection Certificate, a mechanism formally introduced under Regulation 1768/92/EEC (now: Regulation 469/2009/EC, amended). After more than 20 years of implementation since it was first introduced, the common justifications for SPCs are being challenged by recent findings as to their functioning and impact. Similarly, legitimate questions have been voiced as to the negative impact of SPCs on timely access to affordable medicines. On the basis of an analysis of three medicines for hepatitis C and cancer treatments, the present article critically engages with the policy justifications underlying SPCs. It then analyses access challenges to a hepatitis C medicine and an HIV treatment in Europe, highlighting the social cost of the introduction of SPCs. Both the normative and empirical analyses have demonstrated that the common justifications supporting the SPC regime are deeply questionable. The addition of SPC exclusivity has also heavily delayed competition and maintained high medicines prices in European countries. Ultimately, the granting of such extended exclusive private rights on medicines may result in unnecessary suffering and be a factor in the erosion of access to medicines for all.

A trend towards charging for access to research findings, tools and databases is becoming more prominent globally. But charging for the use of research tools and databases that are vital to research supporting national and international policy development might be unjustified. Financial barriers to accessing these tools and databases disproportionately affect low- and middle-income countries, who may have greater need for information that fuels research in their areas of concern. However, changing this trend is potentially possible. One example is the experience with the EuroQol-five-dimensional questionnaire (EQ-5D), a generic measure of health status used in economic evaluations for resource allocation decisions. Increasingly, governments and health-care providers are using the EQ-5D tool in patient-reported outcome measures to monitor quality of health-care provision, diagnose and track disease progression, and involve patients in their health care. The EuroQol Group, which owns the intellectual property rights to the EQ-5D, recently terminated their policy of charging for noncommercial, nonresearch uses of the tool. We share a brief history of this development and examine these charging policies in the context of the EQ-5D\'s use in national health-care research and policies, reflecting the trends and developments in the use of survey instruments on population health.
On observe à l\'échelle mondiale une tendance de plus en plus marquée à la tarification de l\'accès aux résultats, aux outils et aux bases de données de recherche. Cependant, la tarification de l\'utilisation d\'outils et de bases de données essentiels aux recherches appuyant l\'élaboration de politiques nationales et internationales n\'est pas toujours justifiée. Les obstacles financiers qui entravent l\'accès à ces outils et bases de données affectent de manière disproportionnée les pays à revenu faible et intermédiaire, qui peuvent avoir davantage besoin d\'informations pour alimenter des recherches sur leurs sujets de préoccupation. Il est toutefois possible d\'infléchir cette tendance. Le questionnaire EuroQol-five-dimensions (EQ-5D), une mesure générale de l\'état de santé utilisée dans les évaluations économiques pour les décisions relatives à l\'affectation des ressources, constitue un exemple. Les gouvernements et les prestataires de soins de santé utilisent de plus en plus l\'outil EQ-5D dans les mesures des résultats notifiés par les patients pour surveiller la qualité de la prestation des soins de santé, diagnostiquer et suivre l\'évolution d\'une maladie, et associer les patients à leurs soins de santé. Le groupe EuroQol, qui détient les droits de propriété intellectuelle relatifs à l\'EQ-5D, a récemment mis fin à sa politique de tarification pour l\'utilisation de l\'outil à des fins non commerciales et dans un contexte autre que celui de la recherche. Nous retraçons brièvement ce cheminement et examinons ces politiques de tarification dans le contexte de l\'utilisation de l\'EQ-5D dans les recherches et politiques nationales sur les soins de santé, en rendant compte de l\'évolution de l\'utilisation du matériel d\'enquête sur la santé de la population.
La tendencia a cobrar por el acceso a los resultados de las investigaciones, las herramientas y las bases de datos está cobrando cada vez más importancia en todo el mundo. Sin embargo, puede que no esté justificado cobrar por el uso de herramientas de investigación y bases de datos que son vitales para la investigación en apoyo del desarrollo de políticas nacionales e internacionales. Las barreras financieras para acceder a estas herramientas y bases de datos afectan desproporcionadamente a los países de ingresos bajos y medios, que pueden tener una mayor necesidad de información que impulse la investigación en sus áreas de interés. Sin embargo, es posible cambiar esta tendencia. Un ejemplo es la experiencia con el cuestionario de cinco dimensiones EuroQol (EQ-5D), una medida genérica del estado de salud utilizada en las evaluaciones económicas para las decisiones de asignación de recursos. Cada vez más, los gobiernos y los proveedores de la atención de la salud están utilizando la herramienta EQ-5D en las medidas de resultado informadas por el paciente para supervisar la calidad de la prestación de la atención de la salud, diagnosticar y hacer un seguimiento de la progresión de la enfermedad e involucrar a los pacientes en su cuidado de la salud. El Grupo EuroQol, propietario de los derechos de propiedad intelectual de EQ-5D, puso fin recientemente a su política de cobrar por los usos no comerciales y no relacionados con la investigación de la herramienta. En este artículo se presenta una breve historia de este desarrollo y se examinan estas políticas de cobro en el contexto del uso de EQ-5D en la investigación y las políticas nacionales de atención de la salud, reflejando las tendencias y los avances en el uso de los instrumentos de las encuestas sobre la salud de la población.
أصبح الاتجاه نحو فرض رسوم مقابل الاطلاع على نتائج الأبحاث والأدوات وقواعد البيانات، أكثر وضوحاً على مستوى العالم. إلا أن فرض رسوم على استخدام أدوات البحث وقواعد البيانات التي تعد ضرورية للبحث الذي يدعم تطوير السياسات الوطنية والدولية، أمراً غير مبرر. إن العقبات المالية التي تعوق الاطلاع على هذه الأدوات وقواعد البيانات تؤثر بشكل غير متناسب على البلدان ذات الدخل المنخفض والمتوسط، والتي قد تكون بحاجة أكبر إلى المعلومات التي تغذي الأبحاث في مجالات اهتمامها. إلا أن تغيير هذا الاتجاه أمر ممكن ومحتمل. ومثال على ذلك تجربة استبيان EuroQol خماسي الأبعاد (EQ-5D)، وهو مقياس عام للحالة الصحية يتم استخدامه في التقييمات الاقتصادية لقرارات تخصيص الموارد. تستخدم الحكومات وجهات تقديم الرعاية الصحية على نحو متزايد أداة EQ-5D في مقاييس النتائج التي يبلغ عنها المريض، لمراقبة جودة توفير الرعاية الصحية، وتشخيص وتتبع تطور المرض، مع إشراك المرضى في الرعاية الصحية المقدمة لهم. قامت مجموعة EuroQol Group، التي تمتلك حقوق الملكية الفكرية لـ EQ-5D، مؤخراً بإنهاء سياستها الخاصة بفرض رسوم على استخدامات الأداة لأغراض غير تجارية وغير بحثية. نحن نقوم بعرض تاريخ موجز لهذا التطور، ونختبر تلك السياسات الخاصة بفرض الرسوم في سياق استخدام EQ-5D في الأبحاث والسياسات الوطنية للرعاية الصحية، مما يعكس الاتجاهات والتطورات في استخدام أدوات المسح الإحصائي على صحة السكان.
在全球范围内，要求付费以获取研究成果、工具和数据库的现象逐渐成为一种重要趋势。但是，使用对支持国家和国际政策发展的研究至关重要的研究工具和数据库时，相关收费并不合理。为访问这些工具和数据库设置的资金障碍对中低收入国家的影响尤为严重，这是因为中低收入国家可能需要更多信息以推动其相关领域的研究发展。但是，或许可以改变这种趋势。以使用 EuroQol 五维问卷（EQ-5D，在资源分配决策相关经济评估方面使用的通用健康状态测量量表）的经验为例。越来越多的政府部门和医疗保健提供者在患者报告结局测量方面使用 EQ-5D 工具，以监控医疗保健质量、诊断和跟踪疾病进展并吸引患者参与其医疗保健项目。拥有 EQ-5D 的知识产权的欧洲生存质量学会最近终止了一项政策，即其针对出于非商业和非研究目的使用该工具的情况实施的收费政策。我们简单分享了其发展史，并基于 EQ-5D 在国家医疗保健研究和政策领域的使用情况，研究了这些收费政策，以反映使用人口健康调查工具的趋势和发展。.
Тенденция к начислению платы за доступ к результатам, инструментам и базам данных исследований приобретает ярко выраженный характер по всему миру. Но взимание платы за использование инструментов и баз данных исследований, совершенно необходимых для поддержки развития национальных и международных политик, может быть необоснованным. Финансовые барьеры к использованию этих инструментов и баз данных могут непропорционально сильно сказаться на странах со средним и низким уровнем дохода, которые могут испытывать большую потребность в информации, поддерживающей проведение исследований в проблемных для данных стран областях. Однако существует потенциальная возможность изменить такую тенденцию. В качестве одного из примеров можно привести опросник из пяти вопросов EuroQol (EQ-5D) — общий показатель состояния здоровья, используемый при экономической оценке для принятия решений о распределении ресурсов. Правительства стран и медицинские учреждения все чаще используют инструмент EQ-5D для измерения результатов, сообщаемых пациентами, с целью контроля качества оказания медицинской помощи, диагностики и отслеживания течения заболевания, а также вовлечения пациентов в процесс медицинского обслуживания. Компания EuroQol Group, которая владеет правами интеллектуальной собственности на EQ-5D, недавно отказалась от политики начисления платы за некоммерческое использование инструмента, не связанное с проведением исследований. Авторы вкратце рассказывают о развитии данной ситуации и рассматривают политики относительно начисления платы в контексте использования EQ-5D в национальных исследованиях и разработке политик в области здравоохранения, отражающих тенденции и изменения в использовании средств исследования здоровья населения.

Intellectual property law is a crucial determinant of global public health, capable of both endangering and facilitating advances in the health of populations. This Viewpoint explains the most important aspects of the interaction between intellectual property law and public health. We use the plain packaging of tobacco products to illustrate how public health policies may be subject to scrutiny under existing trade and investment law structures. Plain packaging of tobacco products is challenging to implement due to legal complexities and uncertainties surrounding the status of mandated plain packaging for consumer products. While the tobacco industry and its proponents once relied on the denial of scientific evidence to delay legislation and influence consumers, its tactics have shifted to the use of trade threats and investment disputes, directly challenging the sovereignty of governments to enact bona fide public health measures to improve the health of their population.

New innovation ecosystems are emerging that challenge the complex intellectual property and regulatory landscape surrounding drug development in the United States (US). A prime example is an initiative known as the Open Insulin Project. The goal of the project is to sidestep patents and enable generic manufacturers to produce cheaper insulin. However, the US regulatory environment, not patent exclusivity, is the main barrier to insulin affordability. If the Open Insulin Project succeeds in releasing an open protocol for insulin manufacturing, follow-on work could enable a number of new insulin production ecosystems, including \'home-brewed\' insulin. Regulators will need to consider how to proceed in a future where commercial pharmaceuticals remain unaffordable, but patients are empowered to produce drugs for their personal use.

Galantamine is a reversible inhibitor of cholinesterases and an allosteric modulator of neuronal nicotinic acetylcholine receptors which restores reduced cholinergic tone in the central and peripheral nervous system. Characterized in the early 1950s in Bulgaria, it saw limited use for paralytic and neuropathic conditions until the cholinergic hypothesis of Alzheimer\'s disease opened totally new perspectives for its utility. Although constricted supplies at extremely high prices and a fragmented patent situation made its repurposing challenging, galantamine was globally launched as an Alzheimer\'s disease drug in 2000. Many other possible uses have been clinically investigated, and might yet develop into another drug career. This case study is presented as an example for classical on-target drug repurposing and the challenges that such a project can face.

Since 2006, some of the highest ranking European Courts have issued decisions related to the patent eligibility of human embryonic stem cells. The question of patent eligibility of human embryonic stem cells remains, however, still erratic, at least in some aspects. This article will give a short comprehensive overview of the case history, and discuss questions still unsolved.

The protection of pharmaceutical intellectual property (IP) rights is one of the most controversial debates in contemporary public health as countries have to balance incentives for drug development with the necessity of providing life-saving drugs. Compliance with IP protections is mandatory for members of the World Trade Organization (WTO). However, because of the costs associated with IP implementation we should expect late and/or poor implementation in middle-income countries. Surprisingly, this was not the case in Brazil. The country not only just fully implemented the WTO\'s requirement but declined the grace period granted for countries to adapt and included extra IP protections, going against a coalition of local industrialists and activists. Notwithstanding, as the consequences of IP regulations unfolds, Brazil also promoted new alliances that tailored and adjusted the regulations toward public health. We demonstrate that arguments of foreign pressure and lobbying are exaggerated and call attention to domestic shifts, long-term processes of regulatory decision, and political dynamics happening at the local level. By analyzing the case of Brazil, we provide a nuanced contribution to the discussion of IP implementation in middle-income countries and call attention to new models of government-society interactions in regulatory policy.

OBJECTIVE: The Trans Pacific Partnership Agreement (TPP) is a recently concluded free trade agreement involving Australia and 11 other Pacific-rim nations, which has the potential for far-reaching impacts on public health. A health impact assessment (HIA) was carried out during the negotiations to determine the potential future public health impact in Australia and to provide recommendations to mitigate potential harms. This paper explores the findings and outcomes of the HIA, and how this approach can be used to provide evidence for public health advocacy.
METHODS: A modified version of the standard HIA process was followed. The HIA was led by technical experts in HIA, trade policy, and health policy, in collaboration with advocacy organisations concerned with the TPP and health. The HIA reviewed the provisions in leaked TPP text in order to determine their potential impact on future health policy. As part of this process, researchers developed policy scenarios in order to examine how TPP provisions may affect health policies and their subsequent impact to health for both the general and vulnerable populations. The four policy areas assessed were the cost of medicines, tobacco control, alcohol control and food labelling.
RESULTS: In all areas assessed, the HIA found that proposed TPP provisions were likely to adversely affect health. These provisions are also likely to more adversely affect the health of vulnerable populations.
CONCLUSIONS: The HIA produced relevant evidence that was useful in advocacy efforts by stakeholders, and engaging the public through various media platforms.