Creation of the European health data space is one of the core actions promoted by the European Commission in the EU Data Strategy. This task is challenging due to technical, organizational, economic and other issues that require different measures. This paper focuses on the issues in the legal field and identifies four key legal areas where the creation of a European health data space may face obstacles or may influence its development. These areas are: 1) rules on the provision of healthcare in the Member States; 2) protection of personal data in healthcare provision and medical research; 3) control and use of non-personal data and 4) the regulatory framework on AI. The article provides the analysis and comparison of these areas to submit the systemized view on causes and consequences of the identified issues and to suggest the vision of the further legislative process related to the European health data space.
This contribution aims to demonstrate that there is no ‘one-size-fits-all’ approach with regards to exhaustion regimes of patent rights, despite it being largely argued either for or against in the literature. Further, it aims to demonstrate that licenses and contractual limitations play an important role in increasing the potential of parallel imports to enhance access to medicines and it is thus important to analyze their synergies. The review first briefly lays out general considerations necessary for the review of the interplay of parallel imports with compulsory licenses (for export) and voluntary licenses. It then discusses how different outcomes of parallel imports may substantiate different policy approaches. In recognizing this, it showcases how contractual clauses may be an effective tool in implementing differential pricing practices which, despite seeming unduly discriminatory, may ultimately benefit developing and least developed countries. Further, evaluating the relationship between parallel imports and compulsory licenses seems to be needed in existing literature, and, in particular, whether or not to parallel import medicines manufactured on the basis of compulsory licenses. Moreover, because voluntary licenses became an increasing trend in recent years, it appears necessary to analyze how they may support the effectiveness of an international exhaustion regime of patent rights in countries where such regime is appropriate. This paper concludes that one size does not fit all and that policies aiming to enhance access to medicines must concomitantly implement several TRIPS flexibilities. In the case of parallel imports of medicines, not only should an appropriate exhaustion regime of patent rights be adopted, but also, where an international exhaustion regime is deemed appropriate, it should be coupled with measures pertaining to compulsory licenses (for export) and voluntary licenses.
In Europe, drugs that are shown to have new therapeutic indications can receive additional market protection. This study analyses all instances this extra protection was awarded up until the end of 2020. This study pioneers a method to analyse what type of new indications receive the extra protection and shows that it was awarded for treating new patient cohorts as often as new medical conditions. No evidence supports granting extra protection for new patient cohorts. Therefore, this paper argues to pare back the circumstances the extra protection is awarded.
The article provides a legal overview of biased AI systems in clinical genetics and genomics. For the overview, two perspectives to look at bias are taken into consideration: societal and statistical. The paper explores how biases can be defined in these two perspectives and how generally they can be classified. Based on two perspectives, the paper explores three negative consequences of biases in AI systems: discrimination and stigmatization (as the more societal concepts) and inaccuracy of AI’s decisions (more related to the statistical perception of bias). Each of these consequences is analyzed within the frameworks they correspond to. Recognizing inaccuracy as harm caused by biased AI systems is one of the most important contributions of the article. It is argued that once identified, bias in an AI system indicates possible inaccuracy in its outcomes. The article demonstrates it through the analysis of the medical devices framework: if it is applicable to AI applications used in genomics and genetics, how it defines bias, and what are the requirements to prevent them. The paper also looks at how this framework can work together with anti-discrimination and stigmatization rules, especially in the light of the upcoming general legal framework on AI. The authors conclude that all the frameworks shall be considered for fighting against bias in AI systems because they reflect different approaches to the nature of bias and thus provide a broader range of mechanisms to prevent or minimize them.
Labelling rules enable the citizens to get comprehensive information about the content and composition of food products. Labelling helps consumers to make an informed choice while purchasing their foodstuffs. Regulation 1169/2011 on the provision of food information to consumers seeks to ensure a high level of consumer protection, gives the consumer the necessary information to make choices in full knowledge of the facts, and create equal conditions of competition for the food industry.
Recentmonths have seen intensified global calls for an intellectual propertywaiver of COVID-19 related vaccines, treatments and related products.Where one side of the debate elevates Intellectual Property Rights as on obstacle to affordable and expeditious global access to vaccines and treatments, the other side of the debate points to the existing TRIPS flexibilities such as compulsory licensing, the necessity of Intellectual Property Rights for future innovation as well as other factors such as manufacturing capacity and know-how being of greater importance. This dualistic approach risk ignoring the manifold law, economics, and policy nuances inherent in the intersection of intellectual property law and Right-to-Health, as well as innovation and health policy. A balanced approach guided by real world indicators regarding law and economics of pharmaceutical innovation, procedural feasibility of compulsory licensing and legal applicability of an IPR waiver is needed. Thus, the key to understanding the current debates lies in a holistic approach to ratio legis of intellectual property rights, innovation policy and health policy. The innovation inducing facets of monopoly rights, and interconnected monopoly profits, need to be balanced against public policy rationales such as Right-to-Health, but also against the ratio legis of IPRs, which focuses on maximizing societal welfare. After the introduction framing the background regarding unequitable global access to COVID-19 vaccines and treatments paving the way to the current debates on patent waiver and compulsory licensing, the Article proceeds as follows. Section II briefly sketches the main contours of the debate on right-to-health and intellectual property rights from a law and policy perspective. Section III details the legal, historical and procedural background of international codification of patents and the compulsory licensing instrument within the TRIPS agreement, as well some instances of compulsory licensing during COVID-19. Section IV recounts the patent waiver proposal at TRIPS Council and the arguments for and against the proposal. Section V concludes with some law and policy reflections on the balance between Right-to-Health, intellectual property rights and innovation policy. © 2021, Lexxion Verlagsgesellschaft mbH. All rights reserved.
Multiple procedures and projects accelerating patient access to medicinal products have been rolled out in the EU.This paper provides an overview of the procedures currently in place at EU level aiming to accelerate the centralised marketing authorisation procedure for new medicinal products.Specifically, accelerated assessment, parallel consultations of EMA and HTA bodies, the PRIME scheme, SME support, conditional marketing authorisation, exceptional circumstances, CHMP opinions on compassionate use and adaptive pathways are discussed.The coherence of the procedures and implications on applicants' legal certainty is analysed, and the procedures are compared with their most similar US counterparts.Subsequently, the relevance of such procedures for the current Covid-19 crisis is highlighted.It is demonstrated that many of the existing EU procedures are intertwined and many of the EU procedures have a resembling counterpart in the US.Even though for access to most EU procedures the applicant should demonstrate the presence of an 'unmet need', this concept is not defined homogenously for all procedures, reducing legal certainty.In conclusion, the overview of the procedures in place at EU level demonstrates that the system is overly complicated. II.
According to the European Union (EU) as well as several Member States, increased foreign direct investment (FDI) is a potential threat to public security and order. Over the past two years, numerous amendments were made to German investment control law: on the one hand, in view of the new European legal framework (‘EU Screening Regulation’) and, on the other hand, against the background of the threat that the COVID-19 pandemic posed to the supply of health commodities. This article shows which of these new rules apply to the pharmaceutical industry and offers a view on how they may affect the supply of medicines in Germany and the EU in view of their aim to protect national security interests.
