European Pharmaceutical Law Review

M. Ricardo

Portugal: New Medicine Shortage Prevention Measures

葡萄牙：新药品短缺预防措施

This piece addresses the impact of Regulation (EU) 2017/745 on medical devices (MDR) on the pharmaceutical industry. The article approaches this from two different angles, both of which demonstrate the rising importance of new medical devices legislation across developing trends in the pharmaceutical industry. The first section concerns the MDR’s challenges for combination products. Before discussing the applicable legal frameworks, this paper starts by outlining an approach to defining and categorising combinations products. The implications of the MDR on the safety and performance requirements of certain combination products are further examined to clarify the expansions of the MDR’s scope of application. The second section of this paper focuses on the MDR’s approach to digital health technologies. The different ways in which software products are covered by the MDR is discussed, together with the consequences of rearranging such products in higher risk classes. Furthermore, the flexible notion of ‘economic operator’ is contemplated in terms of a pharmaceutical company’s activities in digital health. The reinforced obligations imposed on economic operators and a range of other legal issues in the lifecycle of digital health technologies that will be affected by the MDR are also considered.

V. Murovec

A. Bruyndonckx

S. Vogt

The Impact of the Medical Devices Regulation on the Pharmaceutical Industry: A Focus on Combination Products and Digital Health Technologies

医疗器械法规对制药行业的影响：聚焦于组合产品和数字健康技术

J. Mulder

C. Ceulemans

The European Court of Justice in Generics UK: New Frontiers regarding the Legitimacy of Patent Settlements in Competition Law?

欧洲法院在Generics UK案中的新前沿：关于竞争法中专利和解合法性的探讨？

N. Porxas

I. Losada

The Assessment of the ‘Significant Benefit’ in the Orphan Designation Procedure: Case T-733/17 GMPO

孤儿药认定程序中“显著疗效”的评估：T-733/17 GMPO案

Sabrina Röttger-Wirtz

Editorial

社论

The creation of the European health data space is one of the core actions promoted by the European Commission in its EU Data Strategy. This task is challenging due to technical, organisational, economic 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. 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 analyses and compares these areas and provides a systemised view on causes and consequences. The article concludes with an outlook further legislatives developments related to the European health data space.

A. Kiseleva

P. de Hert

Creating a European Health Data Space: Obstacles in Four Key Legal Areas

创建欧洲健康数据空间：四个关键法律领域的障碍

Recent months have seen intensified global calls for an intellectual property waiver 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.

B. Kianzad

J. Wested

‘No-one is Safe Until Everyone is Safe’ – Patent Waiver, Compulsory Licensing and COVID-19

“没有人是安全的，直到每个人都安全”——专利豁免、强制许可与新冠疫情

S. Röttger-Wirtz

Since the last issue of the European Pharmaceutical Law Review the vaccination campaigns in the Member States with the four currently authorised COVID-19 vaccines Comirnaty (BioNTech/Pfizer), Vaxzevria (AstraZeneca), as well as the Moderna and the Janssen COVID-19 vaccines, have picked up speed.On 17 May, according to the European Centre for Disease Prevention and Control (ECDC), 36% of the adults in the EU/EEA have received at least 1 vaccination dose and 14,4% are fully vaccinated.While currently four vaccines are under rolling review at the European Medicines Agency (CVnCoV; NVX-CoV2373; Sputnik V (Gam-COVID-Vac); and COVID-19 Vaccine (Vero Cell) Inactivated), the political and regulatory attention is shifting towards preparedness for mutations of the virus and the adaptability of the vaccines for such mutations.

G. Gobechia

Does an Initially Authorised Combination Medicinal Product and a Later Authorised Single Component of that Combination Belong to the Same Global Marketing Authorization? - The Tecfidera® Judgment of the General Court in Case T-611/18

最初授权的复方药品与后来授权的该复方单个成分是否属于同一全球上市许可？——欧洲普通法院在T-611/18案中的Tecfidera®判决

Publication Information	Publisher: Lexxion Verlagsgesellschaft mbH，Publishing cycle: ，Journal Type: journal，Open Access Journals: No
Basic data	Year of publication: 2019，Proportion of original research papers: ，Self Citation Rate:， Gold OA Rate:

European Pharmaceutical Law Review

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Portugal: New Medicine Shortage Prevention Measures

The Impact of the Medical Devices Regulation on the Pharmaceutical Industry: A Focus on Combination Products and Digital Health Technologies

The European Court of Justice in Generics UK: New Frontiers regarding the Legitimacy of Patent Settlements in Competition Law?

The Assessment of the ‘Significant Benefit’ in the Orphan Designation Procedure: Case T-733/17 GMPO

Editorial

Creating a European Health Data Space: Obstacles in Four Key Legal Areas

‘No-one is Safe Until Everyone is Safe’ – Patent Waiver, Compulsory Licensing and COVID-19

Editorial

Editorial

Does an Initially Authorised Combination Medicinal Product and a Later Authorised Single Component of that Combination Belong to the Same Global Marketing Authorization? - The Tecfidera® Judgment of the General Court in Case T-611/18

ISSN	2511-7157, 2511-7181
h-index	4