European Health and Pharmaceutical Law Review

J. Wested

European Health & Pharmaceutical Law Review

Editorial

社论

It is my pleasure to write this first Editorial as Managing Editor after taking over the position from Sabrina Röttger-

Excessive pharmaceutical pricing cases in EU have progressed from a theoretical possibility to becoming a recurrent enforcement reality, following heightened law and policy attention on affordability of medicines. This matter gained considerable momentum in the wake of COVID-19 crisis as result of the increased health spending, with debates on affordability raging at WTO and WIPO levels. Unfair pricing in European competition law under Article 102a TFEU denote prices set by a dominant undertaking, capable of affecting trade between member states or in a substantial part of the Union, which do not have a reasonable relationship with their ‘economic value. The main points of dispute in previous jurisprudence and doctrine have concerned the definition of ‘reasonable’ and ‘economic value’ and the calculation of ‘excessiveness’ and ‘unfairness’, as per the seminal assessment test developed by the CJEU in its United Brands case. Although previously described as a ‘rarity’ in competition law, such excessive pricing cases can now be found in Italy, UK, Denmark and Netherlands but also on the DG Competition level. The investigation into Aspen's pricing practices by the European Commission, ending in a commitment decision whereby Aspen reduced prices by 73%, represents a historic case, capable of providing some guidance in this area of law and policy, seen against the doctrinal adversity to the prohibition. As intellectual property law and competition law, on the one hand, and policy issues related to Right-to-Health, affordable healthcare and pharmaceutical innovation on the other hand, interact to a high degree in this context, there is room for reflection on the role of competition law related to fair pricing of medicines. Following the introduction, the article will briefly recount the legal framework in European competition law related to excessive pricing. The third section will elevate the law and economics arguments related to excessive pharmaceutical pricing . The fourth section will detail the recent excessive pricing cases in the pharmaceutical sector. The fifth section will depict the assessment and decision by European Commission in the Aspen case. The sixth section analyses the Commission decision regarding definition of relevant market, dominance, thresholds and benchmarking and other unresolved issues relating to such enforcement. The seventh section concludes.

B. Kianzad

Towards Fair Pricing of Medicines?

迈向药品公平定价？

C. O'Keeffe

J. Sugrue

The Supplementary Protection Certificate for Medicinal Products: Recent Developments and Outlook

药品补充保护证书：最新进展与展望

M. Lugard

A. Melin

F. Huber

A New Way to Manage Supply Chains?

管理供应链的新方法？

P. Cappabianca

Ecopharmacovigilance and the One Health Approach: Protecting The Environment and Tackling Antimicrobial Resistance - Perspectives On The basis of The New EU ‘Pharmaceutical Package’

生态药物警戒与“同一健康”方法：保护环境和应对抗菌药物耐药性——基于欧盟新“药品一揽子计划”的视角

T. Carmeliet

Will Technology Disrupt Healthcare?

技术会颠覆医疗保健吗？

K. Van Delm

Tomato, Potato: When the Detail does Matter - The EU Institution's Understanding of Real World Data

番茄，土豆：细节何时重要——欧盟机构对真实世界数据的解读

W. Vanpoucke

Planet of the Apps: Innovation in Mobile Healthcare at Risk?

应用星球：移动医疗创新面临风险？

出版信息	出版商: Lexxion Verlagsgesellschaft mbH，出版周期: ，期刊类型: journal，开源期刊: 否
基本数据	创刊年份: 2023，原创研究文献占比: ，自引率:， Gold OA占比:

European Health and Pharmaceutical Law Review

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Editorial

Editorial

Towards Fair Pricing of Medicines?

The Supplementary Protection Certificate for Medicinal Products: Recent Developments and Outlook

A New Way to Manage Supply Chains?

Ecopharmacovigilance and the One Health Approach: Protecting The Environment and Tackling Antimicrobial Resistance - Perspectives On The basis of The New EU ‘Pharmaceutical Package’

Editorial

Will Technology Disrupt Healthcare?

Tomato, Potato: When the Detail does Matter - The EU Institution's Understanding of Real World Data

Planet of the Apps: Innovation in Mobile Healthcare at Risk?