| 1. |
- Bhaskar, Sonu, et al.
(författare)
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At the Epicentre of COVID-19 - the Tragic Failure of the Global Supply Chain for Medical Supplies
- 2020
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Ingår i: Frontiers in Public Health. - : Frontiers Media SA. - 2296-2565.
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Tidskriftsartikel (refereegranskat)abstract
- The tragic failure of the global supply chain in the face of the current coronavirus outbreak has caused acute shortages of essential frontline medical devices and personal protective equipment, crushing fear among frontline health workers and causing fundamental concerns about the sustainability of the health system. Much more coordination, integration, and management of global supply chains will be needed to mitigate the impact of the pandemics. This article describes the pressing need to revisit the governance and resilience of the supply chains that amplified the crisis at pandemic scale. We propose a model that profiles critical stockpiles and improves production efficiency through new technologies such as advanced analytics and blockchain. A new governance system that supports intervention by public-health authorities during critical emergencies is central to our recommendation, both in the face of the current crisis and to be better prepared for potential future crises. These reinforcements offer the potential to minimize the compromise of our healthcare workers and health systems due to infection exposure and build capacity toward preparedness and action for a future outbreak.
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| 2. |
- Corrales Compagnucci, Marcelo, et al.
(författare)
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Non-Fungible Tokens as a Framework for Sustainable Innovation in Pharmaceutical R&D: A Smart Contract-Based Platform for Data Sharing and Rightsholder Protection
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Ingår i: International Review of Law, Computers & Technology. - 1360-0869.
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Tidskriftsartikel (refereegranskat)abstract
- Research and Development (R&D) in the pharmaceutical sector traditionally occurred in closed, siloed institutional settings. This approach was a function of a rights-oriented model which framed access and reuse of data (data sharing) as a threat to rights-holders. However, a closed model of explorative collaboration is less suited to today’s more complex scientific ecosystem, where external engagement and dynamic partnering with multiple actors and diverse information sources has become essential. As such, devising alternative approaches is vital in ensuring that opportunities for scientific advances are not lost or innovation stifled.This article introduces a hybrid contractual framework that combines the benefits of the automated functionality of smart contracts and non-fungible tokens embedded in the blockchain with more traditional rights-based licensing schemes. The framework described is based on the outcome of an experimental pilot platform that enabled participants to store, find and reuse data following FAIR data principles. The platform documents real-world physical assets in the drug discovery of chemical molecules in an immutable digital ledger.More generally, smart contracts and non-fungible token’s point us towards an open and global collaborative platform for exploiting and advancing drug research assets. The resulting platform creates mechanisms for resolving issues regarding standardization, interoperability, and disclosure. As such, it overcomes many of the practical hurdles currently obstructing collaboration in pharmaceutical R&D, as well as providing a framework to address the central conflict in drug discovery, namely the demand for greater data sharing and the protection of rights-holder interests.
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| 5. |
- Druedahl, Louise C., et al.
(författare)
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Evolving Biosimilar Clinical Requirements : A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators
- 2021
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Ingår i: BioDrugs. - : ADIS INT LTD. - 1173-8804 .- 1179-190X. ; 35:3, s. 351-361
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Tidskriftsartikel (refereegranskat)abstract
- Background A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics. Objective The aim was to determine the perceptions of industry and medicines agency regulators regarding the value, necessity, and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity. Methods Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis. Results In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician's trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs. Conclusion The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.
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| 6. |
- Druedahl, Louise C., et al.
(författare)
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Interchangeability of biosimilars : A study of expert views and visions regarding the science and substitution
- 2022
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 17:1
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Tidskriftsartikel (refereegranskat)abstract
- Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.
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| 7. |
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Governing, Protecting, and Regulating the Future of Genome Editing : The Significance of ELSPI Perspectives
- 2023
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Samlingsverk (redaktörskap) (refereegranskat)abstract
- This book brings together several outstanding authors in the field and covers questions relating to the fundamental milestones in technology development and governance (Judit Sandor), an analysis of disability questions and empowerment of the community (Pin Lean Lau), right to health opportunities and challenges (Anne Kjersti Befring), the protection of the right to private life and life (Merel M. Spaander), and preconditions for the use of technology for heritable changes in the human genome (Noemi Conditi), and the intersection of genome editing and artificial intelligence (Anastasiya Kiseleva). It also examines the rules relating to the early access of gene therapy medicinal products (Vera Lucia Raposo) and the adequacy of the rules on safety and application of the technology in healthcare within the EU (Michal Koščík and Eliška Vladíková). Moreover, it looks into the availability and accessibility of the technology. The special issue examines the values behind the prohibitions of germline interventions in Europe and explores the feasibility of lifting these bans (Santa Slokenberga, gold OA); it looks at the social justice in the field and the need to ensure better access to biotechnological innovations (Oliver Feeney) as well as examines the morality clauses in patent legislation and their impact on the technology governance (Duncan Matthews, Timo Minssen and Ana Nordberg). At times, even the best technology governance tools fail in ensuring adequate access to the technology and the market actors risk behaving in a way that could undermine the right to health. Here, competition law perspectives come into play and offer tools for ensuring a minimum level of competition in the field (Vladimir Bastidas Venegas, gold OA). The book is an outcome of the Nordic Permed Law Symposium on Human Genome Editing, held online on November 3-4, 2021, and is expected to be published open access, latest September 2022.
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| 8. |
- Groussot, Xavier, et al.
(författare)
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Res judicata i EG –domstolens rättspraxis: en avvägning mellan rättssäkerhet och lagenlighet
- 2007
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Ingår i: Europarättslig tidskrift. - 1403-8722. ; :3, s. 535-567
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Tidskriftsartikel (refereegranskat)abstract
- Ny rättspraxis från EG-domstolen i fallen Köbler och Kühne & Heitz har visat att domstolen är beredd att etablera rättsprinciper som kommer göra det möjligt att på ett effektivt sätt hantera missbruket av acte clair-doktrinen. I det förstnämnda fallet, etablerade domstolen en möjlighet att utkräva skadeståndsansvar av medlemsstaten i det fall den nationella sista instansrätten (in casu den högsta förvaltningsdomstolen), med hjälp av acte clair-doktrinen, begår ett uppenbart brott mot gemenskapsrätten.2 I det senare fallet, konstaterade domstolen att ett förvaltningsorgan är förpliktigat, i enlighet med samarbetsprincipen i art. 10 EG, att ompröva ett beslut för att beakta den tolkning av en relevant gemenskapsrättslig bestämmelse som domstolen gjort under tiden. Det är slående att EG-domstolens domare i dessa två fall gett uttryck för samma logiska grund, nämligen strävan efter en jämvikt mellan rättsäkerhet och lagenlighet. Det är värt att notera att dessa viktiga EG-domstolsbeslut berört principen om res judicata både vad gäller statens skadeståndsansvar och omprövning av beslut. Det är emellertid fortfarande tvetydigt vilket omfång res judicata har, eftersom rättspraxis befinner sig i statu nacendi och således förefaller vara särskilt komplex. Det är allmänt känt att EG-domstolen förstärker och/eller tydliggör en nyetablerad princip genom efterföljande rättspraxis. De fall och förslag till avgöranden från 2006 och 2007, t.ex. TDM, EDF Man Sugar, Kapferer, i-21 och Arcor, Lucchini och Kempter som kan sprida ljus över de principe besluten från 2003 (Köbler) och 2004 (Kühne & Heitz), bör därför analyseras djupgående. Finns här något nytt under solen? Eller bekräftar dessa senare fall endast tidigare rättspraxis? Syftet med denna artikel är att fastställa omfånget av res judicata i ljuset av EG-domstolens senare rättspraxis. För detta ändamål kan två huvudlinjer av fall urskiljas, nämligen fall rörande medlemsstatens skadeståndsansvar och fall rörande ändring av slutgiltiga beslut. Denna rättspraxis är intrikat sammanvävd och måste därför läsas ihop. Vidare har Köbler-doktrinen ansetts vara underordnad den rättspraxis som går på Kühne & Heitz-linje. Om detta förhållande stämmer kan mycket av den kritik som framförts mot Köblerdoktrinen te sig mindre slagkraftig. Först och främst är det nödvändigt att ge en definition av res judicata (1). Vi kommer att undersöka detta koncept i relation till principen om rättssäkerhet (1.1) för att sedan analysera det i ljuset av gemenskapsrättslig lagenlighet (1.2). För det andra fokuserar artikeln på den rad av fall som rör res judicata och medlemstaternas skadeståndsansvar (2). Denna del kommer att titta på de fall som rör principens utveckling (2.1) och sedan dess bekräftande (2.2). För det tredje har vi utvärderat omfånget av res judicata i samband med den rättspraxis som har att göra med ändring av slutgiltiga beslut (3). För detta ändamål, kommer två områden att bli undersökta, å ena sidan, ändring av slutgiltiga förvaltningsbeslut (3.1), å andra sidan, ändring av slutgiltiga domstolsavgöranden (3.2).
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| 9. |
- Groussot, Xavier, et al.
(författare)
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Res judicata in the court of justice case-law: Balancing legal certainty with legality?
- 2007
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Ingår i: European Constitutional Law Review. - 1744-5515. ; 3:3, s. 385-417
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Forms of res judicata - Unwritten principle of EU law - National procedural autonomy v. EC supremacy - Revision of decisions v. state liability - Finality of administrative decisions v. judicial decisions - Higher respect for judicial decisions than for administrative decisions - Res judicata not absolute - ECJ itself under demands of legal certainty - Analogy between res judicata rules and rules of direct and indirect effect.
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| 10. |
- Kongsholm, Nana Cecilie Halmsted, et al.
(författare)
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Challenges for the sustainability of university-run biobanks
- 2018
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Ingår i: Biopreservation and Biobanking. - : Mary Ann Liebert Inc. - 1947-5535 .- 1947-5543. ; 16:4, s. 312-321
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Tidskriftsartikel (refereegranskat)abstract
- Most university biobanks begin like other university research projects, i.e. with an idea conceived by an individual researcher in pursuit of his/her own research interests, publications, funding and career. Some biobanks, however, come to have scientific value that goes beyond the projects that were initially responsible for the collection of the samples and data they contain. Such value may derive from inter alia the uniqueness of the samples in terms of their sheer volume, the quality of the samples, the ability to link the samples with information retrieved in disease registries, or the fact that the samples represent very rare diseases. This paper focuses on biobanks of this kind, and the special obligations that publicly funded universities have to ensure the sustainability of biobanks with continued scientific value. We argue that universities should adopt policies to deal with the various, diverse issues which may arise during the lifecycle of a biobank. The policies should be flexible, accommodate the freedoms of individual researchers, and reflect the multifaceted nature of biobanks. Yet they should be specific enough to provide guidance and robust enough to safeguard legal norms and ethical values. The paper sets out concrete recommendations which universities should consider and act upon.
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