Back to the Roots: A First Marketing Authorisation Is the First Marketing Authorisation ‒ Santen SAS v Directeur général de l’Institut national de la propriété industrielle

2020 ◽  
Author(s):  
Laura Valtere
Keyword(s):  
Marketing Authorisation ◽  
Propriété Industrielle

scholarly journals Patterns of use, effectiveness and safety of gadolinium contrast agents: a European prospective cross-sectional multicentre observational study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jarl Åsbjørn Jakobsen ◽  
Carlo Cosimo Quattrocchi ◽  
Frank H. H. Müller ◽  
Olivier Outteryck ◽  
Andrés Alcázar ◽  
...  
Keyword(s):  
Image Quality ◽  
Observational Study ◽  
Contrast Agents ◽  
Marketing Authorisation ◽  
Safety Data ◽  
Radiological Diagnosis ◽  
Routine Practice ◽  
Diagnostic Confidence ◽  
Cross Sectional ◽  
Wide Range

Abstract Background The EU gadolinium-based contrast agents (GBCA) market has changed in recent years due to the European Medicines Agency decision to suspend the marketing authorisation of linear GBCA and the marketing authorisation of new generic macrocyclic GBCA. The study aims to understand the patterns of (GBCA) use, and to study the effectiveness and safety of GBCA in routine practice across Europe. Methods Prospective, cross-sectional, multicentre, observational study in patients undergoing contrast-enhanced magnetic resonance. Reported usage patterns included indication, referral and examination details. Assessment of effectiveness included changes in radiological diagnosis, diagnostic confidence and image quality. Safety data were collected by spontaneous patient adverse event (AE) reporting. Results 2118 patients were included from 8 centres across 5 European countries between December 2018 and November 2019. Clariscan, Dotarem (gadoteric acid), Gadovist (gadobutrol) and ProHance (gadoteridol) were utilised in 1513 (71.4%), 356 (16.8%), 237 (11.2%) and 12 (0.6%) patients, respectively. Most were performed in CNS-related indications (46.2%). Mean GBCA doses were 0.10 mmol/kg body weight, except for Gadovist (mean 0.12 mmol/kg). GBCA use increased confidence in diagnosis in 96.2% of examinations and resulted in a change in radiological diagnosis in 73.9% of patients. Image quality was considered excellent or good in 96.1% of patients and across all GBCA. Four patients reported AEs (0.19%), with only 1 (0.05%) considered serious. Conclusions This European study confirmed that GBCAs are used appropriately in Europe for a wide range of indications. The study demonstrated a significant increase in diagnostic confidence after GBCA use and confirmed the good safety profile of GBCAs, with comparable results for all agents used.

scholarly journals In the service of secrecy: An enveloped history of priority, proof and patents

2021 ◽  
pp. 135918352110288
Author(s):  
Eva Hemmungs Wirtén
Keyword(s):  
Intellectual Property ◽  
Early Modern ◽  
Property System ◽  
Private And Public ◽  
History Of ◽  
The Individual ◽  
Propriété Industrielle ◽  
The Cost ◽  
Double Envelope ◽  
Double Compartment

This article is about an everyday paper object: an envelope. However, as opposed to most other flat paper containers, the enveloppe Soleau can only be bought from L’Institut national de la propriété industrielle (INPI) in Paris. At the cost of €15 you get a perforated, double-compartment envelope allowing you to constitute proof of creation and assign a precise date to your idea or project. But the enveloppe Soleau is something much more than just a simple and cheap way by which you can prove priority in any creative domain. It is a material footprint anchored to centuries of practices associated with disclosure and secrecy, a gateway into the infrastructure of the intellectual property system and its complicated relationship to the forms of knowledge it purports to hold. The purpose of this article is to consider the making of the enveloppe Soleau as a bureaucratic document, a material device performing a particular kind of legal paperwork. In four different vignettes, the article tracks the material becoming of the enveloppe Soleau as an evidentiary receptacle, beginning by going back to early modern practices of secrecy and priority, continuing with its consolidation in two patents (from 1910 and 1911) to the inventor Eugène Soleau (1852–1929), and ending up, in 2016, dematerialized in the e-Soleau. As a bureaucratic document, the enveloppe Soleau shows just how much work a mundane paper object can perform, navigating a particular materiality (a patented double envelope); formalized processes of proof (where perforations have legal significance); the practices of double archiving (in an institution and with the individual) and strict temporal limitations (a decade). Ultimately, the enveloppe Soleau travels between the material and immaterial, between private and public, between secrecy and disclosure, but also between what we perceive of as the outside and inside of the intellectual property system.

scholarly journals PND72 Measuring the IMPACT of Almitrine Marketing Authorisation Withdrawal on Public Health in France

2020 ◽  
Vol 23 ◽  
pp. S636
Author(s):  
S. Lane ◽  
E. Lynn ◽  
J. Slattery ◽  
S. Shakir
Keyword(s):  
Public Health ◽  
Marketing Authorisation ◽  
The Impact

Libre propos sur la propriété industrielle

Légipresse ◽  
2019 ◽  
Vol N° 62 (HS2) ◽  
pp. 19-157
Author(s):  
Frédéric Benech
Keyword(s):  
Propriété Industrielle

The Magistral Preparation of Advanced Therapy Medicinal Products (ATMPs)

2020 ◽  
pp. 1-7
Keyword(s):  
Marketing Authorisation ◽  
Health Care Systems ◽  
Human Keratinocytes ◽  
Public Health Care ◽  
Medicinal Products ◽  
Bacteriophage Therapy ◽  
Access To Treatment ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy ◽  
Advanced Therapies

Advanced Therapy Medicinal Products (ATMPs) embody innovative therapies that have created great hope for patients suffering from previously untreatable diseases. Unfortunately, the pharaonic cost to produce and authorise ATMPs is a challenge for both patients and public health care systems, ultimately reducing patients’ access to treatment. Over the last 11 years, only 15 ATMP marketing authorisation applications received a positive draft opinion from the European Medicines Agency’s (EMA’s) Committee for Advanced Therapies (CAT). Moreover, due to poor return on investment, several ATMPs have already been removed from the market. In addition to the centralised procedure to obtain a marketing authorisation, the legislator foresees an alternative route for authorising ATMPs, the so-called “ATMP Hospital Exemption”. However, such ATMPs must be produced on a limited scale, on a non-routine basis. As a result, valuable ATMP therapies that have been used for years in hospitals may disappear. To avoid this, we propose, in this paper, an additional possibility to regularise ATMPs: the “Magistral Preparation of ATMPs”. It is a feasible pathway, which was already proposed for bacteriophage therapy, and which is particularly suitable for personalised therapies and considerably decreases the cost of the final products. We also discuss the practical impact of the ATMP regulation for (for-profit) industries and for (non-profit) hospitals. Two practical examples, the cultured human chondrocytes and the cultured human keratinocytes, are discussed.

scholarly journals Differences between the European and Eurasian Good Pharmacovigilance Practices

2021 ◽  
Vol 9 (2) ◽  
pp. 75-84
Author(s):  
A. V. Matveev ◽  
A. E. Krasheninnikov ◽  
E. A. Matveeva ◽  
B. K. Romanov
Keyword(s):  
Marketing Authorisation ◽  
European Medicines Agency ◽  
The European Union ◽  
Current Version ◽  
Eurasian Economic Union ◽  
Expert Analysis ◽  
The Russian Federation ◽  
Economic Union ◽  
Systems Effectiveness ◽  
The Eu

Good pharmacovigilance practices (GVP) of the Eurasian Economic Union (EAEU) were prepared based on the GVP of the European Medicines Agency that have been in force in the European Union (EU) since 2012. The EAEU GVP have been in force in the Russian Federation and the other EAEU member states since 2016. It is important to identify potential differences between the current regulations in order to harmonise requirements for the pharmacovigilance systems in the EU and EAEU. The aim of the study was to analyse and compare GVP requirements in the EU and EAEU. The analysis helped to identify differences in the structure and contents of GVP sections, the definitions of terms (EU GVP definitions are more detailed and supported by examples, subsections, and references to other documents). Moreover, supplements and annexes to the EU GVP contain figures, templates, examples, algorithms, and tables, which are missing in the EAEU GVP. Expert analysis of these differences as applied to assessment of the pharmacovigilance systems’ effectiveness, and practical activities of marketing authorisation holders, medicine developers, and regulatory authorities, demonstrated that the two GVPs are sufficiently harmonised and have very few differences. However, the number of differences between the documents increases, as changes are made to the EU GVP. A more comprehensive harmonisation of the EAEU GVP with the current version of the EU GVP will make it possible to develop and use uniform pharmacovigilance documents in the EU and EAEU, and will facilitate the introduction of EAEU medicines into the global pharmaceutical market.

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