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Principi di legislazione farmaceutica - II Edizione
No full textIl compendio di Legislazione Farmaceutica, arrivato alla sua seconda edizione, è un testo progettato a fini didattici per studenti del Corso di Studi in Farmacia e in Chimica e Tecnologia Farmaceutiche. E' composto da 10 Capitoli e 9 Allegati. Comprende elementari nozioni di Diritto nazionale ed europeo indispensabili per la trattazione della materia che va dalla organizzazione del Servizio Sanitario, all'esercizio della Professione di Farmacista ai nuovi servizi sanitari erogabili nelle farmacie (Servizio infermieristico, fisioterapia, prenotazioni CUP, diagnostica di prima istanza). In questo testo si parla anche delle Professioni Sanitarie nella loro recentissima evoluzione, delle responsabilità professionali del Farmacista (amministrative, penali, civili e deontologiche), dell'articolazione del Servizio Farmaceutico ovvero della dislocazione territoriale delle farmacie aperte al pubblico, di tutti gli aspetti della produzione e distribuzione dei medicinali ad uso umano e ad uso veterinario (medicinali industriali e galenici) compresa la normativa sull'etichettatura e il foglietto illustrativo, della pubblicità dei medicinali -consentita solo per determinate categorie - dei prodotti a valenza sanitaria vendibili nelle farmacie - e loro specifica regolamentazione europea (medical devices, cosmetici, alimenti speciali quali integratori e dietetici, dispositivi medico-chirurgici). Gli allegati comprendono oltre al Codice Deontologico del Farmacista e al suo "Commentario", i vari modelli ufficiali di Ricette, il registro Stupefacenti, il modulo "buono- acquisto", tutti con le proprie specifiche "norme d'uso"
Patentability of antibodies for therapeutic use in Europe
No full textGeneral guidelines are presented on the types of patent protection available for inventions arising from research in the field of monoclonal antibodies, using concepts drawn from European case law and expert practice
THE ITALIAN AND BRITISH PHARMACY MODEL: A COMPARISON
No full textThis study looks at the different methods and roles of Pharmacists in Italy and the United Kingdom. The investigation was prompted by personal experience gained during a curricular internship in summer 2021, as part of an Erasmus student exchange program at Browns Pharmacy1, a group of 11 pharmacies in Birmingham, in the English Midlands, and completed in 2022 in an Italian Pharmacy. The results are reported in the form of comparative Tables.
Although Pharmacists in both Italy and the UK hold ultimate responsibility for the appropriate dispensing of medicines, delivery to the general public is conducted differently. In Italy, drug dispensing takes place on presentation of the patient at the Pharmacy with a detailed medical prescription. The Italian pharma-cist has a wide range of operational tasks: checking the appropriateness of the prescription, personally dispensing medicines in compliance with the procedures established by Legislative Decree 219/20062, receiving payment, and subsequently sending the prescription to the local Health Authority for refund. In the United Kingdom, preparation and control of medical prescriptions generally take place a priori, before the patient comes to the pharmacy. In the UK, the Pharmacist is flanked by a Pharmacy Technician, not a qualified Pharmacist, who deals with the bureaucratic aspects of dispensing. On receipt of the electronic prescription3, the Technician applies the ‘unwrapping principle’ to prepare the exact dosage prescribed by the doctor in advance of patient presentation. The Pharmacist then checks that the prescription is consistent with the therapy and that the technician has prepared it correctly, signs the label on the prepared packages, which, on request, can be delivered to the patient’s home. This well-defined distinction of roles within the U.K. pharmacy service allows the Pharmacist to focus exclusively on the therapeutic aspects of the prescription. Another particular feature Britain’s pharmaceutical service compared to the Italian system is the preparation, on request, of so-called “Trays”, containers in which the medicines prescribed are divided into individual dosages for each day of the week and into four-time slots (morning, lunchtime, afternoon and evening). A further significant difference between the two prescription management systems is the price of medicines. Set up in 1946 with the National Service Act4, the British National Health Service is based, like the Italian system, on the Universalistic Beveridge Model. However, while in Italy the prescription charge, or co-payment, varies according to the medicine, in the UK, all medicines and medical appliances under The Human Medicines Regulation Act 20125 have a fixed charge of 9.35 pounds, for every medicine or appliance on the prescription. Prescription charges are paid, however, only by those patients not falling within any of the various exemption classes. Galenic formulations have not been prepared in British pharmacies since 2010, when the General Pharmaceutical Council6 was established as the main pharmaceutical regulatory body, almost completely replacing the Royal Pharmaceutical Society of Great Britain7. The management of Controlled Drugs (CDs) is very similar in both countries: regulated in Italy, by the Tables and Sections of D.P.R. 309/19908, and in the UK, by Schedules in the 2013 Controlled Drugs Regulation9. Both systems require locked cabinet custody of certain drug categories, purchase in compliance with predefined procedure and documentation, and a Register of inbound and outbound drug transfer. Likewise, pharmacies in both countries supply self-diagnosis tests and vaccinations. However, UK pharmacies do not have a hospital/specialist medical visit booking system, an innovative service now offered by Italian pharmacies and part of the so-called "Pharmacy of Services" model.
1. https://brownspharmacy.com/; 2. https://www.gazzettaufficiale.it/eli/id/2006/06/21/006G0237/sg; 3. https://digital.nhs.uk/services/electronic-prescription-service; 4. https://www.nhs.uk/; 5. https://www.legislation.gov.uk/uksi/2012/1916/contents; Gordon E Appelbe and Joy Wingfield – “Dale and Appelbe’s Pharmacy and Medicines Law” Tenth Edition 2014; 6. https://www.pharmacyregulation.org/; 7. https://www.rpharms.com/; 8. https://www.gazzettaufficiale.it/eli/id/1990/10/31/090G0363/sg; 9. BML group and Royal Pharmaceutical Society – “BNF (British National Formulary)” Edition 81 March-September 2021; Royal Pharmaceutical Society – “Medicines, Ethics and Practice” Edition 43 July 2019; https://www.legislation.gov.uk/uksi/2013/373/contents/made
IS SUSPENSION OF ANTI-SARS-COV2 VACCINE PATENTS THE MOST APPROPRIATE AND FEASIBLE STRATEGY TO DEAL WITH THE COVID-19 PUBLIC HEALTH EMERGENCY?
No full textDuring the Covid-19 pandemic, the exhaustingly heated debate on the advisability of suspending vac-cine patents became a familiar topic not only among patent specialists but also to the general public. There were staunch defenders of patent protection and those for whom patents merely safeguard the economic interests of pharmaceutical companies and deny citizens' right to healthcare. Every generalized health emergency - whether the appearance of HIV or the current Covid-19 pandemic - triggers acrimonious debate on the need to suspend patents covering medical devices and agent necessary to fight the disease. The consensus view is that patent monopolies bar general access to therapeutic treatments. The frequently abstract, ideological and emotional tones adopted during the debate do not help objective assessment of the pros and cons of patent suspension and its feasibility.
This work aims to provide a clear, objective overview of what suspension of anti-SARS-CoV2 (COVID-19) vaccine patents would entail.
Three essential questions are considered:
First, what is the intended purpose underpinning any suspension of anti-Covid vaccine patents;
Second, what patents should be "suspended";
Third, what, if any, legal instruments exist that would enable rapid, effective patent suspension.
EMA/707383/2020 Corr.1; 19 February 2021,
https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty;
EMA/15689/2021 Corr.1; 11 March 2021,
https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax;
https://worldwide.espacenet.com/
WO2021/188969-A2; WO2021/213924-Al; WO2021/213945-A1; WO2021/214204-A1; WO 2021154763 A1; WO 2021159040 A2; WO 2021159130 A2; WO 2021222304 A2: WO 2021231963 A1; US Patent 10,960,070; US16/344,774; US2021/0275664; WO2021/163365; WO2007/024708; EP2578685 B1; US8278036 B2; US8691966 B2; US8748089 B2; US8835108 B2; US9750824 B2; WO2011/071931; WO2014/160243;US11060107B2; US 9,404,127 US9,364,435; US8,058,069; US10166298-B1; US11040112-B2; EP3532103-A; US9737619-B2 (claim 1); EP3532103 (claim 6); WO2021030701; US9,404,127; US9,364,435; US8,058,069
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
PATENT EXTENSION FOR MEDICINAL PRODUCTS IN EUROPE: SUPPLEMENTARY PROTECTION CERTIFICATES, SPECIFIC CASE LAW AND THE EXPORT WAIVER
No full textSupplementary Protection Certificates (SPCs) are 5-year maximum extensions to a 20-year patent for medicinal and plant protection products. The SPC was instituted to offset, at least in part, the period intervening while awaiting the issuance of a Marketing Authorisation (M.A.) for the medicinal or plant-protection product, i.e., between the filing of the patent application and the granting of an M.A.
Article 3 of Regulation EC/469/2009 specifies the conditions for obtaining this I.P. tool which is based on the two legal pillars: patent law and regulatory law.
Under patent law, application for an SPC may be filed for a product that is an active ingredient or combination of active ingredients, if that product is protected by a basic patent currently in force. The product must be an embodiment of the invention protected by the basic patent and must be specifically identified in the claims of the same basic patent by way of its structural characterisation (Medeva C-322/10) or its functional characterisation (HGS vs Eli Lilly C-493/12). In the case of combinations of active ingredients, the combination must be part of the invention covered by the patent, and each of the active ingredients must be specifically identifiable in the light of the information disclosed in that patent.
Under regulatory law, the active ingredient or combination of active ingredients for which an SPC is sought must be contained in a medicinal product with an M.A. pursuant to Directive 2001/83/EC. The medicinal product must contain all the active ingredients mentioned in the SPC application, as confirmed by decisions Georgetown C-422/10, Medeva C-322/10. The medicinal product in question may, however, also comprise other active ingredients.
No product that has been granted an SPC may obtain a second SPC. However, the same patent may generate other SPCs for different products, provided that each product is protected by that same patent and is an ingredient of the Marketing-Authorised medicinal product.
In the special case of a new combination of ingredients consisting of a first active ingredient protected by a basic patent and already the subject matter of an SPC, along with a second active ingredient known in the prior art, a new SPC may be obtained only if the combination is specified in the wording of the claims of the
basic patent and is identified as an embodiment of the invention. However, if the specific combination is not an embodiment of the invention, no new SPC may be allowed (Sanofi C-443/12).
The question of SPC protection of combinations of active ingredients is the subject of open debate in Europe and important decisions of the CJEU on the issue are expected in the very near future.
SPCs may be granted only on the basis of the first M.A. for a medicinal product. A second SPC may not be granted on the basis of a new M.A. for a second therapeutic use or for a new formulation of a product that has already been granted a first M.A. (see Decision C-673/18 - Santen vs INPI and Decision C-443/17-Abraxis Biosciences vs Comptroller).
Regulation EC/469/2009 was recently amended by Regulation EU/2019/933 to include the granting a waiver within the SPC framework to allow the manufacture and storing of generic and biosimilar forms of original active ingredients, yet without affecting the finality of the protection of intellectual property rights that remain one of the cornerstones of innovation, competitiveness and growth in the internal market. (Recital no.7).
In practical terms, the waiver system allows a medicinal containing a product SPC-protected, as well as any connected act strictly necessary for the realization to be manufactured no earlier than six months prior to the expiry of the SPC for the purpose of export to third countries where there is no protection or, for the purpose of temporarily storing product in a EU member state before release onto the market that is allowed the day after SPC expiry
LANDSCAPE REVIEW OF IMPLEMENTING AND DELEGATED ACTS APPLICABLE TO EUROPEAN MEDICAL DEVICE REGULATION 745/2017
No full textIntroduced by the Lisbon Treaty, Implementing and Delegated Acts are a new source of European law. Disciplined respectively by Articles 290 and 291 of the TFEU, they aim to improve the effectiveness of the European decision-making process by simplifying the implementation/execution procedure. This study investigated the Implementing and Delegates Acts pertinent to EU Regulation 745/2017 on medical devices. Although complicated by the fact that these Acts are issued at different times and with different modalities following the entry into force of the Regulation to which they refer, our research was facilitated by the Eur-Lex database. Data extrapolation was followed by careful analysis of each Act and the creation of Tables with succinct but comprehensive summaries in chronological order. The result is an updated overview of a complex ongoing regulatory process. While eight Implementing Acts pursuant to Art 35, 27.2, 106.17, 10.6, 33.8, 5.6, 10.6 of the MDR have been introduced by the Commission at different times, none of the twelve Delegated Acts referred to in Article 115 of the Regulation has yet been forthcoming. Unlike Implementing Acts, Implementing Decisions n. 2021/1182 and 2022/6 stand out for their clarity, with the specific ISO regulation on medical devices official acknowledged as a binding requirement.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.)
https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=celex:32017R0745#:~:text=Regolamento% 20(UE) 2017% 2F745,rilevante ai fini del SEE. )
- Consolidated version of the Treaty on the Functioning of the European Union
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12012E/TXT:it:PDF - C. Rivadossi, Il TFUE e le nuove fonti del diritto dell’Unione Europea. Atti delegati e Atti di esecuzione a confronto, 12 ottobre 2014, Cattedra di diritto pubblico, Università di Brescia.
https://www.forumcostituzionale.it/wordpress/wp-content/uploads/2013/05/rivadossi.pdf
- J. Mendes, Delegated and Implementing Rule Making: Proceduralisation and Consultation De-sign, European Law Journal, Vol. 19, No. 1, January 2013, pp. 22–41
- European Commission, questions and answers European nomenclature of medical devices
https://ec.europa.eu/health/system/files/2021-10/md_q-a_emdn_it_0.pdfo
- European Standardization https://www.cencenelec.eu/european-standardization/
- https://ec.europa.eu/info/law/law-making-process/adopting-eu-law/implementing-and-delegated-acts_it
- Comitology
https://ec.europa.eu/info/law/law-making-process/adopting-eu-law/implementing-and-delegatedacts/comitology_it
- https://eurlex.europa.eu/search.html?SUBDOM_INIT=ALL_ALL&DTS_SUBDOM=ALL_ALL&DTS_DOM=ALL&lang=en&type=advanced&DB_IMPLEMENTING=32017R0745&qid=1636408561747
- https://eurlex.europa.eu/search.html?SUBDOM_INIT=ALL_ALL&DTS_SUBDOM=ALL_ALL&DTS_DOM=ALL&DB_DELEGATED=32017R0745&lang=en&type=advanced&qid=1636408628734rire test
TRADE SECRETS, INTELLECTUAL PROPERTY AND VACCINE
No full textKnow-how is a set of intangible techniques and practices characterized by secrecy such as to provide the holder with an economic advantage. Although this definition is not sufficient to ensure patent coverage, trade secrets can nonetheless be protected under law. EU Directive 2016/943 establishes that trade secrets constitute any information that is: a) secret in the sense that “it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question”; b) has commercial value because it is secret; (c) has been “subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret”. The Covid-19 pandemic caused by a new coronavirus confronted the scientific community with a major challenge: developing a vaccine. An immense effort led to the development and subsequent availability of several effective vaccines and therapies, which, however, are not accessible to the entire world population, especially those in middle and low-income countries. Since research into and development of a new drug entails intangible knowledge and processes protected by trade secret regulations, one hundred international intellectual property specialists have petitioned for a temporary derogation from the TRIPs agreements protecting intellectual property. With its resolution of 10 June 2021, the European Parliament has also come out in favour of a temporary modification to the TRIPs agreements. However, the parties involved have yet to reach a consensus. This study looks at the possible ways in which the parties could achieve an agreement that would protect their rights.
- DIRECTIVE (EU) 2016/943 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (Text with EEA relevance)
- Solenne V., P&SLegal, https://www.pandslegal.it/life-science/proprieta-intellettuale-e-salute-in-emergenza/ consulted on 20/04/2022;
-Tajoli L., Ispi on line, https://www.ispionline.it/it/pubblicazione/trade-vaccini-liberi-tutti-30436 ;
consulted on 20/04/2022;
- Zanoli E., Il Sole 24 ore, https://www.ilsole24ore.com/art/vaccini-ostacoli-licenza-obbligatoria-ADoegkPB; consulted on 03/05/2022;
- Parlamento Europeo, https://www.europarl.europa.eu/doceo/document/RC-9-2021-0306_IT.html ;
consulted on 15/05/2022
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
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