Issue 2, 2016

the decline and fall of the sacra Infermeria 1996 2016 thesynapse.net 20years cardiac surgery in malta: past, present and future developments in the management of acute coronary syndromes the Value of troponin assays in modern thesynapse medical practice the med Ical professI onals’ network Volume 15, 2016 Issue 02 Issn number 2313-8084 ascular cardIoV research supplement InsIde BrexIt edItorIal the pharma Industry & malta’s aVaIlabilIty of medIcInes wenty-third June 2016. This is the referendum date when British, Irish and Commonwealth citizens living in the tUK and Gibraltar, as well as UK nationals who have lived establishment of a new Unitary Patents Court of Europe, part of overseas for less than 15 years will decide whether the UK will which is set to open in the forthcoming months in London. This withdrawal from the EU or not. Although EU citizens living will have exclusive jurisdiction for litigation relating to European in the UK and Gibraltar will not have a vote, citizens from patents. Obviously, if a Brexit materialises, this Court would the Commonwealth countries of Malta and Cyprus can vote. have to re-locate outside the UK. The reason for this is that, apart from the UK, only these two Apart from the European Banking Authority, London European countries are in Commonwealth. also houses the European Medicines Agency which is the Those in favour of UK’s withdrawal from the EU, or Brexit regulatory body responsible for the scientific evaluation, as it is commonly referred to, are mainly Eurosceptics who supervision and safety monitoring of medicines developed argue that such move would allow for better control of irregular by pharmaceutical companies for use in the EU. It is Europe’s migration, as well as gain more control on UK’s own trade equivalent of the US Food and Drug Administration. Obviously, negotiations and reduce unnecessary EU bureaucracy. However, if a Brexit materialises, the Agency would have to move as those arguing against a possible Brexit claim that this would risk well. This transition would definitely slow the approvals of the UK’s current prosperity, undermine current employments, as pharmaceuticals across Europe. It also goes without saying that well as increase trade barriers with the EU. if Britain were to exit Europe it would produce a lacuna in the A possible Brexit also would undoubtedly impinge on the technical capability of EMA since British experts are renowned healthcare sector. According to a letter published last February to be the biggest contributor to its drug evaluation system. in the Financial Times the UK receives more EU funding per Another aspect is that Malta has over 1400 medicines capita for health research than any other EU country. The letter, licensed in Malta which are sourced from the UK market penned by the UK life sciences sector also states that “Not only through various European procedures. Most notably, parallel would an exit from the EU negatively impact the life sciences importation licences, and authorisations in accordance with sector, but changing the current arrangement would lead to article 126(a) of Directive 2001/83/EC [for justified public health disruption, expense, and significant regulatory burdens for a new reasons] are issued in Malta specifically on the premise that authorization system.” This would possibly translate into less they are licensed in another EU /EEA country; the regulatory funding for innovative research projects stemming from the lifecycle of these medicines shadows that of the source country. various European funding programs such as Horizon 2020. So, if indeed, the UK leaves the EU [and possibly the EEA, Another concern relates to the issue of patents, including negotiating a separate trading relationship with the EU], pharmaceutical ones. Currently, different authorities can decide would this lead to a revocation of these licences by the Maltese on the validity and infringement of European patents. However, authorities? this may give rise to various challenges - when either a patent proprietor seeks to enforce a patent or when a third party seeks to revoke a patent in different countries - such as high costs and possible divergent decisions. This is all set to change with the Editor-in-Chief: Dr Wilfred Galea our collaborators Managing Editor: Dr Ian C Ellul FRONT COVER Sales & circulation Director: Carmen Cachia Email: [email protected] Telephone: +356 21453973/4 MPSA Cover: The Sacra Infermeria, the ‘Holy Infirmery’, or the Mediterranean Publisher: The magazine is distributed free of charge to all Maltese doctors, pharmacists Conference Centre as we know it today Medical Portals Ltd & dentists, as well as students of the aforementioned professions, with a print run was a state-of-the-art hospital at the time The Professional Services Centre of 3500 copies. of its establishment by the Order of the Knights of St John Guzi Cutajar Street, Dingli Malta, Europe Annual subscription rates outside Malta: Six issues €90 or equivalent, worldwide Advertising policy: Advertisers are liable for contents of any of the advertisments. The advertisers shall indemnify and hold harmless Medical Portals Ltd against and from any and all claims, damages, liabilities, cost and expenses Production: Outlook Coop whatsoever, including counsel fees, arising from the content of any of their advertisments. Medical Portals Ltd disclaims any responsability or liability for non-compliance of advertising artwork to regulatory units. The opinions expressed in this publication are those of the respective authors and do not necessarly reflect the opinions Printing: Europrint Ltd of the editors or the institutions with which the author is affiliated unless this is clearly specified. Cutterguide: No Printing Process: Off set Size: 210 x 297 mm (A4) Pages: 1 Colors: C M Y K (4 Colors) GD: NB 31098 Native File: Indesign CC Windows Generated in: Acrobat Distiller XI A maintenance bronchodilator treatment for patients with COPD who are breathless Anoro® Ellipta® (umeclidinium bromide/vilanterol) and severe hepatic impairment. No dosage adjustment Middlesex, TW8 9GS, UK. Last date of revision: October Abridged Prescribing Information is required in the elderly, in renal impairment or mild to 2014. Anoro® and Ellipta® are registered trademarks of the ® ▼ This medicinal product is subject to additional moderate hepatic impairment. Acute symptoms: Anoro GlaxoSmithKline group of companies. All rights reserved. ® ® ® monitoring. This will allow quick identifi cation of new Ellipta is not indicated for acute episodes of bronchospasm. Anoro Ellipta was developed in collaboration with safety information. Healthcare professionals are asked to Warn patients to seek medical advice if use of short-acting Theravance, Inc. report any suspected adverse reactions. See section 4.8 on inhaled bronchodilator increases. A re-evaluation of the In order to ensure that this product information refl ects the SPC how to report adverse reactions. patient and of the COPD treatment regimen should be most up-to-date clinical and post-marketing surveillance undertaken. Interactions with other medicinal products: data, please always refer to the latest Summary of Kindly consult the full Summary of Product Characteristics Interaction studies have only been performed in adults. Product Characteristics (SPC) which is available from (SmPC) before prescribing Avoid beta- adrenergic blockers since this may weaken GlaxoSmithKline (Malta) Ltd (Tel: +356 21238131) ® ® Trade Name: Anoro Ellipta Active Ingredients: or antagonize the effect of beta2-adrenergic agonists. 55 micrograms umeclidinium bromide and 22 micrograms Caution is advised when co-administering with strong REPORTING ADVERSE EVENTS (AEs): vilanterol (as trifenatate). Pharmaceutical Form: CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, ® ® Malta & Gibraltar: If you become aware of any AEs, 55 micrograms/22 micrograms inhalation powder, pre- itraconazole, ritonavir, telithromycin). Anoro Ellipta medication errors and/or use during pregnancy in dispensed. Indications: Maintenance bronchodilator should not be used in conjunction with other long-acting association with GSK products, please report the event treatment to relieve symptoms in adult patients with muscarinic antagonists, long-acting beta -adrenergic 2 promptly to: GSK (Malta) Limited, 1, De la Cruz Avenue, Chronic Obstructive Pulmonary Disease (COPD). Dosage agonists or medicinal products containing either of these Qormi QRM 2458, Malta (Tel: +356 21238131) and administration: Inhalation only. One inhalation once agents. Caution is advised with concomitant use with daily of Anoro® Ellipta® at the same time of the day. methylxanthine derivatives, steroids or non-potassium- Malta: alternatively, any suspected AEs and medication Contraindications: Hypersensitivity to the active substances sparing diuretics as it may potentiate possible hypokalaemic errors can also be reported via the national Adverse Drug Reactions (ADRs) reporting system: or to any of the excipients (lactose monohydrate and effect of beta2-adrenergic agonists. Fertility, pregnancy, magnesium stearate). Precautions: Anoro® Ellipta® should and breast-feeding: No available data. Balance risks against Report forms can be downloaded from not be used in patients with asthma. Treatment with Anoro® benefi ts. Side effects: Common: Urinary tract infection, www.medicinesauthority.gov.mt/adrportal and posted Ellipta® should be discontinued immediately in the event of sinusitis, nasopharyngitis, pharyngitis, upper respiratory

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