The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe.
You can subscribe to receive the EAHP EU Monitor by email here [1]. [1]
The European Association of Hospital Pharmacists (EAHP) has launched a recruitment call to hospital pharmacies across Europe encouraging them to sign up to the EAHP-EPSA Internship Platform [2]. The platform enables hospital pharmacies to offer students and young pharmacists from other European countries the opportunity of gaining cross-border practice experience.
More information here [3].
It has been announced that after nearly 4 years of deliberation, political agreement between the European Parliament and European Union (EU) Governments has been reached on the legal texts of a new medical device regulatory regime for the EU.
The full texts of the agreed regulations had not been released at the time of writing, and will still require confirming votes in both the European Parliament and the structures used by representatives of national Governments. Nonetheless, the announcement of the agreement remains significant given the protracted debate thus far between EU institutions about the detail of the proposals.
One of the major sticking points had been difference of view on the reprocessing of medical devices for single use. Quoted on the website of the Regulatory Affairs Professionals Society, Jérôme Unterhuber, spokesman for the Council of the European Union (the coordinating body for EU national governments) said: "The NL Presidency of the Council and the representatives of the EP [European Parliament] agreed that reprocessing and further use of such devices will only be possible where it is explicitly authorised by national law and will be subject to strict rules ensuring safety. For reprocessed single-use devices all the responsibilities of the original manufacturer go over to the reprocessor. The EP had originally asked to allow reprocessing of single-use medical devices unless it is banned by member states."
Beyond new rules around reprocessing of single use devices, the Regulation also aims to achieve:
This article was made with reference to reporting on the Lexocology blog [4] and RAPS Regulatory Focus [5].
European Council of the EU Press Release here [6].
The Directorate General of the European Commission with responsibility for free movement of professionals (DG GROW) has launched a public consultation to seek stakeholder opinions on the proportionality of professional regulation across Europe.
Over the past two years, all EU Member States have been encouraged by the European Commission to conduct what is termed "mutual evaluation" as a means of "screening their regulatory arrangements for professions and ensuring that they are 'proportionate' to legitimate public interest objectives, without creating unnecessary regulatory burden and labour market restriction."
18 of the 28 EU countries, plus Norway, have now submitted "National Action Plans" on professional regulation on the basis of this mutual evaluation exercise.
The Commission now seeks to know what stakeholder opinion is on:
The consultation will remain open until 19th August 2016.
EAHP is currently reviewing the consultation documentation in respect to areas of hospital pharmacist interest.
More information here [7].
The Online First edition of the European Journal of Hospital Pharmacy this week published a special editorial in memoriam to Per Hartvig Honoré, long-standing member of the EJHP editorial board, and former editor of EJHP Science.
Editorial article here [8].
Links
[1] http://www.eahp.eu/newsletter/subscribe
[2] http://www.eahp.eu/students/eahp-epsa-internship-platform
[3] http://www.eahp.eu/press-room/calling-all-hospital-pharmacies-%E2%80%93-join-eahp-epsa-internship-platform
[4] http://www.lexology.com/library/detail.aspx?g=064d68a6-08f0-4bff-bf30-7b4741b4880a
[5] http://www.raps.org/Regulatory-Focus/News/2016/05/25/25017/Updated-EU-Reaches-Agreement-on-New-Medical-Device-IVD-Regulations/
[6] http://www.consilium.europa.eu/en/press/press-releases/2016/05/25-medical-devices/
[7] http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8827
[8] http://ejhp.bmj.com/content/early/2016/05/31/ejhpharm-2016-000979.full