You can subscribe to receive the EAHP EU Monitor by email here [1]. [1]
At the end of December 2013, the European Commission, Council of Ministers (representing EU Governments), and the European Parliament reached agreement [2] on the terms of a new EU clinical trials regulation.
The new regulation will replace the current, and much criticized, 2001 Directive on the operation of clinical trial authorisation procedures within the EU.
The new Regulation is aimed primarily at dealing with criticisms that the 2001 Directive created a more burdensome and bureaucratic environment for conducting clinical trials, with evidence of a reduced number of trials taking place in Europe as a result [3]. The new regulation will therefore:
The proposed regulation was originally published in late 2012 [4]and was subject to scrutiny and review by the European Parliament over the course of 2013. At the end of this process, representatives of the European Parliament, led by Glenis Willmott MEP [5] (UK, Labour Party), conducted extended negotiations with Governments and the European Commission to agree the final content of its terms.
The European Parliament had been particularly keen to achieve improvements in the regulation in terms of public transparency of the clinical trials process. It succeeded in gaining amendments in areas such as:
The trilogue agreement must now receive final endorsement from a full plenary meeting of the European Parliament, scheduled to take place on 12 March 2014 [6].
The text of the trilogue agreement of December 2013 is available here [7].
In late November 2013 the European Medicines Agency (EMA) made available a new online catalogue containing information on medicine shortages that affect, or are likely to affect, more than one European Union (EU) Member State, where the European Medicines Agency has assessed the shortage and provided recommendations to patients and healthcare professionals across the EU.
However the catalogue does not give a complete overview of all medicine shortages occurring in the EU as the Agency consider that most of these are dealt with at a national level.
The catalogue is available via the human medicines section of the EMA website here [9].
On 3 December 2013, the EU Member States adopted Horizon 2020 [10], the EU’s framework programme for research and innovation for 2014-2020, following the European Parliament’s approval of the Regulation establishing the programme on 21 November 2013.
The programme, with a budget of nearly €80 billion over seven years, is the biggest EU research programme yet, and the European Commission claims it is one of the biggest publicly funded programmes worldwide. Horizon 2020 aims to bring all EU-level funding for research and innovation under one roof and provide a single set of rules.
Horizon 2020 is built on three pillars: (i) Excellent Science; (ii) Industrial Leadership; and (iii) Societal Challenges.
Under the third pillar of Societal Challenges, around €1.21 billion will be dedicated to researching the challenge of ‘Health, demographic change and well-being’. Although the work programme for this area is yet to be finalised and adopted, the following topics with open calls may be of interest to hospital pharmacists involved in research:
Deadlines for funding applications fall in March and October 2014.
General information about Horizon 2020 is available here [11].
Information about currently open calls in the area of Health, Demographic Change and Wellbeing is available here [12].
Further information also available here [13].
The February edition of the European Journal of Hospital Pharmacy is now available! The edition contains articles including:
Please see also a short report on polypharmacy, especially in the elderly.
Edition available here [14].
Links
[1] http://www.eahp.eu/newsletter/subscribe
[2] http://europa.eu/rapid/press-release_MEMO-13-1190_en.htm
[3] http://ec.europa.eu/health/files/clinicaltrials/2012_07/press-releases/ip-12-795_en.pdf
[4] http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd
[5] http://www.europarl.europa.eu/meps/en/35743/GLENIS_WILLMOTT_activities.html
[6] http://www.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2013/0243(COD)
[7] http://www.europarl.europa.eu/meetdocs/2009_2014/documents/envi/dv/envi20140122_clinical_trials_/envi20140122_clinical_trials_en.pdf
[8] https://www.eahp.eu/sites/default/files/files/Shortagespicture(2)(1).jpg
[9] http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000376.jsp&mid=WC0b01ac05807477a6
[10] http://ec.europa.eu/programmes/horizon2020/
[11] http://ec.europa.eu/programmes/horizon2020/en/what-horizon-2020
[12] http://ec.europa.eu/programmes/horizon2020/newsroom/548/495
[13] http://www.eahp.eu/content/horizon-2020-health-related-project-calls
[14] http://ejhp.bmj.com/content/21/1.toc