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EU News for October edition
  1. Richard Price
  1. Correspondence to Richard Price, Department of Policy and Advocacy, European Association of Hospital Pharmacy, Brussels 1040, Belgium; richard.price{at}eahp.eu

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EMA responds positively to EAHP's trial transparency concerns

Following representations from the European Association of Hospital Pharmacists (EAHP) and other interested stakeholders, the management board of the European Medicines Agency (EMA) determined to improve its forthcoming policy on transparent reporting of clinical trial results.

At its 12 June 2014 board meeting, the EMA agreed its policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA Executive Director, Guido Rasi, which will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes. The new policy will come into effect from 1 October 2014.

EAHP had been particularly concerned about the previously shared proposals that would have barred the possibility of printing and sharing the data, as this would make secondary analysis highly problematic.

However, Sense About Sense, members of the academic research community, Glenis Willmott MEP and others remain concerned about the complexity of the proposed terms of use within the EMA policy and the operation of redaction.

EU governments cooperate in historic Joint Procurement Agreement for medical countermeasures

The most recent meeting of the EU's health ministers (the EPSCO Council) resulted in the signature of an historic ‘Joint Procurement Agreement’ to procure medical countermeasures. The agreement will enable governments to jointly purchase medicines in case of cross-border threats to health such as pandemics.

Coming after over 3 years of negotiation, the signing ceremony was held on Friday 20 June 2014 at the end of the EPSCO Council in Luxemburg. The need for such agreement came about after the 2009 H1N1 influenza pandemic, which highlighted the need to strengthen the mechanism through which EU member states procure vaccines and …

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