Category: Market/Novel Tech

Month: 02 Nov 2017

Issue: not yet available

New location for European Medicines Agency (EMA) may have a significant impact for patients and industry

Following on from the UK government decision to trigger Article 50 of the Treaty on European Union, and thereby provide notice of the country’s intention to leave the European Union (EU), one near-term impact will be the requirement for the European Medicines Agency (EMA) to move from the UK to a new location. The EMA, located in London since 1995, is a decentralised agency of the EU which evaluates and authorises medical products and is responsible for protecting and promoting human (and animal) health in the 28 Member States of the EU, in addition to the jurisdictions of the European Economic Area (EEA).

 

Nineteen (19) EU cities have submitted competitive bids to become the new host of the EMA, bringing as it does significant expertise, influence and business to the winning bidder. As part of the pending re-location, the EMA itself has undertaken a significant level of business continuity planning in order to ensure that its services and obligations to EU citizens will continue to be met, both before and after its move. A key component to maintaining the regulatory and support services of the EMA will be to insure the highest level of staff retention. The skills, knowledge and know-how of existing EMA staff may be quite technical and bespoke in nature and so turnover of key personnel may present large challenges to the EMA’s management over the coming years. In order to plan and manage such challenges, the EMA has run and published a staff survey specifically designed to assess what level of staff may be retained by the agency in each of the potential 19 cities on offer. While the decision on which city will be chosen will be subject to a vote by one representative of each Member State, the outcome of the survey will be difficult to ignore in terms of patient safety, data integrity and the ability of the EU to insure it competes globally in the pharmaceutical and biotech sectors. A statement from the EMA has said: “The results of the survey emphasise the importance of the upcoming decision on the EMA’s future seat, as the retention of skilled and experienced staff is crucial for the agency’s continuity of operations. The outcome that was shared with staff earlier this month revealed that for certain locations staff retention rates could be significantly less than 30%. This would mean that the agency is no longer able to function and, as there is no backup, this would have important consequences for public health in the EU.”

 

Results of the staff survey indicate that even the best-case scenario would not provide an equivalent level of services over those that exist today. Staff preferences for various locations show that employee departure ranges between losing as much as 94% of personnel, or as little as 19%, depending on which location is chosen. The EMA has categorised the preferences into four main groups, depending on the number of staff remaining at the EMA and the level of services which may be delivered with such staff. In reality, it may be difficult to endorse the bid of a city that results in EMA staff losses of 35% or more. Five locations chosen by EMA staff would result in the least staff departures, ranging from 19% to 35%. 14 of the 19 cities that have bid for the agency will result in 35% or greater losses in staff which would be difficult to justify on grounds of patient safety, data integrity, or on the wider competitive issue for the EU pharma industry. At present the UK’s Guardian newspaper suggests that the current favourites to host the EMA are Dublin, Amsterdam and Stockholm, while the ranked outsiders include Bucharest, Warsaw and Zagreb. According to an EU Council Press release, “it is envisaged that the decision will be taken in the margins of the General Affairs Council (Art. 50)”, scheduled for November 20th, 2017.

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