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- 07/06/2017

Patients Must Be Central in Any Decision on the EMA’s New Home

Pharma Horizon

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Brexit – the United Kingdom’s eventual departure from the European Union – brings with it myriad of challenges, and none more urgent than those that will have a potential impact on patient health. From an industry perspective, securing cooperation on the regulation of medicines for patients and public health as part of the negotiations will be key. It is against this backdrop that the future location of the European Medicines Agency is so important.

We justifiably should be proud of a system of medicines regulation that showcases European collaboration within the EMA. EU Member States’ committed drive to co-operate – agreeing to a single set of rules for medicines regulation and applying their own individual expertise to this process – has created a world-class environment that has seen the development of a marketing authorisation system that benefits patients, companies and academic research alike.

Underpinning this well-functioning system that helps to ensure that EU citizens receive effective, safe and high-quality medicines is a robust framework for pharmacovigilance. This allows for a rapid detection and analysis of medicines safety issues, prompting regulators to move swiftly to secure patient safety where necessary. It is the expertise within the EMA and, more specifically, within its scientific committees – composed of experts sourced from every Member State of the EU – that makes this monitoring system such a success.

So what precisely should the EMA’s new home city look like? Firstly it needs to have outstanding connectivity. This means it must be extremely accessible and have excellent transport links (international, regional and local transport), so that it is capable of welcoming and hosting the estimated 36,000 expert visits that the agency receives annually. It must also be able to handle the vast number of regulatory exchanges that the global pharmaceutical industry.

Also vital will be a suitable building that allows the EMA to host the vast number of essential expert meetings it organises every year. Moreover, the location will have to be able to provide a large number of hotel rooms for the experts who engage EMA and provide input into essential regulatory processes.

Of course the agency would not be able to function without excellent staff, so retaining them or attracting equally competent people must be high on the list. This means ensuring that sufficient and decent housing is available, as well as access to international/European schools for staff with children and employment opportunities for spouses or partners.

EFPIA appreciates the call for business continuity for the agency, as set out in the procedure endorsed by the Heads of States on 22 June 2017. It is important that the EU-27 provided clarity about clear criteria leading to the relocation of the European Medicines Agency. However, the decision about the relocation of the EMA has not been taken yet and we will have to wait till November before we know where the EMA will go. A potential failure to take into account the minimum prerequisites or the failure to achieve a rapid resolution on the future location would threaten the quality of the EMA’s work and may have consequences for patients and public health.

To mitigate any risks that may arise in the interim, once a host city has been selected, appropriate transition arrangements may need to be put in place to allow the agency’s work to continue whilst an orderly transfer of location is undertaken. EFPIA calls on the Heads of State to take into account all six criteria in order to ensure the vital businesses continuity of the EMA.

The citizens of Europe have benefitted from the excellent work undertaken by the EMA and its scientific expertise for over two decades. It would be tragic if its essential activities were to be impeded as a result of the UK’s decision to leave the EU. To be clear: a break in regulatory continuity represents an unacceptable risk to patient health and this is why finding the optimum new location for the EMA is of such importance: in the event of obstruction or failure, Europe possesses no backup option.



 

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