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What will happen to the EMA?

June 06, 2017

by admin

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What will happen to the EMA and how will it affect us?

While I’m sure many people have written extended essays on this topic already, I was particularly interested in the views of regulatory affairs professionals. What’s their perspective?

This is a question I have heard voiced time and time again by my contacts. The scene. We are finishing off a meeting. We both stand up ready to say our goodbyes. At the point where we would typically share simple pleasantries such as, what are your plans for the weekend? Lovely office! Or comments on the weather, instead my contact muses “You know, these are interesting times with the EMA moving! (Concerned look). Intake of breath. Long stare in to the distance.

 

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Nobody yet knows which country will gain the privilege of housing it or what will happen to its hundreds of staff but it’s a much debated topic and there’s plenty of lobbying going on. One thing is for certain, whichever country eventually secures it will win a tremendous prize!

Brussels has released its criteria for the countries who wish to house it and the member states will need to submit their bids by July 31st. Brussels will then need to make a decision as soon as they can. Whoever does win the EMA will need as much time as possible to get their infrastructure in place. The next location needs to be up and running by March 2019. At the top of their list of criteria is the need for whoever takes over to guarantee a smooth continuation.  This is VERY important but much easier said than done.

Aside from the work the EMA does approving and regulating medicine, there is also the infrastructure needed to keep it running. Employing 900 professionals in London along with 35,000+ regulators and scientists who visit each. In addition to this, there is the support network around it such as transportation, provision of hotels for 30,000 nights a year let alone international school places for its staffs’ children. The above is just the tip of the iceberg. Let’s not forget space for their 30,000 boxes of archives too!

I thought it would be fascinating to randomly ask those of you from various companies and countries around Europe their opinion on where the European Medicines agency headquarters might move post Brexit and how this might affect them.  The following points include just a few of those opinions.

1. It will need to move! I imagine to a country where there is a high degree of English fluency as lots of business needs need to be conducted in English. Since a number of people are going to have to relocate, it’s clear to me they will not have time to learn a new language from scratch. The location will also have to accommodate many people and their families. They will need good transportation links as people will be visiting from all over the world. It needs to be a location where people can fly in directly from the rest of Europe. I don’t really know but if you ask me I think it might end up being the Netherlands as it ticks all the boxes. Hopefully it will be a smooth transition and after all, many of their staff are from other European countries already.

2. I think that it will move to Denmark as I have heard they are lobbying effectively. Things may be happening behind the scenes. I also think that it would be good if it was Sweden as they have excellent expertise. Their HA’s have always been helpful in my experience. I believe that when the move finally happens it will be very challenging and will take a huge effort to sort out.

 

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3. In the end it will all be fine and makes no difference. I’m not really worried. The only challenging period is the transition. It might move to Denmark but it doesn’t matter to me.

4. I don’t think there will be any immediate impact but later I wonder how this will affect the MHRA as they work so closely with the European medicines agency. How will this also affect centralised procedures and mutual recognition procedures? I’m purely guessing, but I think it might move to a Scandinavian country.

5. I hear that it might move to Milan or Lisbon. I’m really concerned about it. I just don’t see how there can be a smooth transition and I’m positive everything is going to get slowed down. We are talking about this all the time internally in my company. Also, what about medical device? The MHRA provides huge support to them in this area. I have also heard concerns expressed by potential host countries that were they to win, then their own health authority’s staff might leave to join the EMA.

6. I wonder what will happen to many of the employees in the EMA now. Many of them will not be able to relocate when this happens. It’s just not going to be practical for them.

7. I think Copenhagen is pretty high on my list of where it might go right now however I wonder if they might be too expensive particularly if they need to build an entirely new building. I also acknowledge that over the years London has become too expensive. Many who used to visit and stay in hotels in Canary Warf are now staying in lower cost hotels further away and having to commute in. Using this cost perspective I just don’t see how it can be a country like Sweden because they are also an expensive country.  I also wonder how many staff in the EMA they will keep after the move. I think they might lose a lot of great people. Even if the 900 permanent staff were to commute to the next location temporarily this would be a huge cost and impractical.

 

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Looking to this time of transition it will be very hard to meet standard timelines for new approvals when we are in the middle of moving the agency to another country. It’s easy to imagine the impact that will have on getting medicine in to patient’s hands. I also wonder how companies will feel about having to apply for a separate licence in the UK after this happens. The UK will need to think about what kind of recognition procedures they put in place later too. There’s a huge amount to be considered and there will be massive implications for everyone depending on what the final decisions are.

 

The overriding message I hear from everyone I speak with has been concern for the relocation of the EMA but also and more importantly, the fact that we need to get the transition right wherever the EMA next puts down its roots. Regulatory affairs professionals are intelligent and are used to working in fast paced ever changing environments, for this reason we should be in extremely safe hands.  What are your thoughts?

Ben Hobbins is a Managing Consultant at Talentmark and an expert in supporting pharmaceutical companies employ senior, global leadership level Regulatory Affairs professionals. For a confidential discussion he can be reached at Ben.Hobbins@talentmark.com.

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