Readers in the life science sector will be aware of the proposed relocation of the EMA away from London to another European city in the wake of the Brexit referendum vote. This week, the EMA has published a
press release, with a rather alarming sub-heading:
"Staff survey indicates that the future of public health in Europe is at stake"
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Barcelona - one of the top 5? |
The press release explains that to complement the European Commission's assessment of all bids for the relocation of the Agency submitted by Member States that will be published later this month, the EMA is making available the results of its most recent staff retention survey. The survey indicates that for 65% of EMA staff, the new EMA location will be a determining factor in their decision-making whether to relocate or not. The vote on the EMA's new host city is due to take place in November 2017.
A summary of the results of the survey has been published on the EMA website and can be found
here, along with an explanation of the methodology involved. Each candidate host city is attributed a number, and so remains anonymous. (By way of background the full list of the candidate host cities along with details of their bids can be found
here.)
The five candidate host cities with the most favourable feedback in the survey range from staff retention rates of 65% to 81%. The lowest had a measly staff retention rate of 6% (the author is having fun trying to guess the identify of candidate 19...). In terms of impact on the EMA's workings, the survey notes that staff retention rates of 65%+ (for the five highest rated candidates) "meets EMA requirements" but even in this scenario, there would still be the possibility of some delays for the approval of new medicines and safety monitoring, and some public health initiatives would move at a slower pace. The operational implications for the lowest ranked cities are said to be a "public health crisis".
This GuestKat has heard whisperings in recent weeks about likely staff retention rates after the EMA's relocation, and this survey and press release presents a fascinating insight. The fact that the EMA has been so transparent in releasing the information suggests that the issue of staff retention is being taken very seriously by the agency.
At a certain level, those staff unwilling to move will be replaced. However, by whom and of what calibre and what will be the local standards in the EMA and for the other aspects of their lives? The draw of London is immense and it attracts talent even in agencies such as these (haters of London please refrain).
ReplyDeleteA job for their partners (one of the requirements of the bid) and to have faith in the education system on offer for their non local children (another requirement of the bid) are both key.The issue of schools is especially sensitive. In London they can choose to send their kids to be educated in one of the major languages (French Lycee etc) or in English in a good school as opposed to some start up English language international school staffed by Gap Year students or equivalent or where everyone is a non native speaker and they emerge with some weird accent.Unless of course there is an established British or international school on offer in a host country with a proven track record including for special needs etc, university entrance etc.The simple statement that some MS are making that there will be international schools on offer is not enough. So many MS seem to think that people will be satsified with any old school just because the medium of teaching on offer will be English. (It being accepted that an Italian would not want their kids taught in Bulgarian). Some of the countries on the list have established international schools with fine reputations but those are in Western Europe. In Brussels, these cost about the same as a US college education and is paid by corporations who send their staff out there. That is a lot of money per official per year to fork out as it will be paid by the EMA unless the new host MS foots the bill. There is no money to start a new European School. (In the past, prospective officials turned down job offers at the EPO because of doubts about the international schools on offer).
Finally, a partner stuck at home with no prospect of work in the host country makes for a very unhappy family. The whole issue of agencies and who gets them is ultimately one of human capital not headlines for MS. In short, human medicines are in for a not very smooth transition deal.
It is always dumb to move such entities. If we don't want to see massive delays in drug approvals, they need to think of a better option. That is, leave it where it is. It is being moved for political reasons only and not for the benefit of the organisation, its people and its "customers". I understand the argument that it is an organisation that benefits the host nation economically, otherwise so many member states would not be fighting be hosts, and whatever the costs involved, the gravy train will provide.
ReplyDeleteEven where 65% of people say they are willing to relocate to a preferred city, in reality much fewer will move.
A famous drug company recently moved to a city that was the preference of one man, with the loss of many jobs etc. He was happy to lose many people so he could rebuild. But rebuild what? How many of those people the company wanted to keep actually moved? Pascal?
This situation is complex. It will have to be a MS able to resist the robust lobbying of pharma at many levels. In the UK, you didn't even notice the EMA was there -it was just another regulatory body and so it should be. The idea that human medicines are in future going to be treated as some sort of flagship enterprise or prize does not augur well. So maybe another big MS should get it but chances are it will be treated as a prize.
ReplyDeleteWherever it moves to, there will be loss of staff. The new host MS will, no doubt,seek to fill those posts locally. No doubt that is what some MS want to happen i.e. that non-local staff won't want to move to a particular MS and so they can fill the place with locals on temporary contracts. (Again for the UK , this was irrelevant and indeed UK nationals were the minority).If that happens,the choice of host will start to matter -at many levels and not just for scientific expertise but ability to adjudicate on a file robustly and fairly -before it goes back to the Commission.
If doubts start to creep in at the level of MS about the medicines that have been authorised, then what will happen is that the syetm will fall into disrepute and the Directive (and national authorisationsas opposed to central) will come to the fore; and there will be litigation about decisions.
There may be pressure on the EMA to do what it is set up for and to "approve drugs".
ReplyDeleteSomething like the EPO, whose job apparently is to "grant patents"
Don't worry about the small print on examination and assessment.
Given present events, is it a good idea to move something to Barcelona if the intention is to make sure it's in an EU member state?
ReplyDeleteOr rather would the Spanish government even support its re-location to Barcelona now? Why strengthen the Catalans? Would the EU giving it to Barcelona now be seen as a slap in the face for Madrid?
ReplyDeleteIt is always dumb to move such entities.... Yes, indeed, but it is the consequence of Brexit, and a cost forced upon the rest of Europe by UK's decision to leave the EU.
ReplyDeleteI doubt there will be many who are thrilled by the prospect of 2-3 years, even in the best of situations, before the EMA will be back at full operating speed.
However, EMA has to relocate in order to provide continued service to the people of the European Union after the British ceases to be a member. It will be unacceptable to anyone inside the EU that a regulatory body of this importance should not be regulated directly by EU law, the Commission and the Parliament, and subject to the CJEU, but rather in most (all) aspects be subject to parliamentary and governmental regulations by bodies to which NO EU-citizen will have voting rights.
Of course, it has to move but one would question whether EU citizens have voting rights over it anyway or can in any way exercise any influence over it. It is run by the Commission and the fees are paid by pharma.
ReplyDeleteLook at the EUIPO mess -flush with money from renewals paid by companies and those MS with no viable trade mark system ask for hand outs which are decided by the Council.
Was there any need for a centralised system of the EMA when there is a perfectly viable national system under a directive with mutual recognition.The people of the EU are already well served by that system
To Monday, 2 October 2017 at 10:18:00 BST
ReplyDeleteThe move is a consequence of Brexit, but it has not been forced on anyone. The EMA can happily sit in the UK under the auspices of the ECJCEUCJEU. If any readers of this blog happen to be patent practitioners, they will have heard of an institution called the EPO, which is gloriously known to be independent of its host nations, as are government embassies.
You talk like the disgruntled rejected partner that is 'forced' to drown the cats after the divorce.
Actually, the EMA is an organ of the EU -it is an agency. The EPO is an intergovernmental body i.e. an international organisation.So unfortunately, the EMA cannot sit in the UK post Brexit.
ReplyDeleteOne possible model for UK MAs is the patent Union between Switzerland and Liechtenstein which allows marketing authorisations issued by Switzerland to be recognised automatically in Liechtenstein and therefore elsewhere in the EEA (at least for the grant of an SPC) even though those MAs are granted under different conditions(as the CJEU has done).
I'm afraid anon at 10:21 has missed the point and should read the comment replied to, which stated that the EMA, as an institution, could not be regulated by EU law and would be subject to UK law. The analogy with the EPO is clear. The EPO is not subject to German or Dutch law, as has repeatedly and painfully been pointed out on this blog over recent years.
ReplyDeleteNot sure the Swiss-Lichtenstein model will be welcomed by the EU. An MA granted by the new British regulator (formerly the EMA) could be recognised automatically in the EU, but the EU may not be prepared to pay for a system they benefit from but have no control over.
The EMA has now made available its assessments of the various city bids (as provided to the European Commission), including information on staff retention by city. The top 5 for staff retention were Amsterdam, Barcelona, Copenhagen, Vienna and Milan:
ReplyDeletehttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/10/news_detail_002819.jsp&mid=WC0b01ac058004d5c1
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/10/WC500236018.pdf