EMA Move – The Details
It’s decided. The EMA is moving to Amsterdam, The Netherlands.
They are supposed to be up and running by March 30, 2019 – less than two years away. There are many issues to be resolved by then. In fact there are many issues to be first defined before they can be resolved. To this end several groups have already started the discussion.
Before reading on, have a look at the 3-minute promo video the Dutch did in their bid for the EMA. It is quite amusing actually.
EMA’s Comments on Brexit
First the EMA: The EMA published comments on Brexit. This is EMA’s dedicated page regarding Brexit and it should be checked regularly as it will be updated periodically. In this document the EMA notes that they will start immediately working with the Dutch government to set up a joint governance structure to oversee the relocation. In December, a monitoring chart will be published to allow the public to track progress.
The UK will continue to participate in the activities of the EMA till Brexit is done. The UK will become a “third country” after March 2019. That is, it will not be a part of the EMA or EU and will be treated like any other third country (Author’s comment: maybe). Discussions on this have been underway since April 2017 on how to redistribute the current workload after the UK leaves. A working group on human medicines has been set up and includes members of the CHMP and PRAC. They are working on mapping capacity and expertise (not all member states have equal expertise or manpower), decision making and communication to stakeholders. This document, at the very bottom, has several appendices on the technical issues regarding the physical building and other things the EMA will need in Amsterdam.
Information for Companies
The EMA and European Commission have published some documents on “Information for Companies”. The goal is to ensure an undisrupted supply of medicines to the public. A Q&A was published in December. Some of the key points:
- If a company has a centrally approved MA in the UK, this must be transferred to a country in the EU/EEA.
- If a company has a pending application in the UK and expects approval after March 2019, the company will need to change to an EU member state before March 2019.
- Orphan designation holders in the UK must also transfer the designation to an EU member state.
- If the Qualified Person for PV (QPPV) resides and carries out his/her tasks in the UK, he or she must change place of residence and work to an EU member state.
- If the Pharmacovigilance System Master File is located in the UK, it too must be moved to an EU member state.
- There are multiple additional discussions on manufacturing, biosimilar authorizations, bioequivalence studies in the UK, generic applications, orphan drugs and other topics. See the document for details.
For decentralized and mutual recognition issues see: http://www.hma.eu/535.html.
Another document was issued in November giving details on how many of these changes are actually to be done. See the document for full information on these regulatory matters.
Business Continuity Plan
In October, the EMA published a Business Continuity Plan. It includes information at a high level on ensuring the continuity of EMA’s work. They note it can no longer be “business as usual” as too many things are happening. They are preparing to maintain current staffing but proposing certain “entitlements” to current staff to retrain them and help them move to Amsterdam. They will recruit additional resources as needed over a prolonged time to compensate for staff loss. The EMA is also prioritizing their activities into those which must be done and those which are of a non-strategic character. This will entail setting up a temporary situation whereby not all activities will be done as they are now. Once things are tidied up, they will, in a stepwise manner, have a gradual uptake of all activities.
The highest priority activities are core scientific ones as well as supporting IT applications and communications necessary for the operation of the EMA. Also included are activities to ensure a stable income. Finally the legal obligations that must be done are high priority.
Lower priorities include certain maintenance activities, scientific advice and certification, pediatric activities not linked to specific procedures and processes and others. See the document for more details.
There will be three categories of work: business as usual for some activities, suspension of some activities and reduced output (slowdown) of other activities.
This is a seventeen page document with much detail and if you work with the EMA in your job, it is worth looking at this document.
Well, the companies and industries are reacting to a situation most of them never wanted and many never envisaged. Most of the reactions are fairly obvious in that the industry in Europe and the UK wish for a smooth transition and total cooperation among all parties.
There are several very visible issues pending now including a lease for the London EMA building that will run till 2039 with $470 million due. The problem is that there is no clause that lets the EMA break the lease. So someone may have to pay hundreds of millions of dollars (euros, pounds) for the non-use of the London EMA building.
Another issue is that the new EMA building in Amsterdam will not be ready till late 2018 or even 2019. This means temporary lodgings for the EMA in Amsterdam, probably in several smaller buildings, in 2018 presuming they want to move sooner rather than later. Then another move would be needed in 2019 when the new building is ready.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) put out a statement along with several other EU and British industry groups. Their key points are:
- The phased approach of the Brexit/EMA negotiations should make progress as soon as possible.
- There should be a transition period that lets the companies and health agencies in the EU and member states adapt to the new system.
- Supply disruption of medicines should be avoided. They note that every month 45 million “patient packs” of medicine are supplied from the UK to the EU and 37 million from the EU to the UK. It’s not fully clear what they mean by a patient pack but, in any case, this is a lot of medication.
- They note that many areas required the submission of applications to transfer an MA from the UK to another country as well as applications for batch release sites, quality testing and personnel movements. This must be done expeditiously by all parties to avoid disruptions in March 2019.
We are looking at a very messy situation. There are now about 15 months left to get the EMA set up in Amsterdam. The building (a building) must be ready, IT in place, personnel (~900) transferred or newly hired, etc. As with any large-scale corporate or governmental move, there is much work to be done between now and March 2019. Also, as with any move, there will be bugs, problems and issues to resolve after going live.
Keep in mind that there may be two efforts required for everything:
- One major effort to transfer all needed authorizations, paperwork etc. from EMA London to EMA Amsterdam or another member state health agency. This will keep everything compliant from the EU/EMA point of view.
- The second major effort will be new requirements in the UK to remain compliant in the UK. For example, some products may have to be newly licensed in the UK if they were not centrally approved. New UK regulations may or may not follow current EU requirements. Even if they do, it is entirely likely that they will diverge over time from the EU.
The things to look for will be:
- Has someone taken charge and responsibility in the EMA and in the UK?
- What sort of liaison has been set up with pharma companies?
- What input from industry is sought and is it acted on?
- What are the priorities? Are they logical, reasonable and doable?
- Are priorities given to EU companies over “third country” companies such as those from the US or Japan?
- What happens if the EMA priorities do not match your business needs such that you may have significant disruptions?
- What is happening in the UK in terms of new requirements or obligations?
- Will there be a push for a transition period beyond March 2019 during which the UK still works with the EMA, EudraVigilance etc?
- There will now be only two countries where the English language is a national and native language: Ireland and Malta. There may be a push by France and Germany to have their languages used more including use in drug safety and PV.
Things to look for regarding pharmacovigilance and drug safety:
- The QPPV and the PSMF must be moved to a member state if they are now in the UK.
- Expedited reports may need to go to both EudraVigilance and the (new?) UK safety database.
- If the rapporteur and reviewers of PSURs are in the UK, a new member state must take over this responsibility. This is a transfer of the MA.
- Some products may need to be registered in the UK if their registration is in another member state. This suggests PSURs will need to be submitted to the original member state and now also to the UK.
- We may see more PV inspections by the UK (in addition to those of the EMA and member states) especially since a hefty fee is charged for the inspections. Inspections are a profit center. Whether UK inspections will be accepted by the EMA and vice versa remains to be seen.
- The PRAC, which is headed by a British national, will get new leadership. The UK has always played a strong role in the PRAC and this will change.
- The MHRA will need to create its own “PRAC” or the equivalent.
- Literature searching by the EU/EMA may or may not be accepted in the UK.
- Clinical trial safety is much less centralized than post-marketing PV which is the main focus of discussions and concern now. There will surely be ramifications here.
This will be interesting!
Tags: brexit, drug safety, ema, EU, EudraVigilance, Pharmacovigilance