Creation of UK Medicines Agency post Brexit
Recently there was this excellent thread on twitter highlighting the issues surrounding the work required for timely creation of a UK version of the European Medicines Agency. which the UK will not be a member of after Brexit.I have decided to write to my local MP asking them to table a question to the Department of Health, requiring the department to give a status report on the work to create this much needed regulatory body.
Below is the text of that letter to my MP, which is made available for anyone to copy and adapt as necessary. I think that the letter could be easily adapted to cover anyone of the many agencies that the UK currently benefits from within the EU, and which provide vital regulatory oversight which the UK would not want to loose post Brexit.
Dear Sir/Madam,
I
wanted to bring a matter of vital importance to your attention in the
hope that you can ask either a written question or ask a question on the
floor of the house to the relevant minister. I apologize for the length
of this email, but I wanted to provide you with the relevant
background;
I am sure you are aware as part of our membership of the EU, the UK benefits from the work of the EMA (European Medicines Agency). The EMA is
responsible for the scientific evaluation, supervision and safety
monitoring of medicines in the EU. For the purpose of this email I will
assume that the UK leaves the EU in April 2019 (as stated by Theresa
May), and that a transition deal is agreed covering all EU agencies for 2
years, taking the UK to April 2021.
After 2021 then the UK will have two options for continued regulation of medicines:
- the first is for the UK to abrogate future responsibility for all medication regulation to the EMA, even though the UK will have no say in it's decision making or future regulations that might be applied, This does mean that the UK will in effect still be subject to the Eu regulation, but it also means that UK companies and individuals are in a legal gray area, with no UK chain of authority through the UK courts to a UK regulator, and (as I understand it) very little recourse to take action against the EMA through the European courts, should there be a case of failed regulatory oversight.
- the second is for the UK to create it's own parallel organization (call it the UK Medicines Agency - UKMA) in time for for the UK to leave the EMA in April 2021. As I understand it this form of independent government agency requires primary legislation agreed by parliament, to create the agency, and set out it's key roles and responsibilities. The Minister in charge would then need to appoint an initial chief executive, and governing board, and then set about the task of creating the detailed regulations as required by the agency (and then getting them approved by parliament). The board will need to recruit it's key staff (many of them within the UKMA will need to be scientific experts), and of course this new agency will need an HQ - presumably a purpose built location.
It
is not unreasonable to assume that for the government that the 1st
option (abrogation of decisions to the EMA after EU transition) would
not be acceptable (even for a short period after transition), and that
the UK government will wish to continue to have regulatory oversight of
licensed medication within the UK; therefore the second option (creation
and staffing of a UK agency by April 2021) is the only option available
to the UK government. There is no sensible do nothing approach, The UK
must have some level of regulatory oversight.
I
understand that the creation, and staffing of such an expert agency
from scratch can take at least 3 years (which includes legislation,
buildings, staffing etc); it is likely that the initial staffing is a
problem that will easily take at least 3 years, and can only start once
the agency is authorized and has somewhere to work from. The creation of
a new building can also be a multi-year challenge, assuming that no
suitable large scale empty building is available, and that planning
permission for such a new building is straight forward.
Can
you therefore ask the Department of Health for the status of the
legislation and other preparatory work required to have the UK MA
operational by April 2021, given that work will need to start within the
next few months at the latest to meet that April 2021 deadline (again
assuming a two year transition deal is agreed).
I await your reply on this urgent matter; I am sure you will appreciate
that this is a issue which impact almost every member of society.
P.S. I understand that the EMA is one of many European regulatory agencies that the UK benefits from and where parallel organizations are required (all created by April 2021). I can see a great deal of urgent work to authorize these agencies in the near future, all of which will require parliamentary scrutiny, funding, staffing, headquarters and so on. The next few months will be very busy in parliament, as all of this work needs to be done very soon on top of the existing legislative program; good luck.
