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Brexit and Pharmaceutical industry

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With the Brexit being announced for the end of the month after being postponed in March,
the different economic and industrial players, be they in the public or private stage, have
spent no small amount of time studying and preparing to anticipate the event. The
pharmaceutical industry is one such domain that will be heavily impacted by the Brexit. So
why would it be the case, and what are the solutions to alleviate the damages?
The first notable consequence we will be able to observe will probably be from import-export
activity in the pharmaceutical domain. In fact, each month the United Kingdom imports 37
million boxes of medicines from the European Union, and certain treatments like Insulin are
exclusively produced away from the UK. Knowing there are at least 3,5 million people
suffering from diabetes in the country, some measures will need to be taken for the patients
to keep taking their treatment. Apart from Diabetes medicines and according to BBC, it may
become difficult to find almost two thirds of the products necessary for scanners and cancer
treatment. In front of this shortage concern, some pharmaceutical groups have begun
accumulating reserves of medicines, moreover the government has decided to stock the
equivalent of 6 weeks of treatment some months ago because they feared a « hard Brexit »
with the exit of the UK from the EU single market. According to Anti-Brexit organisation « Best
for Britain », this storage would cause a 2 billion pounds’ financial surcharge.
However, the United Kingdom wouldn’t be impacted alone. Indeed, even though the country
imports a lot, it exports even more with 45 million boxes of medicines shipped to the
European Union countries each month. Moreover, the European Medicines Agency (EMA) has
revealed to be concerned about the availability of 108 medicines references that are only
fabricated in the UK. In addition to these 108 references, the production of almost 3000 drugs
have steps that take place in the English country. Even in the export domain though, there
will be no short amount of economical and organisational post-Brexit issues from the side of
the United Kingdom.
Focusing on these sorts of issues, a direct Brexit consequence could be observed since last
year. As a matter of fact, the European Medicines Agency has decided since September of
2018 to stop taking medicines evaluation contracts with the United Kingdom. Indeed, for a
new drug to be introduced to the market, it must first successfully pass the numeral steps
from a long process to then be able to obtain the marketing authorisation application (AMM).
Yet, these AMMs are only available in Europe if their holders are legally situated in the
European Union. Usually, the Medicines and Healthcare products Regulatory Agency (MHRA)
based in the UK studies and authorises 20 to 30% of European medicines, but with the
coming of the Brexit, about 40 contracts have already been reallocated to other organisations.
In fact, the EMA reckons that an expert must be available for the entire duration of the
evaluation process, which can take a year. Thus, from the beginning of 2018 to the decision
from the EMA to stop taking contracts with the UK, the MHRA could only obtain two
contracts because of a lack of availability. As an economical consequence the MHRA will thus
lose at least 13 million pounds a year.
The European Medicine Agency is responsible for scientific evaluations, supervision and
safety control for medicines in the EU. It is a necessary entity for the flow of medicines in the
EU single market. Since the agency’s foundation in 1995, the headquarters were originally
situated in London, but, with the Brexit, a relocation was necessary, and, since the month of
March this year, the EMA is now based in Amsterdam. However, it is now faced with
organisational issues. As a matter of fact, the European Agency foresees a loss of 25% of their
employees, from a total workforce of 900 people. The situation is as stated because the
agency’s workers needed to be transferred to the new headquarters from the UK, and they
may not be able to adapt to this sudden transfer. Thus a lot of them could choose to resign,
causing some huge financial losses. The relocation will most likely cause some delays in the
medicine evaluation processes, this leading to even more losses.
Juridically, regarding the fate of marketing authorisations, the following rule was established
by the EMA working jointly with the Federal Agency for medicines and Health Products
(FAMPH), as well as the working groups from the Heads of Medicines Agencies (HMA) and it
applies to all medicines : If the address from the marketing authorisation holder, the
manufacturer responsible for batch release, the one responsible for quality control, for
pharmacovigilance or from the pharmacovigilance system master file is situated in the UK, the
AMM holder needs to transfer his activities to another European Union State as soon as
possible.
Incidentally, concerning medical devices, it was decided for the UK to be considered as a
third-party country for their sales. It implies that British firms will need to mandate an
authorised representative in the EU27 to introduce these kinds of devices to the European
market.
All in all, after identifying a maximum number of potential issues brought about by the
coming of the Brexit, it was necessary for the competent authorities to establish a priority
order, so as to limit the damage once the deadline comes. Naturally the first priority in the
pharmaceutical domain will be to make sure that no product remains unavailable for the
patients. As a matter of fact, this is an important public health issue that needs to be
approached with great care.
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