Negotiators on both sides must heed the call of industry and
patient groups in securing the closest possible
regulatory alignment in the next round
of Brexit talks.
Chair of
the Committee, MP, says:
“In
order to minimise harm
to their citizens, both the UK and the EU-27 should
look to secure the closest possible regulatory
alignment in the next round of the Brexit
negotiations. Failure to do so would signal a triumph of
ideology over the best interests of
patients.”
Regulatory
alignment
The
Committee welcomes the Government’s stated intention to maintain
regulatory alignment with the European Medicines Agency (EMA).
The entire supply chain of pharmaceuticals, from research and
development through to the product being available on a pharmacy
shelf, will be adversely affected by regulatory divergence and
seriously so in the event of a 'no deal'
Brexit
However,
the European Council has stated that preserving the
integrity of the Single Market excludes participation based on a
sector-by-sector approach. Any provisions for continued
co-operation between the EU and the UK in the life sciences are
dependent on similar agreements across the whole of the
negotiations. We believe it is not just
prudent, but essential, that scrutiny is undertaken of
the Department of Health and Social Care’s contingency planning
for a ‘no deal’ situation.
Clinical
Trials and Research and
Development
For the
benefit of patients, particularly with rare conditions, on both
sides of the Channel, it is vital that the UK life sciences
sector is
able to continue to
participate in Europe-wide clinical trials. If the UK does not
adopt the new clinical trials regulations and is unable to access
the EU infrastructure developed within the EU to underpin them,
difficulties for patients and the life science industry could
emerge.
The UK
should seek to continue to be a member of EU Research and
Development (R&D) funding and research mechanisms such as
Horizon 2020 after leaving the EU, if possible on the same terms
as it currently enjoys.
Patient
safety
The UK
should also seek mutual recognition of pharmacovigilance
mechanisms by the MHRA and the EMA as a priority in the next
round of negotiations, as the failure to do so could affect
patient safety both in the UK and the EU. It is also in the best
interests of patients for the UK to continue membership
of all
of the major EU
pharmacovigilance systems and databases, including the European
Database on Medical Devices (EUDAMED) and
Eudravigilance.
Trade,
customs and supply chains
We
support the case for free and frictionless trade with the EU. The
Government should assess the impact of the loss of parallel
imports. We also recommend that the Government undertake further
contingency planning on the impact on the supply chain
of a failure to achieve free and frictionless trade in
pharmaceutical products.
