The Chair of the Committee has written to the Secretary of State for Health and Social Care, Rt Hon Jeremy Hunt MP, to ask for clarity on the transitional arrangements set out in the Draft Agreement on the withdrawal of the UK from the EU.
The Committee welcomes a transition period but the letter asks for further information on the following points:
Will the UK have a meaningful role in shaping future policy within the EMA?
The Draft Agreement appears to set out that during transition, UK agencies and industry will continue to have to abide by European Medicines Agency (EMA) laws and regulations. However, unlike present arrangements, it appears that the UK will have no formal method of engaging with the decision-making process of the EMA. Does this limit the UK to becoming entirely a ‘rule taker’ rather than having any meaningful input with regards to the EMA during the transitional period?
Stakeholder scrutiny and Government transparency
What degree of transparency will be afforded by the Government regarding those EMA meetings which the UK continues to be invited to during transition, to allow for parliamentary, stakeholder and public scrutiny?
Whether ‘associate membership’ of EU agencies is achievable
This Draft Agreement appears to outline that during transition, the UK will enjoy a more restrictive relationship with the EMA than the Prime Minister set out for ‘associate membership’. If this understanding is correct, can the Government confirm how it will be seeking to negotiate ‘associate membership’ after the transition period if, for the 21 months previously, if the UK has accepted a significantly ‘worse’ deal from the EU? The Committee reiterates our most recent Brexit report in welcoming the Government’s ambition to seek ‘associate membership’ of the EMA after the transition period, and believes this is in the interests of patients both in the UK and the EU-27.