PAGB considers it vital that there remains effective proportionate regulation for over-the-counter medicines, self care medical devices and food supplements after the UK leaves the EU. PAGB’s priorities are to:
Over-the-counter medicines, self care medical devices and food supplements are rightly highly regulated products. This is imperative to protect public health. Regulation of these products in the UK must continue to be sensible and proportionate, without becoming overly burdensome.
Since the EU referendum on 23 June 2016, PAGB has worked with its member companies and stakeholders to examine the implications and probable impact of the UK’s exit. It is our view that to protect public health and ensure the supply of safe and effective medicines and self care products to the British people, it is vital that the UK maintains a close partnership with the EU, through continued participation in EU regulatory and pharmacovigilance structures and processes and through access to the single market. Mutual recognition arrangements between the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) should be put in place to avoid unnecessary duplication.
We would like the UK to be a ‘trusted partner’ of the EU and for the two parties to work closely together to achieve, as far as is possible, a frictionless border. We would like to see a customs union agreement to minimise the additional time and administrative burden that would result from a hard border. In the meantime, it is vital the UK works to invest in improvements to its customs infrastructure to reduce the impact of any future additional burdens and, more importantly, to ensure the UK does not become, or be perceived to be, a customs weak-spot and an entry point for counterfeit products, falsified medicines or parallel trade, which would in turn undermine the UK’s ability to be a trusted partner of the EU.
PAGB and its member companies are committed to working with Government departments and agencies, including MHRA, to ensure negotiations over the terms of the UK’s departure and any future arrangements take our concerns into account and ensure appropriate measures are put in place to mitigate the risks we have identified to public health and the continued availability of medicines and other self care products in the UK.
PAGB’s position outlines an overview of PAGB’s concerns for the regulation of over-the-counter medicines (including traditional herbal medicines), self care medical devices and food supplements. We have also considered the possible opportunities that exist to improve access to over-the-counter/self care products after the UK has left the EU.