EU Exit and the consumer healthcare industry
The triggering of Article 50 on 29 March 2017 marked the start of two years of negotiations between the UK and the EU in preparation for the UK’s exit from the European Union. PAGB has been working with our members and with Government and regulators as well as organisations in the health, pharmacy, pharmaceutical, food and medical devices sectors in preparation for this event and will continue to do so over the next two years.
Our work in this area is focussed on the practical considerations for day one and transition arrangements for the future. In particular, our members’ priorities are to ensure that there continues to be an effective regulatory system and a clear and smooth transition to the new arrangements. As an industry, we also have an interest in the UK negotiating position on regulatory and supply chain issues, trade and the movement of people as it applies to working arrangements in the UK and Europe.
While the UK is still part of the EU, PAGB continues to work closely with our partners in the Association of the European Self Medication Industry (AESGP) to influence the direction of policy coming from the EU on over-the-counter medicines, self care medical devices and food supplements.
PAGB work on EU Exit is being led by our Chief Executive, John Smith, with support from the wider team. Our member companies are involved in this process through their participation on special committees and working groups. PAGB also keeps members up to date on developments relating to EU Exit on a regular basis.
PAGB is working to influence decisions and debate on EU Exit during the EU negotiations and UK Parliamentary activity on the European Union (Withdrawal) Bill, known as the Repeal Bill.
Ahead of the Second Reading debates on the Repeal Bill taking place in the House of Commons on 7th and 11th September, PAGB sent a briefing outlining PAGB’s key issues to MPs.
Further information on EU Exit is available to PAGB members in the member-only area of this website.
PAGB position on EU Exit
Read PAGB’s EU Exit Position
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:
- Ensure no additional regulatory barriers are introduced
- Agree an ongoing partnership/collaboration with the EU27 and continued participation in regulatory structures and processes
- Ensure appropriate mutual recognition agreements are in place to allow over-the-counter/self care products manufactured in the UK to continue to be exported to the EU and vice versa
- Ensure the UK continues to participate in EU pharmacovigilance systems to protect public health
- Ensure a simple, streamlined transition process to any new arrangements with adequate timescales
- Expand opportunities for self-regulation for over-the-counter products to deliver improvements in availability, access and choice for people in the UK, whilst ensuring sufficient regulatory alignment with the rest of the EU.
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.