The Association of the European Self-Medication Industry (AESGP) represents the manufacturers of non- prescription medicines, food supplements and substance based medical devices. These products are often the first choice for citizens in case of a health issue. Their availability is crucial for the functioning of the European healthcare systems.
Since the day if the referendum priority of our Industry is to ensure that there is minimal disruption to the supply of self-care products in both the European Union (EU) and the United Kingdom (UK), as the UK exits from the EU. We continue to adapt to new regulatory requirements, manufacturing and supply issues including customs arrangements to ensure an uninterrupted supply of self-care products to citizens.
We congratulate efforts that went into the negotiations from both sides and very much welcome the publication of the withdrawal agreement and political declaration. In particular, the self-care Industry supports the ‘free trade area combining deep regulatory and customs cooperation’ referred to in the political declaration. However, it has not alleviated the concerns of the Industry entirely. As the UK government and the European Union endeavour to go through the process of ratification of the agreement but as well continue contingency planning in case ratification process fales, we believe this provides an opportunity for inclusion of specific references to health and supply of medicines and substance based medical devices that can guarantee access to those and protect public health in Europe and UK. For the three legal categories AESGP is representing, this means the following:
1. The United Kingdom should be as integrated in the European marketing authorisation / registration system for medicinal products as possible. In terms of manufacturing and supply (QP certification/release and batch testing/release more specifically), an MRA should be put in place between the UK and the EU to ensure continuity of supply and ultimately avoid disruption of patient access. If no MRA is agreed, temporary EU acceptance of UK batch testing would avoid immediate shortages at time of exit. In light of the positive contributions made in the past, it would be desirable that the Medicines & Healthcare products Regulatory Agency (MHRA) continues to participate in all relevant EU committees at the European Medicines Agency (EMA).
2. Similar as for the medicines, a Mutual Recognition Agreement (MRA) is needed between the EU and the UK for medical devices to ensure the recognition of UK Notified Bodies / CE-mark by EU members. Post-Brexit UK Regulations should continue to align with the EU Medical Device Regulation to avoid disrupt access to innovation.
3. While the availability of food supplements seems to be not in question, the questions around a more liberal approach towards labelling (including claims) and composition (e.g. nutrients levels, food additives uses) has been raised. This should however be handled with care and reflect balanced judgement and robust science to ensure consumer trust and free movement of food supplements between the European Union and the United Kingdom.
4. The customs classification of raw materials and unfinished goods should be based on their intended use and final destination to ensure low tariffs and simple processes for importation between the UK and the EU. There should be a simplified customs clearance procedure for materials and unfinished products which are being shipped between facilities belonging to the same company. Both UK and EU member states’ governments need to make robust border plans in the event of no deal to ensure companies’ supply chains can continue functioning and are not negatively affected by border delays. More specifically relevant authorities should consider:
a. putting fast track lanes or priority routes for medicines and medical technologies into ports and airports;
b. temporary exempting medicines and medical devices from any new customs and borders checks;
c. enable paperwork and regulatory checks to be completed away from the physical border;
d. recognise certificates issued in the UK to ensure that planes can continue to fly.
5. Tariff exemptions between the UK and the EU should continue to apply for self-care products.
The AESGP members continue to invested in ensuring preparedness for every eventuality until there is certainty of orderly exit. Nevertheless, self-care Industry calls for an explicit commitment of EU27 and UK to securing long-term, extensive cooperation in the field of health and medical technologies, which we believe is in the best interests of citizens and public health.
Adopted by the AESGP Board on 21 March, 2019