There are over 650 branded over-the-counter (OTC) medicines and more than 125 self-care medical devices that can be bought by the public from a pharmacy or other retail outlet in the UK without a prescription.
These include hay fever tablets, cold and flu treatments, pain killers and indigestion remedies – the everyday household items people have in their medicine cupboards at home. The UK’s continued close relationship with the EU is crucial to securing the continued supply of these products in the UK and the EU27 countries.
In 2015 alone, the UK imported approximately £1.5bn in consumer healthcare products, while exporting approximately the same amount. Although these products did not take centre stage during the referendum campaign, their availability and affordability will inevitably be affected by the decision to leave the EU, and by the future of the UK’s relationship with the EU after March 2019.
PAGB is the trade association representing the manufacturers of these branded medicines, medical devices and food supplements in the UK. Whatever course the negotiations take, our members are clear that the outcome must not risk continued supply of the consumer healthcare products people use on a day-to-day basis to live well. Our priority is to ensure that when the UK leaves the EU, there are no fewer over-the-counter and self-care products available and those products are no less safe than they are today.
The over-the-counter medicines and medical devices which are readily available in our local pharmacies and supermarkets across the UK are regulated and licensed to shared standards agreed amongst all EU members.
The UK has helped develop these shared standards over forty years of pan-EU collaboration. It is therefore vital that we retain these beyond March 2019, and indeed beyond the mooted 20-month transition period.
These shared standards enable products to be developed, tested and released anywhere in the EU, crossing borders as ingredients and finished products without additional checks or delays.
In order to preserve this frictionless and smooth process, the UK government and the European Commission must put in place, as a priority, mutual recognition agreements. Without these, our continued access to high-quality, affordable consumer healthcare products may be put at risk, facing delays at the border and costly duplication of inspection and testing processes.
These delays and disruptions could in turn have a knock-on effect for the wider healthcare system in the UK. If people are unable to self care for self-treatable conditions it will place additional unexpected pressure on an already stretched primary and urgent care system.
Taking decisions now that will shape the future
Our member companies are already having to make decisions now about how to route supply chains, where to manufacture products, and what resources are needed to ensure products can be released in both markets when the UK has left the EU.
Whilst the UK government has made promising nods towards a commitment to continuity, there still remains much uncertainty and concern as to whether mutual recognition of standards and batch testing and release will be agreed by March 2019.
This means companies are exploring alternative scenarios: how they might restructure supply chains, whether to reactivate dormant entities or find new business locations elsewhere in the EU and what new cross-border collaborations are needed to keep products available to the public.
They are preparing for a worst-case scenario – a costly process, which a quarter of PAGB member companies estimate will cost them more than £1 million a year.
How to secure future supply of medicines and medical devices
While PAGB member companies are taking steps to try and mitigate any potential impact of Brexit on the UK population’s access to over-the-counter medicines and medical devices, uncertainty hinders their efforts. As such, we need the government to provide clarity and certainty on the future relationship with EU as soon as possible.
The easiest means of securing the future supply of over-the-counter medicines and medical devices in the UK would be regulatory harmonisation between the EU and UK following March 2019.
By continuing to adhere to the same high standards and regulations, the development, inspection, assessment, testing and release of products could continue as it currently does.
Ingredients and products could flow across borders during the manufacturing and distribution processes without the need for additional inspections, testing or tariffs. This would mean neither the UK or EU public would face delays in accessing the everyday, over-the-counter products they know and trust.
If it is not possible to agree such an arrangement before 29 March 2019, companies will need sufficient time to transition to any new arrangements. The government would therefore need to secure a simple transition process of at least two years but ideally five, during which there is no divergence from EU regulations.
Although not ideal, this will allow time for both regulators and industry to take the necessary steps to ensure compliance and maintain supply.
As the negotiations continue, PAGB and the consumer healthcare industry are committed to ensuring that from day one, people’s access to high-quality over-the-counter medicines and medical devices is not impacted by the decision to leave the EU.
By John Smith, chief executive of PAGB (Proprietary Association of Great Britain) – the UK trade association representing the manufacturers of branded over-the-counter (OTC) medicines, self care medical devices and food supplements.