Patients are at risk of not having access to potentially life saving drugs if Britain and the European Union fail to agree ongoing co-operation in the regulation of medicines after Brexit, negotiators have been warned.
In a letter to the chief EU negotiator Michel Barnier and his UK counterpart , the industry has urged both sides to understand the importance of ongoing co-operation as part of the negotiations to agree a new relationship between the UK and the EU.
“Securing such an agreement is the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health,” the letter says.
The signatories to the letter are seven industry groups representing thousands of companies across all strands of the life science sector in Europe and the UK. They include the major drugmakers that are members of the Irish Pharmaceutical Healthcare Association and companies involved in Medicines for Ireland, which represents the generics and biosimilars sectors of the industry.
Regulators
The EU has already decided that the European Medicines Agency, which regulates which drugs can be sold across the EU, must be relocated from the UK as a result of the Brexit decision, along with the European Banking Association. Both are currently located in London.
All other EU member states, including Ireland which has expressed a strong interest in bringing the European Medicines Agency to Dublin, have until the end of July to indicate formally their interest in accommodating either or both agencies. A decision will be taken in November.
Britain's business minister Greg Clark and health minister Jeremy Hunt – both among the "remainers" in Theresa May's cabinet – raised the possibility earlier this month of the EU retaining some regulatory control over areas such as medicines.
“We would like to explore this possibility to maintain close regulatory ties between the EU and the UK and to begin these discussions immediately,” the industry bodies say. Such talks would include recognition of existing drug approvals in Europe and co-operation between agencies following Brexit to facilitate R&D, clinical trials, manufacture and supply of medicines.
Forcing the UK’s medicines regulator to withdraw from its current pan-EU role “would mean a loss of capacity and expertise for the network for the review of medicines as well as the capacity across Europe for the surveillance and safety supervision of products”, it says.
It is important that there is as much certainty as possible, as early as possible, the pharma industry says, “to enable the pharmaceutical and life science industry to transition smoothly into the new framework, ensuring there is no disruption to patient access to medicines”.
A disorderly Brexit would risk disruption of medical supplies across EU-UK borders, with border checks, and possible extensive retesting once across the border.
“This would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines,” the letter warns.
