Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (APBI) and BioIndustry Association’s (BIA) chief executive Steve Bates have issued a join statement commenting on the Brexit White Paper and its importance to the pharmaceutical industry.
In the statement from the pharmaceutical industry experts, it says: “Every month, 37 million packs of medicine arrive in the UK from the EU, with 45 million moving the other way. For patients, today’s White Paper sets out the Government’s position on the UK’s future relationship with the EU.
“Our industry’s priority throughout these negotiations is to ensure patients in both the UK and EU can continue to access the medicine and vaccines they need.
“We are pleased to see further detail on the Government’s ambition for the UK’s future membership of the European Medicines Agency (EMA). Whilst today’s approach depends on agreement from both sides, continued cooperation between the UK and EU on the regulation of medicines is in the best interests of patient and public health.”
What did the statement say about manufactured goods?
Manufactured goods – The Paper recognises the importance of the UK keeping supply chains operating efficiently to the benefit of patients, through application of a common rulebook for medicines, and through the UK being an active participant in the EMA, so that pharmaceuticals companies can continue to conduct one series of tests for use in the UK and in the EU. It proposes that UK regulators can conduct technical work for assessment of medicines and participate in ongoing safety monitoring and other elements of pharmaceuticals regulation for the combined EU and UK market.
The UK also proposes that all manufactured goods authorisations, approvals, certifications, and any agency activity undertaken under EU law (for example, to register a chemical), completed before the end of the implementation period, should continue to be recognised as valid in both the UK and the EU. Moreover, any such processes underway as the UK and the EU transition from the implementation period should be completed under existing rules, with the outcomes respected in full.
What was discussed about EU agencies?
EU Agencies – The Paper proposes a role for the UK in EU agencies that provide authorisations for goods in highly regulated sectors – including the European Medicines Agency – “accepting the rules of these agencies and contributing to their costs, under new arrangements that recognise the UK will not be a Member State.”
Additionally, the UK would seek all the current routes to market for human and animal medicine remain available, with UK regulators still able to conduct technical work, including acting as a ‘leading authority’ for the assessment of medicines, and participating in other activities like ongoing safety monitoring and the incoming clinical trials framework.”
Providing UK participation in EU research programmes
Science and innovation – The UK proposes that the future relationship includes a science and innovation accord that provides for UK participation in EU research funding programmes; enables continued cooperation through joint participation in networks, infrastructure, policies and agencies which are to the UK’s and the EU’s joint benefit; and establishes channels for regular dialogue between regulators, researchers and experts.
On EU research funding programmes, the UK wishes to explore association in research and innovation programmes, including Horizon Europe. The accord should also allow the UK and the EU to discuss and agree the UK’s participation in other programmes in the future.
What else does the paper include?
Customs arrangements – The Paper includes the proposal for continued UK application of the Union Customs Code and its modernising reforms. This is very welcome as is the commitment to maintenance of a zero tariff arrangement on all goods between the UK and the EU. It is important that the interim and the final agreements on customs arrangement should ensure continued frictionless movement of goods between the EU and the UK to support the needs of complex just-in-time supply chains built up over the past 45 years, as recognised in the White Paper.
Data – The Paper recognises the need for continued flow of data between UK and EU authorities and contains proposals for UK-EU arrangements on data protection and protection of classified information to facilitate continued data flows.
