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Supply issues

'Unorderly' Brexit risks shortage of life-saving drugs

An ‘unorderly’ Brexit could risk the supply of life-saving medicines to patients because the drugs are held at border checks, piled up in warehouses, or subject to ‘extensive retesting’, the British and European pharmaceutical industries have jointly warned.

In a letter to Brexit minister David Davis and EU chief Brexit negotiator Michel Barnier, a group of pharmaceutical and life science industry bodies, including the Association of the British Pharmaceutical Industry, British Generic Manufacturers Association, BioIndustry Association, Proprietary Association of Great Britain, and their European counterparts, warned that a disorderly Brexit could result in ‘severe disruption’ of most companies’ supply chains, as the flow of medicines from the UK to the continent and back could stall.

The bodies called on the Brexit negotiators to ensure “ongoing cooperation” between the UK and EU on medicines as “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 asks negotiators to explore the possibility of maintaining “close regulatory ties” between the UK and the EU, and it asks for “as much certainty as possible, as early as possible”, so that the pharmaceutical and life sciences industries can adapt to the new arrangements as smoothly as possible.

Current European marketing authorisations that apply across the EU, and continued cooperation between national competent authorities that are facilitated by the European Medicines Agency and the European Commission will be important in maintaining effective ties. The industry bodies also say that any changes to the UK–EU trading relationship should not affect the research, development, manufacture and supply of medicines across Europe, including for clinical trials.

The letter also says that the UK’s Medicines and Healthcare products Regulatory Agency plays a significant part in the surveillance and safety supervision of medicines across Europe and its withdrawal from the European regulatory network would mean experts in pharmacovigilance may need to move to Europe.

The letter can be read at:

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203181

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