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ABPI and BIA have issued responses to the recently published governmental guidance on European Union exit preparedness.
The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) have issued responses to the recently published governmental guidance on European Union exit preparedness.
A letter from Steve Oldfield, chief commercial officer of the Department of Health and Social Care, published on June 26, 2019 alongside a written Ministerial Statement, details updated guidance on the continuity of supply of medicines and medical products in the event of a ‘no-deal’ Brexit. Within the letter, Oldfield highlights that disruption to medicines and medical product supply is still anticipated to be significant and expected to last for six months in the event of a ‘no-deal’ scenario; therefore, there is a continued need for a multi-layered approach-stockpiling, regulatory flexibility, and a coordinated National Supply Disruption Response (NSDR) System-as set out in the original contingency planning prior to the March 29, 2019 deadline.
Further to specific guidance to medicines and medical products suppliers, Oldfield lists the measures the UK government is putting into place to help ensure continuity of supply, such as securing freight capacity, adjustments to regulatory requirements, and the operation of a NSDR unit. Measures specifically relating to medicines, listed in the letter, are strengthening of processes and resources used to deal with medicines shortages, and the procurement of extra warehouse space.
“Pharmaceutical companies have been doing everything in their power to prepare for the UK’s exit from the [European Union] (EU). Our members have been increasing stocks, duplicating testing and planning for alternative routes where possible,” said Mike Thompson, chief executive of ABPI in response to the government guidance. “But some things are outside of their control. Additional government secured freight capacity was key to company planning for a ‘no-deal’ in March and this must be available to companies again as they prepare for the end of October. Our members will be pleased that the government are taking steps to put this capacity in place again and await further information about how this will work in practice. However, it is extremely challenging for pharmaceutical companies to be continually preparing for a ‘no-deal’ Brexit. Leaving the EU with a deal in place remains the best way to minimize any potential disruption to medicines supplies.”
“The BIA again encourages its members to engage in the government’s program, which we are highlighting to them is different to last time around-both in terms of freight support and the ask of industry. Our sector has already endured considerable disruption, duplication and uncertainty, and invested significant time, effort and resource with little government support. There is now an additional requirement around border paperwork which brings additional burden, especially for smaller companies, as much of this work is contracted out work,” said Steve Bates, CEO of BIA in response to the publication of the guidance. “As we have stressed before, a ‘no-deal’, disorderly Brexit must be avoided, as it will negatively impact patients, public health, and the life-sciences sector.”