Biopharma Companies Explain Brexit Preparations

Regulatory NewsRegulatory News | 25 January 2019 |  By 

Gearing up for the prospect of the UK departing from the EU without a deal, biopharma companies are preparing with different precautions costing upward of $100 million per company.

Novartis on Friday offered its take on the latest preparations, raising alarms about the implications.

“Following Parliament’s vote, the risk of UK exiting the EU without a deal is increased and this will be hugely impactful for patients, particularly around the supply and safety of medicines,” Novartis said. “Divergence from the close regulatory and legal cooperation that exists today between the UK and the EU has far-reaching implications for the way the life sciences sector operates and its ability to develop and deliver medicines for UK patients.”

The company also said it’s stockpiling medicines “to ensure continuity of supply to UK patients of the over 120 million packs of medicines we import to the UK from Europe each year.”

In an SEC filing, Pfizer said that its Brexit preparations are set to cost about $100 million, and the company generated about 2% of its worldwide revenues from the UK in 2017.

Pfizer added: “We aim to have sufficient medicine and vaccines reserves at all times to ensure continuity of supply for patients. We have undertaken work to ensure we can continue to supply in the EU and the UK in all Brexit outcome scenarios and are taking into account UK Government guidance from the Department for Health and Social Care on medicine and vaccine supplies in preparation for the UK leaving the EU under a ‘no deal’ scenario.”

GlaxoSmithKline (GSK), meanwhile, said it’s taking a risk-based approach and has been implementing its contingency plans since January 2018, with an immediate focus on its supply chain.

The company’s work has included expanding its ability in the EU and the UK to conduct re-testing and certification of medicines, transferring marketing authorizations registered in the UK to an EU entity, updating packaging and packaging leaflets, amending manufacturing and importation licenses and securing additional warehousing.

“We currently anticipate that the cost to implement these and other necessary changes could be up to £70 million over the next two to three years, with subsequent ongoing additional costs of approximately £50 million per year, including additional customs duties and transaction or administration costs,” GSK said. “Over the longer term, we continue to believe that Brexit will not have a material impact on our business.”

Securing the supply chain is among the biggest concerns of other biopharma companies too.

Roche told Focus that it is actively preparing for Brexit, adding, “Our goal, regardless of the current uncertainty, is to mitigate any risks that may arise to the supply chain to ensure that patients in the UK and mainland Europe continue to have access to medicines and diagnostics.”

Gilead also told Focus it has “contingency plans in place to address potential manufacturing, supply and distribution disruptions. We are preparing for issues that might arise in the context of Brexit, and are working with relevant authorities to ensure any such issues will not affect the continuity of supply of Gilead products inside and outside of the UK.”


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