Sanofi, Novartis, AstraZeneca, and Roche are among the companies planning to stockpile drugs in preparation for a no-deal Brexit, according to reports. The U.K. government is also considering building up stockpiles of medicines in case the country cannot reach a divorce agreement with the EU.
Matt Hancock, the U.K. health secretary, told the Health and Social Care Committee on July 24 that, while the country wishes to reach a Brexit deal with the EU, the government is “working with industry to prepare for the potential need for stockpiling in the event of a no-deal Brexit.”
Hancock added, "We are also focusing on the importance of a continuous supply of medicines that have a short shelf life, so some of the medicines most difficult to provide in a no-deal scenario where there is difficult access through ports will need to be flown in.”
National Health Service (NHS) England Chief Executive Simon Stevens told the BBC One program The Andrew Marr Show, "there is now significant planning going on around all the [Brexit] scenarios, including these medicine supply scenarios."
Stevens continued, "There's extensive work under way now between the Department of Health, other parts of government, the life sciences industry, [and] the pharma companies.”
In a survey published on July 10, the European Medicines Agency (EMA) warned that the supply of more than 100 medicines manufactured solely in the U.K. is at risk of disruption post-Brexit because the necessary work to ensure they can be licensed and released for sale in mainland Europe has not been carried out. According to BioIndustry Association (BIA) and Association of the British Pharmaceutical Industry (ABPI), 45 million packs of medicines are exported from the U.K. to the EU each month, and 37 million are imported from the EU to the UK.
Meanwhile, a GlobalData survey of the global pharma industry, Brexit and the Healthcare Industry – Implications for Pharma, Q2 2018, shows that only 37 percent of respondents believe the UK will be an attractive destination for healthcare research and manufacturing after Brexit, dropping from 48 percent in Q1 2018.
White Paper Proposes EMA Membership
On July 18, the U.K. government voted for the country to negotiate to remain part of the EMA. Under the U.K.’s proposal, as detailed in a July 12 white paper, the country would accept EMA rules and contribute to the agency’s costs but would have no voting rights. This scenario would allow drug products to go through only one approval mechanism to access both markets.
According to the white paper, the U.K. wishes for all the current routes to market for medicines to remain available, leaving U.K. 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.
The U.K.’s wish list includes “bespoke provisions” for pharmaceuticals, “including the release of individual batches by a qualified person based in the U.K. or EU.”
Contract Pharma Industry Lacks Guidance
Outsourcing companies told PharmSource that despite the July 12 white paper, there is a lack of clear advice for the U.K.’s pharmaceutical industry, including contract manufacturing organizations (CMOs). This remains especially true as the EMA has not yet responded to the U.K.’s proposal.
Colin Newbould, director of regulatory affairs and qualified person (QP) services for the U.K. contract packaging organization Wasdell Group, told PharmSource that due to the lack of guidance, “it is not a surprise that many businesses in the U.K. are yet to undertake the necessary work to build contingency plans that will ensure their medicines can continue to be licensed for sale in mainland Europe no matter what the eventual outcomes are of leaving the EU.”
However, the potential impact of Brexit has prompted companies to develop strategies to try to ensure “business-as-usual,” said Newbould, noting that Wasdell Group will open a facility in Ireland later this year to carry out any necessary importation testing for customers supplying the EU.
“The new [Ireland] facility means that although our headquarters will remain in the U.K., our operations and quality systems will continue to meet EU GMP [Good Manufacturing Practice] standards as a minimum,” Newbould explained, noting that Wasdell Group is also working with customers to stockpile goods and change importation sites in preparation for Brexit.
Thomas Beck, senior vice president, quality management at contract development and manufacturing organization (CDMO) Recipharm, told PharmSource that the company expects to see greater demand for outsourced manufacturing services from U.K. marketing authorization holders (MAHs) wishing to supply to Europe.
Beck called for more action and guidance from the EMA to help pharmaceutical manufacturers understand the implications of Brexit and make the required preparations, noting, “the initiatives shown by the U.K. government regarding a pragmatic approach to Brexit have not received any pragmatic response from the EMA, which remains firm in its hard-Brexit approach.”
The best outcome, according to Beck, would be a mutual recognition agreement that is maintained between the EU and U.K., which would mean that there will be limited to no immediate regulatory changes. The worst-case scenario, where no agreement is reached, may result in medicine shortages.
“Treating the U.K. as a ‘third country’ post-Brexit also has the potential to create additional layers of complexity that manufacturers will have to adapt to if they are not already familiar with third-party importation practices,” Beck added.
Responding to the July 12 white paper, the Brexit Health Alliance—a group focused on safeguarding healthcare during negotiations, and whose members include ABPI and multiple NHS networks—stated that a disruption of the drug supply chain and of healthcare are “not theoretical possibilities.” Co-Chair Niall Dickson further emphasized that these consequences “are real risks which can and must be resolved in the negotiations.”
BIA Brexit Lead Laura Collister told PharmSource that the July 12 Brexit white paper reflects a number of policies supported by BIA and the pharma industry, saying, “This is a white paper. It’s a statement of policy by government. It’s not the final deal, but it does provide the basis for detailed future relationship discussions with the EU. Turning the policy into reality needs to be a priority now for U.K. government in the negotiations.”
The July 12 white paper states that EU law will remain in effect in the U.K. for the next 21 months. Under the Medicines and Healthcare Products Regulatory Agency’s (MHRA’s) proposal for an implementation period, published on August 6, the U.K. and EU will continue to recognize each other’s manufacturing and distribution licenses and inspections. However, according to ABPI Deputy Chief Scientific Officer Sheuli Porkess, it is not clear whether such a period will be negotiated as part of the withdrawal agreement.