- U.K. Prime Minister Theresa May was handed a historic defeat in the House of Commons on Tuesday as members of Parliament (MPs) rejected her Brexit withdrawal plan by a margin of 230 votes — the largest ever in the democratic era.
- May's government faces a vote of no confidence today, but the backing of MPs in the European Research Group (ERG) and the Democratic Unionist party (DUP) mean that this is unlikely to topple the government. After that, it will be up to May to come up with a Plan B, or face launching her country out of the European Union with no deal.
- That uncertainty is causing widespread concerns over the potential impact on public health and access to drugs in both the U.K. and Europe, spurring a European pharmaceutical trade group to call for special consideration for the industry's supply chain.
With just 72 days left to go before the U.K. is scheduled to leave the European Union, things appear about as uncertain as they did in the days following the initial Brexit vote in 2016.
Among those with concerns are drug companies operating in the region. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the uncertainty created by the vote and the potential for a no-deal exit could threaten both patient safety and public health. Potential implications include disruptions to the supply of medicines, as well as situations where the development, manufacture and regulation of medicines no longer benefits from mutual recognition between the U.K. and EU.
"Now is the time for policy makers in the UK and the EU to put politics aside and put measures in place to prevent patients being harmed by the consequences of Brexit," said EFPIA director general Nathalie Moll in a statement.
EFPIA called for measures including recognition of U.K. testing and contingency plans to cover trade of clinical trial materials and drug ingredients across borders.
U.K.-based pharma GlaxoSmithKline expressed its disappointment in the lack of an agreement in an emailed statement to BioPharma Dive, restating its commitment to ensure patient access to its products
"The proposed withdrawal agreement and political declaration would have provided greater certainty and time to prepare," wrote a spokesperson for GlaxoSmithKline.
"We are clear a no deal would be a bad outcome," the spokesperson added. "Whilst we are doing everything we can to prepare for a no deal scenario, this involves significant complexity and regulatory activity and there are elements outside of our control, including preparations for the border."
There are worries from outside of the industry too.
The Irish government has highlighted the threats to its own medicine supply that could be caused by a no deal Brexit. Well over half of Ireland's drugs come via the U.K., and any delays could have a particular impact on medications that are supplied by a single source, have a short shelf life, or require specific kinds of transportation and storage.