BioPharma, Pharma, Policy

May postpones vote on Brexit agreement that pharma sector had supported

The agreement would have allowed UK pharmaceutical regulations to remain under EMA authority after Brexit. Uncertainty around the planned withdrawal has caused worry in the life sciences sector.

EU Commission President Jean-Claude Juncker and UK Prime Minister Theresa May during a meeting at the EU headquarters in Brussels, Nov. 21, 2018

British Prime Minister Theresa May threw her country’s planned departure from the European Union into disarray Monday as she canceled a key vote in Parliament on a withdrawal agreement published last month.

Under the agreement – which the UK and EU had already agreed upon – the country would remain subject to EU regulations, including those of the European Medicines Agency, after Brexit, on March 29, 2019. British pharmaceutical trade group the Association of the British Pharmaceutical Industry had expressed concerns about the agreement’s provisions on drug safety, but praised it on account of its preventing potential disruptions to the supply chain.

According to reports in outlets such as The Guardian, Monday’s decision to postpone the vote on the 585-page withdrawal agreement was because May was not confident it would pass in the House of Commons, where it remains deeply unpopular. While the postponement does not cancel the vote entirely, but merely delayed it until later this month or next month, the European Commission – the EU government – has refused to renegotiate the deal. As such, the only alternative is for the UK to leave the EU without a deal in place, which is regarded as potentially disastrous to the country’s economy. However, the European Court of Justice ruled that the UK can also unilaterally cancel Brexit and leave its current relationship in place.

The challenges around Brexit have aroused significant worries among Britain’s life sciences sector.

According to a survey last month by GlobalData, only 17 percent of health professionals in the UK foresee the country as an attractive destination for healthcare companies to conduct research and manufacturing after Brexit. However, an expert said the country’s strong infrastructure in basic science, translational research and clinical development will likely mean it will continue to be a significant player in the field.

At the same time, Brexit has also raised questions about how drugs will be regulated, and how important the UK market will be for drugmakers. While it is possible that a post-Brexit UK could remain under the EMA’s authority, a worst-case scenario is that its local regulatory agency – the Medicines and Healthcare products Regulatory Agency, or MHRA – will become fully separate, leaving the country as a second- or third-tier market compared with the EMA-regulated countries and the US. While Switzerland’s drug regulator, Swissmedic, is also independent from the EMA, the aforementioned expert said it also allows for expedited approval of drugs that already have approval from larger agencies.

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