Bracing for Brexit

There is no precedent, it is the first time a member state is leaving the European Union, says Maria Filancia, scientific administrator with the European Medicines Agency, as the clock ticks on Brexit.

“This is new for companies and regulators,”she says, outlining steps taken by the EMA, given the prevailing uncertainties as negotiations go down to the wire on whether Britain’s exit from the European Union would be softened with a deal on future relations, or not.

On March 1, EMA employees would leave their London premises to move into their new office in Amsterdam, Filancia told the audience at the Indian Pharmaceutical Forum in Mumbai this week. The transition would see some employees shift to the new location, while others work temporarily from their homes, even as another lot quit as they are unable to move to the new place. The EMA expects a 25 per cent staff loss on this count.

“We are working on the assumption of a “no deal” Brexit,” Filancia said, in which case the UK becomes a “third country” for the EU (comprising 27 countries). And given the gravity of the changes and concerns over medicine supplies to the region getting disrupted, she said, the EMA has been engaging with drug companies since 2017 to take the required steps.

For the continuity of supplies, businesses and regulators need to be prepared, she said, highlighting key concern areas that drug companies, including those from India selling into the region, needed to keep an eye on.

In the absence of a deal, the supervision of manufacturing facilities in the UK and acceptance of their certifications, for instance, would involve a case by case, risk-based assessment, she said. As the transition gets under way from March 30, she told companies to continue to ensure compliance, stay updated on the regulatory changes, invest in quality and keep the dialogue going with the regulators.

Ground Zero

Staying prepared for a deal-or-no-deal Brexit on Ground Zero is the UK’s regulator, the Medicines & Healthcare products Regulatory Agency. Mapping the landscape and measures taken by it, MHRA’s Expert GMP Inspector David Churchward told Indian pharma industry representatives that a technical guidance was being published in the coming weeks on the road ahead.

Meanwhile, in the event of a hard Brexit with no deal, “the MHRA was providing new IT systems to replace our access to certain EU systems...if the UK leaves the EU with a deal, the implementation period will come into effect. This will mean no changes in regulation or UK access to EU systems until the end of 2020,” he explained.

The regulations on clinical trials will see relatively little change as long as companies maintain existing standards and mutually accepted data will continue to be recognised. Those seeking marketing authorisations in the country will need a local representative in the UK, as compared to earlier, when it was acceptable to have a representative in the EU region.Packaging needed to be updated, he said, though for now they would accept EU packaging with minimum UK standards. For UK-based firms selling active pharmaceutical ingredients into the EU, they will need a written confirmation, in a hard Brexit scenario. Efforts are under way to ensure snag-free supply chains so medicine access for patients in the UK and EU are not affected, he said. The MHRA was working closely with counterparts towards harmonised or aligned systems.

India outlook

Much will depend on how regulations develop in the EU and UK, post Brexit, said Vikas Bhadoria, Senior Partner, Mckinsey & Company. Companies will look for the fine print on whether they would have to retest products for the UK, the costs involved in filing into two different markets for marketing authorisations and the deal-sweeteners that both sides would throw in to keep companies interested in their markets.

Short-term opportunity

For Indian companies, the EU is one of four key markets, besides the US, India and the Emerging Markets. And a clutch of drugmakers, including Aurobindo, Dr Reddy’s Laboratories, Glenmark, Wockhardt, Lupin, Sun Pharma, Cipla, Intas and Torrent, operate in this market. For those having manufacturing facilities in the UK or EU, the rapidly evolving rules will be important for the long term.

But in the short term, an opportunity could arise for India, as prevailing uncertainties between the EU and UK may cause supply constraints. This could be serviced by companies who have bases in India, he said, as companies operating in these markets brace for Brexit on March 29.

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