Brexit could delay introduction of new cancer drugs by up to two years, experts warn

Following Jeremy Hunt’s suggestion that the UK may not remain part of the European Medicines Agency when it leaves the EU, experts warn that the approval of important new drugs may be delayed for up to two years.

Sir Alasdair Breckenridge

Patients could have to wait up to two years longer to access new cancer drugs after the UK leaves the EU, because drug companies will prioritise winning approval for access to the larger European market, experts have warned.

Giving evidence to the Health Select Committee on 24 January 2017, health secretary Jeremy Hunt said that he did not expect the UK to remain within the London-based European Medicines Agency (EMA) after the UK leaves the EU, prompting drug regulation experts to warn of the potential repercussions.

Speaking to BBC Radio 4’s Today programme on 10 February 2017, Sir Alasdair Breckenridge, former chair of the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medicines and medical devices in the UK, warned that drug companies will prioritise application to the EMA over the UK regulator because the UK market is much smaller than the European market, representing just over 3% of the global market.

Furthermore, an additional drug application will attract a further cost for a drug company. “So therefore there will be delay in getting new drugs — important new drugs, anti-cancer drugs, anti-infective drugs — for patients in the UK,” he said.

Also speaking on the Today programme, David Jefferys, vice president of Japanese drug company Eisai, estimated that UK patients may face a resultant delay of up to two years in accessing new drugs. “Early innovative medicines will be applied for in the United States, Japan and through the European system… The UK will be in the second or indeed the third wave, so UK patients may be getting medicines, 12, 18, [or] 24 months later than they would if we remained in the European system.”

Virginia Acha, executive director for research medicine and innovation at the drug industry body, the Association of the British Pharmaceutical Industry, comments: “The proper functioning of medicines regulation, clinical development and monitoring of public health across Europe has been built upon effective integration and alignment, with the UK playing a valued role.

“If we don’t find a way to continue to align the UK regulatory system with the EU through cooperation, patients in the UK and in Europe both face the real risk of disruption and delay,” she adds. “Securing cooperation between the UK’s medicines agency and the EMA is a sensible solution, and we will continue to make the case for an agreement to be reached.”

Also speaking on the Today programme, Sir Kent Woods, former chief executive of the MHRA, said that he believes an agreement could be reached between the UK and the EU on co-operating over drug regulation in the future, but is concerned about the issue getting absorbed into wider negotiations over trade terms between the UK and the EU.

“If this gets subsumed into potentially a more confrontational issue about trade then we may well lose sight of that public health dimension and that would be my concern,” he added.

 

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Citation
The Pharmaceutical Journal, PJ, February 2017, Vol 298, No 7898;298(7898):DOI:10.1211/PJ.2017.20202328