EU not denying patients life-saving breast cancer drugs

by Luke Lythgoe | 13.06.2016

Several newspapers ran a story last week claiming EU bureaucracy is keeping a revolutionary breast cancer drug from patients. The story appeared in The Times, Daily Mail, Express, Mirror and The Sun, with The Telegraph’s headline saying: “EU red tape ‘condemning cancer victims to early death’”.

The new drug palbociclib – trade name Ibrance – almost doubles the time women with advanced breast cancer have without the disease getting worse. Although the US approved the drug more than a year ago, after an accelerated six-month assessment, the European Medicines Agency (EMA) has yet to approve it.

However, much of the blame for the delay is with palbociclib’s manufacturer, Pfizer. The drug company only submitted its product to the EMA 10 months after it had been approved in America.

Once a medicine is submitted to the EMA, the regulator has seven months to confirm whether the benefits outweigh the risks to patients. But the clock can be stopped if further information is needed. This happened with palbociclib in December four months into the process. After Pfizer provided the information, the assessment resumed.

It is also doubtful palbociclib would already be in British hospitals if we weren’t in the EU. EMA approval is just the first hurdle for a new drug. Breast cancer campaigners are worried that British patients will never benefit from palbociclib because the UK’s own National Institute for Health and Care Excellence (NICE) will deem it not cost-effective enough to be stocked by the NHS.

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Meanwhile, eurosceptics undersell the EMA’s overall record on responding to advances in cancer care. Since 2006, 108 new cancer treatments have been authorised. Of the 17 authorised in 2015, two received an accelerated assessment and two received a conditional marketing authorisation, where it is recognised the benefits of immediate availability outweighs the risk of less comprehensive data.

Would Brexit even bring more urgency to the approval of new cancer drugs than the EMA already offers? After all, medicines need to be properly tested to protect patients.

What the EMA, based in London, does achieve is harnessing the expertise of 28 different member states, cutting back on duplicated time, money and effort by approving drugs across the continent. Brexit would add to the costs of vetting new drugs. And, as EMA sought a new home, Britain’s influence in the key pharmaceutical industry would take a knock.

Edited by Hugo Dixon