Brexit may mean a longer wait for life-saving drugs
Top pharma bosses warn of critical delay
BRITISH patients may have to wait longer for life-saving treatments – with the NHS forced to shell out more for them – because of Brexit, drugs bosses have warned.
Pulling out of the European Union risks delaying the process of getting vital new medicines approved, according to senior executives at some of the world’s biggest pharmaceutical companies.
Delivering their stark warning to the House of Lords last week, they said Brexit could require firms to go through two approval processes – one for Europe and another for the UK.
This would slow things down and add to costs, they said.
All therapies, from pioneering new cancer drugs to cutting-edge treatments for arthritis, must be vetted by regulators before being given to sufferers.
Companies that want to launch new drugs in Britain currently have to apply for approval from the European Medicines Agency ( EMA), which covers all EU countries.
Authorisation from the EMA then automatically gives the drug a green light from the UK regulator, the Medicines and Healthcare products Regulatory Agency, or MHRA. But this system is now at risk due to Brexit, the firms believe. Among those warning of the impact was Mark Hicken, UK boss of Janssen, the pharmaceutical arm of giant American corporation Johnson & Johnson. Speaking to peers on the Lords’ Science and Technology Committee, he said: ‘We wouldn’t want to duplicate or reinvent processes.’ And he warned that the UK – as a far smaller market than the remaining EU – could well end up stuck at the back of the queue for new drugs. ‘There would be a risk there that the UK could slip down the order of when we would be able to make regulatory filings, submissions and so forth,’ he added.
Even British companies such as GlaxoSmithKline may choose to go for European approval ahead of UK authorisation, because only about four per cent of its sales come from its home market.
A double approvals process would also make it more expensive to bring out new drugs in Britain, potentially driving up costs for the NHS, the executives say.
NHS spending on drugs is vast: last year they cost the health service in England alone more than £16 billion, or about a seventh of its entire budget.
As a result, the companies are pressing for a firm agreement to keep the EMA and the MHRA aligned after Brexit, to stop drug approvals becoming bogged down in extra bureaucracy.
Their concerns come less than a fortnight after it emerged that Britain is to lose the headquarters of the EMA to Amsterdam.
The office, currently in Canary Wharf, London, and employing 890 people, will move in 2019.
The European Commission said the relocation was a ‘direct consequence’ of the Brexit vote.
Last year the EMA paid £100 million in salaries alone, while its presence is thought to have boosted Britain’s economy by tens of millions more every year, as drugs firms have chosen to set up offices here to be close to the regulator.