UK biopharma sector wins small victory amid Brexit chaos

The UK has voted to remain in the European Medicines Agency – and it will need to if it wants to avoid delays in drug approvals, data show.

The UK’s preparations to leave the European Union are proceeding slowly and with mounting vitriol, but at least the pharmaceutical sector can comfort itself with a small win. Members of Parliament voted yesterday in favour of ongoing participation in EU medicine regulatory networks, an arrangement that industry has been lobbying for.

Familiar arguments were made to back this position, including the public health benefits of a frictionless flow of medicines across borders. An emotive warning that Britain is at risk of delaying its access to novel therapies suggests that “remainers” are finally taking their gloves off. Still, a look at some hard data on drug approval timelines shows that this claim is not just rhetoric, and could be a real consequence of any regulatory divergence (see analysis below).

A figure of six months was cited in the House of Commons yesterday as the typical delay experienced by Canada and Switzerland in terms of the lag in drug approvals. The argument goes that these relatively small medicine markets are considered a lower priority compared with huge regions like the US and EU, and because these regions operate independent regulatory agencies filings are typically made later.

To test this hypothesis EP Vantage took a look at the regulatory records of some of the world’s biggest medicines, and compared the dates of approval in Switzerland and by the European Medicines Agency (EMA). A sample of 20 was chosen, so it should be noted this presents far from a complete picture.

The analysis found an average time lag of 3.8 months for Swiss approvals, not as dramatic as the politicians suggested. However this figure could easily rise as more medicines are taken into account, because launches of smaller products by smaller companies tend to roll out globally much more slowly. Companies developing the blockbuster products in this analysis would have substantial global regulatory strategies in place, facilitating faster filings in peripheral regions.

Delaying access? Blockbuster drug approvals, EU vs Switzerland
Drug Company Swiss approval  EU approval  Time difference (months)
Humira Abbvie Apr 2003 Sep 2003 5
Keytruda Merck & Co Sep 2015 Jul 2015 -2
Opdivo Bristol-Myers Squibb Nov 2015 Jun 2015 -5
Eliquis Bristol-Myers Squibb Aug 2011 May 2011 -3
Revlimid Celgene Aug 2007 Jun 2007 -2
Avg of 20 blockbusters -3.8
Source: EvaluatePharma, Swiss Medic.

It is certainly plausible that any divergence from Europe’s established regulatory pathways and processes would lead to slower access to medicines in the UK.

The irony is that industry complains that this already happens, but through the actions of Nice. The country’s cost-effectiveness watchdog is frequently criticised for refusing to reimburse costly new treatments, a stance that seems unlikely to shift substantially after a hard or soft Brexit.

It is also far from clear whether yesterday’s vote will make any difference at the end of the day, as the UK’s final Brexit position is far from agreed. In this instance, ministers were voting on inserting a clause into a proposed European trading bill, and this sought to ensure that the government make the UK’s ongoing participation in European medicines a negotiating objective in future talks.

Members of Parliament only voted narrowly to include the clause, by 305 to 301. Notably this represented an embarrassing defeat for the government, one that could be interpreted as signifying strong support for the sector.

For anyone involved in the development, registration or manufacture of medicines, a hard Brexit presents a logistical nightmare. Industry already has contingency plans in place – investments in alternative manufacturing sites and stockpiling of medicines have already commenced.

But it is far from certain whether European politicians will agree to the UK having any ongoing involvement with the EMA. The fate of medicines regulation within the vast and chaotic Brexit negotiations is only one of many unknowable outcomes.

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