Medical drama
Post-brexit drug policy should be a no-brainer
There’s been an awful lot of coverage over the past 48 hours dedicated to the various Brexit Bills that the Government has managed to squeeze through Parliament. Most of the debate centres on issues relating to VAT, customs unions, free trade, tariffs and the like.
It would, therefore, be easy to have missed one rather obscure vote on which the Government was actually defeated this week. MPS supported, albeit by just a handful of votes, an amendment to the Brexit trade Bill that will ensure the UK takes “all necessary steps” to participate in the European Medicines Agency (EMA) after we leave the EU. The EMA is the regulatory body that approves drugs on behalf of all member states. While it’s not exactly top of the agenda for the general public, this vote is hugely significant for the life sciences sector and should be welcomed by all, even the most hard-line of Brexiteers.
That’s because, unlike many areas within the EU where its policy of “harmonisation” actually works to the detriment of its member states, an integrated system of regulating drugs is sensible and rational, whatever side of the Brexit debate you sit on.
Take investment and access. When pharmaceutical and other healthcare companies look at where to spend their cash and where to launch their drugs, they prioritise market size. The US, the EU, and China, come first on the list. They don’t look at France, or Germany, or the UK, which individually account for a tiny proportion of the global pharmaceuticals market. It is the EMA’S clout that makes Britain and other countries attractive destinations for investment and offers their citizens a wide variety of drugs to which they might not otherwise have access.
The people of Switzerland and Canada, for instance, don’t enjoy access to the same range of medications as those who live in the US and Europe because some pharmaceutical companies simply don’t bother seeking regulatory approval in those countries.
Without continued membership of the EMA, the UK might fall into this category. “What would be the impact if we removed ourselves from the EMA and suddenly there were restrictions on drugs for UK patients, many of who are living longer, happier retirements thanks to new medications that are available to them? People would not be happy,” says Steve Bates, the chief executive of the Bioindustry Association, a trade body for the biotech sector.
Pharmaceutical companies, he argues, want a whole package. The key thing for them is how a market stacks up competitively with regards to the US and China. Making things more difficult from a regulatory standpoint is a major turn-off.
It’s not all one-sided, however. It is also in Europe’s interest for Britain to remain part of the EMA, and Brussels would be wise to rethink its hitherto hard stance on the UK’S membership.
For one, the EMA has always been based in London, and Britain’s contribution to the agency is substantial. The UK, through its domestic regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), probably has more expertise in the complex field of drugs regulation than its counterparts in any other European country. This sort of knowledge takes years to build and will not magically transfer with the EMA when it relocates to Amsterdam after Brexit. Instead, it will be challenging for the EMA to ramp up scientific expertise in clinical areas on which it has historically relied on the MHRA for help.
Pharmacovigilance, which monitors the safety of drugs after they have been approved for use, is one such field of science in which the MHRA excels. It would cause a great deal of disruption to the citizens of Europe, and be a disservice to the safety of EU patients, if this know-how were suddenly lost.
There’s also the question of trade. Having a single marketing authority in the EMA enables regulated drugs to meet standards required for all EU states, which provides for frictionless trade. This common rule book makes it simple for pharmaceutical companies, such as Britain’s Astrazeneca, America’s Merck and Switzerland’s Roche, to produce one product, in one standardised package for all 27 member states. What’s more,
‘An integrated system of regulating drugs is sensible and rational, whatever side of Brexit debate you sit on’
the volume of trade between the UK and the rest of Europe is substantial. Every month, 45m packs of medicine leave the UK destined for the rest of the EU, while we import 37m packets from Europe. The complexity involved in unpicking this “is not straightforward”, says Bates, and would lead to “a lot of paperwork”.
Luckily, the Government appears to understand why it is important for the country and its life sciences industry, which ranks among the best in the world, to be aligned with the EMA. While the vote this week in favour to amend the trade Bill was branded a defeat for Theresa May and her administration, it was a defeat in name only. Life sciences is at the heart of Mrs May’s industrial strategy, not least because it is a sector that supports 240,000 jobs and contributes £70bn to the economy each year. The top 25 global pharmaceutical companies and 30 leading global medical tech companies operate in the UK.
This Government has always supported regulatory alignment with the EMA, whether in the form of full membership, the best-case option, or a system of reciprocal approval. The latter scenario would mean the UK could recognise a decision made by the EMA and vice versa, speeding up the regulatory process.
This week, it even hosted the second in a series of roundtables with stakeholders from life science businesses to discuss how to support the sector, ensure it is competitive and negotiate a good relationship with the EU. One government insider told your correspondent he believes May wanted the amendment to pass, but was forced to oppose it as it was being tabled by MP Phillip Lee, who resigned from the Cabinet over Brexit last month.
What all of this suggests is that the issue of how medicines will be regulated post Brexit shouldn’t be an issue at all. It is one of the few areas on which all politicians can, and should, agree. A no-brainer. Now all we need to do is convince Brussels.