October 25, 2021

I, Science

The science magazine of Imperial College

The UK needs to adopt the Breakthrough Therapy model, which allows super drugs into the market faster ...

Tim blog The United Kingdom needs to adopt a Breakthrough Therapy model similar to that in the United States if it is to attract innovative biotech companies to its shores and establish itself as a centre of pharmaceutical innovation.

Two years ago, the regulator in charge of granting approval to pharmaceutical drugs in the US, the Food and Drug Administration (FDA), gained the ability to designate promising experimental drugs as “Breakthrough Therapies”. For a drug to be deemed a Breakthrough Therapy, its developers have to demonstrate that the drug is substantially better than therapies that already exist, and that the drug is intended to treat a serious or life threatening disease. Once a drug gains the hallowed status of Breakthrough Therapy, the FDA will massively speed up its review and approval processes. This can slash the traditionally lengthy process of getting a drug out of the lab and into the hands of patients by months or even years. A handful of drugs with Breakthrough Therapy designation status have already been approved by the FDA and made available to patients, and over 30 more yet-unapproved drugs have been granted the designation. These unapproved drugs work to treat diseases such as Hepatitis C, Duchenne muscular dystrophy and multiple myeloma.

The introduction of such a policy seems to make a lot of sense. If a drug seems promising, it would be unethical to keep it out of reach of patients simply because of bureaucratic obstacles. It would also be a boon for the drug developers, who can cut their development time and get their drugs onto the market sooner.

It’s surely time for the UK to adopt a similar policy innovation. If the UK is to become a hotbed for ground-breaking biotechnology research, it needs to signal to biotechnology companies and investors that its regulatory environment will facilitate such innovation.

It’s something that I’ve thought for a while, so I was pleased to read that the UK government is indeed considering such a strategy. In fact, the UK government might be going one step further than the US Breakthrough Therapy designation. The UK BioIndustry Association report on their blog there has been “active discussion across Whitehall” about the introduction of a new “Promising Innovation Medicine” designation, in recognition of the success of the US Breakthrough Therapy designation. The Promising Innovation Medicine designation might come in conjunction with the introduction of the Early Access to Medicines scheme, which would allow patients on the NHS to access new drugs much more rapidly, even before they have undergone the normal approval procedures in the rest of Europe.

Hopefully, the UK government will indeed adopt such a scheme. With the Promising Innovation Medicine designation and the Early Access to Medicines scheme working in synchrony, state-of-the-art biotech companies will be attracted to the UK, poised to deliver new life-saving medicines to the patients that desperately need them.