England ranks low on the availability of publicly funded new medicines across Europe because of challenges at many different points in the approval process. 

England ranks seventh out of 36 European countries on the availability of publicly funded new medicines across Europe, according to a new report from the European Federation of Pharmaceutical Industries and Associations (EFPIA). 

The report covers medicines approved by the European Medicines Agency (EMA) between 2021 and 2024, tracking availability and speed of access for patients in national health systems.

Around 61% of EMA-approved medicines have been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and are recommended by the National Institute for Health and Care Excellence (NICE) for NHS use in England. Scotland ranks 11th (53%). Among those countries most like the UK in terms of population and economy (France, Germany, Italy, Spain), England ranks fourth, behind Germany, Italy and Spain.

When considering medicines available only to a restricted patient group – known as an “optimised” NICE recommendation, a growing feature of approvals – England falls to 10th, with just 33% of medicines licenced during these four years available on a full, unrestricted basis in line with their regulatory licence. Scotland drops to 13th.

Some UK patients either cannot access a new medicine at all, or only if they meet criteria that exclude many for whom it is licensed.

“Europe has had medicine access problems for 25 years, and global pricing reforms are set to exacerbate these issues,” said EFPIA director general Nathalie Moll. 

“It is unrealistic to expect greater investment into Europe and faster access to new treatments for Europeans if member states also demand the lowest possible prices and the highest government clawback rates. We need to make a choice,” she added. 

Complex environment

The data is especially stark for two groups: cancer patients and those with rare diseases.

For cancer medicines, England ranks 14th, with 59% new medicines available to NHS patients. Scotland ranks 19th (48%). Many of these patients are waiting for treatments that could extend or save their lives.

For orphan medicines – developed for rare diseases with few treatment options – England ranks 11th (50%) and Scotland 13th (47%). For these patients, access to a single medicine can often mean the difference between having a treatment option and having none.

“These gaps are among the reasons the UK needs to reflect the value of medicines for patients with few or no alternatives in a better manner,” said the Association of the British Pharmaceutical Industry (ABPI) in a statement. 

The UK’s declining rate of availability arises from challenges at many different points in the approval process before medicines reach patients. 

The UK’s declining availability reflects several factors in an increasingly complex global regulatory and commercial environment. The first step to a medicine access decision is regulatory licensing – in the US, this is done by the Food and Drug Administration (FDA), in the EU, the EMA, and in the UK, the MHRA.

The ABPI’s analysis of EFPIA’s new Regulatory Indicator shows that around one-third of US-licensed medicines are not licensed in Europe or the UK. This reinforces the concern that UK patients are missing out on medicines available elsewhere.