Comparing new medicine availability across Europe

Each year, the European Pharmaceutical Industry Association (EFPIA) publishes data comparing the availability of new medicines across 36 European countries, as well as the average time it takes to make these new medicines accessible to patients. This article explains what the data shows and what it means for the UK.

What are we waiting for?

In Europe, before most patients can access a new medicine, it must first be independently evaluated for its effectiveness and safety. This is called the licensing or ‘marketing authorisation decision’.

After this, many countries will also assess a medicine for its ‘cost effectiveness’ to decide whether their national health system is prepared to pay for the medicine. This is called the reimbursement decision. 

While countries will have their own unique processes, all countries have the first step and most countries now have some version of the second step.

All this takes time. Any delay means physicians in a country won’t be able to prescribe new approved medicines for patients who could benefit.

What does the EFPIA data measure?

For 20 years EFPIA has tracked the rate of availability of new medicines and the time it takes 36 different countries in Europe to complete this process. The report it produces is called the EFPIA Patients WAIT Indicator Report.

As a starting point, EFPIA uses the date a medicine gets a positive ‘marketing authorisation decision’ from the EU’s medicines regulator, the European Medicines Agency (EMA). Not all countries accept EMA decisions directly, because they may have their own medicine regulator, but EFPIA use the EMA decision for consistency across all countries.

This year's 2024 report, published in June, covers medicines that got a positive EMA ‘marketing authorisation decision’ between 2019-2022.

The EFPIA data measures two key things:

1. Rate of availability – the proportion of new medicines approved by the EMA which are available to patients in a given country.
2. Time to availability – the average number of days it takes a country to make a positive ‘reimbursement decision’ after a positive marketing authorisation decision.

Not all countries will complete the second step for all medicines, and others will only do so with some form of restricted access or a more limited patient population than the one approved by the EMA. EFPIA also track these differences.

How did the UK do in the 2024 EFPIA report (2019-2022)?

In the UK, the first step (marketing authorisation) is managed by the medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

In England, the value for money  decision is largely made by the National Institute for Health and Care Excellence (NICE), with Wales and Northern Ireland largely following NICE decisions too In Scotland, it is the Scottish Medicines Consortium (SMC).

Only after positive decisions are made by these bodies (with a few exceptions) will the NHS in each nation consider paying for and using a new treatment.

The EFPIA report includes 36 countries, including England and Scotland, but not Wales or Northern Ireland.

England

England ranks 9th out of 36 countries for the total number of new medicines that are licensed by the EMA and available to English NHS patients, down from 7th place in the 2023 report.

The 2024 report found 56% of the new medicines approved by the EMA were available to English patients, down from 66% in the 2023 report – meaning the proportion of available medicines has fallen 10%. While this rate is above the EU country average of 43%, it trails the UK’s larger economy peers like Germany, France, Italy, and Spain.

Of the 56% of available medicines in England, 28% are “fully available” (in line with the EMA licensed patient population), and the remaining 28% are available to a restricted subset of patients. An example of this might be a medicine where availability is limited to only the subset of patients with the most severe form of disease.

Finally, England ranks 7th of 36 countries in terms of the time it takes between regulatory approval and availability on the NHS, with an average time of 344 days. This is broadly consistent with the time taken in the 2023 report of 329 days.

Scotland

Scotland ranks 11^th out of 36 countries for the total number of new medicines that are licensed by the EMA and available to Scottish patients, down from 8th in 2023 report.

The 2024 report found that 54% of the medicines approved by the EMA are available to Scottish patients, down from 63% in the 2023 report - meaning the proportion of available medicines has fallen by 9%.

Of the 54% of available medicines in Scotland, 31% are “fully available” (in line with the EMA licensed patient population), and the remaining 23% are available to a restricted subset of patients.

Finally, Scotland ranks 9th of 36 countries in terms of the time it takes between regulatory approval and availability on the NHS, with an average of 368 days. This is an improvement on the 2023 report, when it took 407 days, and Scotland ranked 13^th of 36.  

What does this mean for UK Patients?

Availability of medicines

The results in this year’s EFPIA Patients WAIT Indicator report show that the UK needs to do more to meet its ambition of providing rapid access to new medicines for as many patients as possible.  

England and Scotland have both declined in the rate of availability of new medicines.

Although England and Scotland are above the EU averages for availability, they continue to trail similar countries like Germany, France, Italy, and Spain.

In England, significant factors contributing to its ranking are the increasing number of medicines that are not recommended for use by NICE and the increasing number of NICE appraisals where companies terminate the process before it is completed. Companies have cited a challenging UK access environment as a reason for these increases. 

Of the new medicines available in the UK, around half are limited through optimised/restricted NICE/SMC recommendations. This means some patients won’t receive these medicines even though the medicine is licenced for them. More work is needed to evolve HTA methods to ensure they adequately reflect the benefits new medicines offer patients, their carers and families, and the NHS. 

The latest EFPIA report does not reflect the availability of medicines in 2023, a year when the VPAS payment rate significantly increased to 26.5%. It also does not include licence extensions (except for orphan medicines), which constitute a new medicine for patients who have previously not had access to the medicine for their condition. 

Time to availability

The time to availability for new medicines is broadly consistent year on year for England and continues to improve for Scotland. This positive result for time to availability reflects the UK’s focus on ensuring NICE and SMC guidance is issued as close to licensing as possible.

Time to availability of new medicines remains strong for cancer medicines, for both managed access and for interim funding from the point of NICE draft Guidance. There is an opportunity to utilise the Innovative Medicines Fund in England to level this up for non-cancer medicines.

In seeking rapid patient access to new medicines, doing NICE and SMC evaluations even earlier is not necessarily always the answer. Sufficient evidence and robustness of HTA processes are required for NICE and SMC decision-making. Sufficient evidence may not be available at early submission time points and the robustness of HTA evaluations may be compromised if process timelines are condensed.

A streamlined approach to managed access and/or commercially viable early access pathways may be a viable solution to address access in areas of unmet need for some priority medicines.