Just imagine that patients had access to new medicines on day one after authorisation by the European Commission.

That is our aspiration but we have a long way to go. Currently the average time to patient access from authorization is 517 days. And a system where patients in one European country have to wait ten times longer for a given medicine than in another country or region is simply untenable.

How do we turn imagination in to action?

By ensuring the revision of the Pharmaceutical Legislation creates the right ecosystem for the pharmaceutical industry to continue to discover, develop and deliver new medicines in Europe. That is always the first step to access.

By having the right partners around the table – the root causes behind these delays are multi factorial. Any solutions that can move us towards our shared goal of faster, more equitable access to medicines requires Member States, Industry, patient groups, HTA bodies, payers and healthcare providers.

The access situation in Europe

Millions of people across Europe are not always able to access the scientific breakthroughs when they need them. Data from EFPIA’s Patients W.A.I.T Indicator show that market authorisation and patient access can vary from three months to 2.5 years, depending on the country and region. Figures from the report show that, on average, a new medicine will reach patients fastest in Germany in 128 days; this compares with 918 days in Romania and 1351 days in Malta, with a European average of 517 days. Disparities persist between Northern and Western Europe and Southern and Eastern Europe - with an 80% average variance in availability.WAIT 2022

Understanding the issueThe reasons for these delays are multifactorial. An EFPIA Root Causes Analysis identified 10 interrelated factors that were causing access to medicines to be delayed. The reasons vary between regions of Europe: delays in filing in Western Europe are largely due to the value assessment process and evidence requirements; delays in Eastern Europe are due to health system constraints and the corresponding impact on companies’ decision-making and resource allocation. 

By identifying these issues, it is clear that there is no one-size-fits-all-solution and that no one stakeholder can fix these problems alone. EFPIA is therefore supporting a multi-stakeholder approach to explore a range of initiatives, including a process that would better align value and ability to pay, more efficient value assessments of new vaccines and therapies as well as proposals to ensure solidarity across EU member states.

Bringing innovative solutions

EFPIA’s members have committed to file for pricing and reimbursement (P&R) as soon as possible but certainly within two years after gaining Marketing Authorisation, provided that local systems allow it, as they intensify their efforts to accelerate patient access to their latest medicines. Companies’ progress against this commitment is being tracked in the European Access Portal, an industry-led initiative to increase the visibility of the root causes of patients being unable to access new medicines.

Results from the first ever data set from the Portal show that six out of ten medicines have been filed for pricing and reimbursement in just 14 months, demonstrating industry’s commitment to filing for pricing and reimbursement across the EU27 within two years. A clear picture is also emerging about the exact points of delay. For medicines that have completed the reimbursement process, early trends from the Portal suggest that about a quarter of the delays to patient availability are due to delays in company filing and the rest (75%) occur as the product goes through national pricing and reimbursement processes.  

The pharmaceutical industry has also proposed new pricing structures in a bid to address barriers related to affordability.

EFPIA’s proposal for an Equity-Based Tiered Pricing framework is aimed at ensuring that the countries that can afford less, pay less for medicines. For this to happen, the European Commission and EU Member States will need to amend External Reference Pricing systems. In addition, rules related to the EU internal market will also have to be adapted to prevent parallel trade; buying medicines at lower prices in certain countries and selling them on in markets where they can demand a higher price.

EFPIA and its members are also proposing a greater push towards novel pricing and payment models that will make it easier for Member States to introduce highly innovative medicines, such as cell and gene therapies. The potential clinical benefits of these new therapies are enormous, but limited datasets and a lack of long-term experience with these therapies are not compatible with today’s reimbursement systems.

But these challenges could be surmounted by making greater use of outcomes-based payment models and subscription models, as well as supporting sustainability by paying for medicines over time. Moving forward with more flexible pricing solutions would allow decision makers to manage uncertainty around outcomes over the longer term, whilst providing swift access to lifesaving and life-changing medicines.

Data from the Access Portal shows that that no one sector, organisation or legislation can address medicines access issues in isolation. To make real progress in providing equal access to treatments across Europe, we need all partners around the table to work together to find predictable, practical and timely solutions, while legislators focus the revision of the pharma legislation to ensure Europe remains an attractive location for medicines R&D.