Just imagine that patients had access to a new medicine as soon as it received 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 authorisation is 578 days. And a system where patients in one European country can wait 7 times as long as patients in a neighbouring country for the same medicines must be addressed.

Inequitable and delayed access to medicines continues to challenge Europe’s healthcare systems and negatively impact the health outcomes of its citizens. EFPIA believes we can achieve more equitable and faster access across Europe if stakeholders come together to tackle the issues delaying delivery of innovative medicines.

How do we turn imagination into 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

Understanding the issue

Delays and barriers to access are often due to a combination of factors from slow regulatory process, late initiation of market access assessment and duplicative evidence requirements to reimbursement delays, and local formulary decisions. These challenges are embedded in national-level systems and influence company decisions about where and when to launch new medicines.

The Access Hurdles Portal

The European Access Hurdles Portal was created to help us identify and co-create pragmatic, evidence-based solutions that reduce the disparities in access faced by patients. With 100% participation from EFPIA members and covering 94 medicines approved between January 2021 and June 2024, the data clearly shows that the majority of delays (69%) occur after companies have filed and are awaiting a decision from a Member State. This highlights that access barriers are predominantly within national decision-making systems and the industry response to them. The portal data showed companies are on average filing in 16 out of 27 Members states within two years. It means no one actor or piece of legislation can address these challenges and new ways of working together are required.

Focus on smaller markets

To better understand the unique challenges in smaller European countries, EFPIA has published a new report analysing access conditions in nine markets: seven EU countries (Croatia, Cyprus, Estonia, Latvia, Lithuania, Malta, and Slovenia) and two non-EU countries (Montenegro and North Macedonia). All have populations under four million and below-average availability of innovative medicines. The report identifies specific structural barriers to access that require targeted solutions and its findings provide a solid foundation for strategic dialogue aimed at improving access for patients in smaller European markets.

Bringing innovative solutions

Ensuring that medicines reach citizens regardless of where they live in Europe is a shared ambition and a shared responsibility. However, the lack of consensus on how best to achieve this means that patients in one European country can wait more than 7 times as long as patients in a neighbouring country for the same medicine.

EFPIA’s members have committed to file for pricing and reimbursement (P&R) within two years after gaining EU Marketing Authorisation, provided that local systems allow it. To address the structural barriers causing unavailability and delays, EFPIA is actively engaging at national level – including with smaller countries – to explore practical, tailored solutions for patients.

Those with less should pay less

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

EFPIA’s Equity-Based Tiered Pricing (EBTP) proposal ensures that countries that can afford less, pay less for medicines. This requires changes to External Reference Pricing (ERP) practices and EU internal market rules to prevent parallel trade from undermining fair pricing models. Parallel trade currently allows to buy medicines at lower prices in certain countries and selling them in markets where they can demand a higher price.

Innovative Payment Models

Novel pricing and payment models can also help 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.

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.

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