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 531 days. And a system where patients in one European country can wait more than 6 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

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 4 months to 2.2 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 126 days; this compares with 804 days in Poland a, with a European average of 531 days.


Understanding the issue

Delays and barriers to access are often due to a combination of factors and an EFPIA Root Causes Analysis identified 10 interrelated factors. For example, the speed of health technology assessments, different reimbursement processes or additional layers of regional and local decision making. Duplicative or inconsistent evidence requirements can also cause delay or a lack of availability. Additionally, different countries, HTA bodies and payers may require different endpoints, or some accept real world evidence where others do not.


The reasons vary between regions of Europe as well: 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. 

The European Access Hurdles Portal generates even more detailed insights into the reasons behind the delays to patients getting access to medicines. The Portal is an industry-led initiative to increase the visibility of the root causes of patients being unable to access new medicines. This additional analysis covers 66 medicines, that received a centrally authorised marketing authorisation between January 2021 and December 2023.

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.

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.

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.

Evidence 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.