We’re excited to launch “3 Things About Reimbursement”, the fourth video in our ‘3 Things About’ series designed to simplify complex healthcare topics. In this video, Frederick Thielen explores the complexities of drug reimbursement—a key factor in ensuring patient access to new medicines. While a drug may be approved for use across the EU, reimbursement decisions vary by country, affecting its availability.
Transcript of the video
3 THINGS ABOUT REIMBURSEMENT
Looking at the European Union, you may notice that some medicines are available in one Member State but not in another. This happens even though the European Medicines Agency decides if a drug is effective and safe and can be sold in all EU countries. So, how is it possible that a medicine is legal to sell across the EU but is not available in every Member State?
The reason for this lies in the complex process of drug reimbursement. Just because a drug is legal to sell does not mean that every Member State is willing or able to pay for it. Drug reimbursement plays a crucial role in ensuring that patients have access to necessary medications without bearing the full financial burden. Yet, many aspects of this process remain unseen by the public. Here are three things you might not know about drug reimbursement:
Different evaluation processes
Each EU Member State has its own process for deciding which drugs will be reimbursed and at what price. The EU Treaty of Maastricht, signed in 1992, gave the EU the authority to make central decisions on certain health policies, such as the safety and approval of medicines through the EMA. However, the financing of healthcare systems—including how drugs are reimbursed—was and still is deliberately left to each individual Member State.
This means that while the EMA ensures a drug is safe, effective and can be marketed across the EU, each country then decides if its healthcare system will cover the cost of that drug for patients. Some countries have specialised bodies, called Health Technology Assessment agencies, that evaluate how well a drug works and whether its price is justified based on the promised health benefits. The goal of this process is not just to cut costs or find reasons to say no, as some might believe, but to ensure that patients have access to drugs that provide meaningful health benefits relative to their costs.
Impact of negotiations and pricing agreements
The final price of a drug is often settled after lengthy negotiations between pharmaceutical companies and the bodies who are responsible for the expenditures on drugs, like ministries of Health, national health services or insurance companies. These negotiations can lead to confidential discounts, rebates which are certain types of discounts or refunds, and even value-based agreements where payment is tied to how well the drug performs in the real world.
These pricing agreements aim to align everyone’s interests: ensuring that patients get effective treatments while helping healthcare systems manage their budgets. It is a balancing act between making sure innovative drugs are accessible and healthcare costs are sustainable.
Differences in Patient Access
Drug reimbursement policies vary significantly across different countries and even within regions of the same country. Factors such as local healthcare priorities, economic conditions, and regulatory frameworks influence these policies. This variability means that a drug available through reimbursement in one country or region might not be reimbursed in another. This affects its accessibility and affordability for patients depending on their geographic location.
And even when a drug is reimbursed, patient access can still vary. Some countries may choose to cover a drug for all eligible patients, while others might impose certain restrictions—for example, only reimbursing it for specific conditions or for patients who have already tried other treatments.
There is a lot of nuance behind these decisions and each country is trying to make the best choice for its population, given the available budget and political context. By continuing to innovate, collaborate, and adapt, we can move closer to a future where equitable access to effective treatments is a reality for all.
And don’t miss the making-of video
The videos were filmed on November 28, 2024, at the Gegevens Erasmus Studio of Erasmus University Rotterdam.
We invite you to watch, share, and join the conversation about how we can work together to make healthcare more equitable and effective.