How to set up an EAP without a European presence
Demand for access to unlicensed medications for rare diseases is growing thanks to strong clinical trial data, greater awareness of treatment options, and the rise of patient advocacy groups. Many patients seeking these treatments have exhausted all alternative options and may not qualify for clinical trials.
For patients suffering from these life-threatening, debilitating illnesses, expanded access programs (EAPs) can offer hope for an improved quality of life. There are many benefits to EAPs but also several challenges to overcome, particularly if you don’t have an established European presence.
The benefits of setting up an EAP in Europe
Faster entry into new markets:
The European orphan drug market alone is projected to grow from $41.46bn in 2023 to $60.25bn by 2028. An EAP can help you capitalize on this growth sooner and meet the needs of rare disease patients in the region.
Real world data collection:
An EAP can provide a better reflection of the realities of a drug’s use in the real world. This data can be crucial for future regulatory submissions, pricing and reimbursement negotiations, and improving market access strategies.
Access to diverse patient populations:
Europe offers a diverse demographic and through an EAP you can gather vital information on how your product works across a range of different backgrounds and healthcare systems.
Stronger reputation and networks:
Engaging with clinicians and patient advocacy groups early can foster long-term relationships. Clinicians who adopt the treatment early may become brand advocates, supporting regulatory discussions based on real-world experience.
How to set up a successful EAP in Europe
For biotech companies based outside of Europe, setting up an EAP in Europe may seem daunting. However, with the right partners and strategies, you can design and run a successful EAP without a direct European presence.
There are several steps that international biotechs can take to ensure the success of their European EAP. These include:
- Partnering with local experts: Collaborating with a specialist service provider with extensive experience in managing EAPs across Europe, such as Sciensus, can provide the local expertise you need to successfully navigate regulatory, logistical, and cultural challenges.
- Leveraging an established infrastructure: Our well-established infrastructure, including distribution hubs in the Netherlands, the UK, and Switzerland, can help you ensure efficient drug supply and distribution throughout Europe.
- Navigating the regulatory landscape: Sciensus’ in-depth knowledge of European regulations can help you secure the necessary approvals and ensure your EAP complies with all local requirements.
- Engaging with key stakeholders: Establishing strong communication channels with European healthcare providers and patient advocacy groups is crucial. We offer tailored support to develop and nurture these relationships and ensure that your EAP is well-received.
“If you don’t have a presence in Europe as a company, there’s really no way to do it without a partner. Ideally, you should have one partner, as splitting it up just creates more work and confusion. So, how do you make sure it’s the right partner for you? Make a list of all the things that are important to you when it comes to opening an EAP and try to match that with the right partner. There are small things that you should consider, such as where the customer service is based for that partner. Is it in Europe? Because physicians may need real-time access to help, to place requests, or to ask any questions.”
Sarah Radenovic Director of Managed Access Programs at GSK.
Why partner with Sciensus?
We’re dedicated to ensuring that every patient has access to the life-saving medicines they need, no matter where they live or the regulations in their country.
With 30 years of expertise in global market expansion, Sciensus has a strong track record in the rare and orphan disease sector. Our partnership approach supports the development and launch of therapies across the EU, offering access to our expanded access program services, world-class supply chain, patient support solutions, and nursing programs.
We also empower biotech companies through regulatory, marketing, and commercial strategy expertise. In the past year, we’ve facilitated over $350 million in sales for our clients in Europe.
Our collaborative, personalised approach ensures a faster path to market while addressing the urgent medical needs of patients in need of timely access to innovative treatments. Partnering with Sciensus mitigates risk and adds value to your European growth efforts. We excel in safely launching and delivering vital medication and clinical services to families in need.
Find out more about how Sciensus can support every step of your product launch, including setting up an EAP in Europe.
