The Challenges of Market Access in Europe that Pharma Companies Face: Q&A with Mike Ryan

Mike Ryan
Executive vice president of
Europe and Asia Pacific
EVERSANA

Mike Ryan, executive vice president of Europe and Asia Pacific at EVERSANA, spoke with Pharmaceutical Executive about the unique challenges market access challenges pharma companies face in Europe.

Pharmaceutical Executive: How complex is it to bring a new therapy to multiple countries in Europe?
Mike Ryan: Bringing a new therapy to multiple countries in Europe is hard for a variety of reasons. From a highly fragmented reimbursement landscape to diverse regulatory requirements across the 27 European Union member states, not to mention additional markets like the United Kingdom and Switzerland, it’s no small task.

In Europe, each country conducts its own Health Technology Assessments or HTAs, which are systematic evaluations, on a country-by-country basis. These look at the cost and health benefits of a drug or medical device. These detailed analyses are then used by each country to determine if a therapy should be considered for usage and paid for by the national health service in each country. Each is unique, and if a company is working to enter three or four different markets, the timelines for each assessment can vary, as can the ultimate price each governing body will pay.

In the United States, by contrast, once approved by the FDA, the process can go much faster. Because of this complexity in Europe, launch times can take some time.

PE: What are some of the common challenges you hear from clients who want to come to Europe that prevent them from doing so?
Ryan: By far, the biggest challenge brands face when considering a European launch is navigating the diverse and complex reimbursement systems, dealing with longer approval timelines, and managing the high costs associated with bringing new therapies to market. But that’s not all.

Europe is such a blend of countries with unique cultures and languages, and these all must be considered when determining what a market access approach may look like. For example, how a certain therapy might be perceived in Spain may be very different from how it is perceived in Finland. Additionally, the economic challenges of prioritizing cost-effectiveness and the need for better access to rare and orphan disease products are significant hurdles. In addition, U.S. companies may also have concerns about the costs of opening and maintaining subsidiaries in various countries. These can be expensive and complex, time-intensive efforts to stand up.

It’s not easy, but what we’ve seen is where brands can see strong value is in a partner that know the market and has relationships with governing bodies, clinical experts, and patient advocacy groups.

PE: What should companies consider in a partner to help them come to Europe?
Ryan: Companies should look for partners with a deep understanding of the European reimbursement landscape, experience in navigating HTAs, and the ability to manage price negotiations effectively.

Additionally, it is beneficial to identify partners who can offer solutions like outsourced sales representative teams, local legal infrastructures that may help minimize the need to open multiple subsidiaries, and partners with local marketing expertise.

Finally, as companies consider European launches, data insights into local markets should be built across all strategies. This will help to ensure that appropriate commercial resources are assigned to each market only when it’s necessary to do so. In doing so, partners must understand the intricacies of European data privacy laws and have a proven track record in this area. An effective outsourced partner must take every precaution to manage budgets as appropriately as possible.

PE: Are any countries “easier” from a market access standpoint than others?
Ryan: Yes, some countries are easier from a market access standpoint. For example, Germany typically has the fastest HTA pathways, where approvals can take anywhere from one to three months. In contrast, in Italy and Spain, our experiences show that it may take between 20 to 26 months for the same process. Wealthier nations like Switzerland and France often expedite the reimbursement process for innovative treatments, while countries in Eastern and Southern Europe face significant delays due to budget constraints and less robust healthcare infrastructures.

PE: Any additional final thoughts you hear from customers looking to launch a product in Europe?
Ryan: Based on feedback we have received from our existing clients, we see that companies value a partner that not only understands the nuances of the European markets but also brings integrated commercialization capabilities, allowing them to remain agile while ensuring compliance, market access, and commercial success.

Customers continuously emphasize the need for seamless execution - from launch strategy to field deployment teams and ongoing engagement with stakeholders. Clients believe a strong partner can help bridge the gaps between strategy and execution, ensuring that every decision is informed by both data-driven insights and deep local expertise.When done right, the European market can be a valuable market prospect for companies looking to introduce new therapies. It’s not easy, but in the end, the value to the companies and, most importantly, to patients across the region is worth the effort.