November 30, 2020

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Investors typically anticipate a company will avail itself of such a large market opportunity and unlock the total business value of its assets.

The 28 member-nations of the European Union–and significant non-member states like Switzerland and Norway–represent over 22% of the $800+ billion global pharmaceutical market. Collectively speaking, European markets are highly appealing to any business with products that offer compelling and differentiated value propositions.

But a transfer into Europe is a significant step that shouldn’t be dismissed. Companies that are ill-prepared–and that do not know the secrets to victory in Europe–may expend a tremendous amount of funds while negatively impacting the value of their resources for a long time to come. In short, when it comes to entering Europe, it truly pays to do it correctly the first time.

Unfortunately, for companies which aren’t familiar with Europe, the best way to”do it right the first time” is not always very clear. Even though nearly all of Europe shares a common regulatory system, there are many differences to browse. For instance, the civilizations and people are varied, accessibility and reimbursement schemes–and the associated decision-making approaches–differ widely from market to market, and you will find 24″official and working” languages and 11 official monies to deal with. It’s complicated.

Moreover, companies occasionally begin to think about Europe too late. There are key things that they must do really early to ensure IP protection, establish a team, set their clinical trials for success, and lay the groundwork for market access. Starting these items too late can result in dangers and keep a company from achieving the full potential of its assets.

As a result, the goal of the article is to begin constructing a road map of sorts for businesses which are interested in Europe. Herewe present seven secrets to success in Europe and briefly explain why each is essential. Companies should focus on these keys to achievement if they’re thinking of European market entrance, are in the process of enteringor if they’ve recently entered and are working to solidify their existence.

While we at Blue Matter have significant expertise in many of these areas, we have collaborated with external specialist partners in lots of the secrets below to deliver much more expertise. On the coming months, we’ll publish subsequent articles and resources which will delve into each of these keys in far greater detail. Let’s get started!

Crucial 1 — File & Don’t Forget: Properly securing IP protection & completing regulatory filings
Securing European intellectual property (IP) protection and managing regulatory filings are crucial, meticulous, and process driven exercises. Still, both areas require special attention since they set the commercial playing field for years to come and directly affect a company’s ability to unlock its full commercial potential.

A business which conducts a complete reconnaissance of the applicable IP and regulatory processes will obtain a much better understanding of the mission critical interactions with government. Done correctly, these crucial interactions might enable the business to

Expedite clinical development and review timelines
Prolong exclusivity
Optimize pricing
More efficiently pull through its strategic priorities
Mission crucial interactions with regulators and payers should begin while defining the critical trial strategy. Ideally, employers would seek out joint health and scientific technological advice to ensure clinical endpoints will address unmet needs, differentiate from competitors, and empower access and compensation.

Remembering that the limited resources and time limitations, biotech startups need to aim to align their FDA programs as far as possible to the EMA applications. Additionally, they should conscientiously apply for orphan drug status, or some other regulatory options they could have.

Crucial 2 — Do not Require the Science to market Itself: Leveraging the Ideal commercial model to achieve market success
This secret to success goes well beyond Europe, since it is a really key to commercial success in general, whatever the geographies involved. In a nutshell, even if the product in question is an actual scientific breakthrough that’s highly distinguished from a clinical perspective, the chances are that the science alone will not be enough to allow it to achieve its full potential.

It will need more than this to stand outside. Companies need to effectively engage with stakeholders at the ecosystem to drive awareness, ensure a complete understanding of the way the drug and any related services or operational procedures (e.g., logistics for cell therapies) operate, understand demands, and conquer challenges (like misdiagnosis resulting in long delays in patient finding).

Successful businesses in Europe will have a tactical (and systematic) approach for assessing the market landscape(s), defining the total vision, and determining what must be designed to meet stakeholder requirements. Since resources are limited, they will also need to be smart about how they weigh alternatives and make trade-off decisions.

It’s also important for organizations to consider the way to serve patients in markets where the opportunity is not too significant. Going it alone across all of Europe is rather a significant undertaking and dangers diluting effort in center markets. Devising an effective approach –for example finding a spouse –to maximize value in these smaller markets is useful to both patients and companies.

Selecting the right location for a European headquarters is a significant choice. However, an important proportion of the time, companies select headquarters places using very non-scientific approaches. Perhaps the CEO has an affinity for some city.

Selecting a place utilizing such subjective approaches can result in costly mistakes. Instead, a company should invent a systematic approach to assessing places and making a final choice. There are a vast range of criteria which a company should score and evaluate, such as tax laws and benefits, labor laws, accessibility to transportation, proximity to other life science companies, access to talent, quality of life, and a range of others.

There are too many examples of companies that based their conclusions on subjective aspects, then had to endure years of sub-optimal operation before finally admitting defeat and moving into a better place. A goal approach can help avoid those headaches.

View of the Vltava River and Charle bridge with red foliage, Prague, Czech Republic

Crucial 4 — Europe’s Got Talent:

Determining which HQ & country characters are needed & if to employ them
Employing the proper leadership functions at the right times and in the right sequence is seriously important. U.S. companies often underestimate the time and effort necessary to hire a group in Europe, and at times struggle to determine the best order for key functions, such as the GM and leaders to the Regulatory, Medical Affairs, Market Access, and Clinical Operations functions. Awful timing and improper sequencing can result in poor team dynamics, a scarcity of buy-in for your European plan, along with other challenges.

In addition, European hiring procedures –as well as compensation and benefits expectations–are distinct from those from the U.S. Companies that fail to appreciate the differences can wind up with significant and unexpected delays.

Another important lively, which relates to the talent acquisition in addition to headquarters place, is if to go after talent regardless of location. This would involve setting up a virtual leadership team instead of forcing ability to move to the exact same location. There are important pros and cons for both alternatives.

To be successful, companies need to focus a great deal of attention on the crucial GM role. They also need to choose whether to employ talent regardless of location vs. talent tied to a particular place, comprehend local benefits expectations, and plan the hiring arrangement for their initial waves of hiring.

From a supply chain perspective, a provider wants to be completely compliant and prepared to get purchase orders, deliver merchandise safely and efficiently to clients, send invoices, and collect cash as of Day One of market authorization approval. To attain this for a European market entrance, a provider should comprehend the interlinks between the bodily and merchandise name flows and the monetary stream. These parameters will enable the company to make strategic choices that enable them to optimize supply timelines and tax structures.

Moreover, it is vital to comprehend using the product, the patient, the prescription coverages, the compensation flows, and the socket (hospital, retail, homecare, etc.) to look for the most optimum supply chain that fits the first launching, in addition to possible following launches of new indications or new products. In addition, labelling and packaging considerations accommodating the several languages will need to be well thought through also complying with all the new serialization requirements in the EU.

Especially in the case of Advanced Therapy Medicinal Products (ATMP’s), an early beginning with experienced expert guidance is highly recommended since the European supply chain infrastructure remains underdeveloped for all these products.

As companies create their supply chain strategies, they frequently underestimate the time required to find the necessary licenses. While VAT registration might be on a less critical time interval, procuring a production and export consent and wholesale supply authorization may take around a year.

Third-party sellers can offer client service, information technology, logistics, and finance solutions to help address some of the key issues for a European launch. Choosing the ideal partners that fit the culture and the distribution chain strategies of these biopharma companies is an essential choice. Consequently, biopharma companies will need to acquire the best possible support and begin engaging early to correctly set up contracts and manage these relationships effectively.

In the end, it is important to bear in mind that data points accumulated through the supply chain–coupled with competitive intelligence–will help boost commercial excellence and highest transparency of where the products are at any moment in time. Business need to be proactive in creating effective mechanisms for getting useful industrial information from the supply chain.

Essential 6 — Show Me Value: Immediately engaging with payers

National payers are extremely important. In addition, their needs and expectations may vary widely, as distinct federal payers use various criteria for evaluating medications and making compensation and access decisions.

As a result of this, companies planning to enter Europe have to engage early with payers, preferably starting before they look their critical trials for Europe.

Bright businesses will proactively map the payer landscape, understand the test criteria that crucial payers use, and participate early. This is going to result in more relevant data and provide insights for constructing more tailored and compelling value propositions for payers.

Essential 7 — Europe Isn’t a Country: Assessing the launching sequence & market-specific strategies
Each nation represents a discreet launch into a distinguished health decision-making ecosystem. Given the sophistication, trying to understand all markets or to employ a U.S.-like plan is apt to lead to failure. A regional strategy that reflects EU-specifics is essential.

Before entering any current market, the pharmaceutical company should deeply understand the environment–patients, caregivers, physicians and other pertinent stakeholders–to help build brand propositions which will be significant to those stakeholder groups. These brand propositions often extend well beyond the product’s clinical characteristics and demand a range of elements that can comprise the total brand experience. These can contain tools and support solutions, disease education, development of patient / service communities, and much more. All these things will help create a strong and differentiating brand experience that goes beyond the item’s clinical attributes independently.

What’s more, in Europe, chances to participate patients are somewhat different than they are in the U.S.. An effective engagement strategy, implemented consistently through the individual’s ecosystem, is essential to guarantee value is delivered.

To put in Europe, smart companies define their priority markets and decide the perfect launch sequence for inputting themtaking into consideration matters such as market size, reimbursement, benchmark pricing, as well as the delay between reimbursement and regulatory decisions.

In an ideal situation, the worldwide organization will direct co-creation of the pivotal study and market entry strategy to the priority economies. The needs of those markets–especially for both regulatory and market access–should be fed into the design of the pivotal study and development of engagement strategies.

In reality, companies are not always in the”perfect situation” and start to focus on Europe after critical study design has already taken place. All is not lost in these scenarios, but it certainly does make for a more challenging dynamic.

Hopefully, this guide has provided a brief but useful summary of seven secrets to success once entering Europe. This list isn’t intended to be exhaustive, but instead to cover the keys that we have seen most closely associate with favorable outcomes for biopharma companies. On the coming months, we will handle each of these keys separately. We’ll go into more detail and summarize strategies, tools, and procedures that companies can use as they enter fresh European markets.

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