Why Consider the European Market for the Supply of My Pharmaceutical Product?

Launching a pharmaceutical product in the European Union means you need to adapt your regulatory strategy, but it could be well worth the effort.

For most US-based pharmaceutical companies, launching a drug in Europe means adapting their regulatory strategy to a completely new market. This is why many of them are put off by the idea and prefer to distribute their products domestically or to out-license them. Yet, with the right approach, targeting the European market can be well worth the effort.

The following article will go through these topics to advise our readers as much as possible:

• Why Are EU Launches So Challenging for US Pharma Companies?
• Why Are EU Launches So Challenging for US Pharma Companies?
• The Benefits of Adapting Your Regulatory Strategy to the EU Market
• How to Ensure the Success of Your EU Launch?

Why Are EU Launches So Challenging for US Pharma Companies?

Adapting your regulatory strategy to a market with a variety of standards and different rules from what your teams are used to can be daunting. This adds a level of complexity that affects the supply chain and, without a presence on site, means that you will need to deal with taxes, import duties, and specific distribution regulations. On the other hand, physically expanding your operations across multiple regions implies building infrastructure and putting together new talented teams, which constitutes a significant upfront investment. This is why many US pharma companies avoid flying solo when it comes to conquering the EU market and prefer to out-license their drugs to capable local firms.

However, there is a third option, which is to rely on the services of a pharmaceutical consulting agency to help you fine-tune your regulatory strategy to fit the various requirements for a successful EU launch.

The Benefits of Adapting Your Regulatory Strategy to the EU Market

Out-licensing often means losing out in terms of value, whereas going it alone can get so complex that it is not much more cost-effective. Pharmaceutical consulting companies give you the best of both worlds and allow you to reap the financial rewards of your efforts. This is because pharma firms can typically hope for better stock price when they launch rather than license their products.

Opting for an in-house EU launch also grants you much more control over your own product and lets you oversee its messaging, pricing, branding, and commercialization. This means that the decision-making can still be done from your US headquarters and that you can invest in new operations across multiple regions to take advantage of every opportunity.

By gearing your regulatory strategy towards a global market, you can expand comfortably knowing that you are making the most of all your assets.

How to Ensure the Success of Your EU Launch?

When it comes to pharmaceuticals, being successful means launching the right product, at the right time, with the best ROI possible. Before committing to a resource-intensive launch, ask yourself whether your value proposition is strong enough to guarantee pricing power, or if your drug is going to be used by a sufficiently large group of prescribers. Keep in mind that being the sole responsible for the launch of your own drug creates value, but that it demands just the right regulatory strategy.

Surround yourself with experts by hiring the best talents and partnering up with a reliable consulting agency. You need people who have plenty of experience in launch planning and execution, and who have a perfect grasp of the European markets.

Racing through the stages may result in unforeseen roadblocks which would cause delays and increase costs. Careful preparation is key and will help you mitigate these risks and achieve your strategic goals.

Europe’s new Pharmaceutical Strategy is looking to support innovation, competitiveness, and sustainability all while promoting high-quality, efficient, safe drugs. To make this ambitious agenda a reality, the EU is welcoming solutions to address unmet medical needs and offer more affordable products to make treatments accessible to all.

With the right local knowledge, US pharma firms can expand into a fast-growing market.