Launching in Europe
Early access schemes
Many countries offer early access schemes pre- and/or post-marketing authorization (MA). These programs can take the form of expanded access/extension studies, early access programs, emergency supply mechanisms, and individual named patient importation (NPI) and operate on a country-specific basis. Manufacturers must carefully consider regulatory aspects, communication strategy, data protection, and safety implications across – each on a country-specific basis. Manufacturers must also consider the impact of early access on future pricing and reimbursement – which, again, varies by country and requires a local view, yet also a holistic approach when launching across the region. We have also recently written here about successful early access in the early launch markets of France and Germany.
Pricing and reimbursement
While there are some commonalities, especially the trend towards requiring a health technology assessment (HTA) as part of pricing and reimbursement, we still see significant variations by country with regard to strategies such as the use of positive and negative lists as well as reference pricing. Companies should implement an overall European pricing and reimbursement strategy early on, including all likely future launch countries in the region. For example, it is important to understand the impact that an agreed price in one market may have on other markets. Further, launch sequence may also depend on where payment under local reimbursement can be obtained swiftly and early.
Supply chain planning
Another important consideration throughout the complex European marketplace is appropriate supply chain planning to ensure that product can arrive safely, and efficiently (to the right countries on the right timeline, see above), all while optimizing supply taxes. Supply chain planning is important as early as the clinical supply stage; for commercial supply of sold products it is a business necessity. Often, the transfers of physical product will differ from the requisite sales agreements and legal title necessary for optimizing distribution. Moreover, even with harmonization trends across many parameters, each country still has its own local laws and courts, with which manufacturers – and their third party providers (e.g., 3PL) – must comply. We have also recently expanded upon some of these considerations here.
Commercial launch preparation
European regulations of pre- and post-MA communications are among the most strict and lack a significant harmonized framework. Two key watchouts include advertising regulations and interactions with health care professionals (HCPs). In particular, U.S. companies should be mindful that most EU member states and the UK consider press releases and social media as “advertising” and therefore the content in these communications must be carefully reviewed before release. “Likes” of posts by U.S.-based counterparts within an organization can also result in scrutiny, and we have recently discussed some of these cross-jurisdictional social media risks here. In addition, manufacturers should have a compliance-driven strategy for interacting with HCPs to ensure that appropriate frameworks governing these interaction are not only in place but also followed.
Litigation risks: new representative actions Directive for collective consumer claims
Looking ahead, stakeholders in the life sciences industry should also be mindful of Directive (EU) 2020/1828 on representative actions for the protection of the collective interests of consumers, which will replace the current Injunctions Directive starting from 25 June 2023. The new Directive aims to ensure that representative actions for injunctions and for collective redress (compensation, repair, termination of contract, etc.), brought by so-called Qualified Entities, are available as a minimum standard in all Member States of the EU. Amongst other areas, the Directive will likely impact how manufacturers can be held accountable for several aspects of the product life cycle management processes we discussed above, such as direct to consumer advertising that is not entirely correct, as well as product liability and general product safety issues.
Launching in the U.S.
Market access and the Inflation Reduction Act of 2022 (IRA)
Manufacturers of a product having a payer mix with an expected spend of at least U.S. $ 200 million in annual Medicare sales must now grapple with the impact that the IRA will have on launches. That includes a new focus on launch timing, from managing the timing of an New Drug Application (NDA) or Biologics License Application (BLA)’s submission to maximize the IRA time clock, to ensuring a company is fully launch-ready on PDUFA date +1 with a value story that is fully developed. Rounding out the discussion was a reminder that the new IRA Part B and Part D inflation rebates rely on benchmark prices that are set shortly after launch, and manufacturers should plan and structure any launch incentives with those in mind.
Patient support programs
As with the European framework highlighted above, the U.S. approach to patient support programs requires careful considerations and risk analysis for each specific type of program as these programs potentially implicate complex legal and regulatory frameworks. Importantly, different barriers to access may require different solutions, and not all programs are appropriate for all products and/or patients. Regardless of offering, manufacturers must have in place an appropriate compliance infrastructure at least as of their New Drug Application (NDA)/Biologics License Application (BLA) planning and submission stage. Manufacturers should also give thoughtful consideration to the design of the patient support programs, considering scope and risk of each program but also the cumulative risk of all support programs. The unique circumstances of the product, the disease state, and the barrier to access sought to be addressed will influence the risk analysis for these programs.
Manufacturing, quality, and compliance
As the industry moves towards an increasingly complex global supply chain, manufacturers must be even more vigilant to ensure the consistency and acceptable quality of manufactured drug products. FDA may exercise a more flexible regulatory approach towards manufacturers with advanced quality systems such as demonstrating a commitment to quality culture and continuous improvement. In preparing for launch readiness, manufacturers can benefit from a gap assessment for assurance that they have updated quality agreements and robust quality management systems including procedures, processes and communication plans with their supplier and third party contractors to ensure compliance with current good manufacturing practices (CGMP) and supply chain resilience. Having effective supply chain management, risk mitigation plans, and communication can prevent costly delays in moving product within and outside the U.S. market so that critical medicines are available to those that need them the most.
Next steps
While there are many local differences that manufacturers must carefully consider in order to optimize patient access to their life-saving therapies, the value of early planning – even as early as the clinical phase – applies across regions. Our global team of Life Sciences and Health Care lawyers frequently collaborate to provide strategic, commercial, and tailored advice across the EU Member States and UK, the U.S., and beyond.
If you would like to request a copy of the presentation, please contact our team.
Please contact the authors or the Hogan Lovells attorneys with whom you regularly work for guidance on your organization’s specific launch needs.
Authored by Eliza Andonova, Ina Brock, Kristin Connarn, Lynn Mehler, Mikael Salmela, Jörg Schickert, Jane Summerfield, Alice Valder Curran, Hein van den Bos, and Lowell Zeta.
