The EU has incredible potential to lead healthcare innovation and address the unmet needs that persist for certain patient populations, but right now, the pace of innovation is in decline. As reported in the European Commission’s Future of European Competitiveness report, we see a clear and widening innovation gap between the EU and other global economies.¹²

At Viatris, we are pleased to see that the proposed reform to the EU Pharmaceutical Legislation aims to transform the European pharmaceutical system into one that is patient-centered, resilient and adaptable to future crisis. And we welcome its focus on promoting innovation, particularly for unmet patient needs. The proposal to reward certain repurposed medicines with 4 years of data exclusivity offers a foundation for tackling the challenges Value Added Medicines (VAMs) face and supporting more such products to come to the market.

With healthcare systems across Europe still dealing with the challenges brought by the COVID-19 pandemic and an aging population, the value proposition brought by VAMs - including drug repurposing, drug repositioning and drug combinations is more important - is more important than ever. VAMs can serve as an accessible, affordable type of innovation, helping to addressing healthcare challenges with therapeutic options that address patient and healthcare system needs, and allowing us to expand treatment options with differentiated products to improve patient access and health outcomes.

Despite this, there is not an adequate mechanism to support the development and use of VAMs in Europe. Right now, the EU accounts for just 16% of the total VAMs market, while the US accounts for 65%, meaning many of these medicines either do not currently make it to patients in the EU or arrive much later. To enable off-patent innovation and realize the potential of VAMs, collaboration is needed with policymakers at both European and national levels to find solutions for building the legislative pathways as well as the incentives that will foster the development of VAMs in Europe.

Our commitment:

At Viatris, we have a proven track record to drive innovation across our large and diversified portfolio, searching for more opportunities to address gaps in patient care and future-proof access to medicines:

• In 2024, we announced agreements for a significant global research and development collaboration with Idorsia, under which Viatris received exclusive global development and commercialization rights to two Phase 3 assets - a potential life-saving self-administered medicine for patients with a history of acute myocardial infarction (AMI), or heart attack, and a novel immunology asset that has the potential to be a first-in-class oral therapy for the treatment of systemic lupus erythematosus (SLE), the most common form of lupus. In Europe, we collaborate with partners like Shionogi, Paion, and TB Alliance, among others, to bring innovative medicines to hospital and retail markets.
• Globally, we operate 26 manufacturing and packaging facilities and 10 development centers, including 13 in European countries, such as France, Germany, Ireland, Switzerland, UK and Hungary. At these regional sites, a combined 3,500 employees work to make medicines available for patients - developing, producing and packaging a range of products destined for both European and global markets.
• Going beyond building on our extensive portfolio, we are also driving incremental innovation through our efforts to support the development and use of VAMs across the EU.
• And we’re working with EU institutions and partners along the medicines value chain to address the potential environmental concerns while protecting access to medicines.

Our recommendations:

We are calling for legislative reforms that will pave the way for patients to access safe, timely and affordable innovation of existing medicines:

• Design a fit-for-purpose regulatory framework for VAM: VAMs are based on existing, proven and approved active ingredients. Existing regulatory frameworks don’t offer a clear way to build on existing evidence. A fit-for-purpose pathway would cut down on costs and hurdles for continuous innovation.
• Acknowledge VAM as a category of innovation with proportionate incentives: Currently, developers of new, innovative medicines as well as manufacturers of off-patent medicines are offered certain IP protections as an incentive to bring products to market, but current frameworks do not recognize VAMs. To enable developers to invest in VAM, we support recognition of VAM as a separate category of innovation with proportionate incentives.
• Recognize and define the value of VAM for healthcare systems: Many health systems do not differentiate between VAM and generics, since they are both based on existing molecules. The lack of any process to recognize the additional value of VAM and acknowledge the additional development costs compared to a generic lead to the undervaluation of VAM. Without any mechanism to price VAMs differently than generics, it may not be viable for manufacturers to invest in their development.