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UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system.

Lobbying Activity

Meeting with Olivér Várhelyi (Commissioner) and

11 Sept 2025 · Site visit of UCB factory

Meeting with Maurice Whelan (Head of Unit Joint Research Centre), Tobias Wiesenthal (Head of Unit Joint Research Centre) and

4 Apr 2025 · Scientific roundtable discussion between the European Commission’s Joint Research Centre and the pharmaceutical industry on the topic of leveraging health data and data sciences for innovation

Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

UCB has a fundamental commitment to enabling people living with severe diseases, their caregivers & families to live their best lives. We continuously innovate to bring differentiated solutions with unique outcomes, which help specific patients achieve their life goals. To deliver on that commitment now and into the future, sustainability is a strategic imperative for us. For instance, considering both current and future generations, we do our utmost to minimize our impact on the environment and protect our planet’s health. Building on this, we look forward to working with the EC to better assess and address environmental risks and enhance our environmental sustainability. Overall, a supportive, fit-for-purpose and coherent legislative framework is essential to support both our ambition and Europe’s to be a world-class leader for pharmaceutical innovation. The evaluation of the pharmaceutical legislation is an opportunity to foster an agile and globally-competitive regulatory framework, geared to embrace and accelerate the development of innovative healthcare solutions to help address patients’ needs now and into the future. This requires identifying and reducing barriers and inefficiencies, e.g. by: - reinforcing expertise-driven assessment and removing unnecessary interfaces between EC, EMA and Committees to enable a more centralized authorization framework; - ensuring the acceptance of RWE in medicines evaluation pre/post-authorisation; - expanding EMA’s role in assessing drug-device combination products; - switching from paper to electronic patient information leaflets - simplifying and modernising the post-approval framework for variations. Scientific/technological developments are fast-paced though, so to be future-proof, legislation must be flexible and dynamic enough to accommodate these outside of legislative revisions e.g. via policy documents or guidelines. It is equally critical that the EU pharmaceutical legislation is connected and consistent with its broader context and complementary initiatives. A more aligned EMA/HMA strategy is key in that respect. A detailed and holistic impact assessment of any proposed change against objectives set in the Pharmaceutical Strategy, and in a constant dialogue with impacted stakeholders, will be critical to balance risks, design adequate policy options and avoid unintended effects. For instance, to ensure the EU pharmaceutical system and industry are competitive and continue to deliver innovation responding to patients’ needs in the long-term, a robust and predictable system of incentives to stimulate innovation is critical. But patients’ needs are multiple and unique. Developing effective solutions to address them and ultimately find a cure is a long, complex and risky process, which requires differentiated solutions tailored to various challenges/situations incl. (lack of understanding of disease pathway, long/complex clinical trials in e.g. neurological or rare diseases, small patient populations in rare diseases. Critically, incentives must be reliable to be effective - we believe linking incentives to access conditions will compromise the objective of incentivising and ultimately, improving access to innovation. We acknowledge the challenges facing healthcare systems and are committed to work with the EC and MS to ensure access for all who need our solutions, in a way that is viable for patients, society and UCB. Yet, the causes of access issues are multi-factorial, often rooted in healthcare systems and market dynamics, and can hardly be anticipated at the early stage of a research program. These can only be addressed by stakeholders working together to identify stable and predictable solutions, based on an analysis of access delays and lack of availability of specific products in specific countries. These will however not be addressed by compromising the regulatory and incentive framework, which are integral to the EU innovation and industrial ambitions.
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Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

UCB is dedicated to finding unique solutions for diseases with high degree of patient need. Regardless of the population size, it’s patients’ needs that direct our efforts. Our ambition for patients relies on our ability to innovate & bring differentiated solutions with unique outcomes that help specific patients achieve their goals. The significant need which exists for many patients suffering from rare diseases (RD) highlights the importance of improving our understanding of these and continuing to invest & progress our R&D efforts to deliver solutions for patients, achieve disease modification and ultimately cures. We are committed to working in a way that is sustainable for patients who need our solutions, our communities & society. To fulfil this ambition, the policy & legislative environment is critical to enable the industry in Europe to be an innovation leader and create value for patients now and into the future. The Pediatric and Orphan Regulations have been designed to address pressing unmet needs and have enabled great progress for children and patients suffering from RD: since 2000, more than 170 OMPs have been approved for around 90 RD, almost ¾ of which are very rare (prevalence <2/10000). The fight against RD is complex – for many, scientific knowledge and diagnostic capabilities must be built from scratch, notwithstanding the many clinical development challenges. In partnership with patients, caregivers, researchers and HCP, we are committed to address unmet needs and to work towards developing new solutions for patients. We agree new incentives, with dedicated research funding and accelerated regulatory pathways, can stimulate R&D in areas of unmet need. Alignment and recognition of these by downstream decision-makers (HTA bodies, payers) is also critical to ensure access to new solutions. On the other hand, reducing rewards for fulfilling our PIP obligations or narrowing incentives to ultra-RD or those for which no treatment exists ignore the significant challenges to catalyse the science behind pharmaceutical R&D or that the 1st treatment is rarely the best nor able to address needs from diverse patient populations suffering from complex RD. Such options risk pulling the brake on the significant advances achieved in researching and treating RD without necessarily redirecting R&D into diseases without treatments. Limiting the OD criteria to less prevalent diseases also risks leaving out many RD & patients, especially as a small number of RD affect the majority of patients suffering from RD. Rather these could undermine EU’s attractiveness and excellence for RD research. We welcome the EC ambition to keep pace with scientific/technological developments and to ensure procedures remain efficient. Regulatory authorities should be entrusted with the necessary flexibility to keep up with such developments. Targeted guidance/action plans are appropriate tools to that purpose. We acknowledge challenges facing HC systems: faster and equitable patients’ access to new treatments is a shared goal. However the root causes to these inequalities are multifactorial, cannot be reduced to company decisions and can only be addressed by stakeholders working together. UCB is ready to work with the EC and MS to identify targeted solutions that can ensure access for all patients who need our solutions in a way which is viable for patients, for society and for our company. This dialogue must be based on evidence and requires close collaboration of national healthcare systems e.g. on pan-European evidence generation, meaningful joint clinical assessments and novel pricing-payment models. Challenges will however not be addressed by compromising the regulatory and incentive framework, which are integral to EU’s innovation, industrial & jobs ambitions. We call on the EC to conduct a thorough impact assessment, also considering baseline options and the impact of the 2018 Pediatric Action Plan and the 2016 Orphan Regulation.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

The EU Pharmaceutical Strategy should strive to support Europe’s medical research ecosystem, address our on-going health challenges, enhance the EU’s resilience to global health threats as well as be a key driver for EU’s economic recovery. As a company, our ambition for patients relies on our ability to innovate and bring differentiated solutions with unique outcomes that help specific patients achieve their life goals, and that support the best individual experience. UCB constantly invests to deliver innovative solutions for patients with severe diseases and aspire to achieve disease modification and ultimately, cures for severe diseases. We are committed to working in a way, that is sustainable for the patients who need our solutions, for the communities where we operate and for society. To fulfill this ambition, the policy environment is essential, allowing the industry in Europe to be a world leader in medical innovation and create value for patients now and into the future. We embrace partnerships with other healthcare system stakeholders, the EU and Member States to that purpose. INNOVATION Europe needs a world-class and thriving research & innovation infrastructure to deliver the next generation of treatments. The EU Pharmaceutical Strategy must support this ambition, through a holistic approach, promoting EU industry’s competitiveness and ensuring consistency with EU’s industrial, digital and trade strategies. Developing clinical trial networks, building a European health data space and delivering robust public-private collaboration mechanisms can accelerate the development of health solutions for patients. To place the EU at the forefront of pharmaceutical innovation, the EU must also maintain a world-class IP framework to attract investments into the development of future treatments for the benefit of patients, incl. those with rare and paediatric diseases. A strong incentive system is critical to seizing the potential of scientific and technological advances. Increasing SPC harmonization e.g. through a unitary SPC, can help to increase certainty for innovators and investors. REGULATORY Europe needs a regulatory framework that is stable, fast, effective and globally competitive. We need 1) support for clinical development and regulatory approval times on par with other regions; 2) EU regulators delivering world-class scientific expertise in collaboration with global and regional partners; 3) simplification of the EU regulatory network and connected regulatory oversight of current issues including drug-device/diagnostic combinations, integration of RWE and novel clinical trial designs. 4) The EMA needs further strengthening to deliver on its related 2025 regulatory science strategy. ACCESS We acknowledge the challenges facing healthcare systems and share the concern over inequalities of access to new treatments in Europe. Faster and more equitable access for patients is a shared goal. The root causes of these issues are multi-factorial and can only be addressed by stakeholders working together. We will work with the EU and Member States to ensure access for all the patients in Europe who need our solutions, in a way which is viable for patients, for society and for our company. A High-Level Forum on Better Access to Health Innovation can help identify solutions to broaden and accelerate access to new technologies. This dialogue must be based on evidence of the root causes and drivers of access issues. These will however not be addressed by compromising the regulatory and incentive framework, which are integral to the EU’s innovation and industrial ambitions. ENVIRONMENT Human health is at the core of our business and it is intrinsically linked to the health of our planet. We take action to minimize our environmental footprint across our value chain and support working with stakeholders on how to better address the environmental risks.
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