Recent crises have highlighted the critical need for Europe to secure and strengthen its position as leader in medical innovation. As the European Commission works on the review of the Pharmaceutical Legislation, we need to ensure Europe has the right environment to bring the next generation of treatments to patients. The challenge for the coming decades is not if medical innovation will happen but where it will happen. This article is part of a series explaining that where innovation happens matters for patients, health care systems, the research community, jobs and the economy.
The COVID-19 pandemic revealed the fragile state of health care systems worldwide, and our ability to meet the health care needs of society when we move quickly to achieve a collective outcome. The widespread impact of COVID-19 on all aspects of our health care systems exposed where weaknesses existed that could only stand a small amount of strain. We saw health care systems become overwhelmed, indicating the need for newer and faster scientific and medical innovations to meet the emergent crisis. Despite the external strains on the health care system, the biopharmaceutical industry rose to the challenge.
As of this month, more than 4,500 interventional clinical trials related to COVID-19 are registered on clinicaltrials.gov. The first vaccine against COVID-19 was approved for use in Europe by the end of 2020 — a record for our industry and regulatory systems. This rapid development and scale-up of medicines and vaccines could act as a model for how we can move faster to solve some of the toughest diseases we continue to battle, such as heart disease and cancer. The regulatory and reimbursement framework in Europe was critical in enabling the speed of bringing about effective, innovative options for COVID-19. That same framework is critical to foster and accelerate innovation, and to ensure that each of the EU member countries has the most resilient health system possible.
From an Amgen perspective, our research and development organization aims to discover, develop and deliver transformative medicines that address important treatment gaps in oncology, cardio-metabolic and inflammatory diseases. To achieve this vision, we need to harness opportunities arising from rapid scientific progress and new technologies. Innovation is at the core of our business and is key to how we identify novel therapeutic targets, new innovative and better medicines that keep patients out of the hospital, and ultimately improve health outcomes of the communities in which we live and work by preventing morbidity and mortality.
For instance, we have taken on some of the toughest challenges in cancer research by actively working to be a leader in identifying biomarkers, such as the KRAS gene. A key regulator of signaling pathways responsible for cell proliferation, differentiation, and survival of patients with lung cancer, the KRAS G12C mutation was one of cancer researchers’ toughest challenges of the past 40 years, with many considering the mutation undruggable and leaving patients with limited options. Taking on the KRAS challenge was a race against cancer to deliver a breakthrough discovery quickly as researchers found one of the missing puzzle pieces for people living with non-small cell lung cancer. This research investment in understanding the genetic basis of disease, how gene variations are expressed biologically as disease, and identifying biomarkers and generating targeted therapeutics for these variations, allows us to develop new, precise and personalized medicines that optimize patient outcomes.
For these innovative therapies to reach more patients as quickly as possible, we must have a regulatory environment fit for purpose. We see the EU reforms related to revisions of the Orphan, Paediatric and General Pharmaceutical Legislation as a once-in-a-generation opportunity to update the regulations to support the development of cutting-edge medicines and modernize the regulatory processes to be prepared for transformative new technologies. It is also an opportunity to reaffirm Europe as one of the leading regions for investment in cutting-edge health technologies.
Adoption of innovation will lead to healthier communities that are more resilient
Many people severely impacted by COVID-19 had a range of underlying chronic health conditions, including respiratory issues, cardiovascular disease, obesity, hypertension and diabetes, and were often also of advanced age. While medical services related to the management of these conditions have been deprioritized during COVID-19 (such as reduced screening or doctor’s visits), to prevent a future increase in prevalence rates or seriousness of these conditions, we need to ensure that health care systems quickly return to pre-COVID-19 levels. Technologies like telehealth have received an incredible boost during COVID-19 and taking lessons from this global health challenge can lead us to new and more accessible ways to enable communities to be healthier and more resilient before another crisis occurs.
The spirit of innovation is how responsive we can be to solve the world’s health challenges, and for our industry, the speed at which we can develop new medicines that rapidly and appropriately meet our communities’ health needs is essential, as it is our key contribution to health care systems and outcomes. Reward for innovation is the key to progress. A regulatory and reimbursement ecosystem that broadly rewards, and protects, innovation has a direct impact to incentivize research, development and investment in new medicines and medical technologies, including medicines for rare conditions, and in turn allows Europeans to access those medicines and technologies for better health outcomes.
Innovation is powering economic growth across the Continent
As an industry, our clinical trial footprint and ability to develop, manufacture and supply medicines in Europe contributes a positive impact for society. In the most recent estimates, the pharmaceutical industry was assessed to have contributed €206 billion in gross value add to the EU economy through direct and indirect impacts. This contribution accounts for 1.4 percent of the region’s GDP. Based on the most recent estimates, nearly 2.5 million jobs were supported by our industry, many of which are both highly skilled and highly productive.
To keep up the momentum across Europe and around the globe, medical innovation must be able to not just survive, but thrive. As such, continued support for a reliable innovation ecosystem is necessary to advance solutions for current and future residents of the European Union. As we look to the future, it is important that research and development is allowed to flourish through policies that encourage the work and investment needed to create healthier, more resilient communities. Our industry is committed to solving society’s biggest health challenges as quickly as we can, and a rewarding innovation environment is critical to enable this success.