Recent crises have highlighted the crucial need for Europe to secure and strengthen its position as a leader in medical innovation. As the European Commission works on revising pharmaceutical legislation, we need to ensure that Europe has the right environment to bring the next generation of treatments to patients. The challenge for the coming decades is not whether medical innovation will happen, but where it will happen. This article is part of a series explaining that where innovation happens matters to patients, healthcare systems, the research community, jobs and the economy.
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The COVID-19 pandemic has exposed the fragility of health systems around the world and our ability to meet society’s health needs when we act quickly to achieve a collective result. The widespread impact of COVID-19 on all aspects of our healthcare systems revealed where weaknesses existed that could only withstand a small amount of pressure. We have seen health systems become overwhelmed, indicating the need for newer and faster scientific and medical innovations to deal with the emerging crisis. Despite external pressures on the healthcare system, the biopharmaceutical industry has risen to the challenge.
The regulatory and reimbursement framework in Europe has been key in accelerating the establishment of effective and innovative options for COVID-19. This same framework is essential to foster and accelerate innovation and to ensure that each of the EU member countries has the most resilient health system possible.
As of this month, more than 4,500 interventional clinical trials related to COVID-19 are registered on clinicaltrials.gov. The first COVID-19 vaccine was approved for use in Europe at the end of 2020 – a record for our industry and our regulatory systems. This rapid development and scaling up of drugs and vaccines could serve 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 has been key in accelerating the establishment of effective and innovative options for COVID-19. This same framework is essential to foster and accelerate innovation and to ensure that each of the EU member countries has the most resilient health system possible.
From Amgen’s perspective, our research and development organization aims to discover, develop and deliver transformative medicines that fill important treatment gaps in oncology, cardiometabolic and inflammatory diseases. To realize this vision, we must exploit the opportunities arising from rapid scientific progress and new technologies. Innovation is at the core of our business and is key to identifying new therapeutic targets, new, innovative and better medicines that keep patients out of hospital and ultimately improve health outcomes for communities in which we live and work by preventing morbidity and mortality.
For example, we have overcome 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 in lung cancer patients, KRAS G12C The mutation has been one of cancer researchers’ toughest challenges over the past 40 years, with many viewing the mutation as untreatable and leaving patients with limited options. Taking on the KRAS Challenge was a race against cancer to quickly deliver a breakthrough discovery as researchers found one of the missing pieces of the puzzle for people with non-small cell lung cancer. This investment in research to understand the genetic basis of disease, how genetic variations are expressed biologically as disease, and to identify biomarkers and generate targeted therapies 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 need the right regulatory environment. We see EU reforms linked to revisions to orphan, pediatric and general pharmaceutical legislation as a unique opportunity to update regulations to support the development of cutting-edge medicines and modernize regulatory processes to prepare for a new technology transformation. It is also an opportunity to reaffirm Europe as one of the leading regions for investment in cutting-edge health technologies.
The spirit of innovation is how we can be responsive to solving global health challenges.
Embracing innovation will lead to healthier and more resilient communities
Many people severely affected by COVID-19 suffered from a range of underlying chronic health conditions, including respiratory problems, 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 visits), to avoid a future increase in prevalence rates or severity of these conditions , we need to ensure that health systems return to pre-COVID-19 levels. Technologies like telehealth have received incredible momentum during COVID-19 and learning from this global health challenge can lead us to new, more accessible ways to enable communities to be healthier and more resilient before a another crisis does not occur.
The spirit of innovation is how responsive we can be to solving global health challenges, and for our industry, how quickly we can develop new medicines that respond quickly and appropriately to the health needs of our communities is essential, as it is our main contribution to health care systems and outcomes. Rewarding innovation is the key to progress. A regulatory and reimbursement ecosystem that broadly rewards and protects innovation has a direct impact on incentivizing research, development and investment in new drugs and medical technologies, including drugs for rare diseases, and enables in turn to Europeans to access these medicines and technologies for better health outcomes.
A regulatory and reimbursement ecosystem that broadly rewards and protects innovation has a direct impact on incentivizing research, development and investment in new drugs and medical technologies, including drugs for rare diseases, and enables in turn to Europeans to access these medicines and technologies for better health outcomes.
Innovation fuels economic growth across the continent
As an industry, our clinical trial footprint and ability to develop, manufacture and supply medicines in Europe has a positive impact on society. According to the most recent estimates, the pharmaceutical industry was assessed as having contributed €206 billion in gross value added to the EU economy through direct and indirect impacts. This contribution represents 1.4% of the region’s GDP. According to 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 maintain momentum in Europe and globally, medical innovation must not only survive, but thrive. As such, continued support for a trusted innovation ecosystem is needed 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 can thrive through policies that encourage the work and investments needed to create healthier and more resilient communities. Our industry is committed to solving society’s greatest health challenges as quickly as possible, and a rewarding innovation environment is essential to enable that success.
