Working in our industry brings huge responsibility. We deal with people’s lives, and our medicines give people an opportunity to improve their health, often at the most overwhelming time for them. I had a strong reminder of that recently.
Last month, I met with a colleague, Heiko, who lives in Germany. His young daughter has central nervous system (CNS) neuroblastoma — a type of cancer that tends to affect children under the age of five.
Heiko and his family have been navigating the health system for months, including an overload of information in the form of complex ‘oncological-speak’, treatment guidelines and health insurance claims. They have also been dealing with constant travel to specialist centers — all while juggling the emotional burden of caring for a sick child and the daily challenges of home and work life.
He shared something that stuck in my mind the night I spoke with him, which serves as an important reminder for all of us working in health care.
“Trust must be bigger than fear.”
When their health is at stake, friends, families and colleagues put their trust in their local health care system — every part of it, including industry — in the hope of protecting the future for them and their loved ones.
As Heiko put it to me, “Speed is everything. If you gain enough speed, you gain enough time. And if you have time, you have the hope of more options that can help you.”
Faster, more equitable access to new, life-saving medicines for people living in Europe is a goal that I believe we all share. There are challenges in achieving this, but we at Roche are committed to addressing these, together with everyone involved.
It is the inequality in access to medicines that is untenable.
The average time that patients in the EU wait to get access to a new medicine is around 517 days. Uptake of new technologies can be low and slow, but it is the inequality in access to medicines that is untenable. If you have cancer in Germany, you may need to wait, on average, 128 days to access a new medicine, but if you are a patient in Romania it will take you 918 days to receive the same treatment.
I am concerned that Europe’s policymakers believe this can be fixed with legislation alone. And, even if it could, families like Heiko’s do not have the luxury of waiting four to five years for the ongoing revision to the EU pharmaceutical legislation to attempt to resolve these issues.
Improving access to medicines requires solutions that are developed in partnership with everyone who has a stake in their delivery: industry, member states, health regulators, payers, patients and health care providers. With the right ambition and desire for collaboration, we can act now.
The crucial first step is for governments and policymakers to treat spending on health care and innovation as an investment in economic growth and societal advancement. Improving health care and expanding access to innovation are vital for reducing pressure on health care systems, maintaining a healthy and productive society, and driving future economic growth.
Governments and policymakers have a pivotal role in enabling and encouraging this cycle of improved health and economic benefit. We must take a strategic view of investing in innovation, acknowledging the wider societal value it provides, and find sustainable ways to manage immediate fiscal challenges that do not limit or delay access to new medicines and technologies.
The industry is also driving changes. One concrete commitment pharmaceutical companies have made is to file new medicines for pricing and reimbursement in all member states within two years of EU approval of a new medicine. This will improve timely access to the latest innovations.
The industry has also established a portal for tracking access delays and ensuring companies are held accountable in meeting the two-year filing commitment.
With the right ambition and desire for collaboration, we can act now.
With multiple ongoing legislative changes currently taking place in Europe — from the revision of the EU’s Pharmaceutical Legislation, to the EU’s reform of Health Technology Assessment (HTA) and the introduction of the European Health Data Space (EHDS) — we have a unique opportunity to build a stronger and better European environment for life sciences and health care that serves patients’ best interests. One major opportunity for collaboration is the implementation of the EU’s HTA regulation. This aims to address access delays by streamlining and accelerating highly fragmented HTA processes across Europe. There is only one year to go before this either becomes a meaningful contributor to faster access decisions for patients or — if not adequately in focus during 2024 — risks becoming an additional hurdle for patient access to essential treatments. In order to avoid this scenario, industry involvement in the implementation of EU HTA is crucial to leverage expertise, co-design relevant processes, and ultimately ensure a workable system.
Such actions can reduce some of the delays in accessing new medicines, but they will not solve everything. The majority of delays come from the variation and delays in individual countries’ reimbursement and health care systems. That is why it is critical that member states, payers and health systems collaborate with industry to develop tailored access solutions.
However, there are also proposals on the table today that are concerning and at face value will not lead to improved access for patients. For instance, the EU Commission is proposing to reduce a company’s intellectual property rights — specifically regulatory data protection (RDP) — if a medicine is not available in all member states within two years of receiving marketing authorisation. This would only hinder innovation, without delivering faster, more equitable access to new medicines.
If this were to go ahead as proposed, Europe would become a less attractive place for research. A recently-published study on the impact of the European Commission’s proposal estimated that it would reduce Europe’s share of global R&D investment by one-third by 2040.
I firmly believe this proposal must be reconsidered and focused on policy solutions that ensure patients in Europe continue to benefit from innovation.
As Heiko says, speed, time and hope are all people have. Often, patients are waiting for the next innovation, during which time, their disease progresses or their condition deteriorates. This makes the next clinical trial, the next regulatory approval, the next standard of care, the next reimbursement decision absolutely vital for those who simply cannot wait.
Across industry, there are more than 8,000 new medicines in the global pipeline today. This is the hope Heiko needs, and families like his are trusting us all to deliver.
Speaking with Heiko reminded me that the most effective treatment is the one that makes it to the patient when they need it. It is now our collective responsibility to find the path to making this happen for patients everywhere in Europe.
