With the science moving forward in addressing the burden of cancer, access to potentially life-saving treatments needs to be improved through pharmaceutical regulation in Europe and Spain in particular, writes Candela Calle.
Candela Calle is the Director of the Advisory Council for OncoLAB.
The fight against cancer is one of the most challenging battles of our era. As we advance our understanding of the different pathologies, there is a constant stream of advances in cancer research and treatment development. However, one of the biggest hurdles facing patients is access to these innovations.
In the context of the upcoming pharmaceutical regulation in Europe, currently in the pipeline, it is crucial to reflect on the importance and significance of improved access to new diagnostic techniques and new cancer treatments for the lives of thousands of patients.
Facilitating access to innovative oncology treatments and techniques would not only improve patients’ survival and quality of life but also prolong their life expectancy. Revealing data show that the 1.74-year increase in life expectancy in the first decade of this century in developed countries is 73% directly attributable to the positive effect of new drugs on the health of the population.
In recent months, the need for improvements in the process of evaluating and financing new drugs has become apparent. Improvements that contribute to a more agile, faster access, in a transparent, predictable and, above all, more participatory approach. When a promising new treatment emerges on the horizon, patients cannot afford to wait years to access it because of bureaucratic red tape.
Pharmaceutical regulation must simplify and speed up approval processes to ensure that patients have timely access to potentially life-saving treatments. Cancer does not wait, so the time to lay the groundwork for progress is now.
Moreover, access cannot depend on a patient’s geographic location or financial capacity. European pharmaceutical regulation must ensure equal access for all EU citizens, regardless of their country of residence. This could be achieved through collaborative policies between countries.
Another area of concern relates to the current system of incentives for innovation, as it does not encourage the creation of a competitive environment for industry to increase and extend to all countries of the European Union flexible and equitable access to therapeutic innovation.
To solve the problems of access to innovation, the work must start in the member states themselves, by putting in place effective measures at the national level that are aligned with the European target of reducing access times by an average of approximately 400 to 180 days, listening more to patients, and supporting and evaluating medicines early.
In this process, one aspect is of great importance, the definition of the concept of ‘pharmaceutical innovation’, the basis on which to establish clear criteria to facilitate access for patients.
Pharmaceutical innovation refers not only to the creation of new drugs, but also to the significant improvement in existing treatments, the development of new diagnostic techniques and, in general, the creation of novel therapeutic approaches. These advances can make a difference in patients’ lives and should be recognised as such in regulation.
And in Spain?
The state of patient access to innovative treatments in Spain has worsened in recent years, as shown by the WAIT1 study – published in 2023 – which reports that Spanish patients had to wait an average of 611 days in the period analysed – between 2018 and 2021 – to access innovative therapies already pre-approved by the EMA (European Medicines Agency).
In Germany and Denmark, this period is reduced to 102 and 145 days respectively. Taking these countries as a reference, as well as France, which, although facing the same problem as Spain, has set up early access programmes, the lack of agility and alternatives to the process of access to oncological innovation in Spain is evident.
In the context of the forthcoming European pharmaceutical regulation, it is essential that Spain’s national health system (NHS) advances accordingly and adopts measures that guarantee efficient access to pharmaceutical innovation in oncology. The Spanish NHS has made significant progress in oncology care but still faces significant challenges in terms of access to pharmaceutical innovation.
One of the most notable structural problems is the procedure for evaluating and financing innovative cancer drugs, a process that is often lengthy and bureaucratic. To guarantee equity and cohesion in cancer care throughout Spain, it is necessary to update the portfolio of services and adapt funding resources.
Improving access to pharmaceutical innovation in oncology is not only a matter of justice for patients but also a strategic step towards the sustainability of the Spanish healthcare system. For every euro spent on financing innovation, between 6 and 7 euros are saved on other healthcare services, from emergency visits to surgery. This focus on investing in innovation as an element of the economic sustainability of the NHS is essential to ensure the long-term viability of the health system.
The forthcoming European pharmaceutical regulation provides an opportunity to address these challenges, but Spain must take domestic action to align its policies on access to innovative treatments. In doing so, we will not only provide hope and a better quality of life for cancer patients but also ensure a stronger and more efficient healthcare system for future generations.
The fight against cancer requires multidisciplinary collaboration and a comprehensive vision that addresses the challenges in access to pharmaceutical innovation.
To this end, the OncoLAB Advisory Board, composed of representatives from scientific societies, foundations and professionals in the oncology field and promoted by AstraZeneca, has recently developed and presented the consensus document “Now, solutions: bringing innovation closer to the patient” to contribute to the definition of the meaning of ‘pharmaceutical innovation’ and to the establishment of criteria that facilitate patient access to the most advanced treatments.
As a society, we must commit to unleashing hope and giving patients the best possible tools to beat this serious disease. Pharmaceutical regulation has a key role to play in this mission.