"The numbers show that some CCAAs are far above others. Solutions? That there be common health policies in Spain"

Although Spain is one of the world leaders in clinical trials, patients are recruited “for other people's studies” and there is a lack of intellectual leadership in research, according to Eva Ciruelos, an oncologist at Hospital 12 de Octubre and vice president of the SOLTI Breast Cancer Research Group.. “When the clinical trials are closed we return to a desperate situation of a delay much greater than double or even triple what is allowed in the European Union.”

One of the people who knows the most about breast cancer in Spain, Ciruelos emphasizes the differences in oncology, not only with other European countries, but also between autonomous communities. Something that must be solved if one takes into account that two out of three patients will have cancer in the next decade and that this disease will be “the most frequent in both sexes and the first cause of death above cardiovascular diseases in the next two or three years.”

How can the crisis in the healthcare system affect research groups like SOLTI? It is very difficult to do research in groups like SOLTI: academics, cooperatives, non-profit organizations with an unpaid governing body and that carry out academic research and translational. All funding is obtained solely and exclusively from the resources that come from ongoing studies, that is, some studies finance other studies. Of course, it also depends on how lucky we are to get public funding scholarships or donations from private foundations or from the pharmaceutical industry itself.. These sources of funding can be very good one year and very bad the next: there is no government funding structure to sustain these groups or a minimum amount of money offered to them so that they can survive even in times of greatest weakness.

This is an ailment that all the groups in Spain have and it does not depend on whether there is a period of crisis or not and if we compare ourselves with Europe, we see that it is one of the few countries where the groups do not receive any type of support in any of the CCAA. The paradox is that sometimes at SOLTI we try to solve problems through clinical research that really require care.. To give an example, now in the midst of a crisis in the healthcare system where we realize that we cannot continue with absolutely free universal healthcare within the complexity of, for example, cancer treatment: practically all patients or the majority of They, especially if they have a metastatic disease profile, need diagnostic platforms for molecular study or tumor sequencing that are not financed by Social Security at all. Does the crisis in the health system impact clinical trials in any way? Logically yes, and here there is a paradox. Spain is a great recruiter country and a great participant in clinical research, especially that which comes from other countries and is financed by other groups or by the pharmaceutical industry.. We are usually in the top five at the recruitment level and not only in the number of patients involved in clinical trials, but also in the quality of clinical information provided to those studies and we are constantly congratulated. This means that many of our patients obtain the benefit of being treated or diagnosed with an innovative system of treatment or diagnosis and, in addition, the professional class enjoys learning about this innovation that comes from clinical trials.

The paradox is that when the clinical trial is closed because its recruitment ends, we go back many steps again and we do not manage to make this innovation that we have experienced in that study become a reality of access for all patients, even years after it was completed. the study has finished. It is bread for today and hunger for tomorrow, it is a temporary solution that we enjoy, but be careful because when the clinical trials are closed we return to a desperate situation of a delay much greater than double or even triple what is allowed in the European Union, which are 180 days late. Sometimes this delay reaches 450 or 500 days for the financing evaluations of innovative drugs. It has always been said that Spain is one of the world leaders in clinical trials. Is this maintained or has it changed in some way? Where is Spain in terms of cancer research compared to Europe? Spain occupies the top positions worldwide, many times even above the US because we have a deep understanding of the idea that clinical studies are the best we can offer to a patient, because patients understand it and, furthermore, because patients are more and more protagonists of their disease and are looking for centers where there is a clinical trial for them. Also because the structure of the hospitals allows it; In most centers there are already foundations that receive the necessary money to open a study (even with very unfair differences in central support between different Autonomous Communities), treat patients, there are insurance policies, there are health policies, etc.. Both publicly and privately this works very well and allows us to do quality clinical research.

It is also true that despite the fact that the research is very good, we normally recruit patients for the studies of others, that is, that the intellectual leadership in research in Spain still suffers from working on their own ideas, which recognize the clinical and scientific talent of our professionals. We have to stop “working for others”. Despite this large number of clinical trials, then patients do not always have access to certain drugs, they are not financed or it is done with restrictions. For example, Spain takes 469 days to finance the most innovative cancer drugs approved by Europe compared to 100 in Germany.. Why does this happen? How can we be more efficient on this issue? After the approval of the European agency (EMA), Spain requires that this innovation be approved by the Spanish Medicines Agency (Aemps) as well.. This is probably going to change and this approval is not going to be so necessary since the European one is going to be binding so as not to repeat a step that, although it normally does not take more than three or four weeks and the concordance is 100%, it is still a redundancy that we can avoid.

European regulations require that this time should not exceed 180 days and in Spain we are around 470 days, that is, we almost triple the maximum allowed. But it is not just time, but the large number of steps that are needed, the bureaucracy and the lack of transparency in the process from the approval of Europe until we can finally prescribe (or not prescribe) the drug. Who are the people involved? Why aren't these processes that have to be short, transparent and professionalized more professionalized?

There is also a key part in the process that is negotiating the price with the pharmaceutical company that owns the product, because logically our Ministry has to ensure that this universal health system. From the clinical side, the delay that doctors and patients wait for in an unpleasantly long situation is very unpleasant to find out if we are going to be able to use a drug or not.

There is another added problem: although the resolution is positive, some CCAAs may add additional restrictions to the approval by regulatory agencies, and this is something serious and serious.. It is the patients themselves who denounce that some drugs can be obtained in some autonomies and not in others or that, at least, the indications are not identical. What is the pending issue in oncology, if there is one, in Spain? First , encourage academic research by independent and cooperative groups. Secondly, to improve the processes by making them more transparent and professional and not only in terms of drug approval and reimbursement, but also in terms of prevention and education, starting from primary healthcare, truly listening to our professionals and breaking down regional barriers that do not have make no sense and that all they do is generate more disagreement and aggravate those regional differences that exist.

Thirdly, I believe that we have a serious problem with the medical class currently in Spain, I believe that it is a poorly recognized professional segment and increasingly demotivated due to its often precarious working conditions and with an absolute lack of growth or professional career and specialization.. This means that there is no return of young professionals who are authentic promises, making it really unfair to the country because we bet and spend a lot of money to train great professionals who later if they stay here they will be completely unmotivated and if they do not stay here they will not return. It is a problem not only for the medical class, but for society because without health and without health research there is nothing. Living in Madrid or Barcelona is not the same as living in Lugo or Albacete when it comes to having cancer and being able to access certain treatments and resources. What can be done to end or reduce the inequities between Autonomous Communities in this matter? I think that the problem of access to drugs or additional restrictions also depends on how primary care and specialized care are structured. Screening campaigns work differently in provinces with rural populations that have less access to primary medicine, which is where early diagnosis of many things begins, including breast cancer.. It is not the same to arrive at a hospital where there are multidisciplinary units that offer the patient an interdisciplinary and integrated approach to what to do with their tumor. If a center does not have all the services, the referral systems to a tertiary center where you can receive care under the same conditions as if you lived in a big city must work perfectly.

By this I mean that the necessary improvements in Health are not only a matter of time, of restrictions added to reimbursement processes and drug approval, but that this is born from education and prevention, from schools and through primary care and this is not politics: the numbers show that some CCAAs are well above others. Solutions? That there be common health policies in Spain. Education and Health are two indisputable issues that concern us and that any citizen would put above all else when deciding what is really important and we cannot play with this anymore. One of the Achilles heels in cancer care in Spain it is after treatment: the need of these patients for nutritionists, physiotherapists, but especially psycho-oncologists, psychological support. Is it necessary to create a portfolio of health services that include these types of issues? Without a doubt, of course yes. There is no time, no place, and no professionals in hospitals to cover this comprehensive care of the patient with long-responding cancer, the chronic cancer patient, or the patient who has been cured, and there are no professionals, money, time, or vision in between. and long-term support -which can even come from primary care-. There should be specific health consultations for comprehensive care of cancer survivors, focusing above all on physical exercise and nutrition care, cardiovascular care, gynecological care, sexuality and fertility, especially in women who are cancer survivors, educational care and logically any psychological, social, labor, etc.. that these patients need. It must be borne in mind that from the next decade, approximately 50% of European citizens will suffer from cancer, we will most likely survive it, and we will need specific care and caregivers in these areas of care for society as a whole to function. .Positive results in the fight against cancer have increased survival, but some of these long survivors have treatment sequelae and require continued health care. In what way is chronicity in cancer a challenge for a healthcare system that has already been hit hard? How should this issue be addressed? In these specialized units I think a lot of resources could be saved. Sometimes it is scary when one proposes to set up a unit, but setting up a unit does not mean increasing expenses, but rather the opposite, reducing them and making the system more efficient.. It is necessary to create units for cancer survivors in health centers or, perhaps, in paid weekend shifts in hospitals that optimize the available resources if necessary. Because in addition to the growing incidence of cancer in our era, the Spanish Association Against Cancer claims that at least 70% of cases are curable, with the consequent expected prevalence of long-term survivors in our society. Two weeks ago the ECO Foundation held a day in the European Parliament where politicians and oncologists asked the Government to take advantage of the Spanish Presidency of the European Union to promote the European Plan against Cancer. What aspects should this plan include or what is most urgent to contemplate? Why should the Spanish Presidency focus on cancer and not on other pathologies for which there is perhaps less social awareness, such as mental health? Regarding the other pathologies of course: mental health, rare diseases, pediatrics…. There are so many things to take care of.. but from my point of view as an oncologist I believe that the Spanish presidency should, at least, unify processes to simplify them and make them more uniform within the countries of the Union. We should no longer only break the regional barriers that we mentioned before, but also the barriers between countries of the European Union when health is something so important, as has been revealed in the pandemic.

Of course, unifying approval processes, improving or promoting translational clinical research between different member countries of the Union, trying to maintain minimum standards that all countries should meet, above all education, primary and secondary prevention and, of course, access to drugs where there should not be these huge differences when we compare Spain with Germany or with neighboring countries. Even analyzing these results in health and doing an analysis no longer by Community but globally; survival medians in the European Community and see which countries suffer greater deficits and reinforce them punctually in the way that is required.

And addressing health as a global issue: let's not forget that cancer is going to be the most frequent disease in both sexes and the leading cause of death above cardiovascular disease from the next two or three years; We are already almost in parallel and of course it is where there is more innovation and more research: cancer is number one in clinical trials in Salud ya and, therefore, I think we must take advantage of all this to look at the long term and in the most unified possible.