IN PARTNERSHIP


there is a public hospital network that is “acutely aware of the need to conduct clinical research” and, on the other, there are many Spanish investigators “who are highly renowned worldwide”, meaning Spain is selected for conducting a large number of trials. This is demonstrated based on data from the BEST project promoted by the Innovative Medicines platform and Farmaindustria: of the €1.267m allocated to R&D in 2021 in Spain, 62% (€789m) were spent on clinical trials alone, and a further €156m on basic research. Hospitals have, in most cases, been able to


prepare for this demand, and infrastructures have been put into place to accommodate this research, which has advanced Spain compared to the other neighbouring countries in adapting the clinical trial regulations issued by the European Commission to local regulations. The Spanish Agency of Medicines and Medical Devices (AEMPS) has led this process in Europe, which has allowed the authorisation process of a clinical trial to be accelerated, a very important value because time is money in the world of clinical research. It is estimated the time between collecting


all the information and reaching the first patient is between 90 and 100 days, a “very interesting” time frame to receive all the relevant approvals and to start one of these research processes. It also means patients participating in these trials have access to the latest news and therapies. These are the reasons Spain is a “leader in terms of speed and recruitment”, and Europe will be too, particularly in highly dynamic areas in clinical research and where investigators and scientific publications generated in Spain and Europe stand out, such as with oncohaematology. In fact, sponsors from the United States


come to Spain and Europe to develop all their molecules, particularly because of the time and cost involved in performing the research here compared with what is involved there. They are swamped, recruitment isn’t good, and the commitment is sally flfilled by the sites. If that’s the good part, the bad part would lie in the abundance of health systems. Each country, even each region in some cases, deploys a specific model for collecting information, which means there are too many different models. It is necessary to establish


16 | Outsourcing In Clinical Trials


common databases with well-collected and structured information that provide a more complete understanding of the situation of the diseases in Europe. We must be clear that health is increasingly everyone’s business and does not depend on each individual country or the political parties that govern them.


Sad “inequality” in access It’s no secret that it takes an eternity for a drug to reach some European patients once approved by the European Medicines Agency (EMA). In its July 2022 report on access to medicines from armaindstria set this figre for spain at 517 days, although only a few months ago the delay was over 600 days. This is outrageous. It cannot be understood how it can take up to two years until a drug authorised by the EMA is available for some European patients, in this case Spanish patients. Behind this problem are competing interests:


the economic interest that some health authorities put before the health of the patients or the criteria of the health professional, given that approval is authorised at the European level and the problem lies with the reimbursement price. In addition to this is the inequality in becoming ill or having a disease and the area where one resides. It may well be that you do not have access to a drug because you live in a certain country or region whereas a few kilometres away you would have it. The general opinion of involved parties is


that, once European approval is secured, it should just be a quick formality to obtain the reimbursement price. In Germany, for example, a medicine already approved by the EMA is “immediately” available to any German patient. “Time is money in the world of research”. It’s a pity that, as one of the best places for conducting clinical research, market access for new drugs isn’t available to all patients. This availability depends on the different countries or regions. The objective at the European level should be, as in the case of clinical research, to obtain common legislation and procedures that allow access to the most innovative, effective drugs on an equal basis in all European countries. Let us hope all parties agree this will be the case and that all the innovations brought about by clinical research can be transferred to all European patients without delay.


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